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Bringing people and knowledge together for a healthier world
AstraZeneca & Day Holding
2
AstraZeneca & Day Holding Meeting
Agenda
Brief Introduction of
Iran Pharma Market
Day Holding Structure
3
Regulatory Pathway
comprehensive expertise can help you
confidently interact with regulatory affairs
authorities for different therapeutic area and
package and present all the information
necessary to allow regulatory authorities to
make the right decision .
Transactions
 Hulk Bank Turkey
 Day International(UAE)
Distribution System
Hejrat company is the First largest network
of distribution system and second largest
Iranian pharmaceutical distributor in terms
of market share.
Draft timeline key dates
Registration of IDL and IRC
& drug importation,
importation, shipment, etc.
4
A Great Partnership Demonstration
Next step
Pharmalyze ®
Partners
Omid Darou salamat sales Trend
Pharmalyze® is breakthrough
technology. It provides access to
key Data in market and a
comprehensive picture of selling
progress to support proactive S&M
team decision making.
Day Holding
Western Europe
Size: € 128-150 bn
CAGR (2013-17): -2% to 4%
Middle East
Size: € 12-19 bn
CAGR (2013-17): 12% to 14%
Africa
Size: € 19-26 bn
CAGR (2013-17): 7% to 10%
Central & Eastern Europe
Size: € 48-56 bn
CAGR (2013-17): 4% to 7%
Asia Pacific
Size: € 202-216 bn
CAGR (2013-17): 12% to 15%
North America
Size: € 276-298 bn
CAGR (2013-17): 1% to 4%
Latin America
Size: € 71-78 bn
CAGR (2013-17): 10% to 13%
Low Growth
(< 4%)
Note: WesternEurope includes EU5 and rest of Western Europe; Size: 2013-2017, CAGR is between 2013-2017
High-Mid Growth
(7% to 13%)
High Growth
(12% to 15%)
Low-Mid Growth
(4% to 7%)
Source: IMS Market Prognosis, Apr 2013
Middle-East Demographic
Middle East is one of the fastest growing pharma markets
47%
23%(0-14)
19%(15-24)
45%(25-54)
2%(60-64)
5%(>60)
Iran Demographic
Opportunity scanning
89
Local Producer
93
Importer
30
API Producer
53(80%-10)
Local
Distributor
53%.
79 Million
GDP : 368.9 b USD
GDP PC : 4763 USD
Health Exp. : 6%
Pharma CAGR: 24%
- 20,000,000
0-14
15-24
25-54
55-64
60-64
65
- 20,000,000
0-14
15-24
25-54
55-64
60-64
65
MALE
22%(0-14)
20%(15-24)
44%(25-54)
3%(60-64)
5%(>60)
6 million
>60 YRS
18 million
Obesity
168
124
18 million
HTN
45000
Dies from cancer
 Daru-Pakhsh
 Hejrat
 Razi
 Ferdows
Iran pharmaceutical
Iran is an example of a country that has made considerable advances through Health
Health Ranking
Top 20
Physician
60 K.
Imported
1.2 B Euro
⅓
Local Production
2.04 B Euro
⅔
Total Pharma
3.2 Billion Euro in 2014
Top MNC in Iran pharma
Sanofi
Roche Novo Nordisk
Biotest
Merck Krka
Bayer Schering
Merck Serono
Merck KGaA
Pfizer
Abbott
Novartis
AstraZeneca
Ipsen
Csl Behring
-2%
0%
2%
4%
6%
8%
10%
12%
14%
16%
-25% -15% -5% 5% 15% 25% 35% 45%
CAGR 5Ys
MS
Import Market CAGR
Iran Pharma Franchises
ANTIINFECTIVES
ANTINEOPLASTIC &
IMMUNOMODULATING
ANTIPARASITIC
BLOOD
CARDIOVASCULAR
DERMATOLOGICALS
GENITO URINARYMUSCULO-SKELETAL
SYSTEMIC HORMONAL
GI
ANTI DIABETES
VITAMINS & MINERAL COUGH & COLD
ANTIHISTAMINS
RESPIRATORY
CNS
ANALEGESICS
OPHTHALMIC
CONTRAST MEDIA & DIAGONSTIC
-5%
0%
5%
10%
15%
20%
25%
-5% 5% 15% 25% 35% 45%
CAGR: 2011-2014
MarketShare:2014
Market
CAGR
Bright Roadmap among Hurdles
Iran pharmaceutical Market
It would be unusual for investors to take such risk without the prospect of considerable reward
Regulatory
The Door !
Data
360◦ view of Market
Data
Financial and
Transaction Power
To being able to support
business model
Commercialization
Knowledge
Taking care of brand
Risk
Management
In-house capability to
have flexible
symphonic of Iranian
market rhythms
Day Holding
OrganizationStructure
12
Articulate your vision
Day Holding Structure
Day Vision
“We strive to be the partner of choice for
multinational healthcare and pharmaceutical
companies expanding into Iran. We aim to
consistently differentiate ourselves by serving
all of our stakeholders through value based
medicine.”
Day Mission
To provide healthcare organizations with
innovative therapeutic solutions in different
therapeutic area, market access strategies and
sustainable commercial solutions , while
improving patient care and quality of life in Iran.
13
Business Process Management
Introducing Business process management
structure in Omiddarou salamat.
& Core values
Our Team
Introducing Different Departments
with their team.
Our Service
Day Holding full commercial services
according product life cycle.
Solutions
Unique Solutions based on systematic
thinking in dynamic environment.
14
Collaboration Models
Day different Business Models.
Regulatory Pathway
comprehensive expertise can help you
confidently interact with regulatory
affairs authorities for different
therapeutic area and package and
present all the information necessary
to allow regulatory authorities to make
the right decision .Partnership Process
Partnerships are a key strategic objective
for Day Holding. This objective is achieved
by obtaining increased value from our
existing partnerships and by actively
seeking and evaluating new opportunities
at all times.
Draft timeline with key dates
Registration of IDL and IRC & drug
importation approval, label/pack
adjustment, importation, shipment,
etc.
15
A Great Partnership Demonstration
Success
Innovative Sales & Marketing
business discussions ,sharing of mutual
expectations .
Partners
Omid Darou salamat sales Trend
Founder : Mr. Amirsaeed Malekshahi DAY HOLDING
Senior Leadership : Amirsaeed Malekshahi , chairman of the board, president and chief executive officerHeadquarter : Shahrak Gharb ,Tehran
2010
Day Darou
Omid 20%
2012
Arta Darou
Pars
2008
Opportunity Scanner and
Strategic Development
,
Transaction Management,
Negotiations
Pharmaceutical
Local
Manufacture
Location : Tehran
Marketing &
Sales of Finished
Products
API & Finished product
Distributor
Omid Darou
Day Darou
Salamat
Day Int.
Distribution Unit
28 Branch
Cold chain
Self transport facilities
Mission
MissionMission
Mission
Mission
2010
2009
UAE
Day DarouTaminODS
Germany Tehran
IRAN
IRAN
IRAN
IRAN
MissionMission
Single Prescription
Importation
Trade
Transactions
20132012
Alhavi
Pharmaceutical
1967-35 %
IRAN
Hejrat
Distribution
1965-20 %
IRAN
Iran 2nd
Ranking
Distributor
17
Originator needs to adapt to a systems-oriented approach to protect revenues,
grow market share, and obtain regulatory approval for new Molecule in Iran Market.
How we think
We address the needs of Originator and other healthcare companies including payers and
providers. We use our expertise and insights to help Originator optimize the value of their drug
launch, commercialization and health care delivery. Our mission is To earn Originator's trust by
delivering on our promises with high-quality health care services that help improve outcomes.
We can support Originator from strategy through planning and execution. Through our extensive
range of services, we solve Originator's biggest challenges with better decision making:
decreasing costs, improving productivity, and saving time. The broad scope of our services helps
Originator provider rapidly assess the viability of a growing number of potential new therapies,
cost-effectively accelerate development of the most promising ones, successfully launch new
products to market and evaluate their impact and appropriate use in Iran Market .
Regulatory approval
Optimize the value
Grow market share
Earn Originator's trust By win-win game
Develop his position as well as brand
Leadership in Market
This is our Mission of partnership with MNC
On that time Omiddarou has improved its market and revenue position
18
Business Model characteristics
Targeted and focused positioning for Day Holding
Niche Specialty
Rare or orphan drugs
Protected patent
RX brand
Valid patented products
Unprotected Originals
Expired patented products
Branded Generics
Mostly new local producer
Imported genericsprefer tobe branded
Unbranded Generics
 High Volume & Low Margin
 Tight Control of Cost
 Focus on supply chain
 Purchasing Professionals are the key
stakeholders
 Promote price and Service
 Seek scale to gain cost efficiencies and
market power
 Low Volume & high Margin
 Emphasis on quality
 Focus across a complex set of
stakeholders
 Promote Efficacy ,Safety ,Tolerability
 Seek Differentiation to Drive Demand
Opportunity assessment
Omiddarou Consulting has been a strategic thought partner on hundreds of Product &
Market Opportunity Assessments to our partners. Our success in this space has been
driven by two key components: 1.) Close collaboration and open communication with our
clients, and 2.) Our deep understanding of the hints of relevant markets, products and
therapeutic areas, which inform realistic, targeted and data-driven assumptions and
recommendations .
Opportunity assessment
Providing comprehensive market understanding and insights to support investment and commercialization
Disease Background
Etiology & Pathophysiology
Patient segmentation
Epidemiology
Demand Analysis
System Dynamic
analysis
Triangulation
Statistical analysis
Implementation
and Brand Plan
Next step
Competitor Analysis
Treatment Algorithm
Treatment guidelines
Prescribing drivers of competitors
SWOT of competitors
Candidate analysis
Target Product Profile
validation in Iran
Stakeholder evaluation
Gap analysis of TPP
Finding unmet needs
Market Overview
Treatment algorithm
Treatment guidelines
Prescribing drivers/resistors
Current size
Market trends
Future outlook
Growth Drivers & resistance
Consumer Analysis
Market segmentation
Market sizing(Number of treatable
patients, current and future)
Current standard of cares strength and
weaknesses of care
Unmet needs
Customer Analysis
KOL, treating physician and
payer interviews
In-depth f to f surveys
Influence mapping
Decision making process
Insights and
recommendation
Key finding
Commercial implication
Business Model Canvas
Valuation
Patient and Demand based
forecast models
BC
The
21
Day Holding Mindset
Visioning in Strategic Planning Process
Environmental Analysis
To find threats and
opportunities
Internal Analysis
Identify strength and weakness
Vision
Core Ideology
Envisioned Future of Day Holding
Core Values, BHAG
Strategy
Where to compete
How to compete
Implementation
Balance scorecard
Operational Plans and Budget
Online BPM
Monitor and Control
Pharmalyze
Implementation Dashboard
How we monitor Omiddarou salamat performance against strategic goals
Goal: 1. Implementation of agreed & defined strategies 2. Extension of existing Performance Measurement-Systems (include qualitative measures) 3.Usage of „lead
indicators 4. Improvement of existing SAP based Management Information Systems (MIS) 5. Manage growth & complexity
Internal Process
Business Process Management
of Omiddarou
Learning & Development
 In the current climate of rapid technological
change, it is becoming necessary for knowledge
workers to be in a continuous learning mode.
Financial Perspective
Growth in operational Profit
ROI
Cash in earnings ratio
NPV.
Costumer perspective
if customers are not satisfied, they will
eventually find other suppliers that will meet
their needs. Poor performance from this
perspective is thus a leading indicator of
future decline, even though the current
financial picture may look good..
Business Process management of ODS
Integrated online monitoring system in different steps
24
Integrated System
We wont give up till success
Risk Mitigations
Reliable partnership
pharmalyze™
Integrated data management
system
Strategic
Where to compete
How to compete
Self Distribution
Day Darou Omid
Cover all provinces over 8500
pharmacies
Operational
Effectiveness
Training and knowledge
25
From Supply chain to patients
Business process management
Business
Case
Originator Ministry Of health Supply chain Omid Darou Salamat Dedicated BU
LOA
Documentation
IDL
Triple Pricing
MOH
Approval
IRC
Permission
to import
Order
Registration
Custom
Clearance
transactions
Order for lab
Releasing
Products
Labeling
warehouse
Interactivity
Of S&M
Server &
Database
Product Lunch
Scientific
Communication
Accelerate
Adoption &
Adherence
Prove product
value
Integrated
Channel
Management
Patient
Engagement
Services
(patient
knowledge)
Patient
Use pills
ShipmentPricing
Our Team ,Services,SOLUTIONSIdentify, promote and prove value
27
Different Department process
Our Team
Head Mr.Ahmadi.
Commercial
Department
Head Mr.Yazdanifard.
Business
Support
Head Dr.Farsinejad
Medical
Head Dr.Tabatabaee.
Regulatory
&
Market Access
Head Mr.Anghaee
Sales & MarketingBusiness
Development
Head Dr.Babazadeh.
Pharmalyze®
28
2014
Experienced Management
Dr.Mohsen Khatibi
M a n a g i n g D i r e c t o r o f O m i d D a r o u
Dr.Sadjad Bakhtiar
M a n a g i n g D i r e c t o r o f D a y i n t
Amirsaeed Malekshahi
D a y H o l d i n g F o u n d e r & C E O
29
2014
Senior Non-Executive Board
Dr.Amir Ekhlassi
A s s i s t a n t P r o f e s s o r , U n i v e r s i t y o f
T e h r a n
Abbas Kafash Tehrani
C E O o f p a s s a r g a d B a n k g r o u p
Mohammad Kashti Aray
C E O o f I r a n i a n J e w e l r y A S C
Amirsaeed Malekshahi
Owner and Chairman of Day Holding
Malekshahi is known for his passion, desire, determination, discipline and
dedication, Day Holding said. With annual revenue of $134 million in
2014, Malekshahi and his senior management team are credited with
leading the company to explosive growth in the last three years. And
Malekshahi volunteers his time mentoring youth in the community and
the company contributes to many charitable causes, including the
donation of Medicines to needy organizations.
Amirsaeed Malekshahi is Chief Executive Officer of Omid darou salamat
as well and serves on its Board of Directors. In this role, Malekshahi is
responsible for driving the company’s growth as the Iran’s leading
provider of pharmaceutical services. Omid darou salamat delivers
services and information that enable its partners to evaluate and
demonstrate the availability , global positioning and value of products
over the course of their lifecycle. Malekshahi spends much of his time
with customers, learning more about the challenges they face and
helping them to navigate the complex healthcare environment with
greater productivity and predictability.
Malekshahi has concentrated his career in the healthcare and technology
industries and he is viewed as a leading expert in the provision of
business services within these fields. With 16 years of experience,
Malekshahi brings an integrated, patient-centric view of healthcare,
spanning pharma, payers, and providers to help partners be successful.
Malekshahi spent 7 years at Tadbir kalaye jam, including 5 years in
leadership roles, partnering with many of its key partner globally. As
managing director of Tadbir kalaye jam Health and Products business
areas, he successfully grew the portfolio of businesses. This operating
unit included pharmaceutical firms, payers and providers, and drug
retailers and distributors. Previously, he was the Iran chief operating
officer for Alhavi’s operating group which included production and
distribution .In both operating units, he partnered with clients on their
growth strategies and initiatives, as well as enabling them to deliver
significant operational efficiency improvements.
More recently, he was establishing Omid Darou
salamat for importing medicine and Arta Darou Pars
for API . In this role Malekshahi was expected to grow
company revenue to be a top 3 company in Iran.
Throughout Malekshahi’s career, he has worked with
leading companies on issues of strategy, operations
and pharma technology based on his education in civil
engineering . In addition, Malekshahi has consulted
with and had teams at multiple pharmaceutical firms
off and on since the mid-2000. After leaving Alhavi
Malekshahi worked on a variety of healthcare and
business services opportunities with TKJ . Early in his
career, he was a consultant at TKJ . Omid Darou
salamat established his own production site in kave
industrial city in 2013 ,which will be enable ODS to be
aligned with Ministry of health’s under-licensed
production policy and give this opportunity to
partners to expand their market share with no
limitation .
31
Guiding Us in Our Mission for Better Health
Culture & Value
It takes 30 years to build a reputation and five minutes to
ruin it. If you think about that, you’ll do things differently.
”
“
Amirsaeed Malekshahi
Chairman of Board – Day Holding
Regulatory Affairs
The power of possibilities
OMIDDAROUS’ comprehensive expertise can help you confidently interact with regulatory affairs authorities for different therapeutic
area and package and present all the information necessary to allow regulatory authorities to make the right decision.
100% of approximately 150 submissions to the FDO have passed technical validation for registering IRC.
50+ DIAF and 1.5 million pages published (all document types, e.g., DIAF/pharmacoeconomic/CTD ).
70% of our regulatory professionals hold advanced degrees, with an average of more than 16 years of experience.
It will take approximately three years to register new molecule in Iran pharmacopeia but ODS register it …. .
Registration Pathway
Registration of Molecule and getting IRC code are two Milestone.
Payer and policy maker in Iran
Both are same !
Start
Imported Products
Final
Bring Medicine to
patients
According to article 14 of the Act on Medical Affairs, Pharmaceuticals and Foodstuff (passed in 1955 and amended in 1988), in the
Islamic Republic of Iran the Ministry of Health and Medical Education (MOH) is the main body that, as the Iranian National Drug
Regulatory Authority, regulates and implements the imports, registration, and customs release of any sort of pharmaceutical products.
ReimbursementFood and Drug organization
Ministry of
Welfare and
Social Security
Registration process
IDL & IRC
Registration Time Line
This is a top priority to enter to market before becoming too Late
Registration Process in Iran
IDL
Start
The applicant submit an application to FDO
IRC
Finish
The end of drug registry by getting unique IRC
code, entrance to the Iran Pharma market
FORM Number 1
Pharmaco Economic Files
Price proposal
Having Reference of France, Spain, Italy,
Turkey and Greece and original country
45 Days
Committee secreter
Required Documents :
Just verify the documentation
60 days
Pharmacoeconomics
Evaluation
30 Days
Committee waiting List
1-12 Months
Our core value is to change
it to One Months
Subcommite
Head of Therapeutic
area association
The Actuary
60 Days
IDSEC
Last step-Final Approval
1 Month
Price Approval
Getting Price approval before getting
IRC number
 Technical commitee
 Legal committe
 Price Commitee
Having price of France, Spain, Italy,
Turkey and Greece and original country
Preliminary agreement
Required Documents :
1. LOA
2. CCP
3. DIAF
4. GMP
IRC registeration
The Dossier should preferably
be presented in CTD format
Registration fee:
+ 65,000,000Rial
Day will pay for registration
MOH evaluation
DAY value is to
shorten this step
02
01
43
Submitting Form to IDL Committee
Submitting the Form Number 1
Nov
‘14
Experts of Registration
Will working on file and application to send it to
Committee secretary :
Required Documents :
Just verify the documentation
60 days
Dec
‘14
Registration Process
Iran Drug Registration and Iran Code registration
04
03
Timeline Continued
Head of National Drug
Committee Secretary
Feb
‘15
Specialized Subcommittee
Members of the Committee :
 Evaluation board of the Ministry of Health
 Medical and Pharmaceutical Specialty Association
 Approved and University related Research centers
 President of Iranian Medical Universities of Sciences
 Local Manufacturer Companies
Apr
‘15
05PharmacoEconomy Committee
Pharmacoeconomic committee will require
more information from ODS regulatory
department.
Aug
‘15
Timeline Continued
06
IDSEC
Members of the IDSEC:
Minister of Health (Chairman)
Head of Iranian FDO (Vice Chairman)
Deputy of Health
Deputy of Education
A medical specialist which is consultant of Minister of Health
General Director of Supervision on Medication
(Secretary of the Committee)
Sep
‘1507
08
IRC registration
ODS regulatory
Issue the :
Form NO.1
LOA
Nov
‘15
Finishing
IDL
Registration
Oct
‘15
Timeline Continued
0910Legal Committee
General Director of Laboratories
Deputy of planning
Deputy of Technical
Clinical pharmacists
Local Manufacturer Companies representative
.
Jan
‘16
Technical Committee
Deputy of planning
Deputy of Technical
General Director of Supervision on
Medication
Dec
‘15
11
Documentation preparation
After legal committee Preliminary agreement
Required Documents :
1. LOA
2. CCP
3. DIAF
4. GMP
Mar
‘16
47
CTD + Price approval
Expertise of registration Committee
The Dossier should preferably be
presented in CTD format
Registration fee:
+ 65,000,000 Rial
Day will pay for registration
12
Apr ‘16
CTD
3M
NO Importer
No Local manufacturer
Locally production of
Original Brand
1-2 Local
Manufacturer/Import
3-6 Local
manufacturer/Import
7-10 Local
Manufacturer /import
6M
12
M
24
M
36
M
11 local
Manufacturer/Import
Registration Time Line
24 Months
Total registeration gross steps
Documentation
Submission to subcommitee
Pharmaco Economy Evaluation
IDSC
IRC Registration
Comparison of price with current treatment alternatives or Brand value price ?
Price AnalysisTurkey could be the reference for Iranian pharmaceutical market
Price comparison
Drug Pricing is the main strategy objective of FDO 2015
Pricing Strategy
Our Price positioning
Based on feasible studies.
Local Generics availability
30%
Turkey approval price
25%
Brand
20%
Ministry of health
Weighting the MOH Price concerns
Superiority in pharmacoeconomic
20%
Imported generic availability
5%
Landing Cost
13%
Importer Margin
8-13%
CPT Price Distribution
10%
Pharmacy
15%
46
Choosing the right way to approach
What We do
Patient Demand Contacting to
MOH consulter
Pharmacoeconomic Waiting List Urgency
What we will Bring to patient How we will scientifically
Convince physician
How Professional the file will be
gather to reveal the facts
The Urgency of needs
Ease the invitation process
47
Four Main Documentation
Registration Documents
To Bing successful among
all committees this
evaluation will be the key
Pharmaco economic
assistance
The Dossier should
preferably be presented in
CTD format
.
Dossier (CTD)
Any legal entity that holds an exclusive
agency of the Product License Holder
(PLH) or Marketing Authorization Holder
(MAH), can apply for the registration and
imports of the related pharmaceuticals
at the Division of Pharmaceutical and
Narcotic Affairs.
LOA
Drug Importing Application
Form (DIAF), Appendix 4,
which has to be completed
by the Product License
Holder (PLH)
CCP,DIAF
Medical Affairs
Medical Affairs is responsible for developing and executing medical marketing strategies and tactics for a brand or
therapeutic area. Individuals in Medical Department must work very closely with sales and marketing. We are a key
function on brand or therapeutic area teams.
49
Medical DepartmentWe customize your products value in iran
01 02 03 04
Training
 Internal Trainings
 Literature Services
 KOL Management
 Clinical Development
Prototyping
 Scientific Approvals
 Reimbursement Subsidization
supports
 Outdoor Presentations
Development
 Event Management
Support
 Registration Supports
 Pharmacology
 Code of Ethics
 Competitors analyses
50
Medical Department team
To Deliver the Scientific data to the Market
Medical Manager
There are 57 SoP of Medical
departments.
Medical Advisor
 Registration
 IDL
 PK and PD
 Products
 Competitors
 Pros and Cons
Medical Science Liaison
 Efficacy & Safety
 Comparisons
 Scientific PM Contents
 Brochures
 Posters
 Trials
 Etc.
Medical Analysis
Compression of Different Strategy of
molecules in Market in delivering their
messages
51
Different events delivered by Medical Department
Meet The Team Variation
Medical Representative Training
Medical training Director
 Regular training sessions
 New Products
 Review sessions
 Paper reviews
 Cycle meetings
 Role Plays
 Exams and Evaluations of the MRs
Event Management
Event leadership
 Promotional materials
 Iran Medical Council (IRIMC)
 Ministry of Health (MOH)
 Manufacturer Country
 Medical Research (Helsinki
Declaration and Code of
Ethics)
KOL relation
General Manager
 Round tables
 Advisory Boards
 Expert meetings
 Etc.
Clinical Operations
HR manager
 Clinical trial collaboration
 Clinical data management
 Pharmacovigilance
S&M Team
Driving pharma sales force effectiveness is more critical as old sales models fail to deliver ROI. Success in the New Health demands a cost-conscious sales
strategy built on agility and focus. Look to Day Holding for flexible contract sales force solutions.
New sales outsourcing models are better at managing risk and optimizing portfolio value. Our elite pharma sales forces have helped launch more than 38
products in Iran. And we can help you drive greater returns while reducing fixed overhead costs associated with a large in-house sales force.
Business Unit Structure
BU HEAD
Medical
Marketing
Marketing Manager
Brand Specilist
Brand Manager
Media Manager
Art Manager
Sales
NSM
Supervisor
DSM
Multichannel
Marketo alliance
E detailing Art
Patient
communication
Social Media
Business Support
Pharmalyz ™
Atomation
Marketing
Sales
Market Research
TRADE PHARMACY
Distributor Manager
Pharmacy Manager
HELP DESk.
FTE
FTE
Assistant
Mdrep
Md rep
Md rep
Md rep
Md rep
Market Research
Manager
Example of Prescriber Analysis – Prescriber Segmen
Differentiation and description of target groups
among psychiatrist and Neurologist for MDD
Prescription Rate
Motivation Cost
N,C
Psychiaterist Tier A
Characteristics:
 61% of total patients visited By 80% of Psychiatrist A
 2 % innovator ,15% early adoptor
Core motive: KOL support ,Academic Event Support
Psychiaterist Tier B
Characteristics:
 13% of total Patients v isited By 50% of Psychiatrist B
 4% innovator,18% early adoptor
Core motive: attention (frequent call),promotional support
Neurologist Tier A
Characteristics:
 13% of total Patients visited By 50% of Neurologist A
 10 % of total A early adaptor
 25 % of total A Early majority
 Core motive: KOL support,being Consuler,Academic event support
Hejrat Distribution
Hejrat Distribution Company, the provider of distribution and sale services of drugs, medical facilities, dietary supplements, health and
beauty products, considering the importance and the position of quality in its organization strategies, has chosen the quality
management system based on ISO9001:2008 standard as a proper model for increasing the quality, constant improvement , and
satisfaction of drugstores and health care centers as its customers.
56
Market share
which enjoys almost 13.8% of Iran
total pharmaceutical market share
Storage capacity
10000 pallet in racks
FEFO & FIFO
Inventory control based on
FEFO & FIFO methods
Yearly Income
Total annual income in Hejrat’s last
fiscal year was more than 526 M$.
Regional distribution centers
Hejrat distribution company has
19 regional distribution centers
Cold Storage capacity
Storage capacity: 535 pallet in racks
Including 5 saloons (2090 cubic meters)
Air lock 2-8 °c & 8-15 °c & 0-(-24) °c
Employee  Total: 133 vehicles
 Semi trucks: 106 vehicles
 Trucks: 7 vehicles
 Refrigerated vehicles : 29 vehicles
 Pickups: 20 vehicles
 Cold & Cool rooms: 900 cubed meters
850
 Tablets for order confirmation
 Install GPS to control vehicles location
 Wireless data loggers for warehouses temperature & humidity control
 Uniform packaging for deliverable orders
 Enterprise Resource Planning software
 Online web ordering
57
Pharmalyze®
BUSINESS SUPPORT
Provide timely, relevant, consistent and accurate information of all
shareholders
Data management System
Source of Data
Pharmalyze® is breakthrough
technology. It provides access to key
Data in market and a comprehensive
picture of selling progress to support
proactive S&M team decision making.
Ministry of Health
The Monthly reports of MOH of sales
analyzed in different dimensions by
Qlikview
Distributors
With Self Distribution System we are
enabled to adjust our channel according
our priorities which in impossible in out-
sourcing business model
pharmacies
All pharmacies connected to defined
Physician in the different therapeutic area .The sales
data per day and simultaneously physician targets will
be measured
Prescribers
Prescribing behavior .
Online patient centric -Beta
Knowing patient needs .
We focus on our main market research areas, all types
of therapeutic classifications-as well as looking at
opportunities in promising technologies and early-stage
collaborations. Beyond the asset, we always look for the
right partnership and cultural fit. We are not looking for
compounds that represent marginal improvements
compared to the current standard of the right methods
of analyzing we are thinking about ROI improvement.
How we are aware of Market ?
This is example for Data gathering system
$725,000
Some Money saved since 2015
One of the great advantages of the system is its facility for
preparing standard reports and exporting information for further
statistical analysis.
Some Info from Pharmalyze©
 The system is in compliance with the requirements of
the Data Protection Acts.
 The patient’s medical record number (MRN) is used
as a unique identifier to count the number of patients
treated .
 The number is encrypted and is not reported outside of
the organization.
 A privacy statement is incorporated.
 All information is entered retrospectively and is not
linked in any way to individual patients.
 Patient or clinical information is not recorded in the
system.
 The information input is owned by the Omiddarou where
the service is delivered .
65%
1800 Pharmacy
Involved
5 main Cities
 Tehran
 Isfahan
 Tabriz
 Shiraz
 Mashhad
360° View of Market dynamics
ODS eyes
Product Profile
Market characteristics
Sales vs Target (Yearly)
Company growth
Sales vs Target (Province)
Sales team KPIs
Sales/day
Day sales in depth understanding
of supply chain
Sales/Physician (Monthly)
Updated weekly and analyzed
monthly to measure messeges
Finance reports
4 level information
Analysis
CAPABILITIES
Market & Channel Analyzing
•We help partners increase their sales and marketing operational
efficiency by evaluating processes that differentiate them in the
marketplace.
•We evaluate and recommend new promotional channels, including
investments in new capabilities and partners to respond faster to a
changing customer base.
Market Technology Analyzing
•Evaluations and recommendation for sales and marketing systems,
CRM (both local and BPS-based) and cloud-based services providing
integration with social media networks.
•High-performing organizations need to exploit technology to deliver
optimal and cost-effective services to customers.
62
Full Commercial Services
Day Holding, is the Iran Fastest growing of pharmaceutical commercial services with a network of more than 28
branches conducting business in Iran. ‘We are in the business of getting people to be truly involved with our
products and services to care or improving their health . Day Holding, is a pharmaceutical trading which specializes
in launching pharmaceutical brands as well as rebranding with Focusing on Strong Marketing Department and
Analytic actions ,We deliver inspirational and actionable ideas to help our partner win in the marketplace .”
64
DAY is continually seeking new ways of doing more with less
Services
5 Key Services in pharmaceutical Commercial
Support from patients plays a key role in determining your product’s commercial success. Day Holding specializes in helping brands form
connections and reinforce bonds with patients throughout the entire pharmaceutical lifecycle – from clinical development through
commercialization. As an industry leader in direct-to-patient research in Iran , we are poised to help build strong bridges between your
product and the patients you serve.
Regulatory Analyze Strategic Launch
Scientific
Communication
Optimized
Distribution
Solutions
We help you navigate the value substantiation process from diagnosing stakeholder needs and spheres of
influence to performing real-world benefit-risk and competitive analyses – so you can optimize your product’s
value platform and gain a preferred position on payer formularies at favorable pricing and reimbursement. The
earlier we start collaborating, the more we can help you launch the right product with the right value
proposition and evidence packages.
66
Solutions
The power of possibilities
Positioning of
the Brand
MOH Relationship
Registration
Start-up
(successful Launch)
Emerging Growth
Fast Track Market Penetration
Detailing capacity
Strong Presence In the franchise
Formulated adapted market strategies
Collaboration Model
Day Collaboration Framework articulate optimum partnership
68
Day Collaboration Framework articulate cross-functional and cross-firm co-create value with key leaders and Originator
Gear Business Model
Align Expectation
Develop action Plan
Develop product distribution
agreement
Agreement for win-win
collaboration
Determine Support Level of both side
Review performance
69
Collaboration Business Model in Iran
Own affiliate/office Own sales forceSupply the medicine
Supply the medicine
Supply the medicine
Distributor
Distributor
Distributor
Registration
Non-operation
S & M
Registration
Non-operation
S & M
Registration
Non-operation
+
%
$
Based on sale
Based on what planned
MoneyTransaction From IranTo worldwide
71
Via Day International
Day International the subsidiary
company of Day Holding
Transfer all received money from UAE
BANK to any account to all Countries
From Parsian Bank to
BCP Bank
Money Transfer to all worldwide
account of BCP bank
From Parsian Bank to
Heritage Bank
Money Transfer to all worldwide
account of Heritage Bank
Via HULK Bank TURKEY
All Companies who has an account in
Turkey HULK BANK or account in
Iranian banks who working with Hulk
Bank Can use this way.
How it works ?
Examples of how Omid Darou and all other pharmaceutical companies transfer
their Money from Iran
DAY Internation .FZE
With Normal Transaction money transfer from Iran
To Day international Account in United Arab Bank
Day Internation enable to transfer money to all Account in World in any Bank
Examples
 Lundbeck
 Sigma tue
 Ribusepharm
 Kern & ….
From Iranian Parsian Bank To any
international account of BCP Bank
For Originator who has an account in BCP Bank
Example
Bunge
 www.bunge.com
http://www.bcp-bank.com/
From Iranian Parsian Bank To any internation account
of Heritage Bank
For Originator who has an account in Heritage Bank Example
 CSL Behringer
 Roche
Via Turkey HULK Bank
The Multinational companies opened an account in Turkey Hulk Bank to have full featuers of transactions
Most popular for pharmaceutical companies used this method before parsian bank solution
Examples
 Astrazeneca
 Sanofi
 Merck
 Lilly
http://www.halkbank.com.tr/e/
Partnership Process
we strive continuously to be the partner of choice
Partnership Process
79
Fully integrated company
Day Holding is a fully integrated
company with more than 370
employees in 31 Provinces; we have
core competencies in Fast Track
Market access for Registering new
products, efficient S&M Team
Flexible, fast decision
making on partnerships
Day’s top management is
committed to developing
partnerships and has
designed a process to ensure
structured and fast decision
making when evaluating new
partnering opportunities.
Proven track record of
commercial success
Our Oncology and CHC Products is
a market leader in Iran. we
Fast Track Registration
Dr. Mohsen Khatibi ( OmidDarou GM)
The former Deputy of Minister with 16
years experience in Ministry of health with
his team in regulatory department. Is Our
leverage to have common language with
MOH. Dr.khatibi is currently the member
of many committee in MOH .
Dr.khatibi ( MD/ pharmacoeconomic PhD)
Why partnering with Day ?
Partnership Process
Partners
The Impact ofTrust on the Day & Partners Relationship
2009 2010 20132011 2012 2014
2009
20% growth
2009 : 48 Million$
2010
23% growth
2010 : 58 Million$
2011
18% growth
2011 : 69 Million$
2012
19% growth
2012 : 83 Million$
2013
24% growth
2013 : 102.7 Million USD , $
2014
19% growth
2014 : 123Million$
48 58 69 83
123Value Turnover Trend of
Day Holding
Million US Dollar
Our Investment on Marketing
102.7
Ribosepharm (Germany)
Lyomark (Germany)
Sigma-Tau (Italy)
Generis (Portughal)
Meiji Seika(Japan)
Remedica (Cyprus)
Laboratorio Aldo-Union (Spain)
Bendalis (Germany)
Faes Pharma (Spain)
Arko Pharma(France)
Unipharma (Greece)
Combino Pharm (Spain)
Indimmune (India)
Kern pharma (spain)
Daewoong (South Korea)
Biocol (Portugal)
Future Biotic (USA)
Md tech (Italy)
Lundbeck (Denmark)
Gebro pharma(Austria)
2015
Coming soon !
www .D a y I n t .org
Head Quarter Office
No. 20, 2nd St., Zarafshan shomali St. Sanat
Sq., Shahrak Gharb
Zip: 1466743784, Tehran, Iran.
Tel: (+98) 21 88580017-18
Fax: (+98) 21 88376445
Business CaseDAY Holding Business Development
AstraZeneca Diabetes
Iran
Diabetes
Iran
Omid Darou salamat
2015
INDEX
Diabetes Business Case
Summary
Whole story in one page
Market structure
Registration
Epidemiology
Incidence, Prevalence, Patient
Characteristics,
OAD /Insulin
Treatment paradigm for
treatment in Iran
Guidelines
Market Overview
Market environment
Market analysis
Competitor analysis
Pricing analysis
Price strategy
Registration Pathway
 timeline,
 Steps
 critical gateways
 expected launch date
Forecasts
SummaryLets talk about Whole story at glance
Summary
Epidemiology to Forecast
2 Years
Registration At MOH
Targeted OAD
Patients
Base
The main principal of patient population in Iran Driven by Patient awareness of their diseases .
There are many articles indicate a poor diagnosis rate of patients in Iran .
EpidemiologyDefined the Unmet area in Mixed Patient with new diagnosis pathway
01
11%
Diabetes
9 Million
patient
Iran Demographic2015
89
Local Producer
93
Medicine
Importer
30
API Producer
53 Local Distributor
(80% by 10)
53%
.
22%(0-14)
20%(15-24)
44%(25-54)
3%(60-64)
5%(>60)
8 million
>60 YRS
16 million
Obesity
168
124
18 million
HTN
45000
Dies by
cancer
47%
79 Million population
GDP : 368.9 b USD
GDP Per Capita : 4763 USD
Health Exp. : 6%
Pharma CAGR: 24%
4.5
Mil
Diagnosed
2.8
Mil
Treated
9
Mil
Diabetes
2
Mil
OAD
Lantus
(38k patient)
NovoRapid
(39k patient)
NovoMix
(95k patient)
Regular+NPH
(240k patient)
Regular
(82k patient)
Biphasic
(35k patient)
810
Kilo
insulin
20%
CAGR
Volume
5Y
Diabetes structure
GLICLAZIDE
(74k patient)
REPAGLINIDE
(42k patient)
PIOGLITAZONE
(120k patient)
GLIBENCLAMIDE
(1650k patient)
METFORMIN
(946k patient)
ACARBOSE
(28k patient)
METFORMIN/
GLIBENCLAMIDE
(3k patient)
SITAGLIPTIN
(1k patient)
10%
CAGR
Diabetes Market– Market structure
Levels of narrowing based on potential and actual patients according 2016 lanch strategy
Penetrated
Market
Total Diabetes
Estimated Patients : 6.8 Million patient
Important competitors : NONE
Treated Diabetes
Estimated Patients :4.5 M
Important competitors:
importers
OAD patients
Estimated Patients :2000K patient(2016)
AstraZeneca Diabetes portfolio ®
Estimated Patients :65K patient
Total Dual therapy
Segment
Estimated patients : 1500k
What paradigms are Iranian Kols choose to treat TYPE 2 Diabetes
Treatment paradigmADA guideline 2015
Prescriber Analysis – Prescriber Segmentation
Differentiation and description of target groups among endocrinologist and Internist
Prescription Rate
Motivation Cost
N,C
Endocrinologist Tier A
Characteristics:
 61% of total patients visited By 80% of endocrinologist A
 2 % innovator ,15% early adoptor
Core motive: KOL support ,Academic Event Support
Endocrinologist Tier B
Characteristics:
 13% of total Patients v isited By 50% of endocrinologist B
 4% innovator,18% early adoptor
Core motive: attention (frequent call),promotional support
Internist Tier A
Characteristics:
 13% of total Patients visited By 50% of Internist A
 10 % of total A early adaptor
 25 % of total A Early majority
 Core motive: KOL support,being Consuler,Academic event support
Prescriber Analysis – ABC Analysis of prescriber
Potential
High Medium Low
LowMediumHigh
Shareinsales
BA
A
B
C
C
A
B
C
A-type Prescriber B-type Prescriber C-type prescriber
INT-A
endocrinologist A
INT-B
Endo-C
Endo-B
INT-C
*innovative visualization
Internist : 1000
Prescriber Internist : 850
Internist (Tier A) : 250
Internist (Tier B) : 350
Internist (Tier C) : 250
Endocrinologist : 220
Prescriber endocrinologist : 178
endocrinologist (Tier A) : 35
endocrinologist (Tier B) : 53
endocrinologist (Tier C) : 81
Entry A1c ≥ 7.5%
GLP-1 RA
SGLT-2i
DPP-4i SGLT-2i
MET
or other
1st-line
agent
MET
or other
1st-line
agent +
2nd-line
agen
TZD TZD
BasalInsulin Basalinsulin
+
Colesevelam DPP-4i
t
+
Bromocriptine QR
Colesevelam
AGi Bromocriptine QR
SU/GLN AGi
SU/GLNIf not at goal
in 3 months
proceed to
Triple Therapy
If not at goal in
3 months proceed
to or intensify
insulin therapy
* Order of medications listed represents a suggested hierarchy of usage
P R O G R E S S I O N O F D I S E A S E
LEGEND
Few adverse events
or possible benefits
Use with caution
ADD OR INTENSIF
Y INSULIN
Refer to Insulin Algorithm
Therapy
±Therapy
TRIPLE THERAPY*
GLP-1 RA
DUALTHERAPY*
SYMPTOMS
NO YES
DUAL
INSULIN
Other
OR Agents
TRIPLE
MONOTHERAPY*
Metformin
GLP-1 RA
SGLT-2i
DPP-4i
AGi ZD
SU/GLN
If not at goal in 3 months
proceed to Double Therapy
Entry A1c > 9.0%Entry A1c < 7.5%
L I F E S T Y L E M O D I F I C AT I O N
(Including Medically Assisted Weight Loss)
Rational prescribing:
The principles of drug selection T1 in Iran
Dr.Khamseh & Dr.Kazemi & Dr.Esteghamati
Efficacy Hypo risk Weight
side effects
cost
10%90%
What is important to categorized treatment step
10%
Type 1
90%
Diabetes T2
-
20
40
60
80
100
120
140
160
2010 2011 2012 2013 2014
Mill.Euro
Total MS 53% in 2014 with 3
company:
Novo Nordisk : 43 Mil Euro
Sanofi : 19 Mil Euro
Merck Serono : 7 Mil Euro
MS local companies is 44%
Top Brands in 2014
Novo Rapid (Novo Nordisk): 29 Mil Euro
lantus (Sanofi): 19 Mil Euro
Novo Mix (Novo Nordisk): 12 Mil Euro
Top Molecules in 2014
INSULIN : 81 Mil Euro
METFORMIN : 33 Mil Euro
GLIBENCLAMIDE : 7 Mil Euro
InsulinOAD
DIABETES Therapeutic area
Iran
DIABETES Therapeutic area
Iran
36%
CAGR 5 YS
25%
Diabetes GR 2013
9%
Total Market GR 2013
51%
Local MS (of Diabetes) 2014
4%
MS (of Total) 2014
144
116
81
55
43
Confidential Document
Franchise
-
20
40
60
80
100
120
140
160
2010 2011 2012 2013 2014
Mill.Euro
OTHERs
ALPHA GLUCOSIDASE INHIBITORS
THIAZOLIDINEDIONES
SULFONAMIDES, UREA DERIVATIVES
INSULINS FAST-ACTING
INSULINS A LONG-ACTING
BIGUANIDES
INSULINS INTERMEDIATE-ACTING COMBINED WITH FAST-ACTING
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2010 2011 2012 2013 2014
OTHERs
ALPHA GLUCOSIDASE INHIBITORS
THIAZOLIDINEDIONES
SULFONAMIDES, UREA DERIVATIVES
INSULINS FAST-ACTING
INSULINS A LONG-ACTING
BIGUANIDES
INSULINS INTERMEDIATE-ACTING COMBINED WITH FAST-ACTING
Molecule (Sales Value)
Molecule Value 2013 Value 2014 GR CAGR MS 14
METFORMIN 35,792,421 34,730,158 -3% 26% 60%
GLIBENCLAMIDE 7,986,546 8,627,512 8% 2% 15%
PIOGLITAZONE 5,873,236 6,051,774 3% 25% 10%
ACARBOSE 3,893,847 3,992,244 3% 13% 7%
REPAGLINIDE 1,776,011 2,352,289 32% 15% 4%
GLICLAZIDE 1,735,209 2,145,496 24% 37% 4%
SITAGLIPTIN 146,526 0.25%
METFORMIN/GLIBEN
CLAMIDE
106,452 135,569 27% 0.23%
Others 76,770 1,453 -98% -57% 0.00%
Total 57,240,492 58,183,023 2% 19%
Sales Value
14
20
31
36 358
6
8
8 9
-
10
20
30
40
50
60
70
2010 2011 2012 2013 2014
Mil.Euro
METFORMIN GLIBENCLAMIDE PIOGLITAZONE ACARBOSE REPAGLINIDE GLICLAZIDE SITAGLIPTIN METFORMIN/GLIBENCLAMIDE Others
[CELLRANGE]
[CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE]
[CELLRANGE]
[CELLRANGE]
[CELLRANGE] [CELLRANGE] [CELLRANGE]
[CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE]
[CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE]
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2010 2011 2012 2013 2014
METFORMIN GLIBENCLAMIDE PIOGLITAZONE ACARBOSE REPAGLINIDE GLICLAZIDE SITAGLIPTIN METFORMIN/GLIBENCLAMIDE Others
Molecule Map (Value)
METFORMIN
GLIBENCLAMIDE
PIOGLITAZONE
ACARBOSE
REPAGLINIDE
GLICLAZIDE
-10%
0%
10%
20%
30%
40%
50%
60%
70%
-5% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45%
CAGR 5Ys
MS
Molecule Sales Volume (Based on patient)
Molecule Volume 2013 Volume 2014 GR CAGR MS 14
GLIBENCLAMIDE 1,433,386 1,650,718 15% 4% 58%
METFORMIN 993,189 946,280 -5% 23% 33%
PIOGLITAZONE 100,689 120,599 20% 24% 4%
GLICLAZIDE 44,604 74,507 67% 32% 3%
REPAGLINIDE 29,996 42,797 43% 39% 1%
ACARBOSE 22,517 28,671 27% 25% 1%
METFORMIN/GLIBENC
LAMIDE
2,208 3,306 50% 0%
SITAGLIPTIN - 674 0%
Total 2,626,590 2,867,552 9% 10%
Sales Volume (Based on Patient)
1,419 1,584 1,652 1,433 1,651
-
500
1,000
1,500
2,000
2,500
3,000
3,500
2010 2011 2012 2013 2014
KMGTab
GLIBENCLAMIDE METFORMIN PIOGLITAZONE GLICLAZIDE REPAGLINIDE ACARBOSE METFORMIN/GLIBENCLAMIDE SITAGLIPTIN
[CELLRANGE]
[CELLRANGE] [CELLRANGE]
[CELLRANGE] [CELLRANGE]
[CELLRANGE]
[CELLRANGE] [CELLRANGE]
[CELLRANGE] [CELLRANGE]
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2010 2011 2012 2013 2014
GLIBENCLAMIDE METFORMIN PIOGLITAZONE GLICLAZIDE REPAGLINIDE ACARBOSE METFORMIN/GLIBENCLAMIDE SITAGLIPTIN
Molecule Map (Volume Based on Patient Number.DDD)
CAGR 5Ys
MS
GLIBENCLAMIDE
METFORMIN
PIOGLITAZONE GLICLAZIDE
REPAGLINIDE
ACARBOSE
-10%
0%
10%
20%
30%
40%
50%
60%
70%
-20% -10% 0% 10% 20% 30% 40% 50% 60% 70% 80%
Pricing
Control on Pricing is the main objective of FDO 2015
Pricing Strategy
Medicine price is controlled by
the food and drug organization
through pricing commission
regulations in a cost plus basis
through comparison with selected
reference countries such as turkey
,Greece ,Spain and Original country .
Local Generics availability
30%
Turkey approval price
25%
Brand
20%
Ministry of health
Weighting the importance of principals for
MOH in Pricing process
Superiority in pharmacoeconomic
20%
Imported generic availability
5%
Landing Cost
13%
Importer Margin
8-13%
CPT Price Distribution
10%
Pharmacy
15%
Drug Registration Process in Iran
IDL(Iran Drug List)
Start
The applicant submit an application to FDO
IRC(Iran Registeration Code)
Finish
The end of drug registry by getting unique IRC
code, entrance to the Iran Pharma market
FORM Number 1
Pharmaco Economic Files
Price proposal
Having Reference of France, Spain, Italy,
Turkey and Greece and original country
45 Days
Committee secreter
Required Documents :
Just verify the documentation
60 days
Pharmacoeconomics
Evaluation
30 Days
Committee waiting List
1-12 Months
Our core value is to change
it to One Months
Subcommite
Head of Therapeutic
area association
The Actuary
60 Days
IDSEC
Last step-Final Approval
1 Month
Price Approval
Getting Price approval before getting
IRC number
 Technical commitee
 Legal committe
 Price Commitee
Having price of France, Spain, Italy,
Turkey and Greece and original country
Preliminary agreement
Required Documents :
1. LOA
2. CCP
3. DIAF
4. GMP
IRC registeration
The Dossier should preferably
be presented in CTD format
Registration fee:
+ 65,000,000Rial
Day will pay for registration
MOH evaluation
DAY value is to
shorten this step
Iran Drug List – 24 Months Iran Registration Code– 12 Months
Is under coverage of
reimbursement
ReimbursementThree major Organization
SSO
MSIO
Military
insurance
The Social Security Organization
(SSO):
Generally, 7 million insured persons as well as
1,300,000 old-age pensioners are covered by
the SSO; meanwhile, considering the family
members and dependents of the major insured
individuals, totally, the covered population by
the SSO who receives insurance and medical
services is about 27.5 million persons.
The Medical Service Insurance
Organization (MSIO):
MSIO provides health insurance for
government employees, students, and rural
dwellers. The rural population not covered by
any other insurance plan were entitled to
receive benefits at will in 2000. Patients are
subject to copayment at the point of service.
The Military Personnel
Insurance Organization
Provides health insurance for military
personnel
Reimbursement
Medicine cost reimbursement is mainly
undertaken by three major organizations:
Social Security Organization (public), Medical
Services Insurance Organization (governmental),
and Medical Insurance Services Organization of
Armed Forces (governmental), all of which
reimburse the cheapest medicine registered. The
emerging supplementary insurance companies
are putting constraints on pharmaceutical
expenditure. There is a positive list of
medicines fully covered by the government that
contains specialty drugs.
90% of
Iranian
10 steps to entitle Drugs
in reimbursement List
Approximately
18-24 Months
Registration Dynamics Iran-NDP
Factors influencing the probabilities
The NDA and different parties in the ministry of health (MOH) have problems in making unified decisions that would result in
amelioration or deterioration of NDP indicators. Surely, the drug systems and decision makers have limited resources and technologies
to predict and evaluate the consequences of their decisions.
Available Local molecules
Willingness to Produce
Domestic product share
Cost benefit & Price Competition
Severity of Illness and Demand
Availability of alternative treatment
Affordability
75%
50%
50%
40%
Affordability :
monthly medication costs.
Catastrophic Index
Price competition
Health Expenditure GDP PC
Alternative treatment cost
Severity of illness
Therapeutic area growth
New patients
Astrazeneca portfolio
Oppurtunity assesment
43 %
15%
20 %
11 %
0 %
11 %
Price
27.1€
Registeration Likehood
4
2017 2019
Onglyza®
Kombiglyze XR®
Forxiga®
Xigduo XR®
Byetta®
Bydureon®
Registeration Likehood
6
Registeration Likehood
3
Registeration Likehood
5
Registeration Likehood
2
Registeration Likehood
1
Price
33.3€
Price
30 €
Price
32€
Price
47€
Price
72€
112
Legitimacy of forecast By Diabetes Expertise
No-Reimbursement considered
Forecasting
Launch
250%
117%
59%
2017 2018 2019 2020
OAD Market
From Add-On therapy Glibenclamide market segmented
From Monotherapy uncontrolled patient of Metformin
The Market divided in to eligible patients for DDP-
4,SGLT2,GLP1 .
Potential Patients
Glibenclamide : 1,448,195
Uncontrolled patient of Metformin : 312,609
63,500 in 5th year
24.3 Million Euro
2021
1.2 4.2 9.2 14.7 20 25
38%
2021
22%
2022
Onglyza®
5 year Forecast of Saxagliptin 5mg pack of 28 price 30.60 Euro (Turkey reference Price)
86
1st Year
Vol : 650 k pack
Patient : 1,781
Value : 0.7 million Euro
2nd Year
Vol : 2000 kpack
Patient : 5,479
Value : 2 million Euro
3rd Year
Vol : 4000k pack
Patient : 10,959
Value : 4,3 million Euro
4th Year
Vol : 6000 k pack
Patient : 16,438
Value : 6.4 million Euro
5th Year
Vol : 7800kpack
Patient : 21,370
Value : 8.3 million Euro
3%
7%
13%
18%
22%
Market share of selected segment :
Eligible patient for DDP4
Kombiglyze XR®
5 year Forecast of Saxagliptin & Metformin Hcl XR 2,5 MG/1000 MG 56 FILM of price 36.96 Euro(Turkey reference Price)
86
1st Year
Vol : 300k pack
Patient : 822
Value : 198 K Euro
2nd Year
Vol : 1200k pack
Patient : 3,288
Value : 792K Euro
3rd Year
Vol : 3000k pack
Patient : 8,219
Value : 1,9 million Euro
4th Year
Vol : 5000k pack
Patient : 13,699
Value : 3.3 million Euro
5th Year
Vol : 7000k pack
Patient : 19,178
Value : 4.6 million Euro
1%
4%
9%
14%
19%
Market share of selected segment:
Eligible patient for DDP4+Metformin
Forxiga®
5 year Forecast of Dapagliflozin pack of 28 price 28 Euro
86
1st Year
Vol : 300kpack
Patient : 822
Value : 351 Euro
2nd Year
Vol : 900k pack
Patient : 2,466
Value : 1million Euro
3rd Year
Vol : 1800kpack
Patient : 4,932
Value : 2.1 million Euro
4th Year
Vol : 2400k pack
Patient : 6,575
Value : 2.8 million Euro
5th Year
Vol : 3300Kpack
Patient : 9,041
Value : 3.8 million Euro
5%
13%
24%
29%
38%
Market share of selected segment:
Eligible patient for Dual therapy and triple
therapy with SGLT
Xigduo XR®
5 year Forecast of Dapagliflozin and Metformin Hcl 5/1000 mg pack of 28 price 35 Euro
86
1st Year
Vol : 200 kpack
Patient : 548
Value : 250kEuro
2nd Year
Vol : 600kpack
Patient : 1,644
Value : 750k Euro
3rd Year
Vol : 1200 k pack
Patient : 3,288
Value : 1.5 million Euro
4th Year
Vol : 1800k pack
Patient : 4,932
Value : 2.2million Euro
5th Year
Vol : 2400k pack
Patient : 6,575
Value : 3 million Euro
3%
8%
26%
36%
45%
Market share of selected segment:
Eligible patient for Dual therapy and triple
therapy with SGLT
3% 8% 15% 21% 26%
Bydureon®
5 year Forecast of Exenatide XR pack of 4 price 80.57 Euro(United Kingdom)
86
1st Year
Vol : 10k pack
Patient : 192
Value : 200k Euro
2nd Year
Vol : 30k pack
Patient : 577
Value : 604k Euro
3rd Year
Vol : 60k pack
Patient : 1,154
Value : 1.3 million Euro
4th Year
Vol : 90k pack
Patient : 1,731
Value : 2 million Euro
5th Year
Vol : 130k pack
Patient : 2,115
Value : 2.6 million Euro
2%
6%
12%
17%
21%
Market share of selected segment :
Eligible patient for GLP-1
Thanks for watching
Diabetes Business case Iran
Business Development Department
@Modjtaba Babazadeh
M. Babazadeh@dayint.org

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Iran diabetes market study

  • 1. Bringing people and knowledge together for a healthier world AstraZeneca & Day Holding
  • 2. 2 AstraZeneca & Day Holding Meeting Agenda Brief Introduction of Iran Pharma Market Day Holding Structure
  • 3. 3 Regulatory Pathway comprehensive expertise can help you confidently interact with regulatory affairs authorities for different therapeutic area and package and present all the information necessary to allow regulatory authorities to make the right decision . Transactions  Hulk Bank Turkey  Day International(UAE) Distribution System Hejrat company is the First largest network of distribution system and second largest Iranian pharmaceutical distributor in terms of market share. Draft timeline key dates Registration of IDL and IRC & drug importation, importation, shipment, etc.
  • 4. 4 A Great Partnership Demonstration Next step Pharmalyze ® Partners Omid Darou salamat sales Trend Pharmalyze® is breakthrough technology. It provides access to key Data in market and a comprehensive picture of selling progress to support proactive S&M team decision making.
  • 5. Day Holding Western Europe Size: € 128-150 bn CAGR (2013-17): -2% to 4% Middle East Size: € 12-19 bn CAGR (2013-17): 12% to 14% Africa Size: € 19-26 bn CAGR (2013-17): 7% to 10% Central & Eastern Europe Size: € 48-56 bn CAGR (2013-17): 4% to 7% Asia Pacific Size: € 202-216 bn CAGR (2013-17): 12% to 15% North America Size: € 276-298 bn CAGR (2013-17): 1% to 4% Latin America Size: € 71-78 bn CAGR (2013-17): 10% to 13% Low Growth (< 4%) Note: WesternEurope includes EU5 and rest of Western Europe; Size: 2013-2017, CAGR is between 2013-2017 High-Mid Growth (7% to 13%) High Growth (12% to 15%) Low-Mid Growth (4% to 7%) Source: IMS Market Prognosis, Apr 2013 Middle-East Demographic Middle East is one of the fastest growing pharma markets
  • 6. 47% 23%(0-14) 19%(15-24) 45%(25-54) 2%(60-64) 5%(>60) Iran Demographic Opportunity scanning 89 Local Producer 93 Importer 30 API Producer 53(80%-10) Local Distributor 53%. 79 Million GDP : 368.9 b USD GDP PC : 4763 USD Health Exp. : 6% Pharma CAGR: 24% - 20,000,000 0-14 15-24 25-54 55-64 60-64 65 - 20,000,000 0-14 15-24 25-54 55-64 60-64 65 MALE 22%(0-14) 20%(15-24) 44%(25-54) 3%(60-64) 5%(>60) 6 million >60 YRS 18 million Obesity 168 124 18 million HTN 45000 Dies from cancer  Daru-Pakhsh  Hejrat  Razi  Ferdows
  • 7. Iran pharmaceutical Iran is an example of a country that has made considerable advances through Health Health Ranking Top 20 Physician 60 K. Imported 1.2 B Euro ⅓ Local Production 2.04 B Euro ⅔ Total Pharma 3.2 Billion Euro in 2014
  • 8. Top MNC in Iran pharma Sanofi Roche Novo Nordisk Biotest Merck Krka Bayer Schering Merck Serono Merck KGaA Pfizer Abbott Novartis AstraZeneca Ipsen Csl Behring -2% 0% 2% 4% 6% 8% 10% 12% 14% 16% -25% -15% -5% 5% 15% 25% 35% 45% CAGR 5Ys MS Import Market CAGR
  • 9. Iran Pharma Franchises ANTIINFECTIVES ANTINEOPLASTIC & IMMUNOMODULATING ANTIPARASITIC BLOOD CARDIOVASCULAR DERMATOLOGICALS GENITO URINARYMUSCULO-SKELETAL SYSTEMIC HORMONAL GI ANTI DIABETES VITAMINS & MINERAL COUGH & COLD ANTIHISTAMINS RESPIRATORY CNS ANALEGESICS OPHTHALMIC CONTRAST MEDIA & DIAGONSTIC -5% 0% 5% 10% 15% 20% 25% -5% 5% 15% 25% 35% 45% CAGR: 2011-2014 MarketShare:2014 Market CAGR
  • 10. Bright Roadmap among Hurdles Iran pharmaceutical Market It would be unusual for investors to take such risk without the prospect of considerable reward Regulatory The Door ! Data 360◦ view of Market Data Financial and Transaction Power To being able to support business model Commercialization Knowledge Taking care of brand Risk Management In-house capability to have flexible symphonic of Iranian market rhythms
  • 12. 12 Articulate your vision Day Holding Structure Day Vision “We strive to be the partner of choice for multinational healthcare and pharmaceutical companies expanding into Iran. We aim to consistently differentiate ourselves by serving all of our stakeholders through value based medicine.” Day Mission To provide healthcare organizations with innovative therapeutic solutions in different therapeutic area, market access strategies and sustainable commercial solutions , while improving patient care and quality of life in Iran.
  • 13. 13 Business Process Management Introducing Business process management structure in Omiddarou salamat. & Core values Our Team Introducing Different Departments with their team. Our Service Day Holding full commercial services according product life cycle. Solutions Unique Solutions based on systematic thinking in dynamic environment.
  • 14. 14 Collaboration Models Day different Business Models. Regulatory Pathway comprehensive expertise can help you confidently interact with regulatory affairs authorities for different therapeutic area and package and present all the information necessary to allow regulatory authorities to make the right decision .Partnership Process Partnerships are a key strategic objective for Day Holding. This objective is achieved by obtaining increased value from our existing partnerships and by actively seeking and evaluating new opportunities at all times. Draft timeline with key dates Registration of IDL and IRC & drug importation approval, label/pack adjustment, importation, shipment, etc.
  • 15. 15 A Great Partnership Demonstration Success Innovative Sales & Marketing business discussions ,sharing of mutual expectations . Partners Omid Darou salamat sales Trend
  • 16. Founder : Mr. Amirsaeed Malekshahi DAY HOLDING Senior Leadership : Amirsaeed Malekshahi , chairman of the board, president and chief executive officerHeadquarter : Shahrak Gharb ,Tehran 2010 Day Darou Omid 20% 2012 Arta Darou Pars 2008 Opportunity Scanner and Strategic Development , Transaction Management, Negotiations Pharmaceutical Local Manufacture Location : Tehran Marketing & Sales of Finished Products API & Finished product Distributor Omid Darou Day Darou Salamat Day Int. Distribution Unit 28 Branch Cold chain Self transport facilities Mission MissionMission Mission Mission 2010 2009 UAE Day DarouTaminODS Germany Tehran IRAN IRAN IRAN IRAN MissionMission Single Prescription Importation Trade Transactions 20132012 Alhavi Pharmaceutical 1967-35 % IRAN Hejrat Distribution 1965-20 % IRAN Iran 2nd Ranking Distributor
  • 17. 17 Originator needs to adapt to a systems-oriented approach to protect revenues, grow market share, and obtain regulatory approval for new Molecule in Iran Market. How we think We address the needs of Originator and other healthcare companies including payers and providers. We use our expertise and insights to help Originator optimize the value of their drug launch, commercialization and health care delivery. Our mission is To earn Originator's trust by delivering on our promises with high-quality health care services that help improve outcomes. We can support Originator from strategy through planning and execution. Through our extensive range of services, we solve Originator's biggest challenges with better decision making: decreasing costs, improving productivity, and saving time. The broad scope of our services helps Originator provider rapidly assess the viability of a growing number of potential new therapies, cost-effectively accelerate development of the most promising ones, successfully launch new products to market and evaluate their impact and appropriate use in Iran Market . Regulatory approval Optimize the value Grow market share Earn Originator's trust By win-win game Develop his position as well as brand Leadership in Market This is our Mission of partnership with MNC On that time Omiddarou has improved its market and revenue position
  • 18. 18 Business Model characteristics Targeted and focused positioning for Day Holding Niche Specialty Rare or orphan drugs Protected patent RX brand Valid patented products Unprotected Originals Expired patented products Branded Generics Mostly new local producer Imported genericsprefer tobe branded Unbranded Generics  High Volume & Low Margin  Tight Control of Cost  Focus on supply chain  Purchasing Professionals are the key stakeholders  Promote price and Service  Seek scale to gain cost efficiencies and market power  Low Volume & high Margin  Emphasis on quality  Focus across a complex set of stakeholders  Promote Efficacy ,Safety ,Tolerability  Seek Differentiation to Drive Demand
  • 19. Opportunity assessment Omiddarou Consulting has been a strategic thought partner on hundreds of Product & Market Opportunity Assessments to our partners. Our success in this space has been driven by two key components: 1.) Close collaboration and open communication with our clients, and 2.) Our deep understanding of the hints of relevant markets, products and therapeutic areas, which inform realistic, targeted and data-driven assumptions and recommendations .
  • 20. Opportunity assessment Providing comprehensive market understanding and insights to support investment and commercialization Disease Background Etiology & Pathophysiology Patient segmentation Epidemiology Demand Analysis System Dynamic analysis Triangulation Statistical analysis Implementation and Brand Plan Next step Competitor Analysis Treatment Algorithm Treatment guidelines Prescribing drivers of competitors SWOT of competitors Candidate analysis Target Product Profile validation in Iran Stakeholder evaluation Gap analysis of TPP Finding unmet needs Market Overview Treatment algorithm Treatment guidelines Prescribing drivers/resistors Current size Market trends Future outlook Growth Drivers & resistance Consumer Analysis Market segmentation Market sizing(Number of treatable patients, current and future) Current standard of cares strength and weaknesses of care Unmet needs Customer Analysis KOL, treating physician and payer interviews In-depth f to f surveys Influence mapping Decision making process Insights and recommendation Key finding Commercial implication Business Model Canvas Valuation Patient and Demand based forecast models BC The
  • 21. 21 Day Holding Mindset Visioning in Strategic Planning Process Environmental Analysis To find threats and opportunities Internal Analysis Identify strength and weakness Vision Core Ideology Envisioned Future of Day Holding Core Values, BHAG Strategy Where to compete How to compete Implementation Balance scorecard Operational Plans and Budget Online BPM Monitor and Control Pharmalyze
  • 22. Implementation Dashboard How we monitor Omiddarou salamat performance against strategic goals Goal: 1. Implementation of agreed & defined strategies 2. Extension of existing Performance Measurement-Systems (include qualitative measures) 3.Usage of „lead indicators 4. Improvement of existing SAP based Management Information Systems (MIS) 5. Manage growth & complexity Internal Process Business Process Management of Omiddarou Learning & Development  In the current climate of rapid technological change, it is becoming necessary for knowledge workers to be in a continuous learning mode. Financial Perspective Growth in operational Profit ROI Cash in earnings ratio NPV. Costumer perspective if customers are not satisfied, they will eventually find other suppliers that will meet their needs. Poor performance from this perspective is thus a leading indicator of future decline, even though the current financial picture may look good..
  • 23. Business Process management of ODS Integrated online monitoring system in different steps
  • 24. 24 Integrated System We wont give up till success Risk Mitigations Reliable partnership pharmalyze™ Integrated data management system Strategic Where to compete How to compete Self Distribution Day Darou Omid Cover all provinces over 8500 pharmacies Operational Effectiveness Training and knowledge
  • 25. 25 From Supply chain to patients Business process management Business Case Originator Ministry Of health Supply chain Omid Darou Salamat Dedicated BU LOA Documentation IDL Triple Pricing MOH Approval IRC Permission to import Order Registration Custom Clearance transactions Order for lab Releasing Products Labeling warehouse Interactivity Of S&M Server & Database Product Lunch Scientific Communication Accelerate Adoption & Adherence Prove product value Integrated Channel Management Patient Engagement Services (patient knowledge) Patient Use pills ShipmentPricing
  • 26. Our Team ,Services,SOLUTIONSIdentify, promote and prove value
  • 27. 27 Different Department process Our Team Head Mr.Ahmadi. Commercial Department Head Mr.Yazdanifard. Business Support Head Dr.Farsinejad Medical Head Dr.Tabatabaee. Regulatory & Market Access Head Mr.Anghaee Sales & MarketingBusiness Development Head Dr.Babazadeh. Pharmalyze®
  • 28. 28 2014 Experienced Management Dr.Mohsen Khatibi M a n a g i n g D i r e c t o r o f O m i d D a r o u Dr.Sadjad Bakhtiar M a n a g i n g D i r e c t o r o f D a y i n t Amirsaeed Malekshahi D a y H o l d i n g F o u n d e r & C E O
  • 29. 29 2014 Senior Non-Executive Board Dr.Amir Ekhlassi A s s i s t a n t P r o f e s s o r , U n i v e r s i t y o f T e h r a n Abbas Kafash Tehrani C E O o f p a s s a r g a d B a n k g r o u p Mohammad Kashti Aray C E O o f I r a n i a n J e w e l r y A S C
  • 30. Amirsaeed Malekshahi Owner and Chairman of Day Holding Malekshahi is known for his passion, desire, determination, discipline and dedication, Day Holding said. With annual revenue of $134 million in 2014, Malekshahi and his senior management team are credited with leading the company to explosive growth in the last three years. And Malekshahi volunteers his time mentoring youth in the community and the company contributes to many charitable causes, including the donation of Medicines to needy organizations. Amirsaeed Malekshahi is Chief Executive Officer of Omid darou salamat as well and serves on its Board of Directors. In this role, Malekshahi is responsible for driving the company’s growth as the Iran’s leading provider of pharmaceutical services. Omid darou salamat delivers services and information that enable its partners to evaluate and demonstrate the availability , global positioning and value of products over the course of their lifecycle. Malekshahi spends much of his time with customers, learning more about the challenges they face and helping them to navigate the complex healthcare environment with greater productivity and predictability. Malekshahi has concentrated his career in the healthcare and technology industries and he is viewed as a leading expert in the provision of business services within these fields. With 16 years of experience, Malekshahi brings an integrated, patient-centric view of healthcare, spanning pharma, payers, and providers to help partners be successful. Malekshahi spent 7 years at Tadbir kalaye jam, including 5 years in leadership roles, partnering with many of its key partner globally. As managing director of Tadbir kalaye jam Health and Products business areas, he successfully grew the portfolio of businesses. This operating unit included pharmaceutical firms, payers and providers, and drug retailers and distributors. Previously, he was the Iran chief operating officer for Alhavi’s operating group which included production and distribution .In both operating units, he partnered with clients on their growth strategies and initiatives, as well as enabling them to deliver significant operational efficiency improvements. More recently, he was establishing Omid Darou salamat for importing medicine and Arta Darou Pars for API . In this role Malekshahi was expected to grow company revenue to be a top 3 company in Iran. Throughout Malekshahi’s career, he has worked with leading companies on issues of strategy, operations and pharma technology based on his education in civil engineering . In addition, Malekshahi has consulted with and had teams at multiple pharmaceutical firms off and on since the mid-2000. After leaving Alhavi Malekshahi worked on a variety of healthcare and business services opportunities with TKJ . Early in his career, he was a consultant at TKJ . Omid Darou salamat established his own production site in kave industrial city in 2013 ,which will be enable ODS to be aligned with Ministry of health’s under-licensed production policy and give this opportunity to partners to expand their market share with no limitation .
  • 31. 31 Guiding Us in Our Mission for Better Health Culture & Value It takes 30 years to build a reputation and five minutes to ruin it. If you think about that, you’ll do things differently. ” “ Amirsaeed Malekshahi Chairman of Board – Day Holding
  • 32. Regulatory Affairs The power of possibilities OMIDDAROUS’ comprehensive expertise can help you confidently interact with regulatory affairs authorities for different therapeutic area and package and present all the information necessary to allow regulatory authorities to make the right decision. 100% of approximately 150 submissions to the FDO have passed technical validation for registering IRC. 50+ DIAF and 1.5 million pages published (all document types, e.g., DIAF/pharmacoeconomic/CTD ). 70% of our regulatory professionals hold advanced degrees, with an average of more than 16 years of experience.
  • 33. It will take approximately three years to register new molecule in Iran pharmacopeia but ODS register it …. . Registration Pathway Registration of Molecule and getting IRC code are two Milestone.
  • 34. Payer and policy maker in Iran Both are same ! Start Imported Products Final Bring Medicine to patients According to article 14 of the Act on Medical Affairs, Pharmaceuticals and Foodstuff (passed in 1955 and amended in 1988), in the Islamic Republic of Iran the Ministry of Health and Medical Education (MOH) is the main body that, as the Iranian National Drug Regulatory Authority, regulates and implements the imports, registration, and customs release of any sort of pharmaceutical products. ReimbursementFood and Drug organization Ministry of Welfare and Social Security Registration process IDL & IRC
  • 35. Registration Time Line This is a top priority to enter to market before becoming too Late
  • 36. Registration Process in Iran IDL Start The applicant submit an application to FDO IRC Finish The end of drug registry by getting unique IRC code, entrance to the Iran Pharma market FORM Number 1 Pharmaco Economic Files Price proposal Having Reference of France, Spain, Italy, Turkey and Greece and original country 45 Days Committee secreter Required Documents : Just verify the documentation 60 days Pharmacoeconomics Evaluation 30 Days Committee waiting List 1-12 Months Our core value is to change it to One Months Subcommite Head of Therapeutic area association The Actuary 60 Days IDSEC Last step-Final Approval 1 Month Price Approval Getting Price approval before getting IRC number  Technical commitee  Legal committe  Price Commitee Having price of France, Spain, Italy, Turkey and Greece and original country Preliminary agreement Required Documents : 1. LOA 2. CCP 3. DIAF 4. GMP IRC registeration The Dossier should preferably be presented in CTD format Registration fee: + 65,000,000Rial Day will pay for registration MOH evaluation DAY value is to shorten this step
  • 37. 02 01 43 Submitting Form to IDL Committee Submitting the Form Number 1 Nov ‘14 Experts of Registration Will working on file and application to send it to Committee secretary : Required Documents : Just verify the documentation 60 days Dec ‘14 Registration Process Iran Drug Registration and Iran Code registration
  • 38. 04 03 Timeline Continued Head of National Drug Committee Secretary Feb ‘15 Specialized Subcommittee Members of the Committee :  Evaluation board of the Ministry of Health  Medical and Pharmaceutical Specialty Association  Approved and University related Research centers  President of Iranian Medical Universities of Sciences  Local Manufacturer Companies Apr ‘15 05PharmacoEconomy Committee Pharmacoeconomic committee will require more information from ODS regulatory department. Aug ‘15
  • 39. Timeline Continued 06 IDSEC Members of the IDSEC: Minister of Health (Chairman) Head of Iranian FDO (Vice Chairman) Deputy of Health Deputy of Education A medical specialist which is consultant of Minister of Health General Director of Supervision on Medication (Secretary of the Committee) Sep ‘1507 08 IRC registration ODS regulatory Issue the : Form NO.1 LOA Nov ‘15 Finishing IDL Registration Oct ‘15
  • 40. Timeline Continued 0910Legal Committee General Director of Laboratories Deputy of planning Deputy of Technical Clinical pharmacists Local Manufacturer Companies representative . Jan ‘16 Technical Committee Deputy of planning Deputy of Technical General Director of Supervision on Medication Dec ‘15 11 Documentation preparation After legal committee Preliminary agreement Required Documents : 1. LOA 2. CCP 3. DIAF 4. GMP Mar ‘16
  • 41. 47 CTD + Price approval Expertise of registration Committee The Dossier should preferably be presented in CTD format Registration fee: + 65,000,000 Rial Day will pay for registration 12 Apr ‘16 CTD
  • 42. 3M NO Importer No Local manufacturer Locally production of Original Brand 1-2 Local Manufacturer/Import 3-6 Local manufacturer/Import 7-10 Local Manufacturer /import 6M 12 M 24 M 36 M 11 local Manufacturer/Import
  • 43. Registration Time Line 24 Months Total registeration gross steps Documentation Submission to subcommitee Pharmaco Economy Evaluation IDSC IRC Registration
  • 44. Comparison of price with current treatment alternatives or Brand value price ? Price AnalysisTurkey could be the reference for Iranian pharmaceutical market
  • 45. Price comparison Drug Pricing is the main strategy objective of FDO 2015 Pricing Strategy Our Price positioning Based on feasible studies. Local Generics availability 30% Turkey approval price 25% Brand 20% Ministry of health Weighting the MOH Price concerns Superiority in pharmacoeconomic 20% Imported generic availability 5% Landing Cost 13% Importer Margin 8-13% CPT Price Distribution 10% Pharmacy 15%
  • 46. 46 Choosing the right way to approach What We do Patient Demand Contacting to MOH consulter Pharmacoeconomic Waiting List Urgency What we will Bring to patient How we will scientifically Convince physician How Professional the file will be gather to reveal the facts The Urgency of needs Ease the invitation process
  • 47. 47 Four Main Documentation Registration Documents To Bing successful among all committees this evaluation will be the key Pharmaco economic assistance The Dossier should preferably be presented in CTD format . Dossier (CTD) Any legal entity that holds an exclusive agency of the Product License Holder (PLH) or Marketing Authorization Holder (MAH), can apply for the registration and imports of the related pharmaceuticals at the Division of Pharmaceutical and Narcotic Affairs. LOA Drug Importing Application Form (DIAF), Appendix 4, which has to be completed by the Product License Holder (PLH) CCP,DIAF
  • 48. Medical Affairs Medical Affairs is responsible for developing and executing medical marketing strategies and tactics for a brand or therapeutic area. Individuals in Medical Department must work very closely with sales and marketing. We are a key function on brand or therapeutic area teams.
  • 49. 49 Medical DepartmentWe customize your products value in iran 01 02 03 04 Training  Internal Trainings  Literature Services  KOL Management  Clinical Development Prototyping  Scientific Approvals  Reimbursement Subsidization supports  Outdoor Presentations Development  Event Management Support  Registration Supports  Pharmacology  Code of Ethics  Competitors analyses
  • 50. 50 Medical Department team To Deliver the Scientific data to the Market Medical Manager There are 57 SoP of Medical departments. Medical Advisor  Registration  IDL  PK and PD  Products  Competitors  Pros and Cons Medical Science Liaison  Efficacy & Safety  Comparisons  Scientific PM Contents  Brochures  Posters  Trials  Etc. Medical Analysis Compression of Different Strategy of molecules in Market in delivering their messages
  • 51. 51 Different events delivered by Medical Department Meet The Team Variation Medical Representative Training Medical training Director  Regular training sessions  New Products  Review sessions  Paper reviews  Cycle meetings  Role Plays  Exams and Evaluations of the MRs Event Management Event leadership  Promotional materials  Iran Medical Council (IRIMC)  Ministry of Health (MOH)  Manufacturer Country  Medical Research (Helsinki Declaration and Code of Ethics) KOL relation General Manager  Round tables  Advisory Boards  Expert meetings  Etc. Clinical Operations HR manager  Clinical trial collaboration  Clinical data management  Pharmacovigilance
  • 52. S&M Team Driving pharma sales force effectiveness is more critical as old sales models fail to deliver ROI. Success in the New Health demands a cost-conscious sales strategy built on agility and focus. Look to Day Holding for flexible contract sales force solutions. New sales outsourcing models are better at managing risk and optimizing portfolio value. Our elite pharma sales forces have helped launch more than 38 products in Iran. And we can help you drive greater returns while reducing fixed overhead costs associated with a large in-house sales force.
  • 53. Business Unit Structure BU HEAD Medical Marketing Marketing Manager Brand Specilist Brand Manager Media Manager Art Manager Sales NSM Supervisor DSM Multichannel Marketo alliance E detailing Art Patient communication Social Media Business Support Pharmalyz ™ Atomation Marketing Sales Market Research TRADE PHARMACY Distributor Manager Pharmacy Manager HELP DESk. FTE FTE Assistant Mdrep Md rep Md rep Md rep Md rep Market Research Manager
  • 54. Example of Prescriber Analysis – Prescriber Segmen Differentiation and description of target groups among psychiatrist and Neurologist for MDD Prescription Rate Motivation Cost N,C Psychiaterist Tier A Characteristics:  61% of total patients visited By 80% of Psychiatrist A  2 % innovator ,15% early adoptor Core motive: KOL support ,Academic Event Support Psychiaterist Tier B Characteristics:  13% of total Patients v isited By 50% of Psychiatrist B  4% innovator,18% early adoptor Core motive: attention (frequent call),promotional support Neurologist Tier A Characteristics:  13% of total Patients visited By 50% of Neurologist A  10 % of total A early adaptor  25 % of total A Early majority  Core motive: KOL support,being Consuler,Academic event support
  • 55. Hejrat Distribution Hejrat Distribution Company, the provider of distribution and sale services of drugs, medical facilities, dietary supplements, health and beauty products, considering the importance and the position of quality in its organization strategies, has chosen the quality management system based on ISO9001:2008 standard as a proper model for increasing the quality, constant improvement , and satisfaction of drugstores and health care centers as its customers.
  • 56. 56 Market share which enjoys almost 13.8% of Iran total pharmaceutical market share Storage capacity 10000 pallet in racks FEFO & FIFO Inventory control based on FEFO & FIFO methods Yearly Income Total annual income in Hejrat’s last fiscal year was more than 526 M$. Regional distribution centers Hejrat distribution company has 19 regional distribution centers Cold Storage capacity Storage capacity: 535 pallet in racks Including 5 saloons (2090 cubic meters) Air lock 2-8 °c & 8-15 °c & 0-(-24) °c Employee  Total: 133 vehicles  Semi trucks: 106 vehicles  Trucks: 7 vehicles  Refrigerated vehicles : 29 vehicles  Pickups: 20 vehicles  Cold & Cool rooms: 900 cubed meters 850  Tablets for order confirmation  Install GPS to control vehicles location  Wireless data loggers for warehouses temperature & humidity control  Uniform packaging for deliverable orders  Enterprise Resource Planning software  Online web ordering
  • 57. 57
  • 58. Pharmalyze® BUSINESS SUPPORT Provide timely, relevant, consistent and accurate information of all shareholders
  • 59. Data management System Source of Data Pharmalyze® is breakthrough technology. It provides access to key Data in market and a comprehensive picture of selling progress to support proactive S&M team decision making. Ministry of Health The Monthly reports of MOH of sales analyzed in different dimensions by Qlikview Distributors With Self Distribution System we are enabled to adjust our channel according our priorities which in impossible in out- sourcing business model pharmacies All pharmacies connected to defined Physician in the different therapeutic area .The sales data per day and simultaneously physician targets will be measured Prescribers Prescribing behavior . Online patient centric -Beta Knowing patient needs . We focus on our main market research areas, all types of therapeutic classifications-as well as looking at opportunities in promising technologies and early-stage collaborations. Beyond the asset, we always look for the right partnership and cultural fit. We are not looking for compounds that represent marginal improvements compared to the current standard of the right methods of analyzing we are thinking about ROI improvement.
  • 60. How we are aware of Market ? This is example for Data gathering system $725,000 Some Money saved since 2015 One of the great advantages of the system is its facility for preparing standard reports and exporting information for further statistical analysis. Some Info from Pharmalyze©  The system is in compliance with the requirements of the Data Protection Acts.  The patient’s medical record number (MRN) is used as a unique identifier to count the number of patients treated .  The number is encrypted and is not reported outside of the organization.  A privacy statement is incorporated.  All information is entered retrospectively and is not linked in any way to individual patients.  Patient or clinical information is not recorded in the system.  The information input is owned by the Omiddarou where the service is delivered . 65% 1800 Pharmacy Involved 5 main Cities  Tehran  Isfahan  Tabriz  Shiraz  Mashhad
  • 61. 360° View of Market dynamics ODS eyes Product Profile Market characteristics Sales vs Target (Yearly) Company growth Sales vs Target (Province) Sales team KPIs Sales/day Day sales in depth understanding of supply chain Sales/Physician (Monthly) Updated weekly and analyzed monthly to measure messeges Finance reports 4 level information Analysis CAPABILITIES Market & Channel Analyzing •We help partners increase their sales and marketing operational efficiency by evaluating processes that differentiate them in the marketplace. •We evaluate and recommend new promotional channels, including investments in new capabilities and partners to respond faster to a changing customer base. Market Technology Analyzing •Evaluations and recommendation for sales and marketing systems, CRM (both local and BPS-based) and cloud-based services providing integration with social media networks. •High-performing organizations need to exploit technology to deliver optimal and cost-effective services to customers.
  • 62. 62
  • 63. Full Commercial Services Day Holding, is the Iran Fastest growing of pharmaceutical commercial services with a network of more than 28 branches conducting business in Iran. ‘We are in the business of getting people to be truly involved with our products and services to care or improving their health . Day Holding, is a pharmaceutical trading which specializes in launching pharmaceutical brands as well as rebranding with Focusing on Strong Marketing Department and Analytic actions ,We deliver inspirational and actionable ideas to help our partner win in the marketplace .”
  • 64. 64 DAY is continually seeking new ways of doing more with less Services 5 Key Services in pharmaceutical Commercial Support from patients plays a key role in determining your product’s commercial success. Day Holding specializes in helping brands form connections and reinforce bonds with patients throughout the entire pharmaceutical lifecycle – from clinical development through commercialization. As an industry leader in direct-to-patient research in Iran , we are poised to help build strong bridges between your product and the patients you serve. Regulatory Analyze Strategic Launch Scientific Communication Optimized Distribution
  • 65. Solutions We help you navigate the value substantiation process from diagnosing stakeholder needs and spheres of influence to performing real-world benefit-risk and competitive analyses – so you can optimize your product’s value platform and gain a preferred position on payer formularies at favorable pricing and reimbursement. The earlier we start collaborating, the more we can help you launch the right product with the right value proposition and evidence packages.
  • 66. 66 Solutions The power of possibilities Positioning of the Brand MOH Relationship Registration Start-up (successful Launch) Emerging Growth Fast Track Market Penetration Detailing capacity Strong Presence In the franchise Formulated adapted market strategies
  • 67. Collaboration Model Day Collaboration Framework articulate optimum partnership
  • 68. 68 Day Collaboration Framework articulate cross-functional and cross-firm co-create value with key leaders and Originator Gear Business Model Align Expectation Develop action Plan Develop product distribution agreement Agreement for win-win collaboration Determine Support Level of both side Review performance
  • 69. 69 Collaboration Business Model in Iran Own affiliate/office Own sales forceSupply the medicine Supply the medicine Supply the medicine Distributor Distributor Distributor Registration Non-operation S & M Registration Non-operation S & M Registration Non-operation + % $ Based on sale Based on what planned
  • 71. 71 Via Day International Day International the subsidiary company of Day Holding Transfer all received money from UAE BANK to any account to all Countries From Parsian Bank to BCP Bank Money Transfer to all worldwide account of BCP bank From Parsian Bank to Heritage Bank Money Transfer to all worldwide account of Heritage Bank Via HULK Bank TURKEY All Companies who has an account in Turkey HULK BANK or account in Iranian banks who working with Hulk Bank Can use this way.
  • 72. How it works ? Examples of how Omid Darou and all other pharmaceutical companies transfer their Money from Iran
  • 73. DAY Internation .FZE With Normal Transaction money transfer from Iran To Day international Account in United Arab Bank Day Internation enable to transfer money to all Account in World in any Bank Examples  Lundbeck  Sigma tue  Ribusepharm  Kern & ….
  • 74. From Iranian Parsian Bank To any international account of BCP Bank For Originator who has an account in BCP Bank Example Bunge  www.bunge.com http://www.bcp-bank.com/
  • 75. From Iranian Parsian Bank To any internation account of Heritage Bank For Originator who has an account in Heritage Bank Example  CSL Behringer  Roche
  • 76. Via Turkey HULK Bank The Multinational companies opened an account in Turkey Hulk Bank to have full featuers of transactions Most popular for pharmaceutical companies used this method before parsian bank solution Examples  Astrazeneca  Sanofi  Merck  Lilly http://www.halkbank.com.tr/e/
  • 77. Partnership Process we strive continuously to be the partner of choice
  • 79. 79 Fully integrated company Day Holding is a fully integrated company with more than 370 employees in 31 Provinces; we have core competencies in Fast Track Market access for Registering new products, efficient S&M Team Flexible, fast decision making on partnerships Day’s top management is committed to developing partnerships and has designed a process to ensure structured and fast decision making when evaluating new partnering opportunities. Proven track record of commercial success Our Oncology and CHC Products is a market leader in Iran. we Fast Track Registration Dr. Mohsen Khatibi ( OmidDarou GM) The former Deputy of Minister with 16 years experience in Ministry of health with his team in regulatory department. Is Our leverage to have common language with MOH. Dr.khatibi is currently the member of many committee in MOH . Dr.khatibi ( MD/ pharmacoeconomic PhD) Why partnering with Day ? Partnership Process
  • 80. Partners The Impact ofTrust on the Day & Partners Relationship
  • 81. 2009 2010 20132011 2012 2014 2009 20% growth 2009 : 48 Million$ 2010 23% growth 2010 : 58 Million$ 2011 18% growth 2011 : 69 Million$ 2012 19% growth 2012 : 83 Million$ 2013 24% growth 2013 : 102.7 Million USD , $ 2014 19% growth 2014 : 123Million$ 48 58 69 83 123Value Turnover Trend of Day Holding Million US Dollar Our Investment on Marketing 102.7 Ribosepharm (Germany) Lyomark (Germany) Sigma-Tau (Italy) Generis (Portughal) Meiji Seika(Japan) Remedica (Cyprus) Laboratorio Aldo-Union (Spain) Bendalis (Germany) Faes Pharma (Spain) Arko Pharma(France) Unipharma (Greece) Combino Pharm (Spain) Indimmune (India) Kern pharma (spain) Daewoong (South Korea) Biocol (Portugal) Future Biotic (USA) Md tech (Italy) Lundbeck (Denmark) Gebro pharma(Austria) 2015 Coming soon !
  • 82. www .D a y I n t .org Head Quarter Office No. 20, 2nd St., Zarafshan shomali St. Sanat Sq., Shahrak Gharb Zip: 1466743784, Tehran, Iran. Tel: (+98) 21 88580017-18 Fax: (+98) 21 88376445
  • 83. Business CaseDAY Holding Business Development AstraZeneca Diabetes Iran Diabetes Iran Omid Darou salamat 2015
  • 84. INDEX Diabetes Business Case Summary Whole story in one page Market structure Registration Epidemiology Incidence, Prevalence, Patient Characteristics, OAD /Insulin Treatment paradigm for treatment in Iran Guidelines Market Overview Market environment Market analysis Competitor analysis
  • 85. Pricing analysis Price strategy Registration Pathway  timeline,  Steps  critical gateways  expected launch date Forecasts
  • 86. SummaryLets talk about Whole story at glance
  • 87. Summary Epidemiology to Forecast 2 Years Registration At MOH Targeted OAD Patients Base
  • 88. The main principal of patient population in Iran Driven by Patient awareness of their diseases . There are many articles indicate a poor diagnosis rate of patients in Iran . EpidemiologyDefined the Unmet area in Mixed Patient with new diagnosis pathway
  • 89. 01 11% Diabetes 9 Million patient Iran Demographic2015 89 Local Producer 93 Medicine Importer 30 API Producer 53 Local Distributor (80% by 10) 53% . 22%(0-14) 20%(15-24) 44%(25-54) 3%(60-64) 5%(>60) 8 million >60 YRS 16 million Obesity 168 124 18 million HTN 45000 Dies by cancer 47% 79 Million population GDP : 368.9 b USD GDP Per Capita : 4763 USD Health Exp. : 6% Pharma CAGR: 24%
  • 90. 4.5 Mil Diagnosed 2.8 Mil Treated 9 Mil Diabetes 2 Mil OAD Lantus (38k patient) NovoRapid (39k patient) NovoMix (95k patient) Regular+NPH (240k patient) Regular (82k patient) Biphasic (35k patient) 810 Kilo insulin 20% CAGR Volume 5Y Diabetes structure GLICLAZIDE (74k patient) REPAGLINIDE (42k patient) PIOGLITAZONE (120k patient) GLIBENCLAMIDE (1650k patient) METFORMIN (946k patient) ACARBOSE (28k patient) METFORMIN/ GLIBENCLAMIDE (3k patient) SITAGLIPTIN (1k patient) 10% CAGR
  • 91. Diabetes Market– Market structure Levels of narrowing based on potential and actual patients according 2016 lanch strategy Penetrated Market Total Diabetes Estimated Patients : 6.8 Million patient Important competitors : NONE Treated Diabetes Estimated Patients :4.5 M Important competitors: importers OAD patients Estimated Patients :2000K patient(2016) AstraZeneca Diabetes portfolio ® Estimated Patients :65K patient Total Dual therapy Segment Estimated patients : 1500k
  • 92. What paradigms are Iranian Kols choose to treat TYPE 2 Diabetes Treatment paradigmADA guideline 2015
  • 93. Prescriber Analysis – Prescriber Segmentation Differentiation and description of target groups among endocrinologist and Internist Prescription Rate Motivation Cost N,C Endocrinologist Tier A Characteristics:  61% of total patients visited By 80% of endocrinologist A  2 % innovator ,15% early adoptor Core motive: KOL support ,Academic Event Support Endocrinologist Tier B Characteristics:  13% of total Patients v isited By 50% of endocrinologist B  4% innovator,18% early adoptor Core motive: attention (frequent call),promotional support Internist Tier A Characteristics:  13% of total Patients visited By 50% of Internist A  10 % of total A early adaptor  25 % of total A Early majority  Core motive: KOL support,being Consuler,Academic event support
  • 94. Prescriber Analysis – ABC Analysis of prescriber Potential High Medium Low LowMediumHigh Shareinsales BA A B C C A B C A-type Prescriber B-type Prescriber C-type prescriber INT-A endocrinologist A INT-B Endo-C Endo-B INT-C *innovative visualization Internist : 1000 Prescriber Internist : 850 Internist (Tier A) : 250 Internist (Tier B) : 350 Internist (Tier C) : 250 Endocrinologist : 220 Prescriber endocrinologist : 178 endocrinologist (Tier A) : 35 endocrinologist (Tier B) : 53 endocrinologist (Tier C) : 81
  • 95. Entry A1c ≥ 7.5% GLP-1 RA SGLT-2i DPP-4i SGLT-2i MET or other 1st-line agent MET or other 1st-line agent + 2nd-line agen TZD TZD BasalInsulin Basalinsulin + Colesevelam DPP-4i t + Bromocriptine QR Colesevelam AGi Bromocriptine QR SU/GLN AGi SU/GLNIf not at goal in 3 months proceed to Triple Therapy If not at goal in 3 months proceed to or intensify insulin therapy * Order of medications listed represents a suggested hierarchy of usage P R O G R E S S I O N O F D I S E A S E LEGEND Few adverse events or possible benefits Use with caution ADD OR INTENSIF Y INSULIN Refer to Insulin Algorithm Therapy ±Therapy TRIPLE THERAPY* GLP-1 RA DUALTHERAPY* SYMPTOMS NO YES DUAL INSULIN Other OR Agents TRIPLE MONOTHERAPY* Metformin GLP-1 RA SGLT-2i DPP-4i AGi ZD SU/GLN If not at goal in 3 months proceed to Double Therapy Entry A1c > 9.0%Entry A1c < 7.5% L I F E S T Y L E M O D I F I C AT I O N (Including Medically Assisted Weight Loss)
  • 96. Rational prescribing: The principles of drug selection T1 in Iran Dr.Khamseh & Dr.Kazemi & Dr.Esteghamati Efficacy Hypo risk Weight side effects cost 10%90% What is important to categorized treatment step 10% Type 1 90% Diabetes T2
  • 97. - 20 40 60 80 100 120 140 160 2010 2011 2012 2013 2014 Mill.Euro Total MS 53% in 2014 with 3 company: Novo Nordisk : 43 Mil Euro Sanofi : 19 Mil Euro Merck Serono : 7 Mil Euro MS local companies is 44% Top Brands in 2014 Novo Rapid (Novo Nordisk): 29 Mil Euro lantus (Sanofi): 19 Mil Euro Novo Mix (Novo Nordisk): 12 Mil Euro Top Molecules in 2014 INSULIN : 81 Mil Euro METFORMIN : 33 Mil Euro GLIBENCLAMIDE : 7 Mil Euro InsulinOAD DIABETES Therapeutic area Iran DIABETES Therapeutic area Iran 36% CAGR 5 YS 25% Diabetes GR 2013 9% Total Market GR 2013 51% Local MS (of Diabetes) 2014 4% MS (of Total) 2014 144 116 81 55 43
  • 98. Confidential Document Franchise - 20 40 60 80 100 120 140 160 2010 2011 2012 2013 2014 Mill.Euro OTHERs ALPHA GLUCOSIDASE INHIBITORS THIAZOLIDINEDIONES SULFONAMIDES, UREA DERIVATIVES INSULINS FAST-ACTING INSULINS A LONG-ACTING BIGUANIDES INSULINS INTERMEDIATE-ACTING COMBINED WITH FAST-ACTING 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2010 2011 2012 2013 2014 OTHERs ALPHA GLUCOSIDASE INHIBITORS THIAZOLIDINEDIONES SULFONAMIDES, UREA DERIVATIVES INSULINS FAST-ACTING INSULINS A LONG-ACTING BIGUANIDES INSULINS INTERMEDIATE-ACTING COMBINED WITH FAST-ACTING
  • 99. Molecule (Sales Value) Molecule Value 2013 Value 2014 GR CAGR MS 14 METFORMIN 35,792,421 34,730,158 -3% 26% 60% GLIBENCLAMIDE 7,986,546 8,627,512 8% 2% 15% PIOGLITAZONE 5,873,236 6,051,774 3% 25% 10% ACARBOSE 3,893,847 3,992,244 3% 13% 7% REPAGLINIDE 1,776,011 2,352,289 32% 15% 4% GLICLAZIDE 1,735,209 2,145,496 24% 37% 4% SITAGLIPTIN 146,526 0.25% METFORMIN/GLIBEN CLAMIDE 106,452 135,569 27% 0.23% Others 76,770 1,453 -98% -57% 0.00% Total 57,240,492 58,183,023 2% 19%
  • 100. Sales Value 14 20 31 36 358 6 8 8 9 - 10 20 30 40 50 60 70 2010 2011 2012 2013 2014 Mil.Euro METFORMIN GLIBENCLAMIDE PIOGLITAZONE ACARBOSE REPAGLINIDE GLICLAZIDE SITAGLIPTIN METFORMIN/GLIBENCLAMIDE Others [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2010 2011 2012 2013 2014 METFORMIN GLIBENCLAMIDE PIOGLITAZONE ACARBOSE REPAGLINIDE GLICLAZIDE SITAGLIPTIN METFORMIN/GLIBENCLAMIDE Others
  • 102. Molecule Sales Volume (Based on patient) Molecule Volume 2013 Volume 2014 GR CAGR MS 14 GLIBENCLAMIDE 1,433,386 1,650,718 15% 4% 58% METFORMIN 993,189 946,280 -5% 23% 33% PIOGLITAZONE 100,689 120,599 20% 24% 4% GLICLAZIDE 44,604 74,507 67% 32% 3% REPAGLINIDE 29,996 42,797 43% 39% 1% ACARBOSE 22,517 28,671 27% 25% 1% METFORMIN/GLIBENC LAMIDE 2,208 3,306 50% 0% SITAGLIPTIN - 674 0% Total 2,626,590 2,867,552 9% 10%
  • 103. Sales Volume (Based on Patient) 1,419 1,584 1,652 1,433 1,651 - 500 1,000 1,500 2,000 2,500 3,000 3,500 2010 2011 2012 2013 2014 KMGTab GLIBENCLAMIDE METFORMIN PIOGLITAZONE GLICLAZIDE REPAGLINIDE ACARBOSE METFORMIN/GLIBENCLAMIDE SITAGLIPTIN [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] [CELLRANGE] 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2010 2011 2012 2013 2014 GLIBENCLAMIDE METFORMIN PIOGLITAZONE GLICLAZIDE REPAGLINIDE ACARBOSE METFORMIN/GLIBENCLAMIDE SITAGLIPTIN
  • 104. Molecule Map (Volume Based on Patient Number.DDD) CAGR 5Ys MS GLIBENCLAMIDE METFORMIN PIOGLITAZONE GLICLAZIDE REPAGLINIDE ACARBOSE -10% 0% 10% 20% 30% 40% 50% 60% 70% -20% -10% 0% 10% 20% 30% 40% 50% 60% 70% 80%
  • 105. Pricing Control on Pricing is the main objective of FDO 2015 Pricing Strategy Medicine price is controlled by the food and drug organization through pricing commission regulations in a cost plus basis through comparison with selected reference countries such as turkey ,Greece ,Spain and Original country . Local Generics availability 30% Turkey approval price 25% Brand 20% Ministry of health Weighting the importance of principals for MOH in Pricing process Superiority in pharmacoeconomic 20% Imported generic availability 5% Landing Cost 13% Importer Margin 8-13% CPT Price Distribution 10% Pharmacy 15%
  • 106. Drug Registration Process in Iran IDL(Iran Drug List) Start The applicant submit an application to FDO IRC(Iran Registeration Code) Finish The end of drug registry by getting unique IRC code, entrance to the Iran Pharma market FORM Number 1 Pharmaco Economic Files Price proposal Having Reference of France, Spain, Italy, Turkey and Greece and original country 45 Days Committee secreter Required Documents : Just verify the documentation 60 days Pharmacoeconomics Evaluation 30 Days Committee waiting List 1-12 Months Our core value is to change it to One Months Subcommite Head of Therapeutic area association The Actuary 60 Days IDSEC Last step-Final Approval 1 Month Price Approval Getting Price approval before getting IRC number  Technical commitee  Legal committe  Price Commitee Having price of France, Spain, Italy, Turkey and Greece and original country Preliminary agreement Required Documents : 1. LOA 2. CCP 3. DIAF 4. GMP IRC registeration The Dossier should preferably be presented in CTD format Registration fee: + 65,000,000Rial Day will pay for registration MOH evaluation DAY value is to shorten this step Iran Drug List – 24 Months Iran Registration Code– 12 Months
  • 107. Is under coverage of reimbursement ReimbursementThree major Organization SSO MSIO Military insurance The Social Security Organization (SSO): Generally, 7 million insured persons as well as 1,300,000 old-age pensioners are covered by the SSO; meanwhile, considering the family members and dependents of the major insured individuals, totally, the covered population by the SSO who receives insurance and medical services is about 27.5 million persons. The Medical Service Insurance Organization (MSIO): MSIO provides health insurance for government employees, students, and rural dwellers. The rural population not covered by any other insurance plan were entitled to receive benefits at will in 2000. Patients are subject to copayment at the point of service. The Military Personnel Insurance Organization Provides health insurance for military personnel Reimbursement Medicine cost reimbursement is mainly undertaken by three major organizations: Social Security Organization (public), Medical Services Insurance Organization (governmental), and Medical Insurance Services Organization of Armed Forces (governmental), all of which reimburse the cheapest medicine registered. The emerging supplementary insurance companies are putting constraints on pharmaceutical expenditure. There is a positive list of medicines fully covered by the government that contains specialty drugs. 90% of Iranian 10 steps to entitle Drugs in reimbursement List Approximately 18-24 Months
  • 108. Registration Dynamics Iran-NDP Factors influencing the probabilities The NDA and different parties in the ministry of health (MOH) have problems in making unified decisions that would result in amelioration or deterioration of NDP indicators. Surely, the drug systems and decision makers have limited resources and technologies to predict and evaluate the consequences of their decisions. Available Local molecules Willingness to Produce Domestic product share Cost benefit & Price Competition Severity of Illness and Demand Availability of alternative treatment Affordability 75% 50% 50% 40% Affordability : monthly medication costs. Catastrophic Index Price competition Health Expenditure GDP PC Alternative treatment cost Severity of illness Therapeutic area growth New patients
  • 109. Astrazeneca portfolio Oppurtunity assesment 43 % 15% 20 % 11 % 0 % 11 % Price 27.1€ Registeration Likehood 4 2017 2019 Onglyza® Kombiglyze XR® Forxiga® Xigduo XR® Byetta® Bydureon® Registeration Likehood 6 Registeration Likehood 3 Registeration Likehood 5 Registeration Likehood 2 Registeration Likehood 1 Price 33.3€ Price 30 € Price 32€ Price 47€ Price 72€
  • 110. 112 Legitimacy of forecast By Diabetes Expertise No-Reimbursement considered Forecasting Launch 250% 117% 59% 2017 2018 2019 2020 OAD Market From Add-On therapy Glibenclamide market segmented From Monotherapy uncontrolled patient of Metformin The Market divided in to eligible patients for DDP- 4,SGLT2,GLP1 . Potential Patients Glibenclamide : 1,448,195 Uncontrolled patient of Metformin : 312,609 63,500 in 5th year 24.3 Million Euro 2021 1.2 4.2 9.2 14.7 20 25 38% 2021 22% 2022
  • 111. Onglyza® 5 year Forecast of Saxagliptin 5mg pack of 28 price 30.60 Euro (Turkey reference Price) 86 1st Year Vol : 650 k pack Patient : 1,781 Value : 0.7 million Euro 2nd Year Vol : 2000 kpack Patient : 5,479 Value : 2 million Euro 3rd Year Vol : 4000k pack Patient : 10,959 Value : 4,3 million Euro 4th Year Vol : 6000 k pack Patient : 16,438 Value : 6.4 million Euro 5th Year Vol : 7800kpack Patient : 21,370 Value : 8.3 million Euro 3% 7% 13% 18% 22% Market share of selected segment : Eligible patient for DDP4
  • 112. Kombiglyze XR® 5 year Forecast of Saxagliptin & Metformin Hcl XR 2,5 MG/1000 MG 56 FILM of price 36.96 Euro(Turkey reference Price) 86 1st Year Vol : 300k pack Patient : 822 Value : 198 K Euro 2nd Year Vol : 1200k pack Patient : 3,288 Value : 792K Euro 3rd Year Vol : 3000k pack Patient : 8,219 Value : 1,9 million Euro 4th Year Vol : 5000k pack Patient : 13,699 Value : 3.3 million Euro 5th Year Vol : 7000k pack Patient : 19,178 Value : 4.6 million Euro 1% 4% 9% 14% 19% Market share of selected segment: Eligible patient for DDP4+Metformin
  • 113. Forxiga® 5 year Forecast of Dapagliflozin pack of 28 price 28 Euro 86 1st Year Vol : 300kpack Patient : 822 Value : 351 Euro 2nd Year Vol : 900k pack Patient : 2,466 Value : 1million Euro 3rd Year Vol : 1800kpack Patient : 4,932 Value : 2.1 million Euro 4th Year Vol : 2400k pack Patient : 6,575 Value : 2.8 million Euro 5th Year Vol : 3300Kpack Patient : 9,041 Value : 3.8 million Euro 5% 13% 24% 29% 38% Market share of selected segment: Eligible patient for Dual therapy and triple therapy with SGLT
  • 114. Xigduo XR® 5 year Forecast of Dapagliflozin and Metformin Hcl 5/1000 mg pack of 28 price 35 Euro 86 1st Year Vol : 200 kpack Patient : 548 Value : 250kEuro 2nd Year Vol : 600kpack Patient : 1,644 Value : 750k Euro 3rd Year Vol : 1200 k pack Patient : 3,288 Value : 1.5 million Euro 4th Year Vol : 1800k pack Patient : 4,932 Value : 2.2million Euro 5th Year Vol : 2400k pack Patient : 6,575 Value : 3 million Euro 3% 8% 26% 36% 45% Market share of selected segment: Eligible patient for Dual therapy and triple therapy with SGLT 3% 8% 15% 21% 26%
  • 115. Bydureon® 5 year Forecast of Exenatide XR pack of 4 price 80.57 Euro(United Kingdom) 86 1st Year Vol : 10k pack Patient : 192 Value : 200k Euro 2nd Year Vol : 30k pack Patient : 577 Value : 604k Euro 3rd Year Vol : 60k pack Patient : 1,154 Value : 1.3 million Euro 4th Year Vol : 90k pack Patient : 1,731 Value : 2 million Euro 5th Year Vol : 130k pack Patient : 2,115 Value : 2.6 million Euro 2% 6% 12% 17% 21% Market share of selected segment : Eligible patient for GLP-1
  • 116. Thanks for watching Diabetes Business case Iran Business Development Department @Modjtaba Babazadeh M. Babazadeh@dayint.org

Editor's Notes

  1. We address the needs of Originator including payers and providers in a way of helping patients. We use our expertise and insights to help Originator optimize the value of their drug launch, commercialization and outcomes delivery. Our mission is To earn Originator's trust by delivering on our promises with high-quality professional commercialization services that help improve outcomes and also will improve its market and revenue position. We can support Originator from strategy through planning and execution. Through our extensive range of services, we solve Originator's biggest challenges with better decision making: decreasing costs, improving productivity, and saving time simultaneously with increasing the market share. The broad scope of our services helps Originator and provider rapidly assess the viability of a growing number of potential new therapies, cost-effectively accelerate development of the most promising ones, successfully launch new products to market and be able to evaluate his impact and appropriate use in Iran Market .
  2. Ms Arab Zadeh Ms.Simakhani
  3. The major process authorities which may affect the meeting of the above requirements include: insurance companies' representative, the industry's representative, the physicians community representatives, and the representatives from the Health Deputy Office as the manager and the supervisor of Iranian NHP. These authorities are consulted en route the entry of a drug to the National Drug List. Meanwhile the National Drug Committee secretary will negotiate and debate the entry of the drug with members of the Committee, which is a national committee with about 20 specialized committees, after the preliminary evaluation of the submitted documents and ensuring the safety, efficacy, and cost-efficiency of the nominated drug and the cost-efficiency assessment in comparison to the same rank drugs. If the specialized committee approves the safety, efficacy, and cost-efficiency of the drug and if the drug has been prescribed for a minimum of 3 years in North American or West European countries, it will be referred back to the National Drug Committee for final approval. The members of the Committee include the insurance, industry, and Deputy of Health representatives and a number of pharmacological and clinical specialists designated by the Ministry of Health. If the Committee approves the entry of the drug to the National Drug List, the due process will be executed and the due procedures will be announced to the Medical Association, insurance companies, pharmaceutical manufacturers, and drug importers. The manufacturer or the importer of the drug is then allowed to submit the required documents for registration for the marketing of drugs in the country to the General Department of Medicines Affairs in compliance to additional regulations.
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