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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
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..
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
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
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
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.
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.
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
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/
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
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
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%
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
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
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
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 .
Ms Arab Zadeh
Ms.Simakhani
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.