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‫دکتر‬‫کبریایی‬ ‫عباس‬
‫ته‬ ‫پزشکی‬ ‫علوم‬ ‫دانشگاه‬ ‫داروسازی‬ ‫دانشکده‬ ‫دارو‬ ‫مدیریت‬ ‫و‬ ‫اقتصاد‬ ‫گروه‬ ‫مدیر‬‫ران‬
‫برگزاری‬ ‫تاریخ‬
24‫مردادماه‬98
‫دانشجویان‬ ‫نقش‬ ‫و‬ ‫ایران‬ ‫اقتصاد‬
‫آن‬ ‫آینده‬ ‫در‬ ‫داروسازی‬
‫زاده‬ ‫کبریایی‬ ‫دکتر‬–‫مرداد‬1398
Economic Environment
?
Growing Constrained
0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% 22%
Engineering, Construction
Insurance: Property and Casualty (Stock)
Food Production
Food and Drug Stores
Computers, Office Equiment
Trading
Mail, Package, and Freight Delivery
Specialty Retailers
Chemicals
Energy
Health Care: Insurance and Managed Care
Metals
Beverages
Banks: Commercial and Savings
Network and Other Communications Equipment
Shipping
Aerospace and Defense
Building Materials, Glass
Industrial Machinery
Telecommunications
Household and Personal Products
Food Consumer Products
Tobacco
Pharmaceuticals
Mining, Crude Oil Production
Profit %
Industires
Source: Fortune Global 2010
‫سودآوری‬ ‫نمودار‬25‫جهان‬ ‫برتر‬ ‫صنعت‬
World
Development
Indicators
Database, World
Bank 2015
‫سالمت‬ ‫سهم‬ ‫و‬ ‫جهانی‬ ‫اقتصاد‬ ‫در‬ ‫ایران‬ ‫جایگاه‬
•‫رتبه‬ ‫داخلی‬ ‫ناخالص‬ ‫تولید‬18‫دنیا‬
•‫ملی‬ ‫ناخالص‬ ‫تولید‬ ‫از‬ ‫سالمت‬ ‫سهم‬6.9%‫رتبه‬88‫دنیا‬
•‫سالمت‬ ‫هزینه‬ ‫سرانه‬490$‫رتبه‬81‫دنیا‬
Iran Pharmaceutical Market Trends
1980 1988 1996 2004 2007 2013 2015 2018
Population (Million)based on
last formal census
40 53 62 69 71 76 79.3 82.3
Market Value (Million US$) 660 720 950 1550 2700 4060 4238 4882
Local Manufactured share
(Value)
80% 89% 84% 72% 65% 63% 70% 70%
Total Market Size (Billion
Unit)
5.9 11.3 15.8 26.5 30.8 34.2 35.2 37.9
Local Manufactured share
(Volume)
95% 95% 96% 96% 97% 95% 97% 97%
Total Pharmaceutical
Expenditure Per Capita (US$)
16.5 13.6 15.3 22.5 37.7 52.7 53.4 59.3
17.1
11.7 11.3 10.9
10.3
9.7
9.1 9.1
5.6 5.6 5.2
4.6
4
3.2
6.9
0
2
4
6
8
10
12
14
16
18
UnitedStates
France
Germany
Canada
Japan
Brazil
Italy
UnitedKingdom
China
Turkey
Iraq
Singapore
India
SaudiArabia
Iran,IslamicRep.
Health Expenditure (% GDP)
Various Countries
9
Source: 2014,World Bank Data
Percent
Medicine Expenditure (% of Health Expenditure)
Various Countries
10
12.0
15.816.7
19.9
7.4
21.8
13.9
16.0
14.8
33.6
15.8
18.5
17.2
21.6
9.5 9.4
7.3
22.7
18.6
26.4
19.4
12.6
9.7
11.9
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
Austria
Belgium
Canada
Czech…
Denm…
Estonia
Finland
France
Germa…
Hungary
Iceland
Ireland
Italy
Korea
Nether…
New…
Norway
Poland
Portugal
Slovak…
Slovenia
Sweden
Switze…
United…
%
14
Iran Population Pyramid 2015
Median Age: 28.3
‫سال‬ ‫تا‬ ‫دنیا‬ ‫در‬ ‫جمعیتی‬ ‫هرم‬2020
‫سال‬ ‫در‬ ‫جهان‬ ‫جمعیت‬20056.5‫نفر‬ ‫میلیارد‬
‫که‬ ‫است‬ ‫بوده‬7.3%‫آنها‬(‫معادل‬477.4
‫نفر‬ ‫میلیون‬)‫سن‬ ‫با‬ ‫افراد‬65‫بوده‬ ‫باالتر‬ ‫و‬ ‫سال‬
‫اند‬.‫سال‬ ‫در‬ ‫میشود‬ ‫بینی‬ ‫پیش‬2020‫جمعیت‬
‫مرز‬ ‫از‬ ‫جهان‬7.6‫و‬ ‫بگذرد‬ ‫نفر‬ ‫میلیارد‬9.4%
‫سن‬ ‫با‬ ‫افراد‬ ‫را‬ ‫آن‬65‫تشکیل‬ ‫باالتر‬ ‫و‬ ‫سال‬
‫داد‬ ‫خواهند‬.
Iranian market growth drivers during 2011 to 2016, based on ATC coding
5,183
3,847
371
237
218
188
95
80 55 53 46 28
12
6 9 33
13.7%
7.5%
9.3%
7.8%
2.6%
7.0%
3.2%
5.0%
4.4%
3.3%
11.4%
-1.0%
-3.1%
-5.6%
6.1%
-10%
-5%
0%
5%
10%
15%
3,000
3,500
4,000
4,500
5,000
5,500
CAGR(2011-2016)
Sales(MillionUS$)
Actual CAGR (2011 - 2016) VS. Forecast CAGR (2017 - 2022)
Bubble Size : Market Share (AVG 2014 - 2016)
Alimentary & Metabolism ;
14.6%
Antiinfectives, 15.3%
Antineoplastics &…
Antiparasitic, 0.5%
Blood, 11.2%
Cardiovascular, 5.2%
Dermatologicals, 2.4%
Genito-urinary, 4.8%
Musculo-Skeletal, 4.7%
Nervous system, 10.9%
Respiratory, 7.1%
Sensory organs, 1.0%
Hormonal preparations, 3.8%
-6%
-4%
-2%
0%
2%
4%
6%
8%
10%
12%
14%
16%
0% 1% 2% 3% 4% 5% 6% 7% 8% 9% 10% 11% 12% 13% 14% 15% 16%
ActualCAGR
(2011-2016)
Forecast CAGR
(2017 - 2022)
Total Market CAGR (2011
- 2016)
%6.1
Total Market CAGR (2017
- 2022)
%6.6
Specialty Medicines and Leading
Therapy Areas in 2020
17
Source: IMS Health Market Prognosis, Nov 2015
New Active Substances (NAS) by Therapy
Area Launched in the U.S. 2006-2015
18
Source: IMS Market Prognosis, April 2016
Anatomical Main Group Actual Sales Trend (2002 - 2016)
0
100
200
300
400
500
600
700
800
900
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
SALES(MILLIONUS$) Alimentary
Antiinfectives
Antineoplastic
Antiparasitic
Blood
Cardiovascular
Dermatologicals
Genito-urinary
Musculo-Skeletal
Nervous system
Respiratory
Sensory organs
Hormonal
Preparations
Anatomical Main Group Forecast Sales Trend
0
200
400
600
800
1,000
1,200
1,400
1,600
1,800
2016 F2017 F2018 F2019 F2020 F2021 F2022
SALES(MILLIONUS$) Alimentary
Antiinfectives
Antineoplastic
Antiparasitic
Blood
Cardiovascular
Dermatologicals
Genito-urinary
Musculo-Skeletal
Nervous system
Respiratory
Sensory organs
Hormonal
preparations
over the 22 years from 2008 to 2030, cardiovascular disease,
and cancer are expected to remain the leading causes of
mortality and burden of disease .
The numbers of cases of cardiovascular disease, cancer,
respiratory disease, and diabetes, some of which can be
considered lifestyle diseases, are predicted to increase
during this period, with cardiovascular disease increasing at
the fastest rate.
‫بیماری‬ ‫از‬ ‫ناشی‬ ‫مرگ‬ ‫جهانی‬ ‫روند‬(2020-2000)
‫سال‬ ‫در‬ ‫دیابت‬ ‫شیوع‬2020
Global Medicine Spending and Growth 2009–
2023
Spending Growth
437
462 475
0 %
1 %
%2
%3
%4
5 %
6 %
7 %
%8
%9
%10
0
200
400
600
800
1,000
1,200
1,400
1,600
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023
Forecast
‫داروی‬‫ی‬‫ل‬‫ریا‬‫بازار‬‫ور‬‫کش‬(‫اهی‬‫سال‬1384‫ات‬1394)‫رشد‬‫رنخ‬
‫سا‬‫ب‬‫ک‬‫ر‬‫م‬‫ل‬‫یاهن‬30%)
11,538 14,386 17,548
22,376
28,446
32,467
42,170
57,757
82,984
116,000
135,000
31%
25%
22%
28% 27%
14%
30%
37%
44%
40%
16%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
0
20,000
40,000
60,000
80,000
100,000
120,000
140,000
160,000
1384 1385 1386 1387 1388 1389 1390 1391 1392 1393 1394f
‫بازار‬ ‫حجم‬(‫ریال‬ ‫میلیارد‬) ‫قبل‬ ‫سال‬ ‫به‬ ‫رشد‬(‫درصد‬)
11/05/2018 ‫ابان‬ ‫زاده‬ ‫کبریایی‬ ‫دکتر‬1397 26
Global Market of Medicines (IMS)
Worldwide Medicines Sales by Therapy Area in
2012
Worldwide Medicines Sales by Therapy Area in
2018
Is the benefit gain from the new
treatment greater than the
benefit foregone through
displacement?
23 Years Ratings New Drug “Advances”
by Prescrire (1981-2003)
Rating # %
Bravo 7 0.2%
A real advance 77 2.7%
Offers an advantage 217 7.6%
Possibly helpful 455 15.8%
Nothing new 1,913 66.6%
Not acceptable 80 2.8%
Judgment reserved 122 4.2%
Total 2,871 100
‫سرطان‬ ‫برای‬ ‫دارویی‬ ‫درمان‬ ‫های‬ ‫انتخاب‬
Pipeline ‫مرحله‬ ‫و‬ ‫اندیکاسیون‬ ‫مبنای‬ ‫بر‬ ‫انکولوژی‬
‫توسعه‬ ‫و‬ ‫تحقیق‬
88 90 92 93
ANTIINFECTIVES FOR SYSTEMIC
USE
ANTIINFECTIVES FOR SYSTEMIC
USE
ANTIINFECTIVES FOR SYSTEMIC
USE
ANTIINFECTIVES FOR SYSTEMIC
USE
ALIMENTARY TRACT AND
METABOLISM
ANTINEOPLASTIC AND
IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AND
IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AND
IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AND
IMMUNOMODULATING AGENTS
ALIMENTARY TRACT AND
METABOLISM
ALIMENTARY TRACT AND
METABOLISM
ALIMENTARY TRACT AND
METABOLISM
NERVOUS SYSTEM NERVOUS SYSTEM NERVOUS SYSTEM NERVOUS SYSTEM
BLOOD AND BLOOD FORMING
ORGANS
BLOOD AND BLOOD FORMING
ORGANS
BLOOD AND BLOOD FORMING
ORGANS
BLOOD AND BLOOD FORMING
ORGANS
RESPIRATORY SYSTEM RESPIRATORY SYSTEM RESPIRATORY SYSTEM RESPIRATORY SYSTEM
CARDIOVASCULAR SYSTEM MUSCULO-SKELETAL SYSTEM CARDIOVASCULAR SYSTEM CARDIOVASCULAR SYSTEM
MUSCULO-SKELETAL SYSTEM CARDIOVASCULAR SYSTEM MUSCULO-SKELETAL SYSTEM
GENITO URINARY SYSTEM AND
SEX HORMONES
GENITO URINARY SYSTEM AND
SEX HORMONES
GENITO URINARY SYSTEM AND
SEX HORMONES
GENITO URINARY SYSTEM AND
SEX HORMONES MUSCULO-SKELETAL SYSTEM
VARIOUS
SYSTEMIC HORMONAL
PREPARATIONS
SYSTEMIC HORMONAL
PREPARATIONS
SYSTEMIC HORMONAL
PREPARATIONS
SYSTEMIC HORMONAL
PREPARATIONS VARIOUS DERMATOLOGICALS VARIOUS
DERMATOLOGICALS DERMATOLOGICALS VARIOUS DERMATOLOGICALS
SENSORY ORGANS SENSORY ORGANS SENSORY ORGANS SENSORY ORGANS
ANTIPARASITIC PRODUCTS,
INSECTICIDES AND REPELLENTS
ANTIPARASITIC PRODUCTS,
INSECTICIDES AND REPELLENTS Various Various
ANTIPARASITIC PRODUCTS,
INSECTICIDES AND REPELLENTS
ANTIPARASITIC PRODUCTS,
INSECTICIDES AND REPELLENTS
Top 10 Medicines in Iran, by Volume (1392) vs.
Top 10 Medicines in US (2010)
No. Drug Name Volume
1 METFORMIN HCL 500MG TAB 1,424,743,770
2 ADULT COLD TAB 1,023,136,280
3 RANITIDINE 150MG TAB 1,019,909,120
4 ASA 80MG EC TAB 851,382,550
5 AMOXICILLIN 500MG CAP 843,200,691
6 LOSARTAN POTASSIUM 25MG TAB 838,716,378
7 ACETAMINOPHEN CODEINE (300+10)MG TAB 819,049,275
8 GLIBENCLAMIDE 5MG TAB 732,460,300
9 IBUPROFEN 400MG PEARL 573,303,014
10 METRONIDAZOLE 250MG TAB 479,429,200
Top 10 Medicines in Iran, By Value (1392) vs.
Top 15 Medicines in the World (2012)
No. Drug Name Value (Rial)
1 AMOXICILLIN 500MG CAP 1,535,028,039,500
2 CLOPIDOGREL 75MG TAB 1,250,688,020,000
3 ALBUMIN (HUMAN) 20% 50ML VIAL 1,188,755,677,000
4 CEFIXIME 400MG TAB 1,186,729,855,510
5 INTERFERON B 1A 30 MCG VIAL 996,888,774,674
6 METFORMIN HCL 500MG TAB 898,708,895,350
7 INTERFERON B 1A 44MCG/0.5ML SYRINGE 709,804,519,000
8 ENOXAPARIN 100MG/ML (4,000 U) 0.4ML SYRINGE 688,043,394,000
9 IMMUNE GLOBULIN 5G INJECTION POWDER (IV) VIAL 675,015,250,000
10 FILGRASTIM(GCSF) 300MCG/0.5ML INJ 629,881,663,000
11 ATORVASTATIN 20MG TAB 615,205,095,285
12 TRIPTORELIN ACETATE 3.75MG VIAL 613,786,325,000
13 VALPROATE SODIUM 500MG TAB 590,667,027,000
14 SOMATROPIN 5MG 1.5ML PEN 590,666,845,000
15 IBUPROFEN 400MG PEARL 571,559,823,890
• Analysis of the Iranian pharmaceutical market in the 13-year period
shows that medicine consumption sales value growth has been
28.38% annually. Determination of domestic production and import
reveals that 9.3% and 42.3% annual growth, respectively, have been
experienced.
‫واردات‬‫هب‬‫ید‬‫ل‬‫و‬‫ت‬‫ت‬‫ب‬‫نس‬
(‫ی‬‫ل‬‫ریا‬)‫ور‬‫کش‬‫ی‬‫ی‬‫دارو‬‫بازار‬‫رد‬
85%
82%
80% 78%
76%
72% 70%
68%
66%
64%
60%
64%
61%
63% 61%
66%
15%
18%
20% 22%
24%
28% 30%
32%
34%
36%
40%
36%
39%
37%
39%
34%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
1378 1379 1380 1381 1382 1383 1384 1385 1386 1387 1388 1389 1390 1391 1392 1393 1394 1395
11/05/2018 ‫ابان‬ ‫زاده‬ ‫کبریایی‬ ‫دکتر‬1397 38
‫فضای‬ ‫در‬ ‫فرصتها‬ ‫آفرینش‬‫هاي‬ ‫اقیانوس‬‫آبي‬
،‫مطالعه‬ ‫یک‬ ‫در‬108‫آمد‬ ‫برست‬ ‫زیر‬ ‫نتایج‬ ‫و‬ ‫بررسي‬ ‫را‬ ‫شركت‬.
‫كار‬ ‫به‬ ‫شروع‬86‫عبارتي‬ ‫به‬ ‫و‬ ‫موجود‬ ‫صنایع‬ ‫درامتداد‬ ‫شركتها‬ ‫درصد‬
‫بازار‬ ‫قرمز‬ ‫اقیانوس‬ ‫همان‬ ‫داخل‬ ‫در‬ ‫تدریجي‬ ‫بهبودهاي‬ ‫طریق‬ ‫از‬
‫است‬ ‫بوده‬ ‫فعلي‬.
‫تنها‬ ‫آنها‬ ، ‫حال‬ ‫این‬ ‫با‬62‫و‬ ‫بالقوه‬ ‫آمد‬ ‫در‬ ‫كل‬ ‫از‬ ‫درصد‬39‫از‬ ‫درصد‬
‫اند‬ ‫كرده‬ ‫خود‬ ‫آن‬ ‫از‬ ‫را‬ ‫سود‬ ‫كل‬.‫كار‬ ‫بازار‬ ‫به‬ ‫ورود‬ ‫نحوه‬14‫درصد‬
‫است‬ ‫بوده‬ ‫آبي‬ ‫هاي‬ ‫اقیانوس‬ ‫خلق‬ ‫طریق‬ ‫از‬ ‫شركتها‬ ‫مانده‬ ‫باقي‬.‫آنها‬
38‫و‬ ‫درآمد‬ ‫كل‬ ‫از‬ ‫درصد‬61‫آوردند‬ ‫بدست‬ ‫را‬ ‫سود‬ ‫كل‬ ‫از‬ ‫درصد‬.
‫ارزش‬ ‫آوري‬ ‫نو‬
‫آوري‬ ‫نو‬‫ارزش‬‫استراتژي‬ ‫اساس‬ ‫و‬ ‫پایه‬ ،
‫است‬ ‫آبی‬ ‫اقیانوس‬.
‫ارزش‬ ‫و‬ ‫آوري‬ ‫نو‬ ‫مؤلفه‬ ‫دو‬ ‫هر‬ ‫روي‬ ‫بر‬ ، ‫ارزش‬ ‫نوآوري‬
‫نماید‬ ‫مي‬ ‫یكساني‬ ‫تاكید‬.
Some of the examples of Blue Ocean strategy include
newer therapy classes of COX-2 inhibitors, PDE 5
inhibitor such as Sildenafil Citrate. We conclude that
pharmaceutical companies can grow by value
integration and with the help of Blue Ocean strategy
Other examples:
• Calcitonin gene related peptide (CGRP) antagonist-
Migraine pain
• Beta-amyloid protein antagonist- Alzheimer disease
• primary progressive multiple sclerosis
• Janus kinase (JAK) inhibitors
• Androgen receptor antagonist-Advanced prostate
cancer
• Tyrosine kinase inhibitor-Renal cell cance
• CD20 inhibitor (hMAb) in cancer therapy and
MS.
• Bcl-2 inhibitor (apoptosis control)-melanoma,….
• CETP inhibitor (Antidyslipidemic) torcetrapib,…
• Antisense-oligonucleotide,inhibitor of
apolipoprotein B-100 (ApoB-100) synthesis
• LP-PLA2 inhibitor (Anti-atherosclerosis)
• ACAT-1 inhibitor (Anti-atherosclerosis)
• Antisense drugs are being researched to treat cancers
(including lung cancer, colorectal carcinoma, pancreatic
carcinoma, malignant glioma and malignant melanoma),
diabetes, Amyotrophic lateral sclerosis (ALS), Duchenne
muscular dystrophy and diseases such as asthma, arthritis and
pouchitis with an inflammatory component. Most potential
therapies have not yet produced significant clinical results[citation
needed], though two antisense drugs have been approved by the
U.S. Food and Drug Administration (FDA), fomivirsen (marketed
as Vitravene) as a treatment for cytomegalovirus retinitis and
mipomersen (marketed as Kynamro] for homozygous familial
hypercholesterolemia.
Cont.
• HDL-C mimetic
• inhibitor of secretory phospholipase A2 (sPLA2)
• Prevention of atherothrombotic ischemic events
• arterial thrombosis novel P2Y12 (purinergic receptor
) antagonist for the treatment of arterial thrombosis
in
• patients with ACS
• IBS pathophysiology
Cont.
• Direct factor Xa.Antithrombotic
• Low molecular weight heparin-Antithrombotic
• Direct thrombin (reversible) inhibitor—
Antithrombotic
• Guanylate cyclase activator-Antihypertensive
• DPP4
• GLP1 agonist
•Synthetic Biology is the rational design and
controlled construction of biological
systems
Can we make genes
out of junk DNA ?
Other innovative examples
• Short Interfering RNA (siRNA) Delivery:
• Cell and Stem Cell Therapy
• Targeted Drug Delivery System
• Implantable Delivery System
• Tissue Engineering
• Nanorobot
• Transdermal Delivery of Biopharmaceuticals
• Smart Medication Dispenser
• Smart Infusion Pumps
• Smart Capsules
• . Smartphone For Improving Medication Adherence
• Radio Frequency Identification Technology (RFID)
‫سالهای‬ ‫در‬ ‫برتر‬ ‫کمپانی‬ ‫ده‬ ‫موقعیت‬ ‫بررسی‬
2010،2014،2019
Be positive even if
you are always
surrounded by negative things

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سمینار تامزآپ -چارچوب و قوانین صنعت داروسازی و بیوتکنولوژی

  • 1. ‫دکتر‬‫کبریایی‬ ‫عباس‬ ‫ته‬ ‫پزشکی‬ ‫علوم‬ ‫دانشگاه‬ ‫داروسازی‬ ‫دانشکده‬ ‫دارو‬ ‫مدیریت‬ ‫و‬ ‫اقتصاد‬ ‫گروه‬ ‫مدیر‬‫ران‬ ‫برگزاری‬ ‫تاریخ‬ 24‫مردادماه‬98
  • 2. ‫دانشجویان‬ ‫نقش‬ ‫و‬ ‫ایران‬ ‫اقتصاد‬ ‫آن‬ ‫آینده‬ ‫در‬ ‫داروسازی‬ ‫زاده‬ ‫کبریایی‬ ‫دکتر‬–‫مرداد‬1398
  • 3.
  • 5. 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% 22% Engineering, Construction Insurance: Property and Casualty (Stock) Food Production Food and Drug Stores Computers, Office Equiment Trading Mail, Package, and Freight Delivery Specialty Retailers Chemicals Energy Health Care: Insurance and Managed Care Metals Beverages Banks: Commercial and Savings Network and Other Communications Equipment Shipping Aerospace and Defense Building Materials, Glass Industrial Machinery Telecommunications Household and Personal Products Food Consumer Products Tobacco Pharmaceuticals Mining, Crude Oil Production Profit % Industires Source: Fortune Global 2010 ‫سودآوری‬ ‫نمودار‬25‫جهان‬ ‫برتر‬ ‫صنعت‬
  • 7. ‫سالمت‬ ‫سهم‬ ‫و‬ ‫جهانی‬ ‫اقتصاد‬ ‫در‬ ‫ایران‬ ‫جایگاه‬ •‫رتبه‬ ‫داخلی‬ ‫ناخالص‬ ‫تولید‬18‫دنیا‬ •‫ملی‬ ‫ناخالص‬ ‫تولید‬ ‫از‬ ‫سالمت‬ ‫سهم‬6.9%‫رتبه‬88‫دنیا‬ •‫سالمت‬ ‫هزینه‬ ‫سرانه‬490$‫رتبه‬81‫دنیا‬
  • 8. Iran Pharmaceutical Market Trends 1980 1988 1996 2004 2007 2013 2015 2018 Population (Million)based on last formal census 40 53 62 69 71 76 79.3 82.3 Market Value (Million US$) 660 720 950 1550 2700 4060 4238 4882 Local Manufactured share (Value) 80% 89% 84% 72% 65% 63% 70% 70% Total Market Size (Billion Unit) 5.9 11.3 15.8 26.5 30.8 34.2 35.2 37.9 Local Manufactured share (Volume) 95% 95% 96% 96% 97% 95% 97% 97% Total Pharmaceutical Expenditure Per Capita (US$) 16.5 13.6 15.3 22.5 37.7 52.7 53.4 59.3
  • 9. 17.1 11.7 11.3 10.9 10.3 9.7 9.1 9.1 5.6 5.6 5.2 4.6 4 3.2 6.9 0 2 4 6 8 10 12 14 16 18 UnitedStates France Germany Canada Japan Brazil Italy UnitedKingdom China Turkey Iraq Singapore India SaudiArabia Iran,IslamicRep. Health Expenditure (% GDP) Various Countries 9 Source: 2014,World Bank Data Percent
  • 10. Medicine Expenditure (% of Health Expenditure) Various Countries 10 12.0 15.816.7 19.9 7.4 21.8 13.9 16.0 14.8 33.6 15.8 18.5 17.2 21.6 9.5 9.4 7.3 22.7 18.6 26.4 19.4 12.6 9.7 11.9 0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 Austria Belgium Canada Czech… Denm… Estonia Finland France Germa… Hungary Iceland Ireland Italy Korea Nether… New… Norway Poland Portugal Slovak… Slovenia Sweden Switze… United… % 14
  • 11. Iran Population Pyramid 2015 Median Age: 28.3
  • 12. ‫سال‬ ‫تا‬ ‫دنیا‬ ‫در‬ ‫جمعیتی‬ ‫هرم‬2020 ‫سال‬ ‫در‬ ‫جهان‬ ‫جمعیت‬20056.5‫نفر‬ ‫میلیارد‬ ‫که‬ ‫است‬ ‫بوده‬7.3%‫آنها‬(‫معادل‬477.4 ‫نفر‬ ‫میلیون‬)‫سن‬ ‫با‬ ‫افراد‬65‫بوده‬ ‫باالتر‬ ‫و‬ ‫سال‬ ‫اند‬.‫سال‬ ‫در‬ ‫میشود‬ ‫بینی‬ ‫پیش‬2020‫جمعیت‬ ‫مرز‬ ‫از‬ ‫جهان‬7.6‫و‬ ‫بگذرد‬ ‫نفر‬ ‫میلیارد‬9.4% ‫سن‬ ‫با‬ ‫افراد‬ ‫را‬ ‫آن‬65‫تشکیل‬ ‫باالتر‬ ‫و‬ ‫سال‬ ‫داد‬ ‫خواهند‬.
  • 13.
  • 14.
  • 15. Iranian market growth drivers during 2011 to 2016, based on ATC coding 5,183 3,847 371 237 218 188 95 80 55 53 46 28 12 6 9 33 13.7% 7.5% 9.3% 7.8% 2.6% 7.0% 3.2% 5.0% 4.4% 3.3% 11.4% -1.0% -3.1% -5.6% 6.1% -10% -5% 0% 5% 10% 15% 3,000 3,500 4,000 4,500 5,000 5,500 CAGR(2011-2016) Sales(MillionUS$)
  • 16. Actual CAGR (2011 - 2016) VS. Forecast CAGR (2017 - 2022) Bubble Size : Market Share (AVG 2014 - 2016) Alimentary & Metabolism ; 14.6% Antiinfectives, 15.3% Antineoplastics &… Antiparasitic, 0.5% Blood, 11.2% Cardiovascular, 5.2% Dermatologicals, 2.4% Genito-urinary, 4.8% Musculo-Skeletal, 4.7% Nervous system, 10.9% Respiratory, 7.1% Sensory organs, 1.0% Hormonal preparations, 3.8% -6% -4% -2% 0% 2% 4% 6% 8% 10% 12% 14% 16% 0% 1% 2% 3% 4% 5% 6% 7% 8% 9% 10% 11% 12% 13% 14% 15% 16% ActualCAGR (2011-2016) Forecast CAGR (2017 - 2022) Total Market CAGR (2011 - 2016) %6.1 Total Market CAGR (2017 - 2022) %6.6
  • 17. Specialty Medicines and Leading Therapy Areas in 2020 17 Source: IMS Health Market Prognosis, Nov 2015
  • 18. New Active Substances (NAS) by Therapy Area Launched in the U.S. 2006-2015 18 Source: IMS Market Prognosis, April 2016
  • 19. Anatomical Main Group Actual Sales Trend (2002 - 2016) 0 100 200 300 400 500 600 700 800 900 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 SALES(MILLIONUS$) Alimentary Antiinfectives Antineoplastic Antiparasitic Blood Cardiovascular Dermatologicals Genito-urinary Musculo-Skeletal Nervous system Respiratory Sensory organs Hormonal Preparations
  • 20. Anatomical Main Group Forecast Sales Trend 0 200 400 600 800 1,000 1,200 1,400 1,600 1,800 2016 F2017 F2018 F2019 F2020 F2021 F2022 SALES(MILLIONUS$) Alimentary Antiinfectives Antineoplastic Antiparasitic Blood Cardiovascular Dermatologicals Genito-urinary Musculo-Skeletal Nervous system Respiratory Sensory organs Hormonal preparations
  • 21.
  • 22. over the 22 years from 2008 to 2030, cardiovascular disease, and cancer are expected to remain the leading causes of mortality and burden of disease . The numbers of cases of cardiovascular disease, cancer, respiratory disease, and diabetes, some of which can be considered lifestyle diseases, are predicted to increase during this period, with cardiovascular disease increasing at the fastest rate.
  • 23. ‫بیماری‬ ‫از‬ ‫ناشی‬ ‫مرگ‬ ‫جهانی‬ ‫روند‬(2020-2000)
  • 25. Global Medicine Spending and Growth 2009– 2023 Spending Growth 437 462 475 0 % 1 % %2 %3 %4 5 % 6 % 7 % %8 %9 %10 0 200 400 600 800 1,000 1,200 1,400 1,600 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Forecast
  • 26. ‫داروی‬‫ی‬‫ل‬‫ریا‬‫بازار‬‫ور‬‫کش‬(‫اهی‬‫سال‬1384‫ات‬1394)‫رشد‬‫رنخ‬ ‫سا‬‫ب‬‫ک‬‫ر‬‫م‬‫ل‬‫یاهن‬30%) 11,538 14,386 17,548 22,376 28,446 32,467 42,170 57,757 82,984 116,000 135,000 31% 25% 22% 28% 27% 14% 30% 37% 44% 40% 16% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% 0 20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000 1384 1385 1386 1387 1388 1389 1390 1391 1392 1393 1394f ‫بازار‬ ‫حجم‬(‫ریال‬ ‫میلیارد‬) ‫قبل‬ ‫سال‬ ‫به‬ ‫رشد‬(‫درصد‬) 11/05/2018 ‫ابان‬ ‫زاده‬ ‫کبریایی‬ ‫دکتر‬1397 26
  • 27. Global Market of Medicines (IMS)
  • 28. Worldwide Medicines Sales by Therapy Area in 2012
  • 29. Worldwide Medicines Sales by Therapy Area in 2018
  • 30. Is the benefit gain from the new treatment greater than the benefit foregone through displacement?
  • 31. 23 Years Ratings New Drug “Advances” by Prescrire (1981-2003) Rating # % Bravo 7 0.2% A real advance 77 2.7% Offers an advantage 217 7.6% Possibly helpful 455 15.8% Nothing new 1,913 66.6% Not acceptable 80 2.8% Judgment reserved 122 4.2% Total 2,871 100
  • 32. ‫سرطان‬ ‫برای‬ ‫دارویی‬ ‫درمان‬ ‫های‬ ‫انتخاب‬
  • 33. Pipeline ‫مرحله‬ ‫و‬ ‫اندیکاسیون‬ ‫مبنای‬ ‫بر‬ ‫انکولوژی‬ ‫توسعه‬ ‫و‬ ‫تحقیق‬
  • 34. 88 90 92 93 ANTIINFECTIVES FOR SYSTEMIC USE ANTIINFECTIVES FOR SYSTEMIC USE ANTIINFECTIVES FOR SYSTEMIC USE ANTIINFECTIVES FOR SYSTEMIC USE ALIMENTARY TRACT AND METABOLISM ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ALIMENTARY TRACT AND METABOLISM ALIMENTARY TRACT AND METABOLISM ALIMENTARY TRACT AND METABOLISM NERVOUS SYSTEM NERVOUS SYSTEM NERVOUS SYSTEM NERVOUS SYSTEM BLOOD AND BLOOD FORMING ORGANS BLOOD AND BLOOD FORMING ORGANS BLOOD AND BLOOD FORMING ORGANS BLOOD AND BLOOD FORMING ORGANS RESPIRATORY SYSTEM RESPIRATORY SYSTEM RESPIRATORY SYSTEM RESPIRATORY SYSTEM CARDIOVASCULAR SYSTEM MUSCULO-SKELETAL SYSTEM CARDIOVASCULAR SYSTEM CARDIOVASCULAR SYSTEM MUSCULO-SKELETAL SYSTEM CARDIOVASCULAR SYSTEM MUSCULO-SKELETAL SYSTEM GENITO URINARY SYSTEM AND SEX HORMONES GENITO URINARY SYSTEM AND SEX HORMONES GENITO URINARY SYSTEM AND SEX HORMONES GENITO URINARY SYSTEM AND SEX HORMONES MUSCULO-SKELETAL SYSTEM VARIOUS SYSTEMIC HORMONAL PREPARATIONS SYSTEMIC HORMONAL PREPARATIONS SYSTEMIC HORMONAL PREPARATIONS SYSTEMIC HORMONAL PREPARATIONS VARIOUS DERMATOLOGICALS VARIOUS DERMATOLOGICALS DERMATOLOGICALS VARIOUS DERMATOLOGICALS SENSORY ORGANS SENSORY ORGANS SENSORY ORGANS SENSORY ORGANS ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS Various Various ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
  • 35. Top 10 Medicines in Iran, by Volume (1392) vs. Top 10 Medicines in US (2010) No. Drug Name Volume 1 METFORMIN HCL 500MG TAB 1,424,743,770 2 ADULT COLD TAB 1,023,136,280 3 RANITIDINE 150MG TAB 1,019,909,120 4 ASA 80MG EC TAB 851,382,550 5 AMOXICILLIN 500MG CAP 843,200,691 6 LOSARTAN POTASSIUM 25MG TAB 838,716,378 7 ACETAMINOPHEN CODEINE (300+10)MG TAB 819,049,275 8 GLIBENCLAMIDE 5MG TAB 732,460,300 9 IBUPROFEN 400MG PEARL 573,303,014 10 METRONIDAZOLE 250MG TAB 479,429,200
  • 36. Top 10 Medicines in Iran, By Value (1392) vs. Top 15 Medicines in the World (2012) No. Drug Name Value (Rial) 1 AMOXICILLIN 500MG CAP 1,535,028,039,500 2 CLOPIDOGREL 75MG TAB 1,250,688,020,000 3 ALBUMIN (HUMAN) 20% 50ML VIAL 1,188,755,677,000 4 CEFIXIME 400MG TAB 1,186,729,855,510 5 INTERFERON B 1A 30 MCG VIAL 996,888,774,674 6 METFORMIN HCL 500MG TAB 898,708,895,350 7 INTERFERON B 1A 44MCG/0.5ML SYRINGE 709,804,519,000 8 ENOXAPARIN 100MG/ML (4,000 U) 0.4ML SYRINGE 688,043,394,000 9 IMMUNE GLOBULIN 5G INJECTION POWDER (IV) VIAL 675,015,250,000 10 FILGRASTIM(GCSF) 300MCG/0.5ML INJ 629,881,663,000 11 ATORVASTATIN 20MG TAB 615,205,095,285 12 TRIPTORELIN ACETATE 3.75MG VIAL 613,786,325,000 13 VALPROATE SODIUM 500MG TAB 590,667,027,000 14 SOMATROPIN 5MG 1.5ML PEN 590,666,845,000 15 IBUPROFEN 400MG PEARL 571,559,823,890
  • 37. • Analysis of the Iranian pharmaceutical market in the 13-year period shows that medicine consumption sales value growth has been 28.38% annually. Determination of domestic production and import reveals that 9.3% and 42.3% annual growth, respectively, have been experienced.
  • 38. ‫واردات‬‫هب‬‫ید‬‫ل‬‫و‬‫ت‬‫ت‬‫ب‬‫نس‬ (‫ی‬‫ل‬‫ریا‬)‫ور‬‫کش‬‫ی‬‫ی‬‫دارو‬‫بازار‬‫رد‬ 85% 82% 80% 78% 76% 72% 70% 68% 66% 64% 60% 64% 61% 63% 61% 66% 15% 18% 20% 22% 24% 28% 30% 32% 34% 36% 40% 36% 39% 37% 39% 34% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 1378 1379 1380 1381 1382 1383 1384 1385 1386 1387 1388 1389 1390 1391 1392 1393 1394 1395 11/05/2018 ‫ابان‬ ‫زاده‬ ‫کبریایی‬ ‫دکتر‬1397 38
  • 39. ‫فضای‬ ‫در‬ ‫فرصتها‬ ‫آفرینش‬‫هاي‬ ‫اقیانوس‬‫آبي‬ ،‫مطالعه‬ ‫یک‬ ‫در‬108‫آمد‬ ‫برست‬ ‫زیر‬ ‫نتایج‬ ‫و‬ ‫بررسي‬ ‫را‬ ‫شركت‬. ‫كار‬ ‫به‬ ‫شروع‬86‫عبارتي‬ ‫به‬ ‫و‬ ‫موجود‬ ‫صنایع‬ ‫درامتداد‬ ‫شركتها‬ ‫درصد‬ ‫بازار‬ ‫قرمز‬ ‫اقیانوس‬ ‫همان‬ ‫داخل‬ ‫در‬ ‫تدریجي‬ ‫بهبودهاي‬ ‫طریق‬ ‫از‬ ‫است‬ ‫بوده‬ ‫فعلي‬. ‫تنها‬ ‫آنها‬ ، ‫حال‬ ‫این‬ ‫با‬62‫و‬ ‫بالقوه‬ ‫آمد‬ ‫در‬ ‫كل‬ ‫از‬ ‫درصد‬39‫از‬ ‫درصد‬ ‫اند‬ ‫كرده‬ ‫خود‬ ‫آن‬ ‫از‬ ‫را‬ ‫سود‬ ‫كل‬.‫كار‬ ‫بازار‬ ‫به‬ ‫ورود‬ ‫نحوه‬14‫درصد‬ ‫است‬ ‫بوده‬ ‫آبي‬ ‫هاي‬ ‫اقیانوس‬ ‫خلق‬ ‫طریق‬ ‫از‬ ‫شركتها‬ ‫مانده‬ ‫باقي‬.‫آنها‬ 38‫و‬ ‫درآمد‬ ‫كل‬ ‫از‬ ‫درصد‬61‫آوردند‬ ‫بدست‬ ‫را‬ ‫سود‬ ‫كل‬ ‫از‬ ‫درصد‬.
  • 40. ‫ارزش‬ ‫آوري‬ ‫نو‬ ‫آوري‬ ‫نو‬‫ارزش‬‫استراتژي‬ ‫اساس‬ ‫و‬ ‫پایه‬ ، ‫است‬ ‫آبی‬ ‫اقیانوس‬. ‫ارزش‬ ‫و‬ ‫آوري‬ ‫نو‬ ‫مؤلفه‬ ‫دو‬ ‫هر‬ ‫روي‬ ‫بر‬ ، ‫ارزش‬ ‫نوآوري‬ ‫نماید‬ ‫مي‬ ‫یكساني‬ ‫تاكید‬.
  • 41. Some of the examples of Blue Ocean strategy include newer therapy classes of COX-2 inhibitors, PDE 5 inhibitor such as Sildenafil Citrate. We conclude that pharmaceutical companies can grow by value integration and with the help of Blue Ocean strategy
  • 42. Other examples: • Calcitonin gene related peptide (CGRP) antagonist- Migraine pain • Beta-amyloid protein antagonist- Alzheimer disease • primary progressive multiple sclerosis • Janus kinase (JAK) inhibitors • Androgen receptor antagonist-Advanced prostate cancer
  • 43. • Tyrosine kinase inhibitor-Renal cell cance • CD20 inhibitor (hMAb) in cancer therapy and MS. • Bcl-2 inhibitor (apoptosis control)-melanoma,…. • CETP inhibitor (Antidyslipidemic) torcetrapib,… • Antisense-oligonucleotide,inhibitor of apolipoprotein B-100 (ApoB-100) synthesis • LP-PLA2 inhibitor (Anti-atherosclerosis) • ACAT-1 inhibitor (Anti-atherosclerosis)
  • 44. • Antisense drugs are being researched to treat cancers (including lung cancer, colorectal carcinoma, pancreatic carcinoma, malignant glioma and malignant melanoma), diabetes, Amyotrophic lateral sclerosis (ALS), Duchenne muscular dystrophy and diseases such as asthma, arthritis and pouchitis with an inflammatory component. Most potential therapies have not yet produced significant clinical results[citation needed], though two antisense drugs have been approved by the U.S. Food and Drug Administration (FDA), fomivirsen (marketed as Vitravene) as a treatment for cytomegalovirus retinitis and mipomersen (marketed as Kynamro] for homozygous familial hypercholesterolemia.
  • 45. Cont. • HDL-C mimetic • inhibitor of secretory phospholipase A2 (sPLA2) • Prevention of atherothrombotic ischemic events • arterial thrombosis novel P2Y12 (purinergic receptor ) antagonist for the treatment of arterial thrombosis in • patients with ACS • IBS pathophysiology
  • 46. Cont. • Direct factor Xa.Antithrombotic • Low molecular weight heparin-Antithrombotic • Direct thrombin (reversible) inhibitor— Antithrombotic • Guanylate cyclase activator-Antihypertensive • DPP4 • GLP1 agonist
  • 47. •Synthetic Biology is the rational design and controlled construction of biological systems
  • 48. Can we make genes out of junk DNA ?
  • 49. Other innovative examples • Short Interfering RNA (siRNA) Delivery: • Cell and Stem Cell Therapy • Targeted Drug Delivery System • Implantable Delivery System • Tissue Engineering • Nanorobot • Transdermal Delivery of Biopharmaceuticals • Smart Medication Dispenser
  • 50. • Smart Infusion Pumps • Smart Capsules • . Smartphone For Improving Medication Adherence • Radio Frequency Identification Technology (RFID)
  • 51. ‫سالهای‬ ‫در‬ ‫برتر‬ ‫کمپانی‬ ‫ده‬ ‫موقعیت‬ ‫بررسی‬ 2010،2014،2019
  • 52.
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  • 54. Be positive even if you are always surrounded by negative things