Presentation- Indian Pharmaceutical Industry-2010
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Transcript of Presentation- Indian Pharmaceutical Industry-2010
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Indian Pharmaceutical
IndustryAn Overview
By Prof. (Dr.) Anil Kr. SharmaM.Pharm., P.G.D.B.M., M.G.B.M.
Ph.D (Pharmacy)
Director : Parul Institute of Pharmacy
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Scope :-
Manufacture for marketing of Bulk Drugs (API) and
their value additions (Processed) Formulations,
preparations, extracts and applicable equipments
(sprays/inhalers) or appliances with reference to :-
Medicine (Curative)
Nutrition / Dietary Supplements
Cosmetics
Health Products (Preventive)
Alternative Trends
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Products under Pharmaceuticals
are
either1) Over the Counter (OTC) ProductsOR
2) Prescription Products
AND
EITHER
GENERIC (PHARMACOPOEIAL) PRODUCTS
OR
GENERIC UNDER BRAND NAME PRODUCTSOR
PATENT / PROPRIETORY PRODUCTS
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OPPORTUNITIES AND THREATS
Though remains one of the most
profitable and stable
industry several macro levelvariables are influencing
fundamental changes in theindustry scheme.
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THREATS
Substitute Generic Pharmaceutical threat. New Entrants Bio Pharmaceuticals and Genomes. Increasing Buyer Power :-
a) Third Party
b) Governments Buyer
c) Health Maintenance Organization. Stringent Regulatory Environments. Declining R & D Productivity. Worldwide Compliance of
General Agreements on Traffics and Trade (GATT)
Trade Related Intellectual Property RIGHTS (TRIPS) Emergence of E-Pharmaceuticals.
Economic Recession
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WORLD MARKET SIZE
Contributes total revenue of about US $ 500 Billion in 2007.
Consistent strong growth 7 to 9%.
Growth is proportionate to the Change in disease profile.
Increasing Life style related disease.
Health Awareness.
North America remains largest market (by revenue) about 49%
followed by Europe and Asia Pacific.
Smaller market in Asia Pacific and Latin America are expectedto grow significantly.
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Global Pharmaceutical Industry
Global Pharma sales by region
Region 2003 Sales($) %Global sales ($) % Growth(Constant $)
North America 245 49 11
European union 125 25 8
Rest of Europe 15 3 14
Japan 55 11 3
Asia, Africa and Australia 40 8 12
Latin America 20 4 6
Total 500 100 9
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R e gionwise g loba l pharma sal500 b i ll ion ) - 2007
4 9 %
2 5 %
3 %
1 1
8 %
4 %
N orth A m eric a E u ropean un io n
R es t o f E urop e Japan
A s ia , A frica and A us t ra l iaLa t in A m erica
Global Pharmaceutical IndustryGlobal Pharmaceutical Industry
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Trends in Global PharmaceuticalTrends in Global Pharmaceutical
IndustryIndustry Growing importance of generics
Generics will be a fast-growing segment in regulated markets With USD 10 billion (retail) worth of drugs going off-patent each year on
average, generics represent a major opportunity for India High quality, cost-competitive API and formulations are vital for growth of
generics industry Managed healthcare driving down healthcare costs, boosting generics
Increasing need for new drug pipeline Big pharma companies under great pressure to enhance NCE pipeline Focus on extending patent life through novel drug delivery systems and
therapeutic switch Major potential to select Indian firms to support drug discovery
Consequent structural changes Generics outsourcing R&D outsourcing
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Ind ian Ma rket E vo lut ionEar ly Phase
(1950-75)
M id Phase
(1975-2000)
Recen t Phase
(2000-)S m all S c ale Units M edium / Large S c ale UnitsEmergence of Indian origi
M N C s
M arket Dom inated by M NCsG rowing share of Indian
enti t ies
Global scale of operations
Indian pharmac os
M anufacture of bulk ( largely
publ ic sec tor) and import of
formulations
M anufacture and m arket in
bulk drugs and formulation
Formulat ions / Gener ics f
the wor ld m arket
Inward out look fo r m arke ts Pr imar ily domes t i c
orientation, nominal expor
presence
S trong export focus ,
domes t ic conso l ida t ions.
Inc reasingly high level of
or ientation
Lim ited IP R P rotec tion Lim ited IP R pro tec tion M oves towards IP R protec
post 2005
High P ric e Controls High P ric e Contro ls Reduc ing pric e c ontro ls
Indian Pharmaceutical IndustryIndian Pharmaceutical Industry
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S l N o P ro d u c t C a te g o ryV a l u e
(U S D M
G r o w t h
R a te (%% S h a r
1 G a s t ro In te s t in e Tra c t 1 ,1 2 4 .8 6 .3 2 4 .8
2 A n t ib io t ic s and A n t i B a c te ria ls 8 75 .0 3 .9 1 9 .3
3 A s th m a t ic s 4 6 3 .7 9 .0 1 0 .2
4 C a rd io V a s c u la r S y s te m 4 4 1 .0 1 4 .9 9 .7
5 P a in M a n a ge m e n t 3 5 4 .8 5 .3 7 .8
6 C e n t ra l N e rvo u s S y s te m 3 1 5 .6 9 .3 7 .0
7 D e rm a to log ic a ls 2 4 5 .4 6 .7 5 .4
8 B lo od p ro d uc ts 1 7 5 .2 8 .0 3 .9
9 G y n a e c o lo gy 1 4 5 .5 4 .4 3 .2
1 0 O th e rs 3 9 3 .4 7 .4 9 .4T o ta l 4 ,5 3 4 .3 7 .3 1 0 0 .0
Indian Pharmaceutical IndustryIndian Pharmaceutical Industry
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INDIAN PHARMACEUTICAL Market is
growing continuously in India, majority due to:Growing population @ 2% Approx.Expanding middle class.
Rise of Diseases.Rise in Intellectuality.Rise in Indian MNCs sectors- like Ranbaxy, Dr.
Reddys Lab, Cipla, Zydus etc.
Medical Tourism.Emerging Health InsuranceGrowth of Telemedicine.
Market Growth in IPMMarket Growth in IPM
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AN OVERVIEW
INDIA IS RANKED 15TH IN TERMS OF VALUE and 4th IN TERMS OFVOLUME IN THE GLOBAL PHARMA MARKET HIGH POPULATION GROWING ROBUST ECONOMYSLATES INDIA AS A KEY PLAYER ON THE GLOBAL SCENE
BENCHMERKS :- ACCEPTANCE OF PRODUCT PATENTS. INDIA HAS THE SECOND HIGHEST FDA MANUFACTURING UNITS,
SECOND ONLY TO USA PAVES WAY TO INCREASED RESEARCH & INNOVATION
LAUNCH OF NEW PATENTED PRODUCTS LEADS TO FURTHER GROWTH
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GROWTH MATRIX
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PERFORMANCE MATRIXmultiply by 4.5 for fig in mil$
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multiply by 4.5 for fig in mil$
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multiply by 4.5 for fig in mil$
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d i i h di
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Factors driving the Indian
Pharmaceutical Industry
A combination of strong chemistry skills, regulatory capabilities and quality manufacturing has
positioned India favorably to capitalize on the global pharmaceutical opportunity
Indian Pharmaceutical
Market Overview
Approximately US$7 bn in 2007 withexports accounting for an additionalUS$ 2.5 bn Amongst top 4 markets by volume
globally Strong branded generics market Market growing at a rate 6%-8% as a
result of growing awareness, increasingpenetration & increasing affordability Emerging segments such as CNS,
diabetes etc. growing at 15-20% + Introduction of product patents in India
in 2005 are expected to lead to agreater emphasis on drug discoveryand development
GrowthOpportunitie
s
Generic Exports & API Outsourcing
India is well positioned to target generic exports and
API outsourcing opportunities in the regulated markets
Skilled work force with strong chemistry skillsSignificant and sustainable cost advantage overinternational peersGood understanding of the regulatory framework
India has largest number of US FDA approved
plants outside the US Largest number of DMF filings outside US Indian companies are among the leading players
participating in Para IV challenges
R&D Outsourcing
Skilled work force at competitive costs Significant progress in development of pharma & R&D
infrastructure over last 5 years Focus on early stage processes for NCEs, NDDS,
clinical trials, process re-engineering and dedicatedmanufacturing
5
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Indian Pharma Market had bounced back in 06.
Both acute & chronic therapies have witnessed double digit growth.
The indicators point towards robust growth in all the areas
Pharma companies are laying down their own success path with focus on their
core competence
Companies accordingly bank on different business models like
portfolio diversificationprice premium
price cuts
regional penetration
therapy focus
encash brand equity
And the success has been achieved by setting their own benchmarks and trying
to raise their performance bars themselves.
TO SUMMARISE..
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This representation of the Indian
Pharmaceutical Industry reveals that..
Indian Pharma Companies adopt and implement various long termand short term strategies, however the strategy that leads thepeak of success, is the right strategy.
Apart from the predictable marketing and sales efforts ofcompanies, many times it is uncontrolled market dynamics,intuition and likeability that drive the result of these efforts.
The perfect combination of all these through all the environmentalhighs and lows wades the path for anINDIAN PHARMACEUTICAL INDUCTRYto become successful benchmark
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IT ALSO REVEALS THAT
THERE IS AN IMMENSE TIE UP (TRADE)
OPPORTUNITY
WITH INDIAN PHARMACEUTICAL INDUSTRY.
In fact we as an industry are already at the various stages
of discussions for strategic alliances with various companiesat global level.
Specifically for Hong Kong it serves as our South East Asiatouch Point, it could also serve as an ideal Corporate basefor the organizations.
China is for the Pharma industry a sourcing point, and innear future will become much more than just a bulk supplierdue to the simple fact that nobody wants one time businesspartner, the industry everywhere is looking for long haul, arapport for a long term relations.
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Advantage India
Competent workforce Cost effective industry
Legal & Financial Framework
Information Technology Globalization
Consolidation
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Challenges
Lack of Product PatentProtection
Low R & D Budgets
Limitation of
Technology Sources
Decline Braindrain
Inadequate Profit base
Government Policies
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FORECAST1. Indian Pharmaceutical
Industry to cross US $ 15
Billion by 2015.
2. Market for patented
drugs in India to cross
US $ 5 Billion by 2015.
3. Market for generic drugs
in India to cross US $ 10
Billion by 2015.
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PROSPECTIVES
New ChemicalEntities
Novel Drug DeliverySystem
Market Expansion
Contract Manufacture
Quality Validation
and Accreditation
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