Presentation- Indian Pharmaceutical Industry-2010

8/9/2019 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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