growth perspective of indian pharma industry new delhi 30.10.03

8/2/2019 Growth Perspective of Indian Pharma Industry New Delhi 30.10.03

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VISION: 10/03

Growth Perspective

ofIndian Pharmaceutical Industry

New Delhi

October 30, 2003

byD G Shah

Secretary General

Indian Pharmaceutical Alliance

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Outline of Presentation

Introduction

Global Generics Markets

Opportunities

Challenges-Post 2005

Patents & Implications for the Indian Pharmaceutical Sector

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Boundaries of Change

Demand will Grow Fastest in Emerging Markets

Generic Options Available for Most Large Disease Segments

Westernizationof Disease Patterns in the Developing World

Elderly Population will Fuel Demand In Developed Markets


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Increase in Over 65 Population

4%9%

6% 7%9% 10% 8% 8% 8%

11%9%

16%18%

20%21%

23%24% 24% 24%

28%

0%

5%

10%

15%

20%

25%

30%

35%

India

China

New

Zealand

United

States

Australia

Canada

United

Kingdom

France

Germany

Japan

Year 2000Base

Increase to2030

PercentofPopulation

65+YearsOld

Source: US Census Bureau: National Institutes on Aging

Note: Represents 2002 data

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1998

% absoluteChange in

Volume & Mix

Volume Growth from Generics in Strategic Markets

2002

% absolute

Change inVolume & Mix1.2% 1.4%

4.1% 4.3%

2.5%2.7%

1998 2002

Price Volume & Mix New Elements

83%

Brands

17%Generics

91%

Brands

9%Generics

Source: IMS Health: MIDAS, MAT Dec 2002



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Dramatically Outpaced Brand Growth

% Growth @ Constant Dollars

Retail Only Brands Generics

Canada +15 +19

US +8 +26

Germany +7 +16

UK +8 +34

Japan +2 -6

Italy +2 +77Spain +10 +17

France +1 +43

Source: IMS Health: MIDAS, MAT Dec 2002



2002 Generic Growth

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5%

11%

20% 20%

40%

47% 49%52%

0%

10%

20%

30%

40%

50%

60%

France

Japan

New

Zealand

Australia

Canada

United

States

Germany

United

Kingdom

GenericsPrescriptio

nsas

%o

fTotalPrescrip

tions

Generic Utilization by Country

Source: PharmaHandbook

Note: Represents 2002 data

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Source: Chemexcil

L A C

7%

East Asia

21%

West Europe

19%NorthAmerica

18%

Africa

13%

East Europe

8%

South Asia

8%

West Asia

4%

O A C

2%

Market2001-02

Rs Mn

Share

%Growth

%

East Asia 20,423 20.8 2.4

West Europe 19,049 19.4 10.1

North America 17,675 18.0 53.3

Africa 12,762 13.0 15.0

East Europe 7,761 7.9 -0.9

South Asia 7,435 7.6 9.1

L A C 7,102 7.2 -7.8

West Asia 4,349 4.4 16.4

O A C 1,579 1.6 -3.2

Total 98,135 100.0 12.1

Region-Wise Exports: 2001-02



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Source: Chemexcil

Hong Kong

4%

U K

3%

Singapore

2%Netherland

2%Spain

2%

Switzerlad

2%Sri Lanka

2%

Thailand

2%

Nepal

2%

Canada2%

Mexico

2%

Vietnam

2%

Brazil

4%

China

4%

Nigeria

4%

Japan2%

USA

17%

Germany

5%

Russia

5%Others

36%

Market 2001-02Rs Mn

Share%

Growth%

USA 16,201 16.5 64.4

Germany 4,987 5.1 16.1

Russia 4,771 4.9 -4.0

Nigeria 3,767 3.8 8.9

China 3,747 3.8 40.3

Brazil 3,493 3.6 -4.9

Hong Kong 3,413 3.5 -22.9

U K 2,798 2.9 14.8Vietnam 2,117 2.2 13.2

Singapore 1,948 2.0 -9.3

Netherland 1,911 1.9 -0.1

Spain 1,690 1.7 2.7

Switzerland 1,566 1.6 27.9

Sri Lanka 1,521 1.6 -12.3

Japan 1,501 1.5 7.5

Thailand 1,486 1.5 -0.8

Nepal 1,509 1.5 13.3Canada 1,474 1.5 -12.1

Mexico 1,489 1.5 -8.6

UAE 1,413 1.4 10.1

Others 35,333 36.0 8.9

Total 98,135 100 12.1

Indias Top 20 Markets



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$13

$28$8

$19

$6

$10

2001 2007

$27

$57 2001-07CAGR%

Overall 13.3%

ROW 8.9%

Europe 15.5%

U S 13.6%

Size and Growth ($Billions)

Source: Datamonitor

Global Generics Market


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Leveraging Knowledge Base

Partnering Global Players

Opportunities


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Leveraging Knowledge Base

Lead Optimization

Synthesizing Designed Structure

Manufacture of Clinical Trial Samples

Global Clinical Research Projects

Moving Up the Value Chain of R & D

Opportunities


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Moving up the Value Chain of R & D

NCE

Chiral

NDDS Analogue

Process Development

30%

65%

5%

2000E

Opportunities

30%

35%

2005

35%


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Partnering Global Players

Product Development

In/Out Licensing of New Products

Addressing Public Health Problems

Market Access

Opportunities


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Challenges Post 2005

National Patent Law

Data Exclusivity

Patent Law Treaty (PLT) Substantive Patent Law Treaty (SPLT)

Non Tariff Barriers


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National Patent Law

Manufacture For Exports Under Para 6

Safeguards & Conditions

Patentability



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Patentability

The number of new chemical entities approved for use byUS Food and Drug Administration (FDA) declined to 27 in

2000, compared to about 60 in 1985

but the number of patents granted in the main patentclass for new drug compositions was 6,730 in 2000.

Patenting In Pharmaceuticals

Year: 2000 NCEs: 27 Patents: 6,730


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Patentability

Formulations/Dosage Forms

Salts

Processes

Combinations

Polymorphs

Optional Isomers

New Indications (therapeutic methods)

Patenting Minor or Trivial Developments


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Blanketing: a jungle or a minefield of patents

Flooding: multiple patents, major as well as minor

Fencing: blocking certain lines or directions of R & D

Surrounding: an important central patent is fenced in orsurrounded by other less important patents that block theuse of the central patent, even after its expiration

Networking: building of a patent portfolio to strengthenoverall protection and bargaining power

Patentability

Patenting Strategies


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Data Exclusivity

TRIPS Article 39.3

Period of Exclusivity ?

Retrospective Effect ?

Impact of Data Exclusivity



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Impact Of 10-year Data Exclusivity

PATENT

FILING

CLINICAL

DEVELOPMENT&

REGULATORYAPPROVAL

REGULATORY

APPROVALSOUGHTIN INDIA

REGULATORY

APPROVALGRANTEDIN INDIA

PATENT

EXPIRY

GENERIC

SUBMISSION

GENERIC

APPROVAL

MARKETINGEXCLUSIVITY

IN INDIA

YEARS0 10 13 15 20 25 27

0 10 13 15 20 25 27



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P t t & I li ti f th I di Ph ti l S t


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Patent Law Treaty (PLT)



Diplomatic Conference Comprising 140 States

Adopted PLT by Consensus in June 2000

104 Countries Signed the Final Act For Adoption

and 43 Countries Signed PLT Main Features of PLT

Harmonizes Formality Requirements

Streamlines Procedures for Patenting

Excludes Substantive Patent Law Issues

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Substantive Patent Law Treaty (SPLT)



1st Draft in November 2001

Revised in May 2002-Lays Down World Patent Law

Makes TRIPS Obsolete

Secures What Could Not Be Achieved in TRIPS

Implications

End of Patent Policy as a Tool For National Development Strategies

Deviation Can be Subject to Sanctions

No Exclusions to What is Patentable

A Pipe Dream Takes On Real Proportions!

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Non-tariff Barriers



Spreading Doubts About Product Quality

Working to Deny/Delay Product Registrations

Raising Standards of Regulatory Approvals

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P t t & I li ti f th I di Ph ti l S t


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UN Nod for Generic Drugs



Under no circumstances

do companies based in some countries

that have poor regulatory quality standards

match the standards ofquality, service, and innovation

on a sustainable basis

that international companies provide.

IFPMA

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growth perspective of indian pharma industry new delhi 30.10.03

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