growth perspective of indian pharma industry new delhi 30.10.03
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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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Patents & Implications for the Indian Pharmaceutical Sector
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
Global Generics Markets
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Patents & Implications for the Indian Pharmaceutical Sector
Global Generics Markets
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
Global Generics Markets
Patents & Implications for the Indian Pharmaceutical Sector
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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
Patents & Implications for the Indian Pharmaceutical Sector
Global Generics Markets
2002 Generic Growth
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Patents & Implications for the Indian Pharmaceutical Sector
Global Generics Markets
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
Global Generics Markets
Patents & Implications for the Indian Pharmaceutical Sector
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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
Global Generics Markets
Patents & Implications for the Indian Pharmaceutical Sector
VISION: 10/03
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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
Patents & Implications for the Indian Pharmaceutical Sector
VISION: 10/0310
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Leveraging Knowledge Base
Partnering Global Players
Opportunities
Patents & Implications for the Indian Pharmaceutical Sector
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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
Patents & Implications for the Indian Pharmaceutical Sector
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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%
Patents & Implications for the Indian Pharmaceutical Sector
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Partnering Global Players
Product Development
In/Out Licensing of New Products
Addressing Public Health Problems
Market Access
Opportunities
Patents & Implications for the Indian Pharmaceutical Sector
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Challenges Post 2005
National Patent Law
Data Exclusivity
Patent Law Treaty (PLT) Substantive Patent Law Treaty (SPLT)
Non Tariff Barriers
Patents & Implications for the Indian Pharmaceutical Sector
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National Patent Law
Manufacture For Exports Under Para 6
Safeguards & Conditions
Patentability
Challenges Post 2005
Patents & Implications for the Indian Pharmaceutical Sector
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Challenges Post 2005
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
Patents & Implications for the Indian Pharmaceutical Sector
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Challenges Post 2005
Patentability
Formulations/Dosage Forms
Salts
Processes
Combinations
Polymorphs
Optional Isomers
New Indications (therapeutic methods)
Patenting Minor or Trivial Developments
Patents & Implications for the Indian Pharmaceutical Sector
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Challenges Post 2005
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
Patents & Implications for the Indian Pharmaceutical Sector
VISION: 10/03 19
& l f h d h l S
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Data Exclusivity
TRIPS Article 39.3
Period of Exclusivity ?
Retrospective Effect ?
Impact of Data Exclusivity
Patents & Implications for the Indian Pharmaceutical Sector
Challenges Post 2005
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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
Patents & Implications for the Indian Pharmaceutical Sector
Challenges Post 2005
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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)
Patents & Implications for the Indian Pharmaceutical Sector
Challenges Post 2005
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)
Patents & Implications for the Indian Pharmaceutical Sector
Challenges Post 2005
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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P & I li i f h I di Ph i l S
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Non-tariff Barriers
Patents & Implications for the Indian Pharmaceutical Sector
Challenges Post 2005
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
Patents & Implications for the Indian Pharmaceutical Sector
Challenges Post 2005
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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