GLOBAL HEALTH SCIENCES

Indian Pharmaceutical Industry: Vision 2010

D A Prasanna
Manipal AcuNova Pvt Ltd
Acknowledgement: E & Y
 Vision 2010: Glimpse of Indian Pharma’s Future
November 1, 2010
R&D
R&D Manufacturing
Manufacturing Marketing
Marketing

•• NCE
NCE Research:
Research: Early
Early days,
days, •• API/Bulk
API/Bulk Sourcing:
Sourcing: Emerging
Emerging sourcing
sourcing •• Global
Global Distribution:
Distribution: Mostly
Mostly
Limited
Limited pipeline of 18-20
pipeline of 18-20 NCEs
NCEs base for MNCs
base for MNCs through
through alliances,
alliances,
•• Contract
Contract Research:
Research: Custom
Custom
Current
Current State(2004)
State(2004) Synthesis
Synthesis && Analytical
Analytical services
services
•• Clinical
Clinical Research:
Research: Emerging
Emerging
destination,
destination, about
about 1%
1% of
of global
global
trials
trials

Threshold
Threshold (2005)
(2005)

•• at
at least
least 100
100 NCEs
NCEs in
in various
various •• API/Bulk
API/Bulk Sourcing:
Sourcing: Preferred
Preferred supplier
supplier •• Global
Global Distribution:
Distribution: Top
Top 15-
15-
stages
stages ofof development
development 20
20 Indian
Indian players
players to
to have
have direct
direct
Future
Future State(2010)
State(2010) •• Contract
Contract Manufacturing:
Manufacturing: top top 33 global
global presence
•• Contract presence
Contract Research:
Research: High
High end
end manufacturing
manufacturing sites,
sites, in
in patent
patent protected
protected
drug discovery services
drug discovery services molecules
molecules
•• Clinical
Clinical Research:
Research: At
At least
least 10
10 %
%
of
of global
global trials
trials

August 25, 2005

Vision to Reality : What will get us there ?

• Implementation of new product patent regime

• R&D Innovation

• Maximizing Generics (For Near Term Growth)

• Global outsourcing & partnering

August 25, 2005

Implications of a strict product patent regime post 2005

•• higher
higher domestic
domestic investment
investment in
in basic
basic R&D
R&D and
and discovery
discovery led
led research
research

-Higher
-Higher probability
probability of
of new
new therapies
therapies coming
coming out
out of
of India
India in
in the
the future
future

•• MNCs
MNCs to
to outsource
outsource R&D
R&D and
and manufacture
manufacture of
of patented
patented products
products

-- Strong
Strong boost
boost to
to FDI
FDI in
in pharma
pharma and
and domestic
domestic CRAMS
CRAMS industry
industry

•• Collaborative
Collaborative Research
Research involving
involving IP
IP sharing
sharing

-- Indian
Indian partners
partners will
will move
move up
up the
the value
value chain
chain &
& will
will not
not be
be mere
mere service
service providers
providers

August 25, 2005

 R & D Innovation

The economic fundamentals of new drug development are about

to be altered radically in the future

A
A disease
disease led
led approach
approach toto drug
drug development
development will
will significantly
significantly reduce
reduce time
time and
and
resources
resources that
that are
are required
required

Source:
Source: IBM
IBM Consulting
Consulting

August 25, 2005

Government Run Research Organisations: Industry Collaboration
Government Run Research Organisations: Industry Collaboration

CDRI (Lucknow) IICT (Hyderabad) CCMB (Hyderabad)

Novo Nordisk, Denmark Dr. Reddy’s Laboratories, Hyderabad Shantha Biotechnics Pvt. Ltd., Hyderabad

Krebs Biochemicals Ltd., Hyderabad Lupin Laboratories, Mumbai Dr. Reddy’s Research Foundation, Hyderabad

Avon Organics Ltd., Hyderabad Cadila Laboratories Ltd., Ahemdabad Bangalore Genei Pvt. Ltd., Bangalore

Cipla Ltd., Mumbai SOL Pharmaceuticals Ltd., Hyderabad Dabur Research Foundation, Sahibabad

Dabur India Ltd., Ghaziabad Neuland Laboratories, Hyderabad Biological Evans Ltd., Hyderabad.

Duphar Interfran Ltd., Mumbai Sun Pharmaceuticals Ltd., Mumbai

Hindustan Latex Ltd., Thiruvananthapuram Cipla Ltd., Mumbai

IPCA Labs Ltd., Mumbai Nectar Laboratories Ltd., Hyderabad

Lupin Laboratories Ltd., Mumbai Orchid Chemicals, Chennai

Malladi Drugs & Pharmaceuticals, Chennai Trident Labs Pvt. Ltd., Hyderabad

Nicholas Piramal India Ltd., Mumbai Unichem Labs Ltd., Mumbai

Lumen Marketing Company, Chennai Armour Chemicals Ltd., Mumbai

Ranbaxy Laboratories Ltd., New Delhi Bombay Drug House, Mumbai

Themis Medicare Ltd., Mumbai Cheminor Drugs Pvt. Ltd., Hyderabad

Torrent Pharmaceuticals Ltd., Ahemdabad Torrent Chemicals Ltd., Mumbai

Unichem Laboratories Ltd., Mumbai Coramandal Pharma, Hyderabad

Wockhardt Ltd., Aurangabad. IDPL, New Delhi

August 25, 2005

Compiled by Ernst & Young
 Generics

India is projected to corner about a third of the market by 2007

Large Indian pharma companies are joining the global league by leveraging their low cost cGMP
manufacturing and focusing on regulated markets

India is the largest filer of DMFs outside the US

Product filings (DMFs, ANDAs, CTD/COS) in 2003

200
30%
180 20% of the total DMFs in
160 2003 by Indian
25%
companies
140

120
20%

100
15%
80

60 10%

40
5%
20

0
USA India Germany Italy China Israel France Spain

August 25, 2005

Global Pharmaceutical Outsourcing Market estimated
to exceed $65 bn by 2005…

Source:
Source: OPPI-
OPPI- Monitor
Monitor Group
Group
Study
Study 2003
2003

August 25, 2005

Leveraging India’s Capabilities in Clinical Research…

Easy access to genetically diverse patient pool with varied disease profiles

Well trained medical professionals and clinical investigators with international exposure

Large number of CROS with capabilities to undertake ICH-GCP compliant studies

Translates into….

Higher speed & ease in recruiting large volume patients

Increasing international acceptance of Indian data

30-40% lower costs than the US /Europe

August 25, 2005

Indian Pharmaceutical Industry: Back to the Future !

55 years
years from
from today,
today, could
could
this
this be
be aa possible
possible cover
cover Thank You!!!
story
story !!!
!!!

August 25, 2005