State strategies of governance in global biomedical innovation:

the impact of China and India King’s College London March 15, 2013

Changing Biotechnology Innovation System in

India

Pranav N. Desai dpranav@hotmail.com

Professor, Centre for Studies in Science Policy

Jawaharlal Nehru University, New Delhi – 110067

India holds 2% share of the global

biotech market and has undergone a

structural change

Biopharma is the most dominant

segment

Bioservices and bioinformatics have

emerged as new segments

Agribio grew almost at the rate of

50% CAGR and the growth has

tapered off

The biotech industry remained export

and urban oriented industry. It is for

the first time that in 2012, the

revenues from the domestic sources

(US $ 1.93 billion) surpassed that of

the export sources ( US $ 1.80

billion). US $ = INR 54.6

2

Structure of the Indian Biotech Industry

0%

5%

10%

15%

20%

25%

2007-08 2008-09 2009-10 2010-11 2011-12

3

Growth of Indian Biotech Industry

Source: Biospectrum-ABLE Survey, 2012

0%

10%

20%

30%

40%

50%

60%

70%

BioPharma BioServices BioAgri BioIndustrial BioInformatics

23% 16%

11% 10%

13%

CAGR

4

Sectoral Revenue Share and CAGR (2012)

15%

48%

13%

24%

Micro

Small

Medium

Large

Is the Governance structure task different in India and China

ensuring funding and knowledge transfer?

5

Industrial Structure

68 76 73 74 74

70 68 63 63 63

12

14 20 20 21 26 27 33 34 33

7

4 4 3 2 3 2 1 1 1

13 5

3 1 1 1

1 2 2 2 1 1 1

1 1 1

1 1 1 2

0

20

40

60

80

100

120

2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-11 2011-12

BioAgri

BioIndustrial

BioInformatics

BioServices

BioPharma

Segment-wise Share of Biotech Export (%

share)

6

AgriBi

otech

PharmaBiotec

h

Bioservices BioIndustrial BioInformatics

BioFert

ilizers,

BioPes

ticides,

Seeds,

Bioino

culants,

Plant

growth

regulat

ors

Drugs,

Vaccines,

Medical

equipments and

devices, Drug

molecules

Clinical trials, CROs, clinical

research on: cancer, metabolic

diseases, diabetes,

cardiovascular diseases,

central nervous system.

Custom manufacturing, data

management, site

management, bio equivalence,

bio availability studies,

toxicology studies, kpo for

pharma industry, quality

assurance and regulatory and

medical affairs services to

pharma biotech and medical

device industries.

Enzymes Data on: Genome

sequencing,

structural

genomics,

proteomics, micro-

arrays, data on

medical biotech eg.

design of inhibitors

for cholera toxin

and proteomics

with special

reference to

hepatitis, algorithm

design for sequence

classification,

7 Segmentwise Classification of Biotech Commodity Exports

Moving from Multi-tiered Regulatory Framework

i. Recombinant DNA Advisory Committee (RDAC)

ii. Institutional Biosafety Committees (IBSC)

iii. Review Committee on Genetic Manipulation (RCGM)

iv. Genetic Engineering Approval Committee (GEAC)

v. State Biosafety Coordination Committees (SBCC)

vi. District Level Committees (DLC)

to a single window clearance

The Biotechnology Regulatory Authority of India (BRAI)

Venture Capital

Drivers

8

Institutional Challenges

Inward and outward FDI + Exports

City Cluster Program

Public Private Partnership

Special R&D Incentive for Biotechnology Sector

9

Biotechnology Industry Research

Assistance Programme (BIRAP) A 200 per cent weighted deduction is available

to firms that are engaged in biotechnology

manufacturing or production.

100 per cent tax free status for Biotech Special

Economic Zones (SEZs) for 5 years

Biotechnology Industry Partnership Programme (BIPP) The Biotechnology Industry Partnership Programme (BIPP)

launched recently, has so far benefited 51 companies undertaking

research in futuristic high risk technologies

Small Business Innovation Research Initiative

(SBIRI) The Small Business Innovative Research Initiative (SBIRI)

scheme of Department of Biotechnology to fund early stage

research has benefited more than 89 small and medium biotech

enterprises.

Knowledge Infrastructure (University, research

institutes, private and public R&D)

10

Actors

Production Infrastructure (Firms)

Policy Actors

Is meshwork more desirable than a network in the

governance structure?

0

100

200

300

400

500

600

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Year-wise Publication Trend by India in the Period

2001-2012 in the Reserach Area "Biotechnology and

Apllied Microbiology"

Source: ISI Web of Knowledge

11

9872

10145

11678

11937

12249

15693

17987

23802

24381

71159

CANADA

SPAIN

INDIA

SOUTH KOREA

FRANCE

ENGLAND

GERMANY

JAPAN

PEOPLES R CHINA

USA

Top 10 Countries Publishing in 'Biotechnology & Applied

Microbiology' Research Area in the Period 2001-2012

Source: ibid.

12

0 100 200 300 400 500 600

AUSTRALIA

CANADA

BRAZIL

PEOPLES R CHINA

ENGLAND

FRANCE

JAPAN

GERMANY

SOUTH KOREA

USA

Top 10 Collaborating Countries with India Publishing in

'Biotechnology & Applied Microbiology' Research Area in

the Period 2001-2012

Source: ibid.

13

BIOCHEMISTRY

MOLECULAR

BIOLOGY

21%

MICROBIOLOG

Y

19%

AGRICULTURE

15%

ENERGY FUELS

13%

ENGINEERING

10%

GENETICS

HEREDITY

7%

PLANT

SCIENCES

5%

CHEMISTRY

4%

FOOD SCIENCE

TECHNOLOGY

4%

TOXICOLOGY

2% 14

0

2

4

6

8

10

12

14

16

18

20

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

No. of

Pu

bli

cati

on

s

Year

Year-wise Publication Graph :India and China Collaboration

in 'Biotechnology and Applied Microbiology' Research Area

15

GENETICS

HEREDITY

17%

BIOCHEMISTRY

MOLECULAR

BIOLOGY

14%

AGRICULTURE

12%

PLANT SCIENCES

12%

MICROBIOLOGY

10%

ENERGY FUELS

9%

ENGINEERING

5%

FOOD SCIENCE

TECHNOLOGY

5%

MATHEMATICAL

COMPUTATIONAL

BIOLOGY

5%

TOXICOLOGY

5%

RESEARCH

EXPERIMENTAL

MEDICINE

3% VIROLOGY

3%

India and China Collaboration: Research Areas within 'Biotechnology &

Applied Microbiology'

16

2001-2003 2004-2006 2007-2009 2010-2012

466

712

1115

1387

Indian Patent Filed in Biotechnology (2001-2012) 17

18

19

Patent Cliff

20

Conventional therapies manage

the disease symptoms, while stem

cell therapies treat the cause of the

disease, and from a commercial

perspective this deficit of curative

treatments in conventional

therapies makes stem cell

research a potential goldmine.

Stem cell research also has

enormous potential for cell culture.

Cell culture methods ensure

standardized production and

propagation of highly purified stem

cells and their differentiated

progeny.

21

Type Embryonic Cord Adult Other

Technology Stem Cell

Transplantation

Cord Blood Banking

Xenotransplantation

Cell Based Genomics

Therapeutic Area

Neurology Orthopedic Cardiology

Hematology Diabetes Oncology Other

Dermatology

Segments of Stem Cell Market

22

0

500

1000

1500

2000

2500

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Global Trend in Stem Cell Patenting in 2001-2012 (USPTO + EPO)

Source: Thomson Innovation (accessed and analysed on 07.03.2013)

23

Hungary

New Zealand

Finland

Spain

China

Belgium

South Korea

Denmark

India

Taiwan

Netherlands

Italy

Australia

Sweden

Switzerland

France

UK

Germany

Japan

USA

10

15

26

33

33

70

73

77

78

87

98

99

116

119

219

268

287

578

695

4819

USPTO Granted Patents in Stem Cell in the Period 2001-2012: Top 20 Countries

Source: Thomson Innovation (accessed and analysed on 06.03.2013) Note: India is in 12th Position

24

New Zealand

Hungary

Taiwan

India

Finland

China

Spain

South Korea

Australia

Denmark

Belgium

Netherlands

Sweden

Italy

Switzerland

France

UK

Japan

Germany

USA

7

12

13

23

25

31

39

40

63

67

79

95

129

152

255

261

308

489

849

2548

Source: Thomson Innovation (accessed and analysed on 06.03.2013) Note: India is in 17th Position

25

Brazil

South Africa

Russia

India

New Zealand

Hungary

Austria

Switzerland

Belgium

Finland

China

Spain

South Korea

Netherlands

Australia

Israel

Denmark

Swede

Italy

Canada

France

Germany

UK

Japan

USA

5

7

10

12

15

16

18

18

19

20

21

31

37

39

52

59

67

90

102

164

195

410

422

461

3253

EPO Granted Patents in Stem Cell (2001-2012) Top 25 Countries

Source: Thomson Innovation (accessed and analysed on 05.03.2013)

Note: India is in 22nd Position

26

Maulana Azad Medical College,

New Dehli 3%

Sami Labs Ltd, Bangalore

3%

Tsar Health Pvt Ltd, Gurgaon

3%

Venues Remedies Limited,

Panchkula, Haryana

3%

Torrent Pharmaceuticals Ltd., Ahmedabad

5%

Ranbaxy Laboratories

Limited, Gurgaon

7% Biocon Ltd, Bangalore 8%

Reliance Life Science Pvt Ltd, Mumbai

13% Wockhardt Limited,

Mumbai 13%

CSIR, New Delhi 42%

Top 10 Stem Cell Patent Assignees in USPTO from India in 2001-2012

Assignee/Applicant Type of Stem Cell Number

Reliance Life Sciences Pvt. Ltd. Embryonic Stem Cell

Adult Stem Cell

iPSC

19

8

1

Stempeutics Research Private

Limited,Bangalore

Embryonic Stem Cell

Adult Stem Cell

9

17

Smt. G R Doshi and Smt. K M Mehta

Institute of Kidney Diseases and

Research

Adult Stem Cell 2

Patki Research Foundation & Hospital Adult Stem Cell 1

Advanced Neuro-Science Allies Private

Ltd.

Adult Stem Cell 1

Geeta Shroff, New Delhi

Embryonic Stem Cell 29

Arundhati Mandal Embryonic Stem Cell 1

27

Published Patents in Stem Cell

CTRI

Number

Cell Type

Used

Condition

Treated

Rando

mi-

zation

Total

Patient

Enrolled

Primary

Outcome

Trial

Phase

Sponsor Location

CTRI/2008/

091/000046

Autologou

s

BMMNCs

Acute

Ischemic

Stroke

+ Phase 2 DBT,

Govt. of

India

AIIMS, New Delhi

Army Hospital (R&R),

New Delhi

Armed Forces Medical

College Hospital, Pune

SGPGI, Uttar Pradesh

PGI, Chandigarh

CTRI/2008/

091/000232

Bone

marrow

stem cells

Acute

Myocardial

Infartion

+ 250 Improvemen

t in LV

function

Phase 3 DBT CMC, Tamil Nadu

MHCTC, Maharashtra

PGI, Chandigarh

Army Hospital, New Delhi

SGPGI, Uttar Pradesh

CTRI/2009/

091/000176

Ex Vivo

Cultured

Adult

Allogenic

MSCs

Myocardial

Infarction

+ 20 Phase 1/

Phase 2

Stempeuti

cs

Research

Pvt. Ltd.

Bhagwan Mahaveer Jain

Hospital, Karnataka

Care Hospital, Andhra

Pradesh

Care Institute of Medical

Sciences, Gujarat

MS Ramaiah Hospital and

Narayana Hrudayala

Centre, Karnataka

CTRI/2009/

091/00437

Ex Vivo

Cultured

Adult

Allogenic

MSCs

Dilated

Cardiomyo-

Pathy

+ 20 Safety and

Tolerability

Phase 1 Stempeuti

cs

Research

Pvt. Ltd.

KMC Hospital, Manipal

28

Clinical Trials of Stem Cell Therapy for Cardiac Repair Registered With Clinical

Trials Registry-India (CTRI), Indian Council of Medial Research

CTRI

Number

Cell Type

Used

Condition

Treated

Randomi

-

zation

Total

Patient

Enrolle

d

Primary

Outcome

Trial

Phase

Sponsor Location

CTRI/2009/

091/000590

Stem Cells Heart

Diseases

- 50 Increase in

myocardial

perfusion

N/A Frontier

Lifeline

Pvt. Ltd.

Frontier Lifeline Pvt Ltd..

Tamil Nadu

CTRI/2011/

05/001742

Cardiopoiti

c Stem

Cells

Chronic

Heart

Failue

+ 240 Change in

Left

Ventricular

ejection

Fraction

Phase

2/

Phase

3

Cardio

Bioscienc

es,

Belgium

The Heart Care Clinic, Gujarat

CTRI/2010/

091/000626

Autologous

MNCs

Coronary

Heart

Disease

- 50 Improvemen

t in LVEF

perfusion

N/A Global

Medical

Education

&

Research

Centre

Global Hospital, Andhra

Pradesh

CTRI/2010/

091/000643

Autologous Myocardia

l

Infarction

- 50 Improvemen

t in LVEF

perfusion

N/A Global

Medical

Education

&

Research

Centre

Global Hospital, Andhra

Pradesh

CTRI/2010/

091/000644

Autologous Myocardia

l

Infarction

- 50 Improvemen

t in

Myocardial

function

Phase

1

Global

Medical

Education

&

Research

Centre

Global Hospital, Andhra

Pradesh

29

30

Cipla Ltd, Mumbai

Dr. Reddy's Laboratories Ltd, Hyderabad

Lupin Limited, Mumbai

Reliance Life Sciences Pvt. Ltd, Mumbai

Torrent Pharmaceuticals Ltd, Ahmedabad

USV Limited, Mumbai

Wockhardt Limited, Mumbai

Panacea Biotec Ltd, New Dehli

Piramal Life Sciences Ltd, Mumbai

Sami Labs Limited, Bangalore

CSIR, New Delhi

1

1

1

1

1

1

1

1

2

2

2

2

6

Indian Stem Cell Patent Assigness (EPO) in 2001-2012

31

0

2

4

6

8

10

12

14

16

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Yearwise Graph of Indian Stem Cell Patent Grants (USPTO)

32

23

17

15

23

2001-2003 2004-2006 2007-2009 2010-2012

Indian Stem Cell Granted Patents (USPTO) in 2001-2012

33

0

1

2

3

4

5

6

7

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Yearwise Graph of Indian Stem Cell Patent Grants (EPO)

34

1

3

7

12

2001-2003 2004-2006 2007-2009 2010-2012

Indian Stem Cell Granted Patents (EPO) in 2001-2012

35

Thank you