Market Research India - Clinical Trials Market in India 2009

7/31/2019 Market Research India - Clinical Trials Market in India 2009

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Executive Summary

Market

Revenues from clinical trials were USD 200 mn in 2007; Expected to reach USD 500 mn by 2010

Total 536 clinical trials were conducted in India in 2008

India’s share in global clinical trial market in 2007 was 5% and is likely to reach 15% in 2011

Drivers &

o c n ca r a s con uc e n n a n were ase r a s

Drivers:Cost competitiveness

Disease prevalence in India

Challenges:Shortage of research professionals

Lack of data exclusivity

Sound medical infrastructure

International quality standards

Delays in trial approval

Challenges of unethical trials

Clinical trial can be initiated only after approval from Drugs Controller General of India (DCGI)

Government

Regulations

Clinical trials are governed by Scheduled Y of Drugs and Cosmetics act and Indian Council of

Medical Research (ICMR) guidelines

Registration of trials involving humans has been made mandatory starting in June 2009 on the

Clinical Trials Registry‐India (CTRI) website

Competition

International pharmaceuticals companies are the major sponsors of clinical trials

Many Indian and foreign pharmaceutical companies have tied up with other specialist clinical

research companies for development of new drugs

Internationally certified central laboratories and research institutes also conduct clinical trials in

2CLINICAL TRIALS MARKET – INDIA.PPT

IndiaSome of the leading CROs in India include Vimta Labs, Synchron, Reliance Clinical Research



•

•Overview

•Government Regulations

•Competition

•PE Investments

•Key Developments




Clinical trial is the final step in drug development process after

preliminary laboratory research and animal testing

Drug discoveryPre‐clinical

TestingPhase I Phase II Phase III

FDA Review

and

Approval

Post

Marketing

Testing

Number of Participants PurposeLength

Clinical trials are research studies involving humans and take place in four different phases

• Mainly safety20‐80 Several monthsPhase 1

Phase 1

• Some short term safety but

mainly effectiveness100‐300 Several months to 2 years

Phase 2

Phase 2

• Safety, dosage, effectiveness1000‐3000

• Determine and monitor life‐cycle

1‐4 years

Occurs post‐market

Phase 3


managemen , sa e y surve ance

and adverse

effects

ar es

introduction



•

•Overview


•Competition

•Key Developments




India is fast emerging as the most preferred destination for

clinical trials

Overview Revenues from

Clinical

Trials

USD mn

•Clinical trial research constitutes 2/3rd of R&D spending

500

200

70200

400

600+28%

•Low cost and speedy trials have made

India

a

preferred

destination

for

clinical

trials•India’s share in global clinical trials

Number of Clinical Trials

0

20072002 2010

market is expected to increase from 5%

in 2007 to 15% in 2011

Clinical trials phase wise India ‐2008

20%

Phase 2 Total = 536536

400

600 +143%

65%Phase 3

10% Phase 4

3%2%Phase 1/2

Phase 1

221

0

200

20082007




•

•Overview


•Competition

•PE Investments

•Key Developments




Drivers & Challenges

Challenges

Drivers

Shortage of research professionals

Lack of data exclusivit

Cost competitiveness

Vast patient

population

with

diverse

Delays

in

trial

approval

Sound medical infrastructure

Challenges of unethical trials

International quality standards




India offers significant cost savings in clinical trials

• Multinational pharma companies can achieve cost savings of around 30–50% when outsourcing

clinical trial projects to India

Cost Competitiveness

Impact

Phase US Costs Indian Costs

Phase I USD

20

mn <USD

10

mn

Phase II USD 50 mn <USD 30 mn

Phase III USD 100 mn <USD 60 mn

• Patient recruitment lead‐time is about 30‐40% lower in India compared to the US

• In the

US,

it

might

take

nearly

three

years

to

get

around

100

patients

to

conduct

trials

on

them,

in India the same number could be gathered in about six months

Chemist Productivity and Cost Comparison Overall Indexed Clinical Trial Costs

1.091.20Germany

UK7080

Hrs/Week

15,000

USD

0.52

0.56

0.71

0.730.77

0.93.

SpainPoland

AustraliaFrance

IndiaChina

50

0

20

40

60

0

10,000

5,000

,

800


.n a n a



Wide spectrum of diseases makes India an ideal destination for

clinical trials

Vast patient

population

with

diverse

number

of

diseases

• India with a population of 1 bn has a broad spectrum of diseases

• Diseases like multi‐drug resistant pneumonia, hepatitis B, diabetes and some cancers are far

Impact

more preva en n n a an n e es

• Recent global guidelines make it mandatory to test new drugs across a variety of new gene pools,

making

India ideal

for

clinical

trials

Asthma 40 mn

Cardiovascular Diseases 35 mn

Diabetes 34 mn

HIV/AIDS 4.2mn

Cancer 3 mn

Alzheimer’s 1.5 mn

Epileptic 8 mn

Hypertension 15% of total population

Schizophrenia 1% of total population


HIV

AIDS

Adult

prevalence

rate 0.36%

of

total

population



Sound medical infrastructure has made India an ideal destination

for clinical trials

• India has over a million English speaking, internationally qualified doctors, nurses, and

support staff

Sound Medical

Infrastructure Impact

• India has established world‐class expertise in complex medical practices such as Cardiac care,

Cosmetic surgery, Joint replacements, Neurosurgery etc

• Medical investigations

are

conducted

using

latest

diagnostic

equipment

meeting

the

stringent requirements of FDA

Indian Healthcare Infrastructure ‐ 2006

Public Hospitals 4,049

Private Hospitals 11,334

Hospital Beds 875,000

Doctors 1,000,000

Medical

Colleges 221New Doctors every Year 18,000

Retails chemist Outlets 350,000

Dental Colleges 100


Pharma

Colleges 150



India upholds intellectual property protection as per

international standards

• India became member of WTO in 1995 and agreed to adhere to the product patent regime by

2005

International Quality

Standards Impact

• Regulations passed by the government in 2005, committing itself to uphold and enforce

intellectual property protection as per international standards, has made the US and Europe to

look at

the

country

as

a preferred

destination

for

clinical

trial

outsourcing

• India has been part of the many FDA and European Medicines Agency (EMEA) registration

•The acceptance of data generated from India at all major conferences and journals proves its

credibility




Shortage of research professionals and lack of data exclusivity

could hamper growth in this sector

• India is facing a shortage of Good Clinical Practice (GCP) certified sites and investigators

• Over the next five years about 1,500‐2,000 good clinical practices (GCP) trained investigators

Shortage of

Research

Professionals Impact

supported by 50,000 clinical research professionals would be required in India

6,000CRO Staff

Demand Supply

Gap

1,000

2,000

4,000

300

400

,

S onsor Staff

Investigator

Other Site Staff

Supply

Demand

•

Lack of Data Exclusivity

200

Impact

,

• Indian law has no statutory protection for the data that is submitted to regulatory authorities for

approval of any products

• Although India is a signatory to the TRIPS Agreement, no new law have been introduced to

rotect test data




Delays in trial approval and challenges of unethical trials can

slow down growth in this sector

• Delays in granting approvals is affecting pharmaceutical companies and CROs in India

• Delays happens as the Drugs Controller's office depends on external experts and agencies such

Delays in

trial

approval Impact

as Indian Council of Medical Research for advice and additional permissions required for import

of trial samples and export of blood samples to foreign laboratories

810

MonthsClinical

Trials

Approval

time

111

0

5

IndiaUS CanadaUK

• Supreme Court of India had hauled up two top biotech companies Shanta Biotech & Biocon for

openly conducting illegal clinical trials of new drugs on unsuspecting patients after a litigation

filed

by

Aadar

Destitute

and

Old

People's

Home

(an

NGO)

Challenges of Unethical trials Impact

•NGO alleged that the two companies had conducted improper clinical trials of Streptokinnese ‐ a

new clot‐busting drug used in heart attacks without requisite permissions, as a consequence

eight people lost their lives

•Few incidents of illegal clinical trials has fueled immense concerns of a huge public outcry over


c n ca r a s



•

•Phases in

Clinical

Trials


•Competition

•PE Investments

•Key Developments


l b d l f l f ll



Trials can be initiated only after approval from Drugs Controller

General of India (DCGI)

For Approval purpose clinical trials are classified into two types

• Includes clinical

trials

whose

protocols

have

been

approved by USA, UK, Switzerland, Australia, Canada,

German South Africa Ja an or the EMEA

• Includes

clinical

trials

whose

protocols

have

been

approved in other countries which are not listed in

category A

• Regulatory (DCGI) approval time is within 2‐4 weeks• egu a ory urnaroun me w e ‐

weeks

• India has

well

‐defined

guidelines

for

carrying

out

various

phases

of

clinical

trials

• These guidelines are in line with the global guidelines on clinical research (ICH‐GCP)

• First time exposure of new drugs (of other countries) in Indian healthy volunteers is not allowed as per the

regulations in India

• Clinical research organizations (CROs) have to obtain 'no objection' letter from Drugs Controller General of India

(DCGI)

and

import

license

to

import

the

research

drug• In case samples are exported outside the country an export license is required from Directorate General of Foreign

Trade (DGFT)

• Registration of trials involving humans has been made mandatory starting in June 2009 on the Clinical Trials Registry‐

India (CTRI) website


S h d l f h d C i li i l f



Schedule Y of the Drugs and Cosmetics Act applies to trials of

new drugs

Schedule Y of

Drug

and

Cosmetic

Act

deals

with

regulations

relating

to

clinical

trial

requirements

for

the

import, manufacture and obtaining marketing approval for a new drug in India

ase on mar e ng approva , rugs are c ass e n o ree ca egor es

New drug substances

discovered that are not

New drug substances

discovered that are already New drug substances

approve mar e e n o er

countries

approve mar e e n o er

countries

scovere n n a

• Clinical trials have to be

• It is sufficient if

confirmatory trials (phase

III) are conducted to obtain

data about

the

efficacy

carried out as human

/clinical pharmacology

trials (phase I)

• The phase I trials are

• Permission for clinical

trials were earlier given

with a phase lag

and safety of the drug in a

large number of patients

(minimum 100, in 3‐4

centers)

human volunteers

• Purpose is to determine

the maximum tolerated

dose in humans, adverse

• Clinical trials can now be

conducted concurrently

with other countries


reactions,

etc

ICMR id li k hi l i d i i i



ICMR guidelines seeks to ensure ethical practices and minimize

exploitation of the participants

Indian Council

for

Medical

Research

(ICMR)

Guidelines

for

clinical

trials

• The proposed trial should be carried out, only after approval of the DCGI

• Informed consent is necessary

• First three of the four phases of clinical trials of drug require ethical clearance

• The duration of time lapsing between two trials in the same volunteer should be a minimum of 3 months

• The first phase should involve low risk subjects

•

• Therapeutic or curative vaccines may be given to patients suffering from particular diseases

Surgical procedures/

• Safety data

of

the

medical

device

in

animals

should

be

obtained

• Phase I of drug trials is not necessary for trial on devices

medical devices • Safety procedures to introduce a medical device in the patient should be followed

Diagnostic agents

• In human beings, for investigation and treatment, different radiations ‐ X‐ray, gamma rays etc can be used

• Radiation limits for the use of such materials and X‐rays should be in accordance with the limits set forth by the

Herbal remedies

• Safety measures should be taken to protect research subjects and others who may be exposed to radiation

• For herbal remedies and medicinal plants that are to be clinically evaluated for use in the Allopathic System

procedures laid down by DGCI for allopathic drugs should be followed

•


,



•

•Phases in

Clinical

Trials


•Competition

•PE Investments

•Key Developments


M j li t f CRO i t ti l h ti l



Major clients for CROs are international pharmaceutical

companies

•India has over 50 CROs in clinical trials

Overview

Global Pharma

Com anies• a or sponsors or c n ca r a s are n erna ona

pharmaceuticals companies with huge R&D

spending

•Many Indian and foreign pharmaceutical Outsource

companies have tied up with other specialist

research companies for development of new

drugs

Drug

DiscoveryClinical Trials

• arma compan es are ean ng towar s

outsourcing and concentrating on marketing

without spending time for drug discovery and

manufacturing•Internationally certified central laboratories and

research institutes also take part in clinical trials in

India

CROsResearch

Institutions




Clinical Research Organizations (1/7)

Company Locations Business Description

AcuNova Bangalore,

Manipal and

• Provides end‐to‐end services for Phase I ‐ IV clinical research, including Clinical

Trial Management, Clinical Data Management, PK/PD services and Central Lab

Mangalore

Advinus

Thera eutic

Pune and

Bangalore

• Offers

services

in

drug

discovery,

medicinal

chemistry,

toxicology

studies

• It entered into Joint venture with Johnson and Johnson subsidiary, Ortho‐

McNeil‐Janssen Pharmaceuticals Inc in September 2008

• It has alliances for neglected diseases with Geneva based Drugs for Neglected

Diseases initiative (DNDi) for tropical disease kala azar and anti‐malarial drugs

with Genzyme Corp and Medicines

• Offers lead generation and optimization and early computational chemistry

Aurigene Bangalore aided and design, mining and screening of novel chemical entities.

•Has worked on collaborative discovery programmes with Novo Nordisk on

Diabetes and discovery services with Rheosciences, Denmark

•Has

a

pipeline

of

15

discovery

programs

at

various

stages

Avra Labs Hyderabad• Works in product chemistry, organic synthesis, chiral synthesis technology

• Company is focusing on high‐end contract research, custom synthesis of

complex chemicals and difficult to manufacture intermediates and APIs


Note: This list is not exhaustive





Asian Clinical

• Offers services in Phase I/ II/ III/ IV clinical trials, post‐marketing surveillance,

clinical data management, regulatory services

Trials Limited • Entered into strategic alliance with VPSCRO, a CRO based in Beijing, China to

conduct clinical trial services in India, as well as in China in April 2008

Bioserve Clinical

• Bioavailability / bioequivalence, food effect, dose response, steady state, drug –

drug interaction, special populations, pharmacoscintigraphic imaging

Research Pvt. Ltd Hyderabad • Has completed over 450 studies for various pharmaceutical sponsors

• Completed over 65, for Regulatory submission to US FDA, UK MHRA, SA MCC,

AUS TGA, WHO, Health Canada and other agencies

ClinInvent • Provides services to the pharma, biotech and medical devices industries

Mumbai • It has a tie‐up with MDS Pharma Services, a leading North American CRO

• Company plans to work on projects that involve genomics

• Has expertise in managing several clinical trials in all major therapeutic

ClintecBangalore

ca egor es

• Its clients include pharmaceutical companies such as Abbott, Novartis, Roche

and Wyeth and major biotech companies such as Serono and Chiron

• Present in over 30 countries worldwide







ClinWorld Mumbai and

• Provides clinical trial services, pharmaceutical and bio pharmaceutical analysis ,

pre‐clinical services and regulatory services

• It has clients like Ciba‐Giegy, Glaxo Wellcome

GVK Biosciences Hyderabad

• Offers services in medicinal chemistry, bioinformatics, clinical trials, custom

synthesis and drug discovery

• Its clients include Wyeth, Biogen, Merck & Co

• In March 2009, it got approval from Ministry of Health, Turkey for

Bioequivalence Studies

Hikal Ltd.• Offers

services

in

medicinal

chemistry,

custom

synthesis,

CRAMS

• It has tied u with Merck and Novartis

Mumbai Financials

• Reported total income of USD 67 mn and operating profit of USD 13 mn in

FY2008

•

InnovasynthKhopoli (near

Mumbai)

,

,

• Has alliance with Austin Chemical Company, US







• Provides services in bioinformatics, clinical trials, CRAMS, medicinal chemistry

services, custom synthesis and drug discovery serviceu an

OrganosysNoida • Entered into a drug development joint venture with Lily in 2008

Financials• Reported total income of USD 414 mn and operating profit of USD 91 mn in

FY2008

Karmic

lifesciences Mumbai

• Offers services in clinical trial management, clinical data management, bio‐

statistics, medical writing, regulatory consulting, drug safety &

pharmacovigilance

and

bio‐

analytical

services

across

early

to

late

phase

(phase

I

through IV) and pre‐clinical research

• It has strategic alliances with Strategic Capital Investments LLC and Seahorse

Scientific Services Ltd

Gurgaon

and

• Clinical development (phases I to III), regulatory affairs, clinical data

management, biostatistics and scientific programming, late phase, etc

Ahmedabad • It acquired the Phase II‐IV business of Charles River Clinical Services in 2006







Lambda

Therapeutic

Ahmedabad,

Mumbai and

• Works on all aspects of clinical drug development including clinical trials, clinical

laboratory, data management, bioequivalence/bioavailability studies

Research Ltd Chennai

Lotus Labs Pvt. Bangalore • Phase I to IV clinical trials including bio equivalence studies, drug storage &

s r u on, o‐ana y ca an s a s ca serv ces.

• Many of Lotus Labs’ submission studies have been approved by USFDA, WHO,

EU, Canada and ANVISA

• Lotus submission

studies

have

been

submitted

to

over

45

countries

across

the

Matrix

Laboratories Ltd

Hyderabad • Offers services in Drug Discovery, Development and Commercialization of New

Molecular Entities (NMEs)

• One of the largest Active Pharma Ingredients (API) players with over 70 drug

,

Financials

• Reported an operating loss of USD 8333 in FY 08







Parexel Hyderabad and

Bangalore

• Therapeutic expertise, clinical trials, data sciences, patient recruitment, medical

writing and submission, clinical logistics services

• Operates in 69 locations throughout 52 countries around the world

• It

acquired

ClinPhone

a

leading

clinical

technology

firm

in

August

2008PharmaIntel Kolkata • Offers services in Protocol and CRF designing ,conduct s phase II and III clinical

trials site mana ement for clinical trials and monitorin clinical data

management, post marketing surveillance study, phase IV clinical trial, medical

writing /report writing etc

• It is a part of KPC Life Solutions

PPD Mumbai and • Provides services in reclinical hase I hase II‐III ost‐a roval and labs

New Delhi

• It entered into a strategic collaboration with Merck & Co for vaccine testing

and assay development in April 2009

Reliance Clinical Mumbai and • Offers services in preclinical services, clinical pharmacology and

Services

,

,

laboratory services, pathology laboratory services

• Has conducted over 120 trials, ranging from Phase 1 studies, Phase 2 to 4

studies and bioavailability and bioequivalence studies







SIROMumbai

• Provides services in all phases of clinical trials and in all key areas of the drug

development process

• It has acquired mid sized European CRO Omega in April 2008

SynchronAhmedabad

• Provides

broad

range

of

clinical

research

services

from

phase

I

to

phase

IV

• It acquired Innovance, a start up CRO based in Ahmedabad in 2007

• It commenced o erations in Ban kok in 2007

• Has a Joint Venture with Boston‐based Parexel International

• Contract research and analytical testing, clinical lab – pathology services,

analytical testing

of

water,

food

&

drugs,

environmental

assessment

Vimta Labs LtdHyderabad

trials involving over 120 drugs

Financials

• Reported a Total Income : USD 18 mn and an Operating Profit of USD 5 mn in FY

2008





Clinical Research Institutes (1/3)

Institute Location Areas of

Research

Advanced Centre for

Treatment, Research and Mumbai

• At present comprises of the basic and clinical research wings and a 50‐

bed hospital

Education in Cancer • Conducts research and development on cancer

• Design and

development

of

drugs,

diagnostics/vaccines

right

from

the

synthesis of compounds upto regulatory studies and clinical trials

• Undertakes contractual research work

Central Drug Research

Institute (CDRI) Lucknow

• Research activities are broadly divided into three subgroups:

Drug discovery & development

Regulatory

studies Infrastructural support groups

• Developed a new drug to control and cure depression, the new drug

has been found to be safer that the existing anti‐depression drugs

Institute of

Cytology

&

• Promotes research in the field of cancers

• Institute undertakes

multidisci linar

studies

in

order

to

understand

Preventive Oncology the natural history, biological behavior and mechanisms of

carcinogenesis







Research

National AIDS Research

• It is a National Institutes of Health (NIH) designated unit for HIV / AIDS

Clinical Trials Network

Institute • It participates in clinical trials conducted by global networks of HIV /

AIDS

National Brain Research New Delhi• This center is dedicated to provide infrastructure facilities and a

coordinated multidisciplinary team to work at the frontiers of

neuroscience

National Institute of

Cholera

and

Enteric

Diseases Kolkata

• Conducts research on acute diarrhoeal diseases of diverse etiologies

as

well

as

on

typhoid

fever,

infective

hepatitis

and

HIV/AIDS

related

epidemiological research and screening


Immunology

New Delhi

• The Institute specializes in advanced research addressing the basic

mechanisms involved in body's defence and host‐pathogen

interactions

• In a process of developing a vaccine to safeguard children from

diarrhea caused from rotavirus, vaccine is undergoing clinical trials


NutritionHyderabad

• It works under the Indian Council of Medical Research (ICMR),

Ministry of Health and Family Welfare, Government of India

• Its clinical division offers training, advisory and consultancy services


to the government and other organizations






Research

National Institute of Pune

• Since 1974, it has been functioning as a WHO Collaborating Centre for

arbovirus reference and research

Virology (NIV) • NIV is also the National Monitoring Center for Influenza, Japanese

encephalitis, Rota , Measles and Hepatitis

• A WHO Collaborating Centre for TB Research and Training

• Has conducted randomized controlled clinical trials for treatment of

Tuberculosis Research

Centre (TRC) Chennai

both pulmonary and extra pulmonary TB in collaboration with various

hospitals and medical colleges

• The centre functions from three campuses at Chennai, Tiruvallur and

Madurai





•

•Phases in

Clinical

Trials

•Government

Regulations•Competition

•PE Investments

•Key Developments




PE Investments

Date Company Private Equity

firm Amount Description

30‐Apr‐2009 Karmic Life

Sciences

Indian Angel Network USD 500,000 The investments have been made for minority

stakes in the company

19‐Aug ‐2008 Rubicon

Research

Kotak Private Equity Undisclosed

Amount

Rubicon Research is setting up a clinical trials

supply facility in Ambernath

14‐Sep‐2007 Sai

Advantium

Sequoia Capital India USD 12.5 mn Sequoia Capital India has invested in Hyderabad

based Sai Advantium for 18.34% stake

26‐Jun‐2006 Siro

Clinpharm

Baring Private Equity Undisclosed

Amount

Stake offloaded is less than 30 %




•

•Phases in

Clinical

Trials

•Government

Regulations•Competition

•PE Investments

•Key Developments




Key Developments

Date Development

22‐ Jun‐09 Switzerland‐based contract research organization PFC Pharma Focus has set up an Indian subsidiary

with the help of Excel Life Sciences, a US firm that specialises in running trials in India

15‐May ‐09 GVK Biosciences, has entered into a strategic alliance with Excel Pharma Studies a Chinese research

organization, to conduct clinical trials in Asia. Both the companies will help sponsors to conduct and

manage phase II‐IV clinical trials, statistical analysis and medical writing

5 –May ‐09 Jubilant Organosys Ltd, through its Bangalore, based subsidiary, Jubilant Biosys Ltd, has signed a

research collaboration agreement with, AstraZeneca, focused on delivering novel drug candidates into

the international pharmaceutical company's pre‐clinical pipeline

10 – April ‐09 Suven Life Sciences has completed its phase one multiple ascending dose study of SUVN‐502 in

healthy volunteers.

SUVN

‐502

is

a potent,

safe,

highly

selective,

brain

penetrant

and

orally

active

an agon s a a non per p era recep or s e ‐ , n en e or e symp oma c rea men o

Alzheimer's disease, Schizophrenia and other disorders of memory

23‐ Jan‐09 Syngene, Biocon's (India) contract research firm, has signed a partnership deal with U.S. biotech firm

Sapient Discovery

9‐ Jan‐09 n a s

an axy

a orator es

t

commence

n t a‐stage

c n ca

tr a s

on

an

exper menta

resp ratory

inflammation drug it which it is jointly developing with Britain's GlaxoSmithKline

29‐Sep‐08 India's Orchid Chemicals & Pharmaceuticals Ltd and U.S based Merck & Co Inc announced drug

discovery pact to develop new drugs to treat bacterial and fungal infections. Orchid's research unit, Orchid Research Laboratories will identif dru tar ets and develo them throu h hase II clinical


trials

and

Merck

will

conduct

late‐

stage

clinical

trials

and

sell

the

drugs

after

regulatory

approvals

h k f



Thank you for your timeFor an updated report or any customized research requirements, please contact:

Gaurav Kumar

E‐Mail: [email protected]; [email protected]

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Documents

Market Research India - Clinical Trials Market in India 2009