The clinical trials market in India was valued at INR x1 billion in 2013 and is estimated to reach INR x2 billion by 2018, growing at a CAGR of y1%. India's share of the global clinical trials market was y2% in 2013. Key drivers of growth include lower costs, a large patient population, and increasing R&D spending by pharmaceutical companies. However, new regulations have also brought challenges such as delays in approval and a shortage of research professionals. The document provides an overview of the market size and growth drivers, government regulations, and major players in the clinical trials industry in India.

1. Clinical Trials Market – India
July 2014

2. 2CLINICAL TRIALS MARKET IN INDIA 2014.PPT
Executive Summary
Market
Drivers &
Challenges
Government
Regulations
Competition
 Clinical trials market in India was valued at INR x1 bn in 2013 and is estimated to reach INR x2 bn
by 2018, growing at a CAGR of y1%
 India’s share in the global clinical trials market was y2% in 2013
Drivers:
–Cost competitiveness
–Vast patient population with diverse
number of diseases
–Increasing R&D expenditure by
pharmaceutical companies
–Sound medical infrastructure
–International quality standards
Challenges:
–New regulations brought in several
challenges
–Delays in trial approval
–Shortage of research professionals
–Challenges of unethical trials
Clinical trial can be initiated only after approval from Drugs Controller General of India (DCGI) and
are governed by Schedule Y of Drugs and Cosmetics Act
Registration of trials involving humans has been made mandatory starting in Jun 2009 on the
Clinical Trials Registry-India (CTRI) website
Major Players
Company A Company B Company C Company D
Company E Company F Company G Company H

3. 3CLINICAL TRIALS MARKET IN INDIA 2014.PPT
•Macroeconomic Indicators
•Introduction
•Market Overview
•Drivers & Challenges
•Government Participation
•Competitive Landscape
Clinical Research Organizations
(CROs)
Clinical Research Institutes
•Recent Developments
•Strategic Recommendations
•Appendix

4. 4
Economic Indicators (1/3)
11
12
13
14
15
b2
a2
Q1
d1
c1
b1
a1
Q4
c4
b4
a4
Q3
c3
b3
a3
Q2
d2
c2
INR tn
2013-142012-132011-122010-11
GDP at Factor Cost: Quarterly
Inflation Rate: Monthly
-2
-1
0
1
2
q
Jul 2013 - Aug 2013
p
%
Nov 2013 - Dec 2013
t
Oct 2013 - Nov 2013
s
Sep 2013 - Oct 2013
r
Aug 2013 - Sep 2013
CLINICAL TRIALS MARKET IN INDIA 2014.PPT

5. 5CLINICAL TRIALS MARKET IN INDIA 2014.PPT
Globally, the clinical research market is gaining importance
mainly due to the rising number of new drugs
• China is the leader in the global clinical trials market
followed by Turkey and Malaysia
 Liberal regulatory environment supports clinical trials
 The government encourages pharmaceutical and
biotechnology industries to invest in new drugs and
procedures for treating cancer and AIDS patients
•In 2013, the global market size of clinical research
market was INR x1 bn where the USA contributes
y1% of the business followed by UK
• The major trend in the global market is the rise in
investment by the pharmaceutical and the device
companies in countries with emerging economies
 Multinational pharmaceuticals prefer Asian countries for
clinical trials to overcome the various challenges of drug
discovery and development
•Globally, the major problem for conducting clinical
trials is patient recruitment
Global Market - Overview
Share of Human Clinical Trials (2013)
x3
x2 x1
Segment 3
Segment 2
Segment 1
The cost of carrying out clinical research in
Russia, Argentina, China and India is half
the amount required in the USA
CRO Market Size and Growth (Value-wise)
t
s
r
q
p
INR bn
X%
2018e
a6
2017e
a5
2016e
a4
2015e
a3
2014e
a2
2013
a1

6. 6CLINICAL TRIALS MARKET IN INDIA 2014.PPT
India is emerging as a preferred destination for clinical trials
and the market is expected to show steady growth
Market Overview Market Size and Growth (Value-wise)
Research
Institutions
Global Pharma Companies
Drug Discovery Clinical Trials
Outsource
Contract Research
Organizations
•Clinical trial market in India has the potential to
become the hub for conducting major global
multinational clinical trials
•Major sponsors for clinical trials are international
pharmaceuticals companies with huge R&D spending
 India has a large genetic pool and has a large number of
patients suffering from acute chronic disease
 There are around 60,000 doctors, 45,000 hospitals and
900,000 beds in both public and private hospitals with
electronic medical record facilities in most of them
• Many Indian and foreign pharmaceutical companies
have tied up with other specialist research companies
for development of new drugs
• Pharmaceutical companies are leaning towards
outsourcing and concentrating on marketing without
spending time for drug discovery and manufacturing
• India’s competitive advantage in generic drugs makes
it a potential hub for conducting clinical trials
India has 16% of the world population and
20% of the global burden of diseases
t
s
r
q
p
INR bn
X%
2018e
a6
2017e
a5
2016e
a4
2015e
a3
2014e
a2
2013
a1

7. 7
Drivers & Challenges – Summary
Drivers
Cost competitiveness
Vast patient population with diverse
number of diseases
Increasing R&D expenditure by
pharmaceutical companies
Sound medical infrastructure
International quality standards
Challenges
New regulations have brought in
several challenges
Delays in trial approval
Shortage of research professionals
Challenges of unethical trials
CLINICAL TRIALS MARKET IN INDIA 2014.PPT

8. 8
SAMPLEPorter’s Five Forces Analysis
Competitive RivalryBargaining Power of Suppliers
Bargaining Power of Buyers
Threat of Substitutes
Threat of New Entrants
Impact
x
Impact
x
Impact
x
Impact
x
Impact
x
*Note: BEP (Break-even point)
CLINICAL TRIALS MARKET IN INDIA 2014.PPT

9. 9
SAMPLEKey Ratios of Top 3 Companies – Operational Basis (FY 2013) (1/3)
Competitive Benchmarking (2/5)
0
10
20
30
40
%
Company C
b3a3
Company B
b2a2
Company A
b1
a1
Operating Margin Net Margin
• Company A recorded operating margin of x1%, higher than that of Company B which recorded operating margin of
y2% but lower than that of Company C which recorded operating margin of z3%
• Net margin for Company A , Company B and Company C are a1%, b2% and c3% respectively, wherein Company A has
the highest net margin among these three companies
CLINICAL TRIALS MARKET IN INDIA 2014.PPT

10. 10
SAMPLE
Private: Domestic Company – Company 1
(1/5)
Key People
Products and Services
Company Information Offices and Centres – India
Name Designation
Person 1 Director
Person 2 Director
Person 3 Director
Person 4 Director
Corporate Address
Tel No.
Fax No.
Website
Year of Incorporation Head Office
Category Products/Services
Ready Meals
Instant Mixes
Others
Mumbai
CLINICAL TRIALS MARKET IN INDIA 2014.PPT

11. 11
SAMPLE
Private: Domestic Company – Company 1
(2/5)
Shareholders of the Company Ownership Structure
Name No. of Shares held
23.6%
57.4%
19.0%
Segment
Segment
Segment
CLINICAL TRIALS MARKET IN INDIA 2014.PPT

12. 12
SAMPLEFinancial Snapshot Key Ratios
Particulars
y-o-y change
(2013-12)
2013 2012 2011 2010
Profitability Ratios
Operating Margin
Net Margin
Profit Before Tax Margin
Return on Equity
Return on Capital Employed
Return on Working Capital
Return on Assets
Return on Fixed Assets
Cost Ratios
Operating costs (% of Sales)
Administration costs (% of
Sales)
Interest costs (% of Sales)
Liquidity Ratios
Current Ratio
Cash Ratio
Leverage Ratios
Debt to Equity Ratio
Debt to Capital Ratio
Interest Coverage Ratio
Efficiency Ratios
Fixed Asset Turnover
Asset Turnover
Current Asset Turnover
Working Capital Turnover
Capital Employed Turnover
Private: Domestic Company – Company 1
(3/5)
Improved Decline
Financial Summary
• The company earned a net profit of INR x1 mn in FY 2011, as
compared to net profit of INR x2 mn in FY 2010
• The company reported total income of INR x3 mn in FY 2011,
registering an increase of x4% over FY 2010
• The company earned an operating margin of x5% in FY 2011,
an increase of x6 percentage points over FY 2010
• The company reported debt to equity ratio of x7 in FY 2011, a
decrease of x8% over FY 2010
Net Profit/LossTotal Income
a
t
s
r
q
f
p
b
c
d
e
b4
a4
20112008
a1
b1
2010
a3
b3
2009
a2
b2
CLINICAL TRIALS MARKET IN INDIA 2014.PPT

13. 13
SAMPLE
13
Description News
Overview
• Company 2 has hospital network in Country A, Country B and Country C and is primarily headquartered in
Country D
• Presently located in 10 cities in India having hospitals in Region 1, Region 2 and Region 3
Facilities
• Has core specialties in heart care, brain and spine, bone and joint and minimal access surgery
• Provides advanced medical diagnostics and treatment with personal care
Recognitions
• Obtained NABH accreditation within one and a half years of beginning operation in India
• Hospital A, Region 1, Hospital B, Region 2 has been NABH accredited
Business Highlights
Private: Domestic Company – Company 1
(3/5)
CLINICAL TRIALS MARKET IN INDIA 2014.PPT

14. 14
SAMPLE
TO
WS
Private: Domestic Company – Company 1– SWOT Analysis
(5/5)
CLINICAL TRIALS MARKET IN INDIA 2014.PPT

15. 15
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