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Why India is growing up in \'Clinical Research\'.
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Drug Discovery, Development & Clinical
trials: Current status and the way forward
Presented By
Mr Jeetu GangilM. Pharm (Pharmacy
Practice)Manipal College of
Pharmaceutical SciencesManipal University,
Karnataka
26-27 June 2010, Solan (Himachal Pradesh)
Introduction
• Clinical trials are studies performed with human subjects to test
new drugs or combinations of drugs, new approaches to surgery or
radiotherapy or procedures to improve the diagnosis of disease and
the quality of life of the patient.
• In this presentation, we analyses the career prospects for the
professionals in the clinical research industry and discusses how
India would meet the growing demand for quality and trained
professionals to support local and global pharmaceutical companies
for the conduct of international standard clinical research.
Indian Scenario
• The Indian market is expected to double to nearly $10 billion by
2010 from the existing $5 billion. According to McKinsey &
Company's latest report "India Pharma 2015: Unlocking the
Potential of the Indian Pharmaceuticals Market" the country's
pharma market is all set to provide the third leading growth
opportunity globally. It is expected to triple in size and touch $20
billion by 2015, becoming one of the world's top 10
markets and the global pharmaceutical markets will
more than double to $1.3 trillion by 2020. India is
likely to be in the league of top 10 pharma markets
by 2020. Source; The Times of India, http://timesofindia.indiatimes.com
Drug Discovery & Development
Percentage of Different Models Emerged in Clinical Research
A Evolution in India
Source;Chiltern International Private Limited, India
Recruitment in Clinical Research: Indian Perspective
Demand-Supply Gap 2010 in IndiaSource: Chiltern International
Estimates
Evolution Clinical Trials
Source: Clinical Trial Registry, www.clinicaltrial.gov
January 2007
Is Clinical Research an attractive Pitch?
US $, 600
US $, 900
US $, 1500
US $, 1800
US $, 2000
US $, 2200
2006 2008 2010 2012 2014 2016
Growth of Clinical Trial in IndiaToday India has produced
300 GCP trained
investigators and
approximately 600 trained
CR professionals.
McKinsey estimated that
the Indian CR market will
grow to US$ 1.5 billion in
value by 2010.
The market will triple to $20
billion by 2015 and move into
the world’s top 10
pharmaceutical markets.Source: McKinsey’s Report
Clinical Research; India Vs World
India Vs Western Countries
PositiveFactor
Patient enrollment
Diversity
Costs
Equality
• English competency
• Medical infrastructure
• Western medicine
familiarity
• Companies with
international standards
Has to be Improved
• IPR reputation• Industry standards• Less established infrastructure
Cost Competitiveness of Indian R&D
Clinical Phase
US Costs Indian Costs
I US$ 20 million
<50% of US cost
II US$ 50 million
<60% of US cost
III US$ 100 million
<60% of US cost
Source: Business Week,
Pharmabiz, Cygnus Research
India overtakes China as No.1 destination for clinical trials
• India has piped China to become Asia's most popular
destination for conducting clinical trials. According to the
Planning Commission, around 139 new trials were out
sourced to India recently compared to 98 in China.
Source;
The Times of India
http://timesofindia.indiatimes.com
Is Recession Can Hit Indian Clinical Trials: CROs ?
• Indian clinical research organizations (CROs) do not see any near-
term impact of recession as large pharma customers where these
trials could be conducted at one-fifth of the US cost.
• The cost of clinical trials vary on the basis of complexity and disease
segment, a simple trial in India can cost 15-20% of the US price,
while a more sophisticated trial involving imaging systems may be
50-60% of the US price. Studies suggest that R&D expenditure is
increasing by 15% per year, making global biopharmaceutical
companies look for cheaper options.Source; The Economic Times
http://economictimes.indiatimes.c
om
Conclusion
‘India is the Best’ for clinical Trials’
• India has availability of a large population of treatment-naive patients
with multiethnic and multiracial backgrounds. India has Wide spectrum
of diseases in India. In India the cost of conducting trials can be reduced
up to 30-50% in India.
• India is identified as a major resource center for conducting clinical
trials and data management services. With its large patient populations,
well-trained and enthusiastic investigators, and per-subject trial costs
considerably lower than those in developed nations, it is widely
recognized as a major center for conducting clinical trials. Its increased
regulatory control and its acceptance of the ICH guideline for GCP
further enhance India's reputation as a place to conduct clinical trials.