Booming Clinical Trials Market in India

Publication Date	January 2009
Publisher	RNCOS
Product Type	Report
Pages	105
ISBN Number	not applicable
Product Code	RCS00517

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Summary

According to our research report, "Booming Clinical Trials Market in India", India promises to be one of the hottest destinations for conducting global clinical research, owing to a huge patient pool representing both chronic and infectious diseases, easy recruitment of patients, and high cost savings.

India presently occupies a very small pie of the global opportunity. The total number of clinical trials in India stood at 221 in 2007, which equates to less than 2% of the global clinical trials. With all major pharmaceutical/biotech companies and CROs establishing their presence in India, the number of clinical trials in the country is expected to grow several folds in the next five years. The country is projected to conduct nearly 5% of the global clinical trials by 2012. However, to achieve its goal of becoming a global hub of clinical trials, the country has to overcome challenges like unethical trials, delay in trial approval, inappropriate protection of clinical data, and lack of Good Clinical Practice (GCP) certified sites and investigators.

Surging clinical trials market in India will create enormous opportunities for a number of associated industries, including IVD market, education sector and clinical data management.

"Booming Clinical Trials Market in India" gives an extensive and objective analysis on the Indian clinical trials market. It investigates the advantages/disadvantages India has in becoming a global clinical trials hub. The report exhaustively evaluates and compares the key factors that drug companies and CROs look before outsourcing clinical trials to a country. These include parameters such as patient pool, regulatory environment, cost, infrastructure, human resources and past performance in conducting clinical trials. Thus, this analytical study serves as a useful guide for drug manufacturers, CROs, consultants and investors who are planning to enter the Indian clinical trials market.

Our report provides forecasts on

Size of global clinical research outsourcing market
Size of Indian clinical research outsourcing market
Number of clinical trials in India
Number of patients expected to participate in clinical trials in India
Clinical trials infrastructure and professionals in India
Healthcare indicators in India

Key questions answered in the report

Why are drug manufacturers outsourcing clinical trials?
Where and how many clinical trials are being outsourced?
Where dose India stand in the global clinical trials market?
How big is the clinical trials opportunity in India?
How much does it cost on hiring personnel for various clinical research processes, rent and utilities in India as compared to other countries?
How does clinical trials infrastructure and staff in India vary from other countries?
What are various government regulations/guidelines for conducting clinical trials in India?
What are the Future trends predicted to shape the clinical trials market in India?
How is the clinical trials market impacting associated industries?

Key players analyzed in the report

This section provides business overview on prominent players in the Indian clinical research market like Syngene International Ltd, Quintiles Research (India) Private Limited, Lambda Therapeutic Research Ltd, Vimta Labs Limited and Veeda Clinical Research - India.

Content

1. Analyst View
2. Global Clinical Trials Market
- 2.1 What are Clinical Trials?
- 2.2 Conducting Clinical Trials is becoming Costlier and Difficult
- 2.3 Clinical Research Outsourcing Market
  - 2.3.1 North America
  - 2.3.2 Europe
  - 2.3.3 Latin America
  - 2.3.4 Africa
  - 2.3.5 Asia-Pacific
3. India - Success and Risk Factor Analysis
- 3.1 Access to a Large Patient Pool
- 3.2 Lower Cost
- 3.3 Faster Completion
- 3.4 Improving Infrastructure and Large Pool of Healthcare Professionals
- 3.5 English-based Medical Education and Documentation
- 3.6 Lucrative Pharmaceutical Market
4. Indian Clinical Trials Market
- 4.1 Number of Clinical Trials
- 4.2 Clinical Trials by Type
- 4.3 Patient Participation
- 4.4 Market Trend
- 4.5 Market Share of Key Players
5. Size and Availability of Patient Pool
- 5.1 Population and Demographics
- 5.2 Disease Profile
- 5.3 Patient Availability and Recruitment
6. Regulatory Environment
- 6.1 Regulatory Affairs
- 6.2 The Institutional Ethics Committee (IEC)
- 6.3 Trials that can/cannot be Conducted in India
- 6.4 Clinical Trials Registry
- 6.5 Intellectual Property Protection
- 6.6 Incentives given by the Government
7. Cost Analysis
- 7.1 Phase I Clinical Trials
  - 7.1.1 Cost of Staff
  - 7.1.2 Cost of Utility
- 7.2 Phase II Clinical Trials
  - 7.2.1 Cost of Infrastructure and Staff
  - 7.2.2 Cost of Utility
- 7.3 Phase III Clinical Trials
  - 7.3.1 Cost of Infrastructure and Staff
  - 7.3.2 Cost of Utility
- 7.4 Phase IV Clinical Trials
  - 7.4.1 Cost of Infrastructure and Staff
  - 7.4.2 Cost of Utility
8. Infrastructure & Expertise
- 8.1 Education
- 8.2 Clinical Research Professionals
- 8.3 Hospital Beds
- 8.4 ICH/GCP Compliant Sites
- 8.5 Clinical Data Management
9. Roadblocks
- 9.1 Ethical Issues
- 9.2 Lack of Trained Staff
- 9.3 Intellectual Property Protection
- 9.4 Long Time for Approval
- 9.5 Data Exclusivity
10. Opportunities
- 10.1 Increased Demand for Clinical Research Professionals
- 10.2 Demand for Clinical Training Institutes
- 10.3 Pathology and Diagnostic Market
- 10.4 Clinical Data Management
- 10.5 Business Process Outsourcing
11. Key Players
- 11.1 Syngene International Ltd
- 11.2 Quintiles Research (India) Private Limited
- 11.3 Lambda Therapeutic Research Ltd
- 11.4 Vimta Labs Limited
- 11.5 Veeda Clinical Research - India
List of Figures:
- Figure 2-1: Cost of Developing a New Drug (in Million US$), 1979 to 2012
- Figure 2-2: Global - Pharma R&D Expenditure by Development Function (%), 2006
- Figure 2-3: Global - Pharma R&D Expenditure by Development Function (%), 2008
- Figure 2-4: Global - Clinical Research Outsourcing Market (in Billion US$), 2005-2007
- Figure 2-5: Global - Clinical Research Outsourcing Market by Phase (%)
- Figure 2-6: Global - Clinical Research Outsourcing Market by Region (%), 2005
- Figure 2-7: Global - Clinical Research Outsourcing Market (in Billion US$), 2008-2012
- Figure 3-1: India - Average Cost for Conducting Various Clinical Trial Phases w.r.t US (in Million US$)
- Figure 3-2: India - Time Taken for Conducting Clinical Trials by Phase w.r.t US (in Months)
- Figure 3-3: India - Clinical Trials Completed on Time w.r.t UK, US and Germany
- Figure 3-4: India - Domestic Pharmaceutical Market* (in Billion INR), 2001-02 to 2007-08
- Figure 3-5: India - Forecast for Domestic Pharmaceutical Market* (in Billion INR), 2008-09 to 2011-12
- Figure 4-1: Global - Number of Clinical Trials (2005-2007)
- Figure 4-2: India - Number of Clinical Trials (2005-2007)
- Figure 4-3: India - Number of Clinical Trials (2008-2012)
- Figure 4-4: India - Proportion of Number of Clinical Trials in Global Clinical Trials (%), 2007 & 2012
- Figure 4-5: India - Clinical Trials by Phase (%), 2007
- Figure 4-6: India - Clinical Trials by Therapy (%)
- Figure 4-7: India - Number of Patients Participating in Clinical Trials (2005-2007)
- Figure 4-8: India - Number of Patients Participating in Clinical Trials (2008-2012)
- Figure 4-9: India - Pharma Outsourcing Market (in Million US$), 2004, 2006 & 2007
- Figure 4-10: India - Pharma Outsourcing Market by Segment (%)
- Figure 4-11: India - Clinical Research Outsourcing Market (in Million US$), 2004 & 2006-2008
- Figure 4-12: India - Clinical Research Outsourcing Market by Segment (%)
- Figure 4-13: India - Forecast for Clinical Research Outsourcing Market (in Million US$), 2009-2012
- Figure 4-14: India - Bio-services Market by Player (%), 2006-07
- Figure 5-1: India - Population (in Million), 2001-2008
- Figure 5-2: India - Forecast for Population (in Million), 2009-2012
- Figure 5-3: India - Gender Ratio (%), 2003-2006
- Figure 5-4: India - Population Breakup by Age Group (%), 2001-2008
- Figure 5-5: India - Forecast for Population Breakup by Age Group (%), 2009-2012
- Figure 5-6: India - Number of Deaths due to Various Causes (2005)
- Figure 5-7: India - Various Causes of Death (%), 2005
- Figure 5-8: India - Forecast for Various Causes of Death (%), 2030
- Figure 5-9: India - New and Total Number of Cancer Patients (in Million)
- Figure 5-10: India - New Cancers Incidences (per 00,000 Females), 2005
- Figure 5-11: India - New Cancers Incidences (per 00,000 Males), 2005
- Figure 5-12: India - Number of Hypertension Patients (in Million), 2000, 2007 & 2025
- Figure 5-13: India - Number of Coronary Heart Patients (in Million), 2005 & 2015
- Figure 5-14: India - Number of Deaths due to Various Cardiovascular Diseases (in 000), 2002
- Figure 5-15: India - Number of Deaths due to Neuropsychiatry Conditions (in 000), 2002
- Figure 5-16: India - Number of HIV/AIDS Patients w.r.t South Africa & Nigeria (in Million), 2007
- Figure 5-17: India - Number of Deaths due to Hepatitis B and Hepatitis C (in 000), 2002
- Figure 5-18: India - Recruitment Time for Patients Participating in Clinical Trials w.r.t US (%)
- Figure 5-19: India - Patient Concentration per Site w.r.t US (in Numbers)
- Figure 7-1: India - Average Cost per Patient for Conducting Clinical Trials w.r.t UK, US and Germany (in US$)
- Figure 7-2: India - Average Cost per Patient for Conducting Phase I Clinical Trials w.r.t UK, US and Germany (in US$)
- Figure 7-3: India - Average Cost per Patient for Conducting Phase II Clinical Trials w.r.t UK, US and Germany (in US$)
- Figure 7-4: India - Annual Cost of Office Space for Conducting Phase II Clinical Trials w.r.t UK, US and Germany (in US$)
- Figure 7-5: India - Average Cost per Patient for Conducting Phase III Clinical Trials w.r.t UK, US and Germany (in US$)
- Figure 7-6: India - Annual Cost of Office Space for Conducting Phase III Clinical Trials w.r.t UK, US and Germany (in US$)
- Figure 7-7: India - Average Cost per Patient for Conducting Phase IV Clinical Trials w.r.t UK, US and Germany (in US$)
- Figure 7-8: India - Annual Cost of Office Space for Conducting Phase IV Clinical Trials w.r.t UK, US and Germany (in US$)
- Figure 8-1: India - Number of Individuals with Bachelor and Higher Degree (in Million), 1991, 2004 & 2006
- Figure 8-2: India - Number of Graduates and Postgraduates (in Million), 2004
- Figure 8-3: India - Science Doctorates in Total Doctorates (%), 2004
- Figure 8-4: India - Structure of Medical Education (2005)
- Figure 8-5: India - Number of Doctors w.r.t US & Germany (in 000), 2006
- Figure 8-6: India - Number of Doctors (in 000), 2005-2008
- Figure 8-7: India - Forecast for Number of Doctors (in 000), 2009-2012
- Figure 8-8: India - Number of Nurses w.r.t US & UK (in 000), 2005
- Figure 8-9: India - Number of Nurses (in 000), 2004-2007
- Figure 8-10: India - Number of Nurses (in 000), 2008-2012
- Figure 8-11: India - Number of GCP Trained Investigators (2002 & 2005)
- Figure 8-12: India - Number of GCP Trained Investigators w.r.t US (2005)
- Figure 8-13: India- Number of Hospital Beds (in 000), 2004-2007
- Figure 8-14: India - Number of Hospital Beds w.r.t UK, US and Germany (in 000), 2006
- Figure 8-15: India - Number of Hospital Beds (in 000), 2008-2012
- Figure 8-16: India - Number of Sites for Clinical Trials w.r.t UK, US and Germany
- Figure 9-1: India - Average Time for Approval of Clinical Trials w.r.t UK, US and Germany (in Weeks)
- Figure 10-1: India - Staff Requirement for Conducting Clinical Trials (in Numbers), 2003, 2008 & 2010
- Figure 10-2: India - Independent Path Lab Market (in Billion US$), 2006-2012
- Figure 10-3: India - IVD Market (in Million US$), 2006 & 2010
List of Tables:
- Table 2-1: Drug Discovery, Development & Approval Process
- Table 2-2: Global - R&D Spending (in Million US$) & Number of Clinical Trials Conducted by Top Pharmaceutical Companies (2005)
- Table 2-3: North America - Characteristics of Clinical Research Outsourcing Market (2005)
- Table 2-4: Europe - Characteristics of Clinical Research Outsourcing Market (2005)
- Table 2-5: Latin America - Characteristics of Clinical Research Outsourcing Market (2005)
- Table 2-6: Africa - Characteristics of Clinical Research Outsourcing Market (2005)
- Table 2-7: Asia-Pacific - Characteristics of Clinical Research Outsourcing Market (2005)
- Table 3-1: India - Annual Salaries of Clinical Research Professionals w.r.t US (in US$)
- Table 5-1: India - Number of Diabetic Patients in Age Group 20-79 (in 000), 2003
- Table 5-2: India - Forecast for Number of Diabetic Patients in Age Group 20-79 (in 000), 2025
- Table 5-3: India - Prevalence of Overweight & Obesity in Males & Females (%), 2005 & 2015
- Table 7-1: India - Annual Cost of Staff for Conducting Phase I Clinical Trials w.r.t UK, US and Germany (in US$)
- Table 7-2: India - Annual Cost of Utility for Conducting Phase I Clinical Trials w.r.t UK, US and Germany (in US$)
- Table 7-3: India - Annual Cost of Staff for Conducting Phase II Clinical Trials w.r.t UK, US and Germany (in US$)
- Table 7-4: India - Annual Cost of Utility for Conducting Phase II Clinical Trials w.r.t UK, US and Germany (in US$)
- Table 7-5: India - Annual Cost of Staff for Conducting Phase III Clinical Trials w.r.t UK, US and Germany (in US$)
- Table 7-6: India - Annual Cost of Utility for Conducting Phase III Clinical Trials w.r.t UK, US and Germany (in US$)
- Table 7-7: India - Annual Cost of Staff for Conducting Phase IV Clinical Trials w.r.t UK, US and Germany (in US$)
- Table 7-8: India - Annual Cost of Utility for Conducting Phase IV Clinical Trials w.r.t UK, US and Germany (in US$)