Published: January 2009
Pages: 105
Price (USD): $1,200/single user PDF licence
Report 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.
Report Outline
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
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
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$)
Table 7-8: India Annual Cost of Utility for Conducting Phase IV Clinical Trials w.r.t UK, US and Germany (in US$)
