Booming Clinical Trials Market in India

Published by: RNCOS

Published: Sep. 1, 2009 - 50 Pages

Table of Contents

1. Analyst View

2. Clinical Trials Market Overview

2.1 Global Clinical Research Market

2.2 Clinical Research Market in Asia-Pacific

2.3 Clinical Research Market in India

2.3.1 Number of Clinical Trials

2.3.2 Clinical Trials by Type

2.3.3 Clinical Research Market

2.3.4 Patient Participation

2.3.5 Market Trends

3. Size and Patient Pool Availability

3.1 Population and Demographics

3.2 Disease Profile

3.3 Patient Availability and Recruitment

4. Infrastructure and Expertise

4.1 Education

4.2 Clinical Research Professionals

4.3 Hospital Beds

4.4 ICH/GCP Compliant Sites

5. Cost Analysis

5.1 Phase I Clinical Trials

5.1.1 Cost of Staff

5.1.2 Cost of Utility

5.2 Phase II Clinical Trials

5.2.1 Cost of Infrastructure and Staff

5.2.2 Cost of Utility

5.3 Phase III Clinical Trials

5.3.1 Cost of Infrastructure and Staff

5.3.2 Cost of Utility

5.4 Phase IV Clinical Trials

5.4.1 Cost of Infrastructure and Staff

5.4.2 Cost of Utility

6. Success and Risk Factor Analysis

6.1 Lower Cost

6.2 Faster Completion

6.3 Pathology and Diagnostic Market

6.4 Clinical Data Management

6.5 Increasing Competition between Developing Countries

6.6 Demand-Supply Gap of Clinical Professionals

6.7 Long Time for Approval

7. Regulatory Environment

7.1 The Institutional Ethics Committee (IEC)

7.2 Trials that can/cannot be Conducted in India

7.3 Clinical Trials Registry

7.4 Intellectual Property Protection

7.5 Incentives Given by the Government

8. RNCOS Recommendations

9. Key Players

9.1 Syngene International Ltd

9.2 Quintiles Research (India) Private Limited

9.3 Lambda Therapeutic Research Ltd

9.4 Bioserve Clinical Research Pvt. Ltd.

9.5 Veeda Clinical Research

9.6 IGATE Clinical Research International

9.7 PharmaNet

9.8 Vimta Labs

List of Figures

Figure 2-1: Global - Number of Clinical Trials (2007-2009)

Figure 2-2: Global - Clinical Research Market (Billion US$), 2007-2009

Figure 2-3: Global - Forecast for Clinical Research Market (Billion US$), 2010-2012

Figure 2-4: Global - Clinical Research Market by Phase (%), 2008

Figure 2-5: Asia-Pacific - Share of Countries in Clinical Trial Studies (2008)

Figure 2-6: Number of Clinical Trials (2007-2009)

Figure 2-7: Forecast for Number of Clinical Trials (2010-2012)

Figure 2-8: Clinical Trials by Phase (%)

Figure 2-9: Clinical Trials by Therapy (%)

Figure 2-10: Clinical Research Market (Million US$), 2007-2009

Figure 2-11: Forecast for Clinical Research Market (Million US$), 2010-2012

Figure 2-12: Forecast for Number of Patients Participating in Clinical Trials (Million), 2010-2012

Figure 2-13: Pharma Outsourcing Market (Billion US$), 2007-2009

Figure 2-14: Pharma Outsourcing Market by Segment (%), 2008

Figure 3-1: Population (Million), 2006-2009

Figure 3-2: Forecast for Population (Million), 2010-2012

Figure 3-3: Population Breakup by Age Group (%), 2006-2009

Figure 3-4: Forecast for Population Breakup by Age Group (%), 2010-2012

Figure 3-5: Various Causes of Death (%), 2008

Figure 3-6: Forecast for Various Causes of Death (%), 2030

Figure 3-7: New and Total Number of Cancer Patients (‘000)

Figure 3-8: Number of Hypertension Patients (Million), 2000, 2007 & 2025

Figure 3-9: Number of Coronary Heart Patients (Million), 2005 & 2015

Figure 3-10: Recruitment Time for Patients Participating in Clinical Trials in Comparison to US (Days)

Figure 3-11: Number of Patient per Site in Comparison to US

Figure 4-1: Number of Individuals with Bachelor and Higher Degree (Million), 1991, 2004, 2006 & 2008

Figure 4-2: Number of Graduates and Postgraduates (Million), 2004

Figure 4-3: Share of Science Doctorates in Total Doctorates (2004)

Figure 4-4: Number of Doctors in Comparison to US and Germany (‘000), 2008

Figure 4-5: Number of Doctors (‘000), 2007-2009

Figure 4-6: Forecast for Number of Doctors (‘000), 2010-2012

Figure 4-7: Number of GCP Trained Investigators (2002 & 2005)

Figure 4-8: Number of GCP Trained Investigators in Comparison to US

Figure 4-9: Number of Hospital Beds (‘000), 2007-2009

Figure 4-10: Number of Hospital Beds in Comparison to UK, US and Germany (‘000), 2008

Figure 4-11: Forecast for Number of Hospital Beds (‘000), 2010-2012

Figure 4-12: Number of Sites for Clinical Trials in Comparison to UK, US and Germany

Figure 5-1: Average Cost per Patient for Conducting Clinical Trials in Comparison to UK, US and Germany (US$)

Figure 5-2: Average Cost per Patient for Conducting Phase I Clinical Trials in Comparison to UK, US and Germany (US$)

Figure 5-3: Average Cost per Patient for Conducting Phase II Clinical Trials in comparison to UK, US and Germany (US$)

Figure 5-4: Annual Cost of Office Space for Conducting Phase II Clinical Trials in Comparison to UK, US and Germany (US$)

Figure 5-5: Average Cost per Patient for Conducting Phase III Clinical Trials in Comparison to UK, US and Germany (US$)

Figure 5-6: Annual Cost of Office Space for Conducting Phase III Clinical Trials in Comparison to UK, US and Germany (US$)

Figure 5-7: Average Cost per Patient for Conducting Phase IV Clinical Trials in Comparison to UK, US and Germany (US$)

Figure 5-8: Annual Cost of Office Space for Conducting Phase IV Clinical Trials in Comparison to UK, US and Germany (US$)

Figure 6-1: Average Cost for Conducting Various Clinical Trial Phases in Comparison to US

Figure 6-2: Time Taken for Conducting Clinical Trials by Phase in Comparison to US (Months)

Figure 6-3: Numbers of Clinical Trials Completed on Time in Comparison to UK, US and Germany

Figure 6-4: IVD Market (Million US$), 2008 & 2012

Figure 6-5: Average Time for Approval of Clinical Trials in Comparison to UK, US and Germany (Weeks)

Figure 9-1: Share of Players in Bio-services Market (2008)

List of Tables:

Table 3-1: Number of Deaths due to Various Causes (2005)

Table 3-2: Number of Diabetic Patients in Age Group 20-79 (‘000), 2007

Table 3-3: Forecast for Number of Diabetic Patients in Age Group 20-79 (‘000), 2025

Table 3-4: New Cancers Incidences (per ‘00,000 Females), 2005

Table 3-5: New Cancers Incidences (per ‘00,000 Males), 2005

Table 3-6: Prevalence of Overweight & Obesity in Males and Females (%), 2005 & 2015

Table 4-1: Structure of Medical Education

Table 4-2: Number of GLA Approved Facilities by Type

Table 5-1: Annual Cost of Staff for Conducting Phase I Clinical Trials in comparison to UK, US and Germany (US$)

Table 5-2: Annual Cost of Utility for Conducting Phase I Clinical Trials in Comparison to UK, US and Germany (US$)

Table 5-3: Annual Cost of Staff for Conducting Phase II Clinical Trials in Comparison to UK, US and Germany (US$)

Table 5-4: Annual Cost of Utility for Conducting Phase II Clinical Trials in Comparison to UK, US and Germany (US$)

Table 5-5: Annual Cost of Staff for Conducting Phase III Clinical Trials in Comparison to UK, US and Germany (US$)

Table 5-6: Annual Cost of Utility for Conducting Phase III Clinical Trials in Comparison to UK, US and Germany (US$)

Table 5-7: Annual Cost of Staff for Conducting Phase IV Clinical Trials in Comparison to UK, US and Germany (US$)

Table 5-8: Annual Cost of Utility for Conducting Phase IV Clinical Trials in Comparison to UK, US and Germany (US$)

Table 8-1: Comparison of Factors Affecting Clinical Trials Market among Different Countries

Abstract

The clinical trial market in India looks very lucrative. The country promises to be one of the hottest destinations for conducting global clinical trials, owing to a huge patient pool representing both chronic and infectious diseases, easy recruitment of patients, and high cost savings. Moreover, the market is getting boost from improved IPR protection with changed rules and also from reduced taxes and duties.

According to our new research study on the sector called “Booming Clinical Trials Market in India”, the clinical trial outsourced market in India is forecasted to grow at a CAGR of around 31% during 2010-2012. Presently, the market is characterized by the dominance of phase III and phase II trials, which currently hold more than 80% of the market. This scenario is expected to remain intact in future as well. In terms of competitive landscape, the market is characterized by many small CROs, with certain companies like Syngene, Quintiles, Lambda therapeutics, Vimta labs doing better in comparison of the rest.

Our report has found that one of the biggest reasons attracting drug manufacturers and CROs to India is the country’s vast patient pool. The number of patients for chronic and infectious ailments in India surpasses that of nearly any other country. Moreover, clinical trials for drugs related to central nervous system and cancer have been mainly outsourced to India in recent years. Backed by this factor, the number of clinical studies in India is expected to grow at a CAGR of over 14% during the forecast period. In this regard, the report provides rational analysis of the factors which are supporting the forecast.

Our report provides extensive information on the clinical trial market in India, with detailed description of the regulatory environment and cost factors promoting the market. It also highlights several emerging market trends like clinical data management, pathology and diagnostic market, etc. The research study offers detailed statistical and analytical review on demographics, macroeconomic indicators, disease profile, clinical service market, key drivers and restraints. It contains all the requisite information that will help clients to draw up market strategies and assess opportunity areas in India’s clinical trial market.

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