Booming Clinical Trials Market in India

Table of Contents

1. Analyst View

2. Global Clinical Trials Market

• 2.1 What are Clinical Trials?
• 2.2 Conducting Clinical Trials is becoming Costlier & 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. Indian Clinical Trials Market

• 3.1 Why should Companies Conduct Clinical Trials in India?
  • 3.1.1 Access to a Large Patient Pool
  • 3.1.2 Lower Cost
  • 3.1.3 Faster Completion
  • 3.1.4 Improving Infrastructure & Large Pool of Healthcare Professionals
  • 3.1.5 English-based Medical Education & Documentation
  • 3.1.6 Lucrative Pharmaceutical Market
• 3.2 Market Analysis
  • 3.2.1 Introduction
  • 3.2.2 Size & Availability of Patient Pool
    • 3.2.2.1 Population & Demographics
    • 3.2.2.2 Disease Profile
    • 3.2.2.3 Patient Availability & Recruitment
  • 3.2.3 Regulatory Environment
    • 3.2.3.1 Regulatory Affairs
    • 3.2.3.2 The Institutional Ethics Committee (IEC)
    • 3.2.3.3 Trials that can/cannot be Conducted in India
    • 3.2.3.4 Clinical Trials Registry
    • 3.2.3.5 Intellectual Property Protection
    • 3.2.3.6 Incentives given by the Government
  • 3.2.4 Economic Analysis
    • 3.2.4.1 Phase I Clinical Trials
      • 3.2.4.1.1 Cost of Staff
      • 3.2.4.1.2 Cost of Utility
    • 3.2.4.2 Phase II Clinical Trials
      • 3.2.4.2.1 Cost of Infrastructure & Staff
      • 3.2.4.2.2 Cost of Utility
    • 3.2.4.3 Phase III Clinical Trials
      • 3.2.4.3.1 Cost of Infrastructure & Staff
      • 3.2.4.3.2 Cost of Utility
    • 3.2.4.4 Phase IV Clinical Trials
      • 3.2.4.4.1 Cost of Infrastructure & Staff
      • 3.2.4.4.2 Cost of Utility
  • 3.2.5 Infrastructure & Expertise
    • 3.2.5.1 Education
    • 3.2.5.2 Doctors & Nurses
    • 3.2.5.3 Hospital Beds
    • 3.2.5.4 ICH/GCP Compliant Sites
    • 3.2.5.5 Trained Investigators
    • 3.2.5.6 Clinical Data Management
    • 3.2.5.7 High Rate of Clinical Trials
    • 3.2.5.8 On-time Completion of Clinical Trials
  • 3.2.6 Opportunities
    • 3.2.6.1 Strong Growth for Contract Research Organizations
    • 3.2.6.2 Increased Demand for Clinical Research Professionals
    • 3.2.6.3 Demand for Clinical Training Institutes
    • 3.2.6.4 Pathology & Diagnostic Market
    • 3.2.6.5 Clinical Data Management
    • 3.2.6.6 Business Process Outsourcing
  • 3.2.7 Challenges
    • 3.2.7.1 Ethical Issues
    • 3.2.7.2 Lack of Trained Staff
    • 3.2.7.3 Intellectual Property Protection
    • 3.2.7.4 Long Time for Approval
    • 3.2.7.5 Data Exclusivity

4. Key Players

• 4.1 Quintiles Transnational Corp.
• 4.2 Pfizer Inc.
• 4.3 Roche Group
• 4.4 Dr. Reddy' s Laboratories Ltd.
• 4.5 Sanofi-Aventis S.A.
• 4.6 Ranbaxy Laboratories Ltd.
• 4.7 GlaxoSmithKline plc
• 4.8 Eli Lilly & Company
• 4.9 Novo Nordisk A/S
• 4.10 iGATE Clinical Research International
• 4.11 ClinInvent Research Pvt. Ltd.
• 4.12 Reliance Clinical Research Services Pvt. Ltd.
• 4.13 SIRO Clinpharm Pvt. Ltd.

List of Figures:

• Figure 2-1: Drug Discovery, Development & Approval Process
• Figure 2-2: Cost of Developing a New Drug (in Million US$), 1979, 1991, 1995, 2001, 2003, 2006E & 2008E
• Figure 2-3: Global - Pharma R&D Expenditure by Function (%), 2006
• Figure 2-4: Global - Forecast for Pharma R&D Expenditure by Function (%), 2008
• Figure 2-5: Global - Clinical Research Outsourcing Market (in Billion US$), 2005 & 2006
• Figure 2-6: Global - Forecast for Clinical Research Outsourcing Market (in Billion US$), 2007-2011
• Figure 2-7: Global - Clinical Research Outsourcing Market by Region (%), 2005E
• Figure 3-1: India & US - Average Cost for Conducting Various Phases of Clinical Trials (in Million US$)
• Figure 3-2: India & US - Time Taken for Conducting Clinical Trials by Phase (in Months)
• Figure 3-3: India - Pharmaceutical Market (in Billion US$), 2005, 2006E & 2015E
• Figure 3-4: India - Clinical Trials Market (in Million US$), 2002, 2005 & 2006
• Figure 3-5: India - Forecast for Clinical Trials Market (in Million US$), 2007-2011
• Figure 3-6: India - Population (in Million), 2003-2006E
• Figure 3-7: India - Forecast for Population (in Million), 2007-2011
• Figure 3-8: India - Gender Ratio (%), 2003-2006
• Figure 3-9: India - Population Breakup by Age Group (%), 2003-2006E
• Figure 3-10: India - Forecast for Population Breakup by Age Group (%), 2007-2011
• Figure 3-11: India - Number of Deaths due to Various Causes, 2005
• Figure 3-12: India - Various Causes of Death (%), 2005
• Figure 3-13: India - Forecast for Various Causes of Death (%), 2030
• Figure 3-14: India - New Cancers Incidences (per 100,000 Females), 2005E
• Figure 3-15: India - New Cancers Incidences (per 100,000 Males), 2005E
• Figure 3-16: India - Number of Deaths due to Various Cardiovascular Diseases (in ' 000), 2002
• Figure 3-17: India - Number of Deaths due to Neuropsychiatry Conditions (in ' 000), 2002
• Figure 3-18: South Africa, Nigeria & India - Number of HIV/AIDS Patients (in Million), 2007E
• Figure 3-19: India - Number of Deaths due to Hepatitis B & C (in ' 000), 2002
• Figure 3-20: India & US - Recruitment Time for Patients Participating in Clinical Trials (%)
• Figure 3-21: India & US - Patient Concentration per Site (in Numbers)
• Figure 3-22: India - Number of Patients Participating in Clinical Trials (2005 & 2006E)
• Figure 3-23: India - Forecast for Number of Patients Participating in Clinical Trials (2007-2011)
• Figure 3-24: India, UK, US & Germany - Average Cost per Patient for Conducting Clinical Trials (in US$)
• Figure 3-25: India, UK, US & Germany - Average Cost per Patient for Conducting Phase I Clinical Trials (in US$)
• Figure 3-26: India, UK, US & Germany - Average Cost per Patient for Conducting Phase II Clinical Trials (in US$)
• Figure 3-27: India, UK, US & Germany - Annual Cost of Office Space for Conducting Phase II Clinical Trials (in US$)
• Figure 3-28: India, UK, US & Germany - Average Cost per Patient for Conducting Phase III Clinical Trials (in US$)
• Figure 3-29: India, UK, US & Germany - Annual Cost of Office Space for Conducting Phase III Clinical Trials (in US$)
• Figure 3-30: India, UK, US, & Germany - Average Cost per Patient for Conducting Phase IV Clinical Trials (in US$)
• Figure 3-31: India, UK, US & Germany - Annual Cost of Office Space for Conducting Phase IV Clinical Trials (in US$)
• Figure 3-32: India - Number of Individuals with Bachelors & Higher Degree (in Million), 1991, 2004 & 2006E
• Figure 3-33: India - Number of Graduates & Postgraduates (in Million), 2004
• Figure 3-34: India - Science Doctorates as a Percentage of Total Doctorates, 2004
• Figure 3-35: India - Structure of Medical Education, 2005
• Figure 3-36: US, India & Germany - Number of Doctors (in ' 000), 2006E
• Figure 3-37: India - Number of Doctors (in ' 000), 2005 & 2006E
• Figure 3-38: India - Forecast for Number of Doctors (in ' 000), 2007-2011
• Figure 3-39: US, India & UK - Number of Nurses (in ' 000), 2005E
• Figure 3-40: India - Number of Nurses (in ' 000), 2004-2006E
• Figure 3-41: India - Forecast for Number of Nurses (in ' 000), 2007-2011
• Figure 3-42: India, UK, US & Germany - Number of Hospital Beds (in ' 000), 2006E
• Figure 3-43: India - Number of Hospital Beds (in ' 000), 2004-2006E
• Figure 3-44: India - Forecast for Number of Hospital Beds (in ' 000), 2007-2011
• Figure 3-45: India, UK, US & Germany - Number of Sites for Clinical Trials
• Figure 3-46: India - Number GCP Trained Investigators (2002 & 2005)
• Figure 3-47: India & US - Number of GCP Trained Investigators, 2005
• Figure 3-48: Global - Number of Clinical Trials (2005 & 2006E)
• Figure 3-49: Global - Forecast for Number of Clinical Trials (2007-2011)
• Figure 3-50: India - Number of Clinical Trials (2005 & 2006E)
• Figure 3-51: India - Forecast for Number of Clinical Trials (2007-2011)
• Figure 3-52: India, UK, US & Germany - Percentage of Clinical Trials Completed on Time
• Figure 3-53: India - CRO Market (in Million US$), 2006 & 2010F
• Figure 3-54: India - Staff Requirement for Conducting Clinical Trials (in Numbers), 2003, 2008F & 2010F
• Figure 3-55: India - Pathology Market (in Million US$), 2003-2006E
• Figure 3-56: India - IVD Market (in Million US$), 2006 & 2010F
• Figure 3-57: India, UK, US & Germany - Average Time for Approval of Clinical Trials (in Weeks)

List of Tables:

• Table 2-1: Global - R&D Spending (in Million US$) & Number of Clinical Trials Conducted by Top Pharmaceutical Companies, 2005
• Table 2-2: North America - Characteristics of Clinical Research Outsourcing Market, 2005
• Table 2-3: Europe - Characteristics of Clinical Research Outsourcing Market, 2005
• Table 2-4: Latin America - Characteristics of Clinical Research Outsourcing Market, 2005
• Table 2-5: Africa - Characteristics of Clinical Research Outsourcing Market, 2005
• Table 2-6: Asia-Pacific - Characteristics of Clinical Research Outsourcing Market, 2005
• Table 3-1: India & US - Annual Salaries of Clinical Research Professionals (in US$)
• Table 3-2: India - Number of Diabetic Patients in Age Group 20-79 (in ' 000), 2003
• Table 3-3: India - Forecast for Number of Diabetic Patients in Age Group 20-79 (in ' 000), 2025
• Table 3-4: India, UK, US & Germany - Annual Cost of Staff for Conducting Phase I Clinical Trials (in US$)
• Table 3-5: India, UK, US & Germany - Annual Cost of Utility for Conducting Phase I Clinical Trials (in US$)
• Table 3-6: India, UK, US & Germany - Annual Cost of Staff for Conducting Phase II Clinical Trials (in US$)
• Table 3-7: India, UK, US & Germany - Annual Cost of Utility for Conducting Phase II Clinical Trials (in US$)
• Table 3-8: India, UK, US & Germany - Annual Cost of Staff for Conducting Phase III Clinical Trials (in US$)
• Table 3-9: India, UK, US & Germany - Annual Cost of Utility for Conducting Phase III Clinical Trials (in US$)
• Table 3-10: India, UK, US & Germany - Annual Cost of Staff for Conducting Phase IV Clinical Trials (in US$)
• Table 3-11: India, UK, US & Germany - Annual Cost of Utility for Conducting Phase IV Clinical Trials (in US$)
• Table 4-1: Quintiles Transnational Corp. - Key Financials (in Million US$), 2003-2005
• Table 4-2: Pfizer Inc. - Key Financials (in Million US$), 2004-2006
• Table 4-3: Roche Group - Key Financials (in Million CHF), 2004-2006
• Table 4-4: Dr. Reddy' s Laboratories Ltd. - Key Financials (in Million US$), 2004-2006
• Table 4-5: Sanofi-Aventis S.A. - Key Financials (in Million US$), 2004-2006
• Table 4-6: Ranbaxy Laboratories Ltd. - Key Financials (in Million US$), 2005 & 2006
• Table 4-7: GlaxoSmithKline plc - Key Financials (in Million US$), 2004-2006
• Table 4-8: Eli Lilly & Company - Key Financials (in Million US$), 2004-2006
• Table 4-9: Novo Nordisk A/S - Key Financials (in Million US$), 2004-2006
• Table 4-10: iGATE Clinical Research International - Key Financials (in Million INR), 2005 & 2006