成長著しいインドの治験市場

Abstract

India has emerged as a strong base for clinical trials in recent times. Due to the multitude of benefits it offers, the country is fast growing as a centre for conducting clinical trials for many international companies. So RNCOS has launched its research report called "Booming Clinical Trials Market in India" to give first-hand information on the Indian clinical trials market. It investigates the key competitive advantages/disadvantages India has when it comes to conducting clinical trials in the country. The report also does a through study of the key factors which evaluate the country' s clinical trials, such as patient pool, patient recruitment, cost, time, government regulations, intellectual property, human resources, infrastructure and ethical issues.

India, with its huge patient base, low cost advantage, completion of clinical trials on time, improving infrastructure, and with a strong government support is witnessing a double digit growth in its clinical trials market. All major pharmaceutical companies and Clinical Research Organizations (CROs) have already started conducting their clinical trials in India, and with improving infrastructure, industry friendly regulations and trained workforce, the growth is only likely to increase in future.

However, to achieve its goal of becoming a global hub of clinical trials, the country will have 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.

Key Findings

• Indian clinical trials market is expected to grow at a CAGR of nearly 36% between 2006 and 2011 to register revenues worth US$ 546 Million in future.
• One of the biggest advantages of conducting clinical trials in India is the availability of a large patient pool that can be recruited at much shorter time then it takes to recruit patients in the west.
• India by 2011 will be conducting more than 15% of the total global clinical trials.
• India presently lacks in GCP trained investigators (which are less than 1000). Their demand is projected to reach between 3000 and 6000 by 2010.
• India does not provide "Data Exclusivity" in clinical trials unlike the US and EU members.
• The salaries of a clinical data specialist and Medical writer in India are around 15% and 9% respectively of what they get in the US.
• The clinical trials market will drive the growth of the Diagnostics and Pathology Industry in India.

Key Issues and Facts Analyzed

• Evaluation of past, current and future market trends.
• Discussion about the factors driving the clinical research market.
• An analysis of the opportunities created by the market.
• A review on the government regulations on the market.
• An analysis of the major challenges faced by the market.

Key Players Analyzed

This section provides the overview, key facts financial information of prominent players in the Indian clinical trials market like Quintiles, Ranbaxy, Dr Reddy' s Laboratories, Roche, Pfizer etc.

Research Methodology Used

Information Sources

Information has been sourced from books, newspapers, trade journals, and white papers, industry portals, government agencies, trade associations, monitoring industry news and developments, and through access to more than 3000 paid databases.

Analysis Methods

The analysis methods include ratio analysis, historical trend analysis, linear regression analysis using software tools, judgmental forecasting, and cause and effect analysis.

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