Outsourcing Clinical Trials - A Global Analytical Guide and Comparative Analysis of International Destinations, with Location Attractiveness Index

Table of Contents

1 Introduction

• 1.1 China - A Key Emerging Destination for Clinical Trial Outsourcing
• 1.2 India - From Technology Outsourcing to Clinical Trials
• 1.3 Report Scope

2 Pharma Productivity: Attitudinal Changes Across the Industry

• 2.1 Key Trends Affecting Pharma Industry
• 2.2 Current Strategies to Stimulate Growth and Control Costs
• 2.3 Reasons for Decreasing Pharma R&D Productivity
• 2.4 The Contract Research Outsourcing Market: Rising
• 2.5 The Rise of Site Management Organizations (SMOs)
• 2.6 Increased Workloads and Shortages of Clinical Resources has US Pharma Looking Abroad
• 2.7 The CRO Share of the Outsourcing Market
• 2.8 Globalization of the CRO Market
• 2.9 CROs and the Need for Improved Patient Recruitment

3 Clinical Trials in Central and Eastern Europe (CEE)

• 3.1 Introduction
• 3.2 Location
• 3.3 Target Population
• 3.4 Alternative Medicine
• 3.5 Disease Demographics
• 3.6 Study Investigator Profile
• 3.7 Study Site Characteristics
• 3.8 Regulatory Climate
• 3.9 Study Costs
• 3.10 Clinical Trial Activity
• 3.11 Pharmaceutical Market
• 3.12 Key Market Advantages/Strengths
• 3.13 Key Market Disadvantages/Weaknesses
• 3.14 Recommendations

4 Clinical Trials in Asia

• 4.1 Introduction
• 4.2 Location
• 4.3 Target Population
• 4.4 Alternative Medicine
• 4.5 Disease Demographics
• 4.6 Study Investigator Profile
• 4.7 Study Site Characteristics
• 4.8 Regulatory Climate
• 4.9 Study Cost
• 4.10 Clinical Trials Activity
• 4.11 Pharmaceutical Market
• 4.12 Key Market Advantages/Strengths
• 4.13 Key Market Disadvantages/Weaknesses
• 4.14 Report Recommendations

5 Clinical Trials in India

• 5.1 Introduction
• 5.2 Location
• 5.3 Target Population
• 5.4 Alternative Medicine
• 5.5 Disease Demographics
• 5.6 Study Investigator Profile
• 5.7 Study Site Characteristics
• 5.8 Regulatory Climate
• 5.9 Study Cost
• 5.10 Clinical Trials Activity
• 5.11 Pharmaceutical Market
• 5.12 Key Market Advantages/Strengths
• 5.13 Key Market Disadvantages/Weaknesses
• 5.14 Recommendations: Strategies for Securing a Share of the Indian Market

6 Clinical Trials in Australia and New Zealand (ANZ)

• 6.1 Introduction
• 6.2 Location
• 6.3 Target Population
• 6.4 Alternative Medicine
• 6.5 Disease Demographics
• 6.6 Study Investigator Profile
• 6.7 Study Site Characteristics
• 6.8 Regulatory Climate
• 6.9 Study Costs
• 6.10 Clinical Trial Activity
• 6.11 Pharmaceutical Market
• 6.12 CRO activity
• 6.13 Key Market Advantages/Strengths
• 6.14 Key Market Disadvantages/Weaknesses
• 6.15 Recommendations

7 Clinical Trials in Africa

• 7.1 Introduction
• 7.2 Location
• 7.3 Target Population
• 7.4 Alternative Medicine
• 7.5 Disease Demographics
• 7.6 Study Investigator Profile
• 7.7 Study Site Characteristics
• 7.8 Regulatory Climate
• 7.9 Study Costs
• 7.10 Clinical Trial Activity
• 7.11 Pharmaceutical Market
• 7.12 Key Market Advantages/Strengths
• 7.13 Key Market Disadvantages/Weaknesses
• 7.14 Recommendations

8 Clinical Trials in Latin America

• 8.1 Introduction
• 8.2 Location
• 8.3 Target Population
• 8.4 Alternative Medicine
• 8.5 Disease Demographics
• 8.6 Study Investigator Profile
• 8.7 Study Site Characteristics
• 8.8 Regulatory Climate
• 8.9 Study Costs
• 8.10 Clinical Trial Activity
• 8.11 Pharmaceutical Market
• 8.12 Key Market Advantages/Strengths
• 8.13 Key Market Disadvantages/Weaknesses
• 8.14 Recommendations

9 Clinical Trial Outsourcing Location Attractiveness Index: A Comparative Analysis of International Destinations

• 9.1 Study Cost Indicators
• 9.2 Patient Indicators
• 9.3 Disease Indicators
• 9.4 Clinical Research Indicators
• 9.5 Research Personnel Indicators
• 9.6 Study Site Indicators
• 9.7 Business Environment Indicators
• 9.8 Overall Rank Scores

Tables

• Table 2.1 Patent Expirations Due on Blockbuster Drugs
• Table 2.2 Ways to Reduce Development Costs for a New Drug
• Table 2.3 Global Spending on Development and Clinical Services Outsourcing*
• Table 2.4 Clinical Study Activity Managed Worldwide by Major CROs
• Table 4.1 Overview of Patients Available for Clinical Trials in China
• Table 4.2 Clinical Trial Considerations in Asia
• Table 4.3 Investigative Sites/Hospitals in Selected Asian Countries
• Table 4.4 Regulatory Approval Times in Select Asian Countries
• Table 4.5 Regulatory Bodies in China Required for Clinical Trial Approval
• Table 4.6 Costs of Clinical Trials in China (in US$)
• Table 5.1 Urban India - Population
• Table 5.2 The Cost of Clinical Trials in India vs. the US
• Table 5.3 Top Pharmaceutical Companies' R&D and Manufacturing Offshoring Activities and Ramp-up Plans in India
• Table 5.4 Indian CROs
• Table 5.5 Global CROs in India
• Table 5.6 Leading Service Providers
• Table 7.1 United Nations Definition of Major African Regions
• Table 7.2 Leading Causes of Death for Males and Females Aged between 15 to 59 (Estimates for 2000)
• Table 8.1 United Nations Definition of Latin American Regions
• Table 8.2 Selected Country Indicators in Latin America
• Table 8.3 Clinical Trials Information for the Six Key Clinical Trials Location in Latin America*
• Table 8.4 Clinical Trials in Latin America 1966-2003
• Table 8.5 Clinical Trials in Latin America 2006
• Table 8.6 Approved Clinical Studies in Brazil, by Phase
• Table 9.1 Compensation Cost and Infrastructure Cost Indicators, by Country
• Table 9.2 Compensation Cost and Infrastructure Cost Comparative Indices, by Country
• Table 9.3 Study Cost Index and Study Cost Rank Score
• Table 9.4 Patient Indicators, by Country
• Table 9.5 Population Indicator Index and Population Indicator Rank Score
• Table 9.6 Cardiovascular Disease Statistics
• Table 9.7 Pulmonary Disease Statistics
• Table 9.8 Cancer Disease Statitistics
• Table 9.9 Infectious Disease Statistics
• Table 9.10 Cardiovascular Disease Index
• Table 9.11 Pulmonary Disease Index
• Table 9.12 Cancer Index
• Table 9.13 Infectious Disease Index
• Table 9.14 Disease Index
• Table 9.15 Clinical Research Indicators, by Country
• Table 9.16 Clinical Research Index and Clinical Research Rank Score
• Table 9.17 Research Personnel Indicators, by Country
• Table 9.18 Research Personnel Index and Research Personnel Rank Score
• Table 9.19 Study Site Indicators, by Country
• Table 9.20 Study Site Index and Rank Score
• Table 9.21 Business Environment Indicators, by Country
• Table 9.22 Business Environment Index and Rank Score
• Table 9.23 Clinical Trial Global Attractiveness Index

Graphs

• Graph 2.1 Total Pharma R&D Expenditure (US$ billion)
• Graph 2.2 Total Pharma Clinical Outsourcing Expenditure (US$ billion)
• Graph 2.3 Global Clinical Research Personnel
• Graph 2.4 Pivotal Trial Milestones
• Graph 2.5 Case Report Form Queries/Page Screen
• Graph 2.6 Contract Research Organization Global Industry Revenues
• Graph 2.7 Location of New Offices for US-Based CROs
• Graph 3.1 Fee Partition
• Graph 3.2 Clinical Trials Registered in Western Pharmaceutical Companies in Poland 1995-2001
• Graph 3.3 Clinical Trials Registered by Western Pharmaceutical Companies in Hungary 1992-2000
• Graph 3.4 Drug Sales in the Eight New EU Member States in 2004
• Graph 4.1 Number of Human Clinical Trials in Selected Countries (2006)
• Graph 5.1 Cost Savings of Clinical Trials in India
• Graph 6.1 International Clinical Trials Cost Comparisons in Terms of Overall Pharmaceutical Manufacturing Costs
• Graph 6.2 Mean Fee per Patient (in AU$)
• Graph 6.3 Schemes, Location and Phases of Clinical Trials in Australia
• Graph 7.1 Proposed EDCTP Expenditure (203-2007)
• Graph 8.1 Estimated Annual National Health Expenditure as a Proportion of GDP in Select Latin American Countries
• Graph 8.2 Leading Causes of Death in Latin America
• Graph 8.3 Key Areas of Latin American Investigators' Expertise
• Graph 8.4 Most Common Pending Issues from the Brazilian Ministry of Health
• Graph 8.5 Therapeutic Breakdown of Current Clinical Research in Argentina
• Graph 8.6 Lilly Argentina' s Clinical Trial Activity (1997-2000)
• Graph 8.7 Pfizer Argentina' s Clinical Research Activity
• Graph 8.8 Sponsors of Clinical Research in Argentina
• Graph 8.9 Total Approved Clinical Studies in Brazil, by Year
• Graph 8.10 Latin American Pharmaceutical Market in 2005 by Key Countries
• Graph 9.1 Compensation Cost Indices
• Graph 9.2 Population Related Indices
• Graph 9.3 Cardiovascular Disease Index
• Graph 9.4 Pulmonary Index
• Graph 9.5 Cancer Index
• Graph 9.6 Infectious Disease Index
• Graph 9.7 Disease Incidence Index
• Graph 9.8 Clinical Research Rank Order
• Graph 9.9 Research Personnel Indicators, Rank Order
• Graph 9.10 Study Site Indices
• Graph 9.11 Business Environment Indices
• Graph 9.12 Clinical Trial Global Attractiveness Index