Emerging Market for Clinical Trials in Brazil - Improved Guidelines from ANVISA and CONEP are Shortening the Regulatory Approval Process and Advancing the Market

Report Summary

GBI Research, the leading business intelligence provider, has released its latest report, “Emerging Market for Clinical Trials in Brazil - Improved Guidelines from ANVISA and CONEP are Shortening the Regulatory Approval Process and Advancing the Market” which provides key data, information and analysis of the major trends and issues affecting the clinical trial market in Brazil. The report provides a comprehensive insight of the reasons for outsourcing clinical trials to Brazil and the key services provided by the Clinical Research Organizations (CROs) of Brazil. The report provides a detailed analysis of the Brazilian market in terms of its size, and major service offerings of the CROs in Brazil. The report also discusses the factors that are driving the clinical trial market in Brazil. The report delves into the key documents required by the investigator and the sponsor before, during and after the conduct of clinical trials. The report also provides key alliances between the CROs of other countries and the local CROs of Brazil. Furthermore, the report looks into the major challenges that can restrict the growth of the clinical trials market in Brazil.

Scope

The report analyses the clinical trial market in Brazil, along with the major forces driving the current market and the potential challenges that could restrain the growth. The scope of the report includes -

• The need for outsourcing clinical trials to Brazil.
• Trends in clinical trial registration in Brazil and a comparative analysis of clinical trial registration in Brazil, Russia, India and China (BRIC) and six major Latin American countries.
• Analysis of the key drivers that are fueling the growth of the clinical trial market in Brazil.
• Analysis of the key infrastructural facilities, clinical research professionals and principal investigators in Brazil.
• Analysis of key government regulations in Brazil affecting the clinical trial market.
• Study of 13 major CROs operating in Brazil with SWOT analysis of large multinational CROs.

Reasons to buy

The report will enhance your decision making capability in a rapid and time-sensitive manner. It will allow you to -

• Compare the key capabilities of major clinical trial service providers with your requirements and optimize your R&D costs.
• Develop market entry and market expansion strategies by identifying the key drivers and challenges in the Brazilian clinical trials market.
• Develop effective strategies to maximize the advantages in Brazil through understanding of the regulatory environment.
• Understand the regulatory structure in Brazil and key documents required to register clinical trials in Brazil.

1 Table of Contents

1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 7

2 Emerging Market for Clinical Trials in Brazil – Introduction 9
2.1 GBI Research Report Guidance 10

3 Emerging Market for Clinical Trials, Brazil - Market Overview 11
3.1 The Clinical Research Process- Overview 11
3.1.1 Drug Discovery 11
3.1.2 Pre-clinical Study/Development 12
3.1.3 Clinical Trials 12
3.2 Clinical TrialDesign and Types 13
3.2.1 Types of Design 13
3.3 Role of CROs 18
3.4 Sponsors of Clinical Trials 20
3.5 The Need for Outsourcing Clinical Trials 21
3.5.1 High Risks and Costs Associated With Drug Development 21
3.5.2 Escalating Costs of Clinical Trials 22
3.5.3 Global Increase in the Number of Clinical Trials Conducted 23
3.5.4 Restructuring the R&D 24
3.5.5 Increased Screening Rates during R&D 25
3.5.6 Expiring Patents Pressurize Pharmaceutical Companies to Reduce Costs 25

4 Emerging Market for Clinical Trials, Brazil - Clinical Trial Trends 26
4.1 Analysis of Clinical Trials Registered in Brazil 26
4.1.1 Clinical Trials Registered in 2010 26
4.1.2 Registration of Phase I Clinical Trials 27
4.1.3 Registration of Phase II Clinical Trials 28
4.1.4 Registration of Phase III Clinical Trials 29
4.1.5 Registration of Phase IV Clinical Trials 30
4.2 Comparative Analysis of Registered Clinical Trials in Brazil, Russia, Brazil and China (BRIC) Countries 31
4.3 Comparative Analysis of Registered Clinical Trials in Six Major Countries of Latin America 32
4.4 Comparative Analysis of Population Statistics 33
4.4.1 Distribution of Population among Six Major Countries of Latin America 33
4.4.2 Population Forecast of Brazil 34
4.5 Comparative Analysis of Industry-sponsored Clinical Trials Registered in US Trials Registry 35
4.5.1 Industry-sponsored Clinical Trials Registered in BRIC Countries 35
4.5.2 Industry-sponsored Clinical Trials Registered in Six Major Countries of Latin America 36
4.6 Analysis of Clinical Trials Registered by MNCs in Brazil 37
4.7 Comparative Analysis of Sites for Industry-sponsored Clinical Trials Registered in Six Major Countries of Latin America 38
4.7.1 Number of Registered Sites for Industry-sponsored Clinical Trials 38
4.7.2 Number of Multinational Sites Registered for Industry-sponsored Trials (Phase II / III) 39
4.7.3 Number of Local Sites Registered for Industry-sponsored Trials (Phase II/III) 42
4.8 Number of Recruiting Sites by Multinational Companies (MNCs) in Brazil 45
4.9 Number of Recruiting Sites for Major Therapeutic Areas in Brazil 46

5 Emerging Market for Clinical Trials, Brazil - Market Characterization 48
5.1 Increase in Growth of Global CRO Market will Foster the Growth of the Clinical Trial Market in Brazil 48
5.1.1 Increase in Multinational Sites to Conduct Clinical Trials will Drive the Clinical Trial Market in Brazil 49
5.1.2 Access to a Large Patient Pool 50
5.1.3 Patient Availability for Major Diseases 51
5.1.4 Subject Recruitment, Retention and Speed of Trials 55
5.1.5 Cost Advantage in Brazil 60
5.1.6 Favorable Clinical Infrastructure Improve the Clinical Trial Environment 60
5.1.7 Qualified and Experienced Talent Pool 62
5.1.8 Good Quality of Clinical Trial Data 64
5.2 Market Restraints 64
5.2.1 Issues Related to Intellectual Property and New Medicine Approval 64
5.2.2 Cultural and Socioeconomic Factors Could Cause Problems in Conducting Clinical Research 64
5.3 Clinical Trial Market Size in Brazil 65

6 Emerging Market for Clinical Trials, Brazil - Regulatory Landscape 66
6.1 Introduction 66
6.2 Regulatory Provisions in Brazil Related to Clinical Trials 66
6.3 Major Regulatory Authorities/Institutions in Brazil 67
6.3.1 Ministry of Health (MOH) 67
6.3.2 Agência Nacional de Vigilância Sanitária (ANVISA) 67
6.3.3 Ethics Committees 68
6.4 Key Documents For Conducting Clinical Trials in Brazil 68
6.4.1 Additional Country Specific Documents to be Submitted in Brazil 70
6.5 Clinical Trial Regulation in Brazil 71
6.5.1 Approval Process for Clinical Trials in Brazil 71
6.5.2 Documents Required With the Investigator and Sponsor of Clinical Trials 72
6.6 Recent Regulatory Changes in Clinical Trials 75
6.6.1 Parallel Approval Process by CONEP and ANVISA 75

7 Emerging Market for Clinical Trials, Brazil - CRO Landscape 76
7.1 CRO Profiles 76
7.1.1 Quintiles 76
7.1.2 Covance 78
7.1.3 Kendle 80
7.1.4 PPD 82
7.1.5 PRA International 84
7.1.6 Chiltern 86
7.1.7 ICON plc. 88
7.1.8 Omnicare 90
7.1.9 INC Research 92
7.1.10 PAREXEL 94
7.1.11 Intrials 96
7.1.12 Eurotrials 97
7.1.13 PGS Medical/Statistics 98
7.2 Major Deals in the Brazilian CRO Market 99
7.2.1 Deal Summary 99

8 Emerging Market for Clinical Trials – Brazil - Appendix 100
8.1 Market Definitions 100
8.2 Abbreviations 100
8.3 Research Methodology 101
8.3.1 Coverage 101
8.3.2 Secondary Research 101
8.3.3 Primary Research 101
8.3.4 Expert Panel Validation 102
8.4 Contact Us 102
8.5 Disclaimer 102
8.6 Sources 103

1.1 List of Tables

Table 1: Clinical Trials in Brazil, Global BLA and NME Approvals vs. R&D Spending (bn), 1995-2009
Table 2: Clinical Trials in Brazil, Global BLA and NME Approvals vs. R&D Spending (bn), 1995-2009
Table 3: Clinical Trials in Brazil, Global, Drug Patent Expiry ($m), 2010-2017
Table 4: Clinical Trials in Brazil, Number of Phase l Clinical Trials Registered, 2005-2010
Table 5: Clinical Trials in Brazil, Number of Phase lI Clinical Trials Registered, 2005-2010
Table 6: Clinical Trials in Brazil, Number of Phase III Clinical Trials Registered, 2005-2010
Table 7: Clinical Trials in Brazil, Number of Phase IV Clinical Trials Registered, 2005-2010
Table 8: Clinical Trials in Brazil, Number of Clinical Trials Registered, BRIC, 2010
Table 9: Clinical Trials in Brazil, Number of Clinical Trials in Six Major Countries of Latin America, 2010
Table 10: Clinical Trials in Brazil, Distribution of Population among Six Major Countries of Latin America (%), 2010
Table 11: Clinical Trials in Brazil, Population Forecast of Brazil (Million), 2005 - 2050
Table 12: Clinical Trials in Brazil, Comparative Analysis of Industry-sponsored Clinical Trials Registered, BRIC, 2005 - 2010
Table 13: Clinical Trials in Brazil, Comparative Analysis of Industry-sponsored Clinical Trials Registered, Six Major Countries of Latin America, 2005 - 2010
Table 14: Clinical Trials in Brazil, Number of Clinical Trials Registered by MNCs in Brazil, 2005 - 2010
Table 15: Clinical Trials in Brazil, Number of Registered Sites for Industry-sponsored Clinical Trials, Six Major Countries of Latin America, 2005 - 2010
Table 16: Clinical Trials in Brazil, Number of Multinational Sites for Industry-sponsored Trials (Phase II / III), Six Major Countries of Latin America, 2005 - 2010
Table 17: Clinical Trials in Brazil, Number of Multinational Sites for Industry-sponsored Phase II Trials, Six Major Countries of Latin America, 2008-2010
Table 18: Clinical Trials in Brazil, Number of Multinational Sites for Industry-sponsored Phase III Trials, Six Major Countries of Latin America, 2008-2010
Table 19: Clinical Trials in Brazil, Number of Local Sites for Industry-sponsored Trials (Phase II/III), Six Major Countries of Latin America, 2005-2010
Table 20: Clinical Trials in Brazil, Number of Local Sites for Industry-sponsored Phase II Trials, Six Major Countries of Latin America, 2008 - 2010
Table 21: Clinical Trials in Brazil, Number of Local Sites for Industry-sponsored Phase III Trials, Six Major Countries of Latin America, 2008 - 2010
Table 22: Clinical Trials in Brazil, Number of Recruiting Sites by MNCs (%), 2005-2009
Table 23: Clinical Trials in Brazil, Number of Recruiting Sites for Major Therapeutic Areas, Brazil, 2005-2009
Table 24: Clinical Trials in Brazil, Global, CRO Market ($bn), 2006-2015
Table 25: Clinical Trials in Brazil, Number of Local and Multinational Sites in Major Cities, Brazil, 2005-2009
Table 26: Clinical Trials in Brazil, Patient Population (Million), 2010
Table 27: Clinical Trials in Brazil, Number of Deaths by Major Diseases (%), 2008
Table 28: Clinical Trials in Brazil, Population Forecast for HIV/AIDS (‘000), 2010-2015
Table 29: Clinical Trials in Brazil, Population Forecast for CVD (Million), 2010-2015
Table 30: Clinical Trials in Brazil, Population Forecast for Diabetes (Million), 2010-2015
Table 31: Clinical Trials in Brazil, Population Forecast for Cancer (‘000), 2010-2015
Table 32: Clinical Trials in Brazil, Average Number of Patients per Trial, BRIC, 2005- 2009
Table 33: Clinical Trials in Brazil, Average Number of Patients per Trial, Six Major Countries of Latin America, 2005- 2009
Table 34: Clinical Trials in Brazil, Average Number of Patients per Site, BRIC, 2005-2009
Table 35: Clinical Trials in Brazil, Average Number of Patients per Site, Six Major Countries of Latin America, 2005-2009
Table 36: Clinical Trials in Brazil, Number of Hospitals in Brazil, 2006
Table 37: Clinical Trials in Brazil, Density of Healthcare Personnel per 10,000 Population, 2005
Table 38: Clinical Trials in Brazil, Number of FDA Regulated Principal Investigators, Brazil, 2001 - 2010
Table 39: Clinical Trials in Brazil, Growth Rate of Principal Investigators, Global (%), 2002-2008
Table 40: Clinical Trials in Brazil, Clinical Trial Market, ($m), 2010 - 2015
Table 41: Clinical Trials in Brazil, Regulatory provisions for Clinical Trials, 2011
Table 42: Clinical Trials in Brazil, Major Documents in Conduction of Clinical Trials, 2011
Table 43: Clinical Trials in Brazil, Additional Document/Information Submission To The Authorities
Table 44: Clinical Trials in Brazil, List of Documents Required Before Commencement of Clinical Trials, 2011
Table 45: Clinical Trials in Brazil, List of Documents Required During Conduction of Clinical Trials, 2011
Table 46: Clinical Trials in Brazil, List of Documents Required After Completion of Clinical Trials, 2011
Table 47: Clinical Trials in Brazil, Major Deals in CRO Market, Brail, 2007- 2010

1.2 List of Figures

Figure 1: Clinical Research Process - Overview
Figure 2: Clinical Trials in Brazil, Parallel Group Trial Design, 2010
Figure 3: Clinical Trials in Brazil, Cross-over Trial Design, 2010
Figure 4: Clinical Trials in Brazil, Adaptive Clinical Trial Design, 2010
Figure 5: Clinical Trials in Brazil, Wyeth Learn and Confirm Model, 2010
Figure 6: Clinical Trials in Brazil, Services Offered by CROs, 2010
Figure 7: Clinical Trials in Brazil, Pre-clinical Research to Market Launch Via Clinical Trials, 2009
Figure 8: Clinical Trials in Brazil, Global BLA and NME Approvals vs. R&D Spending (bn), 1995-2009
Figure 9: Clinical Trials in Brazil, Activities of R&D Restructuring, 2010
Figure 10: Clinical Trials in Brazil, Distribution of Clinical Trials by Phase (%), 2010
Figure 11: Clinical Trials in Brazil, Number of Phase l Clinical Trials Registered, 2005-2010
Figure 12: Clinical Trials in Brazil, Number of Phase lI Clinical Trials Registered, 2005-2010
Figure 13: Clinical Trials in Brazil, Number of Phase III Clinical Trials Registered, 2005-2010
Figure 14: Clinical Trials in Brazil, Number of Phase IV Clinical Trials Registered, 2005-2010
Figure 15: Clinical Trials in Brazil, Number of Clinical Trials Registered, BRIC, 2010
Figure 16: Clinical Trials in Brazil, Number of Clinical Trials in Six Major Countries of Latin America, 2010
Figure 17: Clinical Trials in Brazil, Distribution of Population among Six Major Countries of Latin America (%), 2010
Figure 18: Clinical Trials in Brazil, Population Forecast of Brazil (Million), 2005 - 2050
Figure 19: Clinical Trials in Brazil, Comparative Analysis of Industry-sponsored Clinical Trials Registered, BRIC, 2005 - 2010
Figure 20: Clinical Trials in Brazil, Comparative Analysis of Industry-sponsored Clinical Trials Registered, Six Major Countries of Latin America, 2005 - 2010
Figure 21: Clinical Trials in Brazil, Number of Clinical Trials Registered by MNCs in Brazil, 2005 - 2010
Figure 22: Clinical Trials in Brazil, Number of Registered Sites for Industry-sponsored Clinical Trials, Six Major Countries of Latin America, 2005-2010
Figure 23: Clinical Trials in Brazil, Number of Multinational Sites for Industry-sponsored Trials (Phase II/III), Six Major Countries of Latin America, 2005 - 2010
Figure 24: Clinical Trials in Brazil, Number of Multinational Sites for Industry-sponsored Phase II Trials, Six Major Countries of Latin America, 2008 - 2010
Figure 25: Clinical Trials in Brazil, Number of Multinational Sites for Industry-sponsored Phase III Trials, Six Major Countries of Latin America, 2008-2010
Figure 26: Clinical Trials in Brazil, Number of Local Sites for Industry-sponsored Trials (Phase II/III), Six Major Countries of Latin America, 2005-2010
Figure 27: Clinical Trials in Brazil, Number of Local Sites for Industry-sponsored Phase II Trials, Six Major Countries of Latin America, 2008-2010
Figure 28: Clinical Trials in Brazil, Number of Local Sites for Industry-sponsored Phase III Trials, Six Major Countries of Latin America, 2008 - 2010
Figure 29: Clinical Trials in Brazil, Number of Recruiting Sites by MNCs (%), 2005 - 2009
Figure 30: Clinical Trials in Brazil, Number of Recruiting Sites for Major Therapeutic Areas, Brazil, 2005-2009
Figure 31: Clinical Trials in Brazil, Global, CRO Market ($bn), 2006-2015
Figure 32: Clinical Trials in Brazil, Number of Local and Multinational Sites in Major Cities, Brazil, 2005-2009
Figure 33: Clinical Trials in Brazil, Patient Population (Million), 2010
Figure 34: Clinical Trials in Brazil, Number of Deaths by Major Diseases (%), 2008
Figure 35: Clinical Trials in Brazil, Population Forecast for HIV/AIDS (‘000), 2010-2015
Figure 36: Clinical Trials in Brazil, Population Forecast for CVD (Million), 2010-2015
Figure 37: Clinical Trials in Brazil, Population Forecast for Diabetes (Million), 2010-2015
Figure 38: Clinical Trials in Brazil, Population Forecast for Cancer (‘000), 2010-2015
Figure 39: Clinical Trials in Brazil, Average Number of Patients per Trial, BRIC, 2005- 2009
Figure 40: Clinical Trials in Brazil, Average Number of Patients per Trial, Six Major Countries of Latin America, 2005- 2009
Figure 41: Clinical Trials in Brazil, Average Number of Patients per Site, BRIC, 2005- 2009
Figure 42: Clinical Trials in Brazil, Average Number of Patients per Site, Six Major Countries of Latin America, 2005-2009
Figure 43: Clinical Trials in Brazil, Number of FDA Regulated Principal Investigators, Brazil, 2001 - 2010
Figure 44: Clinical Trials in Brazil, Growth Rate of Principal Investigators, Global (%), 2002-2008
Figure 45: Clinical Trials in Brazil, Clinical Trial Market, ($m), 2010 - 2015
Figure 46: Clinical Trials in Brazil, Regulatory Approval Process for Clinical Trials, 2011
Figure 47: Clinical Trials in Brazil, Quintiles, Company Profile, 2011
Figure 48: Clinical Trials in Brazil, Quintiles, SWOT Analysis, 2011
Figure 49: Clinical Trials in Brazil, Covance, Company Profile, 2011
Figure 50: Clinical Trials in Brazil, Covance, SWOT Profile, 2011
Figure 51: Clinical Trials in Brazil, PPD, Company Profile, 2011
Figure 52: Clinical Trials in Brazil, Kendle, SWOT Profile, 2011
Figure 53: Clinical Trials in Brazil, Kendle, Company Profile, 2011
Figure 54: Clinical Trials in Brazil, PPD, SWOT Analysis, 2011
Figure 55: Clinical Trials in Brazil, PRA International, Company Profile, 2011
Figure 56: Clinical Trials in Brazil, PRA International, SWOT Analysis, 2011
Figure 57: Clinical Trials in Brazil, Chiltern, Company Profile, 2011
Figure 58: Clinical Trials in Brazil, Chiltern, SWOT Analysis, 2011
Figure 59: Clinical Trials in Brazil, ICON plc, Company Profile, 2011
Figure 60: Clinical Trials in Brazil, ICON plc, SWOT Analysis, 2011
Figure 61: Clinical Trials in Brazil, Omnicare, Company Profile, 2011
Figure 62: Clinical Trials in Brazil, Omnicare, SWOT Analysis, 2011
Figure 63: Clinical Trials in Brazil, INC Research, Company Profile, 2011
Figure 64: Clinical Trials in Brazil, INC Research, SWOT Analysis, 2011
Figure 65: Clinical Trials in Brazil, PAREXEL, Company Profile, 2011
Figure 66: Clinical Trials in Brazil, PAREXEL, SWOT Analysis, 2011
Figure 67: Clinical Trials in Brazil, Intrials, Company Profile, 2011
Figure 68: Clinical Trials in Brazil, Eurotrials, Company Profile, 2011
Figure 69: Clinical Trials in Brazil, Clinical Trials in Brazil, PGS Medical/Statistics