1 Table of Contents
1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 6
2 Emerging Market for Clinical Trials – Argentina: Introduction 8
2.1 GBI Research Report Guidance 9
3 Emerging Market for Clinical Trials – Argentina: Overview 10
3.1 The Clinical Research Process – Overview 10
3.1.1 Drug Discovery Phase 10
3.1.2 Pre-Clinical Phase 10
3.1.3 Phase I 11
3.1.4 Phase II 11
3.1.5 Phase III 11
3.1.6 Review and Approval from the Regulatory Agencies 11
3.1.7 Post-Marketing Studies 11
3.2 Clinical Trial Design and Types 11
3.2.1 Types of Design 12
3.3 Role of CROs 17
3.4 Sponsors of Clinical Trials 18
3.5 Intellectual Property Protection in Argentina 19
3.5.1 Patents and Utility Models 19
3.5.2 The Copyright Law: 20
3.5.3 Trademark and Trade Names 20
3.5.4 Data Protection 20
3.6 The Need for Outsourcing Clinical Trials 21
3.6.1 High Risks and Costs Associated With Drug Development 21
3.6.2 Escalating Costs of Clinical Trials 22
3.6.3 Global Increase in the Number of Clinical Trials Conducted 23
3.6.4 Restructuring the R&D 24
3.6.5 Increased Screening Rates during R&D 25
3.6.6 Expiring Patents Pressurize Pharmaceutical Companies to Reduce Costs 25
4 Emerging Market for Clinical Trials – Argentina - Clinical Trial Trends 26
4.1 Registration of Phase l Clinical Trials 26
4.2 Registration of Phase ll Clinical Trials 27
4.3 Registration of Phase lll Clinical Trials 28
4.4 Registration of Phase lV Clinical Trials 29
4.5 Clinical Trials Registered in 2010 30
4.6 Comparative Analysis of Registered Clinical Trials in Latin American Countries 31
4.7 Comparative Analysis of Population Statistics in Latin American Countries 32
4.8 Population Forecast of Argentina 33
4.9 Analysis of Clinical Trials Conducted by Multinational Companies in Argentina 34
4.9.1 Number of Clinical Trials Carried Out By Multinational Companies in Argentina 34
4.9.2 Number of Clinical Trials Carried Out for Major Indications 35
4.9.3 Comparative Analysis of Multinational Phase ll Trials in Latin America 36
4.9.4 Comparative Analysis of Multinational Phase lll Trials in Latin America 37
4.9.5 Comparative Analysis of Local Phase ll Trials in Latin America 38
4.9.6 Comparative Analysis of Local Phase lll Trials in Latin America 39
4.9.7 Number of Registered Sites per Million Population 40
5 Emerging Market for Clinical Trials – Argentina: Market Environment Characterization 41
5.1 Increase in the Growth of Global CRO Market will Foster the Growth of the Argentina Clinical Trial Market 41
5.1.1 Access to a Large Patient Population 42
5.1.2 Patient Availability for Major Diseases 43
5.1.3 Forecasts of Major Diseases 44
5.1.4 Subject Recruitment and Speed of Trials 48
5.1.5 Cost Comparison Argentina Versus the US 49
5.1.6 NGSP Approved Laboratories in Argentina 49
5.1.7 Infrastructural Facilities Improve the Clinical Trial Environment 50
5.1.8 Increase in Number of Medical Schools and Increase in Principal Investigators 52
5.2 Market Restraints 54
5.2.1 Substandard Quality in Translations May Potentially Introduce Inconsistency and Inaccuracy 54
5.2.2 Intellectual Property Enforcement Issues 54
5.2.3 In-Depth Training in Good Clinical Practices for Health Care Professionals 54
5.2.4 Cultural and Socioeconomic Factors Can Cause Problems in Conducting Clinical Research 54
5.3 Clinical Trial Market Size in Argentina 55
6 Emerging Market for Clinical Trials – Argentina: Regulatory Landscape 56
6.1 Introduction 56
6.2 Regulatory Provisions in Argentina Related to Clinical Trials 56
6.3 Aministracion Nacional de Medicamentos, Alimentos y Technologia Medica (ANMAT) 57
6.4 Key Documents For Clinical Trials in Argentina 57
6.4.1 Documents That Should be Submitted to Various Committees for the Sites located in the Province of Buenos Aires 60
6.4.2 Timelines for Reporting Adverse Drug Reactions to Regulatory Authorities in Argentina 61
6.5 Clinical Trial Regulation in Argentina 62
6.5.1 Approval Process for Clinical Trials in Argentina 62
6.5.2 Documents Required With the Investigator and Sponsor of Clinical Trials 63
7 Emerging Market for Clinical Trials – Argentina - CRO Landscape 67
7.1 Key CRO Deals in Argentina 67
7.2 CRO Profiles 67
7.2.1 Abel Santos & Asociados 67
7.2.2 Activa CRO 68
7.2.3 Blanchard & Asociados 69
7.2.4 EGCP 70
7.2.5 Klixar 71
7.2.6 LatinClin 72
7.2.7 MMatiss 73
7.2.8 ECLA 74
7.2.9 Quintiles 75
7.2.10 Covance 76
7.2.11 Charles River 78
7.2.12 Kendle 79
7.2.13 Omnicare 81
8 Emerging Market for Clinical Trials – Argentina - Appendix 83
8.1 Market Definitions 83
8.2 Abbreviations 83
8.3 Research Methodology 84
8.3.1 Coverage 84
8.3.2 Secondary Research 84
8.3.3 Primary Research 85
8.3.4 Expert Panel Validation 85
8.4 Contact Us 85
8.5 Disclaimer 85
8.6 Sources 86
1.1 List of Tables
Table 1: Clinical Trials in Argentina, Global BLA and NME Approvals vs R&D Spending, ($bn), 1995-2009
Table 2: Clinical Trials in Argentina, Drug Patent Expiry, Global ($m), 2009-2016
Table 3: Clinical Trials in Argentina, Number of Phase l Clinical Trials Registered, 2005-2010
Table 4: Clinical Trials in Argentina, Number of Phase ll Clinical Trials Registered, 2005-2010
Table 5: Clinical Trials in Argentina, Number of Phase lll Clinical Trials Registered, 2005-2010
Table 6: Clinical Trials in Argentina, Number of Phase lV Clinical Trials Registered, 2005-2010
Table 7: Clinical Trials in Argentina, Number of Clinical Trials Registered in Latin America, 2010
Table 8: Clinical Trials in Argentina, Distribution of Population among Latin American Countries (%), 2010
Table 9: Clinical Trials in Argentina, Population Forecast, 1980-2050
Table 10: Clinical Trials in Argentina, Number of Clinical Trials by MNCs, 1990-2010
Table 11: Clinical Trials in Argentina, Clinical Trials Conducted for Major Indications (%), 1990-2010
Table 12: Clinical Trials in Argentina, Comparative Analysis For Number of Phase ll Trials by Country, 2008-2010
Table 13: Clinical Trials in Argentina, Comparative Analysis For Number of Phase lll Trials by Country, 2008-2010
Table 14: Clinical Trials in Argentina, Comparative Analysis For Number of Phase ll Trials by Country, 2008-2010
Table 15: Clinical Trials in Argentina, Comparative Analysis For Number of Phase lll Trials by Country, 2008-2010
Table 16: Clinical Trials in Argentina, Comparative Analysis for Number of Sites per Million Population in Latin America, 2010
Table 17: Clinical Trials in Argentina, Global, CRO Market ($bn), 2006-2015
Table 18: Clinical Trials in Argentina, Patient Population, 2010
Table 19: Clinical Trials in Argentina, Top 10 Mortality-Causing Diseases in Argentina, 2011
Table 20: Clinical Trials in Argentina, Population Forecast for HIV (‘000), 2010-2015
Table 21: Clinical Trials in Argentina, Population Forecast for CVD, 2010-2015
Table 22: Clinical Trials in Argentina, Population Forecast for Diabetes, 2010-2015
Table 23: Clinical Trials in Argentina, Population Forecast for Cancer (‘000), 2010-2015
Table 24: Clinical Trials in Argentina, Population Forecast for COPD and Asthma (Millions), 2010-2015
Table 25: Clinical Trials in Argentina, Cost Comparison Argentina Versus the US, ($), 2010
Table 26: Clinical Trials in Argentina, National Glycohemoglobin Standardization Program Approved Laboratories, 2011
Table 27: Clinical Trials in Argentina, Number of Hospitals By Province and City, 2011
Table 28: Clinical Trials in Argentina, Number of Healthcare Personnel and Density Per 10,000 Population, 2011
Table 29: Clinical Trials in Argentina, Number of Medical Schools, 1990- 2010
Table 30: Clinical Trials in Argentina, Growth Rate of Principal Investigators, 2001-2006
Table 31: Clinical Trials in Argentina, Clinical Trial Market ($m), 2010-2015
Table 32: Clinical Trials in Argentina, Regulatory provisions for Clinical Trials, 2011
Table 33: Clinical Trials in Argentina, Major Documents in Conduction of Clinical Trials, 2011
Table 34: Clinical Trials in Argentina, Major Document Submission To The Authorities, 2011
Table 35: Clinical Trials in Argentina, List of Documents Required Before Commencement of Clinical Trials, 2011
Table 36: Clinical Trials in Argentina, List of Documents Required During Conduction of Clinical Trials, 2011
Table 37: Clinical Trials in Argentina, List of Documents Required After Completion of Clinical Trials, 2011
Table 38: Clinical Trails in Argentina, Number of Deals in CRO Sector, 2009 - 2010
1.2 List of Figures
Figure 1: Clinical Trials in Argentina, Parallel Group Trial Design, 2010
Figure 2: Clinical Trials in Argentina, Crossover Trial Design, 2010
Figure 3: Clinical Trials in Argentina, Adaptive Clinical Trial Design, 2010
Figure 4: Clinical Trials in Argentina, Wyeth Learn and Confirm Model, 2010
Figure 5: Clinical Trials in Argentina, Services Offered by CROs, 2010
Figure 6: Clinical Trials in Argentina, Preclinical Research to Market Launch Via Clinical Trials, 2009
Figure 7: Clinical Trials in Argentina, Intellectual Property Laws, 2011
Figure 8: Clinical Trials in Argentina, Global BLA and NME Approvals Versus R&D Spending ($bn), 1995-2009
Figure 9: Clinical Trials in Argentina, Activities of R&D Restructuring, 2010
Figure 10: Clinical Trials in Argentina, Number of Phase l Clinical Trials Registered, 2005-2010
Figure 11: Clinical Trials in Argentina, Number of Phase ll Clinical Trials Registered, 2005-2010
Figure 12: Clinical Trials in Argentina, Number of Phase lll Clinical Trials Registered, 2005-2010
Figure 13: Clinical Trials in Argentina, Number of Phase lV Clinical Trials Registered, 2005-2010
Figure 14: Clinical Trials in Argentina, Distribution of Clinical Trials by Phase (%), 2010
Figure 15: Clinical Trials in Argentina, Number of Clinical Trials Registered in Latin America, 2010
Figure 16: Clinical Trials in Argentina, Distribution of Population among Latin American Countries (%), 2010
Figure 17: Clinical Trials in Argentina, Population Forecast (Millions), 1980-2050
Figure 18: Clinical Trials in Argentina, Number of Clinical Trials by Multinational Companies, 2011
Figure 19: Clinical Trials in Argentina, Clinical Trials Conducted for Major Indications (%), 1990-2010
Figure 20: Clinical Trials in Argentina, Comparative Analysis for Number of Phase ll Trials by Country, 2008-2010
Figure 21: Clinical Trials in Argentina, Comparative Analysis for Number of Phase lll Trials by Country, 2008-2010
Figure 22: Clinical Trials in Argentina, Comparative Analysis For Number of Phase ll Trials by Country, 2008-2010
Figure 23: Clinical Trials in Argentina, Comparative Analysis For Number of Phase lll Trials by Country, 2008-2010
Figure 24: Clinical Trials in Argentina, Comparative Analysis for Number of Sites per Million Population in Latin America, 2010
Figure 25: Clinical Trials in Argentina, Global, CRO Market ($bn), 2006-2015
Figure 26: Clinical Trials in Argentina, Patient Population (millions), 2010
Figure 27: Clinical Trials in Argentina, Population Forecast for HIV (‘000), 2010-2015
Figure 28: Clinical Trials in Argentina, Population Forecast for CVD (‘000), 2010-2015
Figure 29: Clinical Trials in Argentina, Population Forecast for Diabetes (Million), 2010-2015
Figure 30: Clinical Trials in Argentina, Population Forecast for Cancer (‘000), 2010-2015
Figure 31: Clinical Trials in Argentina, Population Forecast for COPD and Asthma (Millions), 2010-2015
Figure 32: Clinical Trials in Argentina, Number of Medical Schools, 1990-2010
Figure 33: Clinical Trials in Argentina, Growth Rate of Principal Investigators, 2001-2006
Figure 34: Clinical Trials in Argentina, Clinical Trial Market ($m), 2010-2015
Figure 35: Clinical Trials in Argentina, Clinical Trial Regulation Approval Process, 2011
Figure 36: Clinical Trials in Argentina, Abel Santos & Asociados, Company Profile, 2011
Figure 37: Clinical Trials in Argentina, Activa CRO, Company Profile, 2011
Figure 38: Clinical Trials in Argentina, Blanchard & Asociados, Company Profile, 2011
Figure 39: Clinical Trials in Argentina, EGCP, Company Profile, 2011
Figure 40: Clinical Trials in Argentina, Klixar, Company Profile, 2011
Figure 41: Clinical Trials in Argentina, LatinClin, Company Profile, 2011
Figure 42: Clinical Trials in Argentina, Mmatiss, Company Profile, 2011
Figure 43: Clinical Trials in Argentina, ECLA, Company Profile, 2011
Figure 44: Clinical Trials in Argentina, Quintiles, Company Profile, 2011
Figure 45: Clinical Trials in Argentina, Quintiles, SWOT Analysis, 2011
Figure 46: Clinical Trials in Argentina, Covance, Company Profile, 2011
Figure 47: Clinical Trials in Argentina, Covance, SWOT Profile, 2011
Figure 48: Clinical Trials in Argentina, Charles River, Company Profile, 2011
Figure 49: Clinical Trials in Argentina, Charles River, SWOT Profile, 2011
Figure 50: Clinical Trials in Argentina, Kendle, Company Profile, 2011
Figure 51: Clinical Trials in Argentina, Kendle, SWOT Profile, 2011
Figure 52: Clinical Trials in Argentina, Omnicare, Company Profile, 2011
Figure 53: Clinical Trials in Argentina, Omnicare, SWOT Profile, 2011