Countries covered: United States, Argentina

Emerging Market for Clinical Trials in Argentina - Major Cost Advantages over the US in Conducting Clinical Trials Will Encourage Drug Development

Summary

Company has released its latest report, “Emerging Market for Clinical Trials in Argentina - Major Cost Advantages over the US in Conducting Clinical Trials Will Encourage Drug Development” that provides key data, information and analysis of the major trends and issues affecting the clinical trial market in Argentina. The report provides a comprehensive insight of the reasons for outsourcing clinical trials to Argentina and the key services provided by the CROs of Argentina. The report provides a detailed analysis of the Argentine market in terms of its market size. The report also discusses the factors that are driving and restraining the clinical trial market in Argentina. 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 Argentina.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by Company’s team of industry experts.

Scope

The scope of the report includes -
The need for outsourcing clinical trials to Argentina.
Trends in clinical trial registration in Argentina and a comparative analysis of clinical trial registration in Latin American countries.
Analysis of the key drivers that are fueling the growth of the clinical trial market in Argentina.
Qualitative analysis of the key infrastructural facilities required for conducting clinical trials in Argentina.
Analysis of key government regulations in Argentina affecting the clinical trial market.
Study of eight CROs headquartered in Argentina, and five international CRO’s operating in Argentina with SWOT analysis of international CRO’s.

Reasons to buy

The report will enhance your decision making capability. 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 Argentine market.
Develop effective strategies to maximize the advantages in Argentina through the understanding of the regulatory environment.
Understand the regulatory structure in Argentina and key documents required to register clinical trials in Argentina.

1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Emerging Market for Clinical Trials - Argentina: Introduction
2.1 GBI Research Report Guidance
3 Emerging Market for Clinical Trials - Argentina: Overview
3.1 The Clinical Research Process - Overview
3.1.1 Drug Discovery Phase
3.1.2 Pre-Clinical Phase
3.1.3 Phase I
3.1.4 Phase II
3.1.5 Phase III
3.1.6 Review and Approval from the Regulatory Agencies
3.1.7 Post-Marketing Studies
3.2 Clinical Trial Design and Types
3.2.1 Types of Design
3.3 Role of CROs
3.4 Sponsors of Clinical Trials
3.5 Intellectual Property Protection in Argentina
3.5.1 Patents and Utility Models
3.5.2 The Copyright Law:
3.5.3 Trademark and Trade Names
3.5.4 Data Protection
3.6 The Need for Outsourcing Clinical Trials
3.6.1 High Risks and Costs Associated With Drug Development
3.6.2 Escalating Costs of Clinical Trials
3.6.3 Global Increase in the Number of Clinical Trials Conducted
3.6.4 Restructuring the R&D
3.6.5 Increased Screening Rates during R&D
3.6.6 Expiring Patents Pressurize Pharmaceutical Companies to Reduce Costs
4 Emerging Market for Clinical Trials - Argentina - Clinical Trial Trends
4.1 Registration of Phase l Clinical Trials
4.2 Registration of Phase ll Clinical Trials
4.3 Registration of Phase lll Clinical Trials
4.4 Registration of Phase lV Clinical Trials
4.5 Clinical Trials Registered in 2010
4.6 Comparative Analysis of Registered Clinical Trials in Latin American Countries
4.7 Comparative Analysis of Population Statistics in Latin American Countries
4.8 Population Forecast of Argentina
4.9 Analysis of Clinical Trials Conducted by Multinational Companies in Argentina
4.9.1 Number of Clinical Trials Carried Out By Multinational Companies in Argentina
4.9.2 Number of Clinical Trials Carried Out for Major Indications
4.9.3 Comparative Analysis of Multinational Phase ll Trials in Latin America
4.9.4 Comparative Analysis of Multinational Phase lll Trials in Latin America
4.9.5 Comparative Analysis of Local Phase ll Trials in Latin America
4.9.6 Comparative Analysis of Local Phase lll Trials in Latin America
4.9.7 Number of Registered Sites per Million Population
5 Emerging Market for Clinical Trials - Argentina: Market Environment Characterization
5.1 Increase in the Growth of Global CRO Market will Foster the Growth of the Argentina Clinical Trial Market
5.1.1 Access to a Large Patient Population
5.1.2 Patient Availability for Major Diseases
5.1.3 Forecasts of Major Diseases
5.1.4 Subject Recruitment and Speed of Trials
5.1.5 Cost Comparison Argentina Versus the US
5.1.6 NGSP Approved Laboratories in Argentina
5.1.7 Infrastructural Facilities Improve the Clinical Trial Environment
5.1.8 Increase in Number of Medical Schools and Increase in Principal Investigators
5.2 Market Restraints
5.2.1 Substandard Quality in Translations May Potentially Introduce Inconsistency and Inaccuracy
5.2.2 Intellectual Property Enforcement Issues
5.2.3 In-Depth Training in Good Clinical Practices for Health Care Professionals
5.2.4 Cultural and Socioeconomic Factors Can Cause Problems in Conducting Clinical Research
5.3 Clinical Trial Market Size in Argentina
6 Emerging Market for Clinical Trials - Argentina: Regulatory Landscape
6.1 Introduction
6.2 Regulatory Provisions in Argentina Related to Clinical Trials
6.3 Aministracion Nacional de Medicamentos, Alimentos y Technologia Medica (ANMAT)
6.4 Key Documents For Clinical Trials in Argentina
6.4.1 Documents That Should be Submitted to Various Committees for the Sites located in the Province of Buenos Aires
6.4.2 Timelines for Reporting Adverse Drug Reactions to Regulatory Authorities in Argentina
6.5 Clinical Trial Regulation in Argentina
6.5.1 Approval Process for Clinical Trials in Argentina
6.5.2 Documents Required With the Investigator and Sponsor of Clinical Trials
7 Emerging Market for Clinical Trials - Argentina - CRO Landscape
7.1 Key CRO Deals in Argentina
7.2 CRO Profiles
7.2.1 Abel Santos & Asociados
7.2.2 Activa CRO
7.2.3 Blanchard & Asociados
7.2.4 EGCP
7.2.5 Klixar
7.2.6 LatinClin
7.2.7 MMatiss
7.2.8 ECLA
7.2.9 Quintiles
7.2.10 Covance
7.2.11 Charles River
7.2.12 Kendle
7.2.13 Omnicare
8 Emerging Market for Clinical Trials - Argentina - Appendix
8.1 Market Definitions
8.2 Abbreviations
8.3 Research Methodology
8.3.1 Coverage
8.3.2 Secondary Research
8.3.3 Primary Research
8.3.4 Expert Panel Validation
8.4 Contact Us
8.5 Disclaimer
8.6 Sources

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