Emerging Markets: Latin America Clinical Trials


As R&D costs rise exponentially and trial subjects grow scarce in the US and Europe, life sciences firms are turning to the emerging markets to supplement patient enrollment — and to reduce costs.

Latin America holds about 1/10 of the number of trials of the United States, and Brazil, numbered among the high-profile BRIC market, receives the lion’s share of attention. But savvy companies leverage other nations’ untapped promise: patient availability, advanced knowledge and infrastructure, and ease of communication. These advantages are cultivated in an environment open to clinical development, but scores of questions can create reams of data – and misperceptions – and potentially keep teams away.

Eliminate information clutter and zero in on the key clinical research in emerging markets of Latin America.

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Report Details

Publication Date: November 2010
Pages: 189
Chapters: 3
Metrics: 400+
Charts/Graphics: 100+
Profiles: 12

Top Reasons to Buy this Clinical Trials Latin America Report

Pick the Right Market for Clinical Trials Latin America: Compare costs, timelines, regulatory environments and problem areas across countries as you discover unique benefits to each. Explore ratings for 13 elements of trial success.

Accelerate Patient Recruitment and Retention: Target markets for treatment-naive patients, and discover the factors to ensure easy recruitment and strong retention.

Navigate Tricky Issues: How do companies protect intellectual property? How do they manage longer setup times and overcome regulatory hurdles? Discover which governments protect Clinical Trials Latin America IP and find real-company best practices for managing different regulatory guidelines.

Master Trial Management: Balance reliance on local expertise with trial oversight to build strong partnerships. Uncover fresh strategies to prepare your teams for the challenges that will inevitably flare up.

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource as well as our individual clinical development research reports.

Excerpt from Emerging Markets Clinical Development in Latin America

With nearly 50,000 trials registered in the US alone and more than 20,000 in Western Europe, companies find it increasingly difficult to meet the patient enrollment numbers to give a brand a shot at approval. The blame for this has been placed on everyone from the FDA (impossible-to-meet protocols) to physicians (over-medicating potential patients) to patients (for not caring about research) to the companies themselves for running too many trials, many of which will not end in groundbreaking results.

Because of this confluence of events, R&D costs have skyrocketed as trials take longer and longer to complete — if they even finish. To help combat the patient enrollment problem, many companies have turned to the emerging markets — from the BRIC (Brazil, Russia, India, and China) countries down to countries with less than 10 million inhabitants. Moving to new regions, however, has created its own set of difficulties that pharmaceutical and medical device companies still have not conquered. Questions of quality, regulatory guidelines, intellectual property laws, culture and cost plague clinical development teams. Attempting to differentiate scores of possible clinical trial locations produces reams of data and leaves these teams unsure of the best strategic locations for their trials.

Table of Contents

9              Executive Summary

11           Scoring Latin America

31           Study Methodology

32           Participating Companies

33           Report Layout

34           Profile Layout

37           Running Trials in Latin America: Key Recommendations for Success

43           Brazil

44           Clinical Environment Overview

59           Clinical Development Strategy

78           Clinical Development Profiles

99           Argentina

100         Clinical Environment Overview

114         Clinical Development Strategy

128         Clinical Development Profiles

145         Mexico

146         Clinical Environment Overview

162         Clinical Development Strategy

172         Clinical Development Profiles

181         Working in Other Latin American Countries

186         Clinical Development Profiles

Charts and Graphs

Executive Summary

Scoring Latin America

12           Figure E.1: Latin American Population Compared to US and 5 EU Countries

13           Figure E.2: Number of Studies Registered by Region

13           Figure E.3: Number of Studies Registered in Select Latin American Countries

15           Figure E.4: Scoring Latin America: Patient Access

15           Figure E.5: Scoring Latin America: Patient Retention

17           Figure E.6: Scoring Latin America: Regulatory Environment

18           Figure E.7: Scoring Latin America: Intellectual Property Laws/Practice

20           Figure E.8: Scoring Latin America: Cultural Concerns

21           Figure E.9: Scoring Latin America: Communication/Language

23           Figure E.10: Scoring Latin America: Trial Technology Infrastructure

23           Figure E.11: Scoring Latin America: Supply Chain Management

24           Figure E.12: Scoring Latin America: Available Knowledge Base

25           Figure E.13: Scoring Latin America: Data Standards

26           Figure E.14: Scoring Latin America: Investigator Standards

26           Figure E.15: Scoring Latin America: Site Management Standards

28           Figure E.16: Average Percentage of Budget Saved by Running a Site in Latin America

29           Figure E.17: Average Percentage of Time Saved by Running a Site in Latin America

30           Figure E.18: Scoring Latin America: Anticipated Cost


Clinical Environment Overview

44           Table 1.1: Key Demographic Figures for Brazil (2010)

45           Figure 1.1: Change in Life Expectancy: Brazil (1960–2050)

46           Table 1.2: Top 10 Causes of Death in Brazil, 2002

47           Figure 1.2: Ethnicities in Brazil (2000 Census)

50           Table 1.3: Key Economic Figures, 2009

52           Table 1.4: Key Healthcare System Figures, 2005–2009

53           Figure 1.3: Brazil’s Healthcare Spending as a Percentage of GDP (2009)

54           Figure 1.4: Health Spending by Sector (2005)

56           Figure 1.5: Brazil’s Share of the Latin American Pharmaceutical Market (2009)

59           Figure 1.6: Percentage of Budget Saved by Running a Trial in Brazil

Clinical Development Strategy

60           Figure 1.7: Percentage of Time Saved by Running a Trial in Brazil

62           Figure 1.8: Assigning Clinical Development Responsibilities for Brazil

65           Figure 1.9: Importance of Factors that Impact Clinical Trial Environment for Companies Operating in Brazil

66           Figure 1.10: Scoring Brazil: Clinical Environment Scores

72           Figure 1.11: Importance of Factors that Impact Trial Operations for Companies Operating in Brazil

72           Figure 1.12: Scoring Brazil: Trial Operations Scores

74           Figure 1.13: Percentage of Total Trial Patients Enrolled in Brazil

Clinical Development Profiles

78           Figure 1.14: Profile 1: Company Background

79           Figure 1.15: Profile 1: Experience in Latin America

80           Figure 1.16: Profile 1: Clinical Strategy in Brazil

81           Figure 1.17: Profile 1: Scorecard for Brazil

82           Figure 1.18: Profile 2: Company Background

83           Figure 1.19: Profile 2: Experience in Latin America

84           Figure 1.20: Profile 2: Clinical Strategy in Brazil

85           Figure 1.21: Profile 2: Scorecard for Brazil

86           Figure 1.22: Profile 3: Company Background

87           Figure 1.23: Profile 3: Experience in Latin America

88           Figure 1.24: Profile 3: Clinical Strategy in Brazil

89           Figure 1.25: Profile 3: Scorecard for Brazil

90           Figure 1.26: Profile 4: Company Background

91           Figure 1.27: Profile 4: Experience in Latin America

92           Figure 1.28: Profile 4: Clinical Strategy in Brazil

93           Figure 1.29: Profile 4: Scorecard for Brazil

94           Figure 1.30: Profile 5: Company Background

95           Figure 1.31: Profile 5: Experience in Latin America

96           Figure 1.32: Profile 5: Clinical Strategy in Brazil

97           Figure 1.33: Profile 5: Scorecard for Brazil


Clinical Environment Overview

101         Table 2.1: Key Demographic Figures for Argentina (2010)

102         Figure 2.1: Change in Life Expectancy: Argentina (1960–2050)

103         Table 2.2: Top 10 Causes of Death in Argentina (2002)

104         Figure 2.2: Ethnicities in Argentina (2000 Census)

107         Table 2.3: Key Economic Figures (2009)

109         Table 2.4: Key Healthcare System Figures (2005–2009)

110         Figure 2.3: Argentina’s Healthcare Spending as a Percentage of GDP (2006)

111         Figure 2.4: Argentina’s Health Spending by Sector (2005)

112         Figure 2.5: Argentina’s Share of the Latin American Pharmaceutical Market (2009)

114         Figure 2.6: Percentage of Budget Saved by Running a Trial in Argentina

Clinical Development Strategy

116         Figure 2.7: Percentage of Time Saved by Running a Trial in Argentina

117         Figure 2.8: Assigning Clinical Development Responsibilities for Argentina

120         Figure 2.9: Importance of Factors that Impact Clinical Trial Environment for Companies Operating in Argentina

121         Figure 2.10: Scoring Argentina: Clinical Environment Scores

124         Figure 2.11: Importance of Factors that Impact Trial Operations for Companies Operating in Argentina

125         Figure 2.12: Scoring Argentina: Trial Operations Scores

126         Figure 2.13: Percentage of Total Trial Patients Enrolled in Argentina

Clinical Development Profiles

128         Figure 2.14: Profile 6: Company Background

129         Figure 2.15: Profile 6: Experience in Latin America

130         Figure 2.16: Profile 6: Clinical Strategy in Argentina

131         Figure 2.17: Profile 6: Scorecard for Argentina

132         Figure 2.18: Profile 7: Company Background

133         Figure 2.19: Profile 7: Experience in Latin America

134         Figure 2.20: Profile 7: Clinical Strategy in Argentina

135         Figure 2.21: Profile 7: Scorecard for Argentina

136         Figure 2.22: Profile 8: Company Background

137         Figure 2.23: Profile 8: Experience in Latin America

138         Figure 2.24: Profile 8: Clinical Strategy in Argentina

139         Figure 2.25: Profile 8: Scorecard for Argentina

140         Figure 2.26: Profile 9: Company Background

141         Figure 2.27: Profile 9: Experience in Latin America

142         Figure 2.28: Profile 9: Clinical Strategy in Argentina

143         Figure 2.29: Profile 9: Scorecard for Argentina


Clinical Environment Overview

146         Table 3.1: Key Demographic Figures for Mexico (2010)

147         Figure 3.1: Change in Life Expectancy: Mexico (1960-2050)

148         Table 3.2: Top 10 Causes of Death in Mexico (2008)

149         Figure 3.2: Ethnicities in Mexico (2000 Census)

153         Table 3.3: Key Economic Figures (2009)

156         Table 3.4: Key Healthcare System Figures (2005–2009)

157         Figure 3.3: Mexico’s Healthcare Spending as a Percentage of GDP (2006)

158         Figure 3.4: Mexico’s Health Spending by Sector (2005)

159         Figure 3.5: Mexico’s Share of the Latin American Pharmaceutical Market (2009)

162         Figure 3.6: Percentage of Budget Saved by Running a Trial in Mexico

Clinical Development Strategy

163         Figure 3.7: Percentage of Time Saved by Running a Trial in Mexico

164         Figure 3.8: Assigning Clinical Development Responsibilities for Mexico

167         Figure 3.9: Importance of Factors that Impact Clinical Trial Environment for Companies Operating in Mexico

167         Figure 3.10: Scoring Mexico: Clinical Environment Scores

169         Figure 3.11: Importance of Factors that Impact Trial Operations for Companies Operating in Mexico

170         Figure 3.12: Scoring Mexico: Trial Operations Scores

Clinical Development Profiles

172         Figure 3.13: Profile 10: Company Background

173         Figure 3.14: Profile 10: Experience in Latin America

174         Figure 3.15: Profile 10: Clinical Strategy in Mexico

175         Figure 3.16: Profile 10: Scorecard for Mexico

176         Figure 3.17: Profile 11: Company Background

177         Figure 3.18: Profile 11: Experience in Latin America

178         Figure 3.19: Profile 11: Clinical Strategy in Mexico

179         Figure 3.20: Profile 11: Scorecard for Mexico

Working in Other Latin American Countries

Clinical Development Profiles

186         Figure 4.1: Profile 12: Company Background

187         Figure 4.2: Profile 12: Experience in Latin America

188         Figure 4.3: Profile 12: Clinical Strategy in Peru

189         Figure 4.4: Profile 12: Scorecard for Peru