Emerging Markets Clinical Trials: BRIC Countries

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Emerging markets clinical trials in BRIC are the next frontier of global industry expansion.  As this expansion makes its home in Brazil, Russia, India and China (BRIC), imagine the impact of a patient pool that numbers 3 billion: an immediate cure for patient shortages (or recruitment challenges) that plague studies in North America and Western Europe, unparalleled access to untapped patient populations, and new opportunities to meet the growing medical needs of these countries.

Confidently tap into the potential of the BRIC markets, fulfill protocol, and ultimately, realize significant cost and time savings. Expand your understanding of BRIC, individually and as a whole, using rankings data and best practices found in this report.

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Report Details

Publication Date: November 2010
Pages: 275
Chapters: 4
Metrics: 500+
Charts/Graphics: 150+
Profiles: 23

Top Reasons to Buy this Emerging Markets Clinical Trials BRIC Countries Report

Eliminate Confusion about Emerging Markets Clinical Trials BRIC: Weigh the advantages and drawbacks of different countries and examine rankings for 13 clinical factors to enable strategic decision-making. Gain quick access to relevant demographics and economics information for a comprehensive analysis of the clinical environment.

Master Trial Management in Emerging Markets Clinical Trials BRIC: Learn from top executives’ firsthand experiences — both successes and misfires. Recommendations show your team how to improve CRO selection, management and oversight, and more. Explore 23 in-depth profiles and find one that matches your company’s situation.

Clarify Misperceptions to Boost Success: Differences in cultural attitudes and behavior impact trial success. Knowledge and awareness go a long way in cultivating strong and beneficial relationships with local CROs.

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 Trials BRIC Countries

Even before the economy faltered and the patent cliff approached, the life sciences industry turned to the emerging markets — not to save revenue streams, but to enable them. With tens of thousands of ongoing trials in the United States and Western Europe, companies find it harder and harder to meet the patient enrollment numbers necessary to give a brand a shot at approval. The blame for this issue has been placed on everyone from the FDA and EMEA (for impossible-to-meet protocols) to physicians (for 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.

Table of Contents

13           Executive Summary

15           Scoring BRIC

33           Study Methodology

34           Participating Companies

35           Report Layout

36           Profile Layout

39           Running Trials in BRIC: Key Recommendations for Success

45           Brazil

46           Clinical Environment Overview

61           Clinical Development Strategy

80           Clinical Development Profiles

101         Russia

103         Clinical Environment Overview

116         Clinical Development Strategy

132         Best Practices

136         Clinical Development Profiles

161         India

162         Clinical Environment Overview

175         Clinical Development Strategy

196         Clinical Development Profiles

225         China

226         Clinical Environment Overview

240         Clinical Development Strategy

256         Clinical Development Profiles

Charts and Graphics

Executive Summary

Scoring BRIC

15           Figure E.1: BRIC Population Compared to US and 5 EU Countries

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

17           Figure E.3: Number of Studies Registered in BRIC Countries

18           Figure E.4: Scoring BRIC: Patient Access

18           Figure E.5: Scoring BRIC: Patient Retention

20           Figure E.6: Scoring BRIC: Regulatory Environment

21           Figure E.7: Scoring BRIC: Intellectual Property Laws/Practice

22           Figure E.8: Scoring BRIC: Cultural Concerns

23           Figure E.9: Scoring BRIC: Communication/Language

25           Figure E.10: Scoring BRIC: Trial Technology Infrastructure

25           Figure E.11: Scoring BRIC: Supply Chain Management

27           Figure E.12: Scoring BRIC: Available Knowledge Base

28           Figure E.13: Scoring BRIC: Data Standards

29           Figure E.14: Scoring BRIC: Investigator Standards

29           Figure E.15: Scoring BRIC: Site Management Standards

31           Figure E.16: Average Percent of Budget Saved by Running a Site in BRIC Countries

31           Figure E.17: Average Percentage of Time Saved by Running a Site in BRIC Countries

32           Figure E.18: Scoring BRIC: Anticipated Cost

Brazil

Clinical Environment Overview

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

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

48           Table 1.2: Top 10 Causes of Death in Brazil (2002)

49           Figure 1.2: Ethnicities in Brazil (2000 Census)

52           Table 1.3: Key Economic Figures (2009)

54           Table 1.4: Key Healthcare System Figures (2005–2009)

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

56           Figure 1.4: Health Spending by Sector (2005)

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

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

Clinical Development Strategy

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

64           Figure 1.8: Assigning Clinical Development Responsibilities for Brazil

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

68           Figure 1.10: Scoring Brazil: Clinical Environment Scores

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

74           Figure 1.12: Scoring Brazil: Trial Operations Scores

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

Clinical Development Profiles

80           Figure 1.14: Profile 1: Company Background

81           Figure 1.15: Profile 1: Experience in BRIC

82           Figure 1.16: Profile 1: Clinical Strategy in Brazil

83           Figure 1.17: Profile 1: Scorecard for Brazil

84           Figure 1.18: Profile 2: Company Background

85           Figure 1.19: Profile 2: Experience in BRIC

86           Figure 1.20: Profile 2: Clinical Strategy in Brazil

87           Figure 1.21: Profile 2: Scorecard for Brazil

88           Figure 1.22: Profile 3: Company Background

89           Figure 1.23: Profile 3: Experience in BRIC

90           Figure 1.24: Profile 3: Clinical Strategy in Brazil

91           Figure 1.25: Profile 3: Scorecard for Brazil

92           Figure 1.26: Profile 4: Company Background

93           Figure 1.27: Profile 4: Experience in BRIC

94           Figure 1.28: Profile 4: Clinical Strategy in Brazil

95           Figure 1.29: Profile 4: Scorecard for Brazil

96           Figure 1.30: Profile 5: Company Background

97           Figure 1.31: Profile 5: Experience in BRIC

98           Figure 1.32: Profile 5: Clinical Strategy in Brazil

99           Figure 1.33: Profile 5: Scorecard for Brazil

Russia

Clinical Environment Overview

103         Table 2.1: Key Demographic Figures for Russia (2010)

104         Figure 2.1: Change in Life Expectancy: Russia (1960-2050)

105         Table 2.2: Top 10 Causes of Death in Russia (2002)

106         Figure 2.2: Ethnicities in Russia (2002 Census)

109         Table 2.3: Key Economic Figures (2009)

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

112         Figure 2.3: Russia’s Healthcare Spending as a Percentage of GDP (2006)

113         Figure 2.4: Russia’s Health Spending by Sector (2005)

Clinical Development Strategy

117         Figure 2.5: Percentage of Total Trial Patients Enrolled in Russia

118         Figure 2.6: Percentage of Budget Saved by Running Trial in Russia

119         Figure 2.7: Percentage of Time Saved by Running Trial in Russia

121         Figure 2.8: Assigning Clinical Development Responsibilities for Russia

123         Figure 2.9: Importance of Factors that Impact Clinical Trial Environment for Companies Operating in Russia

124         Figure 2.10: Scoring Russia: Clinical Environment Scores

128         Figure 2.11: Importance of Factors that Impact Trial Operations for Companies Operating in Russia

129         Figure 2.12: Scoring Russia: Trial Operations Scores

Clinical Development Profiles

136         Figure 2.13: Profile 6: Company Background

137         Figure 2.14: Profile 6: Experience in BRIC

138         Figure 2.15: Profile 6: Clinical Strategy in Russia

139         Figure 2.16: Profile 6: Scorecard for Russia

140         Figure 2.17: Profile 7: Company Background

141         Figure 2.18: Profile 7: Experience in BRIC

142         Figure 2.19: Profile 7: Clinical Strategy in Russia

143         Figure 2.20: Profile 7: Scorecard for Russia

144         Figure 2.21: Profile 8: Company Background

145         Figure 2.22: Profile 8: Experience in BRIC

146         Figure 2.23: Profile 8: Clinical Strategy in Russia

147         Figure 2.24: Profile 8: Scorecard for Russia

148         Figure 2.25: Profile 9: Company Background

149         Figure 2.26: Profile 9: Experience in BRIC

150         Figure 2.27: Profile 9: Clinical Strategy in Russia

151         Figure 2.28: Profile 9: Scorecard for Russia

152         Figure 2.29: Profile 10: Company Background

153         Figure 2.30: Profile 10: Experience in BRIC

154         Figure 2.31: Profile 10: Clinical Strategy in Russia

155         Figure 2.32: Profile 10: Scorecard for Russia

156         Figure 2.33: Profile 11: Company Background

157         Figure 2.34: Profile 11: Experience in BRIC

158         Figure 2.35: Profile 11: Clinical Strategy in Russia

159         Figure 2.36: Profile 11: Scorecard for Russia

India

Clinical Environment Overview

163         Table 3.1: Key Demographic Figures for India (2010)

164         Figure 3.1: Change in Life Expectancy: India (1960–2050)

165         Table 3.2: Top 10 Causes of Death in India (2002)

167         Figure 3.2: Ethnicities in India (2000 Census)

169        Table 3.3: Key Economic Figures (2009)

170         Figure 3.3: India’s Healthcare Spending as a Percentage of GDP (2006)

171         Figure 3.4: India’s Health Spending by Sector (2005)

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

Clinical Development Strategy

176         Figure 3.5: Assigning Clinical Development Responsibilities for India

181         Figure 3.6: Importance of Factors that Impact Clinical Trial Environment for Companies Operating in India

182         Figure 3.7: Scoring India: Clinical Environment Scores

189         Figure 3.8: Importance of Factors that Impact Trial Operations for Companies Operating in India

189         Figure 3.9: Scoring India: Trial Operations Scores

191         Figure 3.10: Percentage of Total Trial Patients Enrolled in India

193         Figure 3.11: Percentage of Budget Saved by Running a Trial in India

194         Figure 3.12: Percentage of Time Saved by Running a Trial in India

Clinical Development Profiles

196         Figure 3.13: Profile 12: Company Background

197         Figure 3.14: Profile 12: Experience in BRIC

198         Figure 3.15: Profile 12: Clinical Strategy in India

199         Figure 3.16: Profile 12: Scorecard for India

200         Figure 3.17: Profile 13: Company Background

201         Figure 3.18: Profile 13: Experience in BRIC

202         Figure 3.19: Profile 13: Clinical Strategy in India

203         Figure 3.20: Profile 13: Scorecard for India

204         Figure 3.21: Profile 14: Company Background

205         Figure 3.22: Profile 14: Experience in BRIC

206         Figure 3.23: Profile 14: Clinical Strategy in India

207         Figure 3.24: Profile 14: Scorecard for India

208         Figure 3.25: Profile 15: Company Background

209         Figure 3.26: Profile 15: Experience in BRIC

210         Figure 3.27: Profile 15: Clinical Strategy in India

211         Figure 3.28: Profile 15: Scorecard for India

212         Figure 3.29: Profile 16: Company Background

213         Figure 3.30: Profile 16: Experience in BRIC

214         Figure 3.31: Profile 16: Clinical Strategy in India

215         Figure 3.32: Profile 16: Scorecard for India

216         Figure 3.33: Profile 17: Company Background

217         Figure 3.34: Profile 17: Experience in BRIC

218         Figure 3.35: Profile 17: Clinical Strategy in India

219         Figure 3.36: Profile 17: Scorecard for India

220         Figure 3.37: Profile 18: Company Background

221         Figure 3.38: Profile 18: Experience in BRIC

222         Figure 3.39: Profile 18: Clinical Strategy in India

223         Figure 3.40: Profile 18: Scorecard for India

China

Clinical Environment Overview

226         Table 4.1: Key Demographic Figures for China (2010)

227         Figure 4.1: Change in Life Expectancy: China (1960–2050)

228         Table 4.2: Top 10 Causes of Death in China (2002)

229         Figure 4.2: Ethnicities in China (2000 Census)

232         Table 4.3: Key Economic Figures (2009)

234         Table 4.4: Key Healthcare System Figures (2005-2009)

235         Figure 4.3: China Healthcare Spending as a Percentage of GDP (2007)

236         Figure 4.4: China’s Health Spending by Sector (2005)

Clinical Development Strategy

242         Figure 4.5: Percentage of Budget Saved by Running a Trial in China

242         Figure 4.6: Percentage of Time Saved by Running a Trial in China

243         Figure 4.7: Assigning Clinical Development Responsibilities for China

245         Figure 4.8: Scoring China: Clinical Environment Scores

246         Figure 4.9: Importance of Factors that Impact Clinical Trial Environment for Companies Operating in China

251         Figure 4.10: Importance of Factors that Impact Trial Operations for Companies Operating in China

252         Figure 4.11: Scoring China: Trial Operations Scores

255         Figure 4.12: Percentage of Total Trial Patients Enrolled in China

Clinical Development Profiles

256         Figure 4.13: Profile 19: Company Background

257         Figure 4.14: Profile 19: Experience in BRIC

258         Figure 4.15: Profile 19: Clinical Strategy in China

259         Figure 4.16: Profile 19: Scorecard for China

260         Figure 4.17: Profile 20: Company Background

261         Figure 4.18: Profile 20: Experience in BRIC

262         Figure 4.19: Profile 20: Clinical Strategy in China

263         Figure 4.20: Profile 20: Scorecard for China

264         Figure 4.21: Profile 21: Company Background

265         Figure 4.22: Profile 21: Experience in BRIC

266         Figure 4.23: Profile 21: Clinical Strategy in China

267         Figure 4.24: Profile 21: Scorecard for China

268         Figure 4.25: Profile 22: Company Background

269         Figure 4.26: Profile 22: Experience in BRIC

270         Figure 4.27: Profile 22: Clinical Strategy in China

271         Figure 4.28: Profile 22: Scorecard for China

272         Figure 4.29: Profile 23: Company Background

273         Figure 4.30: Profile 23: Experience in BRIC

274         Figure 4.31: Profile 23: Clinical Strategy in China

275         Figure 4.32: Profile 23: Scorecard for China