臨床開発の新興市場：アフリカ

目次

Abstract

Despite maintaining regional offices within Africa, many major drug and device manufacturers frequently overlook the continent when sponsoring clinical studies. Cultural barriers, political upheaval and uneven infrastructure are certainly causes for the lack of interest. But Africa offers tremendous expertise and opportunity for drug and device companies looking for cost-effective study sites and appropriate patient populations. As challenging as Africa may seem, drug companies have made commitments to improve healthcare across the continent, and these companies' clinical development strategies go hand-in-hand with that improvement. In coming years, the drug and device industries will greatly expand their clinical development presence in Africa, mainly in South Africa and a select few North African nations. Make sure that your clinical strategy team has all the knowledge available about the growth opportunities in these countries. Africa presents a unique profile that interests many multinational life sciences companies. If the following benefits outweigh the challenges for a clinical team - as they often do - trial sponsors will find value in Africa:

• Patient access: Of all emerging regions, Africa has arguably the least access to quality care, ensuring a steady stream of dedicated patients to fill trial enrollments. In addition, the most advanced nations offer highly diverse patient populations that will translate well for submissions in the US and EU.
• Location: Many major European companies are located just across the Mediterranean from North Africa, making travel and communication easier than in Latin America, for example. For American companies, Africa is much closer than Asia.
• Underutilization: Though trial saturation is not a concern in emerging markets yet, Africa is the least saturated. Companies that establish clinical operations bases now will be ahead of the pack when more of the industry turns to Africa.

Table of Contents

• 9 Clinical Development in Africa: Understand the Risks but Do Not Overlook Africa' s Potential
• 11 Scoring Africa
• 31 Study Methodology
• 32 Participating Companies
• 33 Report Layout
• 34 Profile Layout
• 37 Running Trials in Africa: Key Recommendations for Success
• 45 South Africa
• 46 Clinical Environment Overview
• 67 Clinical Development Strategy
• 80 Clinical Development Profiles
• 101 Working in Emerging North African Countries
• 106 Clinical Development Profiles

CHARTS AND GRAPHICS

Executive Summary

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

Scoring BRIC

• 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

• 46 Table 1.1: Key Demographic Figures for Brazil, 2010 Clinical Environment Overview
• 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 Percent 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: Percent 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 (1960-2050)
• 165 Table 3.2: Top Ten 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 Percent of GDP (2006)
• 171 Figure 3.4: 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: Percent of Total Trial Patients Enrolled in India
• 194 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: China' s Key Economic Figures (2009)
• 234 Table 4.4: China' s Key Healthcare System Figures, 2005-2009
• 235 Figure 4.3: China Healthcare Spending as a Percentage of GDP (2009)
• 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: Percent 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

「臨床開発の新興市場：アフリカ」は2010年11月30日にカッティング・エッジ・インフォメーションより発行されました。 当レポートは117 Pagesで構成され、税抜￥742,798より販売しています。