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Reportlinker Adds Emerging Clinical Trial Locations - Eastern Europe: Market Dynamics and the Changing Healthcare and Regulatory Environment
Date:12/1/2009

Primary Data and Information Gathering 133

Secondary data and information gathering 134

Definitions of Product-Life Cycle stages 136

Glossary of abbreviations and acronyms 137

List of Figures

Figure 1.1: Key issues facing Pharma and Biotech companies 16

Figure 1.2: Cost of bringing a drug to market ($m), 1975-2008 21

Figure 1.3: Pharmaceutical R&D expenditure ($bn), 2004-2009e 22

Figure 1.4: Biotechnology R&D expenditure ($bn), 2004-2009e 22

Figure 1.5: Cost of clinical trials in the US ($bn), 2005-2011e 23

Figure 2.6: Comparison of locations across selected countries 38

Figure 2.7: Korean Food and Drug Administration (KFDA) Approval Process 43

Figure 2.8: CRO Segment Leaders 45

Figure 2.9: Enhanced clinical site effectiveness (patients per site) in the emerging countries 48

Figure 2.10: Fewer ineffective sites in the emerging countries 48

Figure 2.11: Critical components for capacity building/conducting clinical trials 54

Figure 2.12: Assessing clinical trial location feasibility 55

Figure 2.13: CRO selection criteria 70

Figure 3.14: Pharmaceutical market by selected Central and Eastern European countries, 2007 84

Figure 3.15: Clinical trials Europe 90

Figure 3.16: Clinical trials by phase (no trials) in the Czech Republic, 2008 91

Figure 3.17: Clinical trials market ($m) in Poland, 2007-2010 92

Figure 3.18: Clinical trials by therapy area (%) in Russia, 2008 93

Figure 3.19: Clinical trials by phase (%) in Russia, 2008 94

Figure 3.20: FDA inspection deficiencies in Russian sites 101

List of Tables

Table 2.1: Demographics of selected emerging markets, 2007 40

Table 2.2: Ethical principles & their application for research 62

Table 3
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