NEW YORK, June 15, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Emerging Market for Clinical Trials in Russia - Curbs on New Drug Approval Timelines and Registration Fees Encourage the Emergence of a Major Global Player

http://www.reportlinker.com/p0555133/Emerging-Market-for-Clinical-Trials-in-Russia---Curbs-on-New-Drug-Approval-Timelines-and-Registration-Fees-Encourage-the-Emergence-of-a-Major-Global-Player.html?utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_Discovery_and_Development

Emerging Market for Clinical Trials in Russia - Curbs on New Drug Approval Timelines and Registration Fees Encourage the Emergence of a Major Global Player

Summary

GBI Research has released its latest report, "Emerging Market for Clinical Trials in Russia - Curbs on New Drug Approval Timelines and Registration Fees Encourage the Emergence of a Major Global Player" that provides key data, information and analysis of the major trends and issues affecting the Clinical Trial market in Russia. The report provides a comprehensive insight of reasons for outsourcing clinical trials to Russia. The report also provides a detailed analysis of Russian clinical trial market structure. Analysis of major companies and countries which sponsor clinical trials in Russia is provided. Patient population analysis is done to highlight the types of diseased population available for conducting clinical trials in Russia. Opinion of industry experts has been incorporated in various parts of the report to emphasize the importance of various factors that affect the clinical trial market scenario in Russia.

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

Scope

The scope of the report includes -

- The need for outsourcing clinical trials to Russia

- Major companies and countries which sponsor clinical trials in Russia

- Trends in clinical trial registration in Russia

- Analysis of the key drivers and restraints that are impacting the growth of Clinical trial market in Russia

- Qualitative analysis of the key Infrastructural facilities present for conducting clinical trials in Russia

- Analysis of new federal law "On circulation of medicine" and its impact on clinical trials market in Russia.

- Study of 11 key CROs operating in Russia.

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 Russian market

- Develop effective strategies to maximize the advantages in Russia through the understanding of the regulatory environment

- Understand the regulatory structure in Russia and key documents required to register clinical trial in Russia

- Gain knowledge about the major indications for which clinical trials can be conducted in Russia

Table of Contents

1 Table of Contents

1 Table of Contents 3

1.1 List of Tables 5

1.2 List of Figures 7

2 Emerging Market for Clinical Trials in Russia - Introduction 9

2.1 GBI Research Report Guidance 9

3 Emerging Market for Clinical Trials in Russia – Overview 10

3.1 The Clinical Research Process – Overview 10

3.1.1 Drug Discovery Phase 10

3.1.2 Pre-Clinical Phase 10

3.1.3 Phase I 11

3.1.4 Phase II 11

3.1.5 Phase III 11

3.1.6 Review and Approval from the Regulatory Agencies 11

3.1.7 Post-marketing Studies 11

3.2 Clinical Trials in Russia - Market Overview 12

3.2.1 Major Countries Sponsoring Clinical Trials in Russia, 2008-2010 (Jan-June) 14

3.2.2 Major Companies Sponsoring Clinical Trials in Russia, 2009 16

3.2.3 Clinical Trials Conducted in Russia by Indication, 2009 17

3.3 Clinical Trial Market Structure in Russia 18

3.3.1 Clinical Trials Conducted in Russia by Study Type 18

3.3.2 Foreign Sponsored Clinical Trials Conducted in Russia by Phase 26

3.3.3 International Multicenter Clinical Trials Conducted in Russia, 2004-2009 33

3.3.4 Local Clinical Trials Conducted by Local Sponsors in Russia, 2004-2009 34

3.3.5 Bioequivalence Studies Conducted by Local Sponsors in Russia, 2004-2009 35

3.3.6 Local Clinical Trials Conducted by Foreign Sponsors in Russia, 2004-2009 36

3.3.7 Approved Foreign Clinical Trials in Russia, 2004- 2010 (Jan - June) 37

3.4 The Need for Outsourcing Clinical Trials 38

3.4.1 High Risks and Costs Associated With Drug Development 38

3.4.2 Escalating Costs of Clinical Trials 39

3.4.3 Global Increase in the Number of Clinical Trials Conducted 40

3.4.4 Restructuring the R&D 41

3.4.5 Increased Screening Rates during R&D 42

3.4.6 Expiring Patents Pressurize Pharmaceutical Companies to Reduce Costs 43

4 Emerging Market for Clinical Trials – Russia - Clinical Trial Trends 44

4.1 Registration of Phase l Clinical Trials 44

4.2 Registration of Phase lI Clinical Trials 45

4.3 Registration of Phase lII Clinical Trials 46

4.4 Registration of Phase lV Clinical Trials 47

4.5 Clinical Trials Registered in 2010 48

5 Market Environment Characterization 49

5.1 CRO Market in Russia, Market Forecast up to 2017 49

5.2 Market Drivers 50

5.2.1 Low Cost of Conducting Clinical Trials 50

5.2.2 High Patient Recruitment Rate 50

5.2.3 High Incidence rate of few Diseases as compared to other Countries 52

5.2.4 Availability of Drug-Naïve Patients 53

5.2.5 High Patient Compliance 53

5.2.6 Good In and Out-Patient Facilities 53

5.2.7 Presence of Experienced Investigators for Clinical Trials 54

5.2.8 Good Quality of Clinical Trial Data because Local GCP is identical to ICH GCP 54

5.3 Market Restraints 55

5.3.1 Increase in the Cost of Experienced Study Staff 55

5.3.2 Limited Experience of Newly Qualified Sites 55

5.3.3 Declining Population of Russia 55

6 Emerging Market for Clinical Trials – Russia, Health Statistics 56

6.1 Key Parameters of Russian Population 56

6.2 Characteristics of Active Trials in Russia 58

6.3 Patient Availability for Major Diseases 59

6.3.1 HIV-AIDS 59

6.3.2 Cancer 61

6.3.3 Diabetes 62

6.4 Tuberculosis (TB) 63

6.5 Mortality by Major Diseases in Russia 64

6.6 Medical Infrastructure in Russia 70

7 Regulatory Landscape 71

7.1 Documents to be Submitted for Clinical Trial Approval 71

7.2 Recent Regulatory Changes in Russia 72

7.3 Timelines for Getting Approval for Conducting Clinical Trials in Russia 74

8 Emerging Market for Clinical Trials – Russia- CRO Landscape 75

8.1 Key CRO Companies- Profile 75

8.1.1 Synergy Research Group 75

8.1.2 Quintiles 75

8.1.3 PPD 77

8.1.4 ICON 79

8.1.5 PAREXEL 80

8.1.6 INC Research 81

8.1.7 Omnicare Clinical Research 81

8.1.8 Pharm-Olam 82

8.1.9 FOCUS Clinical Drug Development 83

8.1.10 Global Clinical Trials 83

8.1.11 PSI 84

9 Emerging Market for Clinical Trials – Russia - Appendix 85

9.1 Market Definitions 85

9.2 Abbreviations 85

9.3 Research Methodology 87

9.3.1 Coverage 87

9.3.2 Secondary Research 87

9.3.3 Primary Research 87

9.3.4 Expert Panel Validation 88

9.4 Contact Us 88

9.5 Disclaimer 88

9.6 Sources 89

List of Tables

1.1 List of Tables

Table 1: Clinical Trials in Russia, Segmentation of Clinical Trials by Study Type, Russia (%), 2005-2010 (Jan –June) 12

Table 2: Clinical Trials in Russia, Number of Clinical Trials by Study Type, Russia, 2005-2010 (Jan-June) 13

Table 3: Clinical Trials in Russia, Major Countries Sponsoring Clinical Trials, Russia, 2008-2010 (Jan –June) 14

Table 4: Clinical Trials in Russia, Number of Clinical Trials Sponsored by Major Countries, Russia, 2009 15

Table 5: Clinical Trials in Russia, Number of Clinical Trials Initiated by Major Companies, Russia, 2009 16

Table 6: Clinical Trials in Russia, Number of Clinical Trials Initiated by Indication (%), Russia, 2009 17

Table 7: Clinical Trials in Russia, Number of Clinical Trials by Study Type, Russia, 2005-2010 (Jan-June) 18

Table 8: Clinical Trials in Russia, Number of Clinical Trials by Study Type, Russia, 2010 (Jan- June) 19

Table 9: Clinical Trials in Russia, Number of Clinical Trials by Study Type, Russia, 2009 20

Table 10: Clinical Trials in Russia, Number of Clinical Trials by Study Type, Russia, 2008 21

Table 11: Clinical Trials in Russia, Number of Clinical Trials by Study Type, Russia, 2007 22

Table 12: Clinical Trials in Russia, Number of Clinical Trials by Study Type, Russia, 2006 23

Table 13: Clinical Trials in Russia, Number of Clinical Trials by Study Type, Russia, 2005 24

Table 14: Clinical Trials in Russia, Number of Clinical Trials by Study Type, Russia, 2004 25

Table 15: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase, Russia, 2005-2010 (Jan-June) 26

Table 16: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase (Number), Russia, 2009 27

Table 17: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase, Russia, 2008 28

Table 18: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase, Russia, 2007 29

Table 19: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase (Number), Russia, 2006 30

Table 20: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase (Number), Russia, 2005 31

Table 21: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase (Number), Russia, 2004 32

Table 22: Clinical Trials in Russia, Number of International Multicenter Clinical Trials Conducted in Russia, 2004-2009 33

Table 23: Clinical Trials in Russia, Number of Local Clinical Trials Conducted by Local Sponsors, Russia, 2004-2009 34

Table 24: Clinical Trials in Russia, Number of Bioequivalence Studies Conducted by Local Sponsors, Russia, 2004-2009 35

Table 25: Clinical Trials in Russia, Number of Local Clinical Trials Conducted by Foreign Sponsors, Russia, 2004-2009 36

Table 26: Clinical Trials in Russia, Number of Approved Foreign Sponsored Clinical Trials, Russia, 2004-2010 (Jan-June) 37

Table 27: Clinical Trials in Russia, Global BLA and NME Approvals vs. R&D Spending, ($bn), 1995-2009 39

Table 28: Clinical Trials in Russia, Drug Patent Expiry, Global, ($m), 2009-2016 43

Table 29: Clinical Trials in Russia, Number of Phase l Clinical Trials Registered, Russia, 2005-2010 44

Table 30: Clinical Trials in Russia, Number of Phase Il Clinical Trials Registered, Russia, 2005-2010 45

Table 31: Clinical Trials in Russia, Number of Phase IlI Clinical Trials Registered, Russia, 2005-2010 46

Table 32: Clinical Trials in Russia, Number of Phase IV Clinical Trials Registered, Russia, 2005-2010 47

Table 33: Clinical Trials in Russia, Number of Clinical Trials Registered by Phase (%), Russia, 2010 48

Table 34: Clinical Trials in Russia, CRO Market, Russia, ($m), 2009-2017 49

Table 35: Clinical Trials in Russia, Comparison of Lab Fees ($) , Russia, 2007 50

Table 36: Clinical Trials in Russia, Recruitment Rate in Moscow per Month for Phase I and II or III Clinical Trials, 2010 51

Table 37: Clinical Trials in Russia, Number of Patients Recruited for Clinical Trials, Russia, 2004-2008 52

Table 38: Clinical Trials in Russia, Number of Reported Patients of Hypertension in Russia, 2009-2015 52

Table 39: Clinical Trials In Russia, Number of Treatment Naïve Patients by Therapy Area (thousand), 2009 53

Table 40: Clinical Trials in Russia , Number of Medical Institutions giving Out-Patient Services (thousand), Russia, 2004-2008 53

Table 41: Clinical Trials in Russia, Population, Russia, (million), 2004-2010 55

Table 42: Clinical Trials in Russia, Population Statistics, Russia, 2010 56

Table 43: Clinical Trials in Russia, Population, Russia, (million), 2004-2010 57

Table 44: Clinical Trials in Russia, Number of Active Trials per Institution, Russia, 2010 58

Table 45: Clinical Trials in Russia, Population and Forecast for HIV, Russia, 2001-2015 59

Table 46: Clinical Trials in Russia, Population Forecast for HIV(million), Russia, 2009-2015 60

Table 47: Clinical Trials in Russia, Population Forecast for Cancer (thousand), Russia, 2009-2015 61

Table 48: Clinical Trials in Russia, Population Forecast for Diabetes (million), Russia, 2009-2015 62

Table 49: Clinical Trials in Russia, Forecast for Tuberculosis Incidence per 100,000, Russia, 2009-2015 63

Table 50: Clinical Trials in Russia, Mortality due to Major Diseases, Russia, 2004-2009 64

Table 51: Clinical Trials in Russia, Total Number of Deaths per 100,000 People, Russia, 2004-2009 65

Table 52: Clinical Trials in Russia, Number of Deaths due to Circulatory Diseases (per 100,000 People), Russia, 2004-2009 66

Table 53: Clinical Trials in Russia, Number of Deaths due to Respiratory Diseases (per 100,000 People), Russia, 2004-2009 67

Table 54: Clinical Trials in Russia, Number of Deaths due to Digestive Diseases (per 100,000 People), Russia, 2004-2009 68

Table 55: Clinical Trials in Russia, Number of Deaths due to Infections and Parasitic Diseases (per 100,000 People), Russia, 2004-2009 69

Table 56: Clinical Trials in Russia, Medical Landscape, Number of Hospital Beds and Doctors, Russia, 2006 70

Table 57: Clinical Trials in Russia, Total Number of Physicians (thousand), Russia , 2004-2008 70

Table 58: Clinical Trials in Russia, Number of Hospitals and Hospital Beds (thousand), Russia, 2004-2008 70

Table 59: Clinical Trials in Russia, Recent Resolutions and Orders, Russia, 2010 73

Table 60: Clinical Trials in Russia, Timelines for Clinical Trial Approval (Days), Russia, 2005-2009 74

List of Figures

1.2 List of Figures

Figure 1: Clinical Trials in Russia, Segmentation of Clinical Trials by Study Type, Russia (%), 2005-2010 (Jan –June) 12

Figure 2: Clinical Trials in Russia, Number of Clinical Trials by Study Type, Russia, 2005-2010 (Jan-June) 13

Figure 3: Clinical Trials in Russia, Major Countries Sponsoring Clinical Trials, Russia, 2008-2010 (Jan –June) 14

Figure 4: Clinical Trials in Russia, Clinical Trials Sponsored by Major Countries (%), Russia, 2009 15

Figure 5: Clinical Trials in Russia, Number of Clinical Trials Initiated by Major Companies, Russia, 2009 16

Figure 6: Clinical Trials in Russia, Number of Clinical Trials Initiated by Indication (%), Russia, 2009 17

Figure 7: Clinical Trials in Russia, Number of Clinical Trials by Study Type, Russia, 2005-2010 (Jan-June) 18

Figure 8: Clinical Trials in Russia, Number of Clinical Trials by Study Type (%), Russia, 2010 (Jan-June) 19

Figure 9: Clinical Trials in Russia, Number of Clinical Trials by Study Type (%), Russia, 2009 20

Figure 10: Clinical Trials in Russia, Number of Clinical Trials by Study Type (%), Russia, 2008 21

Figure 11: Clinical Trials in Russia, Number of Clinical Trials by Study Type (%), Russia, 2007 22

Figure 12 Clinical Trials in Russia, Number of Clinical Trials by Study Type (%), Russia, 2006 23

Figure 13: Clinical Trials in Russia, Number of Clinical Trials by Study Type (%), Russia, 2005 24

Figure 14: Clinical Trials in Russia, Number of Clinical Trials by Study Type (%), Russia, 2004 25

Figure 15: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase, Russia, 2005-2010 (Jan-June) 26

Figure 16: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase (%), Russia, 2009 27

Figure 17: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase (%), Russia, 2008 28

Figure 18: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase (%), Russia, 2007 29

Figure 19: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase (%), Russia, 2006 30

Figure 20: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase (%), Russia, 2005 31

Figure 21: Clinical Trials in Russia, Type of Foreign Sponsored Clinical Trials by Phase (%), Russia, 2004 32

Figure 22: Clinical Trials in Russia, Number of International Multicenter Clinical Trials Conducted in Russia, 2004-2009 33

Figure 23: Clinical Trials in Russia, Number of Local Clinical Trials Conducted by Local Sponsors, Russia, 2004-2009 34

Figure 24: Clinical Trials in Russia, Number of Bioequivalence Studies Conducted by Local Sponsors, Russia, 2004-2009 35

Figure 25: Clinical Trials in Russia, Number of Local Clinical Trials Conducted by Foreign Sponsors, Russia, 2004-2009 36

Figure 26: Clinical Trials in Russia, Number of Approved Foreign Sponsored Clinical Trials, Russia, 2004-2010 (Jan-June) 37

Figure 27: Clinical Trials in Russia, Global BLA and NME Approvals vs. R&D Spending, ($bn), 1995-2009 38

Figure 28: Clinical Trials in Russia, Activities of R&D Restructuring, 2010 41

Figure 29: Clinical Trials in Russia, Number of Phase l Clinical Trials Registered, Russia, 2005-2010 44

Figure 30:Clinical Trials in Russia, Number of Phase Il Clinical Trials Registered, Russia, 2005-2010 45

Figure 31: Clinical Trials in Russia, Number of Phase IlI Clinical Trials Registered, Russia, 2005-2010 46

Figure 32: Clinical Trials in Russia, Number of Phase IV Clinical Trials Registered, Russia, 2005-2010 47

Figure 33:Clinical Trials in Russia, Number of Clinical Trials Registered by Phase (%), Russia, 2010 48

Figure 34: Clinical Trials in Russia, CRO Market, Russia, ($m), 2009-2017 49

Figure 35:Clinical Trials in Russia, Number of Patients Recruited for Clinical Trials, Russia, 2004-2008 51

Figure 36: Clinical Trials in Russia, Population, Russia, (million), 2004-2010 55

Figure 37: Clinical Trials in Russia, Population, Russia, (million), 2004-2010 57

Figure 38: Clinical Trials in Russia, Population Forecast for HIV (million), Russia, 2009-2015 60

Figure 39: Clinical Trials in Russia, Population Forecast for Cancer (thousand), Russia, 2009-2015 61

Figure 40: Clinical Trials in Russia, Population Forecast for Diabetes (million), Russia, 2009-2015 62

Figure 41: Clinical Trials in Russia, Forecast for Tuberculosis Incidence per 100,000, Russia, 2009-2015 63

Figure 42:Clinical Trials in Russia, Mortality due to Major Diseases, Russia, 2004-2009 64

Figure 43: Clinical Trials in Russia, Total Number of Deaths per 100,000 People, Russia, 2004-2009 65

Figure 44: Clinical Trials in Russia, Number of Deaths due to Circulatory Diseases (per 100,000 People), Russia, 2004-2009 66

Figure 45: Clinical Trials in Russia, Number of Deaths due to Respiratory Diseases (per 100,000 People), Russia, 2004-2009 67

Figure 46: Clinical Trials in Russia, Number of Deaths due to Digestive Diseases (per 100,000 People), Russia, 2004-2009 68

Figure 47: Clinical Trials in Russia, Number of Deaths due to Infections and Parasitic Diseases (per 100,000 People), Russia, 2004-2009 69

To order this report:

Drug Discovery and Development Industry: Emerging Market for Clinical Trials in Russia - Curbs on New Drug Approval Timelines and Registration Fees Encourage the Emergence of a Major Global Player

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