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.

Report Highlights
GBI Research, the leading business intelligence provider, 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 the Russian clinical trial market structure. Analysis of major companies and countries which sponsor clinical trials in Russia is undertaken. Patient population analysis is carried out to highlight the patient type which is available for conducting clinical trials in Russia.

The opinion of industry experts has been incorporated in various parts of the report to emphasis the importance of various factors which affects the clinical trial market scenario in Russia.

The clinical trial market in Russia is one of the most important parts of the global clinical trial market. Russia has got the population and the prevalence of diseases which cater as a good pool of subjects in the clinical trials scenario. The high quality of the regulations followed in clinical trials in Russia leads to better optimization of clinical trials. The speed of clinical trials conducted in Russia is high mainly because of the high patient recruitment rate. The number of clinical trials conducted in Russia by foreign sponsors has tripled in the last decade. The quality of the clinical trials in Russia has been accepted by regulatory agencies such as the FDA and the EMA. The FDA approved 19 drugs in 2007with the data for six of these drugs coming from Russian sites. It was also observed by FDA inspection that Russia has good quality of investigators leading to low deficiency rate. Russia has caught the imagination of Big Pharma and this has led to huge investment by major pharmaceutical companies. There is improvement in the infrastructure for the conduction of clinical trials 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.

Contract Research Organization (CRO) Market in Russia is set to Grow due to Implementation of New Drug law

The CRO market in Russia is set to increase due to the implementation of a new federal law “On circulation of medicines” (September 2010). According to this law, the registration of a new drug can only be achieved in the country if the international multicenter clinical trial for the drug is also conducted in Russian sites. In addition, the registration of any generic drug in Russia can only be done if the bioequivalence study is also performed in Russia.

Clinical Trials in Russia, CRO Market, Russia, ($m), 2009-2017

Source: GBI Research, Industry Expert Interviews

The value of the CRO market in Russia is forecast to reach $309m by 2017, growing at a Compounded Annual Growth Rate (CAGR) of 9.5% from 2009 to 2017. The increase in the market from 2009 to 2010 was comparatively small because stagnation in the market was observed due to adaptation of the new law. This involved the transfer of responsibility of issuing licenses for conducting clinical trials from “Federal Services on Monitoring Health Care and Social Development" to the "Ministry of Health and Social Development". This will continue in the first few months of 2011 so the increase in the CRO market will not be huge in 2011. However, from 2011 onwards there will be a significant increase in the CRO market in Russia, due to effective implementation of the new law.

Recent Regulatory Changes in Russia Improves the Conduct of Clinical Trials

The Health and Social Development Ministry of Russia implemented new changes into the country’s pharmaceutical market. These changes have improved the legal regulation on the conduction of clinical trials in Russia. The new law (Federal Law No. 61-FZ on circulation of medicines) came into effect from September 01, 2010. 45 of the proposed 300 amendments were approved by the State Duma. The new law makes it essential for foreign drug makers to conduct clinical trials for their new drugs in Russia. If a clinical trial is done on an international basis then it is mandatory to conduct the trial on Russian patients. As per Clause 5 of Article 3 of the new law, a clinical trial which is conducted outside Russia will only be accepted if it is according to the international agreements of the Russian Federation. As per the new law those drugs which are manufactured for exports and those which have been sold in the Russian market for more than two decades are not required to be registered. It has also been made mandatory for all the local manufacturers to meet the Good Manufacturing Practices (GMP) standards from 2014.

Oncology leads the Way as the Major Indication for which Maximum Number of Clinical Trials were Conducted in Russia in 2009

Clinical Trials in Russia, Number of Clinical Trials Initiated by Indication (%), Russia, 2009

Source: GBI Research, Association of Clinical Trials Organizations (ACTO) Russia

The top six therapeutic areas constitute 85% of the total share of clinical trials conducted in Russia. The major therapeutic areas for which clinical trials are conducted in the country are oncology with 22%, followed by endocrine and metabolic diseases, respiratory system, and circulatory system, each with shares of 14%. This clearly indicates that oncology will lead the way for clinical trials conducted in Russia.
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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
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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
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
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