Clinical trials in CIS countries 2012 - Russia, Ukraine, Belarus and Georgia

The report analyses the conditions for conducting clinical trials. It presents key facts regarding the market’s size (number of clinical trials, value of the market) and condition. It provides data on: key trends and circumstances affecting the sector, present-day market size with forecasts for 2012-2014. It reveals the following information:

• the current and anticipated situation on the market

• market growth opportunities and obstacles

• the average registration time for clinical trials

• main characteristics and market standing of major companies conducting clinical trials.

The report also includes a comparative analysis of conditions governing the performance of clinical trials in the CIS countries analysed.
The operations of major pharmaceutical corporations active in CIS are then presented, with special attention given to number of trials, location, and therapeutic areas.

Key issues:

• value of the clinical trials market CIS, with forecasts for 2012-2014. It includes major trends and circumstances that have affected the development of the sector in the last couple of years
• the number of the clinical trials in the CIS market, with forecasts for 2012-2014
• the current situation on the market, opportunities for and obstacles to its further development
• the average registration time for clinical trials in Poland
• comparative analysis of conditions under which clinical trials are conducted in CIS
• legal aspects of the sector, providing information on the upcoming legislative modifications regarding clinical trials
• largest CROs active in the region as well as sponsors (profiles).

Discover

• Which country should be chosen to conduct a clinical trial and which should be avoided?
• What are the conditions, pros and cons of conducting clinical trials in Russia, Ukraine, Belarus and Georgia?
• Which are the largest sponsors in the region, what kind of drugs are they currently investigating and which phases of clinical trials do they conduct?
• What are the largest CROs in the region?
• In which countries are delays expected during the registration of a clinical trial?
• What is the average time to register a clinical trial in particular countries?
• What are the most important legal regulations?

Report strengths:

• complex and unique analysis of the countries
• profiles of the largest players
• unique forecast for the number of clinical trials/market value
• there is no such publication on the market.

This report is addressed to:

• clinical trials management team
• foreign firms investing in clinical trials
• consulting, research and analytical firms
• government institutions, embassies
• chambers of commerce, professional organisations
• universities, scientific institutes
• financial institutions (banks, brokerage firms, investment funds).

The key companies studied in this report are:

Bayer, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Johnson&Johnson, Eli Lilly, Novartis, Pfizer, Roche, GlaxoSmithKline, Quintiles, Covance, Parexel, ICON, PPD, PRA International, INC Research, Clinstar, CroMos Pharma, Biomaps, AmberCRO, Russlan, Almedis, OCT, Synergy Research Group, AmeRuss, MB Quest, Axis Group, Maxima Health Research, Belnico.

Extract from this report

• Ukraine reports more stable development (with the exception of the 2009 crisis year). The country shows considerable promise, and experts and market players are optimistic about the future. Although the law is not uncomplicated, there are no particularly controversial points in existing regulations regarding clinical trials. The greatest obstacles to the development of clinical trials, not only in Ukraine, but also in Belarus and Russia, include difficulties associated with the import and export of the materials necessary for clinical trials. Formalities on the border require additional time and effort, and this can discourage potential investors, according to companies questioned by PMR.
• Among the CIS countries analysed, Georgia has a marginal share as a proportion of the overall market, mainly due to its geographical features. It is one of many countries with considerable untapped potential. It has, however, a strong position in comparison with Kazakhstan, Uzbekistan, Armenia, Tajikistan and Kyrgyzstan.

Market commentary by expert

Nowadays, it is more and more difficult to find treatment-naïve patients who would be willing to participate in clinical studies. CIS countries, due to their large populations as well as less developed healthcare systems represent a present opportunity for pharmaceutical companies to recruit fast study participants. The markets are also quite difficult due to unclear legislation and a specific business climate. Our report will help companies wanting to start studies in the region, as well as those already operating on the market, to plan strategies. For this comparative analysis we have chosen four countries where the largest number of clinical trials are conducted – Russia, Ukraine, Belarus and Georgia.

Monika Stefańczyk, Head Pharmaceutical market Analyst

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1. Report methodology p. 9

2. Executive summary p. 15

3. Size of the clinical trial market in the CIS between 2004 and 2014 p. 19

   • Main trends and events in clinical trials, 2010-2014 p. 19
     • Russia p. 19
     • Ukraine p. 21
     • Belarus p. 22
     • Georgia p. 23
   • Value of the CIS clinical trials market between 2004 and 2014 p. 24
     • Number of clinical trials conducted in the CIS, 2006-2014 p. 25
     • Number of clinical trials conducted in Russia, 2004-2014 p. 26
     • Number of clinical trials conducted in Ukraine, 2004-2014 p. 30
     • Number of clinical trials conducted in Belarus, 2006-2014 p. 32
     • Number of clinical trials conducted in Georgia, 2006-2014 p. 34

4. Comparative analysis of clinical research environments in the selected CIS countries p. 35

   • Legislation p. 35
   • Ethics committees p. 37
   • Registration of clinical trials p. 38
   • Number of conducted clinical trials p. 38
   • Number of clinical sites p. 40
   • Patient recruitment p. 41
   • Quality p. 42
     • CRF quality p. 42
     • FDA inspections of clinical trials p. 43
   • Cost of clinical trials p. 46
   • Selected CROs present on the market p. 46
   • Corruption p. 47
   • General comparison p. 48

5. Analysis of clinical trials conducted by international concerns p. 49

   • GlaxoSmithKline p. 50
   • Roche p. 52
   • Pfizer p. 54
   • Novartis p. 57
   • Eli Lilly p. 60
   • Johnson & Johnson p. 62
   • Boehringer Ingelheim p. 64
   • Bristol-Myers Squibb p. 66
   • AstraZeneca p. 68
   • Bayer p. 70

6. Profiles of selected CROs operating on the CIS market p. 73

   • International CROs p. 73
     • Quintiles p. 73
     • Covance p. 74
     • Parexel p. 74
     • ICON p. 75
     • PPD p. 76
     • PRA International p. 76
     • INC Research p. 77
     • ClinStar p. 77
     • Cromos Pharma p. 78
     • Biomaps p. 78
     • AmberCRO p. 78
     • Russlan p. 79
   • Local CROs p. 79
     • Almedis p. 79
     • OCT p. 80
     • Synergy Research Group p. 80
     • AmeRuss p. 82
     • MB Quest p. 82
     • Axis Group p. 82
     • Maxima Health Research p. 83
     • Belnico p. 84

7. Assessment of the CIS as a location for clinical trials p. 85

   • Demographic trends p. 85
   • Medical personnel p. 89
   • Healthcare establishments p. 93
     • Number of hospitals p. 93
     • Number of beds p. 93
     • Average stay in hospital p. 94
   • Epidemiological trends p. 94

8. Legislative environment in the CIS countries p. 97

   • Russia p. 97
     • Key legislation and institutions which regulate clinical research p. 97
       • Obtaining a clinical trial licence p. 98
       • Applying to commence clinical trials p. 98
       • Charges for filing applications for clinical trial registration p. 99
       • Duration of application procedure p. 99
       • Refusal to issue a licence p. 100
     • Issuing opinions on clinical trials p. 100
       • Applications to the ethics committee p. 100
       • Expert opinions p. 101
     • Allocation of costs in clinical trials p. 101
     • VAT on medicines in clinical trials p. 101
     • Insuring clinical trials p. 101
     • Liability in clinical trials p. 102
     • Personal data protection in clinical trials p. 102
     • Data exclusivity p. 102
     • Customs formalities on the border p. 102
   • Ukraine p. 103
     • Key legislation and institutions which regulate clinical research p. 103
     • Obtaining a clinical trial licence p. 104
       • Applying to commence clinical trials p. 104
       • Charges for filing applications for clinical trial registration p. 104
       • Time taken to process application p. 105
     • Issuing opinions on clinical trials p. 105
       • Applications to the ethics committee p. 105
       • Expert opinions p. 106
     • Insuring clinical trials p. 106
     • Allocation of costs in clinical trials p. 106
     • Personal data protection in clinical trials p. 106
     • Customs formalities on the border p. 107
     • Data exclusivity p. 107
   • Belarus p. 108
     • Key legislation and institutions which regulate clinical research p. 108
     • Obtaining a clinical trial licence p. 109
       • Applying to commence clinical trials p. 109
       • Charges for filing applications for clinical trial registration p. 109
       • Time taken to process application p. 109
       • Refusal to issue approval p. 109
     • Issuing opinions on clinical trials p. 110
       • Applications to the ethics committee p. 110
       • Expert opinions p. 110
     • VAT on clinical trials p. 110
     • Insuring clinical trials p. 110
   • Georgia p. 111
     • Key legislation and institutions which regulate clinical research p. 111
     • Obtaining a clinical trial licence p. 111
       • Applying to commence clinical trials p. 111
       • Duration of application processing p. 111
     • Issuing opinions on clinical trials p. 112
       • Applications to the ethics committee p. 112
       • Expert opinions p. 112

9. List of graphs p. 113

10. List of tables p. 117

11. About PMR p. 119

12. Contact PMR p. 120

List of graphs

1. Estimated total value (€ m) of clinical trial market in the CIS countries analysed and change, 2010-2014      16
2. Number of new clinical trials registered in the CIS countries analysed and change, 2006-2014      17
3. Number of open clinical trials in the CIS countries analysed, December 2011      23
4. Estimated share of individual CIS countries in the total market value of the clinical trials market in the CIS countries analysed, 2011      24
5. Estimated total value (€ m) of clinical trials market in the CIS countries analysed and change, 2010-2014      25
6. Estimated value (€ m) of clinical trials market in Russia and change, 2004-2014      25
7. Number of new clinical trials registered in the CIS countries analysed and change, 2006-2014      26
8. Number of new clinical trials registered in Russia and change, Q3 2009-Q3 2011      27
9. Number of new clinical trials registered in Russia and change, 2004-2014      28
10. Number of new multicentre clinical trials registered in Russia and change, 2004-2014      28
11. Breakdown of clinical trials in Russia, 2004 – Q1-Q3 2011      29
12. CTs funded by foreign sponsors in Russia, by phase, 2010      29
13. Number of new clinical trials registered in Ukraine and change, 2004-2014      30
14. Number of new multicentre clinical trials registered in Ukraine and change, 2004-2014      31
15. Breakdown of international multicentre clinical trials in Ukraine, by phase, 2004-2010      31
16. Breakdown of international multicentre clinical trials in Ukraine, by therapeutic category, 2004-2010      32
17. Number of new clinical trials in Belarus and change, 2004-2014      33
18. Breakdown of open studies in Belarus, by phase, December 2011      33
19. Number of new clinical trials in Georgia and change, 2006-2014      34
20. Breakdown of open studies in Georgia, by phase, December 2011      34
21. Number of clinical trials in the selected CIS countries, December 2011      39
22. Number of clinical trials carried out in Russia and Ukraine, 1991-2011      40
23. Number of clinical investigator inspections provided in Russia, 1995-2011      43
24. Results of inspections of clinical trials conducted by the FDA in Russia, 1995-2011      43
25. Violations of Good Clinical Practice indicated in Russia, 1995-2011      44
26. Number of clinical investigator inspections carried out in Ukraine, 1996-2011      44
27. Results of inspections of clinical trials carried out by the FDA in Ukraine, 1996-2011      45
28. Violations of Good Clinical Practice indicated in Ukraine, 1996-2011      45
29. Relative cost of conducting clinical research in Russia in comparison with selected other countries, 2008      46
30. Corruption Perception Index in the CIS countries analysed, 1997-2011      48
31. Leading sponsors of clinical trials in the selected CIS countries (number of trials), December 2011       49
32. Breakdown of GlaxoSmithKline clinical trials in the CIS countries analysed, December 2011      50
33. Breakdown of GlaxoSmithKline clinical trials in the CIS countries analysed, by phase, December 2011      51
34. Breakdown of GlaxoSmithKline clinical trials in the CIS countries analysed, by therapeutic category, December 2011      51
35. Breakdown of Roche clinical trials in the CIS countries analysed, December 2011      52
36. Breakdown of Roche clinical trials in the CIS countries analysed, by phase, December 2011      53
37. Breakdown of Roche clinical trials in the CIS countries analysed, by therapeutic category, December 2011      54
38. Breakdown of Pfizer clinical trials in the CIS countries analysed, December 2011      54
39. Breakdown of Pfizer clinical trials in the CIS countries analysed, by phase, December 2011      55
40. Breakdown of Pfizer clinical trials in the CIS countries analysed, by therapeutic area, December 2011      56
41. Breakdown of Novartis clinical trials in the CIS countries analysed, December 2011      57
42. Breakdown of Novartis clinical trials in the CIS countries analysed, by phase, December 2011      58
43. Breakdown of Novartis clinical trials in the CIS countries analysed, by therapeutic category, December 2011      59
44. Breakdown of Eli Lilly clinical trials in the CIS countries analysed, December 2011      60
45. Breakdown of Eli Lilly clinical trials in the CIS countries analysed, by phase, December 2011      60
46. Breakdown of Eli Lilly clinical trials in the CIS countries analysed, by therapeutic category, December 2011      61
47. Breakdown of Johnson & Johnson clinical trials in the CIS countries analysed, December 2011      62
48. Breakdown of Johnson & Johnson clinical trials in the CIS countries analysed, by phase, December 2011      63
49. Breakdown of Johnson & Johnson Pharmaceutical R&D clinical trials in the CIS countries analysed, by therapeutic category, December 2011      63
50. Breakdown of Boehringer Ingelheim clinical trials in the CIS countries analysed, December 2011      64
51. Breakdown of Boehringer Ingelheim clinical trials in the CIS countries analysed, by phase, December 2011      65
52. Breakdown of Boehringer Ingelheim clinical trials in the CIS countries analysed, by therapeutic category, December 2011      65
53. Breakdown of Bristol-Myers Squibb clinical trials in the CIS countries analysed, December 2011      66
54. Breakdown of Bristol-Myers Squibb clinical trials in the CIS countries analysed, by phase, December 2011       67
55. Breakdown of Bristol Myers Squibb clinical trials in the CIS countries analysed, by therapeutic category, December 2011       67
56. Breakdown of AstraZeneca clinical trials in the CIS countries analysed, by therapeutic category, December 2011      68
57. Breakdown of AstraZeneca clinical trials in the CIS countries analysed, by phase, December 2011      69
58. Breakdown of AstraZeneca clinical trials in the CIS countries analysed, by therapeutic category, December 2011      69
59. Number of Bayer clinical trials in the CIS countries analysed, December 2011      70
60. Breakdown of Bayer clinical trials in the CIS countries analysed, by phase, December 2011      70
61. Breakdown of Bayer clinical trials in the CIS countries analysed, December 2011      71
62. Covance net revenue ($ m) and change, 2006-2010      74
63. Parexel service revenues by market area ($ m), 2008-2010       75
64. ICON gross revenue ($ m) and change, 2006-2010      76
65. Experience of SynRG in clinical trials, by phase, until 2011      81
66. Experience of SynRG in clinical research, by area of medicine, until 2011      81
67. Population in Russia (million), 2010-2035       87
68. Population in Georgia (million), 2010-2035      87
69. Population in Belarus (million), 2010-2035      88
70. Population in Ukraine (million), 2010-2035      88
71. Number of people per doctor in the CIS countries analysed, by specialisation, 2010      90
72. Number of oncologists in Ukraine and Belarus, 2010      91
73. Number of people per every oncologist in Ukraine and Belarus (’000), 2010      92
74. Average duration of application process for clinical trials in Russia (calendar days) and change, 2005-H1 2011      100
75. Average time required to issue approval for bringing unregistered medicines into Russia (calendar days) and change, 2005-H1 2011      103

List of tables

1. Number and growth rate of clinical trials in Russia, H1 2010-H1 2011      27
2. Key legal instruments regulating the conduct of clinical trials in the CIS countries analysed, 2011      36
3. Rules pertaining to ethics committees in the CIS countries analysed, 2010      37
4. Registration of clinical trials in the CIS countries analysed, 2011      38
5. Number of clinical trials conducted in the CIS countries analysed, 2011      39
6. Number of clinical trial sites and density in Russia and Ukraine in comparison with selected other countries, 2008      40
7. Patient recruitment per site in a renal carcinoma study in Russia and Ukraine in comparison with selected other countries, 2007      41
8. Patient recruitment per site in a heart failure study in Russia and Ukraine in comparison with selected other countries, 2007      41
9. CRF quality per site in a renal carcinoma study in Russia and Ukraine in comparison with selected other countries, 2007      42
10. CRF quality per site in a heart failure study in Russia and Ukraine in comparison with selected other countries, 2007      42
11. Selected CROs operating on the clinical trial market in the selected CIS countries, 2011      47
12. Conducting clinical trials in Russia and Ukraine in comparison with Romania and Bulgaria, 2009      48
13. Axis Group clinical trials, December 2011      83
14. Populations in the CIS countries analysed (‘000), 2005-2011      85
15. Life expectancy at birth in the CIS countries analysed (years), 2000-2010      86
16. Number of specialist doctors in the CIS countries analysed, by specialisation, 2010      89
17. Medical staff at oncological medical facilities in Russia, 2005, 2009, 2010      91
18. Number of medical personnel in the CIS countries analysed, by basic specialisations, 2010      92
19. Number of hospitals in the CIS countries analysed (‘000), 1995-2010      93
20. Number of hospital beds in the CIS countries analysed (‘000), 1995-2010      93
21. Average length of hospital stay in the CIS countries analysed (number of days), 2000-2010      94
22. Number of newly registered diseases per 100,000 people in the CIS countries analysed, 2010      94
23. Deaths per 100,000 people in the CIS countries analysed, by cause, 2008      95
24. Duration of and delays in application processing for clinical trials in Russia, H1 2011      99
25. Documents required by State Expert Centre for approval of a clinical trial in Ukraine, 2011      104
26. Fees for expert opinions on clinical trials in Ukraine, 2011      105
27. Documents required by Central Ethics Committee for the approval of a clinical trial in Ukraine, 2011      105