General stat numbers for 2015 in the field of clinical trials in Russia are as follows:
Ministry of Health issued 804 permits for clinical trials – a total of 7,2% more than in 2014 – 289 of which were issued for international multicenter clinical trials.
The number of studies grew in almost every type of research:
- Bioequivalence studies of Russian generics grew 8,5% (from 141 in 2014 to 153 in 2015);
- The number of bioequivalence medical research initiated by international sponsors grew 16,3% (from 123 to 143);
- Studies initiated by local sponsors grew 17,6% (from 142 to 167).
Local studies of international sponsors are the only type of clinical trials in Russia that shows 16,1% decrease in the number of issued permits – from 62 in 2014 to 52 in 2015.
Dynamics of market structure
In execution of the 2012 Drug Distribution law, the number of bioequivalence studies of international sponsors grew dramatically – from the prior-to-law 1,8% to 17,8% in 2015. The new Drug Distribution law requires local studies in Russian CROs in order for the drug to be registered in Russia.
This brought to significant decrease in the number of international multicenter clinical trials (IMCT) – from 60% to 35,9%. Their distribution across the country by the number of issued permits for conducting IMCT is as follows:
- Saint Petersburg (254 researches)
- Moscow (231)
- The Republic of Tatarstan (102).
When it comes to participation in IMCT of these territorial entities per 1 million of population, the picture is quite different:
- Yaroslavl Oblast (region) 54.3 IMCT per 1 million of population
- Saint Petersburg – 48.9
- Smolensk Oblast (region) – 46.6
Moscow in only the 16th in this rating with its 18.9 IMCT per 1 million of population.
Market structure according to therapeutic area
Almost a third (32,3%) of permits for international multicenter trials in 2015 were issued for oncology drugs. The greatest number of medical research among generics and biosimilars was done for infectious disease medications – 22,1% in the studies of international sponsors and 19,7% – in studies of the local ones.
Permit issue terms
The average term for obtaining a permit from federal authority to conduct a clinical study was 98 days in 2015 and 95 – in 2014.
Issue of permits took on average:
- 13 days to import a medication
- 19 days to import biological samples.
Share of Russian CRO on the market of clinical studies
The highest percentage (50,5%) of medical research contracts implemented by local CROs was conducted for international multicenter clinical trials.
The percentage of local studies for international sponsors conducted by CROs grew from 23% of 2014 to 31% in 2015. The same is true also for bioequivalence studies for local pharma companies – from 7% in 2014 to 16% in 2015.
Small growth – from 16% to 18% – was seen in bioequivalence studies of generics manufactured by foreign pharma companies.
And local studies of Russian sponsors showed decrease in percentage – from 18% in 2014 to 15% in 2015.
Overall, the share of clinical trials conducted in Russia by local CROs was 29% (the same as in 2014), with 3% share of the so-called other representatives that only organize but don’t conduct clinical studies of their own. These representatives are involved in introduction, distribution and marketing of foreign drugs on the local market for those pharma companies that don’t have their representatives in Russia.
There is also another small category of «other sponsors» on the Russian market of clinical study – Research Institutes, educational institutions and an NGO – which conduct clinical trials of their own medications.