Clinical trials market in Russia
It has been over 15 years currently that Russia takes part in the international clinical trials sponsored by the largest pharmaceutical companies. This implies a chance to rapidly market the new drugs that increases the treatment quality.
Participating of the domestic doctors in the international clinical trials allows gaining valuable experience from foreign colleagues, or get acquainted with innovative pharmaceuticals developments. Such relations are especially important for Russia, since our country still lags behind in the number of the trials conducted.
Russian clinical trials market peculiarities
Currently, in Russia there have benn issued over 550 clinical trials’ approvals, most of the studies approved are international (over 60%); whereas 1/5 of all the studies approved are local studies of the domestic companies.
Over 40% of bioequivalence studies are performed by the domestic manufacturers, whereas only 2% by the foreign ones. Since 2009 in Russia, numbers of clinical trials approvals demonstrate constant decrease.
However, clinical trials’ market in Russia is of a great potential due to large population of the country. As compared to China and other developed countries, here in Russia we have <42% and <80% clinical trials’ approvals, accordingly.
Russian market analysis shows one more acute problem, i.e., lack of pediatric drugs. Due to this, doctors have to prescribe the drugs for unapproved use. Roszdravnadzor issued over 40 approvals for pediatric studies.
Examples of companies who conduct clinical trials in Russia
- Smooth Drag Development – the company fully complies with the international quality standards and affordable cost attracting foreign investors.
- IPHARMA – launched in 2012, the company has a vast experience in clinical trials on hepatitis C, schizophrenia, ovarian cancer, diabetes, etc.
- OCT – founded in 2005 by the experienced team; the company got the profitable orders from the USA and European countries.
Russian clinical trials’ market demonstrates increased demand in the neurology, oncology and rheumatology studies. As compared to 2016 and 2017, there was also noted increased interest to cardiology, hematology and cardiovascular studies; at the same time, a slashed demand revealed regarding the studies in HIV, HCV and psychiatry.
Also in 2019, Russian government made subsidiaries to orphan drugs manufacturers (these drugs are used for the rare diseases treatment).