[Industry Voice #11] Stayble Therapeutics…
OCT Сlinical reports on the progress…
The Asian biotech industry has been experiencing an ever-increasing boom for several years now. Pharmaceutical companies have been receiving substantial influx of funds both in the form of Foreign Direct Investment and governmental financing programs. China, for instance, being one of the largest pharma economies in the world, with a 6.4% growth rate, is expected to reach the USD 573.5 billion mark in 2022. In the meantime, according to the president of South Korea, Moon Jae-in’s roadmap, the country’s share of the world pharmaceutical market will reach 6% by 2030, not without the help of the government, which has allotted a total of USD 2.5 billion to biotech last year according to the OECD.
Given the continuous growth, Asian pharma and biotech companies have started looking for more clinical services options, including new destinations for running multiple clinical trials and obtaining market authorization. According to the state registry of the Ministry of Health of Russia, during the past 5 to 6 years a certain trend has started showing, with a growing number clinical studies by Asian sponsors in Russia.
According to the Russian Ministry of Health's Registry of Approved Clinical Trials, every year, more than 10% of clinical research projects initiated by non-local international sponsors in Russia are accounted for by Asian companies. Moreover, during the period from 2016 to 2019, more than 250 studies were conducted by Asian sponsors in the region. The overall attractiveness of the area in terms of clinical trial services to international sponsors is confirmed by global statistics as well, with Russia entering the top 10 countries of clinical trials performed in 2018 (sources: ISR Research, Russian Ministry of Health Registry of Approved Clinical Trials). In addition to that, according to FDA and EMA reports, clinical trials of 14 out of 158 FDA and 48 out of 78 EMA new drugs were conducted at Russian sites.
FDA regularly performs inspections of clinical sites to determine their compliance with applicable regulations and laws. Publicly available statistics of FDA inspections results helps biotech and pharmaceutical companies choose the best options for placing their future clinical studies. As shown in the table below, during the last 10 years Russia has had the highest NAI rate and has been the only country with no OAI (Official Action Indicated; 0%).
According to FDA, Russia comes second after the US in terms of the number of subjects recruited for studies. Through its case log, OCT Clinical, one of the leading CROs in Eastern Europe, demonstrates that enrollment rates in Russia are on average 1.5 times higher than those of the rest of the world.
New Market Potential
While patients’ availability, and impressive recruitment rates have become one of the trademarks of the Russian clinical research landscape, Asian sponsors have also been closely looking into the fully-fledged marketing opportunities in Russia.
As of now, OCT Clinical’s track record has by far the largest number of studies conducted for Asian sponsors among Russia based CROs, with such companies in its portfolio as SENJU Pharmaceutical (Japan) and Dr. Reddy’s Laboratories (India).
“One of the attractions of product development in Russia is that we can carry out high-quality and efficient clinical development, taking European business into consideration, in a market where significant growth can be expected,” says Shigeru Koshimitsu, Head of Overseas Business Division, SENJU Pharmaceutical CO., LTD.
Dmitry Sharov, the president of OCT Clinical, commented on the trend: “In our experience, in addition to the vast pool of patients and record-setting enrollment rates, Asian pharma are looking at the region as a promising marketplace. That explains their interest in market authorization solutions within clinical research services".
Growing demand for market authorization services is further supported by the establishment of the Eurasian Economic Union (EAEU) signed in May 2017, with Russia as one of the member states. Within the Union, which has a unified set of regulatory and economic standards and rules, a drug registered in one of the member states can obtain market authorization through a simplified procedure within the rest of the countries of the Union. This development undoubtedly adds to the appeal of the region among Asian pharma and biotech companies looking for expansion and further growth opportunities.