Growth in new drug research has slowed sharply

As an analysis by Kommersant showed, over the three quarters of 2023, Russian pharmaceutical manufacturers received 12% more approvals for clinical trials of new drugs year on year. In 2022, the growth was three times higher, with the vast majority of research now being on generics. The decrease in activity of local companies occurs against the backdrop of a significant reduction in testing by international players, who froze investments in Russia after the outbreak of the military conflict in Ukraine. Companies from friendly countries, experts emphasize, are also in no hurry to introduce their drugs to the Russian market.

In January-September 2023, the Russian Ministry of Health issued 431 permits to conduct clinical trials (CTs) of drugs, which is 12% more year-on-year, Kommersant calculated based on data from a specialized registry maintained by the ministry. This is noticeably lower than the figures for the first nine months of 2022, when the number of CIs increased by 37.5% year-on-year.

Activity in new clinical trials is decreasing, confirms the general director of the Association of Russian Pharmaceutical Manufacturers, Viktor Dmitriev. According to him, companies are now engaged, among other things, in registering and bringing to market drugs that have already undergone research.

Since the beginning of 2023, the most requests for clinical trials have come from Russian pharmaceutical companies: this mainly happened in the third quarter, when 153 approvals were issued, an increase of 24.4% year-on-year. As experts interviewed by Kommersant clarify, the dynamics are associated with the extremely low base of July-September 2022, when the total number of issued permits fell by half. If we compare the figures for the third quarter with the pre-crisis 2021, the growth was only 9.2%.

The slowdown in clinical trials was influenced by the trend towards a reduction in the presence of foreign pharmaceutical companies in the Russian market, which began in 2022. Thus, Novartis, MSD, Pfizer announced the suspension of new trials in Russia since the beginning of the military conflict between the Russian Federation and Ukraine in February 2022 (see Kommersant on January 31). In the first six months, the Ministry of Health issued only seven research permits to foreign companies (see Kommersant, August 4). In the third quarter, Western pharmaceutical manufacturers received two more permits compared to 122 in July-September 2022, according to the Ministry of Health’s clinical trials registry data.

RNC Pharma Development Director Nikolay Bespalov emphasizes that for most of the drugs “that Russian companies are technically and organizationally capable of producing,” research was launched last year.

At the same time, most local manufacturers, according to Svetlana Zavidova, executive director of the Association of Clinical Research Organizations, are focused on bringing generics to the market. According to Kommersant’s calculations, over the three quarters of this year, the share of CIs of such funds reached 80% compared to 67.3% a year earlier.

Companies from friendly countries are also testing generics in Russia. Thus, since April, the Turkish Ilko Pharmaceuticals, which is not yet represented in Russia, received seven approvals for clinical trials of its analogues. The research of two of its generics in the Russian Federation was approved by the Iranian AryoGen, which so far supplies only one drug to the country – eptacog alfa for patients with hemophilia. In the third quarter, a number of Indian pharmaceutical companies received approvals for 23 studies, compared with just six a year ago.

Last year it became clear that players from friendly countries would begin to become more active, but for now they are “only looking closely and testing the possibilities and formats of work in Russia,” says Nikolai Bespalov. He expects demand from such companies to increase.

However, the chief researcher of the Umedi network, Alexander Vasilyev, does not yet see “special interest from pharmaceutical manufacturers from friendly countries.” According to him, negotiations took place with players from India, but things have not yet come to real projects.

Polina Gritsenko