In clinical trials, the share of foreign contract research companies fell to 20.5% of the market

Along with the gradual withdrawal of international pharmaceutical holdings from the clinical research market, foreign contract research companies (CROs) also stopped participating in trials. As a result, the share of research conducted with the involvement of such counterparties decreased over two years to 20.5%. At the same time, almost 80% of all trials now involve generics, and these are low-budget and low-profit projects.

In January-November 2023, the share of studies planned with the involvement of a CRO amounted to 20.5%, Kommersant calculated based on data from the clinical trial registry. This is 4.1 percentage points (pp) less than a year ago, and 10.1 pp less than a year ago. less compared to the same period in 2021.

The number of studies involving CROs is not entirely indicative, since not all pharmaceutical companies indicate the organization involved, says Svetlana Zavidova, executive director of the Association of Clinical Research Organizations. Nevertheless, according to her, the dynamics reflect the real picture.

After the outbreak of the Russian-Ukrainian military conflict, the largest international companies, including Pfizer, Novartis, MSD, refused to conduct new clinical trials in Russia. As a result, the share of Russian tests in the total volume increased over the 11 months of 2023 to 79.5% versus 45.5% for the same period in 2021. But if in January-November 2021 the Ministry of Health approved 145 studies involving foreign CROs, then during the same period in 2023 only two permits were issued to the American Agenus and its CRO Atlant Clinical.

International pharmaceutical companies attracted global CROs to the Russian Federation to conduct tests simultaneously in many countries, says IPharma CEO Natalya Rabinovich. Russian pharmaceutical companies, according to her, have never used global CRO, since “it is expensive, not very flexible and irrational.” At the same time, only a few foreign CROs finally left the Russian market: Medpace, Dokumeds and MB Quest (part of Pharm-Olam). The rest are completing the tests they have begun and have taken a wait-and-see approach, says Svetlana Zavidova.

The total number of studies approved in Russia decreased in January-November 2022 by 14% year-on-year, but in 2023 increased again by 1.5%, to 693. At the same time, the share of studies of generics (bioequivalence) increased – to 79% versus 41 .1% for the same period in 2021. Despite the growth of bioequivalence research in absolute numbers, these are usually low-volume and, therefore, relatively low-budget projects, explains Konstantin Zakharov, co-owner of the Eco-Safety research center and owner of Excellen CRO.

In addition, generic companies, he said, usually target the low-cost segment and often try to conduct research without a CRO. Therefore, this market is going through hard times, Mr. Zakharov sums up. Large Russian pharmaceutical companies have their own numerous clinical research departments and rarely attract CROs, adds Natalya Rabinovich. Therefore, competition in the market is growing, she summarizes.

Innovative developments are in short supply on the local market, adds a representative of the Russian contract research organization OST Rus. Russian CROs previously conducted research for small foreign biotech companies, but they also do not work in Russia now, fearing sanctions, Ms. Rabinovich points out.

But, according to her, in 2023, IFarma began to conduct more third-phase studies compared to 2022, which are necessary for the development of new drugs and new indications for old drugs. OST Rus says that it will be difficult to completely replace the departed companies, but players from China, India and Iran may be able to compete. As follows from the profile registry, in January-November 2022, 32 studies involving companies from these countries were approved, a year later – 55.

Polina Gritsenko