Shrinking Generic Segment Due to Economic Challenges
Russian companies firmly hold the lead, initiating about 75% of all new projects. The foundation of the market remains the bioequivalence studies of local sponsors, which accounted for 50.9% of all issued approvals in 2025. However, this particular segment showed a significant decrease of 8.7% (313 protocols versus 343 a year earlier). Analysts attribute this drop to the general deterioration of the economic situation: rising credit costs, increased expenses, and declining profitability force generic drug manufacturers to be much more careful in selecting their portfolio and reduce investments in new projects.
At the same time, the number of local therapeutic efficacy and safety trials initiated by Russian sponsors increased by 10.9% (to 142 protocols). An important trend here was the rise of biosimilars to the first place: due to the cheaper technologies for reproducing biological drugs, they accounted for 21.8% of all local trials by Russian companies, pushing aside conventional generics (19.0%). Original developments accounted for 20.4%.
MRCTs: The Illusion of Growth and Eastern Expansion
The segment of multinational randomized clinical trials (MRCTs) remains at an all-time low, accounting for only 3.6% of the total market volume. The number of new MRCTs does not exceed 7% of the average figures before 2022. Although formally 22 approvals for MRCTs were issued in 2025 (versus 18 a year earlier), exactly half of them (11 protocols) were initiated by Russian developers themselves, who plan to open centers in neighboring countries (for example, in Belarus or Kazakhstan).
Among foreign sponsors of local trials and bioequivalence checks, a final shift in geographical leaders occurred. Almost half of all approvals (48.1%) now come from pharmaceutical companies from India. Belarus takes second place with a share of 16.3%. The combined share of European countries continued to decline, reaching only 18.6%.
Alarming Trend: Concealing Comparator Drugs
In its report, ACTO sounds the alarm about the widespread unfair practice among generic and biosimilar sponsors. Companies increasingly refuse to specify the reference drug in the titles of comparative trial protocols, using vague phrasing. In 2025, the number of such “secret” protocols reached 158, meaning that in almost every third (31%) new comparative trial, the comparator drug remains unnamed. The Association considers this a marker of industry standards degradation, as companies hide important information from patients and independent experts in the public state register.
Legislative Victory: Paper Consents Remain
Despite the decline in international activity, the industry has to actively defend its interests before regulators. One of the main challenges was the Ministry of Health’s attempt to make the electronic form of informed consent (via the ESIA/Gosuslugi system) uncontested and mandatory. Market participants warned that the mandatory use of electronic digital signatures would paralyze patient enrollment, as not all citizens have access to ESIA and know how to use digital tools. Thanks to extensive discussions and consolidated appeals from leading industry associations (ACTO, ARPM, AMFP, etc.), the State Duma adopted a compromise decision. The Federal Law, signed by the President on December 28, 2025, officially enshrined the equality of traditional paper and electronic forms of informed consent, which saved the industry from serious bureaucratic obstacles.
