Innovations wait for no one: barriers and drivers of pharmaceutical industry growth discussed at the “Healthy Society” forum

The Russian pharmaceutical industry is striving to move from import substitution to technological leadership. In 2025, marketing authorizations were granted for medications covering 88 of the 186 international nonproprietary names (INNs) scheduled for domestic manufacturing by 2030. However, the path from drug authorization to real patient access can take at least five years, participants of the "Healthy Society" forum noted. Experts believe that a regulatory fast-track for locally produced medicines could accelerate the introduction of innovations into clinical practice and ensure the return on investment for Russian pharmaceutical companies.

In recent years, the pharmaceutical industry has faced significant challenges—from the COVID-19 pandemic to new geopolitical pressures. This has required the development of a comprehensive drug security system, within which scientific, manufacturing, regulatory, and logistical approaches are continuously evolving.

According to the national project "New Health-Saving Technologies", local production of 186 INNs should be established in Russia by 2030. As of 2025, 294 marketing authorizations have already been issued for 88 INNs, reported Ekaterina Priezzheva, Deputy Minister of Industry and Trade of the Russian Federation.

Product availability is one of the components necessary to ensure reliable drug supply, alongside physical access and affordability, emphasized Sergey Glagolev, Deputy Minister of Health of the Russian Federation.

Localization of innovative medicines by Russian pharmaceutical manufacturers contributes to lower drug prices. However, the formation of an affordable price depends not only on the manufacturer.

Experts noted that one of the key barriers to innovative development in the sector remains the long timelines for integrating new medicines into clinical guidelines, diagnosis-related groups (DRGs), and state programs. Currently, it takes three to four years for medicines to be included in clinical guidelines and up to five years to be incorporated into DRG reimbursement systems. These regulatory barriers, which previously helped protect the healthcare budget from costly therapies, are now slowing the development of the domestic pharmaceutical market.

For example, Petrovax Pharm has invested over RUB 3 billion in a project to localize the production of a meningococcal vaccine, with full-cycle manufacturing expected to launch this year. Under the Immunoprophylaxis Development Strategy until 2035, the meningococcal vaccine was expected to be included in the National Immunization Schedule of the Russian Federation in 2025, but the timeline continues to shift.

The expert emphasized the need to develop a regulatory framework that accelerates market entry for innovations while supporting industry growth. This barrier could be overcome through the introduction of fast-track procedures for domestic medicines, for example, in oncology. Such measures could become a powerful driver for local innovation, complementing existing state support for the development of domestic pharmaceuticals.

Participants of the discussion agreed that Russia’s pharmaceutical supply system has demonstrated steady development in recent years, but it requires further transformation and a shift toward faster and more flexible regulatory mechanisms capable of ensuring the timely introduction of innovative therapies.