The growth of Russia’s clinical research market in the past five years has been impressive. Nearly double the number of clinical trials were approved in 2006 as were in 2000, and the number of patients participating in global clinical trials conducted in Russia more than tripled between 2002 and 2006. In addition, between 2001 and 2006, Form FDA 1572s were filed by more than three times the number of investigators in Russia.
The most distinguishing factor propelling Russia’s growth - attracting pharmaceutical and biotech companies and contract research organizations (CROs) from around the world - is the solid reputation for clinical research the country has built up over the past decade. Drugs developed with data coming from studies conducted in Russia have begun to be approved by the U.S. Food and Drug Administration and the European Medicines Agency—the most important quality marker an emerging market in clinical research could attain...
Another difference between Russia and some other emerging clinical research markets is that pharmaceutical companies have begun to regard Russia as a possible future market for their drugs.
Russia has all the typical hallmarks of an important emerging clinical research market. The country boasts a population of 143 million, made up of mostly treatment-naïve patients; a centralized healthcare system comprising very large hospitals, each specializing in one therapeutic area; a regulatory system that has become increasingly transparent and streamlined; a pool of physicians eager to conduct clinical research; and potential for sustained future growth.
The size of the labor pool and some logistical issues related to import/export processes are the only real checks on the growth of the Russian clinical trials market. But the checks on the growth of western markets, in addition to competition for labor, include much longer patient enrollment timelines.
In recent site surveys conducted by Thomson CenterWatch, 43% of European sites and 45% of U.S. sites responded that patient recruitment and enrollment most often caused delays. A faster time to market and data quality are the main reasons pharmaceutical and biotech companies and CROs choose to conduct research in emerging countries. The more difficult patient enrollment becomes in the West; the stronger growth may be in the East.
In terms of future growth of Russia’s clinical research market, most see a push into Russia’s 15 cities of one million-plus inhabitants as the next logical step. Most companies already work in some of these cities and some already have an office or plan to have one in Novosibirsk, Siberia, a popular location for a third office after Moscow and St. Petersburg. Fully 73% of Russia’s population lives in an urban area, versus 29% in India and 41% in China, according to UNICEF 2005 figures.
Despite some challenges, Russia’s clinical research market has plenty of potential to grow.