The average increase in value is expected to reach 14% and the average increase in volume approximately 13% between 2012 and 2014, according to the latest PMR report “Clinical trials in CIS countries 2012 – Russia, Ukraine, Belarus and Georgia. Development forecasts for 2012-2014”. Despite some turmoil in legislation, these countries will attract investors because of their relatively low costs and the substantial numbers of people willing to participate in clinical trials.
Russia accounts for over 60% of market value
According to our estimates, the overall clinical trial market value of the CIS countries analysed exceeded $532m (€403m) in 2010 and reached $633 (€479m) in 2011 (a 19% year-on-year increase). The largest proportion of this value was accounted for by Russia – 63%, whereas the figure for Ukraine was 33% in 2011.
Political and legal situation crucial for development of clinical trials
“The rate of change of development over the next few years depends on many factors, and those of a political nature in particular. If there are no unexpected events, the market is expected to be worth more than $940m (€712m) in 2014.” Monika Stefanczyk. Head Pharmaceutical Market Analyst estimated. Market players canvassed by PMR observed that the situation pertaining to clinical trials in Russia could change after the parliamentary election due on March 2012. We expect an increase in the market growth rate if appropriate changes in current legislation (making the clinical trial approval process less complicated and time-consuming) are implemented. For the time being, the market in Russia could also accelerate because of new regulations which require conducting more clinical trials and Pharma 2020 plan.
The political situation in Belarus is not expected to change in the near future, and the country’s political isolation from the EU and US will, therefore, continue to hinder the development of clinical trials in this country.
In Ukraine, which has been recently relatively stable politically, it is important to retain this stability in order to continue to develop clinical trials.
It is worthy of note that all of the countries analysed need to compete with other emerging countries. As they are not EU members and are not in the Schengen zone, only a small percentage of their considerable potential has been used. For example, Ukraine uses only 10-15% of its potential, according to European Business Association data. The relatively modest value of these markets and their vast potential are the reasons of the predicted rate of development of Ukraine and Georgia of at least 10-20% over the next three years.
Increase of approximately 13% per annum in number of clinical trials between 2011 and 2014
There was a reduction in the number of newly registered clinical trials in selected CIS countries in 2009 and 2010, when the economic crisis severely affected the market. In 2009 the number of new clinical trials fell by almost 100. The situation reached its nadir, in terms of the number of new clinical trials registered, in 2010, when new legislation on clinical trials came into force in Russia. As Russia is the largest local market, this affected the joint results of all four countries, although Ukraine, for example, experienced growth in 2010. In 2011 alone the CIS market is expected to achieve growth of almost 13%. Between 2012 and 2014 the rate of growth of the number of new clinical trials is expected to be between 12 and 13%, reaching 1,177 trials in 2014.
Russia is the undoubted leader among the CIS countries in terms of both the number of on-going (708) clinical trials and the total (1,796). Estimates suggest that the number of clinical trials conducted every year is 600. Ukraine, with 320 on-going clinical trials, is the second largest market in the CIS. However, in the European arena both countries are relatively marginal. In Germany, which is the European leader, the total number of clinical trials is 8,292. Poland, with a 38,200, 000-strong population, is actively engaged in 2,512 trials. A comparison with the Russian and Ukrainian populations (141,900, 000 and 45,900, 000) reveals little market saturation and vast untapped potential in these countries.
This press release is based on information contained in the latest PMR report entitled “Clinical trials in CIS countries 2012 – Russia, Ukraine, Belarus and Georgia. Development forecasts for 2012-2014”.