According to Synergy Research Group, just several years ago, in 2009, only 19% of medicinal products (27 out of 142) approved by EMA (the European Medicine Agency) have gone through clinical studies in Russia. In 2013 this number increases by 66% and came to 85% (86 drugs out of 101).
The same trend touched upon the medicinal drugs approved by the FDA – in 2013 the share of such products researched in Russia reached 46%, while in 2009 clinical trials with only 8% of drugs approved by FDA were conducted in Russia.
OCT experience also reflects this trend: the total number of clinical trials conducted by our team has increased from 9 trials in 2009 to 34 trials in 2013. 60% (20 studies) of these trials were initiated by the foreign clients.
High enrollment rates in a number of therapeutic areas and costs of clinical trials which seem to be lower in Eastern Europe are far not the only reasons why western pharma and biotech have become so interested in the Russian market. Most of the foreign companies have already realized that low budgets are just a myth here and conducting high quality clinical trials in Russia costs average of the international market. However, speedy recruitment caused by high incidence rates can save time and, as a consequence, costs.
Another reason for such interest lies in the round pace of domestic pharmaceutical industry development.
According to the State Register of Medicines, number of clinical trials initiated by the Russian pharma companies has almost doubled within the past 5 years: from 191 in 2009 to 325 in 2013. The share of clinical trials conducted by our countrymen has increased from 33% in 2009 up to 41% in 2013.
And, again, our experience confirms that: 89% (8 out of 9) of trials conducted by OCT in 2009 were foreign clients’ projects, and just 1 trial was initiated by a Russian company. By 2013, the share of domestic companies’ projects has become 41% (14 trials out of 34).
The federal program “Pharma 2020” initiated by the Russian government in 2012 has been supporting home companies and encouraging them to invest into innovative drugs development. As a result, within just 2 years (from 2012 to 2014) 17 domestic pharmaceutical companies have obtained approvals for conducting clinical trials of their original medicinal products.
Such a sharp turnabout in the number of clinical trials conducted in Russia has led to positive changes in their organization. Requirements of the pharmaceutical and biotech companies regarding the timelines of studies have become tougher. So has become quality control: many foreign companies plan to use data derived from clinical studies conducted in Eastern Europe when filing to FDA or EMA, and OCT experience shows that the level of quality of our services allows that: several products researched in Russia have been approved by FDA and EMA.