Emerging Market for Clinical Trials in Russia

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GBI Research, the leading business intelligence provider, has released its latest report, “Emerging Market for Clinical Trials in Russia – Curbs on New Drug Approval Timelines and Registration Fees Encourage the Emergence of a Major Global Player” that provides key data, information and analysis of the major trends and issues affecting the clinical trial market in Russia. The report provides a comprehensive insight of reasons for outsourcing clinical trials to Russia.

The report also provides a detailed analysis of the Russian clinical trial market structure. Analysis of major companies and countries which sponsor clinical trials in Russia is undertaken. Patient population analysis is carried out to highlight the patient type which is available for conducting clinical trials in Russia.

The opinion of industry experts has been incorporated in various parts of the report to emphasis the importance of various factors which affects the clinical trial market scenario in Russia.

The clinical trial market in Russia is one of the most important parts of the global clinical trial market. Russia has got the population and the prevalence of diseases which cater as a good pool of subjects in the clinical trials scenario. The high quality of the regulations followed in clinical trials in Russia leads to better optimization of clinical trials. The speed of clinical trials conducted in Russia is high mainly because of the high patient recruitment rate. The number of clinical trials conducted in Russia by foreign sponsors has tripled in the last decade. The quality of the clinical trials in Russia has been accepted by regulatory agencies such as the FDA and the EMA. The FDA approved 19 drugs in 2007with the data for six of these drugs coming from Russian sites. It was also observed by FDA inspection that Russia has good quality of investigators leading to low deficiency rate. Russia has caught the imagination of Big Pharma and this has led to huge investment by major pharmaceutical companies. There is improvement in the infrastructure for the conduction of clinical trials in Russia.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts.

Contract Research Organization (CRO) Market in Russia is set to Grow due to Implementation of New Drug law

The CRO market in Russia is set to increase due to the implementation of a new federal law “On circulation of medicines” (September 2010). According to this law, the registration of a new drug can only be achieved in the country if the international multicenter clinical trial for the drug is also conducted in Russian sites. In addition, the registration of any generic drug in Russia can only be done if the bioequivalence study is also performed in Russia.

Clinical Trials in Russia, CRO Market, Russia, ($m), 2009-2017


Source: GBI Research, Industry Expert Interviews

The value of the CRO market in Russia is forecast to reach $309m by 2017, growing at a Compounded Annual Growth Rate (CAGR) of 9.5% from 2009 to 2017. The increase in the market from 2009 to 2010 was comparatively small because stagnation in the market was observed due to adaptation of the new law. This involved the transfer of responsibility of issuing licenses for conducting clinical trials from “Federal Services on Monitoring Health Care and Social Development" to the "Ministry of Health and Social Development". This will continue in the first few months of 2011 so the increase in the CRO market will not be huge in 2011. However, from 2011 onwards there will be a significant increase in the CRO market in Russia, due to effective implementation of the new law.

Recent Regulatory Changes in Russia Improves the Conduct of Clinical Trials

The Health and Social Development Ministry of Russia implemented new changes into the country’s pharmaceutical market. These changes have improved the legal regulation on the conduction of clinical trials in Russia. The new law (Federal Law No. 61-FZ on circulation of medicines) came into effect from September 01, 2010. 45 of the proposed 300 amendments were approved by the State Duma. The new law makes it essential for foreign drug makers to conduct clinical trials for their new drugs in Russia. If a clinical trial is done on an international basis then it is mandatory to conduct the trial on Russian patients. As per Clause 5 of Article 3 of the new law, a clinical trial which is conducted outside Russia will only be accepted if it is according to the international agreements of the Russian Federation. As per the new law those drugs which are manufactured for exports and those which have been sold in the Russian market for more than two decades are not required to be registered. It has also been made mandatory for all the local manufacturers to meet the Good Manufacturing Practices (GMP) standards from 2014.

Oncology leads the Way as the Major Indication for which Maximum Number of Clinical Trials were Conducted in Russia in 2009

Clinical Trials in Russia, Number of Clinical Trials Initiated by Indication (%), Russia, 2009


Source: GBI Research, Association of Clinical Trials Organizations (ACTO) Russia

The top six therapeutic areas constitute 85% of the total share of clinical trials conducted in Russia. The major therapeutic areas for which clinical trials are conducted in the country are oncology with 22%, followed by endocrine and metabolic diseases, respiratory system, and circulatory system, each with shares of 14%. This clearly indicates that oncology will lead the way for clinical trials conducted in Russia.

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