Igor Stefanov
CEO @ SRG CRO & A Kingsman @ ACROSS Global™
The Ministry of Health of the Russian Federation approved the initiation of 184 new clinical trials of all types in Russia during Q3 2018, including local clinical trials (LCT) and bioequivalence (BE) studies with an overall year on year growth rate of 17% by the number of studies.
The dominant type of clinical trials conducted in Russian sites was multi-national multi-center clinical trials (MMCT) with 46% market share and with a year on year growth rate of 30% (from 65 studies in Q3 2017 to 85 studies in Q3 2018). The most prevalent phase of clinical trials conducted in Russian sites by number of studies was Phase III.
Russian Oligopoly
There is a significant level of oligopoly within the Russian Clinical trials market –whereby the top five international sponsors conduct 18% of the total number of studies conducted in this quarter and 27% of all of patients enrolled in these trials. The combined market share of top five Russian Sponsors is approximately 11% of total number of studies conducted in this quarter and 22% of all of patients enrolled in these trials. So in fact the ten largest pharmaceutical companies together account for 29% of all clinical trials conducted in Russia by number of studies and 49% of patients enrolled in these studies.
Thirteen FDA Approvals
During Q3 2018 the Center for Drug Evaluation and Research (CDER) of the FDA approved 13 new drugs as new molecular entities (NME); Four of these 13 drugs were tested in clinical trials involving Russian sites.
Top Five
Top international study sponsors are AstraZeneca, Merck & Co., CSL Behring LLC, Dr. Reddy’s Laboratories and Novartis.
Top domestic pharmaceutical manufacturers are Materia Medica, Gamaleya Research Institute, Biocad, Medsyntez and Nanotek.
The top-5 CROs in Russia are: IQVIA, Parexel, iPharma, PPD and Synergy Research Group.
Tech Trends
We are pleased to introduce the new section – the overview of the latest technological trends. Three top tech trends in the Pharmaceuticals industry in Q3 2018 were:
Improving quality of Patient Relationship with patient-faced services like Medication Adherence apps, Telemedicine services and In-Home Diagnostic devices;
Improving quality, speed and cost-efficiency in clinical trials with Risk Management solutions, Study Data Analysis tools and Study Compliance systems;
Improving speed and cost-efficiency in Clinical Practice of Healthcare Providers with AI-powered automated Diagnostic tools and voice-powered Physician’s Assistant tools.
Need more information?
The Orange Paper is a free publication produced by Synergy Research Group for the pharmaceutical industry since 2007. It pulls together data from numerous public sources into a single brief document to aid decision makers planning to conduct clinical trials. It is produced quarterly, with an annual summary at the close of each year and can be downloaded here. Orange Paper is now available in the NEW FORMAT.
If you need information not covered in The Orange Paper, have suggestions to improve content, or wish to explore partnering with Synergy to speed up your clinical trial, please contact me directly.
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Igor Stefanov is CEO of Synergy Research Group, the World’s First Agile Risk-Based CRO, totally devoted to the Risk Based Thinking in Drug Development.