Clinical Trials in Russia: Market Structure According to Therapeutic Areas

Statistics on IMCT according to therapeutic areas

In 2015 among Russian CRO, just like years before, the leading position on the market of international multicenter clinical trials (IMCT) was occupied by oncology drugs. Conducted in this area were 92 medical studieswhich made 32,3% of the total number of IMCT. In 2014 there were 64 studieswith their share in the total number of IMCT being 22,7%.

Neurology was the second biggest therapeutic area by the number of international multicenter clinical trials: 26 studies (making 9,1%), which showed some growth compared to the 6,0% share it had in 2014.

The third most popular area was rheumatology, with 21 clinical trial (7,4% – slightly lower than the 9,9% share in 2014).

37,5% of this market share was distributed among the following therapeutic areas:

  • Endocrinology –  20 clinical trials (7,0%)
  • Pulmonology – 20 (7,0%)
  • Virulent diseases ­– 20 (7,0%)
  • Dermatology; immunology – 20 (7,0%)
  • Gastroenterology – 15 (5,3%)
  • Cardiology and cardiovascular diseases – 12 (4,2%).

The four therapeutic areas least popular in terms of international multicenter clinical trials in Russia were:

  • Hepatology – with 0 studies,
  • Urology – with 2 (0,7%),
  • Gynecology – with 2 (0,7%),
  • Allergology – with 3 (1,1%).


Distribution of international multicenter clinical trials according to therapeutic areas, 2015 vs 2014


Clinical trials in Russia for local and international sponsors

The statistics of medical research conducted in Russian CROs with regard to local medications as well as bioequivalence of generics and biosimilars look like follows.

Studies conducted for international sponsors

Leading position in this statistics in 2015 (just like in 2014) was occupied by medications used for treatment of virulent diseases – 40 studies that made 22,1% of the total local market.

Next biggest share of 20,4% belonged to medications used in cardiology for treatment of cardiovascular diseases – a total of 37 clinical trials.

Two other prevalent therapeutic areas were pain killers and anti-inflammatory drugs (15 trials, making 8,3%) and gynecology (10 trials, making 5,5%).

The least popular therapeutic areas in these studies conducted for international sponsors were:

  • Urology – with 5 trials and a share of 2,8% in this statistics;
  • Immunology (and transplantation), anesthesiology (surgery  and intensive therapy), and rheumatology – with 4 trials conducted in each area, and with the share of each of these areas making 2,2%;
  • Otorhinolaryngology and dermatology – with 2 trials in each and a share of 1,1% each;
  • Nephrology – with 1 trial (0,6%).

No research was conducted in the areas of hepatology and phthisiology.


Therapeutic areas of Local Research and Studies of Generics and Biosimilars in Terms of Their Bioequivalence Conducted for International Sponsors


Clinical studies conducted for local sponsors

In clinical trials of local medications and bioequivalence medical research of generics and biosimilars conducted for local sponsors (just like for international sponsors) virulent diseases proved to be the most popular therapeutic area for clinical trials in Russia. The share of research in this area showed some growth from 15,6% in 2014 to 19,7% in 2015.

Second most popular therapeutic area – with 29 studies, which made 12,2% of the market – was cardiology and cardiovascular diseases.

The other four areas with considerable number of clinical trials were:

  • Nephrology – 24 studies (10,1%)
  • Pain killers and anti-inflammatory drugs – 21 (8,8%)
  • Endocrinology – 16 (6,7%)
  • Oncology – 15 (6,3%).

Areas with the smallest number of conducted medical research were:

  • Otorhinolaryngology, ophthalmology and X-ray radiography (and radiology) – with 2 studies in each area (and 0,8% of share each);
  • Nephrology, hepatology and general tonics – with 1 study per area, making 0,4% of the market each.


Therapeutic areas of Local Research and Studies of Generics and Biosimilars in Terms of Their Bioequivalence Conducted for Local Sponsors


Molecules most popular in 2015 among developers of generics

The agent most often used in clinical trials of generics in 2015 was amlodipinе with different combinations, researched to be used in treatment of cardiovascular diseases. There were 14 clinical trials with this molecule, only two of which were conducted for Russian sponsors.

Second most popular agent was lamivudine and its combinations used in the therapeutic area of virulent diseases. There were 12 clinical trials with this molecule in 2015 – 8 of them conducted for Russian sponsors and only 4 – for international.

The third place was shared by two agents – moxifloxacin (used for treatment of virulent diseases) and metforminum (alone as well as in different combinations) used in endocrinology – with 10 studies conducted for each of them. The former of the mentioned agents was more popular among international sponsors (6 studies), and the latter – among local sponsors (4 studies).

Clinical trials of original drugs in Russia

The number of these trials conducted for international sponsors in 2015 was quite modest. They were distributed by therapeutic areas the following way:

  • 4 in gastroenterology
  • 2 as pain killers and anti-inflammatory drugs
  • 1 in neurology
  • 1 in urology
  • 1 in otorhinolaryngology

The number of original drug clinical trials conducted in Russian CROs for local sponsors in 2015 was more significant, totaling to 46. The biggest number of studies – 12 – was conducted for the area of virulent diseases. This area was popular in 2014, too, featuring 21 studies.

Oncology was the second most popular therapeutic area featuring 8 clinical trials.

Next comes neurology (with 4 trials) followed by:

  • pulmonology and surgery – with 3 trials for each;
  • dermatology/ immunology,  otorhinolaryngology, gynecologyand X-ray radiography/ radiology – with 2 trials conducted in each.