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The clinical trials market in Poland will grow at a moderate pace of 5% per annum to about €200m in 2014, according to a PMR report.
Poland will remain one of the most attractive countries in the Central and Eastern Europe region because of the large population of patients willing to participate in clinical research (access to innovative treatment is poor in Poland) and the superior quality of the infrastructure associated with the conducting of clinical trials, the most recent PMR report suggests.
Reimbursement Act affects also clinical trials
Between 2009 and 2010 the clinical trials market stagnated and displayed a low rate of growth of about 1–2%. This was definitely a result of the economic crisis, which led to a reduction in spending on R&D projects and thus on clinical trials.
We estimate that in 2011 the clinical trials market on which companies carry out phase I–IV clinical trials of drugs and bioequivalence tests was worth PLN 756m (€184m). In comparison with 2010, the value of the market had increased by 7%.
The Polish clinical trials market is relatively saturated, and we do not expect to see substantial growth.
We predict that between 2012 and 2013 annual growth will be around 3–4%. The CAGR (Compound Annual Growth Rate) for the Polish market between 2012 and 2014 will be around 5%.
This modest increase can also be attributed, to some extent, to the extreme change in the Polish reimbursement system, which has made the operation of the pharmaceutical market in Poland very difficult, particularly for innovative companies.
They will prefer to focus on new marketing and reimbursement strategies instead of clinical trials, and the unfavourable innovation climate could discourage them from carrying out R&D activity.
In 2014, the situation will improve slightly in the wake of adjustment to the new market conditions and because of the proposed Act on Clinical Trials, which is expected to bring some order to the market.
Legal environment still in need of codification
Whereas Polish companies do not spend excessive amounts on research and development, the domestic pharmaceutical industry leads the field in the industrial arena in terms of the number of innovative companies, according to the Gdansk Institute for Market Economics (IBnGR).
56% of pharmaceutical companies carried out innovative projects between 2007 and 2009, either investing in the development of pharmaceuticals or upgrading their production facilities.
Representatives of companies involved in clinical trials in Poland surveyed specifically for the purposes of the report believe that one factor which could affect market growth more than any other over the next few years will be the “tidying up” of the relevant legislation.
This has been the most important factor for the second consecutive edition of the survey. Respondents indicated measures such as the need to ratify the law on clinical trials, which should include the introduction of safeguards not only for the researcher but also for the patient, along with an increase in the transparency of the trial authorisation process.
In 2012, as in previous years, the most significant factor which could have an effect on market development is the continued simplification of the trial registration procedure at the CEBK (Central Register of Clinical Trials). However, this view was taken by considerably fewer respondents than in 2006 and 2008.
Many more respondents than in the previous editions of the survey suggested that the need to clarify contractual issues was an essential factor in the development of the clinical trials market in Poland.
This issue could be resolved by regulating matters pertaining to contracts between sponsors, investigators and trial centres. The Health Ministry plans to introduce these changes as part of the draft Clinical Trials Law.