The Polish market for clinical trials grew by an estimated 7% year on year in 2011.

But that followed a period of stagnation between 2009 and 2010, while the market is expected to show a relatively modest compound annual growth rate (CAGR) of about 5% in 2012-14, according to a new report by business intelligence consultants PMR.

Despite the moderate growth forecast and complicating factors such as reimbursement reform and contractual issues around clinical trials, Poland is expected to remain one of the most attractive destinations for clinical research in Central and Eastern Europe, thanks to its large population of patients with limited access to innovative therapies and the quality of its infrastructure for clinical studies.

The PMR report, Clinical trials in Poland 2012. Development forecasts for 2012-2014, values the market for Phase I-IV trials, including bioequivalence testing, at PLN 756 million (€184 million) in 2011.

The estimated 7% growth against the previous year compared with a relatively flat market in 2010, expanding by just 1-2% over 2009 in a constrained economic climate that saw a reduction in overall spending on research and development.

Moreover, the Polish market for clinical trials market is “relatively saturated”, PMR says. It reckons on year-to-year growth of 3-4% between 2012 and 2013, accelerating somewhat in 2014 to give a CAGR of around 5% for the three-year period.

Reimbursement changes

One reason for the relatively subdued outlook is radical changes to Poland’s drug reimbursement system, which came into effect on 1 January 2012.

Research-based companies in particular “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”, suggests Monika Stefanczyk, head pharmaceutical market analyst at PMR.

She believes the situation will improve slightly in 2014, as companies adjust to the new market conditions and a proposed law on clinical trials comes into force, bringing “some order to the market”.

Need to tidy up

Indeed, ‘tidying up’ the relevant legislation was cited by representatives of companies involved in clinical trials in Poland as the most important factor to drive market growth over the next few years when PMR conducted a survey for report.

Respondents referred to the need to ratify the draft law on clinical trials, which should include safeguards not only for researchers but for patients, and to improve the transparency of the study-approval process.

While considerably fewer respondents than in previous surveys (2006 and 2008) referred to continued simplification of the trial-registration procedure at the CEBK (Central Register of Clinical Trials), this was still regarded as the most important factor in market development for Poland.