Emerging Market for Clinical Trials in Poland - Cost Advantages of Nearly 30% as Compared to the US

Additional Information

GBI Research, the leading business intelligence provider, has released its latest report, “Emerging Market for Clinical Trials in Poland - Cost Advantages of Nearly 30% as Compared to the US” which provides key data, information and analysis of the major trends and issues affecting the clinical trial market in Poland. The report provides a comprehensive insight of the reasons for outsourcing clinical trials to Poland and the key services provided by the Clinical Research Organizations (CROs) of Poland. The report provides a detailed analysis of the Polish market in terms of its size, and major service offerings of the CROs in Poland. The report also discusses the factors that are driving the clinical trial market in Poland. The report delves into the key documents required by the investigator and the sponsor before, during and after the conduct of clinical trials. The report also provides key alliances in the CRO market. Furthermore, the report looks into the major challenges that can restrict the growth of the clinical trials market in Poland.

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.

Rising Costs of Drug Development and a Decrease in R&D Output have Resulted in the Outsourcing of Clinical Trials to Poland

Clinical Trials in Poland, Global, BLA and NME Approvals vs R&D Spending, ($bn), 1995-2010

Source: GBI Research, FDA, PhRMA.org

BLA: Biologic License Application; NME: New Molecule Entry; R&D: Research and Development

GBI Research suggests that over the years pharmaceutical R&D expenditure has been increasing relative to the number of drug approvals. The decreasing number of New Molecular Entities (NME) approvals against ever increasing R&D expenditure has made it difficult for pharmaceutical companies to extract a better Return on Investment (ROI) from their drugs as the cost of developing a single drug has increased exponentially.

Poland holds a strategic advantage in the cost of conducting clinical trials and is much cheaper than in the US. The cost per trial in Poland is nearly 30% less than the cost in the US. The costs of a clinical trial conducted in Poland are relatively low due to a high rate of patient recruitment and excellent quality of data, leading to a reduced number of rejected clinical trials recordings and time-efficient proceedings.

Poland is an Attractive Market for Contract Research Organizations due to Rapid Patient Recruitment and Good Quality Clinical Trial Data

Patient recruitment for clinical trials in western countries is difficult as people have either access to good medical care from government hospitals or they have medical insurance by which they can afford treatment even in private hospitals. However in Poland, access to the national health system is limited and medications is expensive, and hence, with the offer of better medical care, free drugs and diagnostic procedures, patient recruitment in clinical trials is very high. In fact, the comparison of patient recruitment for clinical trials from 2005 to 2009 in Eastern European countries showed that Poland came at the top. The increased benefits for patients participating in clinical trials in turn leads to highly motivated investigators, as they can see the benefits in the work they do more than their colleagues in Western countries. The comparison of the number of US Food and Drug Administration (FDA) audit site inspections carried out between 1997 and 2008 in various countries worldwide showed that Poland has a high standard of clinical trial procedures and provides good quality clinical trial data.

Clinical Trial Market in Poland is Expected to Grow at a Rate of 4% from 2010 to 2015

Clinical Trials in Poland, Poland, Clinical Trial Market, ($m), 2006 - 2015

Source: GBI Research, Primary Research

In 2010, the Polish clinical trial market was worth $265.7m, growing at a compound annual growth rate (CAGR) of 5% from 2006. GBI Research predicts it will grow at 4% to reach $323.3m by 2015. Due to its patient population, speed of patient recruitment, and good quality clinical data, Poland is attracting major pharmaceutical companies to conduct clinical trials in the country. Legislative drawbacks regarding clinical trials and the long trial registration process are the current problems faced by the multi-national companies (MNC’s). However, if these problems are resolved the market may grow at an exorbitant rate in the future.