Why India?   Clinical Research Industry      Europe      Asia      Latin America      United States   Clinical Trials   Clinical Data Management   Central Reference Lab   CLINICAL RESEARCH INDUSTRY       Europe     Asia     Latin America     United States     CRO's provide product development services to the pharmaceutical, biotechnology, and medical-device industries. According to an independent analyst, clinical trials conducted by CRO's are completed on an average of 30 percent more quickly than those conducted in-house. This results in an average time savings of some four to five months, translating to $120 million to $150 million in increased revenue potential. The industry is evolving toward a full-service model, where CRO's offer services from the earliest stages of development through clinical trials and post-approval research.   According to Frost and Sullivan (F&S), the total market revenues for the CRO industry is estimated at $14.37 billion in 2007. Last year, the USA accounted for $4.18 billion of the total, followed by Europe ($2.6bn) and Asia ($0.8bn). Based on a report by Market Researchers, the total CRO market size is estimated to grow at an annual rate of 14-16% to reach $24bn through 2010. The market is highly fragmented and the number of CRO's worldwide has reached over 1,100 despite continued consolidation.   EUROPE: According to the inputs provided by a Frost & Sullivan expert in Contract Services Magazine, Europe, though emerging markets will continue to rise, all eyes will be on Eastern Europe as it strengthens its claim to be the new Mecca for low-cost clinical trials. Spurred by the growing volume of clinical work being outsourced to Eastern European CRO's, Europe is poised to maintain its current position as the second largest market for CRO services globally. According to F&S, in 2007, the European CRO market is estimated to be worth $4.3 billion with a growth rate of 10.4 per cent. One of the key trends in the European CRO market has been Eastern Europe's emergence as a key hub for handling low-cost clinical trials, where as Western Europe faces the subdued state of preclinical-clinical research. A weak national economy compounded by rising drug costs and reduced government funds has headed towards a fall in the level of preclinical research in Western Europe. But Eastern Europe is the sunshine region for the industry. Low costs and the ease of patient recruitment are the key drivers behind the region booming for American and Western European pharma companies. The large percentage of clinical trial costs related to patient compensation is an issue, driving clinical development from West to East, especially large scale and/or multiple trials are required. With limited access to new medicines, patients in Eastern Europe are keen on participating in studies that allow them access to novel drugs. Combined with a record of excellent patient compliance with protocols, the outcome is high-quality data and a speedier regulatory approval. Most leading CRO's now have an established presence in Western as well as in Eastern European countries such as Hungary, Poland and the Czech Republic in addition to making forays into Bulgaria, Russia, and Croatia amongst others. The recent inclusion of ten central and Eastern European countries to the European Union means a larger EU population. The well-developed populations of Romania and Poland become lucrative hubs for clinical trials. Trial data is quicker to obtain, prompt regulatory approval and marketers benefit with advertising novel products to physicians. While making an early entry into these 'virgin' markets seems to be an attractive proposition though potential entrants would do well to tread cautiously. On the regulatory front, some areas significantly impacting the industry today include the EU Clinical Trials Directive and EDC (electronic data capture). For all CRO's in the region, the key competitive factors are likely to be thoroughness, quality of research, project completion timelines, price, knowledge of local regulatory environment, language as well as culture.

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