According to a report published by the International Federation of Pharmaceutical Manufacturer and Association in 2017, pharmaceutical industry invested around US$ 149.8 billion on research and development annually. The companies are downsizing this cost by outsourcing clinical research activities. There are more than 7,000 compounds in preclinical stage of development, out of which around 56 were launched in 2015 and around 225 new chemical and biological entities were launched between 2011 and 2015.
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Moreover, rapid advancement in research of personalized therapy such as CAR-T cell therapies and monoclonal antibody based therapy would boost the demand for specialty CROs market. Currently, many companies are conducting researches on Kymriah and Yescarta, which are CAR-T cell based anticancer therapies that were approved by the U.S. Food and Drug Administration (FDA) in 2017. Rising prevalence of chronic diseases such as cardiovascular disease and cancer is driving the companies to develop effective therapies in the quickest possible time.
According to the World Health Organization (WHO) factsheet in 2017, there were nearly 17.7 million death from CVDs worldwide, which accounts for around 31% of total deaths. Furthermore, increased regulatory requirement for conducting safe clinical research and emphasis by regulatory bodies on post marketing surveillance would aid growth of specialty CROs market. Strategic partnership amongst different players in order to leverage each other’s expertise would further drive the market.
However, rising instances of clinical failure of drugs on entering clinical trial phase is expected to hamper the growth of specialty CROs market. According to the U.S. FDA data, there were more than 25 clinical trials failure cases in the year 2017, most of which were targeted towards cancer treatment. Furthermore, there is risk of intellectual property theft in which crucial data related with drug candidate under investigation is vulnerable to misuse. This is especially case in CROs which are established in developing countries such as India, China.
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Owing to the fact that pharmaceutical and biotech companies in this region spends significant amount on research and development, in order to bring novel therapies to the market. As per the estimation of Pharmaceutical Research and Manufacturers of America (PhRMA) in 2017, on an average the pharmaceutical industry invested around US$ 0.8 billion to US$ 1.7 billion on research and development. According to the U.S. National Library for Medicine, by January 2018, around 264,099 clinical studies were registered, which included all the healthcare product spectrum. Asia Pacific is expected to provide lucrative opportunities for market growth due to the cost effective services offered to the CROs in this region, large number of skilled human resources, and availability of large patient pool.
Some of key players operating in the specialty CROs market include Charles River Laboratories, Profil Abiogenesis Clinpharm, Accell Clinical Research, Accelovance, Aclires, Acquipharma, Cytespace Africa, DATATRAK International, Afraxis, David H Murdock Research Institute, DaVita Clinical Research, Gateway Pharmacology Laboratories, SAGE Labs, and Velesco Pharmaceutical Services.
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