Specialty CRO's Market, by Therapeutic Area Oncology, Cardiovascular Disease, Diabetes, and Others

Specialty CROs offers advantage over conventional CROs, as they are focused on specific area of application based either on therapeutic area or specialty service they offer. Specialty CROs offer solutions to the problems in clinical research such as increasing developmental cost, high rate of lead candidate failure during clinical trial, and stringent regulatory demands such as clinical protocols across the globe. Although it is still considered as an emerging model across the globe, it is gaining significant traction in the Asian economies. Specialty CROs are playing a major role in mid-size or small pharmaceutical and biotech firms, which are working in niche area and has unique clinical research needs. Moreover, they offer cost effective and economical services as compared with large CROs. Large CROs are increasingly focusing on approaching specialty CROs, as they find it difficult to cater to unique problems.

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Market Dynamics

Specialty CROs are majorly providing services to the pharmaceutical and biotech companies and this is expected to gain traction in the near future, owing to increased research and development activities by these companies. Pharmaceutical and biotech companies are engaged in discovering novel molecules to treat chronic diseases such as cancer and cardiovascular diseases. 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. 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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This release was published on openPR.