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  • To Be Published : Apr 2024
  • Code : CMI1627
  • Formats :
      Excel and PDF
  • Industry : Pharmaceutical

Specialty clinical research organizations are distinct service providers in clinical research domain with expertise based on different criteria. Earlier pharmaceutical and biotech firms, which are research driven had conducted majority of the clinical research. However, since last two decades, most of the clinical trial tasks such as lead discovery, preclinical studies, and different phases of clinical trials have been slowly outsourced to external clinical research firms. These firms gained operational expertise, geographic reach, and necessary infrastructure to efficiently conduct different clinical research activities, in order to speed up the drug discovery process. This helps pharmaceutical and biotech firms to launch novel therapies in the quickest possible time. Specialty clinical research organizations goes one step ahead from conventional multitasking clinical research organization. They gained proficiency in one or more niche segments amongst the large ecosystem of clinical research industry, thereby offering improved quality of service to the sponsors.

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.

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.  

Regional Insights

On the basis of geography, global specialty CROs market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to dominate the market over the forecast period, 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.

Competitive Landscape

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.

Market Taxonomy

On the basis of therapeutic area, the global specialty CROs market is segmented into:

  • Oncology
  • Cardiovascular Disease
  • Diabetes
  • Others

On the basis of service, the global specialty CROs market is segmented into:

  • Clinical Trial Management Service
  • Clinical Data Management Service
  • Pharmacovigilance Service
  • Regulatory Affairs/Medical Writing
  • Others

On the basis of region, the global specialty CROs market is segmented into:

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa

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