Regulatory affairs outsourcing is a common practice in the biotechnology and pharmaceutical industry, wherein pharmaceutical, life science, and medical device manufacturing companies are provided with an array of effective services such as medical writing, clinical trial services, and pharmacovigilance.
- Global Regulatory Affairs Outsourcing Market to Expand at Healthy 11.50% CAGR 2015-2023
According to Transparency Market Research, the global regulatory affairs outsourcing market is poised for healthy growth from 2015 to 2023, expanding at an 11.50% CAGR therein. In 2014, the value of the market was pegged at US$1.9 bn, which is projected to rise to US$5.7 bn by 2023. TMR indicates that the rise in cost efficiency, the surge in research and development activities across the globe, and the extensive documentation during device or drug manufacturing have been fueling the regulatory affairs outsourcing market. Emerging economies have also been offering lucrative growth opportunities for players within the market. In contrast, technological advances resulting in rapid price fluctuations and the risks associated with the loss of control, system access, and data security are some of the challenges staring the global regulatory affairs outsourcing market in the face.
- Implementation of Well-structured Regulatory Policies Driving US Market
The global regulatory affairs outsourcing market is segmented into five key regions: Europe, Latin America, North America, Asia Pacific, and the Middle East and Africa. Owing to the fact that the majority of the prominent contract research organizations are located in Europe and North America, these two regions account for the largest shares in the overall regulatory affairs outsourcing market. The US market is larger than the one in Canada and is single-handedly driven by the implementation of well-structured regulatory policies such as the American Recovery and Reinvestment Act (ARRA), the Health Information Technology for Economic and Clinical Health Act (HITECH), and the Patient Protection and Affordable Care Act (PPACA). The US regulatory affairs outsourcing market is also positively impacted by the growing presence of prominent pharmaceutical companies.
The regulatory affairs outsourcing markets in Latin America and Asia Pacific are anticipated to witness the highest growth in the coming years, owing mainly to the rising preference for conducting clinical trials in these two regions and the hike in research and development expenditures.
- Regulatory Affairs Outsourcing Market: Consolidated Nature of Competitive Landscape
The vendor landscape of the global market for regulatory affairs outsourcing is extremely consolidated in nature, with a handful of leading companies accounting for a large chunk in the overall market. ICON plc, Pharmaceutical Product Development, (PPD) LLC, Accell Clinical Research, LLC, Charles River Laboratories International, Inc., Quintiles Transnational Corporation, PAREXEL International Corporation, Medpace, Inc., Criterium, Inc., WuXi App Tec, Clinilabs, Inc., Promedica International, and Covance, Inc. are some of the key names in the global regulatory affairs outsourcing market. A number of large contract research organizations (CROs) have been acquiring smaller CROs to up their operations and have begun offering varied specialized regulatory services with increased efficiency.
The regulatory affairs outsourcing market is also anticipated to benefit from the rise in multi-year strategic collaborations with a number of biotechnology and pharmaceutical companies. The predominant presence of large regional players in developed economies compared to developing and emerging economies is also a major factor influencing the global regulatory affairs outsourcing market. A recent trend, however, that has been noticed is that these companies have begun focusing on the expansion of their businesses in developing countries such as China, India, and Australia.
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