The regulatory affairs outsourcing market is expected to witness significant growth owing to increasing outsourcing activities performed by the healthcare organizations such as outsourcing regulatory service to Clinical Research Organizations (CROs). Increasing number of patent expirations supported by rising costs of R&D activities are some of the major factors that drive the global regulatory affairs outsourcing market growth. Biopharmaceutical and healthcare organizations are expected to collaborate with several outsourcing companies in order to get their devices/drugs approved in the market. The device or drug approval is a time, cost, and documentation centric process. Therefore, providers have been changing their focus to outsource regulatory activities in order to reduce costs and focus on core competencies. These regulatory service providers offer various other services such as clinical trials, medical writing, and pharmacovigilance to biotech and various other companies.
However, high price fluctuations as well as hidden costs of regulatory services provided by different Clinical Research Organizations (CROs) are expected to hamper market growth over the forecast period. Additionally, high risks associated with organizational data security are also anticipated to hinder the regulatory affairs outsourcing market growth.
The regulatory affairs outsourcing market can be segmented on the basis of services, into regulatory consulting, legal representation, regulatory affairs, product registration, and clinical trial applications. The regulatory writing & publishing services segment is expected to witness high growth over the forecast period. This growth may be attributed to growing demand for user-friendly total drug application submission. Furthermore, a suitably written Clinical Study Report (CSR) adds value to the clinical trial documentation, and thereby provides avenues for market growth. Legal representation services and regulatory consulting segment are also expected to exhibit considerable growth over the forecast period. Increasing demand for product safety and efficiency evaluations from different drug manufacturing organizations are a few factors that drive the regulatory affairs outsourcing market demand.
North America is expected to emerge as the most dominant regional market followed by Europe. The growth can be attributed to large number of healthcare companies and increasing R&D cost. Asia Pacific is also expected to witness substantial growth over the forecast period due to increasing pressure of regulatory affairs on local vendors. Emerging economies such as China and India provide several market growth opportunities. Frequently improved regulations including medical device regulatory systems, drug price control, and GMP standards are expected to drive the regional market growth over the next few years. However, complicated regulatory landscape, particularly in the Asian countries could act as a barrier to the foreign companies that lack resources to overcome the aforementioned obstacles.
The key participants in the regulatory affairs outsourcing market include Accell Clinical Research, Clinilabs Inc., Criterium Inc., PRA International, Promedica International, Wuxi AppTec, Medpace Inc., Pharmaceutical Product Development, PAREXEL International Corporation, Charles River Laboratories International Inc., ICON plc, Quintiles Transnational Holdings, and Covance Inc.
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