Monday, 5 February 2018

Regulatory Affairs Outsourcing: Optimizing Performance and Product Value

Regulatory affairs outsourcing has become very common as it is a beneficial option in terms of money, as well as time. Thus, most organizations are looking for partners to manage operational tasks including submission publishing and report publishing. Almost all life sciences organizations are opting for outsourcing to adopt the best practices and to manage tactical tasks. Another major reason is that it helps bring products to the market faster and with lesser expenses.

Regulatory Affairs Outsourcing Market

Regulatory Publishing/Writing Services to Grow at a Fast Pace

Regulatory affairs outsourcing include regulatory publishing and writing, legal representation, regulatory consulting, product registration and clinical trial, and other services. Regulatory publishing and writing accounted for the largest share among all the segments in 2016. The segment is further anticipated to maintain its dominance even during the forecast years (2017 to 2025). This is mainly due to the growing trend among life sciences companies to outsource non-core functions. The segment is predicted to occupy around 35% of share by 2025.

Legal representations segment is likely to be the fastest-growing service segment over the next few years. This growth is credited to the high demand from various regions, especially from relatively new firms that want to gain proper authorization in that particular region. In addition, globalization of clinical trials, particularly in regions such as Latin America and APAC is anticipated to fuel demand for product registration and clinical trial application services. This is projected to contribute toward the increased demand for regulatory affairs outsourcing.

Market Overview

According to a recent research study by Grand View Research, Inc.; the global regulatory affairs outsourcing market is anticipated to grow at a CAGR around 12% from 2017 to 2025. Factors such as changing regulatory landscape and global expansion of these service providers are estimated to augment the market growth over the coming years. PAREXEL International Corp.; Quintiles Transnational Holdings, Inc.; The Pharmaceutical Product Development, LLC; Charles River Laboratories International, Inc.; and Accell Clinical Research, LLC. are some of the key players in the global market.

A strategic acquisition by major Contract Research Organizations (CROs) is the key trend among these players to strengthen their product pipelines and to expand global reach. For instance, PAREXEL International Corp. recently acquired The Medical Affairs Company (TMAC)—one of the leading medical affairs services providers in medical devices, biopharma, and pharma industries. According to officials, this acquisition will help the former gain new and unique medical affairs outsourcing abilities that will further expand and strengthen its commercialization and market access offerings.

In-Depth Research Report On Regulatory Affairs Outsourcing Market:

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