The latest market report published by Credence Research, Inc. “Regulatory Affairs Outsourcing Services Market – Growth, Future Prospects, Competitive Analysis, 2018 – 2026,” the global regulatory affairs outsourcing services market was valued at US$ 3,621.5 Mn in 2017 and expected to reach US$ 9,569.4 Mn by 2026, expanding at a CAGR of 11.3% from 2018 to 2026.
Browse the full report Regulatory Affairs Outsourcing Services Market – Growth, Future Prospects, Competitive Analysis, 2018 – 2026 report at https://bit.ly/2V5PU5a
At present, regulatory functions have become a challenging task for several pharmaceutical manufacturers, where several companies continue to face cost pressure and labor challenges. Struggle to acquire new product approvals, maintenance of compliance while ensuring competitive operation costs have become more evident in the recent years. Simultaneously, investments in regulatory information systems and personnel have also significantly increased in order to automate regulatory activities and publishing. As the trade situation in the pharmaceuticals business is tightening, prominent opportunities for cost reduction through regulatory affairs outsourcing is becoming more and more evident. Therefore, in the current healthcare environment, it is indicated that more and more manufacturers will divert towards sustainable outsourcing of regulatory activities. One prominent challenge to regulatory affairs outsourcing lies in the diversity and complexity of activities involved in the regulatory processes, as there is still an inherent reservation to opt for critical process outsourcing.
Based on the types of services, the global regulatory affairs outsourcing services market is categorized into regulatory writing & publishing, regulatory consulting, clinical trial & product registration, legal representation and other services. Of these, regulatory writing & publishing occupy the largest revenue share in the global market and shall retain its dominance through the forecast period. Clinical trial & product registration, and legal representation shall be the fastest progressing segments through 2026, particularly in the developed markets of North America and Europe. Growing interest of companies from other parts of the world to introduce their businesses and products in Europe and North America and vice versa is a key criteria for supporting the growth of these segments.
Geographically, North America shall be prominent regional market for regulatory affairs outsourcing. The regions domiciles some of the biggest names in the pharmaceuticals and medical devices industry and the presence of the most prominent regulatory body i.e. the FDA. These companies also sit on the largest pool of pipeline candidates that demand robust regulatory operation and compliance. All such factors support the dominance of North America market, globally. On the other hand, high service costs in North America and Europe have urged several market players to divert their outsourcing activities to Asia Pacific. Many of pharmaceutical manufacturers that already have a stronghold in the developed regions are initiating their efforts to enter the emerging markets of Asia Pacific and Middle East & Africa. This has therefore urged the companies to opt for regulatory services in Asia Pacific. It is expected that by the end of the forecast period, Asia Pacific will capture over 40% of the global market share.
The major players operating in the global regulatory affairs outsourcing market are ICON plc, Quintiles Transnational Corporation, PAREXEL International Corporation, Covance, Inc., Clinilabs, Inc., Charles River Laboratories International, Inc., Accell Clinical Research, LLC, Criterium, Inc., Medpace, Inc., Promedica International, WuXi App Tec, Genpact Ltd., PRA Health Sciences, Inc., and Pharmaceutical Product Development (PPD), LLC. The market players are consistently engaged in strategic collaborations, agreements, partnerships and agreements for market sustenance and enhancing their expertise along with regional footprint.
Key Market Movements:
- Low cost and highly efficient outsourcing facilities emerging in Asia Pacific, therefore attracting customers from North America and Europe
- Increasing demand for clinical trial applications and product registration services from the developed regions
- Augmenting preference of biopharmaceuticals manufacturers in opting for regulatory affairs outsourcing in order to gain more focus in core competencies