Regulatory Affairs Outsourcing Market See Incredible Growth 2021-2028 | WuXi AppTec Co., Ltd., Charles River Laboratories, Inc., Accell Clinical Research, LLC

Rising research and development expenditure in the healthcare sector and stringent government regulations are expected to drive growth of the market

The demand for regulatory affairs outsourcing is expected to increase from medical device companies due to rising implementation of stringent regulations on medical devices to support patient safety. For instance, in April 2017, the European government adopted new Medical Device Regulation (MDR 2017/745) and replaced two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive, to improve transparency through a European database on medical devices and an innovative device traceability system based on the unique device identification. Furthermore, medical device companies are required to update their devices according to new regulations by May 2020.

Moreover, key players are focused on adopting various growth strategies such as partnerships and capacity expansions, in order to enhance their offerings in the market, which is expected to drive growth of the market. For instance, in March 2018, Parexel International Corporation and CHA Medical Group collaborated to enhance early phase clinical development in Korea. The collaboration expanded Parexel’s clinical research and regulatory service offerings for biopharmaceutical companies.

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Browse 27 Market Data Tables and 22 Figures spread through 166 Pages and in-depth TOC on ‘Regulatory Affairs Outsourcing Market’- Global Forecast to 2027, by Service Type (Regulatory Consulting and Legal Representation, Product Registration and Clinical Trial Applications, Regulatory Writing and Publishing, Regulatory Submission, and Others), By Application (Pharma and Biotech Products, and Medical Devices) and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)

Furthermore, rising number of seminars and conferences are being conducted for medical device companies, and regulatory affairs and quality assurance staffs, particularly start-up and mid-size companies, to create awareness about major problems faced by manufacturers under the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). For instance, in May 2019, the British Standards Institution (BSI) group organized a seminar on MDR and IVDR regulations to highlight the changes in regulatory requirements for medical device manufacturers and others.

Major players operating in the market are focused on adopting strategies such as acquisition and collaboration, in order to expand their product offerings in the potential markets. For instance, in July 2018, ProPharma Group, Inc. acquired Xendo Holding B.V., a Netherlands-based provider of regulatory affairs services to pharmaceutical, medical device, and healthcare industries.

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Key Takeaways of the Regulatory Affairs Outsourcing Market:

• The global regulatory affairs outsourcing market is expected to exhibit a CAGR of 12.0% over the forecast period. This is attributed to rising adoption of growth strategies by various market players to expand their product portfolio. For instance, in February 2019, IQVIA Holdings Inc. launched IQVIA Biotech suite, which is designed to offer clinical and commercial solutions for small biotech and biopharma companies. The suite offers analytical support for pricing, safety, compliance, and regulatory requirements.

• Among application, the medical devices segment held a dominant position in the regulatory affairs outsourcing market in 2018 due to factors such as upgrading of medical device regulations, and increasing demand for innovative, affordable, and advanced medical devices. For instance, in August 2019, China’s National Medical Products Administration (NMPA) expanded a medical device registration pilot project to cover 21 multiple regions for developing advanced medical devices in China.

• Among region, North America held dominant position in the regulatory affairs outsourcing market in 2018, owing to increasing expenditure on research and development by pharma and biotech companies. For instance, according to Pharmaceutical Research and Manufacturers of America, in 2016, the biopharmaceutical industry invested an estimated US$ 90 billion in research and development activities in the U.S.

• Some of the major players operating in the global regulatory affairs outsourcing market include WuXi AppTec Co., Ltd., Charles River Laboratories, Inc., Accell Clinical Research, LLC, PRA Health Sciences, Inc., Parexel International Corporation, Clinilabs Inc., Criterium Inc., IQVIA Holdings Inc., Medpace Inc., and Certara, L.P.

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