Global Regulatory Affairs Outsourcing Market, 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) was valued at US$ 3,683.7 million in 2019, and is projected to exhibit a CAGR of 12.0% over the forecast period (2019 – 2027, as highlighted in a new report published by .

Increasing research and development expenditure in the healthcare sector, and stringent government regulations to augment the market growth

Increasing implementation of stringent regulations on medical devices to support patient safety is expected to drive the demand for regulatory affairs outsourcing by medical devices companies. 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 have to update their devices according to new regulations by May 2020.

Moreover, key players are adopting various strategies such as partnerships and capacity expansions to enhance their offerings in the market, which is expected to boost the market growth. 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 offering for biopharmaceutical companies

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)

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Furthermore, there are increasing number of seminars and conferences for medical device companies and regulatory affairs and quality assurance staffs, particularly start-up and mid-size companies, to provide insights about major challenges 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.

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

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, owing to increasing adoption business strategies by the market players in order to expand their offerings. 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, owing to factors such as upgrading of medical device regulations, and rising 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 a dominant position in the regulatory affairs outsourcing market in 2018, owing to rising R&D expenditure by pharma and biotech companies. For instance, according to Pharmaceutical Research and Manufacturers of America, in 2016, the biopharmaceutical industry invested an estimated $90 billion in research and development activities in the U.S.
  • Key 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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