Regulatory Affairs Outsourcing Market to be dominated by Legal Representation through 2028

The increasing demand to obtain approval for new products is expected to drive the growth of Global in Regulatory Affairs Outsourcing during the forecast period, 2024-2028.

According to TechSci Research report, “Regulatory Affairs Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028F”, Global regulatory affairs outsourcing market is anticipated to grow at an impressive rate in the forecast period, 2024-2028. This can be ascribed to the pressure to reduce costs by life sciences companies across the region. Additionally, use of generic drugs and demand for drugs & medical devices at lower prices will further boost the growth of the Global regulatory affairs outsourcing market in the forecast period. Besides, uneven economic growth and measures taken by various governments to contain the cost of drugs are driving the demand for regulatory affairs outsourcing market during the forecast period. Also, growing number of new drug applications and increasing complexity of regulatory requirements and pharmaceutical companies are increasingly outsource their regulatory affairs to specialized service providers which will further boost the growth of the market over the years.

However, regulatory affairs services involve navigating various languages, cultures, and legal systems which can slow down the growth of the global regulatory affairs outsourcing market in the forecast period. Also, lack of standardization may restrict the growth of the global regulatory affairs outsourcing market. Similarly, outsourcing regulatory affairs services may increase the risk of errors and omissions which may hamper the growth of the market during the forecast period.

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Regulatory Affairs Outsourcing market can be segmented by service, category, company size, indication, products stage, end use, and region.

Based on the service, the Global Regulatory Affairs Outsourcing Market can be segmented into regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, regulatory submissions, regulatory operations, and other services. The Legal Representation dominated the market in 2022 and is expected to continue maintaining its dominance throughout the forecast period. This can be ascribed to increasing demand for legal representatives across the globe on account of the globalization of medical devices and pharmaceutical companies. Also, increasing the demand for local experts for legal representation for obtaining regulatory approvals and custom clearance is expected to create lucrative growth during the forecast period.

Based on end user, the market can be grouped into medical device companies, pharmaceutical companies, and biotechnology companies. The Pharmaceuticals & Biotechnology Companies segment is expected to dominate during the forecast period on account of the growth in evolving areas, such as biosimilar, orphan drugs, and personalized medicines, which are creating more demand for regulatory services and increased demand for biopharmaceuticals, vaccines, advanced medical devices, and other products.

Major companies operating in the global Regulatory Affairs Outsourcing market are:

·         Accell Clinical Research, LLC.

·         Genpact Ltd.

·         CRITERIUM, INC.

·         Promedica International.

·         WuXi AppTec Co Ltd.

·         Medpace Inc.

·         Charles River Laboratories.

·         ICON plc.

·         Covance, Inc.

·         Parexel International Corporation.

·         Freyr AS.

·         PHARMALEX GMBH

·         NDA Group AB

·         Pharmexon Consulting.

·         Qvigilance

·         BlueReg Group.

In July 2021, ICON plc acquired a CRO involved in providing drug development and regulatory consulting services - PRA Health Sciences. This acquisition was aimed at enhancing the services portfolio of ICON plc.

In August 2021, ProPharma Group acquired iSafety Systems., an Indian pharmacovigilance service provider, for strengthening its market position in pharmacovigilance.

In April 2019, Charles River Laborateries International, Inc. purchased Citoxlab, a non-clinical contract research business. This purchase was undertaken to broaden the company’s product range and boost the market position.

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“North America is expected to dominate in the Global Regulatory Affairs Outsourcing Market on account due to growing research and development activity rising in the number of clinical trials along with presence of key players in the region and strategic collaborations by these companies. Similarly, the availability of a skilled workforce in the region at lower costs compared to the U.S. is another factor is expected to create lucrative growth in the market during the forecast period. Also, the presence of key pharmaceutical and medical device companies and the rise in R&D spending in the region is expected to drive the growth of the market during the forecast period. Furthermore, owing to the presence of two major international regulatory agencies, the European Medicines Agency (EMA) and the U.S. FDA, which regulate more than half of the medical devices worldwide will further be expected to create lucrative opportunities for market growth” said Mr. Karan Chechi, Research Director with TechSci Research, a research-based global management consulting firm.

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