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Regulatory Affairs Outsourcing Global Market Report 2022

Regulatory Affairs Outsourcing Global Market Report 2022

  • August 2022
  • 175 pages
  • ID: 6316130
  • Format: PDF
  • The Business Research Company


Table of Contents

Major players in the regulatory affairs outsourcing market are Accell Clinical Research, LLC, Certara, L.P., Charles River Laboratories International, Inc., Clinilabs Inc., Covance (Labcorp Drug Development), Criterium, Freyr, GenPact Ltd, ICON plc, IQVIA Holdings Inc., Medpace, Parexel International Corporation; Inc, Pharmaceutical Product Development, LLC (PPD), PRA Health Sciences, Promedica International, WuXiAppTec, Inc, and Quintiles Transnational Corporation.

The global regulatory affairs outsourcing market is expected to grow from $6.18 billion in 2021 to $6.95 billion in 2022 at a compound annual growth rate (CAGR) of 12.45%. The regulatory affairs outsourcing market is expected to grow to $11.20 billion in 2026 at a compound annual growth rate (CAGR) of 12.69%.

The regulatory affairs outsourcing market consists of sales of regulatory affairs outsourcing by entities (organizations, sole traders, and partnerships) that refer to external services utilized by the pharmaceutical, biotech and medical devices manufacturing companies to gain fast regulatory approvals from various organizations. These include pharmaceutical regulations, quality, safety, and efficacy criteria, as well as the attitudes and requirements of health authorities.

The services offered by regulatory affairs outsourcing include legal representation, regulatory consulting, product registration & clinical trial application, regulatory writing & publication, and others.Legal representation refers to the legal work done by advocates for the representation of regulatory affairs on behalf of pharmaceutical and medical device companies.

It includes all court work and judiciary work done by a lawyer.They are used for regulatory approvals of medical devices, biologics and drugs used for the treatment of neurology, oncology, immunology, cardiology, and other medical indications.

These services are adopted by companies operating in medical device, biotechnology and pharmaceutical sector.

North America was the largest region in the regulatory affairs outsourcing market in 2021.Asia-Pacific is expected to be the fastest-growing region in the forecast period.

The regions covered in the regulatory affairs outsourcing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The regulatory affairs outsourcing market research report is one of a series of new reports that provides regulatory affairs outsourcing market statistics, including regulatory affairs outsourcing industry global market size, regional shares, competitors with regulatory affairs outsourcing market share, detailed regulatory affairs outsourcing market segments, market trends and opportunities, and any further data you may need to thrive in the regulatory affairs outsourcing industry. This regulatory affair outsourcing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The growth in R&D activities for new vaccines, therapeutics, and medical devices is expected to propel the growth of the regulatory affairs outsourcing market.The companies operating in the medical device, pharmaceutical, and biotechnological sectors are increasingly investing in R&D activities to develop innovative products and expand their business across the globe.

Additionally, these companies are inkling toward outsourcing regulatory affairs to reduce the operational costs and increase the speed of the regulatory process by utilizing professionals involved in it. For instance, according to National Health Expenditures (NHE) report, prepared by the Office of the Actuary at the Centers for Medicare & Medicaid Services (CMS) suggests that federal public health spending was increased to $114.9 billion including spending on vaccine development resulting in 36% increase in federal government spending on health care in 2020. Therefore, the growth in R&D activities for new vaccines, therapeutics, and medical devices is expected to drive the growth of the regulatory affairs outsourcing market.

The advent of efficient software that keeps the record of regulatory affairs is a key trend gaining popularity in the regulatory affairs outsourcing market.Key players operating in the regulatory affairs outsourcing market are focusing on developing efficient software that keeps the record of regulatory affairs.

For instance, in 2019, Freyr, a global regulatory solutions and services company, launched Freyr DMS, an end-to-end electronic regulatory document management solution that can enable regulatory groups and departments to perform operations on regulatory data and documents in a compliant, efficient, and intuitive manner.

In July 2021, ProductLife Group (PLG), a France-based provider of regulatory services to the life science sector acquired ELC Group for an undisclosed amount.The acquisition by PLG is focused on expanding its product offering and operational presence in the regulatory service sector across the globe.

ELC Group, Czech Republic-based involved in offering regulatory consulting services.

The countries covered in the regulatory affairs outsourcing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.

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