Regulatory Affairs Outsourcing Global Market Report 2024

The regulatory affairs outsourcing market size has grown rapidly in recent years. It will grow from $7.6 billion in 2023 to $8.49 billion in 2024 at a compound annual growth rate (CAGR) of 11.6%. The growth observed in the historic period can be attributed to the globalization of regulatory standards, changes in the regulatory landscape, the implementation of industry-specific regulations, the adoption of cost containment strategies, and a heightened focus on core competencies.

The regulatory affairs outsourcing market size is expected to see rapid growth in the next few years. It will grow to $13.83 billion in 2028 at a compound annual growth rate (CAGR) of 13.0%. The expected growth in the forecast period can be ascribed to the increasing complexity of submissions, the ongoing digital transformation in regulatory processes, a heightened emphasis on compliance and risk management, a shift in product development trends, and the growing intricacy in submissions. Key trends anticipated in the forecast period encompass the expansion of the life sciences industry, a focus on sustainability and adherence to environmental regulations, a rising demand for strategic guidance, the utilization of advanced analytics, and the enhancement of risk management practices.

The anticipated growth in research and development (R&D) activities focused on new vaccines, therapeutics, and medical devices is expected to be a significant driver for the regulatory affairs outsourcing market. Companies operating in the medical device, pharmaceutical, and biotechnological sectors are intensifying their investments in R&D to create innovative products and expand their global reach. Concurrently, these companies are increasingly opting to outsource regulatory affairs to optimize operational costs and expedite the regulatory process by leveraging the expertise of professionals in the field. For example, a March 2022 report from the National Health Expenditures (NHE), prepared by the Office of the Actuary at the Centers for Medicare & Medicaid Services (CMS), forecasts an annual growth rate in national health spending averaging 5.1% from 2021 to 2030, reaching nearly $6.8 trillion by 2030. Consequently, the surge in R&D activities for new vaccines, therapeutics, and medical devices is expected to be a driving force behind the growth of the regulatory affairs outsourcing market.

The expected increase in the number of clinical trials is also poised to drive the growth of the regulatory affairs outsourcing market. Clinical trials, crucial research studies involving human participants to assess the safety and efficacy of new medical treatments, interventions, or diagnostic procedures, are adopting regulatory affairs outsourcing as a strategic approach. This approach aims to streamline and expedite the intricate regulatory processes inherent in drug development. By leveraging external expertise, companies can navigate evolving compliance requirements, ensure efficient interactions with regulatory authorities, and thereby accelerate the overall trial timeline. This strategy facilitates timely market access for new pharmaceutical interventions. For instance, data from ClinicalTrials.gov of the United States National Library of Medicine in May 2023 reveals a global total of 452,604 registered clinical trials, with 64,838 actively recruiting participants - a substantial increase from the 365,000 reported in early 2021. This notable expansion in the clinical research landscape signifies the surge in the number of clinical trials, driving the growth of the regulatory affairs outsourcing market.

The emergence of efficient software designed to manage regulatory affairs is a prominent trend gaining traction in the regulatory affairs outsourcing market. Key players in this market are directing their efforts toward developing software solutions that streamline the recording and management of regulatory affairs. An illustration of this trend is evident in the actions of SureClinical, a provider of health science cloud applications and services. In December 2021, SureClinical introduced the Eclinical Ecosystem ECO Applications and Platform Bundle, which allows clinical research organizations to establish connections across people, projects, programs, and processes for a unified clinical view. Alongside supporting project management, document management, site management, and quality management, the ECO bundle also facilitates multiple audits and centralized data and document management.

In July 2021, ICON, an Ireland-based company specializing in drug and device development and commercialization services, acquired PRA Health Sciences Inc. for approximately $12 billion. ICON's objective with this acquisition is to bolster its consulting, clinical, and commercial services portfolio, expand its geographic presence, enhance therapeutic capabilities, and leverage data-powered healthcare technology to provide globally scaled expertise and solutions. PRA Health Sciences Inc., based in the United States, is a contract research organization (CRO) offering advanced healthcare intelligence and regulatory affairs outsourcing services.

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. PLG's strategic acquisition is geared towards broadening its product offerings and strengthening its operational presence in the regulatory services sector on a global scale. ELC Group, based in the Czech Republic, is engaged in providing regulatory consulting services.

Major companies operating in the regulatory affairs outsourcing market report are Thermo Fisher Scientific Inc. (PPD), IQVIA, ICON PLC, Eurofins Scientific, WuXi App Tec, Syneos Health, Catalent Pharma Solutions, Charles River Laboratories International. Inc., Parexel International Corporation, Medpace, Curia, Certara L.P., Amicus GMP, Pace Life Sciences, CTI Clinical Trial & Consulting, Accell Clinical Research LLC, Consumer Product Testing Co., Promedica International, Clinilabs Inc., CliniExperts Pvt. Ltd., Covance Inc., Global Regulatory Services (GRS), Pharma Design Limited, PharmaLex, Hiray Pharma Solutions, LGM Pharma, BlueReg Group, EPiC Auditors Ltd.

North America was the largest region in the regulatory affairs outsourcing market in 2023. 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, Africa. The countries covered in the regulatory affairs outsourcing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Regulatory affairs outsourcing services cover legal representation, regulatory consulting, product registration & clinical trial application, regulatory writing & publication, and others. Legal representation involves advocates handling legal work on behalf of pharmaceutical and medical device companies for regulatory approvals, covering medical devices, biologics, and drugs for various medical indications such as neurology, oncology, immunology, and cardiology. These outsourcing services are commonly adopted by companies in the medical device, biotechnology, and pharmaceutical sectors.

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 regulatory affairs outsourcing market includes revenues earned by entities by providing services such as scope representation, full-service representation, ghostwriting representation, and fixed-rate representation. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


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