Regulatory Affairs Outsourcing Market Report 2025

The regulatory affairs outsourcing market size has grown rapidly in recent years. It will grow from $8.44 billion in 2024 to $9.42 billion in 2025 at a compound annual growth rate (CAGR) of 11.6%. The growth in the historic period can be attributed to globalization of regulatory standards, evolving regulatory landscape, industry-specific regulations, cost containment strategies, 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 $15.93 billion in 2029 at a compound annual growth rate (CAGR) of 14%. The growth in the forecast period can be attributed to increasing complexity of submissions, digital transformation in regulatory processes, emphasis on compliance and risk management, shift in product development trends, growing complexity in submissions. Major trends in the forecast period include expansion of life sciences industry, sustainability and environmental regulations, demand for strategic guidance, utilization of advanced analytics, enhanced risk management.

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 increase in the number of clinical trials is anticipated to drive the growth of the regulatory affairs outsourcing market in the future. Clinical trials are research studies that involve human participants to assess the safety and efficacy of new medical treatments, interventions, or diagnostic procedures. These trials utilize regulatory affairs outsourcing as a strategic method to streamline and accelerate the complex regulatory processes associated with drug development. By leveraging external expertise, companies can navigate changing compliance requirements and ensure effective interactions with regulatory authorities, which in turn helps to speed up the overall trial timeline and enable timely market access for new pharmaceutical interventions. For example, in November 2023, the Association of the British Pharmaceutical Industry, a UK-based trade association, reported that the annual number of industry clinical trials launched in the UK rose by 4.3%, increasing from 394 trials in 2021 to 411 in 2022. Therefore, the rising number of clinical trials is propelling the growth of the regulatory affairs outsourcing market.

The emergence of effective software for recording regulatory affairs is a significant trend gaining traction in the regulatory affairs outsourcing market. Leading companies in this sector are prioritizing the development of software that efficiently manages regulatory records. For instance, in May 2024, Rimsys, a US-based software firm, introduced the beta version of Rimsys Intel, a community-driven regulatory intelligence hub. This platform is free and specifically designed for the medical technology (medtech) sector, aimed at improving access to crucial information for the medtech community.

In January 2022, RQM+ Corp., a US-based MedTech service provider specializing in RA/QA consulting, acquired AcKnowledge Regulatory Strategies for an undisclosed sum. The acquisition is intended to bolster RQM+'s regulatory and quality consulting capabilities for medical devices and in-vitro diagnostics, providing comprehensive regulatory solutions to clients throughout the product lifecycle. AcKnowledge Regulatory Strategies is a US-based firm offering regulatory affairs consulting services.

In December 2023, SGS, a Switzerland-based multinational corporation, formed a partnership with Agilex Biolabs. This collaboration aims to strengthen SGS's footprint in the Asia-Pacific region, leveraging its extensive network of bioanalytical laboratories, including a newly established facility in Shanghai. The partnership is designed to facilitate seamless operational integration, ensuring efficient transfer and validation of methods across different locations. Agilex Biolabs is an Australia-based regulated bioanalytical laboratory that provides substantial support for drug development programs across various sectors, including small molecules and biologics.

Major companies operating in the regulatory affairs outsourcing market include Thermo Fisher Scientific Inc. (PPD), IQVIA, ICON plc, 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, Promedica International, Clinilabs Inc., CliniExperts Pvt Ltd., Global Regulatory Services (GRS), Pharma Design Limited, PharmaLex, Hiray Pharma Solutions, LGM Pharma, BlueReg Group.

North America was the largest region in the regulatory affairs outsourcing market in 2024. 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 involves external services utilized by pharmaceutical, biotech, and medical device manufacturing companies to expedite regulatory approvals from various organizations. These services encompass adherence to pharmaceutical regulations, quality standards, safety measures, efficacy criteria, and compliance with the attitudes and requirements of health authorities.

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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