Regulatory Affairs Outsourcing Market Report 2026

The regulatory affairs outsourcing market size has grown rapidly in recent years. It will grow from $9.43 billion in 2025 to $10.74 billion in 2026 at a compound annual growth rate (CAGR) of 13.9%. The growth in the historic period can be attributed to pharma r&d expansion, clinical research growth, regulatory complexity rise, globalization of trials, increasing approval timelines.

The regulatory affairs outsourcing market size is expected to see rapid growth in the next few years. It will grow to $18.29 billion in 2030 at a compound annual growth rate (CAGR) of 14.2%. The growth in the forecast period can be attributed to biologics expansion, personalized medicine growth, increasing medical device innovation, rising compliance requirements, digital regulatory solutions adoption. Major trends in the forecast period include increasing outsourcing of compliance activities, rising demand for faster regulatory approvals, growing emphasis on clinical documentation services, increasing submission management outsourcing, rising complexity of global regulatory frameworks.

The increase in the number of clinical trials is expected to propel the growth of the regulatory affairs outsourcing market going forward. Clinical trials are scientific studies carried out with human participants to assess the safety, efficacy, and performance of new drugs, therapies, medical devices, or diagnostic methods. Regulatory affairs outsourcing is increasingly used in clinical trials as a strategic approach to manage and accelerate complex regulatory procedures in drug development. By leveraging external regulatory expertise, organizations can navigate evolving compliance requirements more effectively, ensure smooth communication with regulatory authorities, shorten development timelines, and enable faster market entry for new pharmaceutical products. For instance, in December 2024, according to the Association of the British Pharmaceutical Industry (ABPI), a UK-based organization, the number of pharmaceutical industry trials initiated in the UK rose for the second consecutive year, increasing from 411 in 2022 to 426 in 2023. Therefore, the rising number of clinical trials is driving the growth of the regulatory affairs outsourcing market.

Major players operating in the regulatory affairs outsourcing market are concentrating on developing innovative solutions such as regulatory affairs management software to improve compliance efficiency and optimize data handling. Regulatory affairs management software helps organizations centralize, monitor, and maintain regulatory submissions, approvals, and related documentation, reducing administrative workload while ensuring regulatory compliance. For example, in May 2024, Rimsys, a US-based software company, launched the beta version of its community-driven regulatory intelligence platform, Rimsys Intel. This free global regulatory intelligence hub is specifically designed for the medical technology sector and aims to improve access to critical regulatory information for the medtech community.

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 report are Thermo Fisher Scientific Inc. (PPD), IQVIA, ICON plc, Parexel International Corporation, Syneos Health, WuXi AppTec, Charles River Laboratories International Inc., Medpace Holdings Inc., Certara L.P., PharmaLex GmbH, Promedica International, Clinilabs Inc., CliniExperts Pvt Ltd., Global Regulatory Services (GRS), Pharma Design Limited, BlueReg Group, Hiray Pharma Solutions, CTI Clinical Trial & Consulting Services, Accell Clinical Research LLC, Pace Life Sciences, Amicus GMP, MedReg Solutions.

North America was the largest region in the regulatory affairs outsourcing market in 2025. 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, South East Asia, 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, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

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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