Medical Device Affairs Outsourcing Market Report 2025

This Medical Device Affairs Outsourcing market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The medical device affairs outsourcing market size has grown strongly in recent years. It will grow from $5.08 billion in 2024 to $5.45 billion in 2025 at a compound annual growth rate (CAGR) of 7.3%. The growth in the historic period can be attributed to stringent and evolving regulatory requirements, increasing need for specialized knowledge in regulatory affairs, increasingly focused on their core competencies.

The medical device affairs outsourcing market size is expected to see strong growth in the next few years. It will grow to $7.16 billion in 2029 at a compound annual growth rate (CAGR) of 7%. The growth in the forecast period can be attributed to increasing demand for medical devices, increase the need for regulatory approvals and expertise, increasing healthcare expenditure. Major trends in the forecast period include rise in digital health technologies, AI and machine learning are becoming integral in medical devices, shift towards personalized medicine and customized medical devices, increasing emphasis on environmental sustainability.

The growing demand for medical devices is projected to drive the expansion of the medical device affairs outsourcing market. Medical devices encompass a range of instruments, apparatuses, machines, or implants used for diagnosing, treating, or preventing medical conditions. This increased demand is mainly attributed to advancements in treatment efficacy, improved patient outcomes, and the expansion of healthcare facilities. Outsourcing medical device affairs helps optimize operations, enhance compliance, and boost market results, allowing companies to concentrate on innovation and growth while benefiting from external expertise in critical functions. For example, in April 2024, The Medicines and Healthcare products Regulatory Agency (MHRA), a UK-based government body, reported that the number of registered medical products increased from approximately 2.25 million in 2022 to around 3.25 million in 2024. Thus, the rising demand for medical devices is fueling the growth of the medical device affairs outsourcing market.

Leading companies in the medical device affairs outsourcing sector are focusing on improving decentralized clinical trials to boost the efficiency and flexibility of clinical research, enhance patient recruitment and retention, and streamline data collection and analysis processes. Decentralized clinical trials (DCTs) are a model that supports the medical device industry by offering specialized services to improve the efficiency, compliance, and effectiveness of clinical trials, which is crucial for the market introduction of new medical devices. For instance, in March 2023, Syneos Health, a US-based firm providing contract research and commercial services to the pharmaceutical and biotechnology sectors, introduced its Decentralized Clinical Trial (DCT) Site Network. This initiative aims to enhance the adoption and quality of decentralized clinical trials, ultimately improving patient participation and trial outcomes. The integration supports the collection of robust evidence and real-world insights vital for successful commercialization strategies.

In June 2023, Arterex Medical, a US-based medical device contract manufacturing company, acquired NextPhase Medical Devices LLC for an undisclosed amount. This acquisition enhances Arterex's manufacturing capabilities and positions it for future growth in a competitive market. NextPhase Medical Devices LLC is a US-based provider specializing in medical device affairs outsourcing.

Major companies operating in the medical device affairs outsourcing market are Cardinal Health Inc., Flex Ltd., TE Connectivity Ltd., IQVIA Holdings Inc., Laboratory Corporation of America Holdings (Labcorp), Sanmina Corporation, ICON PLC, Celestica Inc., Eurofins Scientific SE, WuXi AppTec Inc., Intertek Group PLC, Charles River Laboratories International Inc., Plexus Corp., PAREXEL International Corporation, Teleflex Incorporated, Phillips-Medisize LLC, Integer Holdings Corporation, Mitutoyo Corporation, Cantel Medical Corp., Pace Analytical Services Inc., Onex Corporation, Sterigenics International LLC, Nortech Systems Incorporated, Nipro Medical Corporation, Avail Medsystems Inc.

Europe was the largest region in the medical device affairs outsourcing market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the medical device affairs outsourcing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the medical device affairs outsourcing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Medical device affairs outsourcing involves hiring external firms or experts to handle regulatory compliance and quality assurance tasks related to medical devices. This strategy is increasingly utilized by medical device companies to manage the complex and evolving regulatory environment, ensuring compliance with various international standards and regulations.

The primary services in medical device affairs outsourcing include regulatory writing and submissions, regulatory registration services, regulatory consulting, and others. Regulatory writing and submissions entail preparing and submitting the required documentation to regulatory authorities for medical device approval. The software used in these services includes cloud-based and on-premise software. These services are employed by various end users, such as pharmaceutical companies, medical technology companies, and others.

The medical device affairs outsourcing market research report is one of a series of new reports that provides medical device affairs outsourcing market statistics, including medical device affairs outsourcing industry global market size, regional shares, competitors with a medical device affairs outsourcing market share, detailed medical device affairs outsourcing market segments, market trends, and opportunities, and any further data you may need to thrive in the medical device affairs outsourcing industry. This medical device affairs 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 medical device affairs outsourcing includes revenues earned by entities by providing services such as data management services, compliance management, and documentation services. 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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