How has the medical device affairs outsourcing market evolved, and where is it heading next?
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 7.0%. 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.
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What are the key drivers behind the rapid expansion of the medical device affairs outsourcing market?
The increasing demand for medical devices is expected to propel the growth of the medical device affairs outsourcing market going forward. Medical devices are instruments, apparatuses, machines, or implants used to diagnose, treat, or prevent medical conditions. The increasing demand for medical devices is primarily due to improved treatment efficacy, enhanced patient outcomes, and expansion of healthcare facilities. Medical device affairs outsourcing helps streamline operations, strengthen compliance, and improve market outcomes, allowing companies to focus on innovation and growth while leveraging external expertise for critical functions. For instance, in April 2024, The Medicines and Healthcare products Regulatory Agency(MHRA), a UK-based government agency, the number of registered medical products with the MHRA increased from 2022 (around 2.25 million) to 2024 (around 3.25 million). Therefore, the increasing demand for medical devices is driving the medical device affairs outsourcing market.
What is the segmentation for the medical device affairs outsourcing market?
The medical device affairs outsourcingmarket covered in this report is segmented –
1) By Service: Regulatory Writing and Submissions, Regulatory Registration Services, Regulatory Consulting, Other Services
2) By Software: Cloud Based Software, On Premise Software
3) By End User: Pharmaceutical Companies, Medical Technology Companies, Other End Users
Subsegments:
1) By Regulatory Writing And Submissions: Clinical Trial Applications (CTAs), Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Summary And Reports For Regulatory Agencies
2) By Regulatory Registration Services: Device Registration, Market Authorization Applications (MAAs), Product Listing And Establishment Registration
3) By Regulatory Consulting: Strategic Regulatory Planning, Regulatory Compliance Audits, Labeling And Advertising Compliance
4) By Other Services: Post-Market Surveillance, Training And Education, Quality Management System (QMS) Support, Risk Management And Assessment
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Who are the most influential companies in the medical device affairs outsourcing market?
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
What are the most influential trends expected to drive the medical device affairs outsourcing market forward?
Major companies operating in the medical device affairs outsourcing market are looking to enhance decentralized clinical trials to enhance the efficiency and flexibility of clinical research, improve patient recruitment and retention, and streamline data collection and analysis processes. A decentralized clinical trial (DCT) refers to a clinical trial model that supports the medical device industry by providing specialized services that enhance the efficiency, compliance, and effectiveness of clinical trials, essential for bringing new medical devices to market. For instance, in March 2023, Syneos Health, a US-based company that provides contract research and commercial services to pharmaceuticals and biotechnology, launched a Decentralized Clinical Trial (DCT) Site Network. This aimed at enhancing the adoption and quality of decentralized clinical trials’ commitment to advancing decentralized solutions in clinical trials, ultimately improving patient participation and trial outcomes. This integration supports the collection of robust evidence and real-world insights essential for successful commercialization strategies.
What are the major regional insights for the medical device affairs outsourcing market, and which region holds the top position?
Europe was the largest region in the medical device affairs outsourcing market in 2024. 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.
What Does The Medical Device Affairs Outsourcing Market Report 2025 Offer?
The medical device affairs outsourcing market research report from The Business Research Company offers global market size, growth rate, regional shares, competitor analysis, detailed segments, trends, and opportunities.
Medical device affairs outsourcing refers to the practice of hiring external firms or experts to manage regulatory compliance and quality assurance tasks related to medical devices. This outsourcing strategy is increasingly adopted by medical device companies to navigate the complex and evolving regulatory landscape, ensuring adherence to various international standards and regulations.
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