What Has Been the Growth of the Medical Device Affairs Outsourcing Market So Far?
The medical device affairs outsourcing market has seen considerable growth due to a variety of factors.
• The market size for outsourcing in medical device affairs has experienced robust growth of late. This market is projected to expand from $5.08 billion in 2024 to $5.45 billion in 2025, demonstrating a compound annual growth rate (CAGR) of 7.3%.
The growth observed in the historic period is a result of rigorous and changing regulatory standards, a growing demand for particular expertise in regulatory affairs, as well as a heightened focus on core competencies.
How Will the Medical Device Affairs Outsourcing Market?
The medical device affairs outsourcing market is expected to maintain its strong growth trajectory in upcoming years.
• Expectations indicate a significant surge in the size of the medical device affairs outsourcing market in the upcoming years. Predictions point towards a growth up to $7.16 billion by 2029, with a compound annual growth rate (CAGR) of 7.0%.
The anticipated expansion during the forecast period is due to factors such as a growing demand for medical devices, an increased need for regulatory approvals and skilled expertise, along with a rise in healthcare spending. The forecast period is also likely to witness emerging trends such as the advancement in digital health technologies, the integration of AI and machine learning in medical devices, a shift towards personalized medicine and custom-made medical devices, and an escalating focus on environmental sustainability.
Which Factors Are Boosting Growth In The Medical Device Affairs Outsourcing Market?
The growth of the medical device affairs outsourcing market is predicted to be driven by the rising demand for medical devices. These devices, which could be instruments, machinery, implants, or apparatuses, are utilized for diagnosing, treating, or averting health conditions. This growing demand is mainly attributed to improved treatment effectiveness, better patient results, and the broadening of healthcare facilities. Outsourcing in medical device affairs aids in streamlining processes, enhancing compliance, and bettering market results, thus allowing companies to concentrate on innovations and growth by utilizing external expertise for vital functions. For example, The Medicines and Healthcare products Regulatory Agency (MHRA), a government agency based in the UK, saw a surge in the number of registered medical products from about 2.25 million in 2022 to approximately 3.25 million in 2024. Hence, the escalating demand for medical devices is propelling the medical device affairs outsourcing market.
What Key Areas Define The Segmentation Of The Global 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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Which Emerging Market Trends Are Altering The Medical Device Affairs Outsourcing Industry?
Leading businesses within the medical device affairs outsourcing market are focusing on improving decentralized clinical trials. This is aimed to boost the efficiency and versatility of clinical research, optimize patient recruitment and retention, and enhance data collection and analysis procedures. A decentralized clinical trial (DCT) is a clinical trial framework that aids the medical device industry by offering unique services that amplify the efficiency, compliance, and efficacy of clinical trials, crucial for the introduction of novel medical devices to the market. For instance, Syneos Health, an American-based company providing research contracting and commercial services to pharmaceutical and biotech industries, launched a Decentralized Clinical Trial (DCT) Site Network in March 2023. This initiative was designed to bolster the adoption and quality of decentralized clinical trials, with a commitment to further decentralized solutions in clinical trials, ultimately boosting patient involvement and trial results. Such integration aids in gathering solid evidence and real-world insights vital for successful marketing strategies.
Who Are the Key Players 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 Is The Most Dominant Region In The Medical Device Affairs Outsourcing Market?
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.
