Medical Device Affairs Outsourcing Market Growth Forecast: Exploring Trends and Opportunities for the Next Decade
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How has the medical device affairs outsourcing market size evolved in recent years?
The medical device affairs outsourcing market has seen steady growth, expected to grow from $5.08 billion in 2024 to $5.45 billion in 2025 at a CAGR of 7.3%. Historical growth was influenced by evolving regulatory requirements, the increasing need for specialized regulatory expertise, and the shift of companies toward focusing on core competencies.
What are the predictions for the medical device affairs outsourcing market size in the coming years?
The medical device affairs outsourcing market is expected to experience strong growth, reaching $7.16 billion by 2029 at a CAGR of 7.0%. Growth factors include rising demand for medical devices, increasing regulatory approval needs, and higher healthcare spending. Major trends involve the rise of digital health technologies, AI and machine learning integration in medical devices, a shift towards personalized and customized medical devices, and greater emphasis on environmental sustainability.
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What key factors are fueling the growth of the medical device affairs outsourcing market?
The increasing demand for medical devices is anticipated to boost the medical device affairs outsourcing market. Medical devices, used for diagnosing, treating, or preventing health conditions, are in greater demand due to their efficacy, better patient outcomes, and the expansion of healthcare facilities. Outsourcing medical device affairs streamlines operations, strengthens compliance, and improves market outcomes by leveraging external expertise. For instance, the number of registered medical products with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) increased from 2.25 million in 2022 to 3.25 million in 2024. The growing demand for medical devices is driving the medical device affairs outsourcing market.
How is the global medical device affairs outsourcing market divided into key segments?
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 key firms paving the way for growth 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
Which trends are expected to transform the medical device affairs outsourcing market?
Top firms in the medical device affairs outsourcing market are working on improving decentralized clinical trials to bolster the effectiveness and flexibility of clinical research, bolster patient engagement and retention, and simplify procedures for data collection and analysis. A decentralized clinical trial (DCT) is a model that benefits the medical device sector by offering specialized services that boost the efficiency, conformity, and efficacy of clinical trials – elements vital for introducing new medical devices to the market. For example, Syneos Health, a US-based firm specializing in contract research and commercial services for pharmacies and biotechnology, introduced a Decentralized Clinical Trial (DCT) Site Network in March 2023. This move was designed to enhance the adoption and quality of DCTs while promoting the progression of decentralized solutions in clinical trials which ultimately enhances patient involvement and trial outcomes. This integration facilitates the acquisition of comprehensive evidence and practical insights that are crucial for effective commercialization strategies.
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What regions are contributing significantly to the growth of 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.
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