The medical device contract manufacturing market is anticipated to expand at a rapid pace, owing to surging demand for different types of medical devices, from an expanding healthcare industry around the world.
WESTFORD, Mass., Aug. 4, 2025 /PRNewswire/ -- SkyQuest Technology Consulting published a report, titled, "Medical Device Contract Manufacturing Market - Global Opportunity Analysis and Industry Forecast, 2025-2032", valued at USD 78.9 Billion in 2024, with a projected CAGR of 11.4% from 2025 to 2032, the market is expected to reach USD 187.15 Billion by the end of 2032. Advancements in manufacturing technologies, and growing emphasis on improving manufacturing capabilities across multiple medical devices, manufacturing verticals are helping create new business scope going forward.
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Medical Device Contract Manufacturing Key Growth Drivers
Increasing popularity of outsourcing medical device manufacturing to focus on core competencies like R&D and marketing is driving market growth. Contract manufacturers offer scalable operations, reduce capital expenditure, and eliminate the need for infrastructure investment. This shift enables Original Equipment Manufacturers (OEMs) to improve profitability and respond quickly to market demands. Hence, rising demand for cost-efficient, high-quality production significantly drives the medical device contract manufacturing market across diverse product segments.
Adoption of advanced manufacturing technologies such as automation, 3D printing, and precision engineering is also creating new opportunities for medical device contract manufacturing companies. These novel technologies allow companies to manufacture complex, miniaturized, and customized devices at scale. The ability to innovate and integrate digital technologies like IoT and AI, into production processes positions CMOs as vital partners.
Recent Developments in Medical Device Contract Manufacturing Market
- In May 2025, Quasar Medical has announced the acquisition of Nordson's contract manufacturing operations located in Galway and Tecate. This strategic move significantly strengthens Quasar's global CDMO capabilities, particularly in the specialized areas of balloon and catheter design, enhancing its service portfolio for medical device manufacturing.
- In March 2025, Flex Ltd, launched a new Product Introduction (NPI) center near Boston. This move was made to support healthcare customers with end-to-end product development, starting from prototyping to production transfer. The company aims to target sectors like surgical robotics and diagnostics. The facility provides DfX services and validation labs. The facility is ISO13485 certified and a ready center that will likely enhance Flex's global healthcare footprint.
- In January 2025, Arterex, a prominent global medical device contract manufacturer, successfully completed its acquisition of Phoenix S.r.l., a European medical device developer and manufacturer with a broad international sales network. This acquisition further expands Arterex's global footprint and manufacturing capabilities in the medical device sector. Financial details of the transaction were not disclosed.
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Competitive Landscape
Medical device contract manufacturing providers should focus on enhancing their manufacturing capabilities, by using advanced manufacturing technologies and integration of smart technologies. Targeting developing countries and medical device start-ups will offer lucrative business for almost all medical device, contract manufacturing providers in the long run.
The major players in the medical device contract manufacturing industry include,
- Thermo Fisher Scientific Inc.
- Jabil Inc.
- Flex Ltd.
- Plexus Corp.
- Sanmina Corporation
- Integer Holdings Corporation
- TE Connectivity Ltd.
- Nipro Corporation
- Onex Corporation (Celestica Inc.)
- West Pharmaceutical Services Inc.
- Benchmark Electronics Inc.
- EQT Group (Recipharm AB)
- Gerresheimer AG
- Kimball Electronics Inc.
- Nortech Systems Incorporated
- Carclo PLC
- Nolato GW Inc.
- Viant Medical Holdings Inc.
- Tecomet Inc.
- SMC Corporation
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Medical Device Contract Manufacturing Market Segmental Analysis
The global medical device contract manufacturing market is segmented into product class, service type, therapeutic area, end user, and region.
- By product class, as of 2024, Class II medical devices dominate the contract manufacturing market due to their broad applications, balanced complexity, and outsourcing suitability.
- By service type, the device development and manufacturing segment dominated the global medical device contract manufacturing market in 2024 owing to rising demand for new devices and components across healthcare sector.
- By end user, the OEMs segment dominated the global medical device contract manufacturing market in 2024, which can be linked to high demand for outsourcing of manufacturing and pressure to reduce costs of their products.
- By therapeutic area, the cardiovascular devices segment dominated the market in 2024 as prevalence of cardiovascular diseases such as hypertensive heart disease, rheumatic heart diseases, myocardial infarction, and atrial fibrillation rises globally.
Regional Outlook
- Presence of a developed healthcare infrastructure and key biotechnology, and medical device companies help cement the dominance of North America in terms of global demand for medical device contract manufacturing. Surge in healthcare R&D and stringent regulatory landscape in the United States and Canada also, bolster the high share of this region.
- The Asia Pacific is slated to emerge as the fastest-growing region for medical device contract manufacturing companies in the long run. Availability of low-cost manufacturing, presence of leading contract manufacturing organizations, and government support are driving revenue generation in this region. China, India, and Japan are slated to be the top countries in this region.
- Europe medical device contract manufacturing market is expected to be driven by rising emphasis on improving operational efficiency of medical manufacturing activities and high demand for biopharmaceutical products. Presence of a skilled workforce and developed infrastructure in countries such as the United Kingdom and Germany also creates new business scope.
- In the LAMEA region, the medical device contract manufacturing market is driven by availability of skilled workforce, favourable regulatory landscape, and rising healthcare spending. Brazil is expected to be the most opportune country in this region along with South Africa, Saudi Arabia, and the United Arab Emirates.
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Major Challenges in Medical Device Contract Manufacturing Industry
Navigating complex and region-specific regulatory environments present a significant challenge for medical device contract manufacturing companies. Different countries enforce varying standards like the U.S. FDA, European MDR, and ISO 13485, requiring extensive documentation, audits, and compliance systems. Constant updates to regulatory frameworks demand continuous investment in quality systems, which create issues for medical device contract manufacturing companies and slow down-market development.
OEMs show hesitation to fully outsource their manufacturing due to concerns over intellectual property (IP) protection and quality control. High risk of data breaches or misuse, especially in cross-border contracts is further impeding the adoption of medical device contract manufacturing in the future. Ensuring strict quality management systems and IP safeguards is often costly and difficult, particularly with newer or smaller CMOs. These concerns hinder trust and limit the extent of outsourcing, restraining the broader adoption of contract manufacturing in the medical device sector.
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