the growth of the Medical Device Contract Manufacturing Market at a CAGR of 9.85% during the forecast period 2025 to 2035

Market Research Future (MRFR) has published a cooked research report on the “Medical Device Contract Manufacturing Market” that contains the information from 2019 to 2035.

The Medical Device Contract Manufacturing Market is estimated to register a CAGR of 9.85% during the forecast period of 2025 to 2035.

MRFR recognizes the following companies as the key players in the Medical Device Contract Manufacturing Market - Kimball Electronics (US), Gerresheimer AG (Germany), West Pharmaceutical Services, Inc. (US), Flex Ltd. (US), Jabil Inc. (US), Sanmina Corporation (US), Integer Holding Corporation (US), Viant Medical Holding, Inc. (US), Nortech Systems Inc. (US), Nemera Development SA (France).

Market Highlights

The Medical Device Contract Manufacturing Market is expected to register a CAGR of 9.85% during the forecast period and is estimated to reach USD 216.70 billion by 2035.

The Medical Device Contract Manufacturing Market is distinguished by the presence of numerous regional and local players catering to the Medical Device Contract Manufacturing Market. Furthermore, the modernization of military fleets and adoption of advanced manufacturing technologies such as additive manufacturing, robotics, and IOT are the major factors driving the growth of the Medical Device Contract Manufacturing Market. Additionally, it is also projected that the modernization of military fleets, adoption of advanced manufacturing technologies such as additive manufacturing, robotics, and IoT, and need for innovative and advanced medical devices will boost the market's growth in the upcoming future.

Access full report @ https://www.marketresearchfuture.com/reports/medical-device-contract-manufacturing-market-11204

Segment Analysis

The Medical Device Contract Manufacturing Market has been segmented based on Device Type, Class, and Service.

Based on device type, the Medical Device Contract Manufacturing Market has been bifurcated into IVD Devices, Diagnostic Imaging Devices, Cardiovascular Devices, Drug Delivery Devices, Orthopedic Devices, Respiratory Care Devices, Ophthalmology Devices, Surgical Devices, Diabetes Care Devices, Dental Devices, Endoscopy and Laparoscopy Devices, Gynecology and Urology Devices, Personal Care Devices, Neurology Devices, Patient Monitoring Devices, Patient Assistive Devices, and Other Devices. Drug Delivery Devices accounted for the largest market share in 2025 and IVD Devices segment is projected to grow during the forecast period. The Medical Device Contract Manufacturing Market encompasses a wide array of medical devices, with In Vitro Diagnostic (IVD) devices being essential for disease diagnosis and health monitoring. 

The increasing prevalence of chronic and infectious diseases, such as diabetes, cardiovascular conditions, and respiratory infections, is a major driver of demand. Other key segments include cardiovascular devices (stents, pacemakers, heart valves), drug delivery devices (insulin pumps, nebulizers, infusion pumps), orthopedic implants, respiratory care devices (ventilators, CPAP machines), ophthalmology tools, surgical instruments, and diabetes care products (CGMs, insulin pens). Additionally, dental equipment, neurology devices, patient monitoring systems, personal care devices, endoscopy and laparoscopy instruments, and patient assistive devices play a significant role in market expansion. Other specialized devices, such as IUDs, implants, biopsy tools, electrophysiological devices, and endodontic instruments, further contribute to the growth of the industry.

Based on the Class, the Medical Device Contract Manufacturing Market has been bifurcated into Class I Medical Devices, Class II Medical Devices, and Class III Medical Devices. Class II Medical Devices accounted for the largest market share in 2025 and Class III Medical Devices is projected to grow during the forecast period. Class II medical devices are classified as medium-risk devices, necessitating more regulatory controls than Class I devices but less stringent than Class III. These gadgets are typically utilized in more sophisticated procedures and provide a larger danger if not appropriately regulated. To ensure their safety and efficacy, Class II devices must fulfill particular performance standards and frequently require premarket notification or "510(k) approval" from regulatory agencies such as the United States Food and Drug Administration (FDA). Class II equipment includes infusion pumps, powered wheelchairs, defibrillators, and specific diagnostic imaging systems. Furthermore, the growing emphasis on patient safety and regulatory compliance drives market expansion. Class II devices must meet strict performance standards to assure their safety and dependability. As healthcare systems around the world prioritize high levels of care and safety, the need for compliant Class II devices that fulfill these criteria is likely to increase.

Based on the Service, the Medical Device Contract Manufacturing Market has been bifurcated into Device Development and Manufacturing Services, Quality Management Services, Packaging and Assembly Services, and Others. Device Development and Manufacturing Services accounted for the largest market share in 2025 and Quality Management Services is projected to grow during the forecast period. Device Development and Manufacturing Services comprise all aspects of medical device design, development, and production. These services encompass conceptual design, prototyping, preclinical and clinical testing, regulatory compliance, and full-scale production. Companies that provide these services work closely with medical device manufacturers to develop innovative goods from concept to market-ready solutions, ensuring that devices meet both functional and regulatory standards. 

This area is critical to the medical device business, providing key assistance throughout the product's life cycle. The rise of personalized medicine and customized devices contributes to the growth of this market sector. With a rising emphasis on adapting medical devices to individual patient demands, there is a greater demand for research and manufacturing services that can handle bespoke solutions. Quality Management Services in the medical device contract manufacturing sector are a comprehensive strategy to ensure that medical devices fulfill strict quality standards throughout their lifecycle. These services include quality planning, control, assurance, and improvement operations that guarantee devices are safe, effective, and meet regulatory criteria. Quality Management Services encompass responsibilities like developing quality management systems (QMS), performing audits and inspections, keeping paperwork, and executing corrective and preventive measures. These services are critical for maintaining high standards and reducing the hazards involved with medical device manufacturing.

Regional Analysis

Based on the region, the Medical Device Contract Manufacturing Market has been segmented into North America, Europe, Asia-Pacific, South and Rest of the World. North America accounted for the largest market share in 2025.

The North American region is the largest market for worldwide medical device contract manufacturing, thanks to a number of specific elements that contribute to its supremacy. This significance is due to the region's strong healthcare infrastructure, creative technological breakthroughs, and favorable regulatory environment. North America's substantial and well-established healthcare infrastructure is a major contributor to market growth. The United States and Canada have modern healthcare systems with high medical standards and major investments in healthcare technology. This infrastructure serves as a firm foundation for the medical device contract manufacturing business, making it easier to produce and distribute a diverse range of medical equipment. The abundance of healthcare facilities, research institutions, and hospitals produces a significant demand for modern medical gadgets, prompting manufacturers to improve their production capacities and quality standards.

Europe is a substantially greater region in the worldwide medical device contract manufacturing industry, driven by a number of key variables that contribute to its rapid expansion. This growth is mostly driven by the region's robust healthcare system, broad consumer needs, and supportive regulatory environment. The comprehensive and advanced healthcare system in Europe is a major driver of the market. Europe has a well-established network of healthcare facilities and institutions that provide high-quality medical care and make significant investments in healthcare infrastructure. The diversified market needs in Europe also play an important role in the region's medical device contract manufacturing growth. Europe is made up of many different countries, each with its own set of healthcare demands and preferences. This diversity allows contract manufacturers to meet distinct geographical demands and adjust their offerings accordingly.

The Asia Pacific area is the fastest-growing market for worldwide medical device contract manufacturing, thanks to a number of specific elements that contribute to its rapid rise. This expansion is largely due to the region's thriving healthcare industry, increased investments in medical technology, and a dynamic regulatory framework. The Asia Pacific medical device contract manufacturing industry is being driven primarily by the region's rapidly expanding healthcare sector. Countries such as China, India, and Southeast Asia see tremendous economic expansion, which leads to an increase in healthcare expenditure and infrastructure development. This growth includes the construction of new hospitals, diagnostic centers, and research institutions, resulting in increased demand for medical gadgets. The rising availability of healthcare services and access to new medical technologies increases the demand for high-quality, cost-effective manufacturing solutions, which benefits contract manufacturers.

The Rest of the World (RoW) area is witnessing much slower growth in the global medical device contract manufacturing industry than other regions. Despite this slower rate, various distinct causes contribute to the market's growth in these areas, including rising healthcare requirements, emerging markets, and increased investment in healthcare infrastructure. The increased need for healthcare services is one of the key drivers of the RoW region's medical device contract manufacturing market. Many countries in this region are facing growing healthcare demands as a result of demographic shifts, such as aging populations and rising chronic disease rates. As these countries work to improve healthcare access and quality, there is an increased need for innovative medical devices. 

This increased demand promotes investment in local manufacturing skills as well as collaboration with contract manufacturers that may deliver specific solutions. Emerging markets in the RoW area also play an important role in growing the medical device contract manufacturing sector. Countries in Latin America, the Middle East, and Africa are gradually improving their healthcare systems and becoming more appealing to global medical device companies. As these markets increase, contract manufacturers will have new opportunities to enter and grow in these locations. The growing number of local healthcare facilities and the steady acceptance of innovative medical technologies all contribute to the demand for dependable manufacturing partners.

Key Findings of the Study

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  The Medical Device Contract Manufacturing Market is expected to reach USD 216.70 billion by 2035, at a CAGR of 9.85% during the forecast period.

  
  


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  The North America Healthcare and Consumer Care Ayurveda Products Market accounted for USD 33.83 billion in 2024

  
  


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  Based on Device Type, Drug Delivery Devices segment held the majority share in 2024.

  
  


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  Kimball Electronics (US), Gerresheimer AG (Germany), West Pharmaceutical Services, Inc. (US), Flex Ltd. (US), Jabil Inc. (US), Sanmina Corporation (US), Integer Holding Corporation (US), Viant Medical Holding, Inc. (US), Nortech Systems Inc. (US), Nemera Development SA (France) are the key market players.