Medical Device Contract Manufacturing Market

The global Medical Device Contract Manufacturing market size was USD 73.61 billion in 2023, and is calculated at USD 81.19 Billion in 2024. The market is projected to reach USD 216.41 Billion by 2034, and register a revenue 10.3% over the forecast period (2025-2034).

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The global Medical Device Contract Manufacturing market is expanding at a steady rate with competition increasing as new entrants and technologies emerge and demand for medical devices and equipment rises along with increasing prevalence of various diseases and medical conditions and need for drugs and medications for treatment, care, and improved patient outcomes. Increasing prevalence of chronic diseases and rapidly aging populations worldwide are among the primary factors driving demand for advanced medical devices, which is creating need for Original Equipment Manufacturers (OEMs) to outsource to Medical Device Contract Manufacturing (MDCM) companies to address rising demand, reduce costs, and reach products faster to market.

Other major factors are reduced Research and Development (R&D) costs and accelerating prototype development through adoption and integration of technological advancements. This has been resulting in the emergence of minimally invasive devices, robotics, and additive manufacturing, which are transforming medical practices and procedures as well as device production. Technological advancements within contract manufacturing are redefining medical device production. For instance, additive manufacturing (3D printing) enables rapid prototyping and precise customization of complex devices. Automation and robotics improve production accuracy, particularly in sophisticated devices like surgical instruments.

Adoption of advanced biocompatible materials and nano-coatings is also on the rise, contributing to safer, more effective devices. Artificial Intelligence (AI), Machine Learning (ML), and Internet of Things (IoT) are being increasingly integrated to streamline production workflows, predict maintenance requirements, and maintain consistency in quality control, all of which enhance efficiency and precision in manufacturing. These innovations and advancements are positioning outsourcing and contract manufacturing a strategic choice for faster, and more cost-efficient outcomes. Also, the shift toward value-based healthcare models and personalized medicine is driving demand for complex, customized devices that contract manufacturers can deliver with flexibility.

In addition, increasingly stringent regulatory standards, particularly in the North America and Europe, are encouraging manufacturers to collaborate with contract manufacturers experienced in compliance, quality management, and regulatory navigation. A number of OEMs, especially small and mid-sized companies, are leveraging outsourcing to access specialized capabilities and focus on core competencies. The demand for wearable and remote monitoring devices, amplified by post-pandemic telehealth adoption, is a key trend supporting market growth. Increased investments in emerging markets and rising focus on sustainability in production practices are also expected to continue to shape new scenarios in the market as companies seek environmentally conscious manufacturing partners and expand geographical reach.

Medical device contract manufacturing continues to gain substantial traction as demand rises for sophisticated, high-quality medical devices. The ongoing shift toward digital health solutions and wearable technology has been presenting an ever-increasing scope and opening up new avenues and opportunities for contract medical device manufacturers worldwide. The growing focus on digital health tools, such as wearables and remote monitoring devices, highlights the shift toward patient-centered and preventive healthcare, made possible by the efficiency of contract manufacturing. One of the primary benefits of contract manufacturing is cost efficiency, and OEMs are leveraging these advantages to achieve significant reduction in capital expenditure, allowing for channeling of resources toward core activities such as research, development, and marketing.

In addition, contract manufacturers provide specialized technical expertise in areas like regulatory compliance, quality assurance, and precision manufacturing, which is crucial for producing complex medical devices. Outsourcing also enables faster production, helping companies reach the market sooner and improve their competitive position. Moreover, contract manufacturers offer scalability, allowing OEMs to adjust production volumes according to demand without investing in additional infrastructure.

Some of the leading players in the contract manufacturing market include Jabil, Flex Ltd., Celestica Inc., Sanmina Corporation, and TE Connectivity. These companies have established global supply chains, advanced production facilities, and robust expertise across various medical technologies, making them valuable partners for OEMs. These companies offer an extensive range of services, from design and development to final assembly and testing, effectively supporting medical device companies through each stage of the production process.

Medical device contract manufacturers are also required to adhere to rigorous processes and formalities to ensure compliance and quality. Regulatory approvals, such as FDA clearance in the US and CE marking in Europe, are essential in this industry, and contract manufacturers streamline these processes to remain compliant. Quality Management Systems (QMS), particularly ISO 13485 certification, are also critical to ensure consistent standards throughout design, manufacturing, and distribution. Additionally, contract manufacturers manage complex supply chains, handling everything from materials sourcing to logistics, which optimizes efficiency and reliability for their OEM clients.

Several emerging trends continue to shape the medical device contract manufacturing landscape. Sustainability is gaining importance, with companies investing in eco-friendly materials and practices to meet global environmental standards. Personalized medicine is also driving demand for customized devices tailored to individual patient needs, supported by advancements in 3D printing and design tools. The increased use of telemedicine and remote healthcare is contributing majorly to rising demand for connected medical devices, which enable patient monitoring outside of clinical settings. These trends highlight the expanding role of contract manufacturing in a rapidly evolving healthcare environment.

Top Medical Device Contract Manufacturing Market Drivers and Trends:

• Aging Populations and Rising Prevalence of Chronic Diseases: A rapidly aging global population and rising prevalence of chronic diseases are primary factors driving steady and inclining demand for medical devices. Older adults more frequently require advanced healthcare solutions, including diagnostic and therapeutic devices, to manage long-term conditions such as cardiovascular disease, diabetes, and arthritis, among others. This demographic trend is increasing the need for high-quality medical devices and, in turn, the need for services of specialized contract manufacturers who can meet regulatory requirements and produce at scale. This sustained demand is contributing significantly to revenue growth of the global Medical Device Contract Manufacturing market.
• Shift to Digital Health and Wearable Technology: The shift toward digital health solutions and wearable technology and increasing adoption of wearable devices for health monitoring, such as fitness trackers and heart rate monitors, is presenting opportunities for OEMs to expand collaborations with contract manufacturers for scalable production of products. This trend is particularly strong post the COVID-19 pandemic, with remote healthcare and real-time patient data monitoring gaining greater emphasis. Contract manufacturers, equipped with expertise in precision electronics and miniaturization, are essential for producing these complex devices efficiently, and the trend is expected to continue to gain traction as digital health becomes a larger part of modern healthcare.
• Regulatory Compliance and Quality Standards: Stringent regulatory requirements in the medical device industry, particularly in regions such as the US and countries in Europe, are driving demand for contract manufacturers skilled in compliance and quality assurance. Medical device production demands adherence to rigorous standards such as ISO 13485 certification and FDA or CE approvals, which can be challenging and resource-intensive for OEMs. Contract manufacturers help streamline these processes by offering established quality management systems and regulatory expertise, making them indispensable partners for OEMs. This capability not only ensures safety, but also accelerates time-to-market.
• Technological Advancements in Manufacturing: Technological innovations such as additive manufacturing (3D printing), robotics, and advanced materials are enhancing the capabilities of contract manufacturers, enabling them to meet the demand for highly specialized medical devices. These technologies allow for faster prototyping, customization, and precision in manufacturing, critical for devices used in personalized medicine and minimally invasive surgeries. Integration of artificial intelligence and machine learning further improves production efficiency and quality control. The ability to incorporate cutting-edge technology in manufacturing processes positions contract manufacturing as essential to growth of the medical device industry.

Medical Device Contract Manufacturing Market Restraining Factor Insights

• High Regulatory Compliance Costs and Complexities: The stringent regulatory requirements for medical devices, particularly in regions such as North America and Europe, pose significant challenges for contract manufacturers. Compliance with standards like FDA approval and CE marking demands substantial investment in quality assurance and regulatory management, which can increase production costs. Smaller OEMs may find these additional costs prohibitive, especially for lower-margin devices. This regulatory burden limits the appeal of contract manufacturing for some companies and can restrain growth in the market by deterring potential clients due to the cost and time investment needed for compliance.
• Intellectual Property and Data Security Concerns: Outsourcing medical device manufacturing involves sharing sensitive Intellectual Property (IP) and data with third-party manufacturers, raising concerns about confidentiality and potential IP theft. OEMs may hesitate to engage with contract manufacturers in regions where IP protections are perceived as weaker or less enforceable, fearing competitive disadvantage or IP loss. These security concerns are amplified with complex devices and those using proprietary technologies, where strict IP protection is essential. This reluctance limits the willingness of some OEMs to outsource, potentially restraining growth of the contract manufacturing market.
• R&D and Innovation Limitations in Outsourcing: While contract manufacturing offers OEMs cost-effective production, it can limit in-house R&D capabilities and innovation control, especially for smaller companies reliant on third-party expertise. Outsourcing may constrain a company’s ability to customize devices during the development phase, impacting flexibility and innovation potential. Moreover, contract manufacturers may lack the specialized R&D infrastructure for niche or advanced device types, such as personalized medicine or cutting-edge wearables. This restriction can deter some OEMs from fully outsourcing development and production, especially as demand for customized and innovative medical solutions increases.

Medical Device Contract Manufacturing Market Opportunities

• Expansion into Emerging Markets and Untapped Regions: Leading medical device contract manufacturers can explore growth by expanding operations into emerging markets such as Asia Pacific, Latin America, and parts of the Middle East, where demand for advanced healthcare infrastructure is rising. These regions, with increasing healthcare expenditure and a growing patient base, present opportunities for manufacturers to establish local partnerships, optimize supply chains, and offer cost-effective manufacturing solutions tailored to regional needs. By establishing facilities closer to these markets, companies can reduce logistics costs and delivery times, creating a more responsive and scalable production model that also aligns with local regulatory requirements.
• Diversification into Specialized and High-Growth Segments: Contract manufacturers can generate additional revenue by diversifying into high-demand segments such as wearable medical devices, minimally invasive surgical instruments, and diagnostic equipment. These segments are expanding rapidly due to trends in remote monitoring and preventive healthcare. Manufacturers can cater to rising demand for personalized and connected health solutions by focusing on specialized capabilities such as miniaturization, sensor integration, and biocompatible materials. This strategy not only supports OEMs in addressing niche markets, but also enables contract manufacturers to leverage higher margins and develop proprietary expertise in specialized manufacturing areas.
• Leveraging Strategic Partnerships, Mergers, and Acquisitions: Forming strategic partnerships and engaging in mergers and acquisitions with technology companies, raw material suppliers, or regional manufacturers can help contract manufacturers strengthen their value chain and expand service offerings. Acquiring companies with advanced capabilities, such as additive manufacturing or automated quality control, can enhance technological edge of manufacturers and attract a wider range of OEM clients. Partnerships with OEMs on co-development projects can further strengthen long-term relationships and position contract manufacturers as integral players in the product innovation process, from concept to commercialization.

Medical Device Contract Manufacturing Market Segmentation:

By Class of Device:

• Class I (Low Risk)
• Class II (Moderate Risk)
• Class III (High Risk)

By Device Type:

• In Vitro Diagnostic (IVD) Devices
  • IVD Consumables
  • IVD Equipment
• Diagnostic Imaging Devices
  • X-ray Systems
  • Ultrasound Systems
  • MRI Machines
  • CT Scanners
• Cardiovascular Devices
  • Pacemakers
  • Stents
  • Defibrillators
  • Angioplasty Balloons
  • Heart Valves
• Drug Delivery Devices
  • Infusion Devices and Administration Sets
  • Syringes
  • Inhalers
  • Autoinjectors and Pen Injectors
• Orthopedic Devices
  • Joint Replacement Devices
  • Spinal Implants
  • Fracture Fixation Devices
  • Orthopedic Braces and Supports
• Respiratory Care Devices
  • Ventilators
  • Nebulizers
  • Oxygen Concentrators
  • Inhalers
• Ophthalmology Devices
  • Surgical Instruments
  • Intraocular Lenses (IOLs)
  • Diagnostic Devices
• Surgical Devices
  • Minimally Invasive Surgical Instruments
  • Robotic Surgery Devices
  • Laparoscopic Surgical Instruments
• Diabetes Care Devices
  • Blood Glucose Monitors
  • Insulin Pumps
  • Continuous Glucose Monitoring (CGM) Systems
• Dental Devices
  • Dental Implants
  • Orthodontic Devices
  • Endodontic Devices
• Endoscopy and Laparoscopy Devices
  • Surgical Endoscopes
  • Diagnostic Laparoscopes
• Gynecology and Urology Devices
  • Diagnostic Devices
  • Surgical Instruments
• Personal Care Devices
  • Hearing Aids
  • Skin Care Devices
  • Home Diagnostic Devices
• Neurology Devices
  • EEG Machines
  • Neurostimulation Devices
• Patient Monitoring Devices
  • Wearables
  • Home Health Monitoring Systems
• Patient Assistive Devices
  • Prosthetics
  • Orthotics
  • Wheelchairs and Mobility Aids
• Other Devices

By Service Type:

• Device Development and Manufacturing Services
• Device and Component Manufacturing
• Process Development Services
• Device Engineering Services
• Packaging Validation Services
• Inspection and Testing Services
• Sterilization Services
• Packaging and Assembly Services
• Primary and Secondary Packaging
• Labeling
• Other Packaging Services
• Other Services
  • Logistics and Supply Chain Management
  • Regulatory and Compliance Consulting
  • Reverse Engineering and Rework Services

Segment Insights:

By Class of Device:

The class II (Moderate Risk) segment is expected to account for largest revenue share among the class of device segments in the global Medical Device Contract Manufacturing market over the forecast period. Class II devices, such as infusion pumps, surgical instruments, and diagnostic equipment, represent a broad category of essential medical tools that are widely used in healthcare settings. Rising prevalence of chronic diseases and rapidly aging global population contribute to the growing demand for these devices. Class II devices strike a balance between safety and functionality, and their relatively simpler regulatory requirements compared to Class III devices allow for faster market entry, which is a key advantage in meeting the high demand. Also, technological advancements such as connected health devices and minimally invasive surgical instruments are driving innovation in the Class II category. As a result, contract manufacturers are capitalizing on the growing demand for moderate-risk devices, making this segment the largest contributor to revenue growth in the market.

By Device Type:

The diagnostic imaging devices segment among the device type segments is expected to account for largest revenue share over the forecast period. Diagnostic imaging technologies, such as X-ray systems, MRI machines, and CT scanners, are foundational to modern healthcare diagnostics and treatment planning. Increasing need for early and accurate diagnosis, supported by rising healthcare awareness and aging population, is driving demand for these devices. In addition, technological innovations, such as AI-powered imaging, have enhanced the efficiency, accuracy, and cost-effectiveness of these devices, making them even more attractive to healthcare providers. Rising global investment in healthcare infrastructure, particularly in emerging economies, further supports the demand for diagnostic imaging devices. Contract manufacturers in this space benefit from the high complexity and precision required in production, driving consistent demand for their expertise in device manufacturing.

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By Service Type:

The device development and manufacturing services segment among the service type segments is expected to account for largest share over the forecast period. Services encompass the entire lifecycle of medical device production, from design and development to manufacturing, and are critical for bringing new devices to market. As the demand for innovative medical devices grows, especially those incorporating advanced technologies like robotics, AI, and IoT, OEMs increasingly turn to contract manufacturers for their specialized expertise. Device development and manufacturing services provide a cost-effective and efficient solution, reducing time-to-market and enabling firms to focus on core competencies like research and regulatory approvals. Moreover, the growing complexity of medical devices and the rising need for precision in production drive adoption of contract manufacturers offering these services, creating a stable revenue stream for the segment.

Regions and Countries

North America

• United States
• Canada
• Mexico

Europe

• Germany
• United Kingdom
• France
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India

Rest of Asia Pacific

• Latin America
• Brazil
• Argentina

Rest of Latin America

• Middle East & Africa
• Saudi Arabia
• South Africa
• United Arab Emirates
• Israel
• Rest of MEA

Medical Device Contract Manufacturing Market Regional Landscape:

Among the regional markets in 2023, North America Medical Device Contract Manufacturing market accounted for largest share in the global market. The US, which is base to a number of leading medical device manufacturers and contract manufacturing companies, accounted for largest revenue share contribution to the market in the region in 2023. Major companies such as Jabil, Flex Ltd., and Sanmina Corporation have extensive operations in the US, which continues to be a hub for innovation, high-tech manufacturing, and medical device regulatory standards. The US Food and Drug Administration (FDA) regulatory framework also ensures strict quality control, which boosts the demand for specialized contract manufacturers. In addition, increasing adoption of advanced medical technologies such as robotic surgery systems and AI-powered diagnostics is boosting the need for high-quality manufacturing services, and supporting growth of the market in the region.

The Asia Pacific Medical Device Contract Manufacturing market is expected to register fastest revenue growth rate over the forecast period. The market in China, India, and Japan are registering steady and inclining growth rate due to increasing OEMs opting to outsource manufacturing contracts due to leverage cost-effective manufacturing capabilities and cater to rising demand for affordable medical devices in these developing economies. China is a major manufacturing hub for medical devices, with companies such as Shanghai United Imaging Healthcare Co. and Mindray gaining prominence. India’s growing pharmaceutical and medical device sectors, supported by favorable government policies and a robust healthcare system, is also contributing significantly to growth of the market in the region. Japan remains a leader in technological advancements, especially in robotic surgery and patient monitoring devices. Asia Pacific is also attractive due to low labor costs and an expanding healthcare infrastructure.

Europe Medical Device Contract Manufacturing market is expected to continue to account for a sizable revenue share contribution to the global market. Germany, Switzerland, and Ireland at the forefront of medical device manufacturing, with strong industrial base and innovation in diagnostic devices and surgical instruments in Germany expected to contribute to support steady revenue growth and attract contracts for manufacturing services from other regions. Ireland is also a significant player due to its favorable corporate tax environment and manufacturing expertise in orthopedic devices and cardiovascular technologies. The CE marking requirement for medical devices in Europe ensures that manufacturers must meet high-quality standards, and this advantage is further supporting the demand for contract manufacturing.

In Latin America, Brazil and Mexico are key markets, with Mexico benefiting from its proximity to the US and its established medical device manufacturing industry driven by favorable trade agreements like the USMCA (formerly NAFTA). Brazil, being the largest healthcare market in Latin America, has been registering incline in demand for locally produced medical devices, especially for diagnostic equipment and surgical instruments.

Medical Device Contract Manufacturing Market Competitive Landscape:

Company List:

• Jabil Healthcare
• Flex Ltd.
• Medtronic
• Phillips-Medisize (a Molex Company)
• TE Connectivity
• Sanmina Corporation
• Celestica Inc.
• Integer Holdings Corporation
• Plexus Corp.
• Benchmark Electronics
• Stryker Corporation
• Cirtec Medical
• West Pharmaceutical Services
• Nipro Corporation
• Tegra Medical
• Trelleborg Sealing Solutions
• Eurofins Scientific
• Forefront Medical Technology
• Oscor Inc.
• Nolato AB

Competitive Landscape:

The competitive landscape in the global Medical Device Contract Manufacturing market is highly dynamic, marked by presence of both established players and emerging companies. Leading contract manufacturers, such as Jabil, Flex Ltd., TE Connectivity, Celestica Inc., and Sanmina Corporation, maintain an edge in the market due to vast experience, extensive global reach, and expertise in handling production of complex medical devices. These companies focus on innovation, quality control, and compliance with stringent regulatory standards to cater to the growing demand for advanced medical technologies. Dominance is also supported by these companies offering end-to-end solutions, from design and development to assembly and packaging, ensuring the efficient delivery of high-quality products.

To maintain market position and expand consumer base, leading companies are adopting key strategies, partnerships, and collaborations to access new technologies and markets. Partnerships with OEMs and healthcare providers enable contract manufacturers to meet specific demands and expand their offerings. Another strategy is geographical expansion, with companies increasingly investing in emerging markets like Asia Pacific and Latin America, where the medical device industry is growing rapidly due to rising healthcare infrastructure and product demand.

Technological innovation is also critical for maintaining a competitive edge, and increasing number of companies are integrating AI, automation, robotics, and 3D printing technologies to improve production efficiency, reduce costs, and enhance product customization. In addition, focusing on sustainability and eco-friendly manufacturing processes is becoming increasingly important, as consumers and regulatory bodies demand more environmentally responsible practices. These strategies are aiding leading companies to strengthen their position in the competitive landscape while catering to the evolving needs of the healthcare industry.

Recent Developments

• September 25, 2024: Sanner Group, which is a global leader in healthcare packaging and Medical Device Contract Manufacturing, announced the acquisition of Gilero LLC, which is a prominent medical device design, development, and manufacturing firm based in Durham, North Carolina. This acquisition strengthens Sanner’s position as a top provider of comprehensive services in the drug delivery, diagnostics, and medical device sectors. Gilero's expertise in design, development, assembly, packaging, and contract manufacturing complements Sanner's existing offerings, enhancing its integrated solutions for clients in the medical and pharmaceutical industries.
• September 23, 2024: Integer Holdings Corporation, which is a leading contract development and manufacturing organization for medical devices, announced it has completed significant expansions in Ireland. Integer officially inaugurated a new European innovation and manufacturing hub in Galway on September 20, and the facility spans 67,000 square feet and represents a US$ 30 million investment aimed at meeting rising demands for research, development, and manufacturing capacity for catheters, medical textiles, and delivery systems. Earlier in the month, Integer also opened an 80,000-square-foot expansion to its guidewire manufacturing facility in New Ross, County Wexford, Ireland, further enhancing production capabilities in the region.
• September 17, 2024: Molex, the parent company of Phillips-Medisize, which is a prominent player in pharmaceutical drug delivery, in vitro diagnostics, and medtech device design and manufacturing, announced that its affiliate, Molex Asia Holdings LTD., has reached an agreement to acquire Vectura Group Limited (Vectura). Vectura, based in Chippenham, UK, specializes in the design and formulation of inhalation drug delivery devices and was previously part of Vectura Fertin Pharma Inc., which is a subsidiary of Philip Morris International (PMI). With this acquisition, Phillips-Medisize and Vectura aim to expand their portfolio, particularly in inhalation-based drug delivery solutions, leveraging combined expertise to support a wider range of innovative drug-device combination products.

Frequently Asked Questions:

Q: What is the global Medical Device Contract Manufacturing market size in 2024 and what is the projection for 2034?

A: The global Medical Device Contract Manufacturing market size was calculated at USD 81.19 billion in 2024 and expected to reach USD 216.41 billion in 2034

Which regional market accounted for largest revenue share in 2023, and what is the expected trend over the forecast period?

A: North America is expected to account for largest revenue share in the global market over the forecast period.

Q: Which are the major companies are included in the global Medical Device Contract Manufacturing market report?

A: Major companies in the market report are Jabil Healthcare, Flex Ltd., Medtronic, Phillips-Medisize (a Molex Company), TE Connectivity, Sanmina Corporation, Celestica Inc., Integer Holdings Corporation, Plexus Corp., Benchmark Electronics, Stryker Corporation, Cirtec Medical, West Pharmaceutical Services, Nipro Corporation, Tegra Medical, Trelleborg Sealing Solutions, Eurofins Scientific, Forefront Medical Technology, Oscor Inc., Nolato AB.

Q: What is the projected revenue CAGR of the global Medical Device Contract Manufacturing market over the forecast period?

A: The global Medical Device Contract Manufacturing market is expected to register a CAGR of 10.3% between 2025 and 2034.

Q: What are some key factors driving revenue growth of the Medical Device Contract Manufacturing market ?

A: Some key factors driving market revenue growths are increasing number of original equipment manufacturers outsourcing to medical device contract manufacturing companies to reduce overall costs, reach products faster to market, and address rising demand for medical devices and equipment driven by increasing prevalence of various diseases and medical conditions and need for drugs and medications for treatment, care, and improved patient outcomes.