Medical Device Contract Manufacturing Market to Reach USD 216.41 Bn by 2035

Vantage Market Research releases its latest comprehensive report on the ‘Medical Device Contract Manufacturing Market’ with a forecast period of 2025-2034. In 2023, the global medical device contract manufacturing market size was USD 73.61 billion, and is calculated at USD 81.19 billion in 2024. The medical device contract manufacturing market is projected to reach USD 216.41 billion in 2034, and register a revenue CAGR of 10.3% over the forecast period (2025-2034).

Market Overview:

The global medical device contract manufacturing market is gaining traction more recently as an increasing number of contract manufacturing companies and Original Equipment Manufacturers (OEMs) enter into collaborations and strategic partnerships and agreements for the manufacture of new and advanced medical devices and equipment. This surge is primarily driven by increasing prevalence of chronic diseases, aging global population and increasing need to address age-related diseases and conditions, and growing need for medical treatments, drugs, and patient care worldwide. 

In addition, advancements in technology and shift toward value-based healthcare, and adoption of cutting-edge technologies, such as additive manufacturing (3D printing), robotics, and automation, are transforming both medical practices and device production. These technologies allow for rapid prototyping and highly customized devices, improving patient outcomes and operational efficiency. Moreover, the integration of Artificial Intelligence (AI), Machine Learning (ML), and the Internet of Things (IoT) into production and operation processes is enhancing quality control and streamlining workflows. 

Moreover, demand for and use of wearable and remote monitoring devices continues to grow, driven by the post Covid-19 pandemic telemedicine trend, and OEMs are increasingly turning to contract manufacturers for support to cater to this rising demand. In addition, rising regulatory standards in key regions, particularly North America and Europe, are encouraging partnerships with experienced manufacturers to navigate compliance challenges. Leading contract manufacturers such as Jabil, Flex Ltd., and TE Connectivity are playing a key role in shaping the industry. Their expertise in various medical technologies, combined with global supply chains and state-of-the-art production facilities, makes them valuable partners to OEMs worldwide.

Looking ahead, trends like sustainability, personalized medicine, and the continued adoption of digital health solutions are expected to drive further market growth. Contract manufacturing is becoming an essential strategic solution, enabling OEMs to focus on their core competencies while meeting the increasing demand for sophisticated, high-quality medical devices.

However, factors such as high regulatory compliance costs and complexities,  Intellectual Property (IP) and data security concerns, and R&D and innovation limitations in outsourcing are expected to have a negative impact on potential growth of the global medical device contract manufacturing market. 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 US Food and Drug Administration (FDA) approval and CE marking demands substantial investment in quality assurance and regulatory management, which can increase production costs. This may retrain smaller OEMs as additional costs can be prohibitive, especially for lower-margin devices. 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. 

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.

Some Key Takeaways:

• 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 Asia Pacific medical device contract manufacturing market is expected to register fastest revenue growth rate over the forecast period. 
• China, India, and Japan are expected to continue to remain major revenue contributors to the Asia Pacific market over the forecast period. 
• OEMs are increasingly opting to outsource manufacturing contracts to leading countries in APAC due to cost-effective manufacturing capabilities and rising demand for affordable medical devices in the region.
• Europe medical device contract manufacturing market is expected to continue to account for a sizable revenue share contribution to the global market over the forecast period.
• Germany, Switzerland, and Ireland at the forefront of medical device manufacturing, with strong industrial base and innovation in diagnostic devices and surgical instruments.
• 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).. 
• 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.
• The diagnostic imaging devices segment among the device type segments is expected to account for largest revenue share over the forecast period.
• The device development and manufacturing services segment among the service type segments is expected to account for largest share over the forecast period.
• The competitive landscape in the global medical device contract manufacturing market is highly dynamic, marked by presence of both established players and emerging companies. 
• Major players such as 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. 

Company List:

• Medtronic
• Flex Ltd.
• Jabil Healthcare
• Boston Scientific
• TE Connectivity
• Plexus Corp.
• Conmed Corporation
• Stryker Corporation
• Zimmer Biomet
• B. Braun Melsungen
• 3M Health Care
• Fujifilm Holdings
• Merit Medical Systems
• Philips Healthcare
• Hon Hai Precision Industry (Foxconn) 

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.

Global 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

Regional Segmentation: 

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