Global Medical Device Contract Manufacturing Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• In January 2023, Integer announced the acquisition of Pulse Technologies, Inc., a privately held technology, engineering, and contract manufacturing company. Pulse Technologies focuses on complex micro machining of medical device components for high-growth markets, including structural heart, heart pump, electrophysiology, leadless pacing, and neuromodulation.

• In November 2023, Jabil Inc. announced the successful acquisition of Retronix, an innovative provider specializing in the reclamation and refurbishment of electronic components. This acquisition was completed earlier in the year.

• In January 2022, MixComm, a pioneer in mmWave antennas to algorithms, selected Advanced Microsystems Technologies, a division of Sanmina, as a lead partner to productize its 5G wireless infrastructure solutions.

• November 2021, Nipro Corporation entered into a partnership with Toyobo for the development of cellulose triacetate (CTA) dialyzers (artificial kidneys).

The segmentation by Device encompasses a diverse range of medical devices that are outsourced for manufacturing purposes. This includes but is not limited to implantable devices, surgical instruments, diagnostic equipment, therapeutic devices, and wearable medical devices. By categorizing the market based on the type of medical devices, stakeholders gain insights into specific market trends, demands, and opportunities within each device category, allowing for tailored strategies and targeted approaches to meet evolving market needs.

The segmentation by Service delineates the various contract manufacturing services offered within the medical device industry. These services may include design and engineering, prototyping, assembly, packaging, sterilization, testing, and regulatory compliance services. By categorizing the market based on services, stakeholders can identify key service providers, assess their capabilities, and evaluate their offerings to align with specific project requirements and objectives.

Geographical segmentation provides a comprehensive view of the Global Medical Device Contract Manufacturing Market across different regions and countries. Key regions covered in this segmentation include North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. Each region presents unique market dynamics, regulatory environments, and growth opportunities for contract manufacturers. By analyzing the market on a geographic basis, stakeholders can identify regional trends, assess market potential, and develop region-specific strategies to capitalize on emerging opportunities and navigate challenges.

Global Medical Device Contract Manufacturing Segment Analysis

In this report, the Global Medical Device Contract Manufacturing Market has been segmented by Device, Service, Class Device and Geography.

Global Medical Device Contract Manufacturing Market, Segmentation by Device

The Global Medical Device Contract Manufacturing Market has been segmented by Device into IVD Devices, Diagnostic Imaging Devices, Cardiovascular Devices, Ophthalmology Devices, Orthopedic Devices, Dental Devices and Others.

IVD (In Vitro Diagnostic) Devices represent a critical segment within the medical device contract manufacturing market, encompassing a wide range of diagnostic tests and equipment used to detect diseases, infections, and other medical conditions. This includes laboratory-based instruments, point-of-care testing devices, and reagents used for diagnostic purposes. Diagnostic Imaging Devices constitute another significant segment, comprising medical devices used to create visual representations of the interior of a body for clinical analysis and medical intervention. This encompasses a diverse range of equipment, such as X-ray machines, MRI (Magnetic Resonance Imaging) scanners, CT (Computed Tomography) scanners, ultrasound devices, and nuclear medicine imaging systems.

Cardiovascular Devices represent a vital category within the medical device contract manufacturing market, encompassing devices used to diagnose and treat conditions affecting the heart and circulatory system. This includes pacemakers, defibrillators, stents, catheters, and other implantable and non-implantable cardiovascular devices. Ophthalmology Devices constitute a specialized segment, focusing on medical devices used for the diagnosis, treatment, and management of eye-related conditions and diseases. This includes devices such as intraocular lenses, laser systems for refractive surgery, diagnostic equipment for vision testing, and surgical instruments for ophthalmic procedures.

Orthopedic Devices represent a significant segment within the medical device contract manufacturing market, encompassing devices used for the diagnosis, treatment, and management of musculoskeletal conditions and injuries. This includes implants, prosthetics, orthoses, surgical instruments, and biomaterials used in orthopedic surgeries and procedures. Dental Devices constitute a distinct category within the medical device contract manufacturing market, encompassing devices used for oral health diagnosis, treatment, and restoration. This includes dental implants, prosthetics, orthodontic appliances, imaging equipment, and dental surgical instruments.

Global Medical Device Contract Manufacturing Market, Segmentation by Service

The Global Medical Device Contract Manufacturing Market has been segmented by Service into Device Development and Manufacturing Service, Quality Management Service and Assembly Service.

Device Development and Manufacturing Service encompasses a comprehensive range of services aimed at the design, development, and manufacturing of medical devices. This includes concept development, product design and engineering, prototype development, and full-scale manufacturing of medical devices. Contract manufacturers offering device development and manufacturing services collaborate closely with medical device companies to bring innovative products to market efficiently and cost-effectively. They leverage their expertise in engineering, materials science, and manufacturing processes to translate concepts into high-quality medical devices that meet regulatory requirements and industry standards.

Quality Management Service is another critical component of medical device contract manufacturing, ensuring that products meet stringent quality and regulatory standards throughout the manufacturing process. This service includes quality assurance, quality control, regulatory compliance, and risk management activities aimed at maintaining product quality, safety, and efficacy. Contract manufacturers implement robust quality management systems (QMS) to monitor and control manufacturing processes, perform inspections and testing, and document compliance with regulatory requirements. By adhering to rigorous quality standards, contract manufacturers demonstrate their commitment to delivering safe and effective medical devices that meet the highest industry standards and regulatory expectations.

Assembly Service encompasses the final stage of the manufacturing process, where individual components and subassemblies are assembled into finished medical devices. This service includes mechanical assembly, electrical assembly, testing, and packaging of medical devices according to customer specifications. Contract manufacturers offering assembly services utilize advanced automation, precision machinery, and skilled labor to ensure efficient and accurate assembly of medical devices while maintaining product quality and consistency. By providing comprehensive assembly services, contract manufacturers enable medical device companies to streamline their supply chains, reduce time-to-market, and focus on core competencies such as research, development, and marketing.

Global Medical Device Contract Manufacturing Market, Segmentation by Class Device

The Global Medical Device Contract Manufacturing Market has been segmented by Device into Class I: General controls, Class II: General controls with special controls, and Class III: General controls, special controls.

The Global Medical Device Contract Manufacturing Market can be segmented based on the classification of medical devices into three distinct categories: Class I, Class II, and Class III. Class I medical devices typically include products that are considered low-risk and are subject to general controls by regulatory bodies. These devices usually require minimal regulatory oversight compared to higher-risk categories and often include products such as bandages, handheld surgical instruments, and other basic tools that do not support or sustain life.

Class II medical devices, on the other hand, are considered moderate-risk and are subject to both general controls and special controls. These devices require additional regulatory measures, such as performance testing or specific labeling requirements, to ensure their safety and efficacy. Class II devices can include diagnostic equipment, infusion pumps, and certain types of surgical tools. Manufacturers of Class II devices need to demonstrate that their products meet the required safety standards before they can be marketed.

Class III medical devices are the highest-risk category, which typically includes products that are life-sustaining, life-supporting, or implanted in the body. These devices are subject to the most stringent regulatory requirements, including general controls, special controls, and premarket approval (PMA). Class III devices include items such as pacemakers, heart valves, and implantable devices. Manufacturers of Class III devices must provide substantial evidence of safety and effectiveness through rigorous testing and clinical trials before their products are approved for use.

Global Medical Device Contract Manufacturing Market, Segmentation by Geography

In this report, the Global Medical Device Contract Manufacturing Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Medical Device Contract Manufacturing Market Share (%), by Geographical Region, 2024

North America represents one of the largest and most mature markets for medical device contract manufacturing, driven by robust healthcare infrastructure, technological innovation, and significant investments in research and development. The region is home to numerous contract manufacturing organizations (CMOs) and medical device companies, particularly in the United States, where favorable regulatory policies and access to skilled labor contribute to market growth and innovation.

Europe is another key region in the Global Medical Device Contract Manufacturing Market, characterized by stringent regulatory standards, advanced manufacturing capabilities, and a strong emphasis on quality and compliance. Countries such as Germany, Switzerland, and the United Kingdom are renowned for their expertise in medical device manufacturing and serve as hubs for contract manufacturing services, catering to both domestic and international markets.

The Asia Pacific region is witnessing rapid growth in the medical device contract manufacturing market, driven by factors such as increasing healthcare expenditures, rising demand for medical devices, and the presence of a large pool of skilled labor and manufacturing facilities. Countries like China, Japan, and Singapore are emerging as major players in the contract manufacturing space, leveraging their cost-effective manufacturing capabilities and strategic geographic location to attract investments and expand market share.

In the Middle East and Africa, the medical device contract manufacturing market is experiencing steady growth, supported by investments in healthcare infrastructure, government initiatives to enhance healthcare access, and rising demand for medical devices to address unmet healthcare needs. While the market in this region is relatively nascent compared to other regions, countries such as the United Arab Emirates, South Africa, and Saudi Arabia are emerging as key markets for contract manufacturing services.

Latin America presents significant growth opportunities for medical device contract manufacturers, fueled by increasing healthcare spending, growing medical tourism, and favorable regulatory reforms. Countries like Brazil, Mexico, and Argentina are witnessing growing demand for contract manufacturing services, driven by the need for cost-effective and high-quality medical devices to meet the healthcare needs of their populations.