GVR Report cover Medical Device Contract Manufacturing Market Size, Share & Trends Report

Medical Device Contract Manufacturing Market Size, Share & Trends Analysis Report By Product (Class I, Class II, Class III), By Services, By Therapeutic Area, By End-use, By Region, And Segment Forecasts, 2025 - 2030

  • Report ID: GVR-4-68040-498-9
  • Number of Report Pages: 150
  • Format: PDF, Horizon Databook
  • Historical Range: 2018 - 2023
  • Forecast Period: 2025 - 2030 
  • Industry: Healthcare

Market Size & Trends

The global medical device contract manufacturing market size was estimated at USD 76.80 billion in 2024 and is projected to grow at a CAGR of 12.36% from 2025 to 2030. The medical device industry across the globe is rapidly evolving with the increasing burden of diseases, rising requirements for innovative medical device products, and cost-effective manufacturing processes. Besides, the CMOs support streamlining medical device companies’ operations, further boosting their efficiency and launching the product to the market quickly.

Medical Device Contract Manufacturing Market Size, By Product, 2020 - 2030 (USD Billion)

Medical device CMOs are driven by increasing outsourcing from OEMs, emerging healthcare needs, and various advantages that CMOs offer, such as scalability and flexibility to enable medical device companies to respond quickly to market fluctuations. With the support of CMOs, medical device companies can further focus on their core competencies, like R&D and marketing, while leveraging expertise, scalability, and cost-efficiency.

Moreover, increasing demand for wearable medical devices, rapid advancements in material sciences, and complexities of medical devices are among the factors anticipated to contribute to the market growth. Besides, the rising requirement for personalized medical devices has further fueled the need for contract manufacturing services. In addition, strategic partnerships between OEMs and contract manufacturers continue to expand and meet the demands of global populations. Furthermore, emerging medical device companies rely on outsourcing services due to the growing medical device innovation trials expected to drive the demand for medical device CMOs services. In addition, the rising number of market players serves as an extension of medical device development, providing expertise & guidance on the design is expected to drive the market need. Such factors are anticipated to drive the market. 

Market Concentration & Characteristics

The medical device contract manufacturing industry growth stage is medium, and growth is accelerating. The market is characterized by the level of M&A activities, degree of innovation, regulatory impact, product expansions, and regional expansions.

Recent advances in Wearable and IoT devices are expected to influence R&D. In addition, AI integration and robotics are rapidly evolving high-throughput new medical device innovation, further driving the market growth. The growing innovation supports simple user interfaces, long-life rechargeable batteries, and low-power components along with low costs.

Medical Device Contract Manufacturing Industry Dynamics

Stringent global regulatory standards and the need to comply with agencies such as the FDA, EU, & other regional authorities. The evolving environmental safety, sustainability & efficacy regulations further impact the market's adherence to guidelines, influencing market competition and growth.

Most small and medium-sized enterprises (SMEs) lack the resources and capital for medical device production. This factor has led to rising partnerships and mergers among companies to expand their service offerings. This competitive dynamic can further enhance the market positively.

The increasing outsourcing requirement for the cost-efficient production of specialized devices is expected to boost the market. In addition, collaboration and acquisition to develop medical devices for improving health fuels the market.

CMOs are expanding their global footprint to cater to the increased need of patients and clients to access new markets. This includes establishing facilities in emerging markets to capitalize on growing demand and reduced operating costs, further fueling the market growth.

Product Insights

The market is segmented into Class I, Class II, and Class III. The class II segment led the market with the largest revenue share of 81.25% in 2024. The high segment growth is primarily attributable to the rising prevalence of chronic diseases, growing aging populations, and technological advancements that have expanded the segment growth. Besides, the growing adoption of wearables and IoT devices has accelerated segment growth. In addition, favorable regulatory frameworks, such as the FDA's 510(k) clearance process and evolving healthcare trends, are expected to fuel the segment. Moreover, increasing demand for user-friendly, portable, and minimally invasive devices contributes to market growth. In addition, these devices have higher risk involved than Class I devices as these are to be in continuous contact with patients, which include diagnostic tools and equipment.

The Class III segment is expected to grow at the fastest CAGR of 11.48% over the forecast period. Class III medical devices are driven by increasing demand as they are critical to patient care and can significantly impact patients' lives. Examples of Class III devices are implantable pacemakers, defibrillators, high-frequency ventilators, cochlear implants, implanted prosthetics, and breast implants. This class requires regulatory from 510k clearance, PMA application, and IDE exemption probable. The category includes 10% of all medical devices. In addition, these are safer and more effective. Such factors are anticipated to drive the segment growth.

Services Insights

Based on the services, the market is segmented into accessories manufacturing, assembly manufacturing, component manufacturing, device manufacturing, packaging and labeling, and others. The accessories manufacturing segment led the market with the largest revenue share of 48.7% in 2024, owing to increasing demand for medical device components as they support enhancing device performance. For example, accessories, such as connectors, catheters, sensors, and adapters, play a significant role in optimizing the performance of surgical tools, diagnostic equipment, and monitoring systems. Besides, emerging personalized medicine & wearable devices & growing adoption of technologically enabled devices have fueled the segment's growth. In addition, the medical device CMOs offer cost-effective driving the market growth.

Moreover, device manufacturing segments are anticipated to grow at the highest CAGR of 13.16% during the forecast period. Innovations in medical devices such as automation, robotics, IoT integration, and 3D printing have contributed to segment growth. Besides, the segment is rapidly emerging due to the growing aging population, the prevalence of diseases, and the need for cost-efficient medical device products. Such factors are anticipated to enhance the segment growth with enhanced functionality, customization, and scalability, reducing time-to-market.

Therapeutic Area Insights

Based on the therapeutic area, the market is segmented into cardiovascular devices, orthopedic devices, ophthalmic devices, diagnostic devices, respiratory devices, surgical instruments, dental, and others. The cardiovascular devices segment led the market with the largest revenue share of 27.17% in 2024. The segment is driven by the increasing prevalence of cardiovascular diseases such as angina pectoris, myocardial infarction, hypertensive heart disease, rheumatic heart diseases, atrial fibrillation, and congenital heart disease, which has fueled the segment's growth. These devices are complex and require technical competence; hence, contract manufacturing offers to meet regulatory requirements, production, warehousing, and distribution capabilities, which ultimately help market players save costs and sustain rising competition.

The ophthalmic devices segment is expected to grow at a significant CAGR during the forecast period. A key trend in the market is the outsourcing of ophthalmic devices, particularly miniature and micro-processed devices. As a result, the services are commonly outsourced to contract manufacturers, including design and engineering, accessory production, and component manufacturing. Furthermore, original equipment manufacturers (OEMs) primarily outsource testing, sterilization, and packaging activities. Such factors are anticipated to drive the segment growth.

End-use Insight

Based on end use, the market is segmented into original equipment manufacturers (OEMs), pharmaceutical & biopharmaceutical companies, and others. The original equipment manufacturers (OEMs) segment led the market with the largest revenue share of 49.54% in 2024. The high growth of the segment is majorly due to the specialized services offered by OEMs, such as device designs and manufacturing of complete products & systems. In addition, some OEMs offer sub-assemblies or parts, which further contribute to segment growth. These manufacturers ideally perform all functions of parts manufacture, sub-assembly, and final production. Hence, such a wide range of medical devices offered across global medical device OEMs is expected to meet the demand of global populations. Such factors are anticipated to drive the market growth. 

Medical Device Contract Manufacturing Market Share, By End-use, 2024 (%)

The pharmaceutical & biopharmaceutical companies segment is expected to grow at a significant CAGR during the forecast period. The segment is driven by significant funding for medical device innovation, such as personalized medical devices, which is one of the key reasons driving this segment. Furthermore, growing innovations and agreements with market players and research institutes have further promoted segment growth. Besides, the current trend in medical devices for small & portable products, including a variety of therapeutic devices, drug delivery systems, and patient monitors, are all becoming smaller while features & performance are improving, which drives the segment growth. 

Regional Insights

Asia Pacific dominated the medical device contract manufacturing market with the largest revenue share of 41.37% in 2024. This growth can be attributed to various factors, such as rising healthcare expenditure and the availability of several opportunities in this region, especially in Japan, China, and India. In Asia Pacific, the market is expected to grow as it is one of the best options for the medical device industry. The region is emerging as a hub for outsourcing drug discovery activities owing to the lower costs and favorable regulatory environment. The CMOs support medical device companies with new product innovation and technological changes while reducing the need for expensive capital equipment. In addition, contract manufacturing of medical devices supports alleviating many challenges and maintaining a balance between new technologies, a rapidly changing supply chain, and material selection challenges. Moreover, a growing number of medical device production due to the ever-increasing disease burden is one of the key factors likely to drive the market growth.

Medical Device Contract Manufacturing Market Trends, by Region, 2025 - 2030

China Medical Device Contract Manufacturing Market Trends

The medical device contract manufacturing market in China held the largest share in Asia Pacific in 2024. The country is one of the major hubs for medical device outsourcing as it supports cost-efficient manufacturing, and the availability of a skilled workforce endorses the production of complex medical devices. Hence, outsourcing services have become one of the most favored strategies in the country. In addition, recent trends in OEM, the adoption of advanced technologies, and collaborations between domestic manufacturers and global OEMs are expected to drive the market.

The Japan medical device contract manufacturing market accounted for the second-largest revenue share in Asia Pacific in 2024 and is also expected to provide a robust opportunity for medical device contract manufacturing services, further driving the market. The country has an increased aging population and growing incidence of various diseases, which has led to a rise in requirements for market services. Furthermore, the dependence on CMO industry players is expected to propel the demand for medical device contract manufacturing. In addition, government healthcare programs and policies to control pricing are anticipated to increase the demand for medical device contract manufacturing in this region.

The medical device contract manufacturing market in India is anticipated to witness at a significant CAGR over the forecast period, owing to the growing number of specialized services offered by contract manufacturers that can enhance efficiency and outcomes. Besides, the presence of cost-efficient production services and extensive expertise support is expected to drive the market.

North America Medical Device Contract Manufacturing Market Trends

The medical device contract manufacturing market in North America is projected to register at a significant CAGR during the forecast period. This can be attributed to technological advancements, growing demand for cutting-edge medical devices, presence of established healthcare, and increasing requirements for outsourcing among medical device companies to reduce operational costs, which is expected to drive efficiency, innovation and save cost for R&D. Moreover, there is increasing adoption of technology such as 3D printing, automation, robotics, and AI-driven processes for high maintenance and efficient systems has led rise in the need for medical device contract manufacturing services.

Moreover, medical device contract manufacturers support medical device companies to focus on core capabilities, sharing associated risks, and improving service delivery, which are pertinent to gaining competitive advantages. In addition, the region’s growing R&D investment, rise in the incidence of various diseases, and increasing need for efficiency, quality, and innovation are driving the market growth in North America.

U.S. Medical Device Contract Manufacturing Market Trends

The medical device contract manufacturing market in the U.S. held the largest share in North America in 2024. In the U.S., the medical device industry makes a range of medical device products. It plays a crucial role in developing new medical technologies that can improve the ability to diagnose and treat various diseases. The growing number of OEMs outsourcing medical device manufacturing, the increasing need for innovative drug options, escalating disease prevalence, the surge in partnerships, and the presence of diversified companies that are mainly engaged in the research and development of new devices for specific therapeutic areas have led to a rise in requirements for services. These services offer scalable solutions, advanced capabilities, and shorter time-to-market, making them strategic partners for device production.

Moreover, companies are outsourcing parts of their regulatory functions to regulatory service providers, further fueling the medical device outsourcing market in the country. Presence of major players such as Jabil Inc., Thermo Fisher Scientific Inc., and Integer Holdings Corporation. FLEX LTD. and Sanmina Corporation are contributing to market growth.

Europe Medical Device Contract Manufacturing Market Trends

The medical device contract manufacturing market in Europe is expected to grow at a significant CAGR during the forecast period, due to the rising demand for biopharmaceutical products and the increasing focus on optimizing resources & costs, facilitating a greater emphasis on innovation capabilities, further fueling medical device production. Besides, most contract manufacturers adopt advanced technologies for medical device production, assembly, and related development, benefiting from the latest technology. In addition, medical device contract manufacturers offer high-quality product production with cost efficiencies and deliver improved operational efficiency, further building long-lasting customer relationships. In addition, the presence of a skilled workforce, well-developed infrastructure, favorable regulatory policies, and increasing adoption of personalized medical devices are expected to drive the market.

The Germany medical device contract manufacturing market accounted for the largest revenue share in 2024. The market is driven by medical technology and the presence of established, small, and medium-sized companies or sub-groups of larger companies. In addition, stringent regulations and evolving standards require contract manufacturers to adopt quality management systems that adhere to proper manufacturing practices, ensuring compliance and patient safety. Moreover, growing demand for wearable and IoT-enabled devices drives demand for micro-manufacturing and advanced electronics integration, which is expected to drive the German market.

The medical device contract manufacturing market in the UK is anticipated to grow at the fastest CAGR over the forecast period. This growth is primarily due to the growing need for contract manufacturing for efficient and effective medical device production to reduce the time to market, further fueling the market. Besides, these CMOs mostly offer regulated services for medical devices, further providing quality assurance, maintaining production costs, and ensuring quality and patient safety. Such factors are anticipated to drive the market. 

Key Medical Device Contract Manufacturing Company Insights

Market players are undertaking various strategic initiatives, such as the launch of new product partnerships, collaborations, and mergers & acquisitions, to strengthen their service portfolio and provide a competitive advantage. For instance, in August 2023, Eurofins BioPharma Product Testing acquired ENCO, expanding its ophthalmic and medical device capabilities. The acquisition enhanced the company’s presence in the southeast U.S. and brought in more experience in ophthalmic products, medical devices, & animal health.

Key Medical Device Contract Manufacturing Companies:

The following are the leading companies in the medical device contract manufacturing market. These companies collectively hold the largest market share and dictate industry trends.

  • Jabil Inc.
  • Thermo Fisher Scientific Inc.
  • Integer Holdings Corporation
  • FLEX LTD.
  • Sanmina Corporation
  • Celestica Inc.
  • Phillips-Medisize
  • Plexus Corp.
  • Nipro Corporation
  • Viant Technology LLC
  • West Pharmaceutical Services, Inc.
  • Mack Molding
  • Cirtec Medical
  • Cogmedix
  • Synecco Ltd
  • TE Connectivity
  • Keller Technology Corp.
  • HDA Technology, Inc.

Recent Developments

  • In June 2024, Donatelle Plastics Incorporated, a medical device contract manufacturer that designs, develops, and manufactures medical components and devices, was acquired by DuPont. The acquisition will bring advanced technologies and capabilities, including medical device injection molding, precision machining, device assembly, liquid silicone rubber processing, and tool building.

  • In December 2023, Visura Technologies Inc. and YKK Corporation of America launched Evevo Manufacturing LLC, a new joint venture that will serve emerging medical device companies in Minneapolis.This is an opportunity to build a new contract manufacturer for start-ups and young companies.

  • In March 2023, Millstone Medical Outsourcing announced the completion of the cleanroom space expansion. The expansion has added 5,000 square feet of Class 10,000/ISO7-rated cleanroom space specifically for medical device packaging. 

Medical Device Contract Manufacturing Market Report Scope

Report Attribute

Details

Market size value in 2025

USD 84.86 billion

Revenue forecast in 2030

USD 151.98 billion

Growth rate

CAGR of 12.36% from 2025 to 2030

Base year for estimation

2024

Historical Year

2018 - 2023

Forecast period

2025 - 2030

Quantitative units

Revenue in USD million/billion and CAGR from 2025 to 2030

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Product, services, therapeutic area, end-use, region

Regional scope

North America; Europe; Asia Pacific; Latin America; MEA

Country scope

U.S.; Canada; Mexico; UK; Germany; France; Italy; Spain; Denmark; Sweden; Norway; Japan; China; India; Thailand; South Korea; Australia; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait

Key companies profiled

Jabil Inc.; Thermo Fisher Scientific Inc.; Integer Holdings Corporation; FLEX LTD.; Sanmina Corporation; Celestica Inc.; Phillips-Medisize; Plexus Corp.; Nipro Corporation; Viant Technology LLC; West Pharmaceutical Services, Inc.; Mack Molding; Cirtec Medical; Cogmedix; Synecco Ltd; TE Connectivity; Keller Technology Corp.; HDA Technology, Inc.

Customization scope

Free report customization (equivalent up to 8 analysts’ working days) with purchase. Addition or alteration to country, regional & segment scope.

Pricing and purchase options

Avail customized purchase options to meet your exact research needs. Explore purchase options

Global Medical Device Contract Manufacturing Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global medical device contract manufacturing market report based on product, services, therapeutic area, end-use and region:

  • Product Outlook (Revenue, USD Million, 2018 - 2030)

    • Class I

    • Class II

    • Class III

  • Services Outlook (Revenue, USD Million, 2018 - 2030)

    • Accessories Manufacturing

    • Assembly Manufacturing

    • Component Manufacturing

    • Device Manufacturing

    • Packaging and Labeling

    • Others

  • Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)

    • Cardiovascular Devices

    • Orthopedic Devices

    • Ophthalmic Devices

    • Diagnostic Devices

    • Respiratory Devices

    • Surgical Instruments

    • Dental

    • Others

  • End-use Outlook (Revenue, USD Million, 2018 - 2030)

    • Original Equipment Manufacturers (OEMs)

    • Pharmaceutical & Biopharmaceutical Companies

    • Others

  • Regional Outlook (Revenue, USD Million, 2018 - 2030)

    • North America

      • U.S.

      • Canada

      • Mexico

    • Europe

      • UK

      • Germany

      • France

      • Italy

      • Spain

      • Denmark

      • Sweden

      • Norway

    • Asia Pacific

      • Japan

      • China

      • India

      • Thailand

      • South Korea

      • Australia

    • Latin America

      • Brazil

      • Argentina

    • Middle East & Africa

      • South Africa

      • Saudi Arabia

      • UAE

      • Kuwait

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