| Study Period | 2019 - 2030 |
| Market Size (2025) | USD 95.81 Billion |
| Market Size (2030) | USD 156.63 Billion |
| CAGR (2025 - 2030) | 10.33 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Low |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Medical Device Contract Manufacturing Market Analysis
The Global Medical Device Contract Manufacturing Market size is estimated at USD 95.81 billion in 2025, and is expected to reach USD 156.63 billion by 2030, at a CAGR of 10.33% during the forecast period (2025-2030).
Contract manufacturing is one of the growing practices across the medical devices sector. It allows medical device companies to focus on their core competencies, such as research and development (R&D) and strategic planning, among others. Key factors such as the growing demand for medical devices and an increasing number of technological advancements in medical devices are expected to drive market growth over the study period. In addition, the growing demand for customized medical devices, and cost-efficient products are further expected to bolster the demand for contract manufacturing services of medical devices.
Additionally, contract manufacturers' capabilities to scale up and scale down production according to market demand can reduce the capital expenditures of the market players. For instance, according to June 2023 data from Bendable Technology Solutions Private Limited, contract manufacturers have the required manufacturing infrastructure and can quickly scale up and down production to meet market fluctuations. Thus, such capabilities associated with contract manufacturers are likely to heighten their importance in the medical device arena over the coming years.
Furthermore, the growing innovations in medical technology, such as minimally invasive surgical devices, digital health solutions, and advanced materials, necessitate specialized manufacturing capabilities. For instance, according to an article published by the European Cardiology Review (ECR) in August 2023, cardiac devices, including leadless permanent pacemakers, have higher applications in the management of cardiac rhythm issues, and the introduction of advanced battery-less pacemakers has created a significant demand for precise manufacturing to reduce the risk of possible complications. Such evolving medical technology and the requirement for specialized manufacturing capabilities have fueled the demand for medical device contract manufacturers as they have all the required infrastructure, including specialized manufacturing units and regulatory accreditation, among others.
Moreover, the evolving medical device sector worldwide and growing government initiatives to foster the medical devices sector are likely to create new business avenues in medical device manufacturing, and this, in turn, is projected to fuel the industry uptake over the study period. For instance, in April 2023, the Government of India approved a new policy for the medical devices sector in India. Under this initiative, the government initiated the production-linked incentive scheme (PLI) to localize and promote the local manufacturing of medical devices in India. Therefore, such initiatives to foster the medical devices sector push manufacturers to outsource their manufacturing activities to expand their product offerings.
Therefore, the above-mentioned factors, such as technology advancements, growing investment in the medical device arena, and supportive government initiatives to promote contract manufacturing, are expected to accelerate market growth over the forecast period. However, factors such as consolidation in the medical device sector are likely to impede industry uptake over the coming years.
Medical Device Contract Manufacturing Market Trends
IVD Devices Segment is Expected to Witness Considerable Growth Over the Forecast Period
In-vitro diagnostic devices are used to diagnose, treat, or prevent health conditions. They are meant to collect and examine biological samples like blood, saliva, or tissue. With the increasing prevalence of chronic and infectious diseases, the demand for IVD equipment is surging. Furthermore, strategic agreements among market players, designed to reshape the outsourcing landscape of IVD devices, are set further to fuel this segment's growth in the years ahead. For instance, according to the Health Facts Report 2023 published by the Ministry of Health Indonesia, infectious disease and parasitic infections ranked 6th among the ten principal causes of hospitalizations in MOH (Medical Officer of Health) hospitals in 2022. This alarming surge in the paradigm of infectious diseases highlights the need for rapid diagnostics to diagnose disease at the early stage for better outcomes.
In addition, according to November 2023 data from China’s Center for Disease Control and Prevention (CDC), the prevalence rate of reported HIV/Aids cases rose from 1.09 per 100,000 people in the past decade to 79.62 in this decade, an increase of more than 7,000% since the past decade. This anticipated rise in the burden of infectious diseases has created a massive demand for rapid IVD tests, and this trend is anticipated to propel the manufacturing of IVD devices, thereby creating a significant demand for contract manufacturing.
Moreover, expanding business agreements and collaborations between manufacturers to widen contract manufacturing of IVD devices are further anticipated to bolster industry uptake over the coming years. For instance, in April 2024, Prolight Diagnostics appointed FlexMedical Solutions as a contract manufacturing partner to produce disposable cartridges for the Psyros point-of-care system. Similarly, in January 2024, Agape Diagnostics Ltd. and Fujirebio Holdings, Inc. signed a CDMO agreement to manufacture Cartridge CLIA system reagents for immunology devices Mispa i121 and Mispa i60. Such ongoing agreements and deals between market players to transform contract manufacturing practices in the IVD arena are further expected to offer lucrative business opportunities for segment growth.
Hence, the factors mentioned above, including the growing demand for IVD devices amid the increased disease burden and surge in initiatives by market players, are expected to boost market growth over the study period.
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North America Is Expected to Witness Considerable Growth Over the Forecast Period
North America is expected to witness significant growth opportunities over the forecast period. Factors such as the region's increasing demand for medical devices, growing demand for technologically advanced medical devices, and supportive government initiatives to foster medical device manufacturing in North America are anticipated to support the regional market. Moreover, the surge in the burden of chronic diseases has further propelled the demand for new-generation medical diagnostics.
The rise in the burden of chronic diseases in the region is projected to support regional market growth over the forecast period. For instance, according to the American Cancer Society, the estimated number of new cancer cases ramped up from 1.9 million in 2023 to 2.0 million in 2024. The most common type of cancers diagnosed in 2023 were breast, lung, and hematological malignancies. This significant rise in the burden of chronic diseases has created a robust demand for medical devices in the region, and this trend is likely to facilitate regional market expansion over the coming years.
Moreover, growing strategic developments such as acquisitions and mergers in the medical device sector are further expected to offer new growth avenues for market growth in the region. For instance, in January 2024, TekniPlex Healthcare acquired Seisa Medical following their strategic agreement. This acquisition helped TekniPlex Healthcare expand its offerings in minimally invasive and interventional therapies. In addition, it helped the company foster its contract manufacturing capabilities in the medical device sector. Such growing strategic business activities are further expected to shape the regional market uptake.
Therefore, the growing demand for medical devices, the surge in the incidence of chronic diseases, and rising strategic acquisitions are expected to support regional market growth over the study period.
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Medical Device Contract Manufacturing Industry Overview
The medical device contract manufacturing market is fragmented and has several significant players. Key market players are actively pursuing both organic and inorganic strategies to enhance their revenue shares. Some companies currently dominating the market are Biofortuna Limited, Jabil Inc., Synecco, Gerresheimer AG, and Fujirebio.
Medical Device Contract Manufacturing Market Leaders
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Jabil Inc.
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Gerresheimer AG
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Synecco
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Biofortuna Limited
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Fujirebio
- *Disclaimer: Major Players sorted in no particular order
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Medical Device Contract Manufacturing Market News
- July 2024: Tube Investments of India (TII) planned to strengthen contract manufacturing operations for its medical arm by establishing a new facility in Andhra Pradesh, India.
- April 2023: Biomerics completed a 24,000 sq. ft. expansion of its balloon and balloon catheter manufacturing operations at its Texas site. Biometrics is one of the contract manufacturers in the United States.
Medical Device Contract Manufacturing Industry Segmentation
As per the scope of the report, medical device contract manufacturing is an outsourcing model where a company specializes in producing medical devices or components on behalf of another organization, ensuring compliance with industry standards and regulations. This arrangement allows clients to focus on core competencies while leveraging the expertise and resources of contract manufacturers to bring high-quality products to market efficiently.
The market is segmented by devices, services, and geography. By devices, the market is segmented as, (IVD devices, diagnostic imaging devices, cardiovascular devices, drug delivery devices, endoscopy devices, ophthalmology devices, orthopedic devices, dental devices, and other devices. By drug delivery devices, the market is sub-segmented as syringes, pen injectors, and others. By services, the market is segmented as device development and manufacturing services, quality management services, and assembly services. The device development and manufacturing services segment is further sub-segmented as, device engineering service, process development service, and device manufacturing service. In addition, the quality management service is further sub-segmented as inspection & testing service and packaging & validation service. By geography the market is segmented as North America, Europe, Asia Pacific, Middle East and Africa, and South America. The report also covers the market sizes and forecasts for the medical device contract manufacturing market in major countries across different regions. For each segment, the market size is provided in terms of value (USD).
| By Device | IVD Devices | ||
| Diagnostic Imaging Devices | |||
| Cardiovascular Devices | |||
| Drug Delivery Devices | Syringes | ||
| Pen Injectors | |||
| Others | |||
| Endoscopy Devices | |||
| Ophthalmology Devices | |||
| Orthopedic Devices | |||
| Dental Devices | |||
| Other Devices | |||
| By Service | Device Development and Manufacturing Service | Device Engineering Service | |
| Process Development Service | |||
| Device Manufacturing Service | |||
| Quality Management Service | Inspection & Testing Service | ||
| Packaging Validation Service | |||
| Assembly Service | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle-East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
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Medical Device Contract Manufacturing Market Research FAQs
How big is the Global Medical Device Contract Manufacturing Market?
The Global Medical Device Contract Manufacturing Market size is expected to reach USD 95.81 billion in 2025 and grow at a CAGR of 10.33% to reach USD 156.63 billion by 2030.
What is the current Global Medical Device Contract Manufacturing Market size?
In 2025, the Global Medical Device Contract Manufacturing Market size is expected to reach USD 95.81 billion.
Who are the key players in Global Medical Device Contract Manufacturing Market?
Jabil Inc., Gerresheimer AG, Synecco, Biofortuna Limited and Fujirebio are the major companies operating in the Global Medical Device Contract Manufacturing Market.
Which is the fastest growing region in Global Medical Device Contract Manufacturing Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Global Medical Device Contract Manufacturing Market?
In 2025, the North America accounts for the largest market share in Global Medical Device Contract Manufacturing Market.
What years does this Global Medical Device Contract Manufacturing Market cover, and what was the market size in 2024?
In 2024, the Global Medical Device Contract Manufacturing Market size was estimated at USD 85.91 billion. The report covers the Global Medical Device Contract Manufacturing Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Global Medical Device Contract Manufacturing Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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Global Medical Device Contract Manufacturing Industry Report
The report on Medical Device Contract Manufacturing provides a comprehensive market overview, detailing the market share, market size, and industry analysis. The report covers various device segments such as IVD devices, diagnostic imaging devices, cardiovascular devices, drug delivery devices, endoscopy devices, ophthalmology devices, orthopedic devices, dental devices, and other devices. It also includes insights into services like device development and manufacturing service, quality management service, and assembly service.
The industry report highlights the global market trends and provides an in-depth market analysis. The report also includes a market forecast, offering an industry outlook and market predictions up to the specified year. The market growth and market leaders are evaluated, presenting a clear picture of the market segmentation and market value.
Geographically, the report segments the market into North America, Europe, Asia-Pacific, Middle East and Africa, and South America, providing detailed market data for each region. The industry research includes a historical overview and a market review, ensuring a thorough understanding of the market dynamics.
The report example includes industry reports and a free report PDF download, offering valuable industry information and industry statistics. The report also discusses the market outlook, industry trends, and growth rate, providing a holistic view of the market. Research companies and industry sales are also covered, ensuring a comprehensive market review.
