MEDTECH & BIOPHARMA DEVICE CMO/CDMO MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2026 - 2033)

Global MedTech & Biopharma Device CMO/CDMO Market Size and Forecast – 2026 To 2033

The global medtech & biopharma device CMO/CDMO market is expected to grow from USD 110,227.2 Mn in 2026 to USD 271,758.5 Mn by 2033, registering a compound annual growth rate (CAGR) of 13.8% from 2026 to 2033. The market for medtech & biopharma device CMO/CDMO is poised for significant expansion, fueled by the growing outsourcing of medical device and drug-device combination product development and manufacturing activities by pharmaceutical, MedTech, and biotechnology companies.

According to India Brand Equity Foundation, India's medical device exports surged 88% between FY2019 and FY2025 to reach USD 3.64 billion (Rs. 31,120 crore), highlighting the increasing scale of global medical device manufacturing and supply chain outsourcing activities.

(Source: India Brand Equity Foundation)

Key Takeaways of the Global MedTech & Biopharma Device CMO/CDMO Market

• Medical devices are projected to hold 52.1% of the global medtech & biopharma device CMO/CDMO market share in 2026, making it the dominant product/device type segment across North America due to the region's large medical technology industry and strong outsourcing adoption among device manufacturers. For instance, the U.S. medical technology sector comprises more than 6,500 medical device companies, creating substantial demand for outsourced design, engineering, and manufacturing services.
• Contract manufacturing is projected to hold 39.8% of the global medtech & biopharma device CMO/CDMO market share in 2026, making it the dominant service type segment across Asia Pacific due to the region's expanding manufacturing infrastructure, cost advantages, and increasing investments in medical technology production. For instance, the Government of India allocated USD 400 million (Rs.3,420 crore) under the Production Linked Incentive (PLI) Scheme for Medical Devices to strengthen domestic manufacturing capabilities and attract global production contracts. The initiative is expected to further support outsourcing activities and contract manufacturing demand across the region.
• Class I is projected to hold 48.2% of the global medtech & biopharma device CMO/CDMO market share in 2026, making it the dominant device class segment across Europe due to the high production volume of low-risk medical consumables, healthcare accessories, and diagnostic products. For instance, the European medical technology market was valued at approximately USD 172.8 billion (€160 billion) in 2023, accounting for 26.1% of the global medical device market, reflecting the region's strong manufacturing base and extensive commercialization of lower-risk medical devices. The large-scale production of such products continues to support outsourcing demand for Class I device manufacturing across the region.
• North America maintains its dominance with an expected share of 37.3% in 2026, bolstered by the presence of a mature medical technology ecosystem, advanced manufacturing infrastructure, and strong adoption of outsourced product development and manufacturing services. For instance, according to AdvaMed's statistical June 2023 update, the U.S. medical technology industry generated approximately USD 148.7 billion in revenues and shipments, highlighting the scale of medical device manufacturing activities that support the demand for specialized CMO/CDMO services across the region.
• Asia Pacific is expected to exhibit the fastest growth with an estimated contribution of 27.7% share in 2026, driven by expanding medical device manufacturing capabilities, increasing healthcare investments, and supportive government initiatives aimed at strengthening regional MedTech production. The region continues to attract outsourcing contracts owing to its cost-efficient manufacturing base and growing technical expertise. For instance, Singapore produces more than 10% of the world's medical devices by value and serves as a major manufacturing hub for several leading global MedTech companies, reinforcing the region's importance in contract development and manufacturing activities.
• Growing Adoption of Smart and Connected Medical Devices: The increasing adoption of AI-enabled, connected, and software-integrated medical devices is driving demand for specialized CMO/CDMO services. These next-generation devices require expertise in design, engineering, regulatory compliance, validation, and precision manufacturing, prompting MedTech and biopharma companies to outsource development and production. As product complexity continues to rise, outsourcing partners play a critical role in accelerating commercialization while ensuring quality and regulatory compliance.
• Expansion of Connected and Smart Medical Device Manufacturing: The rapid emergence of connected drug delivery devices, remote monitoring systems, and digital health-enabled medical technologies is creating new opportunities for MedTech CMO/CDMOs. Manufacturers are increasingly seeking partners capable of integrating electronics, sensors, software, and data connectivity into medical devices while meeting stringent regulatory requirements. This shift is enabling CDMOs to move beyond traditional manufacturing and offer higher-value engineering, design, and lifecycle management services.

Segmental Insights

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Why Do Medical Devices Dominate the Global MedTech & Biopharma Device CMO/CDMO Market?

Medical devices are projected to hold a market share of 52.1% in 2026, fueled by the increasing reliance of MedTech and Biopharma OEMs for product design, prototyping, engineering and commercial manufacturing outsourced services. Modern medical technologies require an increased level of sophisticated and advanced design with MedTech and Biopharma CMO/CDMO partners offering efficient, innovative and proven product design, prototype, engineering and commercial manufacturing processes. For instance, in November 2025, TE Connectivity expanded its prototyping capabilities in the U.S. with two PROPELUS Prototype Centers in Oregon and Minnesota. These centers provide medical device companies faster development of next-generation devices, leading to quick commercialization. (Source: TE Connectivity)

Why Does Contract Manufacturing Represent the Largest Service Type Segment in the MedTech & Biopharma Device CMO/CDMO Market?

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Contract manufacturing is projected to hold a market share of 39.8% in 2026, due to rapid increasing demand from device OEM customers to outsource commercial production to dedicated providers for greater scalability, improved manufacturing efficiency, faster time-to-market, and reduced capital expenditure. CMO/CDMOs possess broad end-to-end services including precision manufacturing, clean room assembly, sterilization, packaging, and world-wide distribution logistics. For instance, in September 2025, Freudenberg Medical expanded its Costa Rican operations with a USD 25 million investment into a second production facility. The facility aims at increasing capabilities of AI, virtual reality technologies, to boost production efficiencies while meeting greater customer needs for medical device outsourced manufacturing. (Source: Freudenberg Medical)

Class I Segment Dominates the Global MedTech & Biopharma Device CMO/CDMO Market

The Class I segment is projected to hold a market share of 48.2% in 2026, attributed to high volumes of product, well-established processes and extensive use in everyday medical care. Since their risks are lower, Class I device manufacturing entails fewer regulations and thus is suitable for outsourced production in volumes at lower costs. For instance, according to the U.S. FDA, the vast majority of Class I medical device types are exempt from Premarket Notification (510(k)) and permit manufacturers to market a broad range of low-risk devices based upon general controls-also boosting a high volume of contract manufacturing and time to market. (Source: Food and Drug Administration)

Currents Events and their Impact

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(Source: Food and Drug Administration, Food and Drug Administration)

MedTech & Biopharma Device CMO/CDMO Market Dynamics

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Market Drivers

• Rising Outsourcing of Medical Device Manufacturing: Medical device manufacturers are turning to external, specialized OEM contract manufacturing organizations to ensure their products achieve market launch faster by scaling manufacturing capacity, accessing cutting-edge technologies, lowering production risk and the number of resources invested. Device complexity, especially around minimally invasive, implantable devices, also means that the specialized engineering and manufacturing expertise only available from OEM Contract Development and Manufacturing Organizations is in greater demand than ever. For instance, in September 2024, Integer Holdings finished two facility enhancements in Ireland. A new innovative medical device manufacturing site in Galway and a larger guidewire manufacturing facility in New Ross, enhancing its capabilities to address a wide array of customers’ outsourced manufacturing of complicated medical devices needs.
• Growing Demand for Drug-Device Combination Products: The growing trend of biologics and self-care applications is creating strong demand for drug-device combinations, like autoinjectors, pre-filled syringes, wearable and respiratory delivery devices, etc. Delivering these products often involves specific device engineering skills, as well as specialized Sterile Filling / Packaging, device Assembly, and supply-chain solutions. Thus, many pharmaceutical innovators are now turning to experienced Contract Manufacturing Organizations (CMOs / CDMOs). For instance, on June 15, 2026, Ensera and Argonaut Manufacturing Services established a new strategic partnership aimed at simplifying and optimizing drug-device combination product development, manufacturing and supply, to provide integrated services from initial design through commercial production.

Emerging Trends

• Increasing Adoption of Design-for-Manufacturing (DfM) and Early Engineering Support: Biopharma companies and MedTech OEMs are integrating CMO/CDMOs into product development very early in the life-cycle. This integration addresses device design, manufacturability, and regulatory readiness to shorten development, time-to-market and production costs.
• Rising Investment in High-Mix, Low-Volume Manufacturing Capabilities: To accommodate the increasing demand for highly specialized custom medical devices, minimally invasive devices and new specialized therapeutic products, the CMOs and CDMOs offer flexible manufacturing lines, which allow for quicker delivery time of devices and ensure top quality & quality compliance of product lines.

Regional Insights

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Why is North America a Strong Market for MedTech & Biopharma Device CMO/CDMO?

North America leads the global medtech & biopharma device CMO/CDMO market, accounting for an estimated 37.3% share in 2026, driven by the region's success in developing highly complex medical devices, combination drug-device products and digitally enabled healthcare technologies. North America has mature capabilities in high-precision device manufacturing, design for manufacturing, sterilization, and robust regulatory expertise in managing highly complex medical devices. A favorable regulatory landscape, together with ongoing commitment from stakeholders to foster device innovation, quality manufacturing, and market readiness, further accelerates the acceptance of outsourced solutions for device development and manufacturing.

For instance, the U.S. FDA’s Breakthrough Devices Program aims to fast track the development, review and marketing clearance of qualified medical devices and combination products that have the potential to treat or diagnose conditions that are life-threatening or irreversibly debilitating. Through this program, sponsors gain early U.S. FDA collaboration and are placed into prioritized regulatory review programs that spur further invention and commercialization, boosting the demand for specialized CMO/CDMOs that offer a full continuum of device development support, regulatory expertise, and manufacturing services. (Source: Food and Drug Administration)The demand for sophisticated biologics delivery systems, the trend towards connected medical devices and the demand for comprehensive, end-to-end outsourced solutions will further consolidate North America’s position as an industry leader.

Why Does the Asia Pacific MedTech & Biopharma Device CMO/CDMO Market Exhibit High Growth?

The Asia Pacific medtech & biopharma device CMO/CDMO market is expected to exhibit the fastest growth with an estimated contribution of 27.7% share to the global market in 2026, driven by accelerating expansion of advanced medical device production capabilities, an augmenting manufacturing strength in precision engineering, and increasing production of drug-device combination products. The region provides the market players a relatively cost-effective manufacturing base and extensive capacity and engineering talent pools for intricate medical device manufacturing.

Government driven initiatives, that aim at increasing domestic production and technological intensification and attracting investments for advance MedTech applications, are expected to push the market further in this region. For instance, with a view to further boost indigenous manufacturing capability, the government of India has launched the Promotion of Medical Device Parks Scheme. The scheme envisages the creation of dedicated medical device manufacturing clusters with shared infrastructure, common testing facilities and logistics. Creation of such clusters will promote the development of an ecosystem for indigenous manufacturing of medical devices and help make high value medical devices. (Source: Department of Pharmaceuticals)

Global MedTech & Biopharma Device CMO/CDMO Market Outlook for Key Countries

Why is the U.S. Leading Innovation and Adoption in the MedTech & Biopharma Device CMO/CDMO Market?

The U.S. dominates the medtech & biopharma device CMO/CDMO market due to its proficiency in production of highly complex drug-device combination products, along with high-end technologies. The U.S has a robust foothold in manufacturing wearable drug delivery devices, smart devices, and connected devices. Such devices necessitate high end-engineering, high precision, integrated engineering support, comprehensive and dedicated life-cycle support services.

Is Japan a Favorable Market for MedTech & Biopharma Device CMO/CDMO?

Japan is one of the most promising markets for the medtech & biopharma device CMO/CDMO market due to the country’s superior capabilities in precision engineering, microfabrication, and sophisticated high-quality manufacturing for advanced medical devices and combination products. Japan has proven technological expertise in minimally invasive devices, diagnostics devices, and biologics delivery device development and manufacturing. High growth potential due to concentration of innovation and manufacturing of high value technology driven device instead of volume driven one is anticipated in Japanese CMO/CDMO.

Is China Emerging as a Key Growth Hub for the MedTech & Biopharma Device CMO/CDMO Market?

China is positioned as a key growth hub in the global medtech & biopharma device CMO/CDMO market driven by its booming manufacturing capabilities for medical devices, diagnostics and drug-device combination products. The country brings high volume precision manufacturing capacity, a well-connected supply chain and a deepening expertise of complex devices manufacturing and clean room processes to the international community. With an insatiable appetite for both low cost, high volume and advanced medical device solutions, China is quickly solidifying its reputation as a center of excellence for Outsourced R&D and commercial manufacturing.

Why Does Germany Top the European MedTech & Biopharma Device CMO/CDMO Market?

Germany is the leader in the European market for medtech & biopharma device CMO/CDMO owing to the country’s depth of specialization in high-complexity device manufacturing, advanced industrial technology, and the focus on precision engineering. Germany plays a critical role in Europe’s minimally invasive medical device, advanced diagnostic systems, and sophisticated drug device combination device sectors where quality, high technical expertise and precision manufacturing is paramount. The country's sophisticated industrial infrastructure places Germany as the central hub for outsourcing advanced device design and development in the region.

Is MedTech & Biopharma Device CMO/CDMO Market Developing in India?

India is a high-potential market for medtech & biopharma device CMO/CDMO due to its sophisticated precision engineering, sterile and aseptic medical device manufacturing capabilities, and experience in handling of drug-device combinations. In addition to the availability of skilled engineering manpower and cost advantages of manufacturing in the country, more companies are looking to outsource engineering activities like product designing and prototyping, validation services and commercial production.

Product Innovation Landscape in the Global MedTech & Biopharma Device CMO/CDMO Market

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How is the expansion of biologics and advanced drug delivery devices creating new growth opportunities in the medtech & biopharma device CMO/CDMO market?

With the rise of biologics and sophisticated drug delivery device technologies, the development and manufacturing outsourcing in complex delivery platforms by major biopharmaceutical firms opens the door to new market opportunities for MedTech and biopharma device CDMO/CMOs. Ophthalmic drug delivery systems, advanced delivery devices such as wearable injectors and combination devices all represent growth markets for CMOs and CDMOs that possess both deep expertise in sterile manufacturing, device engineering, regulatory compliance and know how to get innovative combinations approved. For instance, in April 2026, LTS Lohmann Therapie-Systeme AG added ophthalmic drug delivery capabilities to its CDMO service offering, increasing its expertise in sterile eye care drug products to keep pace with the growing need for cutting-edge drug delivery solutions. (Source: LTS Lohmann Therapie-Systeme AG)

Market Players, Key Development, and Competitive Intelligence

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Key Developments

• In May 2026, GI Partners completed the acquisition of the CDMO and Cell Solutions businesses from Charles River Laboratories and established Rose BioSolutions. The transaction strengthens manufacturing and development capabilities for biologics and advanced therapies while expanding CDMO service offerings. The development highlights growing private equity investment and consolidation trends aimed at enhancing scale, specialized expertise, and capacity within the global CDMO market.
• In November 2025, Amber Lifesciences highlighted its position as a global CMO/CDMO partner for the supply of DEXAFIN (dexamethasone), supporting pharmaceutical companies with end-to-end manufacturing services. The announcement reflects the increasing reliance on specialized contract manufacturers to ensure scalable production, regulatory compliance, and uninterrupted drug supply. Such developments underscore the growing importance of CDMOs in strengthening global pharmaceutical supply chains.

Competitive Landscape

The global medtech & biopharma device CMO/CDMO market is moderately consolidated, and the competition focus on leading technology, design engineering expertise, regulatory compliance experience, manufacturing scale-up expertise and end-to-end life cycle management services for medical devices & drug-device combination products. Competitors are strategically expanding their geographic manufacturing base, and investing heavily on automation and smart manufacturing technologies, as well as growing capabilities for biologics drug delivery device and digital connectivity in medical devices. Mergers & acquisitions, as well as collaborations with MedTech & Pharma OEMs for long-term strategic relationships remain to be important for competition building up strategy. Key focus areas include:

• Development and manufacturing of drug-device combination products, including autoinjectors, wearable injectors, and inhalation devices.
• Expansion of advanced manufacturing capacity through automation, digital quality systems, and smart factory initiatives.
• Strengthening regulatory, engineering, and design capabilities to support faster product development and global market approvals.
• Strategic partnerships, acquisitions, and geographic expansion to broaden service offerings and increase manufacturing capacity across high-growth markets.

Market Report Scope

MedTech & Biopharma Device CMO/CDMO Market Report Coverage

Analyst Opinion (Expert Opinion)

• MedTech & biopharma device CMO/CDMO market is expected to see consistent growth in the long term driven by growing demand for seamless development and manufacturing partners for complex medical devices, drug-device combination products and connected health technologies. As both MedTech and Pharma focus on shrinking capital outlay and internal resource requirements, outsourcing will shift away from simple transaction manufacturing to more long-term partnerships covering design, development, engineering, regulatory and ongoing product life-cycle.
• The maximum opportunities will probably exist within drug-device combination products, namely autoinjectors, wearable injectors and connected drug delivery devices. North America is poised to continue dominating demand with a robust biologics pipeline, while Asia Pacific may emerge as a preferred manufacturing destination based on their growing production capacities and cost-competitiveness. Industry stakeholders ought to prioritize increasing capacity at high-tech manufacturing facilities, investing in automation and digital quality management systems, fortifying expertise in both combo product engineering and regulatory processes.
• In order to obtain a competitive advantage, market participants must broaden the capacity to support the rapid uptake in drug-device combination products including auto injectors, wearable devices, inhalations devices, and connected medical devices. Increased investment into automation, digital manufacturing solutions and AI driven quality management systems will increase manufacturing productivity and assure regulatory adherence. Improving human factors engineering, design-for-manufacturing (DFM) and global regulatory assistance capacity through strategic alliances, targeted capacity expansions within the high-growth region of Asia Pacific will ensure providers retain top positions on both preferred CMO and CDMO supplier contracts with top Pharma & MedTech businesses.

Market Segmentation

• Product/Device Type Insights (Revenue, USD Mn, 2021 - 2033)
  • Drug-Device Combination Products
  • Medical Devices
  • Diagnostics and Laboratory Devices/Equipment
  • Other Product / Device Types
• Service Type Insights (Revenue, USD Mn, 2021 - 2033)
  • Design Development and Engineering Services
  • Contract manufacturing
  • Supply Chain Management
  • Quality and Regulations
  • Other Value-Added Services
• Device Class Insights (Revenue, USD Mn, 2021 - 2033)
  • Class I
  • Class II
  • Class III
• Regional Insights (Revenue, USD Mn, 2021 - 2033)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Integer Holdings Corporation
  • Jabil Inc.
  • Flex Ltd.
  • Sanmina Corporation
  • Phillips-Medisize
  • Nordson MEDICAL
  • West Pharmaceutical Services
  • Gerresheimer AG
  • SteriPack Group
  • Nipro Corporation

Sources

Primary Research Interviews

• Executives and business development heads from MedTech & Biopharma Device CMO/CDMO companies
• Engineering, product development, and manufacturing directors from medical device OEMs
• Quality assurance and regulatory affairs professionals specializing in medical devices and combination products
• Supply chain and procurement managers from pharmaceutical, biotechnology, and medical device companies
• Experts in drug-device combination products, autoinjectors, wearable injectors, and diagnostics
• Manufacturing operations and validation managers from sterile and high-precision device manufacturing facilities

Stakeholders

• MedTech & Biopharma Device CMO/CDMO providers
• Medical device manufacturers (OEMs)
• Pharmaceutical and biotechnology companies
• Drug-device combination product developers
• Diagnostic and laboratory device manufacturers
• End-use Sectors
  • Pharmaceutical companies
  • Biopharmaceutical & biotechnology companies
  • Medical device companies
  • Diagnostic laboratories
  • Research institutions and healthcare providers
• Regulatory & Health Bodies
  • U.S. Food and Drug Administration (FDA)
  • European Commission – Medical Devices (MDR/IVDR)
  • European Medicines Agency (EMA)
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • National Medical Products Administration (NMPA), China
  • Medicines and Healthcare products Regulatory Agency (MHRA), UK

Databases

• FDA 510(k) Premarket Notification Database
• FDA PMA Database
• FDA Medical Device Registration & Listing Database
• EUDAMED (European Database on Medical Devices)
• OECD Health Statistics
• World Bank Data
• WHO Global Health Observatory (GHO)

Magazines

• Medical Design & Outsourcing
• Medical Product Outsourcing (MPO)
• Medical Device Network
• MD+DI (Medical Design & Development)
• Pharmaceutical Manufacturing
• Pharma Manufacturing

Journals

• Nature Biomedical Engineering
• Journal of Medical Devices (ASME)
• Medical Devices: Evidence and Research
• Journal of Pharmaceutical Innovation
• Advanced Drug Delivery Reviews
• Therapeutic Delivery

Newspapers

• The Wall Street Journal
• Financial Times
• USA Today
• The New York Times

Associations

• AdvaMed (Advanced Medical Technology Association)
• MedTech Europe
• Medical Device Manufacturers Association (MDMA)
• Asia Pacific Medical Technology Association (APACMed)
• International Organization for Standardization (ISO)
• Regulatory Affairs Professionals Society (RAPS)

Public Domain Sources

• U.S. Food and Drug Administration (FDA)
• European Commission – Medical Devices
• World Health Organization (WHO)
• OECD
• World Bank
• U.S. Department of Commerce
• National Institutes of Health (NIH)
• India Brand Equity Foundation (IBEF)
• Singapore Economic Development Board (EDB)

Proprietary Elements

• CMI Data Analytics Tool, Proprietary CMI Existing Repository of information for last 10 years.