Medical Device Contract Manufacturing Market

Market Size

The global medical device contract manufacturing market size, valued at USD 92.6 billion in 2025, is projected to reach USD 99.8 billion in 2026 and USD 181.4 billion by 2035, with a CAGR of 6.9% during the forecast period 2026 to 2035. This market is growing steadily, driven by continuous technological advancements, leading to the development of complex and innovative medical devices. This has prompted the medical device companies to seek specialized services from medical device contract manufacturing companies.

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Market Report: Key Takeaways

• With the rising complexity of technologically advanced medical devices, along with the need for reliable user interfaces in these devices, the industry has observed stringency in the regulatory framework of the USFDA and the EU for market approval. This has necessitated medical device companies to leverage contract manufacturing services to navigate the regulatory landscape.
• In terms of class of medical devices, class III medical devices account for 50% of the overall medical device contract manufacturing market. This is primarily due to the fact that these devices are classified as high-risk and therefore require extensive clinical studies, which are both time-consuming and resource intensive.
• Within the type of medical device, therapeutic devices capture the largest (43%) share of the market; this trend is unlikely to change in the future. This can be attributed to the rising prevalence of chronic diseases, which, in turn, increases the demand for therapeutic devices, such as insulin pumps, respiratory devices and infusion pumps.
• With respect to the therapeutic area, cardiovascular disorders currently hold around close to 30% of the medical device contract manufacturing industry share. This dominance stems from the intricacies associated with the medical devices designed for cardiovascular disorders owing to the integration of various advanced technologies (including pulsed field ablation).
• In terms of geographical regions, North America holds close to 45% share of the medical device contract manufacturing industry.
• In terms of company size, mid-sized companies dominate (~45%) the medical device contract manufacturing market share.

Market Overview

Over the past decade, the medical device industry has experienced a surge in research and innovation driven by numerous scientific and technological breakthroughs. This progress, coupled with the increasing disease burden on healthcare systems, has heightened the demand for advanced and minimally invasive medical devices. However, one of the primary challenges faced by this industry is the complex and time-consuming product development lifecycle for new medical devices. The clinical stage, in particular is resource-intensive, involving significant costs and substantial risks. Additionally, new advancements have facilitated the development and enforcement of more informed regulatory guidelines and instructions to ensure the safety of medical devices.

To address these challenges, many medical device developers are actively outsourcing medical device manufacturing to contract service providers that possess the necessary expertise and capabilities to navigate these complexities. A contract manufacturer can be defined as an organization offering assistance to a medical device or pharmaceutical or biotechnology sponsor company for the development and manufacturing of medical devices on their behalf on contractual basis. These activities span from preclinical development of novel products to post-marketing research studies.

The role of contract manufacturers has expanded beyond mere compliance; these organizations now foster innovation by leveraging new technologies and methodologies to streamline the medical device development processes. In addition to this, the medical device landscape is rapidly changing, driven by the advancements in material sciences, digital health technologies, and personalized medicines. As these innovations present new opportunities for patient care, they also introduce complexities that require expert guidance to navigate regulatory landscapes effectively. The synergy between manufacturers and CMOs will be crucial in ensuring that safe and effective medical devices reach patients efficiently, ultimately improving health outcomes and enhancing the quality of care across diverse populations.

Recent Developments

• In February 2026, Norman Noble announced the introduction of engineering design services in order to further strengthen their contract development and manufacturing services of medical devices.
• In January 2026, AbbVie, a US-based company acquired the manufacturing facility of West Pharmaceutical Services, to further strengthen its drug delivery device manufacturing capabilities and broaden access to the growing MedTech industry.
• In January 2026, Tecomet announced a merger with Orchid Orthopedic Solutions aimed at enhancing their MedTech solution capabilities, expanding reach and supporting long-term growth.
• In November 2025, Sanmina announced the expansion of its Fermoy medical facility in North Cork, Ireland. Through this expansion, the company aims to enhance its capabilities across various medical devices, including wearable medical devices.
• In the November 2025, China National Medical Products Administration (NMPA) issued the revised Good Manufacturing Practice for Medical Devices, with major focus on digitalization in manufacturing processes, sterile packaging validation and cybersecurity for connected drug delivery devices.
• In October 2025, Vance Street Capital announced a strategic partnership with MRPC (Molded Rubber and Plastic Corporation), a medical device contract manufacturer, to support the former company’s continued expansion and capability enhancement across the full product lifecycle, encompassing specialized silicone and thermoplastic molding, cleanroom assembly, packaging, sterilization management and integrated supply chain solutions.

Medical Device Contract Manufacturing Market Trends

• Mergers and Acquisitions: In recent years, several medical device contract manufacturing companies have entered into various mergers / acquisition deals with other players to consolidate their presence in this field. Interestingly, most of the agreements were acquisitions, followed by mergers. For instance, in August 2025, Cirtec Medical completed the acquisition of Top Tool in order to further strengthen its position in the medical device design and development services market.
• Rise in Clinical Trials for Medical Devices: Over the years, there has been a notable increase in the number of clinical trials focused on medical devices. This surge is driven by the complex manufacturing process of innovative medical devices, which highlights the importance of contract manufacturing. These organizations offer specialized services, such as design for manufacturing, prototype services, component manufacturing and assembly, packaging and sterilization, labeling, storage, and delivery of the final product to its clients. As technology continues to evolve, medical devices are becoming more intricate, prompting the medical device companies to seek support from medical device contract manufacturers to navigate regulatory affairs and conduct clinical trials. Together, these factors are expected to drive market growth.

Industry Experts on Medical Device Contract Manufacturing Market

The medical device contract manufacturing industry report includes detailed transcripts of interviews conducted with the following individuals:

• Chief Research and Technology Director, Mid-sized Company, US
• Former President and Chief Executive Officer, Large Company, Sweden
• Chief Executive Officer, Mid-sized Company, Hungary
• Chief Operating Officer, Large Company, US
• Senior Vice President of Head of Commercial, Large Company, US
• Vice President Global Marketing and Commercial Operations, Large Company, US
• Senior Director Business Development Medical Device, Very Large Company, China
• Director of Business Development, Small Company, Sweden
• Senior Account Manager, Mid-sized Company, Canada
• Technical Director and Partner, Small Company, India
• Assistant Manager, Small Company, India
• General Manager, Small Company, Germany
• Former Lead Trainer and QC Manager, Mid-sized Company, Pakistan
• Former Business Development Consultant, Mid-sized Company, Germany
• Former Research Study Assistant, Small Company, Germany

Medical device contract manufacturing industry will mark a turning point in MedTech industry in the coming future. Sara E. Dyson, Vice President of Underwriting Operations and Risk Management, Medmarc Insurance states, “The most significant change in outsourcing over the last 20 years has been the evolution of CMOs offering solely manufacturing services to offering manufacturing services in addition to an array of services related to product design, project management, quality and regulatory, and aftermarket logistics.”

Market Drivers

• Growing Demand for Connected Medical Devices and Implants: The rising potential of medical devices, particularly combination products, to treat chronic diseases is prompting the players active in this domain to collaborate with device manufacturers. Notably, these products are generally complex in nature and offer superior efficacy at lower costs compared to other treatment modalities. Therefore, medical device companies seek support from contract manufacturers for their specialized services.
• Market Expansion: The rapid expansion of healthcare expenditures and infrastructure development in emerging economies, such as Japan, India and China are significantly driving the growth of medical device contract manufacturing companies. Further, favorable government-led initiatives, such as India’s Production Linked Incentive (PLI) scheme, coupled with the increasing prevalence of chronic diseases are fueling strong demand for cost-effective, high-quality manufacturing solutions in these countries. To mitigate geopolitical risks, reduce costs, and enhance supply chain resilience, multinational contract manufacturers are increasingly shifting and diversifying their manufacturing footprint toward these emerging markets.

Market Segmentation Analysis

Class III Medical Devices Leading the Medical Device Contract Manufacturing Market

• In 2026, class III medical devices hold 50% of the overall market share. This can be attributed to the fact that class III medical devices necessitate a meticulous development process due to the potential risks associated with their use. As a result, medical devices companies often outsource key aspects of medical device manufacturing to specialized organizations
• Moreover, it is important to highlight that class III medical devices are likely to grow at a higher CAGR during the forecast period. This is due to the fact that these devices are often used for providing life support, making it crucial for medical device developers to minimize use-related hazards.

Mid-sized Companies Driving the Global Industry

• According to the medical device contract manufacturing market forecast, the mid-sized companies accounts for more than 40% of the market. This can be attributed to the fact that mid-sized contract manufacturers tend to focus on the development of medical devices for specific target indications. In addition, to maintaining a competitive edge, these companies offer more competitive and transparent pricing structures, which becomes particularly important for start-ups and mid-sized medical device companies while selecting suitable contract manufacturers.
• In future, the large companies are likely to experience high market growth during the forecast period. This can be attributed to the fact that large companies have dedicated resources and required expertise, sophisticated facilities and requisite capabilities to meet the regulatory compliance. Further, their ability to scale operations provide flexible and adaptable capabilities to meet the evolving demands of their clients.

Market Regional Insights

North America Dominates the Medical Device Contract Manufacturing Industry

North America is dominating the market for medical device contract manufacturing, securing close to 45% of the overall revenue share. This can be attributed to the presence of major market players, high healthcare expenditure, favorable patient demographics and a robust regulatory framework in North America. Further, within this region, the US serves as a global hub for advanced technologies, such as 3D printing, robotics, and AI-driven production, which are important components of class II and III medical devices.

Adoption of Contract Manufacturing Services in Asia Pacific

Asia Pacific is the fastest growing region as per our medical device contract manufacturing  market analysis.  This can be attributed to the region's increasing geriatric population driving the demand for user-friendly devices that address age-related health concerns, along with the rising investments for R&D enabling manufacturers to develop innovative products. Additionally, rapid expansion of manufacturing capacities in countries, including China accompanied by the widespread adoption of advanced manufacturing technologies is driving the growth of market in these countries. Notably, in January 2026, Lubrizol announced the opening of its advanced medical manufacturing facility in Chennai, India, strengthening its CDMO capabilities for precision medical device components.

Medical Device Contract Manufacturing Market: Scope of the Report

Market Segments

Based on the research, we have segmented the Medical Device Contract Manufacturing Market into class of medical device, type of medical device, therapeutic area, company size and geographical regions

By Class of Medical Device

• Class I
• Class II
• Class III

By Type of Medical Device

• Therapeutic Devices
• Diagnostic Devices
• Drug Delivery Devices
• Other Medical Devices

By Therapeutic Area

• Cardiovascular Disorders
• Orthopedic Disorders
• Metabolic Disorders
• Neurological Disorders
• Ophthalmological Disorders
• Respiratory Disorders
• Oncological Disorders
• Gastrological Disorders
• Other Disorders

By Company Size

• Very Small
• Small
• Mid-sized
• Large

By Geographical Regions

• North America
• Europe
• Asia-Pacific
• Middle East and North Africa
• Latin America