Medical Device Outsourcing Market Size, Share & Industry Analysis, By Outsourced Service Type (Design and Development Services, Regulatory, Quality & Clinical Support Services, Packaging & Labeling Services, Sterilization Services, Logistics & Aftermarket Services, and Others), By Application (Cardiovascular, Orthopedic, Dental, Respiratory, and Others), By End-user (Medical Device Companies, Pharmaceutical & Biotechnology Companies, and Others), and Regional Forecast, 2026-2034

The global medical device outsourcing market size was valued at USD 154.54 billion in 2025. The market is projected to grow from USD 164.08 billion in 2026 to USD 278.81 billion by 2034, exhibiting a CAGR of 6.9% during the forecast period. North America dominated the global medical device outsourcing market with a market share of 37.79% in 2025.

Medical device outsourcing is the process of appointing outside partners to help design, develop, test, and manufacture medical devices instead of doing everything inside one company. It includes contract design teams, engineering support, component and consumable manufacturing, assembly, packaging, and quality documentation. The market growth is attributed to rising emphasis of the reduced operational cost, core competencies, improved cash flow, and superior operational efficiency. In addition, technological developments coupled with globalization of healthcare market is also projected to have a positive impact on the market.

• For instance, in February 2021, SteriPack Group announced acquisition of HS Design Inc. with an aim to improve its design capabilities.

Furthermore, many key industry players, such as Flex Ltd., Jabil Inc., TE Connectivity, Sanmina Corporation, and Integer Holdings Corporation operating in the market, are focusing on developing various innovative technologies to offer better products with improved accuracy and efficiency.

MEDICAL DEVICE OUTSOURCING MARKET TRENDS

Rising Emphasis on Outsourcing of Quality and Compliance Activities is One of Important Trend Observed in Market

The market is witnessing rising shift of preference of medical device manufacturers toward outsourcing of quality-related activities such as documentation support, process validation, and regulatory preparation. Also, as compliance requirements grow stricter, maintaining large in-house quality teams becomes costly and time-consuming. In addition, outsourcing companies already have required infrastructure to conduct quality and compliance activities, which reduces overall turnaround time of the process.

• For instance, in February 2025, ArisGlobal announced expanding of its quality, and safety compliance services for medical devices with the help of automation.

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MARKET DYNAMICS

MARKET DRIVERS

Enabling of Faster Launches with Fewer In-house Resources by Original Equipment Manufacturers to Accelerate Market Growth

Outsourcing companies enables faster completion of services, leading to faster launching of new products and technologies in the market. As outsourcing companies are heavily equipped with heavy infrastructure which reduces overall process time considerably. In addition, outsourcing also helps to minimize bottlenecks by implementation of regulated processes. Medical device companies face short timelines and high expectations for safety and performance.

MARKET RESTRAINTS

Loss of Control Over Processes and Supplier Dependence to Restrain Market Growth

Loss of control over processes and dependency on third party companies is projected to have negative impact on the global medical device outsourcing market growth. When work is outsourced, the device company must rely on another firm’s timelines, staffing, and quality culture. Any delay at the partner can delay the launch. In addition, companies also worry about protecting confidential designs and processes, especially for new products. If a supplier becomes too important, switching partners can be hard as tools, documents, and know-how sit outside the OEM.

MARKET OPPORTUNITIES

One-stop Partners for Design-to-Manufacturing to Offer Lucrative Market Opportunities

Outsourcing companies offer one-stop solution for all of the services required for medical device manufacturing. Many device makers want fewer vendors and smoother handoffs from design to mass production. This creates opportunity for outsourcing firms to offer end-to-end services under one contract, improving accountability and speed. Industry consolidation supports this model, as CDMOs buy design houses and specialty manufacturers to widen capabilities. Moreover, increasing number of strategic developments among market players is also projected offer a substantial opportunity for the market growth.

• For instance, in May 2025, Quasar Medical announced acquisition of Nordson MEDICAL with an aim to consolidate its medical device outsourcing services. Also, this acquisition will also help the company to strengthen its presence in Ireland and Mexico.

MARKET CHALLENGES

Managing Quality Across Many Sites to Pose a Critical Challenge to Market Growth

Outsourcing often involves multiple factories and sub-suppliers, sometimes in different countries. Keeping quality consistent requires strong documentation, training, and frequent audits. Small gaps, such as unclear specifications, weak change control, or missing traceability can trigger rework and slow approvals. As companies outsource more, they need stronger supplier management teams and clearer contracts to avoid surprises. This is especially important for higher-risk devices, where regulators expect records from design through manufacturing and packaging at all times.

Segmentation Analysis

By Outsourced Service Type

Requirement of Specialized Skills for Design and Development Phase to Boost Design and Development Services Segment Growth

Based on outsourced service type, the market is divided into design and development services, regulatory, quality & clinical support services, packaging & labeling services, sterilization services, logistics & aftermarket services, and others.

The design and development services segment is anticipated to account for the largest medical device outsourcing market share. Design and development work is outsourced heavily as it needs specialized skills and equipment, but many device companies cannot keep large expert teams for every project. In addition, outsourcing companies can provide industrial design, engineering, prototyping, testing plans, and design-for-manufacturing support.

• For instance, in October 2024, NAMSA and Termuo Corporation entered into a strategic outsourcing partnership with an aim to accelerate product launch and regulatory processes.

The regulatory, quality & clinical support services segment is anticipated to rise with a CAGR of 7.9% over the forecast period.  

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By Device Class

Strict Regulations for Class II Devices Accelerated Segment Growth

Based on device class, the market is segmented into class I, class II, and class III.

In 2025, the class II segment dominated the global market. Class II devices are higher-risk products that often support or sustain life, so they need stronger controls, testing, and documentation. Many OEMs outsource as specialist partners already have validated processes, cleanroom capability, and quality systems suited to strict requirements. Outsourcing also reduces the chance of mistakes when moving from development to scaled production.

• For instance, in February 2025, Arterex completed acquisition of Adroit USA Inc. in order to expand its capabilities of medical device manufacturing.

The class III segment is anticipated to rise with a CAGR of 7.4% over the forecast period.  

By Device Type

High Demand of Consumables Boosted Segment Growth

Based on device type, the market is segmented into consumables, capital equipment, implantable devices, in vitro diagnostics (IVD) devices, and others.

In 2025, the consumables segment dominated the global market. Consumables including tubing sets, catheters, disposables, and single-use components are used every day, so demand is steady and repeat purchasing is common. As volumes are high, device companies often outsource to partners that can run efficient production lines, manage raw materials, and deliver consistent quality. In addition, outsourcing also supports quick scaling when hospitals or programs increase usage.

• For instance, in January 2026, Fulflex announced setting of new standards and ways of sustainable manufacturing. The company also has plans to apply these standards for manufacturing of consumables.

The implantable devices segment is anticipated to rise with a CAGR of 7.6% over the forecast period.  

By Application

Considerable Prevalence of Cardiovascular Conditions to Boost Segment Growth

Based on application, the market is segmented into cardiovascular, orthopedic, dental, respiratory, and others.

In 2025, the cardiovascular segment dominated the global market. Cardiovascular devices range from implants to delivery systems and disposables used in common procedures. The category is large as heart disease care is widespread and hospitals perform high volumes of interventions. Many cardiovascular products also have tight performance and quality requirements, pushing OEMs to use experienced outsourcing partners for materials, precision manufacturing, and documentation.

• For instance, in April 2022, Integer Holdings Corporation announced the acquisition of Aran Biomedical in order to strengthen cardiovascular implant manufacturing.

The respiratory segment is anticipated to rise with a CAGR of 7.3% over the forecast period.  

By End-User

Higher Production of Medical Device Companies to Accelerate Segment Growth

Based on end-user, the market is segmented into medical device companies, pharmaceutical and biotechnology companies, and others.

In 2025, medical device companies held highest market share. Outsourcing is mainly used by device OEMs as they own the product roadmap and must balance speed, quality, and cost. Large OEMs outsource to add capacity, enter new regions, or access specialist processes, while smaller firms outsource as they do not have factories at all. Furthermore, the segment is set to hold 77.4% share in 2026.

In addition, pharmaceutical and biotechnology companies segment is projected to grow at a CAGR of 7.3% during the study period.

Medical Device Outsourcing Market Regional Outlook

By geography, the market is categorized into Europe, North America, Asia Pacific, Latin America, and the Middle East & Africa.

North America

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North America held the dominant share in 2024, valuing at USD 55.25 billion, and also maintained the leading share in 2025, with USD 58.45 billion. The market in North America is expected to increase due to higher emphasis on cost reduction, higher emphasis on core competencies, and growing number of product launches.

U.S. Medical Device Outsourcing Market

Based on North America’s strong contribution and the U.S. dominance within the region, the U.S. market can be analytically approximated at around USD 52.81 billion in 2026, accounting for roughly 32.2% of global sales.

Europe

Europe is projected to record a growth rate of 6.3% in the coming years, which is the second highest among all regions, and reach a valuation of USD 47.53 billion by 2026. The region is estimated to witness considerable market growth due to rising investments for new product development, and growing number of outsourcing service providing companies.

U.K. Medical Device Outsourcing Market

The U.K. market in 2026 is estimated at around USD 7.71 billion, representing roughly 4.7% of global revenues.

Germany Medical Device Outsourcing Market

Germany’s market is projected to reach approximately USD 10.69 billion in 2026, equivalent to around 6.5% of global sales.

Asia Pacific

Asia Pacific is estimated to reach USD 43.91 billion in 2026 and secure the position of the third-largest region in the market. Rising healthcare demand and favorable government policies to boost accelerate market growth.

Japan Medical Device Outsourcing Market

The Japan market in 2026 is estimated at around USD 7.61 billion, accounting for roughly 4.6% of global revenues.

China Medical Device Outsourcing Market

China’s market is projected to be one of the largest globally, with 2026 revenues estimated at around USD 14.57 billion, representing roughly 8.9% of global sales.

India Medical Device Outsourcing Market

The India market in 2026 is estimated at around USD 9.74 billion, accounting for roughly 5.9% of global revenues.

Latin America and Middle East & Africa

The Latin America and Middle East & Africa regions are expected to witness moderate growth in this market during the forecast period. The Latin America market is set to reach a valuation of USD 7.13 billion in 2026. Growing investments by market players along with growing emphasis on contract manufacturing to accelerate market growth.

GCC Medical Device Outsourcing Market

The GCC is set to reach a value of USD 1.33 billion in 2026.

South Africa Medical Device Outsourcing Market

The South Africa market is projected to reach around USD 0.55 billion in 2026, representing roughly 0.33% of global revenues.

COMPETITIVE LANDSCAPE

Key Industry Players

Rising Number of Collaborations Coupled with Higher Quality of Services by Key Players to Boost Market Progress

The global medical device outsourcing market holds a semi-consolidated market structure, constituting prominent players such as Flex Ltd., Jabil Inc., TE Connectivity, Sanmina Corporation, and Integer Holdings Corporation. The significant global medical device outsourcing market share of these companies is due to numerous strategic activities, including distribution collaborations and implementation of new programs.

• For instance, in October 2025, Flex announced the incorporation of AI infrastructure in order to boost production by 30%.

Other notable players in the global market Plexus Corp., Celestica HealthTech, West Pharmaceutical Services, Phillips-Medisize, and Nextern. These companies are expected to prioritize collaborations to increase their global market share during the forecast period.

LIST OF KEY MEDICAL DEVICES OUTSOURCING COMPANIES PROFILED IN REPORT:

• Flex Ltd. (Singapore)
• Jabil Inc. (U.S.)
• TE Connectivity (Ireland)
• Sanmina Corporation (U.S.)
• Integer Holdings Corporation (U.S.)
• Plexus Corp. (U.S.)
• Celestica HealthTech (Canada)
• West Pharmaceutical Services (U.S.)
• Phillips-Medisize (U.S.)
• Nextern (U.S.)
• Tecan Contract Manufacturing (Switzerland)
• Forefront Medical Technology (U.S.)   

KEY INDUSTRY DEVELOPMENTS

• March 2025: Flex announced opening of new production facilities in North America to cater customer demand.
• January 2025: Arterex announced acquisition of Phoenix S.r.l. The strategic step was taken to strengthen its position in Italy.
• July 2024: FP Technologies acquired AJR Enterprises, expanding outsourced manufacturing for patient-safe handling products.
• November 2023: Nissha announced a capital and business partnership with EndoTheia.
• December 2021: Integer Holdings Corporation acquired Oscor, Inc. in order to strengthen manufacturing of cardiovascular devices, neurostimulation, and peripheral vascular devices.

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