Global Medical Device Contract Manufacturing Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Device;
IVD Devices, Diagnostic Imaging Devices, Cardiovascular Devices, Ophthalmology Devices, Orthopedic Devices, Dental Devices and OthersBy Service;
Device Development & Manufacturing Service, Quality Management Service, and Assembly ServiceBy Class Device;
Class I: General Controls, Class II: General Controls with Special Controls, and Class III: General Controls with Special ControlsBy End-Use;
Original Equipment Manufacturers (OEMs), Pharmaceutical & Biopharmaceutical Companies, and OthersBy Geography;
North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2021 - 2031)Introduction
Global Medical Device Contract Manufacturing Market (USD Million), 2021 - 2031
Medical Device Contract Manufacturing Market was valued at USD 27,603.02 million in the year 2024. The size of this market is expected to increase to USD 56,268.39 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 10.7%.
Global Medical Device Contract Manufacturing Market Growth, Share, Size, Trends and Forecast
*Market size in USD million
CAGR 10.7 %
Study Period | 2025 - 2031 |
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Base Year | 2024 |
CAGR (%) | 10.7 % |
Market Size (2024) | USD 27,603.02 Million |
Market Size (2031) | USD 56,268.39 Million |
Market Concentration | Low |
Report Pages | 386 |
Major Players
- Jabil Inc.
- Gerresheimer AG
- Synecco
- Invetech
- Biofortuna Limited
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Global Medical Device Contract Manufacturing Market
Fragmented - Highly competitive market without dominant players
The Medical Device Contract Manufacturing Market is experiencing strong growth, fueled by the increased reliance of healthcare firms on third-party production. By outsourcing manufacturing operations, companies are able to enhance cost-efficiency and operational focus, especially as nearly 55% of new medical devices now rely on external manufacturing partners for development.
Rising Focus on Quality Assurance Standards
As regulatory requirements tighten, the demand for high-quality and compliant production has intensified. Contract manufacturers are increasingly valued for their ability to meet strict regulatory benchmarks. It is estimated that 60% of agreements prioritize quality control and compliance services, reinforcing the importance of certified and proven manufacturing capabilities.
Advanced Technologies Reshaping Manufacturing Processes
The adoption of cutting-edge production technologies, including robotics and 3D printing, is elevating contract manufacturing capabilities. These tools are enabling higher accuracy and reduced lead times. More than 45% of contract manufacturers have implemented automated systems, helping improve efficiency and meet complex production needs.
Flexibility and Cost Optimization
Outsourcing medical device production is helping companies achieve scalable manufacturing models and reduce fixed infrastructure costs. Contract manufacturers provide flexibility to adjust production volumes, supporting quicker market response. About 50% of firms highlight increased financial agility and manufacturing scalability as major outsourcing advantages.
Long-Term Partnerships Driving Market Momentum
An increasing number of companies are building strategic, long-term relationships with contract manufacturers to ensure consistent output and shared growth. These collaborations are built on aligned goals and production synergies. Data shows that over 65% of such engagements transition into multi-year partnerships, demonstrating the lasting impact of outsourcing in the medical device sector.
Global Medical Device Contract Manufacturing Market Recent Developments
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In January 2023, Integer announced the acquisition of Pulse Technologies, Inc., a privately held technology, engineering, and contract manufacturing company. Pulse Technologies focuses on complex micro machining of medical device components for high-growth markets, including structural heart, heart pump, electrophysiology, leadless pacing, and neuromodulation.
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In November 2023, Jabil Inc. announced the successful acquisition of Retronix, an innovative provider specializing in the reclamation and refurbishment of electronic components. This acquisition was completed earlier in the year.
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In January 2022, MixComm, a pioneer in mmWave antennas to algorithms, selected Advanced Microsystems Technologies, a division of Sanmina, as a lead partner to productize its 5G wireless infrastructure solutions.
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November 2021, Nipro Corporation entered into a partnership with Toyobo for the development of cellulose triacetate (CTA) dialyzers (artificial kidneys).
Segment Analysis
In this report, the Global Medical Device Contract Manufacturing Market has been segmented by Device, Service, Class Device,End-use, and Geography.
Global Medical Device Contract Manufacturing Market, Segmentation by Device
The Global Medical Device Contract Manufacturing Market has been segmented by Device into IVD Devices, Diagnostic Imaging Devices, Cardiovascular Devices, Ophthalmology Devices, Orthopedic Devices, Dental Devices, and Others.
IVD Devices
IVD devices represent around 30% of the medical device contract manufacturing market. The segment includes test kits, reagents, and lab equipment, driven by the growing emphasis on early diagnosis, personalized medicine, and demand for COVID-19 testing.
Diagnostic Imaging Devices
Diagnostic imaging devices contribute nearly 20% of the market. Contract manufacturers support the production of X-ray machines, MRI scanners, and ultrasound systems, vital for modern diagnostic workflows.
Cardiovascular Devices
Cardiovascular devices account for approximately 15% of the market. Contract manufacturers provide solutions for catheters, stents, and pacemakers, supporting innovations in cardiac care.
Ophthalmology Devices
Ophthalmology devices hold about 10% of the market. This segment covers intraocular lenses, diagnostic equipment, and surgical tools, addressing rising cases of vision disorders.
Orthopedic Devices
Orthopedic devices represent nearly 10% of the market. Contract manufacturers produce implants, surgical instruments, and prosthetics to meet the growing demand for joint replacement and spinal procedures.
Dental Devices
Dental devices contribute roughly 8% of the market. This includes implants, brackets, and aligners, supported by increasing demand for aesthetic and restorative dental treatments.
Others
Other devices, including ENT instruments, neurological devices, and general surgical tools, make up around 7% of the market. Contract manufacturers offer specialized production capabilities to meet evolving clinical needs.
Global Medical Device Contract Manufacturing Market, Segmentation by Service
The Global Medical Device Contract Manufacturing Market has been segmented by Service into Device Development and Manufacturing Service, Quality Management Service, and Assembly Service.
Device Development and Manufacturing Service
Device development and manufacturing service holds about 60% of the medical device contract manufacturing market. It covers design, prototyping, and full-scale production, ensuring seamless supply chain and efficient product delivery.
Quality Management Service
Quality management service accounts for approximately 25% of the market. It includes quality assurance, testing, and regulatory compliance to ensure medical devices meet international standards and safety regulations.
Assembly Service
Assembly service makes up around 15% of the market. This involves the precise integration of medical device components, with labeling, packaging, and final quality checks to ensure reliable and compliant finished products.
Global Medical Device Contract Manufacturing Market, Segmentation by Class Device
The Global Medical Device Contract Manufacturing Market has been segmented by Device into Class I: General controls, Class II: General controls with special controls, and Class III: General controls, special controls.
Class I: General Controls
Class I devices make up about 25% of the medical device contract manufacturing market. These low-risk devices, like bandages and surgical gloves, require basic regulatory oversight focused on general safety.
Class II: General Controls with Special Controls
Class II devices account for nearly 50% of the market. They include surgical drapes, infusion pumps, and diagnostic equipment, subject to special controls and performance standards for enhanced safety and effectiveness.
Class III: General Controls and Special Controls
Class III devices hold approximately 25% of the market. This high-risk category includes implantable devices, requiring stringent premarket approvals, extensive clinical testing, and comprehensive quality management systems.
Global Medical Device Contract Manufacturing Market, Segmentation by End Use
The Global Medical Device Contract Manufacturing Market has been segmented by End Use into Original Equipment Manufacturers (OEMs), Pharmaceutical & Biopharmaceutical Companies, and Others.
Original Equipment Manufacturers (OEMs)
OEMs hold about 65% of the global medical device contract manufacturing market. They partner with contract manufacturers for custom solutions, cost efficiency, and scalability, enabling focus on innovation and market expansion.
Pharmaceutical & Biopharmaceutical Companies
Pharmaceutical & biopharmaceutical companies contribute approximately 25% of the market. They outsource drug delivery devices, diagnostic systems, and combination products to contract manufacturers, concentrating on R&D and product commercialization.
Others
Others account for nearly 10% of the market, comprising research organizations, startups, and small companies. Contract manufacturing provides them with specialized resources, regulatory support, and accelerated product development.
Global Medical Device Contract Manufacturing Market, Segmentation by Geography
In this report, the Global Medical Device Contract Manufacturing Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.
Regions and Countries Analyzed in this Report
Global Medical Device Contract Manufacturing Market Share (%), by Geographical Region
North America
North America captures nearly 40% of the global medical device contract manufacturing market. The region boasts strong regulatory compliance, advanced manufacturing capabilities, and a concentration of major OEMs, particularly in the U.S..
Europe
Europe holds about 30% of the market, supported by countries such as Germany, France, and the UK. The region’s emphasis on quality standards, R&D investment, and regulatory stringency promotes market growth.
Asia Pacific
Asia Pacific represents around 20% of the market, with rapid growth in China, India, and Japan. Expanding manufacturing bases, rising healthcare investment, and increasing partnerships with global OEMs drive the region’s growth.
Middle East & Africa
Middle East & Africa contribute approximately 5% of the market. Growth is propelled by improving healthcare systems, rising demand for medical devices, and increasing emphasis on modern technologies.
Latin America
Latin America accounts for nearly 5% of the market, led by Brazil and Mexico. The region’s growth is driven by increasing healthcare spending, growing contract manufacturing collaborations, and adoption of advanced medical solutions.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Medical Device Contract Manufacturing Market. These factors include; Market Drivers, Restraints and Opportunities.
Comprehensive Market Impact Matrix
This matrix outlines how core market forces—Drivers, Restraints, and Opportunities—affect key business dimensions including Growth, Competition, Customer Behavior, Regulation, and Innovation.
Market Forces ↓ / Impact Areas → | Market Growth Rate | Competitive Landscape | Customer Behavior | Regulatory Influence | Innovation Potential |
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Drivers | High impact (e.g., tech adoption, rising demand) | Encourages new entrants and fosters expansion | Increases usage and enhances demand elasticity | Often aligns with progressive policy trends | Fuels R&D initiatives and product development |
Restraints | Slows growth (e.g., high costs, supply chain issues) | Raises entry barriers and may drive market consolidation | Deters consumption due to friction or low awareness | Introduces compliance hurdles and regulatory risks | Limits innovation appetite and risk tolerance |
Opportunities | Unlocks new segments or untapped geographies | Creates white space for innovation and M&A | Opens new use cases and shifts consumer preferences | Policy shifts may offer strategic advantages | Sparks disruptive innovation and strategic alliances |
Drivers, Restraints and Opportunity Analysis
Drivers
- Rising demand for outsourcing manufacturing services
- Increasing complexity of medical devices
- Focus on cost reduction and efficiency
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Growing need for regulatory compliance expertise - The increasing demand for regulatory compliance expertise significantly boosts the Global Medical Device Contract Manufacturing Market. Meeting the strict and varying regulatory standards across regions requires specialized knowledge, which contract manufacturers provide efficiently. This expertise accelerates product approvals and minimizes the risks associated with non-compliance, protecting companies from costly delays and reputational damage.
Contract manufacturers often have dedicated teams focused on quality assurance and regulatory affairs that keep pace with evolving guidelines such as FDA rules, ISO certifications, and MDR standards. This proactive approach ensures manufacturing processes comply with regulations from the outset, reducing the need for costly corrections later in the development cycle.
As regulations continuously evolve to address new technologies and patient safety, partnering with contract manufacturers who possess strong compliance capabilities becomes a strategic asset. This allows medical device companies to concentrate on innovation and market expansion while relying on their partners to maintain regulatory standards.
Restraints
- High dependency on third-party manufacturers
- Quality control challenges in outsourcing
- Regulatory hurdles and compliance risks
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Intellectual property protection concerns - Protecting intellectual property is a critical challenge in the Global Medical Device Contract Manufacturing Market. Outsourcing production means sharing proprietary designs and innovations with third-party manufacturers, which raises concerns about potential theft, unauthorized use, or leaks of sensitive information.
Many companies hesitate to fully outsource manufacturing due to fears that contract manufacturers, especially those serving multiple clients, might compromise their trade secrets. Without robust confidentiality agreements and security protocols, valuable innovations can be at risk of being replicated by competitors.
The global nature of contract manufacturing adds further complexity, as legal protections for intellectual property vary across countries. This disparity can leave companies vulnerable to infringement and complicate enforcement efforts, requiring significant investment to safeguard patents and designs internationally.
Opportunities
- Expansion in emerging healthcare markets
- Advancements in manufacturing technologies
- Rising collaborations and partnerships
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Increasing demand for customized solutions - The expansion of healthcare infrastructure and increasing medical device demand in emerging markets offers substantial growth opportunities for the Global Medical Device Contract Manufacturing Market. Developing regions often lack local manufacturing capacities that meet global quality standards, making outsourced contract manufacturing an attractive solution.
Contract manufacturers can tap into these markets by establishing local facilities or partnering with regional firms, which helps reduce logistics costs and improves supply chain efficiency. Governments in these areas frequently support healthcare development through incentives, creating a favorable environment for manufacturing growth.
Rising healthcare awareness and expanding middle-class populations drive demand for customized medical devices, further increasing the need for adaptable and scalable manufacturing solutions. This encourages contract manufacturers to innovate and tailor their offerings to specific regional healthcare requirements.
Competitive Landscape Analysis
Key players in Global Medical Device Contract Manufacturing Market include:
- Jabil Inc.
- Gerresheimer AG
- Synecco
- Invetech
- Biofortuna Limited
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Market Share Analysis
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Device
- Market Snapshot, By Service
- Market Snapshot, By Class Device
- Market Snapshot, By End-use
- Market Snapshot, By Region
- Global Medical Device Contract Manufacturing Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
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Rising demand for outsourcing manufacturing services
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Increasing complexity of medical devices
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Focus on cost reduction and efficiency
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Growing need for regulatory compliance expertise
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- Restraints
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High dependency on third-party manufacturers
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Quality control challenges in outsourcing
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Regulatory hurdles and compliance risks
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Intellectual property protection concerns
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- Opportunities
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Expansion in emerging healthcare markets
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Advancements in manufacturing technologies
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Rising collaborations and partnerships
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Increasing demand for customized solutions
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- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Medical Device Contract Manufacturing Market, By Device, 2021 - 2031 (USD Million)
- IVD Devices
- Diagnostic Imaging Devices
- Cardiovascular Devices
- Ophthalmology Devices
- Orthopedic Devices
- Dental Devices
- Others
- Global Medical Device Contract Manufacturing Market, By Service, 2021 - 2031 (USD Million)
- Device Development and Manufacturing Service
- Quality Management Service
- Assembly Service
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Global Medical Device Contract Manufacturing Market, By Class Device, 2021 - 2031 (USD Million)
- Class I: General controls
- Class II: General controls with special controls
- Class III: General controls with special controls
- Global Medical Device Contract Manufacturing Market, By End-use, 2021 - 2031 (USD Million)
- Original Equipment Manufacturers (OEMs)
- Pharmaceutical & Biopharmaceutical Companies
- Others
- Global Medical Device Contract Manufacturing Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Medical Device Contract Manufacturing Market, By Device, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Jabil Inc.
- Gerresheimer AG
- Synecco
- Invetech
- Biofortuna Limited
- Company Profiles
- Analyst Views
- Future Outlook of the Market