Austin, United States, June 12, 2026 (GLOBE NEWSWIRE) -- “The Medical Device Contract Manufacturing Market was valued at USD 87.32 billion in 2025 and is projected to reach USD 268.6 billion by 2035, expanding at a CAGR of 11.89% during 2026–2035, according to a new report by SNS Insider.”
The global medical device contract manufacturing market is experiencing significant growth due to the increase in outsourcing of production from OEMs to specialized CMOs. The trend of stringent regulations, increasing product complexity, and manufacturing costs has prompted many OEMs to take advantage of manufacturing partners who offer state-of-the-art cleanrooms, automation processes, sterilization processes, and quality management systems. CMOs are incorporating robotics, AI-assisted quality checks, precision engineering, and additive manufacturing to make their production processes more efficient and enable faster development and commercialization of future medical devices.
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Growing OEM Outsourcing and Advanced Manufacturing Technologies Accelerate Market Expansion
OEMs of medical devices have been increasingly teaming up with established CMOs to concentrate on innovation by capitalizing on their manufacturing strengths and regulatory compliance know-how. With high demands for connective health devices, minimally invasive surgical tools, implants, IVDs, and combined drugs-device products, substantial business opportunities lie ahead for contract manufacturers. Significant investments have been made in automation, digital manufacturing processes, process monitoring through artificial intelligence, and precision machining technology.
Leading Market Players Listed in the Medical Device Contract Manufacturing Market Report are:
- Jabil Inc. (Jabil Healthcare)
- Flex Ltd. (Flex Medical)
- Plexus Corp.
- Integer Holdings Corporation
- Celestica Inc.
- Kimball Electronics Inc.
- Tecomet Inc.
- Nordson MEDICAL
- Resonetics LLC
- Freudenberg Medical GmbH
- Confluent Medical Technologies
- Minnetronix Medical Inc.
- Lake Region Medical (Integer)
- Tegra Medical LLC
- Micro Systems Technologies GmbH
- Arterex Medical Solutions
- IEC Electronics Corp.
- SurModics Inc.
- Phillips-Medisize (Molex)
- Viant Medical LLC
Segmentation Analysis:
By Service Type, Device Development & Manufacturing Dominated the Market; Quality Management & Testing Segment to Grow with the Fastest CAGR Globally
Device Development & Manufacturing dominated with around 54.3% revenue share in 2025, due to the scope of end-to-end manufacturing services that OEMs look for in outsourcing production a single CMO relationship covering design transfer, process validation, pilot production, and commercial-scale manufacturing. Quality Management & Testing services is the fastest growing segment at about 14.4% CAGR, partly due to the progressive tightening of medical device regulatory requirements under EU MDR and FDA’s enhanced inspection programmes globally.
By Device Type, Diagnostic & In-Vitro Diagnostic Devices Dominated the Market; Drug Delivery Devices Segment to Grow with the Fastest CAGR Globally
Diagnostic & IVD Devices dominated with approximately 28.2% revenue share in 2025 due to the extraordinary scale of global IVD test consumption whose COVID-19 pandemic acceleration created lasting installed base expansion across lateral flow, PCR, and clinical chemistry diagnostic platforms. Drug Delivery Devices are growing fastest at approximately 12.4% CAGR, driven by the biologics and biosimilar market's expansion creating growing demand for auto-injectors, pen injectors, pre-fillable syringes, and inhalation delivery devices globally.
By End Use, Original Equipment Manufacturers Dominated the Market; Pharmaceutical & Biopharmaceutical Companies Segment to Witness Fastest CAGR Growth Globally
OEMs dominated with approximately 67% market share in 2025 due to medical device companies' continued reliance on contract manufacturing as their primary production strategy across both established product lines and new technology categories whose manufacturing complexity exceeds captive infrastructure capability. Pharmaceutical & Biopharmaceutical Companies are projected to register the fastest CAGR of around 11.8% during 2026–2035, as combination drug-device products and biologics delivery systems increasingly require specialized device manufacturing capability that pharmaceutical companies are sourcing from medical device CMOs globally.
Regional Insights:
Asia Pacific dominated the global medical device contract manufacturing market in 2025, in terms of revenue, which accounted for 38.7% share owing to cost-effective manufacturing infrastructure, highly skilled precision engineering workforce, and sophisticated cleanroom assembly capability across China, Singapore, Malaysia, Thailand, and India. China accounts for around 52.4% of total Asia Pacific revenues, driven by its scale in medical device manufacturing at global export volumes and concentration of OEM manufacturing partnerships.
North America is the fastest growing regional market, with growth driven by the expansion of OEM outsourcing among leading US device companies, near-shoring investment driven by supply chain resilience priorities, and growing regulatory compliance complexity creating CMO engagement above vertically integrated production capability.
- The U.S. Medical Device Contract Manufacturing Market was valued at approximately USD 29.8 Billion in 2025 and is expected to grow significantly through 2035, expanding at a CAGR of approximately 12.1% from 2026–2035. The U.S. is home to world-leading OEM customers Medtronic, Abbott, Boston Scientific and Becton Dickinson, making it the leader in North American medical device contract manufacturing.
The Europe Medical Device Contract Manufacturing Market is estimated to be USD 24.45 Billion in 2025 and is projected to reach USD 71.26 Billion by 2035, growing at a CAGR of 11.30% during 2026–2035. The Europe Medical Device Contract Manufacturing Market is a technically sophisticated market where EU MDR's stringent post-market surveillance, clinical evidence, and quality management system requirements are creating regulatory-driven outsourcing to certified CMOs whose established notified body relationships and compliant quality system infrastructure meaningfully reduce OEM compliance burden.
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Recent Developments:
- 2025: Arterex acquired Phoenix S.r.l., a leading Italian medical device solution provider, expanding its European presence and enhancing capabilities in device development, finished device assembly, and regulatory packaging for the EU MDR compliance-driven outsourcing market.
- 2025: Integer Holdings acquired Pulse Technologies for USD 140 million, enhancing precision machining and coating capabilities for cardiovascular and implantable device applications and strengthening Integer's end-to-end development capabilities for high-complexity device programmes.
Exclusive Sections of the Report (The USPs):
- OUTSOURCING STRATEGY & OEM PARTNERSHIP ANALYSIS – Evaluates outsourcing trends, supplier selection criteria, strategic manufacturing partnerships, and evolving business models across global medical device OEMs.
- REGULATORY COMPLIANCE & QUALITY MANAGEMENT BENCHMARKING – Provides insights into FDA, MDR, ISO 13485, and global regulatory requirements shaping contract manufacturing operations and product approvals.
- MANUFACTURING TECHNOLOGY & AUTOMATION ASSESSMENT – Examines adoption of robotics, AI-powered inspection systems, additive manufacturing, digital quality management, and smart factory technologies.
- CAPACITY EXPANSION & SUPPLY CHAIN INTELLIGENCE – Analyzes manufacturing footprint expansion, supply chain resilience, component sourcing strategies, and production scalability across key regions.
- DEVICE CATEGORY & END-MARKET OPPORTUNITY ANALYSIS – Identifies growth opportunities across diagnostics, implantable devices, surgical instruments, drug delivery systems, and connected medical technologies.
- COMPETITIVE LANDSCAPE & STRATEGIC COMPANY PROFILES – Profiles leading contract manufacturers based on manufacturing capabilities, technological expertise, geographic presence, strategic collaborations, acquisitions, and expansion initiatives.
Medical Device Contract Manufacturing Market Report Scope
| Report Attributes | Details |
| Market Size in 2025 | USD 87.32 Billion |
| Market Size by 2035 | USD 268.6 Billion |
| CAGR | CAGR of 11.89% From 2026 to 2035 |
| Base Year | 2025 |
| Forecast Period | 2026-2035 |
| Historical Data | 2022-2024 |
| Key Segments | • By Service Type (Device Development & Manufacturing, Finished Device Assembly, Precision Components & Sub-Assemblies, Sterilization Services, Quality Management & Testing) • By Device Type (Cardiovascular Devices, Diagnostic & In-Vitro Diagnostic Devices, Drug Delivery Devices, Orthopedic Devices, Surgical Instruments, Others) • By End Use (Original Equipment Manufacturers (OEMs), Pharmaceutical & Biopharmaceutical Companies, Others) |
| Regional Analysis/Coverage | North America (US, Canada), Europe (Germany, UK, France, Italy, Spain, Russia, Poland, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN Countries, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Mexico, Colombia, Rest of Latin America). |
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