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United States Medical Device Contract Manufacturing (CMO) Market 2025-2033: Outsourcing Trends & OEM Partnerships
Medical Device Contract Manufacturing (CMO) Market Size 2033
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United States: Recent Industry Developments
✅ December 2025: Leading U.S. contract manufacturers expanded cleanroom and ISO 13485-certified facilities to support rising outsourcing of Class II and Class III medical devices.
✅ November 2025: Increased demand for end-to-end services (design, prototyping, and regulatory support) accelerated partnerships with medtech startups.
✅ October 2025: Automation and digital manufacturing adoption improved scalability for implantable and diagnostic device production.
Japan: Recent Industry Developments
✅ December 2025: Japanese CDMOs strengthened precision manufacturing capabilities for minimally invasive and diagnostic medical devices.
✅ November 2025: Strategic collaborations between domestic OEMs and contract manufacturers focused on advanced materials and microfabrication.
✅ October 2025: Regulatory-aligned manufacturing practices boosted Japan's role as a high-quality outsourcing hub for global medtech firms.
GCC: Recent Industry Developments
✅ December 2025: GCC governments accelerated localization initiatives to expand medical device manufacturing under national healthcare diversification plans.
✅ November 2025: Investments in medical industrial zones supported contract manufacturing of consumables and diagnostic devices.
✅ October 2025: Public-private partnerships enhanced regional capabilities in sterile manufacturing and assembly services.
List of Top Key Player:
Jabil Inc., Thermo Fisher Scientific Inc. (PPD), Integer Holdings Corporation, Sanmina Corporation, Celestica Inc., Phillips Medisize, Plexus Corp., Inc., and Gerresheimer AG
Industry Developments:
January 2026
• Adoption of AI-driven quality management systems enhanced compliance and reduced time-to-market.
• Expansion of Class III device manufacturing capacities to meet rising demand in cardiovascular and orthopedic segments.
• Increased collaborations between manufacturers and biotech firms for custom component manufacturing.
December 2025
• Surge in packaging & assembly service contracts due to growing demand for single-use respiratory devices.
• Regulatory harmonization efforts simplified approval processes across North America and Europe.
• Significant investments made in cleanroom infrastructure to support ophthalmic device production.
November 2025
• Emerging interest in sustainable manufacturing practices within device component production.
• New quality management service certifications gained by leading contract manufacturers.
• Growth observed in outsourcing of device manufacturing in emerging markets, especially Asia-Pacific.
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Forecast Projection:
The Global Medical Device Contract Manufacturing Market is poised for significant growth between 2025 and 2032. In 2024, the market maintained a steady upward trajectory, and with strategic initiatives by leading players accelerating adoption, the market is expected to soar throughout the forecast period. Companies leveraging these trends are well-positioned to capture emerging opportunities and maximize revenue potential.
Market Key Segmentations:
• By Device Class
Class II Devices hold the largest share, fueled by growing demand for mid-risk medical devices requiring regulatory oversight.
Class I Devices maintain steady demand due to simple design and broad usage.
Class III Devices are a high-growth segment, driven by complex, life-critical device innovation.
• By Service Type
Device & Component Manufacturing Services dominate, supported by increasing outsourcing of precision manufacturing.
Quality Management Services are crucial, reflecting rising regulatory and compliance standards.
Packaging & Assembly Services hold a significant share, driven by demand for ready-to-use finished devices.
• By Therapeutic Area
Cardiovascular Devices lead market share, powered by rising cardiovascular disease prevalence and technological advancements.
Orthopedic Devices follow, supported by aging populations and rising musculoskeletal disorders.
Ophthalmic Devices and Respiratory Devices segments show steady growth, reflecting increasing chronic conditions and innovative treatments.
Regional Growth Analysis:
⇥ North America - 43.78%
Dominates the market with the largest revenue share, driven by advanced healthcare infrastructure and high outsourcing adoption.
⇥ Europe - 27.5%
Strong presence due to established medical device regulations and a mature manufacturing ecosystem.
⇥ Asia-Pacific - 21.7%
Fastest-growing region, expected to grow at a CAGR of 10.7%, fueled by rising healthcare investments and manufacturing capabilities.
⇥ Middle East & Africa - 4.3%
Growing demand linked to increasing healthcare infrastructure development and medical tourism.
⇥ South America - 2.72%
Emerging market with gradual growth driven by expanding healthcare services and regulatory improvements.
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Latest Mergers & Acquisitions Update
✔️ Completed / Announced Deals
• SK Capital Partners completes acquisition of LISI Group's medical division, forming a new contract manufacturing platform (Precera Medical), bolstering precision component CDMO capabilities.
• SK Capital's earlier agreement to acquire LISI Medical from LISI Group underscores private equity interest in specialized medical device manufacturing assets.
• Private equity investment in Currier Plastics, a precision plastics contract manufacturer, demonstrating financial investor interest in CMOs serving device OEM supply chains.
✔️ MedTech M&A Trends
• Boston Scientific announced acquisition of Penumbra ($14.5B) - one of the first major MedTech deals of 2026, expanding interventional device portfolio (relevant to CMOs supplying such products).
• Industry‐wide M&A roundup for 2025 shows multiple supplier & device maker transactions across the space.
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Additional Relevant Deals (2025)
• Quasar Medical acquired Nordson's contract manufacturing operations, enhancing balloon and catheter production capability in 2025.
• Arterrex completed acquisition of Phoenix S.r.l., broadening its European manufacturing footprint.
• Integer Holdings acquired Precision Coating, adding advanced surface technologies to its medical manufacturing portfolio.
• DuPont agreement to acquire Donatelle Plastics, a CM business focused on medical device components.
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