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Medical Device Outsourced Manufacturing Market - Global Forecast 2025-2032

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    Report

  • 190 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 5674830
UP TO OFF until Jan 01st 2026
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The medical device outsourced manufacturing market is transforming how healthcare stakeholders approach operational excellence, compliance, and innovation. Senior executives are increasingly relying on specialized partners to optimize processes, reduce complexities, and adapt quickly to industry changes.

Market Snapshot: Medical Device Outsourced Manufacturing Market

The global medical device outsourced manufacturing market stands at USD 34.87 billion in 2024, with robust momentum forecast through a compound annual growth rate (CAGR) of 11.3%. According to recent projections, the market is set to grow to USD 38.86 billion in 2025 and achieve USD 82.13 billion by 2032. Key drivers fueling this expansion include rapid advancements in process automation, the diversification of device offerings, and an unwavering focus on achieving and maintaining international quality standards. Medical device outsourcing now serves as a foundational strategy for companies pursuing optimized scalability, cost efficiency, and rapid adaptation across various healthcare channels.

Scope & Segmentation

  • Product Types: Cardiology devices, diagnostic equipment, orthopedic implants, catheters, tubing, dental devices, and surgical instruments form the crucial product segments. These groups support specialized clinical workflows and expand access to solutions across diverse therapeutic areas.
  • Service Types: Services span assembly, packaging, distribution logistics, sterilization, product development, scalable manufacturing, and prototyping. This suite accelerates product launches and ensures alignment with evolving regulatory and regional demands.
  • Process Types: The market relies on additive manufacturing, blow molding, CNC machining, extrusion, and injection molding. These processes enable precise, scalable solutions for both high-volume and custom device production.
  • Material Types: Outsourcing leverages advanced electronic sensors, premium metals such as aluminum and titanium, circuit boards, high-grade polycarbonate and polypropylene plastics, and medical-grade silicones to enhance device performance and reliability.
  • End Use Settings: Applications include ambulatory care centers, hospitals, specialty clinics, general clinics, and home health organizations. Supporting decentralization, these settings drive demand for safe, patient-centric manufacturing solutions.
  • Regions: The Americas, Europe, Middle East & Africa, and Asia-Pacific represent major markets, each shaped by regional regulatory regimes, operational expenses, and supply chain structures that influence market entry and growth strategies.
  • Companies Covered: The competitive field features Jabil Inc., Flex Ltd., Sanmina Corporation, Celestica Inc., Plexus Corp., Benchmark Electronics, TT Electronics plc, Kimball Electronics, Integer Holdings Corporation, and SMTC Corporation, which contribute to global efficiencies and technological leadership.

Key Takeaways for Industry Stakeholders

  • Outsourcing empowers organizations to allocate resources where they drive the most value, such as research and new product innovation, thereby enhancing operational strengths and market reach.
  • Employing automation and digital twin simulation technologies increases responsiveness to rapidly shifting regulatory environments, reducing product development time and boosting manufacturing agility.
  • Enhanced serialization and digital documentation practices improve supply chain transparency and facilitate tight compliance with traceability standards across international operations.
  • Adopting responsible sourcing coupled with a focus on energy efficiency increases organizational resilience, helping to meet regulatory requirements and stakeholders' sustainability objectives.
  • Establishing or expanding manufacturing capacity at the regional level strengthens the ability to respond to demographic shifts, regulatory changes, and unforeseen supply chain disruptions.

Tariff Impact on Outsourced Manufacturing

Recent shifts in United States tariff policy have prompted manufacturers to reevaluate supplier partnerships and global sourcing structures. Initiatives such as nearshoring and supplier diversification are now prioritized to reduce exposure to risk and help maintain a steady flow of critical medical devices.

Methodology & Data Sources

This analysis synthesizes findings from senior-level interviews with original equipment manufacturer executives and leading contract manufacturing organizations. Additional input is sourced from regulatory filings, patent evaluations, insights from industry experts, and published market studies to deliver an integrated perspective on sector trends.

Why This Report Matters

  • Senior leaders receive clear, actionable guidance through deep segmentation and detailed regional analysis, supporting proactive risk management and agile supply chain planning.
  • The report brings forward the influence of automation and digital innovation on market opportunities, helping organizations direct investment strategies that align with evolving industry requirements.
  • Recommendations are designed to help organizations proactively address changing regulations and patients’ needs, ensuring robust positioning for future market developments.

Conclusion

The changing landscape of medical device outsourced manufacturing highlights the importance of agile, technology-focused partnerships. Strategic collaboration is essential for organizations that seek sustained resilience and operational success in a continually evolving regulatory context.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Increasing adoption of additive manufacturing techniques for customized medical implants and devices
5.2. Growing partnership models between device OEMs and CDMOs to accelerate regulatory approval pathways
5.3. Rising integration of advanced robotics and automation in contract manufacturing facilities for precision assembly
5.4. Expansion of nearshoring and regional manufacturing hubs to mitigate supply chain disruptions for medical devices
5.5. Implementation of continuous manufacturing processes to enhance throughput and quality consistency in device production
5.6. Surge in demand for sterile contract fill finish services driven by growth in injectable and biologic medical products
5.7. Heightened focus on cybersecurity and data integrity compliance in outsourced manufacturing of connected medical devices
5.8. Adoption of AI driven process analytics and digital twins to optimize production efficiency and reduce costs in CDMOs
5.9. Increasing emphasis on sustainable manufacturing practices and ecofriendly materials in medical device outsourcing
5.10. Strategic consolidation of small specialized CMOs by global players to broaden service portfolios and capabilities
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Medical Device Outsourced Manufacturing Market, by Product Type
8.1. Cardiology Devices
8.2. Catheters And Tubing
8.3. Dental Devices
8.4. Diagnostic Equipment
8.5. Orthopedic Implants
8.6. Surgical Instruments
9. Medical Device Outsourced Manufacturing Market, by Service Type
9.1. Assembly & Packaging
9.1.1. Primary Packaging
9.1.2. Secondary Packaging
9.2. Design & Development
9.2.1. Concept Development
9.2.2. Engineering Analysis
9.3. Logistics
9.3.1. Cold Chain
9.3.2. General Logistics
9.4. Manufacturing
9.4.1. Custom Manufacturing
9.4.2. Volume Manufacturing
9.5. Prototyping
9.5.1. Bridge Manufacturing
9.5.2. Rapid Prototyping
9.6. Sterilization
9.6.1. E-Beam
9.6.2. Ethylene Oxide
9.6.3. Gamma Irradiation
10. Medical Device Outsourced Manufacturing Market, by Process Type
10.1. Additive Manufacturing
10.1.1. Electron Beam Melting
10.1.2. Fused Deposition Modeling
10.1.3. Selective Laser Sintering
10.1.4. Stereolithography
10.2. Blow Molding
10.3. CNC Machining
10.4. Extrusion
10.5. Injection Molding
11. Medical Device Outsourced Manufacturing Market, by Material Type
11.1. Electronic Components
11.1.1. Circuit Boards
11.1.2. Sensors
11.2. Metal
11.2.1. Aluminum
11.2.2. Stainless Steel
11.2.3. Titanium
11.3. Plastic
11.3.1. Polycarbonate
11.3.2. Polyethylene
11.3.3. Polypropylene
11.3.4. PVC
11.4. Silicone
11.4.1. High Consistency Silicone
11.4.2. Liquid Silicone
12. Medical Device Outsourced Manufacturing Market, by End Use
12.1. Ambulatory Care Centers
12.2. Clinics
12.3. Home Healthcare
12.4. Hospitals
12.5. Specialty Centers
13. Medical Device Outsourced Manufacturing Market, by Region
13.1. Americas
13.1.1. North America
13.1.2. Latin America
13.2. Europe, Middle East & Africa
13.2.1. Europe
13.2.2. Middle East
13.2.3. Africa
13.3. Asia-Pacific
14. Medical Device Outsourced Manufacturing Market, by Group
14.1. ASEAN
14.2. GCC
14.3. European Union
14.4. BRICS
14.5. G7
14.6. NATO
15. Medical Device Outsourced Manufacturing Market, by Country
15.1. United States
15.2. Canada
15.3. Mexico
15.4. Brazil
15.5. United Kingdom
15.6. Germany
15.7. France
15.8. Russia
15.9. Italy
15.10. Spain
15.11. China
15.12. India
15.13. Japan
15.14. Australia
15.15. South Korea
16. Competitive Landscape
16.1. Market Share Analysis, 2024
16.2. FPNV Positioning Matrix, 2024
16.3. Competitive Analysis
16.3.1. Jabil Inc.
16.3.2. Flex Ltd.
16.3.3. Sanmina Corporation
16.3.4. Celestica Inc.
16.3.5. Plexus Corp.
16.3.6. Benchmark Electronics, Inc.
16.3.7. TT Electronics plc
16.3.8. Kimball Electronics, Inc.
16.3.9. Integer Holdings Corporation
16.3.10. SMTC Corporation

Companies Mentioned

The companies profiled in this Medical Device Outsourced Manufacturing market report include:
  • Jabil Inc.
  • Flex Ltd.
  • Sanmina Corporation
  • Celestica Inc.
  • Plexus Corp.
  • Benchmark Electronics, Inc.
  • TT Electronics plc
  • Kimball Electronics, Inc.
  • Integer Holdings Corporation
  • SMTC Corporation

Table Information