의료기기 CDMO 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the medical device CDMO market size was valued at USD 127.75 billion in 2025 and is estimated to grow from USD 134.78 billion in 2026 to reach USD 180.76 billion by 2031, at a CAGR of 6.05% during the forecast period (2026-2031).

This report is Segmented by Product Type (Diagnostics, Therapeutics, Drug-Device Combinations), Service (Contract Development, Contract Manufacturing, Packaging, Others), Device Class (Class I, II, III), Application (Cardiovascular, Orthopedic, Surgical, Others), End Use (OEMs, Pharma Companies, Others), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Value (USD).

Global Medical Device CDMO Market Trends and Insights

Outsourcing of Complex Device Development and Manufacturing

The medical device CDMO market is gaining support from the steady rise in complex programs that many OEMs no longer want to manage fully inside their own networks. Miniaturization, connectivity, and mixed electromechanical design are making it harder for internal plants to cover every manufacturing step with the needed validation discipline. Integer Holdings stated in its first quarter 2026 earnings release that customers are continuing to look for more outsourcing, which shows that this shift is still active in 2026. Plexus also reported Healthcare and Life Sciences revenue growth ahead of its target range in fiscal second quarter 2026, which points to healthy demand for specialist external production support. Once OEMs narrow internal tooling depth and process engineering coverage, the ability to bring those programs back in-house becomes weaker. That creates a longer relationship cycle in the medical device CDMO market, and it favors suppliers that can take a program from design transfer into validated production without a break in responsibility.

Rising Demand for Combination Products and Drug Delivery Systems

The medical device CDMO market is seeing stronger demand from drug-device combinations because these programs require device engineering, sterile process control, and drug-side compliance at the same time. The FDA Quality Management System Regulation became effective in February 2026, and that raised the compliance standard for manufacturers operating across device and drug requirements. The FDA Office of Combination Products also issued draft guidance on Unique Device Identifier requirements for combination products in June 2025, which signaled continued regulatory attention on this category. That dual burden makes scale and integrated quality systems more valuable in the medical device CDMO market because smaller specialists often lack matching pharmaceutical infrastructure. Jabil's February 2025 acquisition of Pharmaceutics International showed how established device-focused suppliers are building drug manufacturing capability before competitive pressure becomes harder to manage. As a result, growth is moving toward suppliers that can handle both the physical device and the regulated drug interface within one operating model.

Regulatory Validation Burden Across Multi-Jurisdiction Programs

The medical device CDMO market still faces a heavy regulatory burden when one program must satisfy the FDA, EU MDR, and national requirements at the same time. The FDA Quality Management System Regulation took effect in February 2026 and incorporated ISO 13485 by reference, which increased the importance of documented control over outsourced processes and supplier management. RAPS reported that outsourcing and purchasing controls appeared among the main Form 483 observation areas during early QMSR-era inspections, which reinforces how directly regulators are reviewing external manufacturing oversight. BVMed data published in the 2026 German MedTech outlook showed that 93% of German MedTech manufacturers are SMEs, and that matters because smaller organizations feel the documentation burden more sharply. In the medical device CDMO market, the environment favors providers with in-house regulatory teams, but it also raises fixed operating costs across the sector. The result is a market where compliance capability is becoming as important as factory footprint.

Other drivers and restraints analyzed in the detailed report include:

1. Pharma-Medtech Convergence and Integrated Development Models
2. Reshoring and Supply Chain Risk Rebalancing for Critical Devices
3. Long Qualification Cycles for High-Risk and Class III Devices

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Drug-device combination products held 56.21% of the medical device CDMO market share in 2025, which made them the clear center of product demand. That leadership reflects the wider use of autoinjectors, pre-filled syringes, inhaled drug-device systems, and implant-linked delivery formats. In the medical device CDMO market, these programs carry more than volume, because they also combine device engineering with pharmaceutical compliance and sterile process expectations. Suppliers that serve this category must maintain aligned quality systems across both sides of the product, which narrows the pool of eligible vendors. That narrower supplier base supports stronger customer dependence on operators that already passed qualification for integrated programs.

Therapeutics is projected to grow at a 6.81% CAGR from 2026 to 2031, which shows that future demand is moving toward chronic disease delivery and implant-enabled treatment formats. Biosimilar wearable delivery platforms and newer implantable therapeutic modalities are expanding the need for manufacturing partners that can manage precision assembly over longer product lifecycles. Diagnostics remains smaller in revenue terms, but it is becoming more relevant where point-of-care platforms include microfluidics, compact sensing, and embedded analytics. Jabil's January 2026 manufacturing partnership with TxSphere, including fill-finish support for primary drug packs, showed how the medical device CDMO market is moving toward one coordinated production chain for combination programs. Taken together, product demand is increasingly favoring suppliers that can manage therapy, device, and packaging interfaces as one integrated operating model.

Contract development accounted for 42.83% share of the medical device CDMO market size in 2025, while contract manufacturing is projected to grow at a 7.94% CAGR through 2031. The larger development base shows that OEMs still depend heavily on outside support for design transfer, testing, validation planning, and quality documentation. These services reduce time-to-market pressure without requiring customers to keep full engineering depth across every program type. They also create early engagement points that can later convert into long production contracts. In the medical device CDMO market, front-end involvement often shapes supplier selection well before a commercial manufacturing award is finalized.

Contract manufacturing is growing faster because OEMs continue to shift fixed production assets and specialized assembly work toward external partners with existing infrastructure. Device manufacturing and assembly still cover the broadest range of projects, from finished units to advanced subassemblies that need traceability and controlled process discipline. Component manufacturing is gaining importance in cardiovascular and neuromodulation work, where tolerance control and precision machining are harder to scale inside generalist plants. Packaging and regulatory affairs are also becoming more strategic, because customers increasingly want submission support and manufacturing coordination under one commercial agreement. That keeps the medical device CDMO market oriented toward full-service platforms that can move from development into supply continuity without handing the program across multiple vendors.

Complete Report Scope:

• By Product Type
  • Diagnostics
  • Therapeutics
  • Drug-Device Combination Products
• By Service
  • Contract Development
    • Product Design and Development Services
    • Testing and Validation
    • Quality Management
    • Others
  • Contract Manufacturing
    • Accessories Manufacturing
    • Assembly Manufacturing
    • Component Manufacturing
    • Device Manufacturing
  • Packaging
  • Regulatory Affairs
• By Device Class
  • Class I
  • Class II
  • Class III
• By Application
  • Cardiovascular Devices
  • Orthopedic Devices
  • Ophthalmic Devices
  • Diagnostic Devices
  • Respiratory Devices
  • Surgical Instruments
  • Dental
  • Others
• By End Use
  • Original Equipment Manufacturers
  • Pharmaceutical and Biopharmaceutical Companies
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America remains one of the most value-dense parts of the medical device CDMO market because it combines large OEM presence, regulatory proximity, and a deep base of advanced manufacturing talent. The United States continues to attract premium investment in this market, and Gerresheimer's expansion in Peachtree City, Georgia, showed continued confidence in domestic cleanroom and automated device production capacity. Integer Holdings also pointed to continued focus on electrophysiology, structural heart, neurovascular, and neuromodulation in the first quarter of 2026, which aligns with the higher-value segments that support outsourcing demand in the region. Mexico is absorbing added nearshoring interest through its established medical manufacturing clusters, and that supports cross-border production strategies for U.S. customers. Costa Rica, while outside formal North America, remains tightly linked to North American sourcing decisions and strengthens the regional supply chain through compliant, lower-cost production capacity.

Europe is projected to grow at a 7.82% CAGR through 2031, giving it the fastest regional pace in the medical device CDMO market. That growth is tied closely to the region's compliance environment, because stricter EU MDR requirements are pushing more OEM and pharma customers toward suppliers with validated European manufacturing sites and established regulatory experience. BVMed data showed that 93% of German MedTech manufacturers are SMEs, which helps explain why external regulatory and manufacturing support is becoming more important across the region. Ireland has become a notable sub-hub, and Quasar Medical's acquisition of the Galway facility added scale to its European position in interventional device programs. Spain, France, and Italy remain established outsourcing bases, especially where orthopedic, dental, and precision component work already has an industrial foundation.

Asia-Pacific held 39.41% of the medical device CDMO market share in 2025, which kept it as the largest regional base by revenue. That position reflects the region's long-standing role in high-volume production for Class I and lower-complexity Class II devices, supported by facilities across China, India, South Korea, and other manufacturing centers. Plexus secured a next-generation point-of-care ultrasound program for its Xiamen facility in the fiscal second quarter of 2026, which showed that Asian sites are also winning more technically complex work. The Middle East and Africa and South America remain smaller in the medical device CDMO market, with Brazil standing out, where domestic device activity and local registration needs are supporting greater interest in regional manufacturing partnerships.

1. Benchmark Electronics, Inc.
2. Celestica
3. Cogmedix, Inc.
4. Flex
5. Gerresheimer
6. Integer Holdings
7. Jabil
8. Kimball Electronics, Inc.
9. Mack Molding Co., Inc.
10. Nipro
11. Nortech Systems
12. Phillips-Medisize Corporation
13. Plexus Corp.
14. Recipharm
15. Sanmina Corporation
16. Synecco Ltd
17. Stryker
18. TE Connectivity Ltd.
19. Thermo Fisher Scientific
20. Viant Medical

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Outsourcing of Complex Device Development and Manufacturing
  • 4.2.2 Rising Demand for Combination Products and Drug Delivery Systems
  • 4.2.3 Expansion of High-Precision, Low-Touch Manufacturing Capabilities
  • 4.2.4 Pharma-Medtech Convergence and Integrated Development Models
  • 4.2.5 Sustainability-Led Material Substitution in Device Components
  • 4.2.6 Reshoring and Supply Chain Risk Rebalancing for Critical Devices
• 4.3 Market Restraints
  • 4.3.1 Regulatory Validation Burden Across Multi-Jurisdiction Programs
  • 4.3.2 IP Leakage Risk in Shared Design and Tooling Environments
  • 4.3.3 Long Qualification Cycles for High-Risk and Class III Devices
  • 4.3.4 Capacity Bottlenecks in Sterile, Cleanroom, and Specialized Assembly
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Product Type
  • 5.1.1 Diagnostics
  • 5.1.2 Therapeutics
  • 5.1.3 Drug-Device Combination Products
• 5.2 By Service
  • 5.2.1 Contract Development
    • 5.2.1.1 Product Design and Development Services
    • 5.2.1.2 Testing and Validation
    • 5.2.1.3 Quality Management
    • 5.2.1.4 Others
  • 5.2.2 Contract Manufacturing
    • 5.2.2.1 Accessories Manufacturing
    • 5.2.2.2 Assembly Manufacturing
    • 5.2.2.3 Component Manufacturing
    • 5.2.2.4 Device Manufacturing
  • 5.2.3 Packaging
  • 5.2.4 Regulatory Affairs
• 5.3 By Device Class
  • 5.3.1 Class I
  • 5.3.2 Class II
  • 5.3.3 Class III
• 5.4 By Application
  • 5.4.1 Cardiovascular Devices
  • 5.4.2 Orthopedic Devices
  • 5.4.3 Ophthalmic Devices
  • 5.4.4 Diagnostic Devices
  • 5.4.5 Respiratory Devices
  • 5.4.6 Surgical Instruments
  • 5.4.7 Dental
  • 5.4.8 Others
• 5.5 By End Use
  • 5.5.1 Original Equipment Manufacturers
  • 5.5.2 Pharmaceutical and Biopharmaceutical Companies
  • 5.5.3 Others
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Benchmark Electronics, Inc.
  • 6.3.2 Celestica Inc.
  • 6.3.3 Cogmedix, Inc.
  • 6.3.4 Flex Ltd.
  • 6.3.5 Gerresheimer AG
  • 6.3.6 Integer Holdings Corporation
  • 6.3.7 Jabil Inc.
  • 6.3.8 Kimball Electronics, Inc.
  • 6.3.9 Mack Molding Co., Inc.
  • 6.3.10 Nipro Corporation
  • 6.3.11 Nortech Systems, Inc.
  • 6.3.12 Phillips-Medisize Corporation
  • 6.3.13 Plexus Corp.
  • 6.3.14 Recipharm AB
  • 6.3.15 Sanmina Corporation
  • 6.3.16 Synecco Ltd
  • 6.3.17 Stryker Corporation
  • 6.3.18 TE Connectivity Ltd.
  • 6.3.19 Thermo Fisher Scientific Inc.
  • 6.3.20 Viant Medical

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment