Medical Device CDMO Industry Report (2026-2031): Growth Driven by Increasing Outsourcing of Medical Device Manufacturing

Medical Device CDMO Industry Report (2026-2031): Growth Driven by Increasing Outsourcing of Medical Device Manufacturing Dublin, Aug. 20, 2026 (GLOBE NEWSWIRE) -- The "Medical Device CDMO - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)" has been added to ResearchAndMarkets.com's offering.

The global medical device contract development and manufacturing organization (CDMO) market was valued at USD 127.75 billion in 2025 and is projected to increase from USD 134.78 billion in 2026 to USD 180.76 billion by 2031. The market is expected to register a compound annual growth rate (CAGR) of 6.05% during the 2026-2031 forecast period.

Medical device CDMO market growth is being driven by the outsourcing of complex product development, increased demand for drug-device combination products, and the need for specialized regulatory and manufacturing expertise. Medical device original equipment manufacturers (OEMs) are increasingly relying on external partners to support miniaturization, connectivity, precision assembly, validation, and advanced electromechanical design.

Complex Medical Device Outsourcing Supports Long-Term Growth

Many OEMs are reducing their reliance on internal manufacturing networks as product complexity and compliance requirements increase. Specialized medical device CDMOs can provide integrated support spanning design transfer, testing, validation, process engineering, and commercial-scale manufacturing. This approach allows customers to accelerate time to market while avoiding significant investment in dedicated facilities and technical resources.

Industry activity in 2026 continued to demonstrate demand for outsourced medical device manufacturing. Integer Holdings reported that customers were pursuing additional outsourcing opportunities, while Plexus recorded strong Healthcare and Life Sciences revenue growth during its fiscal second quarter. As OEMs reduce internal tooling and production capabilities, qualified CDMO relationships are likely to become longer and more strategically important.

Combination Products and Drug Delivery Systems Lead Demand

Drug-device combination products accounted for 56.21% of the medical device CDMO market in 2025. Demand is expanding across autoinjectors, prefilled syringes, inhalation systems, wearable delivery platforms, and implant-connected therapies. These products require coordinated device engineering, pharmaceutical compliance, sterile manufacturing, packaging, and quality management.

The FDA Quality Management System Regulation, effective in February 2026, increased the importance of harmonized quality controls and documented oversight. Regulatory attention to Unique Device Identifier requirements for combination products is also reinforcing the need for integrated compliance capabilities.

CDMOs are responding by expanding their pharmaceutical and fill-finish expertise. Jabil's acquisition of Pharmaceutics International in February 2025 and its January 2026 manufacturing partnership with TxSphere illustrate the industry's movement toward coordinated production models that connect drug manufacturing, primary packaging, device assembly, and commercial supply.

Therapeutic devices are forecast to record a 6.81% CAGR from 2026 to 2031, supported by chronic disease management, wearable drug delivery, biosimilars, and implantable treatment platforms. Diagnostics also present growth opportunities as point-of-care systems increasingly incorporate microfluidics, compact sensors, and embedded analytics.

Contract Manufacturing Positioned for Faster Expansion

Contract development represented 42.83% of the medical device CDMO market in 2025, reflecting strong demand for product design, testing, validation planning, design transfer, and quality documentation. Early involvement allows CDMOs to influence manufacturability and can create a direct path to long-term production agreements.

Contract manufacturing is projected to grow at a 7.94% CAGR through 2031. OEMs are transferring specialized assembly, component production, and finished-device manufacturing to external partners with validated infrastructure. Precision component manufacturing is becoming especially important in cardiovascular, electrophysiology, neurovascular, and neuromodulation applications.

Packaging and regulatory services are also gaining strategic importance as customers seek fewer supplier handoffs. Full-service medical device CDMOs that can manage development, manufacturing, packaging, regulatory coordination, and supply continuity under one operating model are well positioned to capture future demand.

Regulatory Compliance Shapes Provider Selection

Medical device manufacturers must manage increasingly complex requirements across the United States, the European Union, and national markets. The FDA's incorporation of ISO 13485 into its Quality Management System Regulation has increased scrutiny of outsourced processes, purchasing controls, supplier management, and documentation.

This environment favors medical device CDMOs with established regulatory teams and mature quality systems, although it also raises operating costs and extends qualification timelines, particularly for high-risk and Class III devices. Additional market influences include pharma-medtech convergence, reshoring initiatives, supply chain risk reduction, and the localization of critical device production.

Regional Medical Device CDMO Market Highlights

Asia-Pacific held the largest regional share at 39.41% in 2025. China, India, South Korea, and other manufacturing centers continue to support high-volume production while securing more technically complex programs. Plexus' next-generation point-of-care ultrasound program at its Xiamen facility highlights the region's expanding advanced manufacturing capabilities.

Europe is forecast to post the fastest regional CAGR of 7.82% through 2031. EU Medical Device Regulation requirements are encouraging OEMs and pharmaceutical companies to work with CDMOs that operate validated European facilities. Demand is particularly strong among small and medium-sized manufacturers requiring external regulatory, development, and production support.

North America remains a high-value medical device CDMO market due to its concentration of major OEMs, advanced manufacturing talent, and proximity to U.S. regulators. Investment continues in cleanroom capacity, automation, cardiovascular devices, structural heart technologies, and neuromodulation. Mexico is benefiting from nearshoring, while established supply chains in Costa Rica continue to support North American sourcing strategies.

Across all regions, the medical device CDMO market is moving toward integrated partnerships capable of managing increasingly sophisticated products throughout development and commercial production. Providers combining technical expertise, scalable manufacturing, regulatory knowledge, and resilient supply chains are expected to benefit most from market growth through 2031.

Key Topics Covered

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

For more information about this report visit https://www.researchandmarkets.com/r/rgwckn

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