의료기기 위탁생산 시장 규모, 점유율, 성장 분석 : 기기 유형별, 제품별, 서비스별, 치료 분야별, 최종 용도별, 지역별 - 산업 예측(2025-2032년)

Global Medical Device Contract Manufacturing Market size was valued at USD 70.83 billion in 2023 and is poised to grow from USD 78.9 billion in 2024 to USD 187.15 billion by 2032, growing at a CAGR of 11.4% during the forecast period (2025-2032).

The medical device contract manufacturing market is witnessing strong growth, propelled by heightened demand for medical devices and technological advancements. The sector's resilience and recovery are evident, particularly with a surge in outsourcing as companies seek contractor expertise for devices like ventilators and COVID-19-related products. This diverse market landscape is leading companies without in-house manufacturing to increasingly rely on contract manufacturers, further fueling growth. Global initiatives aimed at enhancing the acceptance and usage of medical devices, including new regulatory frameworks, also play a significant role in market expansion. Notably, the in vitro diagnostic (IVD) device segment is expected to capture a substantial market share due to rising demand for point-of-care devices, with North America-especially the US-serving as a critical market driver.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Medical Device Contract Manufacturing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Medical Device Contract Manufacturing Market Segments Analysis

Global Medical Device Contract Manufacturing Market is segmented by Device Type, Product, Service, Therapeutic Area, End-use and region. Based on Device Type, the market is segmented into IVD Devices, Diagnostic Imaging Devices, Cardiovascular Devices, Drug Delivery Devices, Orthopedic Devices, Respiratory Care Devices, Ophthalmology Devices, Surgical Devices, Diabetes Care Devices, Dental Devices, Endoscopy & Laparoscopy Devices, Gynecology/Urology Devices, Personal Care Devices, Neurology Devices, Patient Monitoring Devices, Patient Assistive Devices and Other Devices. Based on Product, the market is segmented into Class I, Class Ii and Class Iii. Based on Service, the market is segmented into Device Development and Manufacturing, Quality Management, Packaging And Assembly Services and Other Services. Based on Therapeutic Area, the market is segmented into Cardiovascular Devices, Orthopedic Devices, Ophthalmic Devices, Diagnostic Devices, Respiratory Devices, Surgical Instruments, Dental and Others. Based on End-use, the market is segmented into Original Equipment Manufacturers (OEMs), Pharmaceutical & Biopharmaceutical Companies and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Medical Device Contract Manufacturing Market

The Global Medical Device Contract Manufacturing market is primarily driven by the escalating demand for medical devices, which stems from the rising prevalence of chronic illnesses, an aging population, and advancements in healthcare technologies. As the need for cutting-edge equipment grows, original equipment manufacturers (OEMs) are increasingly partnering with contract manufacturers to improve efficiency and reduce operational costs. This collaborative approach leverages shared core competencies, facilitating quicker production schedules while promoting the development of world-class medical technologies. The combination of these factors is significantly propelling the growth of the medical device contract manufacturing sector worldwide.

Restraints in the Global Medical Device Contract Manufacturing Market

A significant obstacle for the global medical device contract manufacturing market is the intricate landscape of regulatory compliance. Each country and region imposes its own unique standards regarding the manufacturing and certification of medical devices, exemplified by the rigorous requirements set forth by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in Europe. These varying regulations present challenges for manufacturers and original equipment manufacturers (OEMs), as they must navigate a complex web of compliance requirements that can impact production timelines, increase operational costs, and hinder market entry strategies in different geographic areas.

Market Trends of the Global Medical Device Contract Manufacturing Market

The Global Medical Device Contract Manufacturing market is witnessing a significant trend driven by the adoption of advanced manufacturing technologies such as automation, 3D printing, and robotics. These innovations are transforming the landscape of medical device production by enhancing efficiency, reducing costs, and allowing for precise customization. The integration of 3D printing enables rapid prototyping and the delivery of intricate components, while automation ensures consistent quality and scalability in manufacturing processes. As companies seek to leverage these technologies, the industry is poised for substantial growth, enhancing productivity and fostering innovation across the medical device sector, ultimately improving patient care outcomes.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global Medical Device Contract Manufacturing Market Size by Device Type & CAGR (2025-2032)

• Market Overview
• IVD Devices
  • IVD Consumables
  • IVD Equipment
• Diagnostic Imaging Devices
• Cardiovascular Devices
• Drug Delivery Devices
  • Infusion Devices & Administration Sets
  • Syringes
  • Inhalers
  • Autoinjectors & Pen Injectors
• Orthopedic Devices
• Respiratory Care Devices
• Ophthalmology Devices
• Surgical Devices
• Diabetes Care Devices
• Dental Devices
• Endoscopy & Laparoscopy Devices
• Gynecology/Urology Devices
• Personal Care Devices
• Neurology Devices
• Patient Monitoring Devices
• Patient Assistive Devices
• Other Devices

Global Medical Device Contract Manufacturing Market Size by Product & CAGR (2025-2032)

• Market Overview
• Class I
• Class Ii
• Class Iii

Global Medical Device Contract Manufacturing Market Size by Service & CAGR (2025-2032)

• Market Overview
• Device Development and Manufacturing
  • Device And Component Manufacturing
  • Process Development
  • Device Engineering
• Quality Management
  • Packaging Validation
  • Inspection And Testing
  • Sterilization Services
• Packaging And Assembly Services
  • Primary And Secondary Packaging
  • Labeling
  • Other Packaging and Assembly Services
• Other Services

Global Medical Device Contract Manufacturing Market Size by Therapeutic Area & CAGR (2025-2032)

• Market Overview
• Cardiovascular Devices
• Orthopedic Devices
• Ophthalmic Devices
• Diagnostic Devices
• Respiratory Devices
• Surgical Instruments
• Dental
• Others

Global Medical Device Contract Manufacturing Market Size by End-use & CAGR (2025-2032)

• Market Overview
• Original Equipment Manufacturers (OEMs)
• Pharmaceutical & Biopharmaceutical Companies
• Others

Global Medical Device Contract Manufacturing Market Size & CAGR (2025-2032)

• North America (Device Type, Product, Service, Therapeutic Area, End-use)
  • US
  • Canada
• Europe (Device Type, Product, Service, Therapeutic Area, End-use)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Device Type, Product, Service, Therapeutic Area, End-use)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Device Type, Product, Service, Therapeutic Area, End-use)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Device Type, Product, Service, Therapeutic Area, End-use)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Medtronic (Ireland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Terumo Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Hologic, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi AppTec (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Integer Holdings Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Jabil Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Flex Ltd. (Singapore)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sanmina Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• TE Connectivity (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Celestica Inc. (Canada)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Kimball Electronics (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Plexus Corp. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Benchmark Electronics, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• TT Electronics plc (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nipro Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Mitsubishi Chemical Holdings Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Phillips-Medisize Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nordson Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• LISI Group (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations