의료기기 아웃소싱 시장 규모, 점유율, 성장 분석 : 서비스별, 용도별, 클래스별, 지역별 - 업계 예측(2026-2033년)

Medical Device Outsourcing Market size was valued at USD 142.82 Billion in 2024 and is poised to grow from USD 160.1 Billion in 2025 to USD 399.23 Billion by 2033, growing at a CAGR of 12.1% during the forecast period (2026-2033).

The medical device outsourcing market is witnessing significant growth driven by rising demand for diverse medical equipment and heightened competition among outsourcing vendors aiming to deliver advanced devices. The integration of automation and artificial intelligence in health diagnostics fuels an increasing need for innovative medical solutions within the healthcare sector. Consequently, outsourcing vendors are capitalizing on various opportunities, significantly boosting market development. Major original equipment manufacturers and subcontractors, particularly in developed regions such as North America and Europe, are adopting these advanced technologies more rapidly than their counterparts in developing nations. Furthermore, leading outsourcing firms are emphasizing innovation to create superior and efficient devices, addressing the escalating healthcare demands globally and enhancing overall market potential.

Top-down and bottom-up approaches were used to estimate and validate the size of the Medical Device Outsourcing 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.

Medical Device Outsourcing Market Segments Analysis

Global Medical Device Outsourcing Market is segmented by Service, Application, Class and Region. Based on Service, the market is segmented into Quality Assurance, Regulatory Affairs Services (Clinical Trials Applications And Product Registrations, Regulatory Writing And Publishing, Legal Representation, Others), Product Design and Development Services (Designing & Engineering, Machining, Molding, Packaging), Product Testing & Sterilization Services, Product Implementation Services, Product Upgrade Services, Product Maintenance Services, Contract Manufacturing (Accessories Manufacturing, Assembly Manufacturing, Component Manufacturing, Device Manufacturing). Based on Application, the market is segmented into Cardiology, Diagnostic imaging, Orthopedic, IVD, Ophthalmic, General and Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care, Others. Based on Class, the market is segmented into Class I, Class II, Class III. Based on Region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Medical Device Outsourcing Market

The rising incidence of cardiovascular diseases, coupled with the escalating investments in research and development, is significantly propelling the growth of the Medical Device Outsourcing market. As healthcare providers and manufacturers strive to meet the increasing demand for innovative medical solutions, there is a heightened focus on outsourcing as a strategic approach to enhance efficiency and reduce costs. Additionally, advancements in technology and the pursuit of improved patient outcomes are further stimulating collaboration between medical device companies and outsourcing partners. This dynamic environment is fostering a robust growth trajectory within the industry as stakeholders adapt to emerging healthcare challenges.

Restraints in the Medical Device Outsourcing Market

The growth of the global medical device outsourcing market is significantly hindered by the rigorous government regulations that govern the certification and approval processes for medical devices. These stringent requirements can lead to lengthy delays, complicating the path to market for new innovations. Compliance with such regulations often demands substantial resources and investment from companies, which can deter potential entrants and slow down the overall pace of development in the sector. Consequently, the evolving regulatory landscape poses a formidable challenge that can restrict market expansion and stifle competition, thereby impacting the dynamics of the medical device outsourcing industry.

Market Trends of the Medical Device Outsourcing Market

The medical device outsourcing market is witnessing significant growth driven by the increasing integration of advanced robotics across healthcare technologies. This trend reflects a growing demand for specialized robotic systems that enhance precision, efficiency, and innovation in medical device manufacturing. As manufacturers seek to streamline operations and reduce costs, they are increasingly outsourcing production to leverage expert capabilities in robotics. This strategic shift not only fosters the development of cutting-edge devices but also opens up new avenues for collaboration and investment, positioning the outsourcing sector as a key player in the evolution of the medical device landscape.

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
  • Driver & Opportunities
  • Restraints & Challenges
• Porters Analysis & Impact
  • 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
• Technological Advancement
• Regulatory Landscape
• Value Chain Analysis
• Case Study Analysis
• PESTEL Analysis
• Macro-Economic Indicators
• Market Attractiveness Index

Global Medical Device Outsourcing Market Size by Service & CAGR (2026-2033)

• Market Overview
• Quality Assurance
• Regulatory Affairs Services
  • Clinical Trials Applications And Product Registrations
  • Regulatory Writing And Publishing
  • Legal Representation
  • Others
• Product Design and Development Services
  • Designing & Engineering
  • Machining
  • Molding
  • Packaging
• Product Testing & Sterilization Services
• Product Implementation Services
• Product Upgrade Services
• Product Maintenance Services
• Contract Manufacturing
  • Accessories Manufacturing
  • Assembly Manufacturing
  • Component Manufacturing
  • Device Manufacturing

Global Medical Device Outsourcing Market Size by Application & CAGR (2026-2033)

• Market Overview
• Cardiology
• Diagnostic imaging
• Orthopedic
• IVD
• Ophthalmic
• General and Plastic Surgery
• Drug Delivery
• Dental
• Endoscopy
• Diabetes Care
• Others

Global Medical Device Outsourcing Market Size by Class & CAGR (2026-2033)

• Market Overview
• Class I
• Class II
• Class III

Global Medical Device Outsourcing Market Size & CAGR (2026-2033)

• North America (Service, Application, Class)
  • US
  • Canada
• Europe (Service, Application, Class)
  • UK
  • Germany
  • Spain
  • France
  • Italy
  • Rest of Europe
• Asia-Pacific (Service, Application, Class)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia Pacific
• Latin America (Service, Application, Class)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Service, Application, Class)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2025
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2025
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2021-2023)

Key Company Profiles

• SGS SA
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Laboratory Corporation of America Holdings
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eurofins Scientific SE
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pace Analytical Services, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Intertek Group plc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXiAppTec
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• North American Science Associates, LLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• TUV SUD
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GTCR (Sterigenics U.S., LLC )
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• RJR Consulting, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Mandala International
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Freyr
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Global Regulatory Partners
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• EQT Private Equity (PAREXEL International Corporation)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• UL LLC (Emergo)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Accell Clinical Research, LLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Criterium, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• iuvo BioScience (Promedica International)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ICON plc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendation