세계의 의료기기 아웃소싱 시장 규모, 점유율, 동향 분석 : 서비스별, 용도별, 클래스 유형별, 지역별, 부문별 예측(2025-2033년)

Medical Device Outsourcing Market Summary

The global medical device outsourcing market size was estimated at USD 128.80 billion in 2024 and is projected to reach USD 386.08 billion by 2033, growing at a CAGR of 13.29% from 2025 to 2033. The market is driven by increasing demand for medical devices, combined with the rising price competition and the requirement to reduce costs.

Regulatory approval procedures are becoming more stringent & time-consuming, and market players aim to receive product approvals on the first attempt to gain higher market share. Medical device companies have to manage continuous changes in regulatory requirements, which span over different business activities and multiple geographies worldwide. Noncompliance with changing regulatory requirements may result in penalties and delays, which may lead to loss of revenue. Geographic expansion by medical device companies aimed at speedy approvals in global markets is expected to further contribute to an increase in the adoption of outsourcing models for regulatory affairs services.

The medical device business is under continual pressure to regulate costs without compromising on the R&D process, time to market, or the associated safety & quality. Novel technologies, process developments, and a rapidly aging population are factors driving segment growth. As a result, regulations become increasingly stringent and complex due to heightened market competition. Medical device Original Equipment Manufacturers (OEMs) can benefit from increased agility, low operational costs, and reduced time to market, as well as high return on investment by outsourcing some of their operations. OEMs can also transform their companies into strategic investments from cost centers. Hence, this is expected to create demand for medical affairs outsourcing services.

Global Medical Device Outsourcing Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global medical device outsourcing market report based on service, application, class type, and region:

• Service Outlook (Revenue, USD Million, 2021 - 2033)
• Quality Assurance Services
• Regulatory Affairs Services
  • Clinical trials applications and product registrations
  • Regulatory writing and publishing
  • Legal representation
  • Other
• 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 Services
  • Accessories Manufacturing
  • Assembly Manufacturing
  • Component Manufacturing
  • Device Manufacturing
• Application Outlook (Revenue, USD Million, 2021 - 2033)
• Cardiology
  • Class I
  • Class II
  • Class III
• Diagnostic imaging
  • Class I
  • Class II
  • Class III
• Orthopedic
  • Class I
  • Class II
  • Class III
• IVD
  • Class I
  • Class II
  • Class III
• Ophthalmic
  • Class I
  • Class II
  • Class III
• General and plastic surgery
  • Class I
  • Class II
  • Class III
• Drug delivery
  • Class I
  • Class II
  • Class III
• Dental
  • Class I
  • Class II
  • Class III
• Endoscopy
  • Class I
  • Class II
  • Class III
• Diabetes care
  • Class I
  • Class II
  • Class III
• Others
  • Class I
  • Class II
  • Class III
• Class Type Outlook (Revenue, USD Million, 2021 - 2033)
• Class I
• Class II
• Class III
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Norway
  • Sweden
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait
  • Oman
  • Qatar

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased database
  • 1.4.2. GVR's internal database
  • 1.4.3. Secondary sources
  • 1.4.4. Primary research
• 1.5. Information or Data Analysis
  • 1.5.1. Data analysis models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity flow analysis (Model 1)
  • 1.7.2. Value chain based analysis (Model 2)
  • 1.7.3. Multivariate Analysis (Model 3)
• 1.8. List of Secondary Sources
• 1.9. List of Primary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Landscape Insights

Chapter 3. Medical Device Outsourcing Market: Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Ancillary Market Outlook
• 3.2. Medical Device Outsourcing Market Dynamics
  • 3.2.1. Market Driver Impact Analysis
  • 3.2.2. Market Restraint Analysis
  • 3.2.3. Market Opportunities
• 3.3. Technological Landscape
• 3.4. Pricing Model Analysis
• 3.5. Tariff Impact Analysis
• 3.6. Supply Chain Analysis
• 3.7. Market Analysis Tools
  • 3.7.1. Porter's Five Forces Analysis
  • 3.7.2. PESTEL by SWOT Analysis

Chapter 4. Medical Device Outsourcing Market: Service Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Medical Device Outsourcing Market Service Movement Analysis
• 4.3. Global Medical Device Outsourcing Market Size & Trend Analysis, by Service, 2021 to 2033 (USD Million)
• 4.4. Contract Manufacturing Services
  • 4.4.1. Contract Manufacturing Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Quality Assurance Services
  • 4.5.1. Quality Assurance Services Market Estimates and Forecasts, 2021 - 2033 (USD million)
• 4.6. Regulatory Affairs Services
  • 4.6.1. Regulatory Affairs Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.7. Product Design & Development Services
  • 4.7.1. Product Design & Development Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.8. Product Testing & Sterilization Services
  • 4.8.1. Product Testing & Sterilization Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.9. Product Implementation Services
  • 4.9.1. Product Implementation Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.10. Product Upgrade Services
  • 4.10.1. Product Upgrade Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.11. Product Maintenance Services
  • 4.11.1. Product Maintenance Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. Medical Device Outsourcing Market: Application Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Medical Device Outsourcing Market Application Movement Analysis
• 5.3. Global Medical Device Outsourcing Market Size & Trend Analysis, by Application, 2021 to 2033 (USD Million)
• 5.4. Cardiology
  • 5.4.1. Cardiology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Diagnostic Imaging
  • 5.5.1. Diagnostic Imaging Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. Orthopedic
  • 5.6.1. Orthopedic Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.7. IVD
  • 5.7.1. IVD Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.8. Ophthalmic
  • 5.8.1. Ophthalmic Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.9. General & Plastic Surgery
  • 5.9.1. General & Plastic Surgery Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.10. Drug Delivery
  • 5.10.1.1. Drug Delivery Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.11. Dental
  • 5.11.1. Dental Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.12. Endoscopy
  • 5.12.1. Endoscopy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.13. Diabetes Care
  • 5.13.1. Diabetes Care Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.14. Others
  • 5.14.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Medical Device Outsourcing Market: Class type Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Global Medical Device Outsourcing Market Class type Movement Analysis
• 6.3. Global Medical Device Outsourcing Market Size & Trend Analysis, by Class type, 2021 to 2033 (USD Million)
• 6.4. Class I
  • 6.4.1. Class I Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Class II
  • 6.5.1. Class II Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Class III
  • 6.6.1. Class III Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Medical Device Outsourcing Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Dashboard
• 7.2. Global Regional Market Snapshot
• 7.3. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
• 7.4. North America
  • 7.4.1. North America Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.2. U.S.
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Competitive Scenario
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. U.S. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Competitive Scenario
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Canada Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Competitive Scenario
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Mexico Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.5. Europe
  • 7.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Competitive Scenario
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Europe Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Competitive Scenario
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Germany Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Competitive Scenario
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. France Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Competitive Scenario
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. Italy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Competitive Scenario
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Spain Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Competitive Scenario
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Denmark Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Competitive Scenario
    • 7.5.8.3. Regulatory Framework
    • 7.5.8.4. Sweden Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Competitive Scenario
    • 7.5.9.3. Regulatory Framework
    • 7.5.9.4. Norway Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.2. Japan
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Competitive Scenario
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Japan Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.3. China
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Competitive Scenario
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. China Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Competitive Scenario
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. India Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.5. Australia
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Competitive Scenario
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Australia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.6. South Korea
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Competitive Scenario
    • 7.6.6.3. Regulatory Framework
    • 7.6.6.4. South Korea Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.7. Thailand
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Competitive Scenario
    • 7.6.7.3. Regulatory Framework
    • 7.6.7.4. Thailand Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.7. Latin America
  • 7.7.1. Latin America Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Competitive Scenario
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. Brazil Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Competitive Scenario
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Argentina Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.8. Middle East & Africa
  • 7.8.1. Middle East & Africa Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Competitive Scenario
    • 7.8.2.3. Regulatory Framework
    • 7.8.2.4. South Africa Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Competitive Scenario
    • 7.8.3.3. Regulatory Framework
    • 7.8.3.4. Saudi Arabia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Competitive Scenario
    • 7.8.4.3. Regulatory Framework
    • 7.8.4.4. UAE Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Competitive Scenario
    • 7.8.5.3. Regulatory Framework
    • 7.8.5.4. Kuwait Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.6. Oman
    • 7.8.6.1. Key Country Dynamics
    • 7.8.6.2. Competitive Scenario
    • 7.8.6.3. Regulatory Framework
    • 7.8.6.4. Oman Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.7. Qatar
    • 7.8.7.1. Key Country Dynamics
    • 7.8.7.2. Competitive Scenario
    • 7.8.7.3. Regulatory Framework
    • 7.8.7.4. Qatar Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
  • 8.1.1. Market Leaders
  • 8.1.2. Emerging Players
• 8.2. Medical Device Outsourcing Market Share Analysis, 2024
• 8.3. Company Profiles
  • 8.3.1. SGS SA
    • 8.3.1.1. Company Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Service/Service Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. Laboratory Corporation of America Holdings
    • 8.3.2.1. Company Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Service/Service Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. Eurofins Scientific
    • 8.3.3.1. Company Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Service/Service Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. Pace Analytical Services, Inc.
    • 8.3.4.1. Company Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Service/Service Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. Intertek Group plc
    • 8.3.5.1. Company Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Service/Service Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. Wuxi AppTec
    • 8.3.6.1. Company Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Service/Service Benchmarking
    • 8.3.6.4. Strategic Initiatives
  • 8.3.7. Charles River Laboratories
    • 8.3.7.1. Company Overview
    • 8.3.7.2. Financial Performance
    • 8.3.7.3. Service/Service Benchmarking
    • 8.3.7.4. Strategic Initiatives
  • 8.3.8. Freyr
    • 8.3.8.1. Company Overview
    • 8.3.8.2. Financial Performance
    • 8.3.8.3. Service/Service Benchmarking
    • 8.3.8.4. Strategic Initiatives
  • 8.3.9. PAREXEL International Corporation
    • 8.3.9.1. Company Overview
    • 8.3.9.2. Financial Performance
    • 8.3.9.3. Service/Service Benchmarking
    • 8.3.9.4. Strategic Initiatives
  • 8.3.10. Criterium, Inc.
    • 8.3.10.1. Company Overview
    • 8.3.10.2. Financial Performance
    • 8.3.10.3. Service/Service Benchmarking
    • 8.3.10.4. Strategic Initiatives
  • 8.3.11. Medpace
    • 8.3.11.1. Company Overview
    • 8.3.11.2. Financial Performance
    • 8.3.11.3. Service/Service Benchmarking
    • 8.3.11.4. Strategic Initiatives
  • 8.3.12. ICON plc.
    • 8.3.12.1. Company Overview
    • 8.3.12.2. Financial Performance
    • 8.3.12.3. Service/Service Benchmarking
    • 8.3.12.4. Strategic Initiatives
  • 8.3.13. IQVIA Inc.
    • 8.3.13.1. Company Overview
    • 8.3.13.2. Financial Performance
    • 8.3.13.3. Service/Service Benchmarking
    • 8.3.13.4. Strategic Initiatives
  • 8.3.14. Integer Holdings Corporation
    • 8.3.14.1. Company Overview
    • 8.3.14.2. Financial Performance
    • 8.3.14.3. Service/Service Benchmarking
    • 8.3.14.4. Strategic Initiatives