의료기기 분석 시험 아웃소싱 시장 규모, 점유율, 동향 분석 : 서비스별, 치료 분야별, 최종 용도별, 기기 유형별, 지역별, 부문 예측(2025-2030년)

Medical Device Analytical Testing Outsourcing Market Growth & Trends:

The global medical device analytical testing outsourcing market size is estimated to reach USD 10.53 billion by 2030, expanding at a CAGR of 8.3% from 2025 to 2030, according to a new report by Grand View Research, Inc. Several medical device companies outsource analytical testing operations to decrease business risks, accelerate product market entrance, and lower expenses. As a result of this considerable rise in spending levels, medical device original equipment manufacturers (OEMs) quickly shift to outsourcing as a cost-cutting technique. The testing requirements of medical device manufacturers (MDMs) reflected variations in the medical/healthcare market as it recovered from the COVID-19 slowdown.

In 2021, the need for European Medical Device Regulation (MDR) remediation standards, as well as the ever-increasing regulatory demands in the leachables & extractables (E&L) arena, accounted for a significant portion of the testing effort. However, due to delays and a lack of external resources and labor, labs' ability to expand capacity has been limited. Regulatory authorities are focusing on testing technique validation, especially data quality, including repeatability and reproducibility. There is also a trend of more deterministic testing methods. This enables companies to acquire more statistically reliable data to determine if their products meet the criteria. For example, the medical device sector and testing labs confront considerable hurdles in adopting ISO 10993-18:2020 E&L testing regulations while still meeting FDA expectations.

The FDA had requested the use of conservative techniques to reduce areas of ambiguity or potential inaccuracy in E&L testing throughout 2021.Furthermore, intensifying competition in the medical device industry is expected to create growth opportunities for the market. In such an intensely competitive environment, companies must reduce the time to market. Considering that the approval processes for medical devices are not simple, companies need a better understanding of updated regulatory norms and protocols. Not all companies have such expertise; hence, outsourcing these functions to a specialized firm is a better option for medical device companies. Recent studies have shown significant opportunities for both suppliers and buyers in the medical device industry.

For smaller companies, outsourcing manufacturing, and development functions is an effective alternative to cut costs. For larger companies, outsourcing activities enable them to focus on core business activities and drive future growth. Based on end-uses, the hospital segment accounted for the largest revenue share in 2022 due to high patient volume and increased hospital management budget allocation for these surgeries. The reprocessed devices segment is projected to witness the fastest CAGR during the forecast period due to the low prices of these devices. They cost about 30 to 40% less than new devices; thus, the demand for such products is significant in price-sensitive low- and medium-income countries.

Medical Device Analytical Testing Outsourcing Market Report Highlights:

• Material characterization dominated the market and accounted for a share of 18.1% in 2024. Material characterization is crucial for maintaining quality, mitigating risks, ensuring regulatory compliance, and optimizing cost and time efficiency
• The cardiology segment led the market with a revenue share of 22.2% in 2024 due to the high demand for cardiovascular devices as a result of the increased prevalence of related conditions
• Asia Pacific medical device analytical testing outsourcing market is expected to register the fastest CAGR of 8.9% in the forecast period. This is owing to the region's large population base, low per capita income, and demand for accessible treatment solutions
• North America medical device analytical testing outsourcing market dominated the global market with a revenue share of 39.1% in 2024. This can be attributed to the presence of various multinational players, such as Charles River Laboratories, WuXi AppTec, and SGS SA
• Moreover, the increased need for scrutiny pertaining to the quality of devices and reorganizing of classes is a key factor expected to impose additional testing requirements on manufacturers. These requirements can be met by partnering with laboratories that perform tests at an affordable price rather than installing in-house analytical tools

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Services
  • 1.2.2. Therapeutic Areas
  • 1.2.3. End Use
  • 1.2.4. Device Type
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Data Visualization
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

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

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Business Environment Analysis
  • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat of New Entrants
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTLE Analysis

Chapter 4. Medical Device Analytical Testing Outsourcing Market: Services Business Analysis

• 4.1. Services Market Share, 2024 & 2030
• 4.2. Services Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, by Services, 2018 to 2030 (USD Million)
• 4.4. Extractable and Leachable
  • 4.4.1. Extractable and Leachable Market, 2018 - 2030 (USD Million)
• 4.5. Material Characterization
  • 4.5.1. Material Characterization Market, 2018 - 2030 (USD Million)
• 4.6. Physical Testing
  • 4.6.1. Physical Testing Market, 2018 - 2030 (USD Million)
• 4.7. Bioburden Testing
  • 4.7.1. Bioburden Testing Market, 2018 - 2030 (USD Million)
• 4.8. Sterility Testing
  • 4.8.1. Sterility Testing Market, 2018 - 2030 (USD Million)
• 4.9. Other Tests
  • 4.9.1. Other Tests Market, 2018 - 2030 (USD Million)

Chapter 5. Medical Device Analytical Testing Outsourcing Market: Therapeutic Areas Business Analysis

• 5.1. Therapeutic Areas Market Share, 2024 & 2030
• 5.2. Therapeutic Areas Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, by Therapeutic Areas, 2018 to 2030 (USD Million)
• 5.4. Cardiology
  • 5.4.1. Cardiology Market, 2018 - 2030 (USD Million)
• 5.5. Diagnostic Imaging
  • 5.5.1. Diagnostic Imaging Market, 2018 - 2030 (USD Million)
• 5.6. Orthopedic
  • 5.6.1. Orthopedic Market, 2018 - 2030 (USD Million)
• 5.7. IVD
  • 5.7.1. IVD Market, 2018 - 2030 (USD Million)
• 5.8. Ophthalmic
  • 5.8.1. Ophthalmic Market, 2018 - 2030 (USD Million)
• 5.9. General & Plastic Surgery
  • 5.9.1. General & Plastic Surgery Market, 2018 - 2030 (USD Million)
• 5.10. Drug Delivery
  • 5.10.1. Drug Delivery Market, 2018 - 2030 (USD Million)
• 5.11. Endoscopy
  • 5.11.1. Endoscopy Market, 2018 - 2030 (USD Million)
• 5.12. Dental
  • 5.12.1. Dental Market, 2018 - 2030 (USD Million)
• 5.13. Diabetes Care
  • 5.13.1. Diabetes Care Market, 2018 - 2030 (USD Million)
• 5.14. Others
  • 5.14.1. Others Market, 2018 - 2030 (USD Million)

Chapter 6. Medical Device Analytical Testing Outsourcing Market: End Use Business Analysis

• 6.1. End Use Market Share, 2024 & 2030
• 6.2. End Use Segment Dashboard
• 6.3. Market Size & Forecasts and Trend Analysis, by End Use, 2018 to 2030 (USD Million)
• 6.4. Hospital
  • 6.4.1. Hospital Market, 2018 - 2030 (USD Million)
  • 6.4.2. Equipment
    • 6.4.2.1. Equipment Market, 2018 - 2030 (USD Million)
  • 6.4.3. Consumables
    • 6.4.3.1. Consumables Market, 2018 - 2030 (USD Million)
    • 6.4.3.2. Syringes
      • 6.4.3.2.1. Syringes Market, 2018 - 2030 (USD Million)
    • 6.4.3.3. Wound Care
      • 6.4.3.3.1. Wound Care Market, 2018 - 2030 (USD Million)
    • 6.4.3.4. Others
      • 6.4.3.4.1. Others Market, 2018 - 2030 (USD Million)
• 6.5. Others
  • 6.5.1. Others Market, 2018 - 2030 (USD Million)

Chapter 7. Medical Device Analytical Testing Outsourcing Market: Device Type Business Analysis

• 7.1. Device Type Market Share, 2024 & 2030
• 7.2. Device Type Segment Dashboard
• 7.3. Market Size & Forecasts and Trend Analysis, by Device Type, 2018 to 2030 (USD Million)
• 7.4. Reprocessed Devices
  • 7.4.1. Reprocessed Devices Market, 2018 - 2030 (USD Million)
  • 7.4.2. Hospital
    • 7.4.2.1. Hospital Market, 2018 - 2030 (USD Million)
  • 7.4.3. Others
    • 7.4.3.1. Others Market, 2018 - 2030 (USD Million)
• 7.5. Others
  • 7.5.1. Others Market, 2018 - 2030 (USD Million)

Chapter 8. Medical Device Analytical Testing Outsourcing Market: Regional Estimates & Trend Analysis

• 8.1. Regional Market Share Analysis, 2024 & 2030
• 8.2. Regional Market Dashboard
• 8.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
• 8.4. North America
  • 8.4.1. North America Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, By Country, 2018 - 2030 (USD Million)
  • 8.4.2. U.S.
    • 8.4.2.1. Key Country Dynamics
    • 8.4.2.2. Regulatory Framework
    • 8.4.2.3. Competitive Insights
    • 8.4.2.4. U.S. Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.4.3. Canada
    • 8.4.3.1. Key Country Dynamics
    • 8.4.3.2. Regulatory Framework
    • 8.4.3.3. Competitive Insights
    • 8.4.3.4. Canada Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.4.4. Mexico
    • 8.4.4.1. Key Country Dynamics
    • 8.4.4.2. Regulatory Framework
    • 8.4.4.3. Competitive Insights
    • 8.4.4.4. Mexico Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
• 8.5. Europe
  • 8.5.1. Europe Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, By Country, 2018 - 2030 (USD Million)
  • 8.5.2. UK
    • 8.5.2.1. Key Country Dynamics
    • 8.5.2.2. Regulatory Framework
    • 8.5.2.3. Competitive Insights
    • 8.5.2.4. UK Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.5.3. Germany
    • 8.5.3.1. Key Country Dynamics
    • 8.5.3.2. Regulatory Framework
    • 8.5.3.3. Competitive Insights
    • 8.5.3.4. Germany Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.5.4. France
    • 8.5.4.1. Key Country Dynamics
    • 8.5.4.2. Regulatory Framework
    • 8.5.4.3. Competitive Insights
    • 8.5.4.4. France Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.5.5. Italy
    • 8.5.5.1. Key Country Dynamics
    • 8.5.5.2. Regulatory Framework
    • 8.5.5.3. Competitive Insights
    • 8.5.5.4. Italy Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.5.6. Spain
    • 8.5.6.1. Key Country Dynamics
    • 8.5.6.2. Regulatory Framework
    • 8.5.6.3. Competitive Insights
    • 8.5.6.4. Spain Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.5.7. Norway
    • 8.5.7.1. Key Country Dynamics
    • 8.5.7.2. Regulatory Framework
    • 8.5.7.3. Competitive Insights
    • 8.5.7.4. Norway Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.5.8. Denmark
    • 8.5.8.1. Key Country Dynamics
    • 8.5.8.2. Regulatory Framework
    • 8.5.8.3. Competitive Insights
    • 8.5.8.4. Denmark Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.5.9. Sweden
    • 8.5.9.1. Key Country Dynamics
    • 8.5.9.2. Regulatory Framework
    • 8.5.9.3. Competitive Insights
    • 8.5.9.4. Sweden Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
• 8.6. Asia Pacific
  • 8.6.1. Asia Pacific Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, By Country, 2018 - 2030 (USD Million)
  • 8.6.2. Japan
    • 8.6.2.1. Key Country Dynamics
    • 8.6.2.2. Regulatory Framework
    • 8.6.2.3. Competitive Insights
    • 8.6.2.4. Japan Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.6.3. China
    • 8.6.3.1. Key Country Dynamics
    • 8.6.3.2. Regulatory Framework
    • 8.6.3.3. Competitive Insights
    • 8.6.3.4. China Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.6.4. India
    • 8.6.4.1. Key Country Dynamics
    • 8.6.4.2. Regulatory Framework
    • 8.6.4.3. Competitive Insights
    • 8.6.4.4. India Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.6.5. South Korea
    • 8.6.5.1. Key Country Dynamics
    • 8.6.5.2. Regulatory Framework
    • 8.6.5.3. Competitive Insights
    • 8.6.5.4. South Korea Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.6.6. Australia
    • 8.6.6.1. Key Country Dynamics
    • 8.6.6.2. Regulatory Framework
    • 8.6.6.3. Competitive Insights
    • 8.6.6.4. Australia Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.6.7. Thailand
    • 8.6.7.1. Key Country Dynamics
    • 8.6.7.2. Regulatory Framework
    • 8.6.7.3. Competitive Insights
    • 8.6.7.4. Thailand Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
• 8.7. Latin America
  • 8.7.1. Latin America Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, By Country, 2018 - 2030 (USD Million)
  • 8.7.2. Brazil
    • 8.7.2.1. Key Country Dynamics
    • 8.7.2.2. Regulatory Framework
    • 8.7.2.3. Competitive Insights
    • 8.7.2.4. Brazil Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.7.3. Argentina
    • 8.7.3.1. Key Country Dynamics
    • 8.7.3.2. Regulatory Framework
    • 8.7.3.3. Competitive Insights
    • 8.7.3.4. Argentina Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
• 8.8. MEA
  • 8.8.1. MEA Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, By Country, 2018 - 2030 (USD Million)
  • 8.8.2. South Africa
    • 8.8.2.1. Key Country Dynamics
    • 8.8.2.2. Regulatory Framework
    • 8.8.2.3. Competitive Insights
    • 8.8.2.4. South Africa Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.8.3. Saudi Arabia
    • 8.8.3.1. Key Country Dynamics
    • 8.8.3.2. Regulatory Framework
    • 8.8.3.3. Competitive Insights
    • 8.8.3.4. Saudi Arabia Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.8.4. UAE
    • 8.8.4.1. Key Country Dynamics
    • 8.8.4.2. Regulatory Framework
    • 8.8.4.3. Competitive Insights
    • 8.8.4.4. UAE Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
  • 8.8.5. Kuwait
    • 8.8.5.1. Key Country Dynamics
    • 8.8.5.2. Regulatory Framework
    • 8.8.5.3. Competitive Insights
    • 8.8.5.4. Kuwait Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Participant Overview
• 9.2. Company Market Position Analysis
• 9.3. Company Categorization
• 9.4. Strategy Mapping
• 9.5. Company Profiles/Listing
  • 9.5.1. SGS Societe Generale de Surveillance SA
    • 9.5.1.1. Overview
    • 9.5.1.2. Financial Performance
    • 9.5.1.3. Product Benchmarking
    • 9.5.1.4. Strategic Initiatives
  • 9.5.2. Toxikon, Inc. (Laboratory Corporation of America Holdings)
    • 9.5.2.1. Overview
    • 9.5.2.2. Financial Performance
    • 9.5.2.3. Product Benchmarking
    • 9.5.2.4. Strategic Initiatives
  • 9.5.3. Eurofins Scientific
    • 9.5.3.1. Overview
    • 9.5.3.2. Financial Performance
    • 9.5.3.3. Product Benchmarking
    • 9.5.3.4. Strategic Initiatives
  • 9.5.4. Pace Analytical Services, LLC
    • 9.5.4.1. Overview
    • 9.5.4.2. Financial Performance
    • 9.5.4.3. Product Benchmarking
    • 9.5.4.4. Strategic Initiatives
  • 9.5.5. Intertek Group plc
    • 9.5.5.1. Overview
    • 9.5.5.2. Financial Performance
    • 9.5.5.3. Product Benchmarking
    • 9.5.5.4. Strategic Initiatives
  • 9.5.6. Wuxi AppTec
    • 9.5.6.1. Overview
    • 9.5.6.2. Financial Performance
    • 9.5.6.3. Product Benchmarking
    • 9.5.6.4. Strategic Initiatives
  • 9.5.7. North American Science Associates, LLC
    • 9.5.7.1. Overview
    • 9.5.7.2. Financial Performance
    • 9.5.7.3. Product Benchmarking
    • 9.5.7.4. Strategic Initiatives
  • 9.5.8. Envigo (Inotiv)
    • 9.5.8.1. Overview
    • 9.5.8.2. Financial Performance
    • 9.5.8.3. Product Benchmarking
    • 9.5.8.4. Strategic Initiatives
  • 9.5.9. Charles River Laboratories
    • 9.5.9.1. Overview
    • 9.5.9.2. Financial Performance
    • 9.5.9.3. Product Benchmarking
    • 9.5.9.4. Strategic Initiatives