의료 기기 검사 서비스 시장 기회, 성장 촉진 요인, 산업 동향 분석, 예측(2025-2034년)

The Global Medical Devices Testing Services Market, valued at USD 8.6 billion in 2024, is projected to grow at a robust CAGR of 8.8% from 2025 to 2034. This growth is largely driven by an increasing need to meet stringent regulatory requirements that ensure medical devices' safety, performance, and efficacy. With continuous innovations in healthcare technology, the demand for comprehensive and rigorous testing services is more essential than ever. Medical device manufacturers are prioritizing testing to comply with international regulatory standards and avoid costly product recalls or safety issues. As the complexity of medical devices such as wearables, implantable technologies, and diagnostic tools rises, so does the need for advanced testing methods. The need to ensure safety and effectiveness through clinical and preclinical trials, as well as microbiological testing, will continue to shape the future of the market.

Among the various testing services, microbiology and sterility testing dominated the market in 2024, generating USD 3 billion. This service is critical in detecting microbial contamination and validating sterilization techniques, which is crucial for ensuring that devices meet safety standards. The growing emphasis on infection control in healthcare facilities further drives the demand for these services. Given that healthcare-associated infections remain a top concern, the need for sterility testing is expected to continue its upward trajectory.

The medical devices testing services market is also segmented into clinical and preclinical testing. The clinical testing segment, which is expected to grow at a CAGR of 8.7%, is projected to reach USD 13.1 billion by 2034. Clinical trials are essential for validating the safety and efficacy of medical devices under real-world conditions, ensuring they meet both regulatory and market expectations. As medical technology advances, clinical testing is becoming even more critical in assessing the usability, biocompatibility, and overall safety of devices like wearables and implants. The increasing complexity of these devices requires a more detailed approach to clinical evaluations, especially with newer innovations that integrate seamlessly into the human body.

The U.S. medical devices testing services market garnered USD 2.2 billion in 2024 and is expected to grow at a CAGR of 7.8% from 2025 to 2034. North America, driven by its advanced healthcare infrastructure and strong regulatory framework, remains a dominant player in the global market. The region benefits from a well-established network of regulatory bodies, such as the FDA, that enforce comprehensive testing protocols to ensure the highest safety and quality standards for medical devices. This rigorous regulatory landscape, combined with considerable investments in R&D and testing services, makes North America a hub for medical devices testing.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Growing focus on strict approval norms
    • 3.2.1.2 Consistent and rapid advancements in medical technologies
    • 3.2.1.3 Rising need for verification and validation of medical devices
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Lack of skilled professionals and testing facilities
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Technology landscape
• 3.6 Future market trends
• 3.7 Porter's analysis
• 3.8 PESTEL analysis
• 3.9 Value chain analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Company market share analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Services, 2021 - 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Microbiology and sterility testing
  • 5.2.1 Antimicrobial testing
  • 5.2.2 Pyrogen and endotoxin testing
  • 5.2.3 Sterility test and validation
  • 5.2.4 Bioburden determination
  • 5.2.5 Other microbiology and sterility testings
• 5.3 Biocompatibility tests
• 5.4 Chemistry test
• 5.5 Package validation

Chapter 6 Market Estimates and Forecast, By Phase, 2021 - 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Clinical
• 6.3 Preclinical

Chapter 7 Market Estimates and Forecast, By Device Class, 2021 - 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Class III
• 7.3 Class II
• 7.4 Class I

Chapter 8 Market Estimates and Forecast, By Mode, 2021 - 2034 ($ Mn)

• 8.1 Key trends
• 8.2 Outsourced
• 8.3 In-house

Chapter 9 Market Estimates and Forecast, By End Use, 2021 - 2034 ($ Mn)

• 9.1 Key trends
• 9.2 Medical device manufacturers
• 9.3 Clinical research organizations (CROs)
• 9.4 Academic and research institutions
• 9.5 Other end users

Chapter 10 Market Estimates and Forecast, By Region, 2021 - 2034 ($ Mn)

• 10.1 Key trends
• 10.2 North America
  • 10.2.1 U.S.
  • 10.2.2 Canada
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 France
  • 10.3.4 Spain
  • 10.3.5 Italy
  • 10.3.6 Netherlands
• 10.4 Asia Pacific
  • 10.4.1 China
  • 10.4.2 Japan
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 South Korea
• 10.5 Latin America
  • 10.5.1 Brazil
  • 10.5.2 Mexico
  • 10.5.3 Argentina
• 10.6 Middle East and Africa
  • 10.6.1 South Africa
  • 10.6.2 Saudi Arabia
  • 10.6.3 UAE

Chapter 11 Company Profiles

• 11.1 charles river
• 11.2 element
• 11.3 eurofins
• 11.4 intertek
• 11.5 labcorp
• 11.6 NAMSA
• 11.7 Pace
• 11.8 SGS
• 11.9 Sterigenics
• 11.10 TUV SUD
• 11.11 WuXiAppTec