미국의 의료기기 검사 서비스 시장 규모, 점유율, 동향 분석 : 서비스별, 단계별, 부문별 예측(2025-2033년)

U.S. Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service, By Phase, And Segment Forecasts, 2025 - 2033

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한글목차

미국의 의료기기 검사 서비스 시장 요약

미국의 의료기기 검사 서비스 시장 규모는 2024년에 22억 3,000만 달러로 추계되며, 2025-2033년에 CAGR 9.66%로 성장하며, 50억 9,000만 달러에 달할 것으로 예측됩니다.

시장을 주도하는 것은 강력한 규제 프레임워크, 빠른 기술 혁신, 시장에 진입하는 장비의 복잡성입니다.

고령화, 만성질환 증가, 기술 혁신 파이프라인의 강화 등도 시장 성장의 요인입니다. 각 제조업체들은 컴플라이언스 비용 절감, 복잡한 규제 대응, 제품 출시의 신속화 등을 목적으로 시험 업무의 아웃소싱을 추진하고 있습니다. 또한 미국 식품의약국(FDA)의 엄격한 안전 및 성능 기준과 ISO 및 IEC 표준과 같은 국제 규정 준수 요구사항은 전문적인 제3자 시험 서비스에 대한 수요를 촉진하고 있습니다. 이러한 서비스는 특히 저침습 수술기구, 이식형 기기, 영상 진단 시스템, 웨어러블 기술 등 고성장 분야에서는 규제 준수, 리스크 감소, 시장 출시 시간 단축을 위해 필수적입니다.

또한 첨단 소재, 소형화, 인공지능(AI), 사물인터넷(IoT), 무선 기술 통합으로 인한 기기 설계의 복잡성으로 인해 사이버 보안 검증, 소프트웨어 성능 테스트, 사용성 엔지니어링, 상호운용성 평가 등 테스트 요구사항이 확대되고 있습니다. 또한 신규 디바이스 및 차세대 디바이스의 임상시험이 급증함에 따라 전기적 안전성, 전자기 호환성(EMC), 기계적 내구성, 미생물학적 안전성, 생체 적합성 평가 능력에 대한 요구가 높아지고 있습니다. 또한 현재 시험 프로세스는 타당성 연구, 성능 검증, 시판 후 조사 등 여러 단계를 거쳐 제품의 유효성과 환자 안전성을 보장하고 있습니다.

목차

제1장 분석 방법·범위

제2장 개요

제3장 의료기기 검사 서비스 시장 : 변동 요인·동향·범위

• 시장 연관 전망
  • 모시장 전망
  • 관련/부수 시장 전망
• 시장 역학
  • 시장 성장 촉진요인의 분석
  • 시장 성장 억제요인의 분석
  • 시장이 해결해야 할 과제
  • 시장 기회
• 기술 상황
• 가격 모델 분석
• 관세의 영향 분석
• 밸류체인 분석
  • 공급 동향
  • 수요 동향
• 시장 분석 툴
  • Porter's Five Forces 분석
  • SWOT 분석에 의한 PESTEL
  • COVID-19의 영향 분석

제4장 미국의 의료기기 검사 서비스 시장 : 서비스별 추정·동향 분석

• 미국의 의료기기 검사 서비스 시장 : 대시보드, 서비스별
• 미국의 의료기기 검사 서비스 시장 : 변동 분석, 서비스별
• 서비스별(2021-2033년)
• 생체 적합성 시험
  • 심혈관 디바이스 생체 적합성 시험
  • 정형외과 디바이스 생체 적합성 시험
  • 치과 임플란트 기기 생체 적합성 시험
  • 더말 필러 생체 적합성 시험
  • 일반 외과 임플란트 기기 생체 적합성 시험
  • 신경외과 임플란트 기기 생체 적합성 시험
  • 안과 임플란트 기기 생체 적합성 시험
  • 기타
• 화학 테스트
  • 화학 특성 평가(E&L)
  • 분석 방법 개발과 검증
  • 독성 리스크 평가와 컨설팅
• 미생물·무균 시험
  • 바이오버든 측정
  • 발열 물질·엔도톡신 검사
  • 무균 시험·검증
  • 항균 시험
  • 기타
• 패키지 검증

제5장 미국의 의료기기 검사 서비스 시장 : 단계별 추정·동향 분석

• 미국의 의료기기 검사 서비스 시장 : 대시보드, 단계별
• 미국의 의료기기 검사 서비스 시장 : 변동 분석, 단계별
• 단계별(2021-2033년)
• 전임상
  • 소형 동물
  • 대형 동물
  • 기타
• 임상

제6장 경쟁 구도

• 참여 기업
• 시장 현황 분석(히트맵 분석, 2024년)
• 기업 개요
  • SGS SA
  • Laboratory Corporation of America Holdings
  • Nelson Laboratories, LLC
  • TUV SUD
  • Charles River Laboratories
  • Element Minnetonka
  • Eurofins Scientific
  • Pace Analytical Services LLC
  • Intertek Group Plc
  • North America Science Associates Inc.(NAMSA)

KSA

영문 목차

영문목차

U.S. Medical Device Testing Services Market Summary

The U.S. medical device testing services market size was estimated at USD 2.23 billion in 2024 and is projected to reach USD 5.09 billion, growing at a CAGR of 9.66% from 2025 to 2033. The market is driven by a strong regulatory framework, rapid technological innovations, and the increasing complexity of devices entering the market.

Other factors contributing to market growth are an aging population, a rise in chronic diseases, and a robust innovation pipeline. Manufacturers are increasingly outsourcing testing functions to reduce compliance costs, navigate regulatory complexities, and accelerate product launches. Besides, the stringent safety and performance standards set by the U.S. Food and Drug Administration (FDA) and international compliance requirements such as ISO and IEC standards fuel demand for specialized third-party testing services. These services are essential for ensuring regulatory compliance, mitigating risks, and accelerating the time-to-market for manufacturers, particularly in high-growth sectors like minimally invasive surgical tools, implantable devices, diagnostic imaging systems, and wearable technologies.

In addition, the rising complexity in device design due to advanced materials, miniaturization, and the integration of artificial intelligence (AI), Internet of Things (IoT), and wireless technologies has expanded testing requirements to encompass cybersecurity validation, software performance testing, usability engineering, and interoperability assessments. Besides, the surge in clinical trials for both novel and next-generation devices has increased the demand for capabilities in electrical safety, electromagnetic compatibility (EMC), mechanical durability, microbiological safety, and biocompatibility evaluation. Also, the current testing processes cover multiple stages, including feasibility studies, performance verification, and post-market surveillance, ensuring product efficacy and patient safety.

U.S. Medical Device Testing Services Market Report Segmentation

This report forecasts revenue growth at the country level 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 U.S. medical device testing services market report based onservice and phase:

• ServiceOutlook (Revenue, USD Million, 2021 - 2033)
• Biocompatibility Tests
• Cardiovascular Device's Biocompatibility Tests
• Orthopedic Device's Biocompatibility Tests
• Dental Implant Devices' Biocompatibility Tests
• Dermal Filler's Biocompatibility Tests
• General Surgery Implantation Devices Biocompatibility Tests
• Neurosurgical Implantation Devices Biocompatibility Tests
• Ophthalmic Implantation Device's Biocompatibility Tests
• Others
• Chemistry Test
• Chemical characterization (E&L)
• Analytical method development and validation
• Toxicological Risk Assessment and consulting
• Microbiology & Sterility Test
• Bioburden Determination
• Pyrogen & Endotoxin Testing
• Sterility Test & Validation
• Antimicrobial Testing
• Others
• Package Validation
• Phase Outlook (Revenue, USD Million, 2021 - 2033)
• Preclinical
• Large animal research
  • Biocompatibility Tests
  • Chemistry Test
  • Microbiology & Sterility Test
• Small animal research
  • Biocompatibility Tests
  • Chemistry Test
  • Microbiology & Sterility Test
• Clinical

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Service
  • 1.2.2. Phase
• 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
  • 1.7.2. Parent Market Analysis
• 1.8. List Of Secondary Sources
• 1.9. List Of Abbreviations
• 1.10. Objectives

Chapter 2. Executive Summary

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

Chapter 3. U.S. Medical Device Testing Services Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Complexity in Product Design Of Medical Device Testing Services
    • 3.2.1.2. Intense Competition in Medical Device Industry
    • 3.2.1.3. Increasing number of smaller Players lacking in-house testing capabilities
    • 3.2.1.4. Strict Approval Norms
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Legal and Regulatory Issues
    • 3.2.2.2. Delays in contractual obligations
  • 3.2.3. Market Challenges
  • 3.2.4. Market Opportunities
• 3.3. Technology Landscape
• 3.4. Pricing Model Analysis
• 3.5. Tariff Impact Analysis
• 3.6. Value Chain Analysis
  • 3.6.1. Supply Trends
  • 3.6.2. Demand Trends
• 3.7. Market Analysis Tools
  • 3.7.1. Porter's Five Force Analysis
  • 3.7.2. PESTEL by SWOT Analysis
  • 3.7.3. COVID-19 Impact Analysis

Chapter 4. U.S. Medical Device Testing Services Market: Service Estimates & Trend Analysis

• 4.1. U.S. Medical Device Testing Services Market, By Service: Segment Dashboard
• 4.2. U.S. Medical Device Testing Services Market, By Service: Movement Analysis
• 4.3. U.S. Medical Device Testing Services Market Estimates & Forecasts, By Service, 2021 - 2033
• 4.4. Biocompatibility Tests
  • 4.4.1. Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.2. Cardiovascular Device's Biocompatibility Tests
    • 4.4.2.1. Cardiovascular Device's Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.3. Orthopedic Device's Biocompatibility Tests
    • 4.4.3.1. Orthopedic Device's Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.4. Dental Implant Devices' Biocompatibility Tests
    • 4.4.4.1. Dental Implant Devices' Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.5. Dermal Filler's Biocompatibility Tests
    • 4.4.5.1. Dermal Filler's Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.6. General Surgery Implantation Devices Biocompatibility Tests
    • 4.4.6.1. General Surgery Implantation Devices Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.7. Neurosurgical Implantation Devices Biocompatibility Tests
    • 4.4.7.1. Neurosurgical Implantation Devices Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.8. Ophthalmic Implantation Device's Biocompatibility Tests
    • 4.4.8.1. Ophthalmic Implantation Device's Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.9. Others
    • 4.4.9.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Chemistry Test
  • 4.5.1. Chemistry Test Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5.2. Chemical characterization (E&L)
    • 4.5.2.1. Chemical Characterization (E&L) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5.3. Analytical method development and validation
    • 4.5.3.1. Analytical Method Development and Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5.4. Toxicological Risk Assessment and consulting
    • 4.5.4.1. Toxicological Risk Assessment and Consulting Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.6. Microbiology & Sterility Testing
  • 4.6.1. Microbiology & Sterility Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6.2. Bioburden Determination
    • 4.6.2.1. Bioburden Determination Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6.3. Pyrogen & Endotoxin Testing
    • 4.6.3.1. Pyrogen & Endotoxin Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6.4. Sterility Test & Validation
    • 4.6.4.1. Sterility Test & Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6.5. Antimicrobial Testing
    • 4.6.5.1. Antimicrobial Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6.6. Others
    • 4.6.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.7. Package Validation
  • 4.7.1. Package Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Medical Device Testing Services Market: Phase Estimates & Trend Analysis

• 5.1. U.S. Medical Device Testing Services Market, By Phase: Segment Dashboard
• 5.2. U.S. Medical Device Testing Services Market, By Phase: Movement Analysis
• 5.3. U.S. Medical Device Testing Services Market Estimates & Forecasts, By Phase, 2021 - 2033
• 5.4. Preclinical
  • 5.4.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.4.2. Small Animals
    • 5.4.2.1. Small Animals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.2.2. Biocompatibility Tests
      • 5.4.2.2.1. Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.2.3. Chemistry Tests
      • 5.4.2.3.1. Chemistry Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.2.4. Microbiology & Sterility Tests
      • 5.4.2.4.1. Microbiology & Sterility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.4.3. Large Animals
    • 5.4.3.1. Large Animals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.3.2. Biocompatibility Tests
      • 5.4.3.2.1. Biocompatibility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.3.3. Chemistry Tests
      • 5.4.3.3.1. Chemistry Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.3.4. Microbiology & Sterility Tests
      • 5.4.3.4.1. Microbiology & Sterility Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.4.4. Others
    • 5.4.4.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Clinical
  • 5.5.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Competitive Landscape

• 6.1. Participant Categorization
• 6.2. Market Position Analysis, 2024 (Heat Map Analysis)
• 6.3. Company Profiles
  • 6.3.1. SGS SA
    • 6.3.1.1. Company Overview
    • 6.3.1.2. Financial Performance
    • 6.3.1.3. Service Benchmarking
    • 6.3.1.4. Strategic Initiatives
  • 6.3.2. Laboratory Corporation of America Holdings
    • 6.3.2.1. Company Overview
    • 6.3.2.2. Financial Performance
    • 6.3.2.3. Service Benchmarking
    • 6.3.2.4. Strategic Initiatives
  • 6.3.3. Nelson Laboratories, LLC
    • 6.3.3.1. Company Overview
    • 6.3.3.2. Financial Performance
    • 6.3.3.3. Service Benchmarking
    • 6.3.3.4. Strategic Initiatives
  • 6.3.4. TUV SUD
    • 6.3.4.1. Company Overview
    • 6.3.4.2. Financial Performance
    • 6.3.4.3. Service Benchmarking
    • 6.3.4.4. Strategic Initiatives
  • 6.3.5. Charles River Laboratories
    • 6.3.5.1. Company Overview
    • 6.3.5.2. Financial Performance
    • 6.3.5.3. Service Benchmarking
    • 6.3.5.4. Strategic Initiatives
  • 6.3.6. Element Minnetonka
    • 6.3.6.1. Company Overview
    • 6.3.6.2. Financial Performance
    • 6.3.6.3. Service Benchmarking
    • 6.3.6.4. Strategic Initiatives
  • 6.3.7. Eurofins Scientific
    • 6.3.7.1. Company Overview
    • 6.3.7.2. Financial Performance
    • 6.3.7.3. Service Benchmarking
    • 6.3.7.4. Strategic Initiatives
  • 6.3.8. Pace Analytical Services LLC
    • 6.3.8.1. Company Overview
    • 6.3.8.2. Financial Performance
    • 6.3.8.3. Service Benchmarking
    • 6.3.8.4. Strategic Initiatives
  • 6.3.9. Intertek Group Plc
    • 6.3.9.1. Company Overview
    • 6.3.9.2. Financial Performance
    • 6.3.9.3. Service Benchmarking
    • 6.3.9.4. Strategic Initiatives
  • 6.3.10. North America Science Associates Inc. (NAMSA)
    • 6.3.10.1. Company Overview
    • 6.3.10.2. Financial Performance
    • 6.3.10.3. Service Benchmarking
    • 6.3.10.4. Strategic Initiatives

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