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封面
市场调查报告书
商品编码
1609940

北美和欧洲临床前医疗设备测试服务市场规模、份额和趋势分析报告：2025-2030 年按服务、地区和细分市场预测

North America And Europe Preclinical Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service, By Region, And Segment Forecasts, 2025 - 2030
出版日期: | 出版商: Grand View Research | 英文 120 Pages | 商品交期: 2-10个工作天内

价格

北美和欧洲临床前医疗设备测试服务市场成长与趋势：

Grand View Research, Inc.最新报告显示，2025年至2030年，北美和欧洲临床前医疗设备测试服务市场规模将以9.3%的复合年增长率成长，2030年达到31.4亿美元。

越来越多缺乏内部测试能力的小型医疗设备和产品设计的复杂性是推动市场成长的关键因素。

在过去的十年中，在市场上运营的公司数量有所增加。如此庞大的数量造成了激烈的竞争。防御性和进攻性行销策略相结合来维持市场。例子包括广泛的研究和开发、有竞争力的价格、新产品发布、共同开发、区域扩张和併购。

COVID-19 大流行对这些服务产生了巨大的需求。上半年这种成长幅度不大，但随着产业适应疫情期间的运营，下半年这种成长变得更加明显。个人防护设备的生产和测试增加，一些因新冠疫情而暂停的计划已恢復个人防护设备的生产。疫情增加了对各种医疗设备的需求，并转移了人们对手术所需设备的注意力。 COVID-19 疫苗、人工呼吸器和脉动式血氧监测仪系统是需求成长的关键产品。

北美和欧洲临床前医疗设备测试服务市场亮点

  • 2024年，生物相容性测试领域以44.7%的销售份额占据市场主导地位。生产安全有效的产品是医疗设备製造商的首要任务，而品质保证对于实现这一目标至关重要。
  • 预计化学测试产业在预测期内将以 9.6% 的最快复合年增长率成长。化学测试为医疗设备产业的整个价值链提供支援。
  • 北美临床前医疗设备测试服务市场占据主导地位，2024 年将占 55.0% 的显着份额。

目录

第一章调查方法和范围

第 2 章执行摘要

第 3 章：北美和欧洲临床前医疗设备测试服务市场变数、趋势和范围

  • 市场体系展望
    • 母市场展望
    • 相关/附随市场展望
  • 市场动态
    • 市场推动要素分析
    • 市场限制因素分析
  • 市场分析工具
    • 波特五力分析
    • PESTEL分析
    • COVID-19 影响分析

第四章北美和欧洲临床前医疗设备测试服务市场：服务评估和趋势分析

  • 细分仪表板
  • 北美和欧洲临床前医疗设备测试服务市场：波动分析
  • 2018-2030年北美及欧洲临床前医疗设备测试服务规模及趋势分析
  • 生物相容性测试
  • 化学测试
  • 微生物学和无菌测试
    • 微生物附着量测量
    • 热原和内毒素检测
    • 无菌测试和检验
    • 抗菌活性测试
    • 其他的
  • 包裹检验

第五章北美和欧洲临床前医疗设备测试服务市场：区域估计和趋势分析

  • 2024 年及 2030 年区域市场占有率分析
  • 区域市场仪表板
  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 英国
    • 德国
    • 法国
    • 义大利
    • 西班牙
    • 丹麦
    • 瑞典
    • 挪威

第六章 竞争状况

  • 公司分类
  • 2023 年企业市场分析
  • 公司简介
    • SGS SA
    • Toxikon, Inc.
    • Eurofins Scientific
    • Pace Analytical Services LLC
    • Intertek Group Plc
    • WUXI APPTEC
    • TUV SUD AG
    • Sterigenics International LLC
    • Nelson Labs
    • North American Science Associates, Inc.
    • American Preclinical Services
    • Charles River Laboratories International, Inc.
Product Code: GVR-4-68039-817-3

North America And Europe Preclinical Medical Device Testing Service Market Growth & Trends:

The North America and Europe preclinical medical device testing services market size is expected to reach USD 3.14 billion by 2030, expanding at a CAGR of 9.3% from 2025 to 2030, according to a new report by Grand View Research, Inc. The increase in the number of small medical devices lacking in-house testing capabilities and complexity in product design are the major factors driving the growth of the market.

There has been an increase in the number of players operating in the market over the last decade. Due to this large number, it has witnessed fierce competition. To sustain the market, a mix of defensive and offensive marketing strategies is used. For instance, extensive R&D, competitive pricing, new product launches, collaborative development, regional expansion, and mergers and acquisitions.

The COVID-19 pandemic has created a huge demand for these services. The rise was not significant in the first half, but it became more significant in the second as the industry adapted to operating during the pandemic. There has been an increase in the production and testing of personal protective equipment, and several projects that were put on hold because of COVID have resumed personal protective equipment. The epidemic has increased demand for a wide range of medical gadgets, diverting attention from those needed for surgery. COVID-19 vaccinations, ventilators, and pulse oximeters are the main goods seeing an increase in demand.

North America And Europe Preclinical Medical Device Testing Services Market Highlights

  • In 2024, the biocompatibility tests segment dominated the market, accounting for a revenue share of 44.7%. Manufacturing safe and effective goods is a top priority for medical device manufacturers, and quality assurance is crucial in accomplishing this aim.
  • The chemistry test segment is expected to rise with the fastest CAGR of 9.6% in the forecast period. Chemistry tests support the medical device industry across the value chain.
  • North America preclinical medical device testing services market dominated in 2024 with a larger share of 55.0%.

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & 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. Market Formulation & Validation
  • 1.6. Model Details
    • 1.6.1. Commodity Flow Analysis
    • 1.6.2. Bottom-up Approach
  • 1.7. List of Secondary Sources
  • 1.8. List of Abbreviations
  • 1.9. Objectives

Chapter 2. Executive Summary

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

Chapter 3. North America and Europe Preclinical 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
      • 3.2.1.2. Strict approval norms
      • 3.2.1.3. Increase in number of small medical device lacking in-house testing capabilities
      • 3.2.1.4. Intense competition in medical device industry
    • 3.2.2. Market restraint analysis
      • 3.2.2.1. Legal and Regulatory Issues
  • 3.3. Market Analysis Tools
    • 3.3.1. Porter's Five Forces Analysis
    • 3.3.2. PESTEL Analysis
    • 3.3.3. COVID-19 Impact Analysis

Chapter 4. North America and Europe Preclinical Medical Device Testing Services Market: Service Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. North America and Europe Preclinical Medical Device Testing Services Market; Method Movement Analysis
  • 4.3. North America and Europe Preclinical Medical Device Testing Services Size & Trend Analysis, by Method, 2018 to 2030 (USD Million)
  • 4.4. Biocompatibility Tests
    • 4.4.1. Biocompatibility tests market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.5. Chemistry Test
    • 4.5.1. Chemistry test market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.6. Microbiology & Sterility Testing
    • 4.6.1. Microbiology & sterility testing market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.6.2. Bioburden Determination
      • 4.6.2.1. Bioburden determination market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.6.3. Pyrogen & Endotoxin Testing
      • 4.6.3.1. Pyrogen & endotoxin testing market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.6.4. Sterility Test and Validation
      • 4.6.4.1. Sterility test and validation market estimates and forecasts 2018 to 2030 (USD Million)
      • 4.6.4.2. Ethylene Oxide (EO) gas sterilization
        • 4.6.4.2.1. Ethylene oxide (EO) gas sterilization market estimates and forecasts 2018 to 2030 (USD Million)
      • 4.6.4.3. Gamma-irradiation
        • 4.6.4.3.1. Gamma-irradiation market estimates and forecasts 2018 to 2030 (USD Million)
      • 4.6.4.4. E-beam sterilization
        • 4.6.4.4.1. E-beam sterilization market estimates and forecasts 2018 to 2030 (USD Million)
      • 4.6.4.5. X-ray sterilization
        • 4.6.4.5.1. X-ray sterilization market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.6.5. Antimicrobial Activity Testing
      • 4.6.5.1. Antimicrobial activity testing market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.6.6. Others
      • 4.6.6.1. Others market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.7. Package Validation
    • 4.7.1. Package validation market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 5. North America and Europe Preclinical Medical Device Testing Services Market: Regional Estimates & Trend Analysis

  • 5.1. Regional Market Share Analysis, 2024 & 2030
  • 5.2. Regional Market Dashboard
  • 5.3. North America
    • 5.3.1. North America Market Estimates and Forecasts 2018 to 2030 (USD Million)
    • 5.3.2. U.S.
      • 5.3.2.1. Key country dynamics
      • 5.3.2.2. Competitive scenario
      • 5.3.2.3. Regulatory framework
      • 5.3.2.4. U.S. market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.3.3. Canada
      • 5.3.3.1. Key country dynamics
      • 5.3.3.2. Competitive scenario
      • 5.3.3.3. Regulatory framework
      • 5.3.3.4. Canada market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.3.4. Mexico
      • 5.3.4.1. Key country dynamics
      • 5.3.4.2. Competitive scenario
      • 5.3.4.3. Regulatory framework
      • 5.3.4.4. Mexico market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4. Europe
    • 5.4.1. Europe Market Estimates and Forecasts 2018 to 2030 (USD Million)
    • 5.4.2. UK
      • 5.4.2.1. Key country dynamics
      • 5.4.2.2. Competitive scenario
      • 5.4.2.3. Regulatory framework
      • 5.4.2.4. UK market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.3. Germany
      • 5.4.3.1. Key country dynamics
      • 5.4.3.2. Competitive scenario
      • 5.4.3.3. Regulatory framework
      • 5.4.3.4. Germany market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.4. France
      • 5.4.4.1. Key country dynamics
      • 5.4.4.2. Competitive scenario
      • 5.4.4.3. Regulatory framework
      • 5.4.4.4. France market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.5. Italy
      • 5.4.5.1. Key country dynamics
      • 5.4.5.2. Competitive scenario
      • 5.4.5.3. Regulatory framework
      • 5.4.5.4. Italy market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.6. Spain
      • 5.4.6.1. Key country dynamics
      • 5.4.6.2. Competitive scenario
      • 5.4.6.3. Regulatory framework
      • 5.4.6.4. Spain market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.7. Denmark
      • 5.4.7.1. Key country dynamics
      • 5.4.7.2. Competitive scenario
      • 5.4.7.3. Regulatory framework
      • 5.4.7.4. Denmark market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.8. Sweden
      • 5.4.8.1. Key country dynamics
      • 5.4.8.2. Competitive scenario
      • 5.4.8.3. Regulatory framework
      • 5.4.8.4. Sweden market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.9. Norway
      • 5.4.9.1. Key country dynamics
      • 5.4.9.2. Competitive scenario
      • 5.4.9.3. Regulatory framework
      • 5.4.9.4. Norway market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 6. Competitive Landscape

  • 6.1. Company Categorization
  • 6.2. Company Market Position Analysis, 2023
  • 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. Toxikon, Inc.
      • 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. Eurofins Scientific
      • 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. Pace Analytical Services LLC
      • 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. Intertek Group Plc
      • 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. WUXI APPTEC
      • 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. TUV SUD AG
      • 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. Sterigenics International 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. Nelson Labs
      • 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 American Science Associates, Inc.
      • 6.3.10.1. Company overview
      • 6.3.10.2. Financial performance
      • 6.3.10.3. Service benchmarking
      • 6.3.10.4. Strategic initiatives
    • 6.3.11. American Preclinical Services
      • 6.3.11.1. Company overview
      • 6.3.11.2. Financial performance
      • 6.3.11.3. Service benchmarking
      • 6.3.11.4. Strategic initiatives
    • 6.3.12. Charles River Laboratories International, Inc.
      • 6.3.12.1. Company overview
      • 6.3.12.2. Financial performance
      • 6.3.12.3. Service benchmarking
      • 6.3.12.4. Strategic initiatives

List of Tables

  • Table 1 List of Tables
  • Table 2 List of Secondary Sources
  • Table 3 List of Abbreviations
  • Table 4 North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 5 North America and Europe Preclinical Medical Device Testing Services Market, by Region, 2018 - 2030 (USD Million)
  • Table 6 North America North America and Europe Preclinical Medical Device Testing Services Market, by Country, 2018 - 2030 (USD Million)
  • Table 7 North America North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 8 U.S North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 9 Canada North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 10 Mexico North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 11 Europe North America and Europe Preclinical Medical Device Testing Services Market, by Country, 2018 - 2030 (USD Million)
  • Table 12 Europe North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 13 UK North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 14 Germany North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 15 France North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 16 Italy North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 17 Spain North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 18 Denmark North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 19 Sweden North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 20 Norway North America and Europe Preclinical Medical Device Testing Services Market, by Service, 2018 - 2030 (USD Million)

List of Figures

  • Fig. 1 Market segmentation
  • Fig. 2 Market research process
  • Fig. 3 Information procurement
  • Fig. 4 Primary research pattern
  • Fig. 5 Market research approaches
  • Fig. 6 Value chain-based sizing & forecasting
  • Fig. 7 QFD modelling for Market share assessment
  • Fig. 8 Market formulation & validation
  • Fig. 9 North America and Europe Preclinical Medical Device Testing Services Market revenue, 2018 - 2030 (USD Million)
  • Fig. 10 North America and Europe Preclinical Medical Device Testing Services Market snapshot
  • Fig. 11 North America and Europe Preclinical Medical Device Testing Services Market driver impact
  • Fig. 12 North America and Europe Preclinical Medical Device Testing Services Market restraint impact
  • Fig. 13 North America and Europe Preclinical Medical Device Testing Services Market: Service takeaways (USD Million)
  • Fig. 14 North America and Europe Preclinical Medical Device Testing Services Market: Service movement analysis
  • Fig. 15 Biocompatibility Tests Market, 2018 - 2030 (USD Million)
  • Fig. 16 Chemistry Test Market, 2018 - 2030 (USD Million)
  • Fig. 17 Microbiology & Sterility Testing Market, 2018 - 2030 (USD Million)
  • Fig. 18 Bioburden Determination Market, 2018 - 2030 (USD Million)
  • Fig. 19 Pyrogen & Endotoxin Testing Market, 2018 - 2030 (USD Million)
  • Fig. 20 Sterility Test and Validation Market, 2018 - 2030 (USD Million)
  • Fig. 21 Ethylene Oxide (EO) gas sterilization Market, 2018 - 2030 (USD Million)
  • Fig. 22 Gamma-irradiation Market, 2018 - 2030 (USD Million)
  • Fig. 23 E-beam sterilization Market, 2018 - 2030 (USD Million)
  • Fig. 24 X-ray sterilization Market, 2018 - 2030 (USD Million)
  • Fig. 25 Antimicrobial Activity Testing Market, 2018 - 2030 (USD Million)
  • Fig. 26 Others Market, 2018 - 2030 (USD Million)
  • Fig. 27 Package Validation Market, 2018 - 2030 (USD Million)
  • Fig. 28 Regional Marketplace: Key takeaways
  • Fig. 29 Regional outlook, 2024 & 2030
  • Fig. 30 North America North America and Europe Preclinical Medical Device Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 31 U.S. North America and Europe Preclinical Medical Device Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 32 Canada North America and Europe Preclinical Medical Device Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 33 Mexico North America and Europe Preclinical Medical Device Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 34 Europe North America and Europe Preclinical Medical Device Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 35 UK North America and Europe Preclinical Medical Device Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 36 Germany North America and Europe Preclinical Medical Device Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 37 France North America and Europe Preclinical Medical Device Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 38 Italy North America and Europe Preclinical Medical Device Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 39 Spain companion animal Health Market, 2018 - 2030 (USD Million)
  • Fig. 40 Sweden North America and Europe Preclinical Medical Device Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 41 Denmark North America and Europe Preclinical Medical Device Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 42 Norway North America and Europe Preclinical Medical Device Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 43 Market participant categorization