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市場調查報告書
商品編碼
1609940

北美和歐洲臨床前醫療設備測試服務市場規模、佔有率和趨勢分析報告：2025-2030 年按服務、地區和細分市場預測

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個工作天內

價格

北美和歐洲臨床前醫療設備測試服務市場成長與趨勢：

Grand View Research, Inc.最新報告顯示，2025年至2030年，北美和歐洲臨床前醫療設備測試服務市場規模將以9.3%的複合年成長率成長，2030年達到31.4億美元。

越來越多缺乏內部測試能力的小型醫療設備和產品設計的複雜性是推動市場成長的關鍵因素。

在過去的十年中，在市場上營運的公司數量有所增加。如此龐大的數量造成了激烈的競爭。防禦性和進攻性行銷策略相結合來維持市場。例子包括廣泛的研究和開發、有競爭力的價格、新產品發布、共同開發、區域擴張和併購。

COVID-19 大流行對這些服務產生了巨大的需求。上半年這種成長幅度不大，但隨著產業適應疫情期間的營運，下半年這種成長變得更加明顯。個人防護設備的生產和測試增加，一些因新冠疫情而暫停的計劃已恢復個人防護設備的生產。疫情增加了對各種醫療設備的需求，並轉移了人們對手術所需設備的注意力。 COVID-19 疫苗、人工呼吸器和脈動式血氧監測儀系統是需求成長的關鍵產品。

北美和歐洲臨床前醫療設備測試服務市場亮點

  • 2024年，生物相容性測試領域以44.7%的銷售佔有率佔據市場主導地位。生產安全有效的產品是醫療設備製造商的首要任務，而品質保證對於實現這一目標至關重要。
  • 預計化學測試產業在預測期內將以 9.6% 的最快複合年成長率成長。化學測試為醫療設備產業的整個價值鏈提供支援。
  • 北美臨床前醫療設備測試服務市場佔據主導地位，2024 年將佔 55.0% 的顯著佔有率。

目錄

第1章調查方法和範圍

第 2 章執行摘要

第 3 章：北美和歐洲臨床前醫療設備測試服務市場變數、趨勢和範圍

  • 市場體系展望
    • 母市場展望
    • 相關/附隨市場展望
  • 市場動態
    • 市場推動要素分析
    • 市場限制因素分析
  • 市場分析工具
    • 波特五力分析
    • PESTEL分析
    • COVID-19 影響分析

第4章北美和歐洲臨床前醫療設備測試服務市場：服務評估和趨勢分析

  • 細分儀表板
  • 北美和歐洲臨床前醫療設備測試服務市場：波動分析
  • 2018-2030年北美及歐洲臨床前醫療設備測試服務規模及趨勢分析
  • 生物相容性測試
  • 化學測試
  • 微生物學和無菌測試
    • 微生物附著量測量
    • 熱原和內毒素檢測
    • 無菌測試和檢驗
    • 抗菌活性測試
    • 其他
  • 包裹檢驗

第5章北美和歐洲臨床前醫療設備測試服務市場：區域估計和趨勢分析

  • 2024 年及 2030 年區域市場佔有率分析
  • 區域市場儀表板
  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 英國
    • 德國
    • 法國
    • 義大利
    • 西班牙
    • 丹麥
    • 瑞典
    • 挪威

第6章 競爭狀況

  • 公司分類
  • 2023 年企業市場分析
  • 公司簡介
    • 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