北米と欧州の前臨床医療機器試験サービスの市場規模、シェア、動向分析レポート：サービス別、地域別、セグメント別予測、2025年～2030年

北米と欧州の前臨床医療機器試験サービス市場の成長と動向：

Grand View Research, Inc.の最新レポートによると、北米と欧州の前臨床医療機器試験サービス市場規模は、2025年から2030年にかけてCAGR 9.3％で拡大し、2030年には31億4,000万米ドルに達する見込みです。

自社での試験能力を欠く小型医療機器の増加や製品設計の複雑さが、市場の成長を促す主な要因となっています。

過去10年間で、市場で事業を展開する企業数は増加しています。この数の多さが、激しい競合を生んでいます。市場を維持するために、守りと攻めのマーケティング戦略が混在しています。例えば、広範な研究開発、競合価格設定、新製品の発売、共同開発、地域拡大、M&Aなどです。

COVID-19の大流行は、こうしたサービスに対する大きな需要を生み出しました。この増加は前半はそれほど大きくなかったが、業界がパンデミック時の運営に適応するにつれて、後半はより顕著になった。個人用保護具の生産とテストが増加し、COVIDのために中断していたいくつかのプロジェクトが個人用保護具を再開しました。パンデミックによって、さまざまな医療機器の需要が高まり、手術に必要なものから注意がそれています。COVID-19予防接種、人工呼吸器、パルスオキシメーターは需要が増加している主な商品です。

北米と欧州の前臨床医療機器試験サービス市場のハイライト

• 2024年には、生体適合性試験分野が44.7%の売上シェアを占め、市場を独占しました。医療機器メーカーにとって、安全で効果的な製品を製造することは最優先事項であり、品質保証はこの目的を達成する上で極めて重要です。
• 化学検査分野は、予測期間中に最も速いCAGR 9.6％で上昇すると予想されています。化学検査はバリューチェーン全体で医療機器産業をサポートします。
• 北米の前臨床医療機器試験サービス市場は、2024年に55.0%の大きなシェアで優位を占めています。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 北米と欧州の前臨床医療機器試験サービス市場の変数、動向、範囲

• 市場系統の見通し
  • 親市場の見通し
  • 関連/付随市場の見通し
• 市場力学
  • 市場牽引要因分析
  • 市場抑制要因分析
• 市場分析ツール
  • ポーターのファイブフォース分析
  • PESTEL分析
  • COVID-19の影響分析

第4章 北米と欧州の前臨床医療機器試験サービス市場：サービスの推定・動向分析

• セグメントダッシュボード
• 北米および欧州の前臨床医療機器試験サービス市場：変動分析
• 北米および欧州の前臨床医療機器試験サービスの規模と動向分析、2018～2030年
• 生体適合性試験
• 化学的検査
• 微生物学および無菌試験
  • バイオバーデン測定
  • 発熱物質およびエンドトキシン検査
  • 無菌試験と検証
  • 抗菌活性試験
  • その他
• パッケージ検証

第5章 北米と欧州の前臨床医療機器試験サービス市場：地域の推定・動向分析

• 地域別市場シェア分析、2024年および2030年
• 地域市場ダッシュボード
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • 英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • デンマーク
  • スウェーデン
  • ノルウェー

第6章 競合情勢

• 企業分類
• 企業市況分析、2023年
• 企業プロファイル
  • 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.

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

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