北美和歐洲臨床前醫療器械測試服務市場規模、份額和趨勢分析報告：按服務（生物相容性測試、化學測試、微生物學和無菌測試）、地區、細分市場、預測 2022-2030

北美和歐洲臨床前醫療器械檢測服務市場增長及趨勢

根據 Grand View Research, Inc. 的最新報告，預計到 2030 年，北美和歐洲的臨床前醫療器械測試服務市場規模將達到 29.2 億美元，複合年增長率為 8.7%。我來了。越來越多沒有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增長的主要因素。

在過去十年中，活躍在市場上的玩家數量有所增加。這種數量的增加迫使市場競爭激烈。有防禦性和進攻性營銷策略的混合來維持市場。例子包括大規模研發、有競爭力的定價、新產品發布、聯合開發、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。上半年沒有上漲那麼多，但下半年更加明顯，因為該行業已經適應了大流行期間的運營。個人防護裝備的生產和測試有所增加，幾個因新冠疫情而暫停的項目正在恢復個人防護裝備。此外，疫情增加了對各種醫療設備的需求，我們不能將目光從手術所需的設備上移開。 COVID-19 疫苗、呼吸機、脈搏血氧儀等是需求增加的主要項目。

北美和歐洲臨床前醫療器械測試服務市場亮點

微生物學和無菌檢測部門將在 2021 年以 34.3% 的收入份額主導市場。這是包括在臨床前醫療器械試驗中的主要試驗之一。這些測試有助於識別設備上可能存在的任何微生物。

按測試類型劃分，無菌測試和驗證在 2021 年以 45.7% 的收入份額領先市場。

預計北美將在 2021 年引領全球市場，在預測期內實現 8.8% 的最快複合年增長率。

2021 年，歐洲的收入份額達到了可觀的 36.6%。這是由於對降低成本的需求不斷增加以及支持該地區增長的產品設計的複雜性增加。

內容

第一章調查方法及範圍

• 市場細分和範圍
  • 服務
• 調查方法
• 信息採購
  • 購買的數據庫
  • GVR 內部數據庫
  • 輔助信息
  • 初步調查
• 信息或數據分析
  • 數據分析模型
• 市場製定和驗證
• 型號詳情
  • 商品流向分析（模型 1）
  • 量價分析（模型 2）
• 輔助信息列表
• 主要信息列表
• 目的

第 2 章執行摘要

• 市場展望

第 3 章北美和歐洲臨床前醫療器械測試服務市場變量、趨勢和範圍

• 市場系列展望
  • 母公司市場展望
  • 相關/子公司市場展望
• 繪製滲透率和增長前景
• 市場動態
  • 市場驅動因素分析
    • 產品設計複雜性
    • 嚴格的審批標準
    • 不具備自檢功能的小型醫療器械增加
    • 競爭加劇
  • 市場約束分析
    • 法律和監管問題
    • 延遲的合同義務
  • 繪製滲透率和增長前景
  • 新冠疫情影響分析
  • 分析重大交易和戰略聯盟
  • 行業分析 - 搬運工
  • PESTLE 分析

第 4 章北美和歐洲臨床前醫療器械檢測服務市場：服務細分分析

• 北美和歐洲臨床前醫療器械測試服務市場：定義和範圍
• 北美和歐洲臨床前醫療器械測試服務市場：2021 年和 2030 年服務市場份額分析
• 生物相容性測試
• 化學測試
• 微生物學和無菌檢測
  • 生物負載測量
  • 熱原和內毒素檢測
  • 無菌測試和驗證
    • 環氧乙烷 (EO) 氣體滅菌
    • 伽馬射線照射
    • 電子束滅菌
    • X 射線滅菌
  • 抗菌活性測試
  • 其他
• 包裹驗證

第 5 章北美和歐洲臨床前醫療器械檢測服務市場：區域分析

• 北美和歐洲臨床前醫療器械測試服務市場：定義和範圍
• 北美和歐洲臨床前醫療器械測試服務市場：2021 年和 2030 年區域市場份額分析
• 北美
  • 美國
  • 加拿大
• 歐洲
  • 英國
  • 德國
  • 法國
  • 意大利
  • 西班牙
  • 荷蘭
  • 比利時
  • 瑞士
  • 俄羅斯
  • 瑞典

第 6 章競爭格局

• 公司簡介
  • SGS SA，
    • 公司概況
    • 財務表現
    • 服務基準
    • 戰略舉措
  • Toxikon Inc.
    • 公司概況
    • 財務表現
    • 服務基準
    • 戰略舉措
  • 歐陸科學
    • 公司概況
    • 財務表現
    • 服務基準
    • 戰略舉措
  • 佩斯分析服務有限公司
    • 公司概況
    • 財務表現
    • 服務基準
    • 戰略舉措
  • 美國臨床前服務
    • 公司概況
    • 財務表現
    • 服務基準
    • 戰略舉措
  • 無錫應用技術
    • 公司概況
    • 財務表現
    • 服務基準
    • 戰略舉措
  • Tuv Sud Ag
    • 公司概況
    • 財務表現
    • 服務基準
    • 戰略舉措
  • Sterigenics International LLC
    • 公司概況
    • 財務表現
    • 服務基準
    • 戰略舉措
  • 尼爾森實驗室
    • 公司概況
    • 財務表現
    • 服務基準
    • 戰略舉措
  • 北美科學協會公司
    • 公司概況
    • 財務表現
    • 服務基準
    • 戰略舉措
  • 查爾斯河國際實驗室有限公司
    • 公司概況
    • 財務表現
    • 服務基準
    • 戰略舉措

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 2.92 billion by 2030, expanding at a CAGR of 8.7%, 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:

• Microbiology & Sterility Testing segment dominated the market with a revenue share of 34.3% in 2021. It is one of the major tests included in pre-clinical medical device testing. These examinations aid in identifying any microorganisms that could be present in the apparatus

• Based on test type, sterility test and validation led the market with a revenue share of 45.7% in 2021

• North America led the global market in 2021 and is projected to witness the fastest CAGR of 8.8% during the forecast years

• In Europe, the market held a considerable revenue share of 36.6% in 2021. This is due to the rising demand for cost-cutting and increasing complexity in product designing, which is supporting the growth of the region

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
  • 1.1.1. Services
• 1.2. Research Methodology
• 1.3. Information Procurement
  • 1.3.1. Purchased database
  • 1.3.2. GVR's internal database
  • 1.3.3. Secondary sources
  • 1.3.4. Primary research
• 1.4. Information or Data Analysis
  • 1.4.1. Data analysis models
• 1.5. Market Formulation & Validation
• 1.6. Model Details
  • 1.6.1. Commodity flow analysis (Model 1)
  • 1.6.2. Volume price analysis (Model 2)
• 1.7. List of Secondary Sources
• 1.8. List of Primary Sources
• 1.9. Objectives
  • 1.9.1. Objective 1
  • 1.9.2. Objective 2
  • 1.9.3. Objective 3
  • 1.9.4. Objective 4

Chapter 2. Executive Summary

• 2.1. Market Outlook

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. Penetration & Growth Prospect Mapping
• 3.3. Market Dynamics
  • 3.3.1. Market driver analysis
    • 3.3.1.1. Complexity in Product design
    • 3.3.1.2. Strict Approval Norms
    • 3.3.1.3. Increase in the number of small medical devices lacking in-house testing capabilities
    • 3.3.1.4. Intensifying Competition
  • 3.3.2. Market restraint analysis
    • 3.3.2.1. Legal and Regulatory Issues
    • 3.3.2.2. Delays in contractual obligation
  • 3.3.3. Penetration & Growth Prospect Mapping
  • 3.3.4. Covid Impact Analysis
  • 3.3.5. Major Deals and Strategic Alliances Analysis
  • 3.3.6. Industry Analysis - Porter's
  • 3.3.7. Pestle Analysis

Chapter 4. North America and Europe Preclinical Medical Device Testing Services Market: Services Segment Analysis

• 4.1. North America and Europe Preclinical Medical Device Testing Services Market: Definition & Scope
• 4.2. North America and Europe Preclinical Medical Device Testing Services Market: Services Market Share Analysis, 2021 & 2030
• 4.3. Biocompatibility Tests
  • 4.3.1. Biocompatibility Tests Market, 2018 - 2030 (USD Million)
• 4.4. Chemistry Test
  • 4.4.1. Chemistry Test Market, 2018 - 2030 (USD Million)
• 4.5. Microbiology & Sterility Testing
  • 4.5.1. Microbiology & Sterility Testing Market, 2018 - 2030 (USD Million)
  • 4.5.2. Bioburden Determination
    • 4.5.2.1. Bioburden Determination Market, 2018 - 2030 (USD Million)
  • 4.5.3. Pyrogen & Endotoxin Testing
    • 4.5.3.1. Pyrogen & Endotoxin Testing Market, 2018 - 2030 (USD Million)
  • 4.5.4. Sterility Test and Validation
    • 4.5.4.1. Sterility Test and Validation Market, 2018 - 2030 (USD Million)
    • 4.5.4.2. Ethylene Oxide (EO) gas sterilization
    • 4.5.4.2.1. Ethylene Oxide (EO) gas sterilization Market, 2018 - 2030 (USD Million)
    • 4.5.4.3. Gamma-irradiation
    • 4.5.4.3.1. Gamma-irradiation Market, 2018 - 2030 (USD Million)
    • 4.5.4.4. E-beam sterilization
    • 4.5.4.4.1. E-beam Sterilization Market, 2018 - 2030 (USD Million)
    • 4.5.4.5. X-ray sterilization
    • 4.5.4.5.1. X-ray sterilization Market, 2018 - 2030 (USD Million)
  • 4.5.5. Antimicrobial activity testing
    • 4.5.5.1. Antimicrobial activity testing Market, 2018 - 2030 (USD Million)
  • 4.5.6. Others
    • 4.5.6.1. Others Market, 2018 - 2030 (USD Million)
• 4.6. Packaging Validation
  • 4.6.1. Packaging Validation Market, 2018 - 2030 (USD Million)

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

• 5.1. North America and Europe Preclinical Medical Device Testing Services Market: Definition & Scope
• 5.2. North America and Europe Preclinical Medical Device Testing Services Market: Regional Market Share Analysis, 2021 & 2030
• 5.3. North America
  • 5.3.1. North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
  • 5.3.2. U.S.
    • 5.3.2.1. U.S. North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
  • 5.3.3. Canada
    • 5.3.3.1. Canada North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• 5.4. Europe
  • 5.4.1. Europe North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
  • 5.4.2. UK
    • 5.4.2.1. UK North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
  • 5.4.3. Germany
    • 5.4.3.1. Germany North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
  • 5.4.4. France
    • 5.4.4.1. France North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
  • 5.4.5. Italy
    • 5.4.5.1. Italy North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
  • 5.4.6. Spain
    • 5.4.6.1. Spain North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
  • 5.4.7. The Netherlands
    • 5.4.7.1. Netherlands North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
  • 5.4.8. Belgium
    • 5.4.8.1. Belgium North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
  • 5.4.9. Switzerland
    • 5.4.9.1. Switzerland North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
  • 5.4.10. Russia
    • 5.4.10.1. Russia North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
  • 5.4.11. Sweden
    • 5.4.11.1. Sweden North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)

Chapter 6. Competitive Landscape

• 6.1. Company Profiles
  • 6.1.1. SGS SA,
    • 6.1.1.1. Company overview
    • 6.1.1.2. Financial performance
    • 6.1.1.3. Service benchmarking
    • 6.1.1.4. Strategic initiatives
  • 6.1.2. Toxikon Inc.
    • 6.1.2.1. Company overview
    • 6.1.2.2. Financial performance
    • 6.1.2.3. Service benchmarking
    • 6.1.2.4. Strategic initiatives
  • 6.1.3. Eurofins Scientific
    • 6.1.3.1. Company overview
    • 6.1.3.2. Financial performance
    • 6.1.3.3. Service benchmarking
    • 6.1.3.4. Strategic initiatives
  • 6.1.4. Pace Analytical Services Llc
    • 6.1.4.1. Company overview
    • 6.1.4.2. Financial performance
    • 6.1.4.3. Service benchmarking
    • 6.1.4.4. Strategic initiatives
  • 6.1.5. American Preclinical Services
    • 6.1.5.1. Company overview
    • 6.1.5.2. Financial performance
    • 6.1.5.3. Service benchmarking
    • 6.1.5.4. Strategic initiatives
  • 6.1.6. Wuxi AppTec
    • 6.1.6.1. Company overview
    • 6.1.6.2. Financial performance
    • 6.1.6.3. Service benchmarking
    • 6.1.6.4. Strategic initiatives
  • 6.1.7. Tuv Sud Ag
    • 6.1.7.1. Company overview
    • 6.1.7.2. Financial performance
    • 6.1.7.3. Service benchmarking
    • 6.1.7.4. Strategic initiatives
  • 6.1.8. Sterigenics International LLC
    • 6.1.8.1. Company overview
    • 6.1.8.2. Financial performance
    • 6.1.8.3. Service benchmarking
    • 6.1.8.4. Strategic initiatives
  • 6.1.9. Nelson Labs
    • 6.1.9.1. Company overview
    • 6.1.9.2. Financial performance
    • 6.1.9.3. Service benchmarking
    • 6.1.9.4. Strategic initiatives
  • 6.1.10. North American Science Associates, Inc.
    • 6.1.10.1. Company overview
    • 6.1.10.2. Financial performance
    • 6.1.10.3. Service benchmarking
    • 6.1.10.4. Strategic initiatives
  • 6.1.11. Charles River Laboratories International, Inc.
    • 6.1.11.1. Company overview
    • 6.1.11.2. Financial performance
    • 6.1.11.3. Service benchmarking
    • 6.1.11.4. Strategic initiatives

List of Tables

• Table 1 List of Secondary Sources
• Table 2 List of Abbreviations
• Table 3 North America and Europe Preclinical Medical Device Testing Services market, by country, 2018 - 2030 (USD Million)
• Table 4 North America and Europe Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 7 U.S. Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 8 Canada Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 9 Europe Preclinical Medical Device Testing Services market, by country, 2018 - 2030 (USD Million)
• Table 10 Europe Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 11 UK Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 12 Germany Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 13 France Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 14 Italy Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 15 Spain Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 16 Netherlands Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 17 Belgium Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 18 Switzerland Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 19 Russia Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)
• Table 20 Sweden Preclinical Medical Device Testing Services market, by services, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 Market research process
• Fig. 2 Information procurement
• Fig. 3 Primary research pattern
• Fig. 4 Market research approaches
• Fig. 5 North America and Europe Preclinical Medical Device Testing Services market snapshot (2021)
• Fig. 6 North America and Europe Preclinical Medical Device Testing Services market segmentation
• Fig. 7 Parent market outlook
• Fig. 8 Related/ancillary market outlook
• Fig. 9 Penetration & growth prospect mapping
• Fig. 10 Market driver relevance analysis (Current & future impact)
• Fig. 11 Market restraint relevance analysis (Current & future impact)
• Fig. 12 Porter's five forces analysis
• Fig. 13 SWOT analysis, by factor (political & legal, economic and technological)
• Fig. 14 North America and Europe Preclinical Medical Device Testing Services market outlook: Segment dashboard
• Fig. 15 North America and Europe Preclinical Medical Device Testing Services market: Service movement analysis
• Fig. 16 Biocompatibility Tests market, 2018 - 2030 (USD Million)
• Fig. 17 Chemistry Test market, 2018 - 2030 (USD Million)
• Fig. 18 Microbiology & Sterility Testing market, 2018 - 2030 (USD Million)
• Fig. 19 Bioburden Determination market, 2018 - 2030 (USD Million)
• Fig. 20 Pyrogen & Endotoxin Testing market, 2018 - 2030 (USD Million)
• Fig. 21 Sterility Test and Validation market, 2018 - 2030 (USD Million)
• Fig. 22 Ethylene Oxide (EO) gas sterilization market, 2018 - 2030 (USD Million)
• Fig. 23 Gamma-irradiation market, 2018 - 2030 (USD Million)
• Fig. 24 E-beam sterilization market, 2018 - 2030 (USD Million)
• Fig. 25 X-ray sterilization market, 2018 - 2030 (USD Million)
• Fig. 26 Antimicrobial activity testing market, 2018 - 2030 (USD Million)
• Fig. 27 Others market, 2018 - 2030 (USD Million)
• Fig. 28 Package validation market, 2018 - 2030 (USD Million)
• Fig. 29 North America and Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 31 U.S. Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 32 Canada Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 33 Europe Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 34 France Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 35 Germany Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 36 UK Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 37 Italy Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 38 Spain Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 39 Netherlands Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 40 Belgium Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 41 Switzerland Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 42 Russia Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)
• Fig. 43 Sweden Preclinical Medical Device Testing Services market, 2018 - 2030 (USD Million)