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North America and Europe Preclinical Medical Device Testing Services Market Size, Share & Trends Analysis Report by Services (Biocompatibility Tests, Chemistry Test), and Segment Forecasts, 2021-2028

  • ID: 5516265
  • Report
  • December 2021
  • Region: Europe, North America
  • 100 Pages
  • Grand View Research
The North America and Europe preclinical medical device testing services market size is expected to reach USD 5.6 billion by 2028. The market is expected to expand at a CAGR of 11.2% in 2020. COVID-19 has created a huge demand for medical devices and this trend is going to be followed in the coming years. The main driver of this market is the growing stringent regulations for medical devices that are expected to help in the formation of precise and innovative devices.







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.

COVID-19 has created a huge demand for these services. During the first half, the growth was not drastic, but it increased in the second half as the industry learned to operate amid the pandemic. Various projects that were postponed due to COVID have resumed and there has been a spike in production and testing of Personal Protective Equipment (PPE). There are many other medical devices in high demand during the pandemic, which shifted the focus from the devices required during surgery. The major products experiencing a surge in demand are the COVID-19 vaccines, ventilators, and pulse oximeters.

North America and Europe Preclinical Medical Device Testing Service Market Report Highlights

  • The chemistry test is expected to witness a CAGR of 11.5% over the forecasted period as they help in checking the safety parameters of medical devices
  • The sterility test and validation segment accounted for the largest revenue share of 45.6% and is expected to witness a CAGR of 11.3% over the forecast period
  • North America accounted for the largest revenue share of 54.9% in 2020. This is due to the large number of market players operating in the region
  • In Europe, the market is expected to witness a CAGR of 11.2% over the forecast period. This is due to rising demand for cost-cutting and increasing complexity in product designing
Frequently Asked Questions about the North American and European Preclinical Medical Device Testing Services Market

What is the estimated value of the North American and European Preclinical Medical Device Testing Services Market?

The North American and European Preclinical Medical Device Testing Services Market was estimated to be valued at $2.7 Billion in 2021.

What is the growth rate of the North American and European Preclinical Medical Device Testing Services Market?

The growth rate of the North American and European Preclinical Medical Device Testing Services Market is 11.0%, with an estimated value of $5.6 Billion by 2028.

What is the forecasted size of the North American and European Preclinical Medical Device Testing Services Market?

The North American and European Preclinical Medical Device Testing Services Market is estimated to be worth $5.6 Billion by 2028.

Who are the key companies in the North American and European Preclinical Medical Device Testing Services Market?

Key companies in the North American and European Preclinical Medical Device Testing Services Market include SGS SA, Toxikon Inc., Eurofins Scientific, Pace Analytical Services, Inc., WuXiAppTec, Inc., North American Science Associates, Inc., TÜV SÜD A.G., American Preclinical Services and Charles River Laboratories International, Inc..

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.1.1. Study design
1.1.2. Indication
1.1.3. Regional scope
1.1.4. Estimates and forecast timeline
1.2. Research Methodology
1.3. Information Procurement
1.3.1. Purchased database
1.3.2. 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)
1.6.1.1. Approach 1: Commodity flow approach
1.7. List of Secondary Sources
1.8. List of Primary Sources
1.9. Objectives
1.9.1. Objective 1: Understanding the market dynamics
1.9.2. Objective 2: Understanding the market estimates and forecasts
1.9.3. Objective 3: Understanding the attributes such as strategy framework, competitor categorization
1.9.4. Objective 4: Understanding the key product and application scopes to conclude on the market size
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights
Chapter 3. North America & 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. Intensifying Competition
3.3.1.3. Increase in number of small medical device lacking in-house testing capabilities
3.3.1.4. Strict Approval Norms
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. Industry Challenges
3.4. North America & Europe Preclinical Medical Device Testing Services: Market Analysis Tools
3.4.1. Industry Analysis - Porter’s
3.4.1.1. Supplier Power
3.4.1.2. Buyer Power
3.4.1.3. Substitution Threat
3.4.1.4. Threat from new entrant
3.4.1.5. Competitive rivalry
3.4.2. PESTEL Analysis
3.5. COVID-19 pandemic impact on clinical trial activity
Chapter 4. North America & Europe Preclinical Medical Device Testing Services: Segment Analysis, By services, 2016 - 2028 (USD Million)
4.1. Segment Dashboard
4.2. Study Design Market Share Analysis, 2020&2028
4.3. Global North America & Europe Preclinical Medical Device Testing Services, By services, 2016 to 2028
4.4. Market Size & Forecasts and Trend Analyses, 2016 to 2028for the following
4.4.1. Biocompatibility Test
4.4.2. Chemistry Test
4.4.3. Microbiology Test & Sterility
4.4.3.1. Bioburden Determination
4.4.3.2. Pyrogen & Endotoxin Testing
4.4.3.3. Sterility Test and Validation
4.4.3.4. Antimicrobial activity testing
4.4.4.4. Others
4.4.4. Package Validation
Chapter 5. North America & Europe Preclinical Medical Device Testing Services: Regional Market Analysis, by region, 2016 - 2028 (USD Million)
5.1. Regional Market Dashboard
5.2. Regional Market Share Analysis, 2020&2028
5.3. Market Size, & Forecasts, and Trend Analysis, 2016 to 2028:
5.4. North America
5.4.1. Market estimates and forecast, by country, 2016 - 2028 (USD Million)
5.4.2. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.4.3. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.4.4. U.S.
5.4.4.1. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.4.4.2. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.4.5. Canada
5.4.5.1. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.4.5.2. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.5. Europe
5.5.1. Market estimates and forecast, by country, 2016 - 2028 (USD Million)
5.5.2. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.5.3. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.5.4. Germany
5.5.4.1. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.5.4.2. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.5.5. U.K.
5.5.5.1. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.5.5.2. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.5.6. France
5.5.6.1. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.5.6.2. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.5.7. Italy
5.5.7.1. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.5.7.2. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.5.8. Spain
5.5.8.1. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.5.8.2. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.5.9. Netherlands
5.5.9.1. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.5.9.2. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.5.10. Belgium
5.5.10.1. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.5.10.2. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.5.11. Switzerland
5.5.11.1. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.5.11.2. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.5.12. Russia
5.5.12.1. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.5.12.2. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
5.5.13. Sweden
5.5.13.1. Market estimates and forecast, by services, 2016 - 2028 (USD Million)
5.5.13.2. Market estimates and forecast, by test type, 2016 - 2028 (USD Million)
Chapter 6. North America & Europe Preclinical Medical Device Testing Services Market - Competitive Analysis
6.1. Key companies profiled
6.1.1. SGS SA
6.1.1.1. Company Overview
6.1.1.2. Financial Performance
6.1.1.3. Product 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. Product 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. Product Benchmarking
6.1.3.4. Strategic Initiatives
6.1.4. Pace Analytical Services, Inc.
6.1.4.1. Company Overview
6.1.4.2. Financial Performance
6.1.4.3. Product Benchmarking
6.1.4.4. Strategic Initiatives
6.1.5. WuXiAppTec, Inc.
6.1.5.1. Company Overview
6.1.5.2. Financial Performance
6.1.5.3. Product Benchmarking
6.1.5.4. Strategic Initiatives
6.1.6. North American Science Associates, Inc.
6.1.6.1. Company Overview
6.1.6.2. Financial Performance
6.1.6.3. Product Benchmarking
6.1.6.4. Strategic Initiatives
6.1.7. TÜV SÜD A.G.
6.1.7.1. Company Overview
6.1.7.2. Financial Performance
6.1.7.3. Product Benchmarking
6.1.7.4. Strategic Initiatives
6.1.8. American Preclinical Services
6.1.8.1. Company Overview
6.1.8.2. Financial Performance
6.1.8.3. Product Benchmarking
6.1.8.4. Strategic Initiatives
6.1.9. Sterigenics International LLC
6.1.9.1. Company Overview
6.1.9.2. Financial Performance
6.1.9.3. Product Benchmarking
6.1.9.4. Strategic Initiatives
6.1.10. Charles River Laboratories International, Inc.
6.1.10.1. Company Overview
6.1.10.2. Financial Performance
6.1.10.3. Product Benchmarking
6.1.10.4. Strategic Initiatives
6.1.11. Nelson Labs
6.1.11.1. Company Overview
6.1.11.2. Financial Performance
6.1.11.3. Product Benchmarking
6.1.11.4. Strategic Initiatives
List of Tables
Table 1 North America & Europe Preclinical Medical Device Testing Services Market, by Region, 2016-2028 (USD Million)
Table 2 North America & Europe Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 3 North America & Europe Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 4 North America Preclinical Medical Device Testing Services Market, by Region, 2016-2028 (USD Million)
Table 5 North America Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 6 North America Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 7 U.S. Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 8 U.S. Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 9 Canada Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 10 Canada Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 11 Europe Preclinical Medical Device Testing Services Market, by Region, 2016-2028 (USD Million)
Table 12 Europe Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 13 Europe Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 14 U.K. Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 15 U.K. Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 16 Germany Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 17 Germany Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 18 France Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 19 France Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 20 Italy Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 21 Italy Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 22 Spain Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 23 Spain Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 24 Netherlands Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 25 Netherlands Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 26 Belgium Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 27 Belgium Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 28 Switzerland Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 29 Switzerland Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 30 Russia Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 31 Russia Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
Table 32 Sweden Preclinical Medical Device Testing Services Market, by Service, 2016-2028 (USD Million)
Table 33 Sweden Microbiology & Sterility Testing Market, by Test Type, 2016-2028 (USD Million)
List of Figures
Fig. 1 Market research process
Fig. 2 Data triangulation techniques
Fig. 3 Primary research pattern
Fig. 4 Market research approaches
Fig. 5 QFD modeling for market share assessment
Fig. 6 Market formulation & validation
Fig. 7 North America & Europe preclinical medical device testing services: Market snapshot
Fig. 8 North America & Europe preclinical medical device testing services: Market segmentation
Fig. 9 North America & Europe preclinical medical device testing services market strategy framework
Fig. 10 Parent market outlook
Fig. 11 Related/ancillary market outlook
Fig. 12 North America & Europe preclinical medical device testing services market driver impact
Fig. 13 North America & Europe preclinical medical device testing services restraint impact
Fig. 14 North America & Europe preclinical medical device testing services market porter’s five forces analysis
Fig. 15 North America & Europe preclinical medical device testing services market PESTEL analysis
Fig. 16 North America & Europe preclinical medical device testing services market: services segment dashboard
Fig. 17 North America & Europe preclinical medical device testing services market: service movement analysis
Fig. 18 Biocompatibility tests market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 19 Chemistry test market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 20 Microbiology & sterility testing market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 21 Package Validation market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 22 North America & Europe preclinical medical device testing services market: Segment dashboard
Fig. 23 North America & Europe preclinical medical device testing services market: test type movement analysis
Fig. 24 North America & Europe preclinical medical device testing services market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 25 Global North America & Europe preclinical medical device testing services market: Regional movement analysis
Fig. 26 Global North America & Europe preclinical medical device testing services market: Regional outlook and key takeaways
Fig. 27 North America market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 28 U.S. market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 29 Canada market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 30 Europe market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 31 U.K. market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 32 Germany market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 33 France market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 34 Italy market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 35 Spain market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 36 Netherlands market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 37 Belgium market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 38 Switzerland market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 39 Russia market estimates and forecast, 2016 - 2028 (USD Million)
Fig. 40 Sweden market estimates and forecast, 2016 - 2028 (USD Million)

Companies Mentioned

  • SGS SA
  • Toxikon Inc.
  • Eurofins Scientific
  • Pace Analytical Services, Inc.
  • WuXiAppTec, Inc.
  • North American Science Associates, Inc.
  • TÜV SÜD A.G.
  • American Preclinical Services
  • Sterigenics International LLC
  • Charles River Laboratories International, Inc.
  • Nelson Labs

Methodology

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