Product Code: SR1323A86_Report
The global medical device testing market size reached US$ 11.8 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 17.5 Billion by 2028, exhibiting a growth rate (CAGR) of 6.6% during 2023-2028.
Medical device testing refers to the process of inspecting the design and production efficiency of various active and non-active medical equipment. It involves prototype, biocompatibility, chemistry, microbiology and sterility testing, package validation, electrical, mechanical and functional safety assessments and software testing. These tests are conducted for cardiovascular, neuro and orthopedic devices, dental implants and material components. The service providers also offer in-house or outsourced testing, inspection and certification services to the consumers. These services ensure that the device is reliable and safe to use in clinical or emergency settings. As a result, medical device testing finds extensive applications across hospitals, clinics and other healthcare and diagnostic centers.
Significant growth in the medical industry, along with the increasing requirement of validation and verification of medical devices, represents one of the key factors creating a positive outlook for the market. Moreover, as the coronavirus disease (COVID-19) continues to spread across the globe, there has been a significant increase in the demand for efficient testing systems to develop low-cost medical devices which is further augmenting the market growth. Additionally, various technological advancements, such as the utilization of artificial intelligence (AI), robotics and automation in the testing processes, are acting as other major growth-inducing factors. Device manufacturers use automated quality assurance tools to increase the accuracy of clinical equipment and wearable medical devices with minimal human intervention in the testing processes. Other factors, such as increasing complexities in product design, along with the widespread adoption of outsourced testing services, are anticipated to drive the market further.
Key Market Segmentation:
- IMARC Group provides an analysis of the key trends in each sub-segment of the global medical device testing market report, along with forecasts at the global, regional and country level from 2023-2028. Our report has categorized the market based on service, type, testing type, device class and device type.
Breakup by Service:
- Testing Services
- Inspection Services
- Others
Breakup by Type:
Breakup by Testing Type:
- Biocompatibility Testing
- Chemistry Testing
- Bio-Burden Determination
- Anti-Microbial Activity and Sterility Testing
- Others
Breakup by Device Class:
- Class I
- Class II
- Class III
Breakup by Device Type:
- Implantable Medical Devices
- Non-Active Medical Devices
- In-Vitro Diagnostic Medical Devices
- Ophthalmic Medical Devices
- Others
Breakup by Region:
- North America
- United States
- Canada
- Asia-Pacific
- China
- Japan
- India
- South Korea
- Australia
- Indonesia
- Others
- Europe
- Germany
- France
- United Kingdom
- Italy
- Spain
- Russia
- Others
- Latin America
- Brazil
- Mexico
- Others
- Middle East and Africa
Competitive Landscape:
- The competitive landscape of the industry has also been examined along with the profiles of the key players being American Preclinical Services LLC, Charles River Laboratories International Inc., Element Materials Technology, Eurofins Scientific LLC, Intertek Group Plc, North American Science Associates Inc., Pace Analytical Services LLC (LAB Holdings Inc.), SGS SA, Sterigenics U.S. LLC (Sotera Health LLC), Toxikon Corporation, TUV Rheinland Aktiengesellschaft, TUV SUD Aktiengesellschaft and WuXi AppTec.
Key Questions Answered in This Report:
- How has the global medical device testing market performed so far and how will it perform in the coming years?
- What has been the impact of COVID-19 on the global medical device testing market?
- What are the key regional markets?
- What is the breakup of the market based on the service?
- What is the breakup of the market based on the type?
- What is the breakup of the market based on the testing type?
- What is the breakup of the market based on the device class?
- What is the breakup of the market based on the device type?
- What are the various stages in the value chain of the industry?
- What are the key driving factors and challenges in the industry?
- What is the structure of the global medical device testing market and who are the key players?
- What is the degree of competition in the industry?
Table of Contents
1 Preface
2 Scope and Methodology
- 2.1 Objectives of the Study
- 2.2 Stakeholders
- 2.3 Data Sources
- 2.3.1 Primary Sources
- 2.3.2 Secondary Sources
- 2.4 Market Estimation
- 2.4.1 Bottom-Up Approach
- 2.4.2 Top-Down Approach
- 2.5 Forecasting Methodology
3 Executive Summary
4 Introduction
- 4.1 Overview
- 4.2 Key Industry Trends
5 Global Medical Device Testing Market
- 5.1 Market Overview
- 5.2 Market Performance
- 5.3 Impact of COVID-19
- 5.4 Market Forecast
6 Market Breakup by Service
- 6.1 Testing Services
- 6.1.1 Market Trends
- 6.1.2 Market Forecast
- 6.2 Inspection Services
- 6.2.1 Market Trends
- 6.2.2 Market Forecast
- 6.3 Others
- 6.3.1 Market Trends
- 6.3.2 Market Forecast
7 Market Breakup by Type
- 7.1 In-House
- 7.1.1 Market Trends
- 7.1.2 Market Forecast
- 7.2 Outsourced
- 7.2.1 Market Trends
- 7.2.2 Market Forecast
8 Market Breakup by Testing Type
- 8.1 Biocompatibility Testing
- 8.1.1 Market Trends
- 8.1.2 Market Forecast
- 8.2 Chemistry Testing
- 8.2.1 Market Trends
- 8.2.2 Market Forecast
- 8.3 Bio-Burden Determination
- 8.3.1 Market Trends
- 8.3.2 Market Forecast
- 8.4 Anti-Microbial Activity and Sterility Testing
- 8.4.1 Market Trends
- 8.4.2 Market Forecast
- 8.5 Others
- 8.5.1 Market Trends
- 8.5.2 Market Forecast
9 Market Breakup by Device Class
- 9.1 Class I
- 9.1.1 Market Trends
- 9.1.2 Market Forecast
- 9.2 Class II
- 9.2.1 Market Trends
- 9.2.2 Market Forecast
- 9.3 Class III
- 9.3.1 Market Trends
- 9.3.2 Market Forecast
10 Market Breakup by Device Type
- 10.1 Implantable Medical Devices
- 10.1.1 Market Trends
- 10.1.2 Market Forecast
- 10.2 Non-Active Medical Devices
- 10.2.1 Market Trends
- 10.2.2 Market Forecast
- 10.3 In-Vitro Diagnostic Medical Devices
- 10.3.1 Market Trends
- 10.3.2 Market Forecast
- 10.4 Ophthalmic Medical Devices
- 10.4.1 Market Trends
- 10.4.2 Market Forecast
- 10.5 Others
- 10.5.1 Market Trends
- 10.5.2 Market Forecast
11 Market Breakup by Region
- 11.1 North America
- 11.1.1 United States
- 11.1.1.1 Market Trends
- 11.1.1.2 Market Forecast
- 11.1.2 Canada
- 11.1.2.1 Market Trends
- 11.1.2.2 Market Forecast
- 11.2 Asia-Pacific
- 11.2.1 China
- 11.2.1.1 Market Trends
- 11.2.1.2 Market Forecast
- 11.2.2 Japan
- 11.2.2.1 Market Trends
- 11.2.2.2 Market Forecast
- 11.2.3 India
- 11.2.3.1 Market Trends
- 11.2.3.2 Market Forecast
- 11.2.4 South Korea
- 11.2.4.1 Market Trends
- 11.2.4.2 Market Forecast
- 11.2.5 Australia
- 11.2.5.1 Market Trends
- 11.2.5.2 Market Forecast
- 11.2.6 Indonesia
- 11.2.6.1 Market Trends
- 11.2.6.2 Market Forecast
- 11.2.7 Others
- 11.2.7.1 Market Trends
- 11.2.7.2 Market Forecast
- 11.3 Europe
- 11.3.1 Germany
- 11.3.1.1 Market Trends
- 11.3.1.2 Market Forecast
- 11.3.2 France
- 11.3.2.1 Market Trends
- 11.3.2.2 Market Forecast
- 11.3.3 United Kingdom
- 11.3.3.1 Market Trends
- 11.3.3.2 Market Forecast
- 11.3.4 Italy
- 11.3.4.1 Market Trends
- 11.3.4.2 Market Forecast
- 11.3.5 Spain
- 11.3.5.1 Market Trends
- 11.3.5.2 Market Forecast
- 11.3.6 Russia
- 11.3.6.1 Market Trends
- 11.3.6.2 Market Forecast
- 11.3.7 Others
- 11.3.7.1 Market Trends
- 11.3.7.2 Market Forecast
- 11.4 Latin America
- 11.4.1 Brazil
- 11.4.1.1 Market Trends
- 11.4.1.2 Market Forecast
- 11.4.2 Mexico
- 11.4.2.1 Market Trends
- 11.4.2.2 Market Forecast
- 11.4.3 Others
- 11.4.3.1 Market Trends
- 11.4.3.2 Market Forecast
- 11.5 Middle East and Africa
- 11.5.1 Market Trends
- 11.5.2 Market Breakup by Country
- 11.5.3 Market Forecast
12 SWOT Analysis
- 12.1 Overview
- 12.2 Strengths
- 12.3 Weaknesses
- 12.4 Opportunities
- 12.5 Threats
13 Value Chain Analysis
14 Porters Five Forces Analysis
- 14.1 Overview
- 14.2 Bargaining Power of Buyers
- 14.3 Bargaining Power of Suppliers
- 14.4 Degree of Competition
- 14.5 Threat of New Entrants
- 14.6 Threat of Substitutes
15 Price Analysis
16 Competitive Landscape
- 16.1 Market Structure
- 16.2 Key Players
- 16.3 Profiles of Key Players
- 16.3.1 American Preclinical Services LLC
- 16.3.1.1 Company Overview
- 16.3.1.2 Product Portfolio
- 16.3.2 Charles River Laboratories International Inc.
- 16.3.2.1 Company Overview
- 16.3.2.2 Product Portfolio
- 16.3.2.3 Financials
- 16.3.2.4 SWOT Analysis
- 16.3.3 Element Materials Technology
- 16.3.3.1 Company Overview
- 16.3.3.2 Product Portfolio
- 16.3.3.3 Financials
- 16.3.4 Eurofins Scientific LLC
- 16.3.4.1 Company Overview
- 16.3.4.2 Product Portfolio
- 16.3.5 Intertek Group Plc
- 16.3.5.1 Company Overview
- 16.3.5.2 Product Portfolio
- 16.3.5.3 Financials
- 16.3.5.4 SWOT Analysis
- 16.3.6 North American Science Associates Inc.
- 16.3.6.1 Company Overview
- 16.3.6.2 Product Portfolio
- 16.3.7 Pace Analytical Services LLC (LAB Holdings Inc.)
- 16.3.7.1 Company Overview
- 16.3.7.2 Product Portfolio
- 16.3.8 SGS SA
- 16.3.8.1 Company Overview
- 16.3.8.2 Product Portfolio
- 16.3.8.3 Financials
- 16.3.9 Sterigenics U.S. LLC (Sotera Health LLC)
- 16.3.9.1 Company Overview
- 16.3.9.2 Product Portfolio
- 16.3.10 Toxikon Corporation
- 16.3.10.1 Company Overview
- 16.3.10.2 Product Portfolio
- 16.3.11 TUV Rheinland Aktiengesellschaft
- 16.3.11.1 Company Overview
- 16.3.11.2 Product Portfolio
- 16.3.11.3 Financials
- 16.3.12 TUV SUD Aktiengesellschaft
- 16.3.12.1 Company Overview
- 16.3.12.2 Product Portfolio
- 16.3.12.3 Financials
- 16.3.13 WuXi AppTec
- 16.3.13.1 Company Overview
- 16.3.13.2 Product Portfolio
- 16.3.13.3 Financials