Market Overview:

The global medical device testing market grew at a CAGR of around 6% during 2015-2020. 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. Looking forward, IMARC Group expects the global medical device testing market to exhibit moderate growth during the next five years.

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 for growth at the global, regional and country level from 2021-2026. Our report has categorized the market based on region, service, type, testing type, device class and device type.

Breakup by Service:

• Testing Services
• Inspection Services
• Others
   

Breakup by Type:

• In-House
• Outsourced
   

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 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, TÜV Rheinland Aktiengesellschaft, TÜV SÜD 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?

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 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   TÜV Rheinland Aktiengesellschaft
            16.3.11.1 Company Overview
            16.3.11.2 Product Portfolio
            16.3.11.3 Financials
        16.3.12   TÜV SÜD 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

List of Figures

Figure 1: Global: Medical Device Testing Market: Major Drivers and Challenges
Figure 2: Global: Medical Device Testing Market: Sales Value (in Billion US$), 2015-2020
Figure 3: Global: Medical Device Testing Market Forecast: Sales Value (in Billion US$), 2021-2026
Figure 4: Global: Medical Device Testing Market: Breakup by Service (in %), 2020
Figure 5: Global: Medical Device Testing Market: Breakup by Type (in %), 2020
Figure 6: Global: Medical Device Testing Market: Breakup by Testing Type (in %), 2020
Figure 7: Global: Medical Device Testing Market: Breakup by Device Class (in %), 2020
Figure 8: Global: Medical Device Testing Market: Breakup by Device Type (in %), 2020
Figure 9: Global: Medical Device Testing Market: Breakup by Region (in %), 2020
Figure 10: Global: Medical Device Testing (Testing Services) Market: Sales Value (in Million US$), 2015 & 2020
Figure 11: Global: Medical Device Testing (Testing Services) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 12: Global: Medical Device Testing (Inspection Services) Market: Sales Value (in Million US$), 2015 & 2020
Figure 13: Global: Medical Device Testing (Inspection Services) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 14: Global: Medical Device Testing (Others) Market: Sales Value (in Million US$), 2015 & 2020
Figure 15: Global: Medical Device Testing (Others) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 16: Global: Medical Device Testing (In-House) Market: Sales Value (in Million US$), 2015 & 2020
Figure 17: Global: Medical Device Testing (In-House) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 18: Global: Medical Device Testing (Outsourced) Market: Sales Value (in Million US$), 2015 & 2020
Figure 19: Global: Medical Device Testing (Outsourced) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 20: Global: Medical Device Testing (Biocompatibility Testing) Market: Sales Value (in Million US$), 2015 & 2020
Figure 21: Global: Medical Device Testing (Biocompatibility Testing) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 22: Global: Medical Device Testing (Chemistry Testing) Market: Sales Value (in Million US$), 2015 & 2020
Figure 23: Global: Medical Device Testing (Chemistry Testing) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 24: Global: Medical Device Testing (Bio-Burden Determination) Market: Sales Value (in Million US$), 2015 & 2020
Figure 25: Global: Medical Device Testing (Bio-Burden Determination) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 26: Global: Medical Device Testing (Anti-Microbial Activity and Sterility Testing) Market: Sales Value (in Million US$), 2015 & 2020
Figure 27: Global: Medical Device Testing (Anti-Microbial Activity and Sterility Testing) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 28: Global: Medical Device Testing (Others) Market: Sales Value (in Million US$), 2015 & 2020
Figure 29: Global: Medical Device Testing (Others) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 30: Global: Medical Device Testing (Class I) Market: Sales Value (in Million US$), 2015 & 2020
Figure 31: Global: Medical Device Testing (Class I) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 32: Global: Medical Device Testing (Class II) Market: Sales Value (in Million US$), 2015 & 2020
Figure 33: Global: Medical Device Testing (Class II) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 34: Global: Medical Device Testing (Class III) Market: Sales Value (in Million US$), 2015 & 2020
Figure 35: Global: Medical Device Testing (Class III) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 36: Global: Medical Device Testing (Implantable Medical Devices) Market: Sales Value (in Million US$), 2015 & 2020
Figure 37: Global: Medical Device Testing (Implantable Medical Devices) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 38: Global: Medical Device Testing (Non-Active Medical Devices) Market: Sales Value (in Million US$), 2015 & 2020
Figure 39: Global: Medical Device Testing (Non-Active Medical Devices) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 40: Global: Medical Device Testing (In-Vitro Diagnostic Medical Devices) Market: Sales Value (in Million US$), 2015 & 2020
Figure 41: Global: Medical Device Testing (In-Vitro Diagnostic Medical Devices) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 42: Global: Medical Device Testing (Ophthalmic Medical Devices) Market: Sales Value (in Million US$), 2015 & 2020
Figure 43: Global: Medical Device Testing (Ophthalmic Medical Devices) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 44: Global: Medical Device Testing (Others) Market: Sales Value (in Million US$), 2015 & 2020
Figure 45: Global: Medical Device Testing (Others) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 46: North America: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 47: North America: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 48: North America: Medical Device Testing Market: Breakup by Country (in %), 2020
Figure 49: United States: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 50: United States: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 51: Canada: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 52: Canada: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 53: Asia-Pacific: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 54: Asia-Pacific: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 55: Asia-Pacific: Medical Device Testing Market: Breakup by Country (in %), 2020
Figure 56: China: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 57: China: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 58: Japan: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 59: Japan: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 60: India: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 61: India: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 62: South Korea: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 63: South Korea: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 64: Australia: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 65: Australia: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 66: Indonesia: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 67: Indonesia: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 68: Others: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 69: Others: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 70: Europe: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 71: Europe: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 72: Europe: Medical Device Testing Market: Breakup by Country (in %), 2020
Figure 73: Germany: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 74: Germany: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 75: France: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 76: France: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 77: United Kingdom: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 78: United Kingdom: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 79: Italy: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 80: Italy: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 81: Spain: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 82: Spain: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 83: Russia: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 84: Russia: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 85: Others: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 86: Others: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 87: Latin America: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 88: Latin America: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 89: Latin America: Medical Device Testing Market: Breakup by Country (in %), 2020
Figure 90: Brazil: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 91: Brazil: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 92: Mexico: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 93: Mexico: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 94: Others: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 95: Others: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 96: Middle East and Africa: Medical Device Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 97: Middle East and Africa: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 98: Middle East and Africa: Medical Device Testing Market: Breakup by Country (in %), 2020
Figure 99: Global: Medical Device Testing Industry: SWOT Analysis
Figure 100: Global: Medical Device Testing Industry: Value Chain Analysis
Figure 101: Global: Medical Device Testing Industry: Porter's Five Forces Analysis

List of Tables

Table 1: Global: Medical Device Testing Market: Key Industry Highlights, 2020 and 2026
Table 2: Global: Medical Device Testing Market Forecast: Breakup by Service (in Million US$), 2021-2026
Table 3: Global: Medical Device Testing Market Forecast: Breakup by Type (in Million US$), 2021-2026
Table 4: Global: Medical Device Testing Market Forecast: Breakup by Testing Type (in Million US$), 2021-2026
Table 5: Global: Medical Device Testing Market Forecast: Breakup by Device Class (in Million US$), 2021-2026
Table 6: Global: Medical Device Testing Market Forecast: Breakup by Device Type (in Million US$), 2021-2026
Table 7: Global: Medical Device Testing Market Forecast: Breakup by Region (in Million US$), 2021-2026
Table 8: Global: Medical Device Testing Market: Competitive Structure
Table 9: Global: Medical Device Testing Market: Key Players