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Medical Device Testing Market by Service Type (Certification Services, Inspection Services, Testing Services), Test Type (Chemical, Physical, & Biocompatibility Testing, Cybersecurity Testing, Electrical Safety), Device Class, Phase, Device Type, Sourcing

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from $4,949 182 Pages 360iResearch June, 2024 IRE18856088
Best Price Guarantee
Price from $4,949
Length 182 Pages
Publisher 360iResearch
Published Date June, 2024
SKU IRE18856088

Medical Device Testing Market by Service Type (Certification Services, Inspection Services, Testing Services), Test Type (Chemical, Physical, & Biocompatibility Testing, Cybersecurity Testing, Electrical Safety), Device Class, Phase, Device Type, Sourcing Type, End-Users - Global Forecast 2024-2030


The Medical Device Testing Market size was estimated at USD 10.83 billion in 2023 and expected to reach USD 11.67 billion in 2024, at a CAGR 7.85% to reach USD 18.40 billion by 2030.

Medical device testing is the systematic, regulated process of assessing and validating medical devices' safety, reliability, and performance. This extensive process ensures that the device performs as intended and safeguards users, including healthcare professionals and patients, from potential device-related harm. This process often involves a series of rigorous tests adhering to international and national standards and regulations, including those established by organizations such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Innovations in medical device technologies, stringent regulatory compliances, and increasing awareness about patient safety primarily shape market growth. However, the medical device testing market faces challenges owing to high testing costs acting as a significant barrier for new entrants, and the lengthy approval process for new medical devices may hinder market growth. In addition, the increasing adoption of wearable medical devices, growth in home and remote patient care, and the rising application of AI, IoT, and other innovative technologies in the medical field offer tremendous opportunities for the medical device testing market.

Regional Insights

In the Americas, the medical device testing market has exhibited resilience and growth in recent years, attributed to the region's stringent regulatory standards promulgated by the Food and Drug Administration (FDA) and the increasing need for high-quality medical devices. The healthcare sector has been poised for innovation fueled by critical factors such as the increasing aging population and the prevailing chronic diseases, including diabetes and cardiovascular disorders. The EMEA region presents an encouraging growth for the medical device testing market. The European market, driven by technological advancements, increased research funding, and high healthcare expenditure, has contributed heavily to medical device testing in the EMEA region. The Middle East and African regions have comparatively less market share but provide substantial growth potential owing to rapidly developing healthcare infrastructure and increasing healthcare spending.

Meanwhile, the APAC region encapsulates a vast diversity from mature markets, including Japan and Australia, to emerging ones, such as China and India. The increasing healthcare spending, aging population, and surge in health consciousness in the region fuel this growth. In addition, government policies' encouragement of local manufacturing is potentially stimulating market growth.

Market Insights
  • Market Dynamics

    The market dynamics represent an ever-changing landscape of the Medical Device Testing Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.
    • Market Drivers
      • Increasing requirements for new medical devices to undergo rigorous regulatory standards
      • Government initiatives to establish and strengthen medical device manufacturing and testing facilities
      • Increasing trend of outsourcing medical device testing services
      • Market Restraints
        • Extended lead time and costs associated with qualification tests
        • Market Opportunities
          • Emerging potential for cybersecurity testing with the advent of smart medical devices
          • Ongoing introduction of new medical device testing services and facilities
          • Market Challenges
            • Complexities associated with medical device testing
            • Market Segmentation Analysis
              • Service Type: Growing requirement for inspection services driven by the ever-growing complexity and diversity of medical technologies
              • Test Type: Emerging applications of cybersecurity testing with advent of advanced technologies in medical devices
              • Device Class: Requirement of rigorous PMA processes for class III devices to ensure safety and effectiveness before reaching the market
              • Technology: Escalating adoption of medical device testing services for mobile devices
              • Phase: Significant penetration of medical devices testing in the clinical phase
              • Sourcing Type: Higher preferences for in-house testing for highly proprietary or sensitive devices
              • End-Users: Proliferating need from medical device manufacturers
              • Market Disruption Analysis
              • Porter’s Five Forces Analysis
              • Value Chain & Critical Path Analysis
              • Pricing Analysis
              • Technology Analysis
              • Patent Analysis
              • Trade Analysis
              • Regulatory Framework Analysis
              FPNV Positioning Matrix

              The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Medical Device Testing Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

              Market Share Analysis

              The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Medical Device Testing Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

              Recent Developments
              • UL Solutions Rolls Out Medical Device Testing in Michigan, Helping the Industry Advance Safety of Healthcare Technology

                UL Solutions is expanding its services to Michigan by launching new medical device testing services at its laboratory in Rochester Hills, Michigan. With this service, UL Solutions aims to contribute to advancing safety in the medical device industry. The company is committed to delivering accurate and reliable testing results, helping companies meet regulatory requirements, and ensuring the well-being of patients.

                Element Materials Technology Announces USD 8 Million Expansion in Cincinnati

                Element Materials Technology has announced an expansion of USD 8 million in Cincinnati to enhance its medical device testing services. This development encompasses the addition of laboratory and office space and the integration of the latest testing technology and equipment. Moreover, this expansion is expected to create 30 new jobs, with a specific emphasis on hiring highly experienced personnel possessing strong technical backgrounds.

                Element Materials Technology Expands Connected Technology Testing Capabilities with Acquisition of CTK

                Element Materials Technology (EMT) has acquired CTK, which allows them to enhance their connected technology testing capabilities. With CTK's labs in the US and Australia, EMT can now offer testing services for medical devices. This acquisition significantly expands EMT's testing capabilities, enabling them to provide a comprehensive range of services to medical device manufacturers.
              Strategy Analysis & Recommendation

              The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Medical Device Testing Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

              Key Company Profiles

              The report delves into recent significant developments in the Medical Device Testing Market, highlighting leading vendors and their innovative profiles. These include 5D Health Protection Group Ltd., Alliance Technologies, LLC, Almac Group Limited, AMETEK, Inc., Applied Technical Services, LLC, Bioneeds India Pvt. Ltd., Boston Analytical, Bureau Veritas S.A., Cetecom Advanced GmbH, Charles River Laboratories, Inc., Clark Testing, DDL, Inc., DEKRA SE, Device Conformity and Testing, LLC, Element Materials Technology, Eurofins Scientific SE, ImpactQA, Innovatech Labs, LLC, Intertek Group PLC, iuvo BioScience, LLC, Laboratory Corporation of America Holdings, Maven Profcon Services LLP, Measur Oy, MED Institute Inc., Medical Engineering Technologies, Nemko Group, North American Science Associates, LLC, Pace Analytical Services, LLC, Q Laboratories, Inc., Qualitest Group, Qualizeal India LLP, Sanbor Medical Corporation, ScienceSoft Corporation, SGS S.A., STEMart, Sterigenics U.S., LLC by Sotera Health company, STERIS PLC, TA Instruments by Waters Corporation, Tentamus Group GmbH, Test Labs Ltd., The British Standards Institution, The Smithers Group Inc., TÜV SÜD AG, UL LLC, and WESTPAK, Inc..

              Market Segmentation & Coverage

              This research report categorizes the Medical Device Testing Market to forecast the revenues and analyze trends in each of the following sub-markets:
              • Service Type
                • Certification Services
                • Inspection Services
                • Testing Services
                • Test Type
                  • Chemical, Physical, & Biocompatibility Testing
                  • Cybersecurity Testing
                  • Electrical Safety
                  • Environmental Testing
                  • Mechanical Testing
                  • Device Class
                    • Class I
                    • Class II
                    • Class III
                    • Phase
                      • Clinical
                      • Preclinical
                      • Device Type
                        • Active Implant Medical Device
                        • Active Medical Device
                        • In-Vitro Diagnostic Medical Device
                        • Mobile Medical Devices
                        • Non-Active Medical Device
                        • Ophthalmic Medical Device
                        • Orthopedic & Dental Medical Device
                        • Vascular Medical Device
                        • Sourcing Type
                          • In-House
                          • Outsourced
                          • End-Users
                            • Contract Manufacturing Organization
                            • Medical Device Manufacturers
                            • Research Institutions
                            • Region
                              • Americas
                                • Argentina
                                • Brazil
                                • Canada
                                • Mexico
                                • United States
                                  • California
                                  • Florida
                                  • Illinois
                                  • New York
                                  • Ohio
                                  • Pennsylvania
                                  • Texas
                                  • Asia-Pacific
                                    • Australia
                                    • China
                                    • India
                                    • Indonesia
                                    • Japan
                                    • Malaysia
                                    • Philippines
                                    • Singapore
                                    • South Korea
                                    • Taiwan
                                    • Thailand
                                    • Vietnam
                                    • Europe, Middle East & Africa
                                      • Denmark
                                      • Egypt
                                      • Finland
                                      • France
                                      • Germany
                                      • Israel
                                      • Italy
                                      • Netherlands
                                      • Nigeria
                                      • Norway
                                      • Poland
                                      • Qatar
                                      • Russia
                                      • Saudi Arabia
                                      • South Africa
                                      • Spain
                                      • Sweden
                                      • Switzerland
                                      • Turkey
                                      • United Arab Emirates
                                      • United Kingdom


                                      Please Note: PDF & Excel + Online Access - 1 Year


1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Market Dynamics
5.1.1. Drivers
5.1.1.1. Increasing requirements for new medical devices to undergo rigorous regulatory standards
5.1.1.2. Government initiatives to establish and strengthen medical device manufacturing and testing facilities
5.1.1.3. Increasing trend of outsourcing medical device testing services
5.1.2. Restraints
5.1.2.1. Extended lead time and costs associated with qualification tests
5.1.3. Opportunities
5.1.3.1. Emerging potential for cybersecurity testing with the advent of smart medical devices
5.1.3.2. Ongoing introduction of new medical device testing services and facilities
5.1.4. Challenges
5.1.4.1. Complexities associated with medical device testing
5.2. Market Segmentation Analysis
5.2.1. Service Type: Growing requirement for inspection services driven by the ever-growing complexity and diversity of medical technologies
5.2.2. Test Type: Emerging applications of cybersecurity testing with advent of advanced technologies in medical devices
5.2.3. Device Class: Requirement of rigorous PMA processes for class III devices to ensure safety and effectiveness before reaching the market
5.2.4. Technology: Escalating adoption of medical device testing services for mobile devices
5.2.5. Phase: Significant penetration of medical devices testing in the clinical phase
5.2.6. Sourcing Type: Higher preferences for in-house testing for highly proprietary or sensitive devices
5.2.7. End-Users: Proliferating need from medical device manufacturers
5.3. Market Trend Analysis
5.3.1. Innovations and developments in smart medical devices creating need for medical device testing services in the Americas
5.3.2. Substantial focus on domestic production and exports of medical devices raising the need for robust medical device testing services in the APAC region
5.3.3. Presence of well-established regulations governing medical devices elevating the need for medical device testing services in the EMEA region
5.4. Cumulative Impact of High Inflation
5.5. Porter’s Five Forces Analysis
5.5.1. Threat of New Entrants
5.5.2. Threat of Substitutes
5.5.3. Bargaining Power of Customers
5.5.4. Bargaining Power of Suppliers
5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis
6. Medical Device Testing Market, by Service Type
6.1. Introduction
6.2. Certification Services
6.3. Inspection Services
6.4. Testing Services
7. Medical Device Testing Market, by Test Type
7.1. Introduction
7.2. Chemical, Physical, & Biocompatibility Testing
7.3. Cybersecurity Testing
7.4. Electrical Safety
7.5. Environmental Testing
7.6. Mechanical Testing
8. Medical Device Testing Market, by Device Class
8.1. Introduction
8.2. Class I
8.3. Class II
8.4. Class III
9. Medical Device Testing Market, by Phase
9.1. Introduction
9.2. Clinical
9.3. Preclinical
10. Medical Device Testing Market, by Device Type
10.1. Introduction
10.2. Active Implant Medical Device
10.3. Active Medical Device
10.4. In-Vitro Diagnostic Medical Device
10.5. Mobile Medical Devices
10.6. Non-Active Medical Device
10.7. Ophthalmic Medical Device
10.8. Orthopedic & Dental Medical Device
10.9. Vascular Medical Device
11. Medical Device Testing Market, by Sourcing Type
11.1. Introduction
11.2. In-House
11.3. Outsourced
12. Medical Device Testing Market, by End-Users
12.1. Introduction
12.2. Contract Manufacturing Organization
12.3. Medical Device Manufacturers
12.4. Research Institutions
13. Americas Medical Device Testing Market
13.1. Introduction
13.2. Argentina
13.3. Brazil
13.4. Canada
13.5. Mexico
13.6. United States
14. Asia-Pacific Medical Device Testing Market
14.1. Introduction
14.2. Australia
14.3. China
14.4. India
14.5. Indonesia
14.6. Japan
14.7. Malaysia
14.8. Philippines
14.9. Singapore
14.10. South Korea
14.11. Taiwan
14.12. Thailand
14.13. Vietnam
15. Europe, Middle East & Africa Medical Device Testing Market
15.1. Introduction
15.2. Denmark
15.3. Egypt
15.4. Finland
15.5. France
15.6. Germany
15.7. Israel
15.8. Italy
15.9. Netherlands
15.10. Nigeria
15.11. Norway
15.12. Poland
15.13. Qatar
15.14. Russia
15.15. Saudi Arabia
15.16. South Africa
15.17. Spain
15.18. Sweden
15.19. Switzerland
15.20. Turkey
15.21. United Arab Emirates
15.22. United Kingdom
16. Competitive Landscape
16.1. Market Share Analysis, 2023
16.2. FPNV Positioning Matrix, 2023
16.3. Competitive Scenario Analysis
16.3.1. UL Solutions Rolls Out Medical Device Testing in Michigan, Helping the Industry Advance Safety of Healthcare Technology
16.3.2. Element Materials Technology Announces USD 8 Million Expansion in Cincinnati
16.3.3. Element Materials Technology Expands Connected Technology Testing Capabilities with Acquisition of CTK
16.3.4. New Microbiology and Chemistry Laboratory Opens to Accelerate Scientific Discovery
16.3.5. Industries and IT Minister Launches Three Made-In-Telangana Medical Devices
16.3.6. MedCrypt and Stratigos Security Partner to Offer Specialized Penetration Testing and Security Assessments for Life-Saving Medical Devices
16.3.7. New Alliance Enables Medical Device OEMs With End-To-End AM Solution
16.3.8. Molbio Diagnostics Partners with SigTuple To Build Next-Gen Point-Of-Care Diagnostic Testing Devices
16.3.9. Grand Opening of New Bioanalytical Laboratory in Pudong, China
16.3.10. DDL and Gateway Analytical Announce Joint Agreement
16.3.11. Element Materials Technology Acquires National Technical Systems
16.3.12. Clinimark Acquired by Element Materials Technology
17. Competitive Portfolio
17.1. Key Company Profiles
17.2. Key Product Portfolio

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