Medical Device Testing Market by Service Type, Test Type, Device Class, Phase, Device Type, Sourcing Type, End-Users

List of Tables

The Medical Device Testing Market is projected to reach USD 18.40 billion by 2030 from USD 10.07 billion in 2022, at a CAGR of 7.81% during the forecast period.

Global Medical Device Testing Market

KEY MARKET STATISTICS
Base Year [2022]	USD 10.07 billion
Estimated Year [2023]	USD 10.83 billion
Forecast Year [2030]	USD 18.40 billion
CAGR (%)	7.81%

Market Segmentation & Coverage:

This research report analyzes various sub-markets, forecasts revenues, and examines emerging trends in each category to provide a comprehensive outlook on the Medical Device Testing Market.

Based on Service Type, market is studied across Certification Services, Inspection Services, and Testing Services. The Testing Services commanded largest market share of 47.97% in 2022, followed by Certification Services.

Based on Test Type, market is studied across Chemical, Physical, & Biocompatibility Testing, Cybersecurity Testing, Electrical Safety, Environmental Testing, and Mechanical Testing. The Chemical, Physical, & Biocompatibility Testing commanded largest market share of 31.74% in 2022, followed by Electrical Safety.

Based on Device Class, market is studied across Class I, Class II, and Class III. The Class III commanded largest market share of 58.51% in 2022, followed by Class I.

Based on Phase, market is studied across Clinical and Preclinical. The Clinical commanded largest market share of 57.46% in 2022, followed by Preclinical.

Based on Device Type, market is studied across 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, and Vascular Medical Device. The Ophthalmic Medical Device commanded largest market share of 18.84% in 2022, followed by Non-Active Medical Device.

Based on Sourcing Type, market is studied across In-House and Outsourced. The Outsourced commanded largest market share of 52.34% in 2022, followed by In-House.

Based on End-Users, market is studied across Contract Manufacturing Organization, Medical Device Manufacturers, and Research Institutions. The Medical Device Manufacturers commanded largest market share of 46.34% in 2022, followed by Contract Manufacturing Organization.

Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom. The Americas commanded largest market share of 40.43% in 2022, followed by Europe, Middle East & Africa.

Market Statistics:

The report provides market sizing and forecasts across 7 major currencies - USD, EUR, JPY, GBP, AUD, CAD, and CHF; multiple currency support helps organization leaders to make well-informed decisions. In this report, 2018 to 2021 are considered as historical years, 2022 is base year, 2023 is estimated year, and years from 2024 to 2030 are considered as forecast period.

FPNV Positioning Matrix:

The FPNV Positioning Matrix is an indispensable tool for assessing the Medical Device Testing Market. It comprehensively evaluates vendors, analyzing key metrics related to Business Strategy and Product Satisfaction. This enables users to make informed decisions tailored to their specific needs. Through advanced analysis, vendors are categorized into four distinct quadrants, each representing a different level of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V). Be assured that this insightful framework empowers decision-makers to navigate the market with confidence.

Market Share Analysis:

The Market Share Analysis offers invaluable insights into the vendor landscape Medical Device Testing Market. By evaluating their impact on overall revenue, customer base, and other key metrics, we provide companies with a comprehensive understanding of their performance and the competitive environment they confront. This analysis also uncovers the level of competition in terms of market share acquisition, fragmentation, dominance, and industry consolidation during the study period.

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., TUV SUD AG, UL LLC, and WESTPAK, Inc..

The report offers valuable insights on the following aspects:

1. Market Penetration: It provides comprehensive information about key players' market dynamics and offerings.

2. Market Development: In-depth analysis of emerging markets and penetration across mature market segments, highlighting lucrative opportunities.

3. Market Diversification: Detailed information about new product launches, untapped geographies, recent developments, and investments.

4. Competitive Assessment & Intelligence: Exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of leading players.

5. Product Development & Innovation: Intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast for the Medical Device Testing Market?

2. Which products, segments, applications, and areas hold the highest investment potential in the Medical Device Testing Market?

3. What is the competitive strategic window for identifying opportunities in the Medical Device Testing Market?

4. What are the latest technology trends and regulatory frameworks in the Medical Device Testing Market?

5. What is the market share of the leading vendors in the Medical Device Testing Market?

6. Which modes and strategic moves are suitable for entering the Medical Device Testing Market?

Product Code: MRR-6611A511165C

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. Limitations
1.7. Assumptions
1.8. 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

4.1. Introduction
4.2. Medical Device Testing Market, by Region

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

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. FPNV Positioning Matrix
16.2. Market Share Analysis, By Key Player
16.3. Competitive Scenario Analysis, By Key Player
- 16.3.1. Merger & Acquisition
  - 16.3.1.1. Element Materials Technology Expands Connected Technology Testing Capabilities with Acquisition of CTK
  - 16.3.1.2. Element Materials Technology Acquires National Technical Systems
  - 16.3.1.3. Clinimark Acquired by Element Materials Technology
- 16.3.2. Agreement, Collaboration, & Partnership
  - 16.3.2.1. MedCrypt and Stratigos Security Partner to Offer Specialized Penetration Testing and Security Assessments for Life-Saving Medical Devices
  - 16.3.2.2. New Alliance Enables Medical Device OEMs With End-To-End AM Solution
  - 16.3.2.3. Molbio Diagnostics Partners with SigTuple To Build Next-Gen Point-Of-Care Diagnostic Testing Devices
  - 16.3.2.4. DDL and Gateway Analytical Announce Joint Agreement
- 16.3.3. New Product Launch & Enhancement
  - 16.3.3.1. UL Solutions Rolls Out Medical Device Testing in Michigan, Helping the Industry Advance Safety of Healthcare Technology
  - 16.3.3.2. Industries and IT Minister Launches Three Made-In-Telangana Medical Devices
- 16.3.4. Award, Recognition, & Expansion
  - 16.3.4.1. Element Materials Technology Announces USD 8 Million Expansion in Cincinnati
  - 16.3.4.2. New Microbiology and Chemistry Laboratory Opens to Accelerate Scientific Discovery
  - 16.3.4.3. Grand Opening of New Bioanalytical Laboratory in Pudong, China

17. Competitive Portfolio

17.1. Key Company Profiles
- 17.1.1. 5D Health Protection Group Ltd.
- 17.1.2. Alliance Technologies, LLC
- 17.1.3. Almac Group Limited
- 17.1.4. AMETEK, Inc.
- 17.1.5. Applied Technical Services, LLC
- 17.1.6. Bioneeds India Pvt. Ltd.
- 17.1.7. Boston Analytical
- 17.1.8. Bureau Veritas S.A.
- 17.1.9. Cetecom Advanced GmbH
- 17.1.10. Charles River Laboratories, Inc.
- 17.1.11. Clark Testing
- 17.1.12. DDL, Inc.
- 17.1.13. DEKRA SE
- 17.1.14. Device Conformity and Testing, LLC
- 17.1.15. Element Materials Technology
- 17.1.16. Eurofins Scientific SE
- 17.1.17. ImpactQA
- 17.1.18. Innovatech Labs, LLC
- 17.1.19. Intertek Group PLC
- 17.1.20. iuvo BioScience, LLC
- 17.1.21. Laboratory Corporation of America Holdings
- 17.1.22. Maven Profcon Services LLP
- 17.1.23. Measur Oy
- 17.1.24. MED Institute Inc.
- 17.1.25. Medical Engineering Technologies
- 17.1.26. Nemko Group
- 17.1.27. North American Science Associates, LLC
- 17.1.28. Pace Analytical Services, LLC
- 17.1.29. Q Laboratories, Inc.
- 17.1.30. Qualitest Group
- 17.1.31. Qualizeal India LLP
- 17.1.32. Sanbor Medical Corporation
- 17.1.33. ScienceSoft Corporation
- 17.1.34. SGS S.A.
- 17.1.35. STEMart
- 17.1.36. Sterigenics U.S., LLC by Sotera Health company
- 17.1.37. STERIS PLC
- 17.1.38. TA Instruments by Waters Corporation
- 17.1.39. Tentamus Group GmbH
- 17.1.40. Test Labs Ltd.
- 17.1.41. The British Standards Institution
- 17.1.42. The Smithers Group Inc.
- 17.1.43. TUV SUD AG
- 17.1.44. UL LLC
- 17.1.45. WESTPAK, Inc.
17.2. Key Product Portfolio

18. Appendix

18.1. Discussion Guide
18.2. License & Pricing