의료기기 검사 시장 : 서비스 유형별, 검사 유형별, 디바이스 클래스별, 단계별, 디바이스 유형별, 쏘싱 유형별, 최종사용자별 - 세계 예측(2025-2030년)

The Medical Device Testing Market was valued at USD 10.83 billion in 2023, expected to reach USD 11.67 billion in 2024, and is projected to grow at a CAGR of 7.85%, to USD 18.40 billion by 2030.

The medical device testing market plays a vital role in ensuring the safety and efficacy of medical devices, encompassing rigorous evaluation processes like performance testing, biocompatibility, and regulatory compliance verification. These evaluations are crucial not only for meeting stringent regulatory standards but also for safeguarding patient safety and enhancing device reliability. Rising incidences of chronic diseases, innovations in medical technology, and increased adoption of advanced diagnostic tools are key growth influencers, driving the demand for strict testing protocols. The rapid integration of IoT, AI, and machine learning in medical devices also necessitates comprehensive testing to ensure cybersecurity and data integrity. This emerging trend presents opportunities for businesses to expand their services to include digital health solutions, which could catalyze growth significantly. Moreover, personalized medicine and wearable medical technology offer potential avenues for market expansion, urging companies to innovate testing methodologies tailored for these new technologies. However, the market faces challenges such as high costs of advanced testing equipment and technical expertise, regulatory complexities across different regions, and lengthened approval processes that can impede swift product launches. To mitigate these constraints, fostering partnerships with technology developers and regulatory bodies can be invaluable. Areas ripe for research and innovation include developing faster, cost-effective testing methods utilizing cloud-based platforms and exploring blockchain systems for enhancing compliance traceability. To sustain growth, companies should focus on R&D investments to keep pace with technological advancements and cultivate agile testing frameworks that navigate the regulatory landscape effectively. The market is characterized by dynamic competition and constant evolution, necessitating adaptive strategies for businesses to maintain their competitive edge. Embracing emerging technologies and proactive regulatory alignment will be crucial for companies aspiring to capture burgeoning opportunities in the medical device testing landscape.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Medical Device Testing Market

The Medical Device Testing Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• 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

Porter's Five Forces: A Strategic Tool for Navigating the Medical Device Testing Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Medical Device Testing Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Medical Device Testing Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Medical Device Testing Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Medical Device Testing Market

A detailed market share analysis in the Medical Device Testing Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Medical Device Testing Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Medical Device Testing Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

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

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:

• Based on Service Type, market is studied across Certification Services, Inspection Services, and Testing Services.
• Based on Test Type, market is studied across Chemical, Physical, & Biocompatibility Testing, Cybersecurity Testing, Electrical Safety, Environmental Testing, and Mechanical Testing.
• Based on Device Class, market is studied across Class I, Class II, and Class III.
• Based on Phase, market is studied across Clinical and 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.
• Based on Sourcing Type, market is studied across In-House and Outsourced.
• Based on End-Users, market is studied across Contract Manufacturing Organization, Medical Device Manufacturers, and Research Institutions.
• 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 report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

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. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

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

Companies Mentioned

• 1. MED Institute Inc.
• 2. Test Labs Ltd.
• 3. Bioneeds India Pvt. Ltd.
• 4. Bureau Veritas S.A.
• 5. Boston Analytical
• 6. UL LLC
• 7. Sanbor Medical Corporation
• 8. STERIS PLC
• 9. Innovatech Labs, LLC
• 10. Laboratory Corporation of America Holdings
• 11. STEMart
• 12. TA Instruments by Waters Corporation
• 13. Maven Profcon Services LLP
• 14. 5D Health Protection Group Ltd.
• 15. Q Laboratories, Inc.
• 16. WESTPAK, Inc.
• 17. Sterigenics U.S., LLC by Sotera Health company
• 18. Qualitest Group
• 19. DEKRA SE
• 20. The British Standards Institution
• 21. ImpactQA
• 22. Clark Testing
• 23. TUV SUD AG
• 24. Qualizeal India LLP
• 25. Measur Oy
• 26. The Smithers Group Inc.
• 27. Tentamus Group GmbH
• 28. AMETEK, Inc.
• 29. North American Science Associates, LLC
• 30. Medical Engineering Technologies
• 31. iuvo BioScience, LLC
• 32. SGS S.A.
• 33. Applied Technical Services, LLC
• 34. Cetecom Advanced GmbH
• 35. DDL, Inc.
• 36. Pace Analytical Services, LLC
• 37. Nemko Group
• 38. Element Materials Technology
• 39. Device Conformity and Testing, LLC
• 40. Intertek Group PLC
• 41. ScienceSoft Corporation
• 42. Alliance Technologies, LLC
• 43. Eurofins Scientific SE
• 44. Charles River Laboratories, Inc.
• 45. Almac Group Limited