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Medical Device Validation and Verification - Global Strategic Business Report

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    Report

  • 92 Pages
  • November 2024
  • Region: Global
  • Global Industry Analysts, Inc
  • ID: 5303229
The global market for Medical Device Validation and Verification was estimated at US$869.9 Million in 2023 and is projected to reach US$1.8 Billion by 2030, growing at a CAGR of 10.6% from 2023 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions.

Global Medical Device Validation and Verification Market - Key Trends and Drivers Summarized

Why Is Medical Device Validation and Verification Critical?

Medical device validation and verification are critical processes that ensure medical devices meet regulatory standards and perform as intended before they are released to the market. Validation confirms that the device meets the needs of users under actual conditions, while verification ensures that the product complies with design specifications. These processes are essential in the development of medical devices to prevent malfunctions, ensure patient safety, and comply with regulatory requirements from agencies such as the FDA and the European Medicines Agency (EMA). Effective validation and verification processes are key to reducing product recalls, improving patient outcomes, and maintaining the reputation of medical device companies.

What Innovations Are Shaping the Medical Device Validation and Verification Market?

Innovations in simulation tools, automation, and data analytics are reshaping the medical device validation and verification market. Simulation software allows engineers to test the performance of devices in virtual environments before physical prototypes are produced, speeding up the development process and reducing costs. Automated testing systems are also improving efficiency by running multiple tests simultaneously and collecting real-time data for analysis. Furthermore, advanced data analytics tools are helping manufacturers identify potential issues early in the development process, enabling proactive adjustments to device design or production processes. These innovations are making the validation and verification process more thorough, faster, and cost-effective.

How Do Market Segments Define the Growth of Medical Device Validation and Verification?

Product types include diagnostic equipment, therapeutic devices, and implants, with diagnostic equipment accounting for the largest market share due to the stringent requirements for accuracy and reliability. Service types include in-house testing and outsourced services, with many companies opting for outsourcing to benefit from specialized expertise. Geographically, North America leads the market, driven by the strong regulatory framework and advanced healthcare infrastructure, while Europe and Asia-Pacific are also key markets due to their growing medical device industries.

What Factors Are Driving the Growth in the Medical Device Validation and Verification Market?

The growth in the medical device validation and verification market is driven by several factors, including increasing regulatory scrutiny, the growing complexity of medical devices, and the rising demand for reliable and safe medical equipment. As medical devices become more sophisticated, particularly with the integration of digital technologies, validation and verification processes must evolve to ensure compliance with global standards. Regulatory agencies are also implementing stricter guidelines, making thorough validation and verification essential to gaining market approval. Additionally, the increasing focus on patient safety and the rise in device recalls are prompting manufacturers to invest more in these critical processes, further driving market growth.

Key Insights:

  • Market Growth: Understand the significant growth trajectory of the Mechanical Testing Technology segment, which is expected to reach US$668.4 Million by 2030 with a CAGR of a 9.9%. The Biological Technology segment is also set to grow at 11.4% CAGR over the analysis period.
  • Regional Analysis: Gain insights into the U.S. market, which was estimated at $227.5 Million in 2023, and China, forecasted to grow at an impressive 13.8% CAGR to reach $401.0 Million by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Why You Should Buy This Report:

  • Detailed Market Analysis: Access a thorough analysis of the Global Medical Device Validation and Verification Market, covering all major geographic regions and market segments.
  • Competitive Insights: Get an overview of the competitive landscape, including the market presence of major players across different geographies.
  • Future Trends and Drivers: Understand the key trends and drivers shaping the future of the Global Medical Device Validation and Verification Market.
  • Actionable Insights: Benefit from actionable insights that can help you identify new revenue opportunities and make strategic business decisions.

Key Questions Answered:

  • How is the Global Medical Device Validation and Verification Market expected to evolve by 2030?
  • What are the main drivers and restraints affecting the market?
  • Which market segments will grow the most over the forecast period?
  • How will market shares for different regions and segments change by 2030?
  • Who are the leading players in the market, and what are their prospects?

Report Features:

  • Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2023 to 2030.
  • In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
  • Company Profiles: Coverage of major players in the Medical Device Validation and Verification market such as Charles River, Element Materials Technology, Eurofins Scientific SE, Global Services Pte., Ltd, Intertek and more.
  • Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Some of the 36 companies featured in this Medical Device Validation and Verification market report include:

  • Charles River
  • Element Materials Technology
  • Eurofins Scientific SE
  • Global Services Pte., Ltd
  • Intertek
  • NAMSA
  • Pacific Biolabs
  • QuEST
  • SGS SA
  • Steris Laboratories
  • Sterling Medical Devices
  • Toxikon Corporation
  • TÜV SÜD AG

Table of Contents

I. METHODOLOGYII. EXECUTIVE SUMMARY
1. MARKET OVERVIEW
  • Influencer Market Insights
  • World Market Trajectories
  • Global Economic Update
  • Medical Device Validation and Verification - Global Key Competitors Percentage Market Share in 2024 (E)
  • Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2024 (E)
2. FOCUS ON SELECT PLAYERS
3. MARKET TRENDS & DRIVERS
  • Technological Advancements in Testing and Simulation Tools Strengthen Business Case for Adoption
  • Growing Focus on Ensuring Safety and Efficacy of Medical Devices Expands Addressable Market
  • Expansion of Validation and Verification in Class III and High-Risk Medical Devices Fuels Market Growth
  • Increasing Adoption of Automated Testing and Digital Twin Technology Expands Market Opportunities
  • Technological Innovations in Software Validation and Cybersecurity Testing Propel Market Expansion
  • Rising Focus on Meeting ISO and FDA Standards for Device Approval Strengthens Demand for Validation Services
  • Growing Use of Validation and Verification in Wearable and Implantable Medical Devices Expands Market Potential
  • Focus on Reducing Time-to-Market and Enhancing Product Reliability Drives Demand for Validation Solutions
  • Rising Adoption of Risk-Based Testing and Validation for Complex Medical Devices Expands Addressable Market
  • Technological Advancements in Usability Testing and Human Factors Engineering Propel Market Growth
  • Increasing Focus on Post-Market Surveillance and Continuous Validation Drives Adoption of Validation Services
  • Rising Demand for Validation and Verification in Medical Software and Mobile Health Applications Expands Market Opportunities
4. GLOBAL MARKET PERSPECTIVE
  • Table 1: World Recent Past, Current & Future Analysis for Medical Device Validation and Verification by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 2: World Historic Review for Medical Device Validation and Verification by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 3: World 16-Year Perspective for Medical Device Validation and Verification by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets for Years 2014, 2024 & 2030
  • Table 4: World Recent Past, Current & Future Analysis for Mechanical Testing by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 5: World Historic Review for Mechanical Testing by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 6: World 16-Year Perspective for Mechanical Testing by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 7: World Recent Past, Current & Future Analysis for Biological by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 8: World Historic Review for Biological by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 9: World 16-Year Perspective for Biological by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 10: World Recent Past, Current & Future Analysis for EMC / ECI by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 11: World Historic Review for EMC / ECI by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 12: World 16-Year Perspective for EMC / ECI by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 13: World Recent Past, Current & Future Analysis for Electrical Safety Testing by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 14: World Historic Review for Electrical Safety Testing by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 15: World 16-Year Perspective for Electrical Safety Testing by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 16: World Recent Past, Current & Future Analysis for Diagnostics by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 17: World Historic Review for Diagnostics by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 18: World 16-Year Perspective for Diagnostics by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 19: World Recent Past, Current & Future Analysis for Therapeutic by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 20: World Historic Review for Therapeutic by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 21: World 16-Year Perspective for Therapeutic by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 22: World Recent Past, Current & Future Analysis for Implants by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 23: World Historic Review for Implants by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 24: World 16-Year Perspective for Implants by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 25: World Medical Device Validation and Verification Market Analysis of Annual Sales in US$ Thousand for Years 2014 through 2030
  • Table 26: World Recent Past, Current & Future Analysis for Oncology by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 27: World Historic Review for Oncology by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 28: World 16-Year Perspective for Oncology by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 29: World Recent Past, Current & Future Analysis for Orthopedics by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 30: World Historic Review for Orthopedics by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 31: World 16-Year Perspective for Orthopedics by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 32: World Recent Past, Current & Future Analysis for Respiratory by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 33: World Historic Review for Respiratory by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 34: World 16-Year Perspective for Respiratory by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 35: World Recent Past, Current & Future Analysis for Neurology by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 36: World Historic Review for Neurology by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 37: World 16-Year Perspective for Neurology by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 38: World Recent Past, Current & Future Analysis for Other Therapeutic Areas by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 39: World Historic Review for Other Therapeutic Areas by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 40: World 16-Year Perspective for Other Therapeutic Areas by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
III. MARKET ANALYSIS
UNITED STATES
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United States for 2024 (E)
CANADA
JAPAN
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Japan for 2024 (E)
CHINA
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in China for 2024 (E)
EUROPE
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Europe for 2024 (E)
FRANCE
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in France for 2024 (E)
GERMANY
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Germany for 2024 (E)
ITALY
UNITED KINGDOM
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United Kingdom for 2024 (E)
SPAINRUSSIAREST OF EUROPE
ASIA-PACIFIC
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Asia-Pacific for 2024 (E)
AUSTRALIA
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Australia for 2024 (E)
INDIA
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in India for 2024 (E)
SOUTH KOREAREST OF ASIA-PACIFIC
LATIN AMERICA
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Latin America for 2024 (E)
ARGENTINABRAZILMEXICOREST OF LATIN AMERICA
MIDDLE EAST
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Middle East for 2024 (E)
IRANISRAELSAUDI ARABIAUNITED ARAB EMIRATESREST OF MIDDLE EAST
AFRICA
  • Medical Device Validation and Verification Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Africa for 2024 (E)
IV. COMPETITION

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Charles River
  • Element Materials Technology
  • Eurofins Scientific SE
  • Global Services Pte., Ltd
  • Intertek
  • NAMSA
  • Pacific Biolabs
  • QuEST
  • SGS SA
  • Steris Laboratories
  • Sterling Medical Devices
  • Toxikon Corporation
  • TÜV SÜD AG

Table Information