Global Medical Device Validation Verification Market Overview
Medical Device Validation & Verification Market was valued at USD 764.7 Billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 11.5% to reach USD 2059.7 Billion by 2034.
Medical device validation is the process to check the quality of medical devices, such as MRI equipment, Defibrillators etc. Both software and hardware components are tested under medical device validation & verification. The medical device validation consists of, factory testing, certificate testing, and R&D testing.
Global Medical Device Validation Verification Market Drivers & Restraints
Increasing product complexity
Rising regulatory focus on quality control for manufacturing operations, on additional safety, testing, and reporting procedures needs advanced test equipment and instrumentation on-site in manufacturing laboratories and facilities. The accuracy of test results rely largely on the accuracy of test and measurement instruments, used for a particular test process. There is a growing demand for TIC services in medical devices, due to increasing demand for good quality and standard products across the industry.
Stringent Regulations
International governing laws by leading bodies, such as the U.S. Food and Drug Administration (FDA), are continuously improving owing to stringent regulatory policies set by different countries. Further, due to advancement in technology, medical devices are becoming smaller in size with more complex design. Therefore, medical device validation and verification has become even more important. This validation and verification process supports in designing the good quality medical devices with minimum error. Moreover, validation and verification also help to decrease the production cost of medical devices.
However, threat of information loss to the OEM and penetration & growth prospect mapping may hamper the growth of the global market.
Global Medical Device Validation Verification Market Segmentations & Regional Insights
The global medical device validation & verification market is segmented based on therapeutic area, application, technology, and region.
On the basis of therapeutic area, the global medical device validation & verification market is segmented into cardiovascular, dermatology, orthopedics, nephrology, respiratory, neurology, oncology, ENT, and others. Based on application, the target market is segmented into diagnostics, therapeutic, and implants (active implantable medical device and medical implants. Based on application, the target market is segmented into mechanical testing, biological, EMC/ECI, and electrical safety testing
Regional Insights:
On region the global medical device validation & verification market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America accounted highest share in 2019 owing to increasing complexity in product design and recent technological advancements in medical devices. Additionally, medical device manufacturers are focusing on North America owing to driving healthcare industry in the region. Europe accounted for the second highest share in the global market in 2019 owing to well-developed healthcare infrastructure. Asia Pacific is projected to account considerable market share over the forecast period owing to growing regulatory focus on quality control while manufacturing medical devices, especially in emerging economies, such as India and China. Moreover, increasing medical tourism in developing economies is projected to boost the market in Asia Pacific. Certain regions such as the Middle East & Africa and Latin America are expected to register lucrative growth over the forecast period owing to rapidly growing healthcare industry.
Report Scope:
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Attribute |
Details |
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Base year for estimation |
2023 |
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Forecast period |
2024 – 2034 |
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Market representation |
Revenue in USD Billion & CAGR from 2024 – 2034 |
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Market Segmentation |
By Therapeutic area- Cardiovascular, Dermatology, Orthopedics, Nephrology, Respiratory, Neurology, Oncology, ENT, and Others By Application – Diagnostics, Therapeutic, and Implants (Active Implantable Medical Device and Medical Implants By Technology- Mechanical testing, Biological, EMC/ECI, and Electrical safety testing |
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Regional scope |
North America - U.S., Canada Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific Latin America - Brazil, Mexico, Argentina, Rest of Latin America Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa |
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Report coverage |
Revenue forecast, company share, competitive landscape, growth factors, and trends |
Segments Covered in the Report:
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2024 to 2034. For the purpose of this study, has segmented the global medical device validation & verification market report based on therapeutic area, application, technology, and region.
Global Medical Device Validation & Verification Market, By Therapeutic area:
- Cardiovascular
- Dermatology
- Orthopedics
- Nephrology
- Respiratory
- Neurology
- Oncology
- ENT
- Others
Global Medical Device Validation & Verification Market, By Application:
- Diagnostics
- Therapeutic
- Implants
- Active Implantable Medical Device
- Medical Implants
Global Medical Device Validation & Verification Market, By Technology:
- Mechanical testing
- Biological
- EMC/ECI
- Electrical safety testing
Global Medical Device Validation & Verification Market, By Region:
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- North America
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- U.S.
- Canada
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- Europe
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- Germany
- UK
- France
- Russia
- Italy
- Rest of Europe
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- Asia Pacific
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- China
- India
- Japan
- South Korea
- Rest of Asia Pacific
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- Latin America
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- Brazil
- Mexico
- Rest of Latin America
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- Middle East & Africa
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- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
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- North America
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Global Medical Device Validation Verification Market Competitive Landscape & Key Players
The key players operating the global medical device validation & verification market includes SGS SA, QuEST Global Services Pte. Ltd, Intertek, Element Materials Technology, Toxikon Corporation, TÜV SÜD AG, Eurofins Scientific SE, Charles River, Sterling Medical Devices, North American Science Associates, Inc., Pacific Biolabs, and Steris Laboratories. Rapid utilization of advanced healthcare technology for better healthcare is one of the key factors affecting competition in the market. Moreover, prominent players are adopting strategies, such as new product launches and mergers & acquisitions in order to retain market share and diversify the product portfolio. For instance, in 2017, SGS SA has expanded its extractable and leachable testing services with new equipment and specialist analyst at its facility in New Jersey, U.S.
Global Medical Device Validation Verification Market Company Profile
- SGS SA
- QuEST Global Services Pte. Ltd
- Intertek
- Element Materials Technology
- Toxikon Corporation
- TÜV SÜD AG
- Eurofins Scientific SE
- Charles River
- Sterling Medical Devices
- North American Science Associates, Inc.
- Pacific Biolabs
- Steris Laboratories
Global Medical Device Validation Verification Market Highlights
FAQs
The global medical device validation & verification market accounted for US$ 8.56 billion in 2017 and is estimated to be 12.26 billion by 2023 and is anticipated to register a CAGR of 6.18%.
The market report has been segmented on the basis of therapeutic area, application, technology, and region.
Emerging trends include the adoption of automated validation processes, the increasing complexity of medical devices requiring robust verification, and the incorporation of artificial intelligence in validation, presenting significant opportunities in the global Medical Device Validation & Verification Market.
Factors driving the market include the growing regulatory requirements for medical device safety and efficacy, the need for rigorous validation to meet quality standards, advancements in technology necessitating comprehensive verification, and the increasing emphasis on patient safety in healthcare systems worldwide.
The report covers regions worldwide. North America is expected to dominate the Medical Device Validation & Verification Market, driven by a well-established healthcare regulatory framework, a high concentration of medical device manufacturers, and ongoing advancements in technology. Other influential regions include Europe and Asia-Pacific.
The prominent player operating in the global medical device validation & verification market includes SGS SA, QuEST Global Services Pte. Ltd, Intertek, Element Materials Technology, Toxikon Corporation, TÜV SÜD AG, Eurofins Scientific SE, Charles River, Sterling Medical Devices, North American Science Associates, Inc., Pacific Biolabs, and Steris Laboratories.