The global medical device validation and verification market size is expected to reach USD 1.71 billion by 2030, expanding at a CAGR of 8.8% from 2025 to 2030, according to a new report by Grand View Research, Inc.
Increase in demand for advanced and quality medical products and rising complexity with respect to product designing and engineering are anticipated to boost market growth. Rapid innovations in healthcare have increased the need for companies to incorporate new technologies and software applications in their products to meet the demand for validation and verification. Increase in product complexity, availability of newer types of material, and high risk of product failures are some of the key factors increasing the need for validation and verification services.
North America dominated the global medical device validation and verification market, accounting for 44.88% share of the overall revenue in 2019. Rapid growth in manufacturing of medical devices to meet high demand for efficient healthcare services, including validation and verification, is one of the major factors contributing to the regional market growth. In addition, stringent regulatory environment in U.S. is fueling market growth in the region.
Asia Pacific is anticipated to expand at a CAGR of 12.1% during the forecast period. This can be attributed to increased opportunities for players, especially in Japan, China, and India, improved regulatory framework, and increase in the number of medical devices companies.
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The oncology segment dominated the market, with a revenue share of 26.5% in 2024, driven by the rising incidence of cancer globally, demanding advanced medical devices for diagnosis, treatment, and monitoring.
The diagnostics segment dominated the market with the largest revenue share of 44.0% in 2024, driven by increasing demand for early disease detection and a shift towards preventive healthcare, emphasizing early diagnosis for better treatment outcomes and lower costs.
The therapeutic segment is projected to grow at a CAGR of 9.0% over the forecast period. It is fueled by the rising prevalence of chronic diseases like diabetes and cardiovascular conditions, demanding validated devices such as drug delivery systems and infusion pumps for effective management.
North America medical device validation & verification market dominated the global market with a revenue share of 45.2% in 2024.
Grand View Research has segmented the global medical device validation & verification market on the basis of therapeutic area, application, implants, technology, and region:
Medical Device Validation & Verification Therapeutic Area Outlook (Revenue, USD Billion, 2018 - 2030)
Cardiovascular
Dermatology
Orthopedics
Nephrology
Respiratory
Neurology
Oncology
ENT
Others
Medical Device Validation & Verification Application Outlook (Revenue, USD Billion, 2018 - 2030)
Diagnostics
Therapeutic
Implants
Medical Device Validation & Verification Implants Outlook (Revenue, USD Billion, 2018 - 2030)
Active Implantable Medical Device
Medical Implants
Medical Device Validation & Verification Technology Outlook (Revenue, USD Billion, 2018 - 2030)
Mechanical Testing
Biological
EMI/EMC
Electrical Safety Testing
Medical Device Validation & Verification Regional Outlook (Revenue, USD Billion, 2018 - 2030)
North America
U.S.
Canada
Mexico
Europe
UK
Germany
France
Italy
Spain
Denmark
Sweden
Norway
Asia Pacific
Japan
China
India
Australia
South Korea
Thailand
Latin America
Brazil
Argentina
Middle East & Africa
South Africa
Saudi Arabia
UAE
Kuwait
List of Key Players of Medical Device Validation & Verification Market
SGS Société Générale de Surveillance SA
QuEST Global Services Pte. Ltd.
Intertek.
Element Materials Technology
TÜV SÜD AG
Eurofins Scientific SE
Charles River.
Sterling Medical Devices
Toxikon Corporation.
Steris Laboratories.
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