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Global Medical Device Testing Market Opportunities 2025, Forecast To 2034

5 Mar, 2025

How Has The Medical Device Testing Market Size Evolved In Recent Years?

The medical device testing market has seen considerable growth due to a variety of factors.
• Over the recent years, the size of the medical device testing market has witnessed significant expansion. From $9.89 billion in 2024, it is projected to reach $10.49 billion in 2025, exhibiting a compound annual growth rate (CAGR) of 6.0%. The surge during the historic period can be credited to tough regulatory standards, the increasing intricacy of medical devices, the globalization of the medical device sector, the rise in chronic diseases, and emphasis on patient safety.

What Does Future Hold for The Medical Device Testing Market?

The Medical Device Testing market is expected to maintain its strong growth trajectory in upcoming years.
• In the coming years, the medical device testing market size is anticipated to experience robust growth, with a projection to reach $13.39 billion by 2029. This will occur at a compound annual growth rate (CAGR) of 6.3%.
Several factors contribute to this growth during the forecast period, including the evolution in medical technology, a rise in the outsourcing of testing services, swift expansion of personalized medicine, a developing regulatory environment, and an emphasis on cybersecurity for medical devices. The forecast period is also expected to witness some key trends such as improved regulatory compliance testing, growth in biocompatibility testing methods, the application of simulation and modeling techniques plus a spike in the demand for sterility testing and the launch of testing services for connected devices.

What Are The Primary Growth Drivers In The Medical Device Testing Market?

The surge in medical device recalls is propelling the growth of the medical device testing market. This recall is a corrective measure undertaken by the device's manufacturer or distributor to eliminate or rectify issues with the medical device. The method of medical device testing aids manufacturers in spotting potential safety conflicts linked to devices and can assist in deciding if a medical recall is required to safeguard patient safety and device efficacy. It also contributes to enhancing the quality of the product to prevent future medical recalls. For example, Sedgwick, a U.S.-based IT service management firm, reported 719 medical recalls in the second quarter of 2022, an increase of 11% from the first quarter of 2022. Consequently, the escalating number of medical device recalls is fueling the expansion of the medical device testing market.

What Is The Segmentation Of The Global Medical Device Testing Market?

The medical device testing market covered in this report is segmented –
1) By Testing Type: Physical Testing, Chemical Or Biological Testing, Cybersecurity Testing, Microbiology And Sterility Testing, Other Testing Type
2) By Device Class: Class I, Class II, Class III
3) By Sourcing Type: In-House, Outsourced
4) By Service Type: Testing Services, Inspection Services, Certification Services
5) By End-User: Hospital, Research Center, Homecare Clinics, Other End-User Subsegments:
1) By Physical Testing: Mechanical Testing, Environmental Testing, Electrical Testing
2) By Chemical Or Biological Testing: Chemical Composition Analysis, Biocompatibility Testing, Toxicological Assessment
3) By Cybersecurity Testing: Vulnerability Assessment, Penetration Testing, Risk Assessment
4) By Microbiology And Sterility Testing: Microbial Contamination Testing, Sterility Assurance Testing, Endotoxin Testing
5) By Other Testing Types: Performance Testing, Usability Testing, Regulatory Compliance Testing

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What Emerging Trends Are Shaping The Medical Device Testing Market Landscape?

Introducing innovative products is a key trend becoming increasingly popular in the medical device testing market. To maintain their standing in the market, major firms are producing novel products. For example, Nelson Labs, a laboratory testing service provider based in the US, unveiled Nelson Labs Mark in February 2022. This product testing verification program substantiates test reports and provides reliable product performance data. The program is dedicated to medical device testing and verification. Its unique feature is a two-factor consumer authentication process, which can be used to verify the genuineness of tests. Initially, the testing will focus on masks and respirator devices.

Who Are the Key Players In The Medical Device Testing Market?

Major companies operating in the medical device testing market include:
• Intertek Group plc.
• SGS SA
• Bureau Veritas Group
• TUV SUD AG
• TUV Rheinland Group
• Pace Analytical Services LLC.
• Charles River Laboratories Inc.
• UL Solutions
• North American Science Associates LLC
• Medistri SA
• WuXi AppTec Inc.
• Cordant Health Solutions
• GE Healthcare Technologies Inc.
• Thermo Fisher Scientific Inc.
• Biomedical Device Labs
• NSF International
• Analytical Lab Group LLC
• Boston Analytical
• DDL Inc.
• Element Materials Technology
• Empirical Testing Corp.
• Eurofins Scientific
• Gateway Analytical LLC
• iuvo BioScience
• Laboratory Corporation of America Holdings
• Microtest Laboratories Inc.
• Nelson Laboratories LLC
• National Technical Systems Inc.
• Pacific Biolabs Inc.
• Sterigenics International LLC
• Toxikon Corporation
• WCG Imaging
• Westpak Inc.

What Are The Regional Insights Into The Medical Device Testing Market?

North America was the largest region in the medical device testing market in 2024. Asia-Pacific is expected to be the fastest-growing region in the medical testing device market report during the forecast period. The regions covered in the medical device testing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa