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What fueled the previous growth in the medical device testing market?

The market of medical device testing has experienced substantial growth in the past few years. It is estimated to expand from $9.89 billion in 2024 to $10.49 billion in 2025, marking a compound annual growth rate (CAGR) of 6.0%. Factors such as strict regulatory norms, the rising complexity of devices in the medical field, the worldwide expansion of the medical device industry, an increase in chronic diseases, and emphasis on patient safety have contributed to the expansion in the previous period.

What will be the medical device testing market size in the future?

In the coming years, the medical device testing market is anticipated to witness significant growth. It is projected to expand to $13.39 billion by 2029, with a compound annual growth rate (CAGR) of 6.3%. This growth during the forecast period can be due to medical technology advancements, the rise in outsourcing of testing services, the fast-paced growth of personalized medicine, widening regulatory landscape, and the emphasis on medical device cybersecurity. The forecast period will also see key trends such as amplified regulatory compliance testing, the proliferation of biocompatibility testing methods, the application of simulation and modeling techniques, and a rise in demand for sterility testing, along with the onset of testing services for connected devices.

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What main drivers are fueling expansion in the medical device testing market?

The medical device testing market is being propelled forward due to a surge in the recall of medical devices. A device recall constitutes a procedure where distributors or manufacturers of these devices take the necessary corrective measures to rectify the medical device’s issues. Medical device manufacturers often employ medical device testing to pinpoint possible safety concerns related to their devices, which can aid in deciding if a medical recall is obligatory to uphold patient safety and device efficacy. This process also assists in enhancing product quality to prevent such recalls. For example, Sedgwick, an IT services management firm based in the US, reported that in 2022 there were 719 medical device recalls in the second quarter, marking an 11% increase from the first quarter of 2022. Consequently, the escalation in the recall of medical devices is fueling the growth of the medical device testing market.

What key areas define 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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Who are the dominant players expanding their reach 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.

How are evolving market trends shaping medical device testing Strategies?

The medical device testing market is experiencing growth due to an emerging trend focused on product innovations. The vitality of introducing novel products is being recognized by the leading companies to maintain their foothold in the market. To illustrate, Nelson Labs, known for its US-based laboratory testing services, launched a testing verification program called Nelson Labs Mark in February 2022. This ground-breaking product provides certified test reports and reliable data concerning product efficacy. Its distinctiveness lies in accommodating two-factor authentication for consumers, enabling them to verify test authenticity. Initially, the application of this testing program is designated for masks and respirator devices.

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Which regions are emerging as leaders in 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

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