Medical device testing is the process of demonstrating that the device is reliably and safely performed in use. In new product development, extensive design validation testing is applied. This includes performance testing, toxicity, and chemical analysis, and sometimes human factors or even clinical testing. Ongoing quality assurance testing is generally more limited. This usually includes dimensional checks, some functional tests, and packaging verification. Various types of medical testing services are available there in the market such as inspection services, certification services, and others.
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Data Bridge Market Research analyses that the North America Medical Device Testing Market is expected to grow at a CAGR of 12.0% in the forecast period of 2023 to 2030 and is expected to reach USD 4,094.16 million by 2030.
Key Findings of the Study
Rising demand for In-vitro tests
In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases.
In-vitro tests are used in various disease detections such as HIV infections, malaria, and hepatitis among others. The prevalence of such diseases is rapidly increasing across the globe, which leads to the increasing demand for in-vitro tests and various medical devices. As medical devices have become widely available for various diseases due to the rapid manufacturing of medical testing companies, it is a major factor driving the growth of the market.
Report Scope and Market Segmentation
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Report Metric
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Details
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Forecast Period
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2023 to 2030
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Base Year
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2022
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Historic Year
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2021 (Customizable to 2015 – 2020)
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Quantitative Units
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Revenue in USD Million
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Segments Covered
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Service Type (Testing Services, Inspection Service and Certification Services), Testing Type (Physical Testing, Chemical/Biological Testing, Cybersecurity Testing, Microbiology and Sterility Testing, and Others), Phase (Preclinical and Clinical), Sourcing Type (In-House and Outsourced), Device Class (Class I, Class II and Class III), Product (Active Implant Medical Device, Active Medical Device, Non-active Medical Device, In vitro Diagnostics Medical Device, Opthalmic Medical Device, Orthopedic and Dental Medical Device, Vascular Medical Device, and Others
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Countries Covered
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U.S., Canada, and Mexico
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Market Players Covered
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Intertek Group plc (U.K.), SGS SA (Switzerland), Bureau Veritas (France), TUV SUD (Geramny), TUV Rheinland (Germany), Pace (U.S.), Charles River Laboratories. (U.S.), UL LLC (U.S.), North American Science Associates, LLC (U.S.), WuXi AppTec (China), NSF. (U.S.), Laboratory Corporation of America Holdings (U.S.), Eurofins Scientific (Luxembourg), Nelson Laboratories, LLC- A Sotera Health company (U.S.), Gateway Analytical. (U.S.), Element Materials Technology (U.K.), Hohenstein (U.S), Cigniti (India), Q Laboratories (U.S.), and IMR Test Labs (U.S.)
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Data Points Covered in the Report
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In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework
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Segment Analysis
North America medical device testing market is segmented on the basis of service type, testing type, phase, sourcing type, device class, and product.
- On the basis of service type, the market is segmented into testing services, inspection services, and certification services.
In 2023, the testing services segment of the service type segment is expected to dominate the market
In 2023, the testing services segment is expected to dominate the market due to the rising prevalence of medical testing among the population. In 2023, the testing services segment of the service type segment is expected to dominate the market with 68.35% market share.
In 2023, the chemical/biological testing segment of the testing type segment is expected to dominate the market
In 2023, the chemical/biological testing segment is expected to dominate the market, as this type of testing is very important for the medical devices to be marketed.
- On the basis of testing type, the market is segmented into physical testing, chemical/biological testing, cybersecurity testing, microbiology and sterility testing, and others. In 2023, the chemical/biological testing segment is expected to dominate the market with 35.85% market share.
- On the basis of phase, the market is segmented into preclinical and clinical. In 2023, the preclinical segment is expected to dominate the North America medical device testing market with 79.46% market share.
- On the basis of sourcing type, the market is segmented into in-house and outsourced. In 2023, the outsourced segment is expected to dominate the market with 73.46% market share.
- On the basis of device class, the market is segmented into class I, class II, and class III. In 2023, the class I segment is expected to dominate the market with 42.40% market share.
- On the basis of product, the market is segmented into active implant medical device, active medical device, non-active medical device, in vitro diagnostics medical device, ophthalmic medical device, orthopedic and dental medical device, vascular medical device and others. In 2023, the non-active medical device segment is expected to dominate the market with 28.14% market share.
Major Players
Some of the major players operating in the market are Intertek Group plc (U.K.), SGS SA (Switzerland), Bureau Veritas (France), TUV SUD (Geramny), TUV Rheinland (Germany), Pace (U.S.), Charles River Laboratories. (U.S.), UL LLC (U.S.), North American Science Associates, LLC (U.S.), WuXi AppTec (China), NSF. (U.S.), Laboratory Corporation of America Holdings (U.S.), Eurofins Scientific (Luxembourg), Nelson Laboratories, LLC- A Sotera Health company (U.S.), Gateway Analytical. (U.S.), Element Materials Technology (U.K.), Hohenstein (U.S), Cigniti (India), Q Laboratories (U.S.), and IMR Test Labs (U.S.).
Market Development
- In February 2022, WuXi STA, a WuXi AppTec, announced that it received the 2022 CMO Leadership Awards in all six core categories, including Capabilities, Compatibility, Expertise, Quality, Reliability, and Service, and scored as a 2022 CMO Leadership Award Champion in four core categories. It is the eighth year that WuXi STA has been selected as an award winner and the third consecutive year recognized in all six core categories. This has helped the company to increase its global presence in the market.
- In January 2022, SGS SA announced that the company had collaborated with Microsoft. The collaboration has integrated Microsoft’s cross-industry expertise, advanced data solutions, productivity platforms, and the global network and leading industry competence to develop innovative solutions for the Testing, Inspection, and Certification (TIC) industry’s customers. This has helped the company to increase its global presence and make strong foot-prints in the market.
- In November 2021, Laboratory Corporation of America Holdings announced the acquisition of Toxikon. This would increase the company's capacity for nonclinical development testing for clients in the pharmaceutical, biotech, and medical device industries. Once completed, the deal would give the company a strategic foothold that will enable it to collaborate with clients in the biotechnology and pharmaceutical industries in the Boston, Massachusetts, region and expand its robust nonclinical development portfolio.
- In September 2021, Bureau Veritas announced that the company had completed its acquisition of AET, a France-based testing company providing product development, project management, and user experience testing services for consumer goods markets. This has helped the company to expand its services in various sectors and increase its global presence in the market.
Regional Analysis
Geographically, the countries covered in the market report are U.S., Canada, and Mexico.
As per Data Bridge Market Research analysis:
The U.S. is the dominant and fastest growing country in the market during the forecast period 2023 - 2030
The U.S. is expected to dominate the market owing to the higher level of investments by U.S. manufacturers and increasing escalation in the innovation of medical devices. The U.S. will continue to dominate the market in terms of market share and market revenue and will continue to flourish its dominance during the forecast period. This is due to the growing demand for in vitro testing and the rising need for verification and validation of medical devices.
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