Recent years have witnessed a significant acceleration in technological developments within the healthcare sector. These advancements in medical device technology have revolutionized the landscape, offering patients painless and uncomplicated treatment options. Moreover, innovations and upgrades in medical devices have significantly improved the precision and speed of disease diagnosis. Additionally, these innovations are paving the way for cost-effective, technology-based therapeutic tools during the treatment of various diseases.
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Market Growth and Projections
The global medical device testing market is on a remarkable growth trajectory. It is projected to reach USD 8,423.14 million by 2029, up from USD 3,832.27 million in 2021, at an impressive Compound Annual Growth Rate (CAGR) of 10.8% during the forecast period from 2022 to 2029. The escalating demand for global verification and validation of medical devices is one of the key drivers behind this growth. Additionally, the increasing healthcare expenditure aimed at providing better health services is contributing to the market’s expansion. Major market players are also focusing on service launches and approvals to cater to this burgeoning demand.
Driving Factors
Verification and Validation of Medical Devices: The need for the verification and validation of medical devices is increasing globally. Medical devices are becoming more compact and intricate, often employing advanced, engineered plastics in their design. Ensuring the validation and verification (V&V) of these devices has become paramount. This trend leads to enhanced repeatability, fewer errors, reduced rework, faster time to market, heightened competitiveness, and lower production costs. Moreover, stricter standards and regulations related to medical device validation and verification are further fueling the growth of the medical device testing market.
Segment Analysis
The global medical device testing market can be segmented into several key categories:
- Service Type: This includes testing services, inspection services, and certification services. In 2022, testing services are expected to dominate the market due to their prevalence in various regions.
- Testing Type: Categories within this segment include physical testing, chemical/biological testing, cybersecurity testing, microbiology and sterility testing, and others. In 2022, chemical/biological testing is anticipated to lead the market due to its crucial role in ensuring the safety and efficacy of medical devices.
- Phase: Segments are preclinical and clinical. Preclinical testing is deemed crucial for medical device testing and is expected to dominate the market in 2022.
- Sourcing Type: Options are in-house and outsourced. Outsourced testing is anticipated to dominate the market due to its cost-effectiveness, which is preferred by manufacturers.
- Device Class: Segments are class I, class II, and class III. Class I is projected to lead the market in 2022, largely due to increased research and development activities for class I medical devices.
- Product: This includes active implant medical devices, active medical devices, non-active medical devices, in-vitro diagnostics medical devices, and various others. Non-active medical devices are expected to dominate the market in 2022, reflecting their extensive use and the need for rigorous testing before entering the market.
Major Players
Several key companies operate in the medical device testing market. These players include SGS, Eurofins Scientific, Bureau Veritas, Intertek, TÜV SÜD, DEKRA, BSI, TÜV Rheinland, and more. These companies are actively engaged in advancing the industry and providing essential testing and validation services.
Market Developments
- TÜV SÜD exhibited its capabilities as a one-stop shop for medical device testing at Medtec LIVE in April 2021. The company showcased its services, including electrical and functional safety testing, cybersecurity and software, EMC, and biocompatibility.
- In June 2020, Intertek expanded its personal protective equipment services, including N95 respirator precertification testing, aligned with National Institute for Occupational Safety and Health (NIOSH) standards.
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