Richmond, Dec. 18, 2023 (GLOBE NEWSWIRE) -- According to a research report "Medical Device Testing Market”, by Service Type (Testing Services {Functional Testing, Performance Testing, Safety Testing, Biocompatibility Testing, Usability Testing, Software Validation and Verification, Environmental Testing, Inspection Services, Certification Services and Others}, Inspection Services, Certification Services and Others), Sourcing Type (In-house and Outsourced), Phase (Preclinical and Clinical), Device Class (Class I, Class II and Class III), Technology (Active Implant Medical Device, Active Medical Device, Non-active Medical Device, In Vitro Diagnostic Medical Device, Ophthalmic Medical Device, Orthopedic and Dental Medical Device and Others) and Region - Global Forecast to 2030.
Global Medical Device Testing Market Report Scope:
| Report | Details |
| Market size value in 2023 | USD 10.4 Billion |
| Market size value in 2030 | USD 14.6 Billion |
| CAGR (2023-2030) | 4.9% |
| Forecast Period | 2023–2030 |
| Historic Data | 2019 |
| Forecast Units | Value (USD Million/USD Billion) |
| Segments Covered | Service Type, Sourcing Type, Phase, Device Class, Technology and Region |
| Geographies Covered | North America, Europe, Asia Pacific, and RoW |
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| Sample of Companies Covered |
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TOC Covers in Depth & Breath on Medical Device Testing Market
170 - Market Data Tables
65 - List of Figures
225 – Pages
The report includes Vendor Assessment (Company Profiles, Market Positioning, Strategies, Recent Developments, Capabilities & Product Offerings / Mapping), Technology Assessment (Developments & Economic Impact), Partner & Customer Ecosystem (Product Services, Proposition & Key Features) Competitive Index & Regional FootPrint by MarketDigits.
Market Overview
The evaluation of medical devices, known as medical device testing, involves a comprehensive process to ensure their safety, effectiveness, and performance align with regulatory standards. This includes a series of tests, experiments, and evaluations that cover various aspects such as design, functionality, durability, sterility, biocompatibility, electrical safety, and usability. The demand for testing has increased due to the expanding presence of medical device manufacturers in emerging markets, necessitating compliance with diverse regulatory environments. The growing complexity of devices, including those with multiple components and integrated software, requires intricate testing protocols, contributing to market growth. Competitive pressures driving companies to attain certifications and standards for a competitive edge further support market expansion. Additionally, widespread adoption of testing as a proactive risk management strategy to prevent high litigation costs from device malfunctions boosts market growth. The rise in global healthcare expenditure, leading to increased demand for quality-assured medical devices, is also a positive factor influencing market growth.
Major Vendors in the Global Medical Device Testing Market:
- BSI Group
- Dekra Testing and Certification GmbH
- Eurofins Scientific
- Institute for Testing and Certification Inc.
- Intertek Group PLC
- SGS SA
- TUV Rheinland
- UL LLC
- Bureau Veritas
- Element Materials Technology
- Gateway Analytical LLC
- Medistri SA
- Pace Analytical Services LLC
- WuXi AppTec
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The global expansion of the healthcare industry
The expanding healthcare industry on a global scale presents a significant opportunity for various players in the medical device testing market. With improved healthcare access worldwide, especially in emerging markets, there is a rising demand for advanced medical devices. This demand is driven by factors such as population growth, increasing disposable incomes, and a growing awareness of healthcare and wellness. Consequently, there is a need for reliable testing services to ensure that these devices meet stringent regulatory standards in terms of safety, effectiveness, and compliance. Testing facilities and services play a crucial role in supporting the worldwide expansion of the healthcare industry by offering assurance to manufacturers, healthcare providers, and patients. This, in turn, contributes to the overall growth and credibility of the global medical device sector.
Market Dynamics
Drivers:
- Increasing demand for medical devices
- Increasing need for validation and verification of medical devices
- Technological advancements including IoT and AI technologies
Opportunities:
- Providing testing services for new medical devices
- Using technology to improve efficiency
- Developing new testing services
Connectivity of mobile devices with medical equipment
The integration of mobile technology with medical devices is transforming the healthcare landscape. Dedicated applications and connectivity enable seamless interactions between mobile devices and medical equipment, empowering individuals to monitor and manage their health on the move. This integration enhances accessibility and enables timely interventions, leading to improved health outcomes. The rapid progress in wireless technologies and sensor-based devices has ushered in a new era of mobile medical devices, significantly improving the quality of life for patients while lowering healthcare costs for both providers and individuals. The compact size and networking capabilities of these mobile medical devices provide substantial benefits, allowing patients to make fewer hospital visits and affording healthcare providers the advantage of reduced administrative overheads and care expenses.
The market for Medical Device Testing is dominated by North America.
In 2022, North America emerged as the dominant force in the market. In North America, the stringent regulatory landscape is compelling companies to heavily invest in thorough evaluation processes. This strict regulatory framework naturally boosts the demand for advanced testing services. Moreover, the region is a hub for technological innovation, hosting numerous high-tech companies, research institutions, and startups dedicated to medical devices. The rapid development of new technologies requires equally advanced testing services, fostering a thriving market. Additionally, North America contributes significantly to global healthcare spending, and the substantial investments in healthcare infrastructure and medical technology contribute to the need for extensive and specialized medical device testing.
The Asia-Pacific, rapid economic growth translates into increased healthcare expenditure, driving the demand for a diverse range of medical devices and, consequently, their testing. The region is also experiencing substantial expansion in healthcare infrastructure, including hospitals and clinics, leading to a growing demand for certified medical devices and testing services. Additionally, various policies implemented by regional governments to strengthen medical device regulations are propelling market growth.
The Class III Segment is Anticipated to Hold the Largest Market Share During the Forecast Period
Based on device class, the market is segmented into Class I, Class II, and Class III. In 2022, the market was predominantly led by the Class III segment and is anticipated to maintain the largest share in Medical Device Testing throughout the forecast period. Regulatory bodies, notably the U.S. FDA, typically subject Class III devices to more rigorous testing and certification requirements. The regulatory emphasis on stringent testing ensures that manufacturers of these devices make significant investments in testing services. Compared to Class I devices, Class III devices tend to have a larger market size in Medical Device Testing. This financial incentive motivates medical device manufacturers to allocate resources for comprehensive testing, safeguarding their investments. Class III encompasses many breakthrough and innovative medical devices, including implantable devices, advanced diagnostic equipment, and complex surgical instruments, which necessitate cutting-edge testing methods to assess their safety and efficacy.
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