Medical Device Testing Market revenue to reach USD 25 Billion by 2035, says Research Nester

Prominent medical device testing market players include SGS S.A., TUV Rheinland Group, Eurofins Scientific, Cordant Health Solutions, Legacy Medical Services, LLC, Omega Laboratories, Inc., and GE Healthcare.


New York, March 12, 2024 (GLOBE NEWSWIRE) -- The global medical device testing market size is projected to grow at a CAGR of over ~5% from 2023 to 2035. The market is expected to garner a revenue of USD 25 billion by the end of 2035, up from a revenue of ~USD 9 billion in the year 2022.Consumers repeatedly are demanding effectiveness, outstanding performance, and security from medical devices. This factor has raised the demand for the verification and validation of medical devices. Therefore, it is compulsory for manufacturers to properly define and test medical devices for confirmation of quality. The government authorities of various regions have mandated the medical testing procedure for medical devices before their use. Advancement in technology such as the adoption 0f AI or IoT in multiple medical devices is expected to create lucrative growth opportunities for the sector. Various companies are now incorporating these technologies into their devices.

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Innovative and advanced medical devices aid in accurate results of disease diagnosing invention in medical devices and also offers cost-friendly technology-based therapeutic tools for disease treatment. Various government authorities and companies do promote medical research centers. In 2021, PaxeraHealth declared that it had established an AI-based imagining platform in the United States. The increasing complexity of medical devices and the integration of advanced technologies drive the demand for comprehensive testing.

Increasing Demand for Medical Devices across the Globe to Boost Market Growth

As the utilization of medical devices grows, consumers start demanding devices that ensure safe, and effectiveness and meet regulatory requirements. This attribute has boosted the growth in the medical device testing market, as market players now offering testing services and equipment to ensure the quality of medical devices. As per the statistics, the revenue in the Medical Devices segment reached a value of ~USD 480 billion in 2021. As the geriatric population increases, the demand for various medical devices also seems to grow owing to the demand for treatment of aged people suffering from various health conditions and diseases. This has increased the invention of innovative and advanced medical devices as well as raised the focus on ensuring that these devices are effective and safe with the help of rigorous testing methods. By 2030, 1 in 6 people is estimated to be over the age of 60 years old. An estimated 2.1 billion people are anticipated to be above the age of 60 or under the geriatric population by 2050 globally. The complexities in medical devices are growing day by day, which is expected to drive the need for specialized testing services and devices. As medical devices become complex the testing needed for the medical equipment to check their safety and effectiveness becomes complex which raises the demand for medical device testing. 

Medical Device Testing Market: Regional Overview

The market is segmented into five major regions including North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa region.

Expanding Healthcare Infrastructure to Drive the Market Growth in Asia Pacific Region

The medical device testing market in Asia Pacific region is estimated to garner the largest revenue by the end of 2035. The expansion of healthcare infrastructure in the region, marked by increased investments in hospitals, clinics, and medical facilities, necessitates a parallel growth in the market. As healthcare systems become more sophisticated, the demand for reliable and compliant medical devices intensifies, driving the need for comprehensive testing services. According to a report by the World Bank, healthcare spending in Asia Pacific has been consistently increasing, with an average annual growth rate of 7.4%. The prevalence of chronic diseases underscores the importance of accurate and reliable medical devices for diagnosis, treatment, and management. To ensure the effectiveness of these devices, rigorous testing becomes crucial. The market responds to the escalating demand for devices that meet high standards in accuracy and safety.

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Innovations in Medical Device Technologies to Propel the Growth in the North America Region

The North America medical device testing market is estimated to garner the highest CAGR by the end of 2035. The continuous influx of innovative medical devices requires comprehensive testing to guarantee their safety, efficacy, and adherence to regulatory standards. As the U.S. fosters an environment conducive to medical device development, the demand for testing services escalates to meet the evolving technological landscape. The United States is a global leader in medical device innovation, with over 6,500 medical device companies, according to the U.S. Food and Drug Administration (FDA). Stringent regulatory oversight in North America, particularly by the FDA, necessitates rigorous testing to ensure that medical devices meet or exceed safety and performance standards. As regulatory requirements evolve and become more complex, manufacturers seek testing services to navigate the approval process successfully. The substantial investment in healthcare underscores the importance of reliable and effective medical devices. As healthcare spending continues to rise, so does the demand for high-quality testing services to validate the performance and safety of medical devices, ensuring optimal patient outcomes and cost-effectiveness.

Medical Device Testing, Segmentation by Services

  • Testing
  • Inspection
  • Certification

Amongst these segments, the testing segment in the medical device testing market is anticipated to hold the largest share over the forecast period. Testing procedures within the medical device industry evolve to encompass patient-centric considerations. Usability testing and patient experience assessments become integral to ensure that medical devices are not only effective but also user-friendly, aligning with the shift toward more patient-centric healthcare. Patient-centric healthcare models are gaining prominence, with a survey reporting that 77% of surveyed healthcare consumers believe patient-generated data is essential for their healthcare. Public health crises emphasize the crucial role of testing in the medical device industry. The demand for accurate diagnostic devices, along with the need for expedited testing and validation processes, has grown significantly in response to global health challenges, driving the testing segment forward. With the increasing connectivity of medical devices, cybersecurity testing has become a critical component of the overall testing segment. The surge in cyber threats necessitates rigorous testing to ensure that devices are resilient against potential vulnerabilities, safeguarding patient data and preventing unauthorized access. As medical devices become more sophisticated, the testing segment experiences a surge in demand.

Medical Device Testing, Segmentation by End User

  • Hospital
  • Research Center
  • Homecare Clinics

Amongst these segments, the hospital segment in the medical device testing market is anticipated to hold a significant share over the forecast period. The escalating prevalence of chronic diseases places an increasing burden on hospitals to provide effective diagnostics and treatments. Advanced medical devices play a pivotal role in managing and treating these conditions, driving the demand for innovative technologies within hospital settings. According to the World Health Organization (WHO), non-communicable diseases (NCDs) are responsible for 71% of global deaths, with cardiovascular diseases, cancer, respiratory diseases, and diabetes being the major contributors. Hospitals are at the forefront of adopting cutting-edge medical technologies to enhance patient care and outcomes. The continuous evolution of medical devices with improved capabilities and precision supports hospitals in delivering state-of-the-art healthcare services, leading to a heightened demand for these devices. Hospitals are prioritizing patient satisfaction and engagement. This shift toward patient-centric care emphasizes the importance of medical devices that enhance the overall patient experience, such as advanced monitoring systems, telehealth technologies, and user-friendly diagnostic devices.

Few of the well-known industry leaders in the medical device testing market that are profiled by Research Nester are SGS S.A., TUV Rheinland Group, Eurofins Scientific, Cordant Health Solutions, Legacy Medical Services, LLC, Omega Laboratories, Inc., GE Healthcare, and other key market players.

Recent Development in the Medical Device Testing Market

  • Eurofins Scientific and Transgenic Inc. Acquired Genetic Lab Co., Ltd. To establish a network of clinical diagnostics laboratories in Asia. 
  • Intertek expanded its business to personal protective equipment services, including respirator precertification testing after COVID-19.

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