Global Preclinical Medical Device Testing Services Market (2022 to 2030) – Size, Share & Trends Analysis Report –

DUBLIN–(BUSINESS WIRE)–The “Preclinical Medical Device Testing Services Market by Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Testing, Package Validation), by Region, and Segment Forecasts, 2022-2030” report has been added to’s offering.

The global preclinical medical device testing services market share is expected to reach USD 4.9 billion by 2030, according to this report. The rising incidence of diseases has provided manufacturers with different approaches for the formation of medical devices and increasing demand for technologically advanced medical devices are the main factors driving the market growth.

The pace of technological advancement in the healthcare industry has vastly increased in recent years. Medical device technology advancements support simple, painless treatment during disease management. Additionally, advancements in medical device technology help with accurate and quick disease diagnosis results, as well as the affordability of technology-based therapeutic tools for disease treatment.

Furthermore, numerous governmental agencies and healthcare institutions support medical research facilities. This funding is primarily intended to promote global health care innovations. The growth of medical device testing in the anticipated period is therefore supported by expanding innovation and technological advancement.

Preclinical testing plays a crucial role in the process of creating new products. Before beginning human testing, most of this testing has been completed and reports should be available. According to ISO-10993, biocompatibility testing results are needed to be included in 510(k) notifications for Class II equipment that has immediate patient contact or contact with the blood supply. This shows that the new device’s risks are “substantially equivalent” to the predicate device’s risks. In order to show the utility of the new device, validate electrical safety, or examine electromagnetic interference, the testing also involves animal and bench studies.

COVID-19 has created an enormous demand for these services. The growth was not significant during the first half, but it became more significant during the second as the industry adopted the new norms at a faster pace amid the pandemic. Numerous projects that were halted because of COVID have been restarted and PPE kits are witnessing an increase in production and testing. During the pandemic, many medical devices in high demand diverted attention from the equipment needed for surgery. The COVID-19 vaccines, ventilators, and pulse oximeters are the main products that witnessed a spike in demand.

Preclinical Medical Device Testing Services Market Report Highlights

  • The Microbiology & sterility testing segment dominated the market with a revenue share of 34.2% in 2021. It is one of the main tests included in pre-clinical medical device testing These examinations aid in identifying the occurrence of microorganisms in the device
  • Based on microbiology & sterility test type, sterility test and validation dominated the market with a revenue share of 45.6% in 2021
  • The chemistry test segment is anticipated to exhibit the fastest CAGR of 9.0%. The test is conducted in order to categorize, recognize, and understand the chemicals used in the production of medical devices
  • Asia Pacific led the global market in 2021 and is projected to witness the fastest CAGR of 9.0% during the forecast years due to the low cost of outsourcing medical device testing services

Market Dynamics


  • Complexity in Product design
  • Strict Approval Norms
  • Increase in number of small medical device lacking in-house testing capabilities


  • Legal and Regulatory Issues

Companies Mentioned

  • SGS SA,
  • LabCorp
  • Eurofins Scientific
  • Pace Analytical Services LLC
  • Intertek Group PLC
  • Wuxi AppTec
  • Tuv Sud Ag
  • Sterigenics International LLC
  • Nelson Labs
  • North American Science Associates, Inc.
  • Charles River Laboratories International, Inc.

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