Preclinical Medical Device Testing Services Market To Reach $6.55 Billion By 2030

Preclinical Medical Device Testing Services Market Growth & Trends

The global preclinical medical device testing services market size is expected to reach USD 6.55 billion by 2030, registering a CAGR of 9.20%, according to a new report by Grand View Research, Inc. 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.

 Request a free sample copy or view report summary: Preclinical Medical Device Testing Services Market Report

Preclinical Medical Device Testing Services Market Report Highlights

• In 2024, the biocompatibility tests segment dominated the market, accounting for a revenue share of 45.06%. The test is a critical step for medical device development where an assessment of biocompatibility helps medical device manufacturers ensure the device’s safety for patients & provides data that can be used to support regulatory compliance.

• The chemistry test segment is anticipated to exhibit the fastest CAGR of 9.63%. 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 2024 and is projected to witness the fastest CAGR of 9.47% during the forecast years due to the low cost of outsourcing medical device testing services

Preclinical Medical Device Testing Services Market Segmentation

Grand View Research has segmented the global preclinical medical device testing services market report on the basis of service, and region:

Preclinical Medical Device Testing Services Outlook (Revenue, USD Million, 2018 - 2030)

• Biocompatibility Tests

• Chemistry Test

• Microbiology & Sterility Testing

  • Bioburden Determination

  • Pyrogen & Endotoxin Testing

  • Sterility Test and Validation

    • Ethylene Oxide (EO) gas sterilization                        

    • Gamma-irradiation                             

    • E-beam sterilization                           

    • X-ray sterilization

  • Antimicrobial Activity Testing

  • Others

• Package Validation

Preclinical Medical Device Testing Services Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America

• U.S.

• Canada

• Mexico

• Europe

• UK

• Germany

• France

• Italy

• Spain

• Sweden

• Denmark

• Norway

• Asia Pacific

• Japan

• China

• India

• Thailand

• South Korea

• Australia

• Latin America

• Brazil

• Argentina

• Middle East & Africa

• South Africa

• Saudi Arabia

• UAE

• Kuwait

List of Key Players of the Preclinical Medical Device Testing Services Market   

• SGS SA

• Eurofins Scientific

• Pace Analytical Services LLC

• Intertek Group Plc

• WUXI APPTEC

• TÜV SÜD AG

• Sterigenics International LLC

• Nelson Labs

• North American Science Associates, Inc.

• Charles River Laboratories International, Inc.