North America And Europe Preclinical Medical Device Testing Services Market Size, Share & Trends Analysis Report By Services (Biocompatibility Tests, Chemistry Test), And Segment Forecasts, 2021 - 2028

Report Overview

North America and Europe preclinical medical device testing services market size was valued at USD 2.4 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 11.2% from 2021 to 2028. The preclinical medical device testing services market is expected to grow lucratively during the COVID-19 pandemic. The main drivers for this market are the emerging players operating in this industry over the past decade.

The preclinical medical device testing services market is expected to grow lucratively during the COVID-19 pandemic. The main drivers for this market are the emerging player operating in this industry over the past decade. The current COVID-19 pandemic has positively impacted the preclinical medical device testing services market. Growth was slower in the first quarter, but it picked up in the second as the industry learned to operate amid a pandemic.

The major equipment tested is Personal Protective Equipment (PPE), due to the decreased demand for surgical medical devices caused by the COVID-19 pandemic. Advisory services with testing firms are completely booked, as medical device manufacturers rush to be ready for the new EU-MDR, which was supposed to be effective as of May 2021. Other products experiencing an increase in demand are medical testing kits for COVID-19 and ventilators.

The market is competitive, in which they have to fulfill complex requirements for efficacy and safety testing. These requirements vary with the type of medical device. There is a rise in preclinical spending for medical devices, thus contributing to market growth. In 2017 a survey was conducted by the International Federation of Pharmaceutical Manufacturers and Association, and it shows that around USD 149.8 billion was spent on preclinical trials. Modern equipment is composed of complex functions, and the need to test the compliance of the device with regulatory requirements is becoming important. For the device to be accurate, durable, and easy to use, it needs to undergo extensive testing.

Service Insights

The microbiology and sterility testing segment dominated the North America and Europe preclinical medical device testing services market and accounted for the largest revenue share of 34.3% in 2020; it is likely to remain dominant over the forecast period. Producing safe & effective products is a core goal of medical device manufacturers, and sterility assurance is a major component for achieving it. Many single-use medical devices are terminally sterilized by radiation methods, such as e-beam or gamma. In addition, the FDA and other regulatory bodies require validation of the sterilization process, which generally requires sterility testing.

The chemistry test segment is anticipated to exhibit the fastest CAGR of 11.5% over the forecast period. This helps to check the safety parameters of medical devices. These activities are easily outsourced by various companies. For instance, WuXiAppTec performed a chemical evaluation test for a client that failed cytotoxicity testing. Thus, this rise in ancillary testing is expected to boost revenue generation in the industry over the forecasted period.

Regional Insights

North America led the market for preclinical medical device testing services, with the largest revenue share of 54.9% in 2020. This is largely due to the presence of a large number of players in this region. It is also the top manufacturing hub for complex, highly reliable, and high-end medical devices. There is a rapid increase in the manufacturing of medical devices to meet the rising demand for efficient and cost-effective healthcare in this region. Besides this, the presence of the FDA is fueling the growth of the market for medical device testing services.

In Europe, the preclinical medical device testing service is expected to witness a CAGR of 10.9% over the forecasted period. This is due to the rising demand for cost-cutting and increasing complexity in product design, which has a high impact on the rendering drivers for the medical device analytical testing outsourcing market in European nations. A steady increase in the outsourcing of services for contract manufacturers and component suppliers has been observed in the last two decades. However, notified bodies such as the European Medical Device Regulation (EMDR) are also involved in the scrutiny of outsourced medical devices.

Key Companies & Market Share Insights

Key parameters affecting the competitive nature of the market include geographic expansion, collaboration, partnership, mergers, and acquisition. For example, in November 2019, WuXiAppTec lab testing division expanded its toxicology facility in Suzhou China to provide full-service preclinical and clinical-stage toxicology. Some of the prominent players in the North America And Europe preclinical medical device testing services market include:

• Nelson Labs

• TUV SUD AG

• American Preclinical Services

• Sterigenics International LLC

North America And Europe Preclinical Medical Device Testing Services Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the North America And Europe preclinical medical device testing services market on the basis of services and region:

• Services Outlook (Revenue, USD Million, 2016 - 2028)

  • Biocompatibility Tests

  • Chemistry Test

  • Microbiology & Sterility Testing

    • Bioburden Determination

    • Pyrogen & Endotoxin Testing

    • Sterility Test and Validation

    • Antimicrobial activity testing

    • Others

  • Package Validation

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Netherlands

    • Belgium

    • Switzerland

    • Russia

    • Sweden