North America And Europe Preclinical Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Testing), By Region, And Segment Forecasts, 2022 - 2030

Report Overview

North America and Europe preclinical medical device testing services market size was valued at USD 1.38 billion in 2021 and is anticipated to exhibit a CAGR of 8.7% during the forecast period. 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. Medical device companies today are operating in different worlds. In developed countries, such as the U.S., there is pricing pressure; hence, operators are exploring every possible way to reduce costs throughout the value chain. On the other hand, it is in the developing economy where the actual potential lies. However, developing regions are likely to be price sensitive. Hence, market players today are striving hard to reduce the overall cost of devices. Outsourcing testing operations helps companies focus on product development and enhance marketing efforts.

Moreover, in such an intensely competitive environment, companies must reduce the time to market from the developmental phase. Considering that the approval processes for medical devices are not simple, companies need to have a sound knowledge of updated regulatory norms and protocols. As a result, medical device companies prefer to outsource it to a specialized firm.

During the COVID-19 pandemic, the preclinical medical device testing services industry is anticipated to expand profitably. The new players who have entered this market during the past ten years are its key drivers. The market for preclinical medical device testing services has benefited from the ongoing COVID-19 pandemic. Growth started more slowly in the first quarter, but it quickened in the second as companies adapted to the pandemic.

Due to the decline in demand for surgical medical devices brought on by the COVID-19 pandemic, personal protective equipment (PPE) is the main piece of equipment being tested. As medical device manufacturers scramble to prepare for the new EU-MDR, which was expected to go into effect as of May 2021, advisory services with testing companies are booked. A rise in demand is also being seen for ventilators and COVID-19 medical diagnostic kits.

The European Commission has adopted revised harmonized standards to expedite the production of gloves, medical face masks, sterilization devices & disinfectants, and containers for intravenous injections, as well as to alter the specific requirements for emergency & transport ventilators. In collaboration with the European Committee for Electro Technical Standardization (CENELEC) and the European Committee for Standardization (CEN), the European Commission has agreed to make several harmonized standards freely available.

Most medical devices are classified by the FDA as Class II or Class III. These classes require higher control and monitoring. Class II devices need pre-market notification, whereas Class III devices need pre-market approval (PMA) from the regulatory bodies. Apart from this special compliance, the basic ones include labeling requirements, manufacturing plant-established registration, medical device listing, quality systems regulation, and Medical Device Reporting (MDR). The FDA’s Center for Devices and Radiological Health (CDRH) mandates the framework and standards regarding the manufacturing, labeling, packaging, and storage of imported devices sold in the U.S.

Services Insights

The Microbiology & sterility testing segment accounted for the maximum revenue share of 34.3% in 2021. It is one of the major tests included in pre-clinical medical device testing. Manufacturing safe and effective goods is a top priority for medical device manufacturers, and sterility assurance is a crucial step in accomplishing this aim. By using radiation techniques like e-beam or gamma rays, many single-use medical devices are terminally sterilized. Additionally, confirmation of the sterilization procedure is required by the FDA and other regulatory agencies, which typically call for sterility testing.

The chemistry test segment is anticipated to exhibit the fastest CAGR of 8.9% during the forecast period. Medical devices are also subjected to chemistry tests, along with pharmaceutical formulations. Testing is performed to check if medical devices contain any solutes or chemicals that may leach into the surrounding environment when used with the intended liquid. These tests help investigate the safety parameters of medical devices. Hence, the FDA is also facilitating additional data analysis, such as polymer and colorant examinations, to provide a more holistic view of the safety of these tests. This is expected to positively impact the segment growth during the forecast period.

Regional Insights

North America led the market for preclinical medical device testing services, with the largest revenue share of 63.4% in 2021. 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 8.5% during the forecast 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

The key strategies adopted by key players to maintain their market share include mergers, acquisitions, and partnerships, among others. For instance, 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:

• SGS SA

• Toxikon, Inc.

• Eurofins Scientific

• Pace Analytical Services LLC

• Intertek Group Plc

• WUXI APPTEC

• TÜV SÜD AG

• Sterigenics International LLC

• Nelson Labs

• North American Science Associates, Inc.

• American Preclinical Services

• Charles River Laboratories International, Inc.

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

North America And Europe Preclinical Medical Device Testing Services Market Segmentation

This report forecasts revenue growth at regional & country levels and provides an analysis of the industry trends in each of the sub-segments from 2018-2030. For this study, Grand View Research has segmented North America and Europe preclinical medical device testing services market based on services and region:

• Service 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

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • France

    • Germany

    • U.K.

    • Italy

    • Spain

    • Netherlands

    • Belgium

    • Switzerland

    • Russia

    • Sweden