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

Report Overview

The global medical device testing services market size was valued at USD 7.5 billion in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 9.0% throughout the forecast period. The COVID-19 pandemic has accelerated the demand for testing services around the world in the short term. The market is primarily driven by the growing impact of strict government regulations, which resulted in the growing demand for the verification and validation of medical devices. In addition, the rise in small medical device firms without in-house expertise is accelerating market expansion.

Technology advancements like wearable and artificial intelligence (AI), along with a focus on real-time patient monitoring, have created a complex ecosystem for medical devices. To receive a marketing authorization, these devices must go through methodical testing in a hurry. The need for medical device testing services to be outsourced is expected to increase because conducting these tests in-house takes a lot of time, cost, and labor.

Ongoing technological development in the medical industry is also likely to have a positive impact on the demand for testing services during the forecast period. Advancement in the development and standardization of novel in-vitro test methods, particularly for sensitization, cytotoxicity, and irritation, is also likely to propel market growth. These are some of the most basic tests required for all medical devices.

Medical device testing demand rose significantly in response to COVID-19. However, the vast majority of medical equipment being tested is personal protective equipment (PPE) because there are not enough medical devices available. Testing of PPE includes confirming their reusability, even with regard to single-use masks. Most face masks were designed to be single-use items before the pandemic began. Many manufacturers are working on ways to test these masks for multiple uses, but their global scarcity is forcing them to do so. Fitment checks, original filtration specifications compliance checks, and sterilization checks are all part of the test.

Medical device regulations vary by country, and each manufacturer is required to abide by them when promoting its goods there. For instance, the U.S. adheres to FDA regulations, Canada demands Health Canada registration, Europe takes into account CE approval, and India demands CDSCO approval. Consequently, it is difficult to introduce a product on a global scale because of the disparate regulations in various nations. 

Services Insights

The Microbiology & sterility testing segment accounted for the maximum revenue share of 34.2% in 2021. Microbiology and sterility testing are conducted to eliminate or reduce the risk of contamination in the production process, which could result in infections in patients or users of the products. The regulatory process for the devices could be delayed if such tests are not conducted. The segment is further divided into testing for Pyrogen and Endotoxin, determining the bioburden, validating sterility tests, and determining anti-microbial activity tests. 

The chemistry test segment is expected to rise with the fastest CAGR of 9.4% during the forecast period. Chemical testing is done for characterizing, identifying, and comprehending the chemicals used for manufacturing medical devices. Chemical testing complies with the ISO 10993-17 and 10993-18T regulations. According to biocompatibility standards, it is a requirement for all medical devices to obtain chemical information, which results in chemical characterization for the majority of medical devices. 

From low-risk items like medical spatulas and disinfectants to high-risk items like implants and cardiac pacemakers, this category includes a wide variety of products. Manufacturers could perhaps anticipate potential toxicities and take precautions against them by analyzing the chemicals that commute from the device to the patient. The complexities associated with the designing of medical devices are driving the segment growth.

Phase Insights

The clinical segment dominated the market and accounted for more than 68.8% share of the global revenue in 2021. The segment is also anticipated to register the fastest growth during the forecast period. The cost of the medical device testing services related to the clinical stage is much higher than preclinical, which is a key factor in determining the largest market in the clinical phase. Furthermore, the testing of medical devices requires more time in each phase than it does in the preclinical stage, and the volume of testing is also higher in the clinical stage, which a major factor is contributing to the market for medical device testing services.

The preclinical phase of medical device testing includes the determination of efficacy, safety, and biocompatibility of prosthesis, biomaterial, and a few others. The preclinical segment accounts for a smaller share as compared to the clinical phase as of 2021. This is due to the fact that the cost of preclinical tests is comparatively cheaper than the clinical phase. Moreover, the segment held a lower share owing to the fact that the majority of medical devices are in the clinical phase across the analysis period, thus limiting its volume as well. However, the segment is poised to witness stable growth across the forecast time frame, owing to the increasing number of companies investing in the R&D of novel medical devices for the treatment of rare diseases. 

Regional Insights

The Asia Pacific region dominated the market for medical device testing services with the largest revenue share of 40.9% in 2021. The region is also anticipated to expand significantly throughout the forecast period as a result of the expanding international interest in Chinese and Indian markets, driven by the strict product approval standards in China, and improvements in the healthcare infrastructure. Due to China's prominence as the world's top exporter, more medical device testing services are already offered there in order to maintain compliance with international standards. 

North America accounted for the second-largest share in 2021 and is expected to develop at a CAGR similar to the global market during the forecast period. The major factors driving this regional market are expected to be the increasing complexity in product design and growing efforts toward cost-cutting. Besides, the presence of stringent regulatory bodies such as the FDA is fueling the market growth. The rapid increase in the manufacturing of medical devices to meet the high demand for efficient healthcare in the region is expected to be one of the major factors that can be attributed to the market growth in North America. 

Key Companies & Market Share Insights 

Companies are increasingly focusing on specific areas as a result of the high competition in the market. For instance, TÜV SÜD announced in 2021 that it would attend MedTech LIVE to demonstrate its capacity as a one-stop shop for medical device testing. In order to improve their product portfolio and gain a competitive edge, market players are also actively involved in a variety of strategic initiatives, such as the introduction of new services, collaborations, partnerships, mergers & acquisitions, and geographic expansion. 

For instance, Intertek Plc announced in June 2020 that its personal protective equipment services would now include N95 respirator precertification testing in accordance with the National Institute for Occupational Safety and Health standards. In addition, Euro fins Medical Device Testing is also determined to offer qualified assistance in evaluating the security and effectiveness of the methods implemented in the fight against COVID-19. Some prominent players in the global medical device testing services market include:

• SGS SA

• Toxikon, Inc

• American Preclinical Services

• Sterigenics International LLC

• River Laboratories International Inc

• Medical Device Testing Services

• North America Science Associates Inc

• Euro fins Scientific

• Pace Analytical Services LLC

• Intertek Group Plc

Medical Device Testing Services Market Report Scope

Global Medical Device Testing Services Market Segmentation 

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

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

  • Biocompatibility Tests

  • Chemistry Test

  • Microbiology & Sterility Testing

    • Bioburden Determination

    • Pyrogen & Endotoxin Testing

    • Sterility Test and Validation

    • Antimicrobial Activity Testing

    • Others

  • Package Validation

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

  • Preclinical

  • Clinical

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

  • North America

    • U.S.

    • Canada

  • Europe

    • France

    • Germany

    • U.K.

    • Italy

    • Spain

    • Netherlands

    • Belgium

    • Switzerland

    • Russia

    • Sweden

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Malaysia

    • Indonesia

    • Singapore

    • Philippines

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Israel

    • Egypt