Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Test), By Phase (Preclinical, Clinical), By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global medical device testing services market size was estimated at USD 8.1 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 9.0% from 2023 to 2030. Increasing influence of strict regulations by the government, rise in the number of small medical device companies that lack in-house expertise, and increasing demand for verification and validation for medical devices are some of the driving factors for the market.

COVID-19 provoked a surge in demand for medical device testing. But since medical devices are in short supply, the vast majority of medical equipment being tested are Personal Protective Equipment (PPE). PPE testing comprises validating their reuse, including single-use masks. Until the onset of the pandemic, most facemasks were intended as single-use products. However, owing to their global shortage, numerous manufacturers are working on options to test these masks for multiple uses. The test includes fitment tests, adherence to original filtration specifications, and sterilization tests.

Additionally, technological advancements such as artificial intelligence (AI), and wearables, combined with a special emphasis on real-time monitoring of patients, has led to a complex medical device ecosystem. These devices should undergo rigorous testing under accelerated conditions in order to obtain marketing authorization. Conducting these tests in-house requires a lot of time, cost, and labor and this is projected to augment the demand for outsourcing medical device testing services.

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 the market growth. These are some of the most basic tests required for all medical devices.

The increasing pipeline of drugs for oncology and rare disease is further expected to propel the growth of breakthrough therapy market over the forecast period. Majority of medical device testing services granted are for oncology and rare diseases. The drugs approved by FDA in oncology and rare disease segment are expected to achieve peak sales over the forecast period, thereby contributing to the market growth.

Furthermore, a large number of medical device companies have outsourced testing operations to minimize business risks, hasten product market entry, and reduce costs. These lead to significant rise in expenditure levels and, therefore, medical devices original equipment manufacturers rapidly switch to outsourcing as one of the effective cost curbing tool. Implantable Medical Devices (IMDs) are being used increasingly in order to improve patients’ medical outcome. Designers of IMDs must balance complexity, reliability, power consumption, and costs. Consequently, companies are shifting their focus to innovation rather than noncore activities and, therefore, outsourcing these activities to launch efficient devices. All these factors are expected to increase the medical device testing services market over the forecast period.

Service Insights

The microbiology and sterility testing segment accounted for the major revenue share of 34.2% in 2022. 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 2022. 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 2022. 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 41.0% in 2022. 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 2022. 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

Key companies in the market undertake several strategic initiatives such as partnerships, novel service launches, regional expansion, mergers and acquisitions to strengthen their position in the market. For instance, in April 2023, Eurofins Medical Device Testing expanded its capabilities for Extractables & Leachables in Germany. The company has more than 20 laboratories in Europe, North America. Moreover, in January 2022, TÜV SÜD announced that it expanding its medical device testing laboratory facility in New Brighton, Minnesota.The company provides end-to-end testing for all medical equipment. The laboratory also offers biological and chemical testing of medical equipment, which is a complement to TÜV SÜD's present active medical device testing capabilities. Some of the prominent players in the global medical device testing services market include:

• SGS S.A.

• Labcorp (Toxikon, Inc)

• American Preclinical Services

• Sterigenics International LLC

• Charles River Laboratories

• Element Minnetonka

• North America Science Associates Inc.

• Eurofins Scientific

• Pace Analytical Services LLC

• Intertek Group Plc.

Recent Developments

• In June 2023, NAMSA entered into an outsourcing partnership with Terumo Aortic to support the commercialization of Terumo Aortic’s cutting-edge aortic disease products. As per this strategic initiative, NAMSA planned to offer Terumo Aortic access to clinical experts as well as access to its skilled teams of cardiovascular-focused experts.

• In February 2023, Eurofins Viracor LLC (part of Eurofins Scientific) announced the commercialization of a revolutionary test to assess the expansion and perseverance of Chimeric Antigen Receptor T-Cell (CAR-T) therapy in patients with B cell lymphomas and pre-B cell acute lymphoblastic leukemia. CAR-T therapy is a radical form of immunotherapy that deploys genetically modified T-cells to target cancer cells and has shown hopeful results in treating different types of cancers.

• In January 2023, Eurofins Scientific announced the acquisition of assets for the development of a state-of-the-art, well-equipped lab campus in Hyderabad (Genome Valley). The new laboratory campus is purposed to support large global and Indian pharmaceutical clients, as well as small biotech organizations, in diverse areas, including analytical R&D, synthetic organic chemistry, bioanalytical services, in-vivo pharmacology, formulation R&D, and safety toxicology.

• In May 2022, Labcorp unveiled the launch of an at-home collection kit with the help of Labcorp OnDemand. This advanced solution measures hemoglobin A1c (HbA1c) from a given blood sample. This test is purposed to assess whether individuals are at risk for diabetes or prediabetes.

• In May 2022, Sterigenics announced the commencement of processing operations at the expanded electron beam facility in Indiana. The E-beam accelerator at this plant is used to sterilize medical and pharmaceutical products. By deploying electron beam irradiation, the facility can efficiently eliminate microorganisms and other probable contaminants from these products, thereby making them safe for usage in medical settings.

• In November 2021, Labcorp announced plans to acquire Toxikon. The objective of this transaction was to build a strategic footprint for the company to associate with biotechnology and pharmaceutical clients in Boston and reinforce its robust nonclinical development portfolio for medical device testing and drug development.

• In March 2021, NAMSA announced the acquisition of American Preclinical Services (APS), in Minneapolis to expand NAMSA’s portfolio of preclinical development solutions. Preclinical studies comprise testing the safety and efficacy of medical devices on animal models and in laboratory settings to measure their performance and potential risks.

• In February 2021, Charles River Laboratories International, Inc. announced that it had entered into a strategic partnership with Kibur Medical. The objective of this strategy was to deliver special access to Kibur’s implantable microdevice (IMD) for preclinical in-vivo oncology studies.

Medical Device Testing Services Market Report Scope

Global Medical Device Testing Services Market Report Segmentation

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

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

  • Biocompatibility Tests

  • Chemistry Test

  • Microbiology & Sterility Testing

    • Bioburden Determination

    • Pyrogen & Endotoxin Testing

    • Sterility Test & Validation

    • Antimicrobial Testing

    • Others

  • Package Validation

• Phase (Revenue, USD Billion, 2018 - 2030)

  • Preclinical

  • Clinical

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

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Netherlands

    • Belgium

    • Switzerland

    • Russia

    • Sweden

    • Denmark

    • Norway

  • 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

    • Kuwait