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

Report Overview

The global medical device testing services market size was estimated at USD 8.7 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 11.3% from 2022 to 2030. The COVID-19 pandemic has accelerated the demand for testing services around the globe in the short term. The market is majorly driven by the increasing influence of strict regulations by the government that led to the increasing demand for verification and validation for medical devices. Besides, the rise in the number of small medical device companies that lack in-house expertise is also boosting the market growth.

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 is personal protective equipment (PPE). PPE testing comprises validating their reuse, including single-use masks. Until the onset of the pandemic, most face masks were intended as single-use products. However, owing to their global shortage, numerous manufacturers are working on the 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 wearable, combined with a special emphasis on real-time monitoring of the patients, have led to a complex medical device ecosystem. These devices should undergo rigorous testing under accelerated conditions 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 market growth. These are some of the most basic tests required for all medical devices.

Medical device guidelines differ by country, and it is mandatory for every manufacturing company to follow these guidelines when marketing their products in a particular country. The U.S., for example, follows FDA guidelines, Canada requires Health Canada Registration, Europe considers CE approval and India requires CDSCO approval. Hence, such varied regulations in different countries make it challenging to launch a product on a global scale.

Service Insights

Microbiology and sterility testing dominated the market with 34.2% of revenue share in 2021. The segment is further divided into bioburden determination, pyrogen & endotoxin testing, sterility test &validation, and anti-microbial activity testing. Microbiology and sterility testing is performed to eliminate or reduce the risk of contamination in the production process, which may cause infections in patients or users of the products. Failure to perform such tests might delay the regulatory process for the devices.

Package & validation for medical devices ensure product integrity and protect against damage throughout the supply chain. Though the market is less monopolized and accounted for 14.0% of the revenue share in 2021. The manufacturers are now considering environmental and economic factors to revalidate their packaging. Also, regulatory authorities such as FDA have increased their focus on medical device packaging, which is acting as a driving force behind the market growth.

Phase Insights

The preclinical phase led the market and accounted for more than 65.0% share of the global revenue in 2021. The segment is also expected to dominate the market during the forecast period, as the major portion of biocompatibility, microbiology, and chemistry tests are performed in this phase. The number of preclinical studies is increasing in the medical devices industry with the growing complexity of medical technologies. Although biocompatibility testing is essential for new devices, biological effects can progressively be addressed by pairing the characterization of the materials with activities of risk assessment.

Medical device testing services during the clinical trial phase are expected to grow significantly in the coming years. As medical devices are critical they have a direct impact on human lives. Hence, the medical device manufacturers are required to follow the testing along with verification & validation practices ensuring the quality & reliability of medical devices. This is expected to contribute to market growth.

Regional Insights

The Asia Pacific region led the global market with the largest market share of 42.2% in 2021. The region is also expected to grow at a significant rate during the forecast period due to the growing global interest in China and India markets, stringent product approval in countries such as China, and the advancements in healthcare infrastructure. China is the leading exporter for many companies around the world, which has resulted in an increase in medical device testing services within the country to maintain compliance with international standards.

North America accounted for the second-largest share in 2021 and is expected to grow at CAGR similar to the global market during the forecast period. The major factors driving this regional market are expected to be 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.

Key Companies &Market Share Insights

Being a very competitive market space, companies are increasing their emphasis in certain areas. For example, in 2021, TÜV SÜD announced that it would present itself at Medtec LIVE, to exhibit its ability to be a one-stop shop for medical device testing.  Also, the market players are undertaking various strategic initiatives such as the launch of new services, partnerships, collaborations, mergers & acquisitions, and geographic expansion, aiming to strengthen their product portfolio and provide a competitive advantage. For example, in June 2020, Intertek Plc announced the addition of N95 respirator precertification testing to the National Institute for Occupational Safety and Health standards to its personal protective equipment services. Euro fins Medical Device Testing is also determined to provide professional support in evaluating the safety and efficacy of devices used 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

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis on the latest industry trends in each of the sub-segments from 2017 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, 2017 - 2030)

  • Biocompatibility Tests

  • Chemistry Test

  • Microbiology & Sterility Testing

    • Bioburden Determination

    • Pyrogen & Endotoxin testing

    • Sterility Test & Validation

    • Antimicrobial Testing

    • Others

  • Package Validation

• Phase Outlook (Revenue, USD Million, 2017 - 2030)

  • Preclinical

  • Clinical

• Regional Outlook (Revenue, USD Million, 2017 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • 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