Medical Device Testing Services Market To Reach $16.78 Billion By 2030

Medical Device Testing Services Market Growth & Trends

The global medical device testing services market size is expected to reach USD 16.78 billion by 2030, registering a CAGR of 9.44% from 2024 to 2030, according to a new report by Grand View Research, Inc. Increasing complexity in product design and stringent government regulations are driving demand for medical device testing services.

Significant rise in preclinical spending is a recent trend among pharmaceutical and medical device companies, which is expected to significantly contribute to market growth. According to the global health center, for pharmaceuticals, supporting preclinical research required 73 months and cost USD 7 million for biologics, it took 47 months and cost USD 6.3 million.

With modern medical devices offering a host of complex functions, the need for appropriate tests to check the compliance of the device with regulatory requirements is becoming vital. In order to meet the requirement of enhanced accuracy, ease of use, and durability, medical devices need to undergo extensive tests. This is expected to deliver competitive advantage to manufacturers.

On the other hand, an increase in the need for production efficiency and safety and rising regulatory requirements for medical devices are some of the major factors driving the market growth. Regulatory bodies such as the European Medicines Agency, U.S. Food and Drug Administration, Therapeutic Goods Administration, and other country regulatory bodies require documentation and testing to certify that medical devices meet efficacy and safety standards prior they can be sold and marketed to patients and healthcare providers.

The COVID-19 pandemic has created an unprecedented demand for medical device testing services. This is largely due to the increasing demand for COVID-10 related products such as masks, PPE, & respiratory equipments. Besides, countries such as Mexico, Spain, and France have published pertinent specifications and standards, namely the UNE 0064-1, UNE 0064-2, AFNOR-SPEC-S76 & UNE 0065, which must be met until a mask can be sold.

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Medical Device Testing Services Market Report Highlights

• The microbiology and sterility testing was the leading segment in 2022 with a market share of 34.2% and is likely to remain dominant over the forecast period. Producing safe and effective products is a core goal of medical device manufacturers, and sterility assurance is a major component for achieving it

• Biocompatibility tests held the largest share in 2023. This is attributed to strict requirements for biocompatibility testing set by global regulatory bodies to ensure that their devices are safe to use before being made available in the market

• The clinical segment held the largest market share in 2023 and accounted for 68.8% of the market share as this stage is mostly focused on assessing safety & biocompatibility of medical devices

• On the other hand, The preclinical market accounted for the 39.74% share in 2023. The preclinical phase of medical device includes determination of efficacy, safety, and biocompatibility of prosthesis, biomaterials, and medical devices

• Raw materials, packaging, and design all have an impact on a device's safety and compatibility, and preclinical testing of all of these factors is an important step in determining a device's market potential

• Asia Pacific dominated the global medical device testing services market in 2023, holding a revenue share of 41.1%. This is due to rising demand for medical devices in developing nations such as India and china

• North America is estimated to show growth at a lucrative rate in the market over the forecast period. This can be attributed to the fact that it is one of the top manufacturing hubs of highly reliable, complex, and high-end medical devices

Medical Devices Testing Services Market Segmentation

Grand View Research has segmented the global medical device testing services market on the basis of on service, phase and region:

Medical Device Testing Services Service Outlook (Revenue, USD Billion, 2018 - 2030)

• Biocompatibility Tests

• Cardiovascular Device's Biocompatibility Tests

• Orthopedic Device's Biocompatibility Tests

• Dental Implant Devices' Biocompatibility Tests

• Dermal Filler's Biocompatibility Tests

• General Surgery Implantation Devices Biocompatibility Tests

• Neurosurgical Implantation Devices Biocompatibility Tests

• Ophthalmic Implantation Device's Biocompatibility Tests

• Others

• Chemistry Test

• Chemical characterization (E&L)

• Analytical method development and validation

• Toxicological Risk Assessment and consulting

• Microbiology & Sterility Test

• Bioburden Determination

• Pyrogen & Endotoxin Testing

• Sterility Test & Validation

• Antimicrobial Testing

• Others

• Package Validation

Medical Device Testing Services Phase Outlook (Revenue, USD Billion, 2018 - 2030)

• Preclinical

  • Large animal research

    • Biocompatibility Tests

    • Chemistry Test

    • Microbiology & Sterility Test

  • Small animal research

    • Biocompatibility Tests

    • Chemistry Test

    • Microbiology & Sterility Test

• Clinical

Medical Device Testing Services Regional Outlook (Revenue, USD Billion, 2018 - 2030)

• North America

  • U.S.

  • Canada

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

  • Netherlands

  • Belgium

  • Switzerland

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Malaysia

  • Indonesia

  • Singapore

  • Philippines

  • Thailand

• Latin America

  • Brazil

  • Mexico

  • Argentina

  • Colombia

  • Chile

• Middle East and Africa (MEA)

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

  • Israel

  • Egypt

List of Key Players in the Medical Device Testing Services Market

• SGS SA

• Laboratory Corporation of America Holdings

• Nelson Laboratories, LLC

• TÜV SÜD

• Charles River Laboratories

• Element Minnetonka

• North America Science Associates Inc. (NAMSA)

• Eurofins Scientific

• Pace Analytical Services LLC

• Intertek Group Plc

• WuXi AppTec