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 9.49% from 2025 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

• On the basis of service segment, the market is classified into biocompatibility testing, chemistry testing, microbiology & sterility testing, and package validation.

• On the basis of phase segment, the market is segregated into preclinical and clinical. The clinical segment accounted for the largest market share in 2024.

• The North America Medical Device Testing Services market is projected to grow at the fastest CAGR over the forecast period.

• Asia Pacific accounted for the largest market share of 41.18% in 2024. The evolving medical device testing services are expected to increase the market demand in the region, owing to established healthcare infrastructure with government initiatives.

Medical Device Testing Services Market Segmentation

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

Medical Device Testing Service Outlook (Revenue, USD Million; 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 Million; 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 Million; 2018 - 2030)

• North America

  • U.S.

  • Canada

  • Mexico

• 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

  • Argentina

  • Colombia

  • Chile

• Middle East & Africa

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

  • Israel

  • Egypt

List of Key Players of Medical Device Testing Services Market

• SGS SA

• Laboratory Corporation of America Holdings

• Nelson Laboratories, LLC

• TÜV SÜD

• Charles River Laboratories

• Element Minnetonka

• Eurofins Scientific

• Pace Analytical Services LLC

• Intertek Group Plc

• North America Science Associates Inc. (NAMSA) (WuXi AppTec)