Medical Device Testing Services Industry Overview

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.

Gather more insights about the market drivers, restrains and growth of the Medical Device Testing Services Market 

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.

Browse through Grand View Research's Medical Devices Industry Research Reports.

• The global biosimilar contract manufacturing market size was valued at USD 8.59 billion in 2023 and is expected to grow at a CAGR of 15.9% from 2024 to 2030. 
  
  
• The global fill-finish pharmaceutical contract manufacturing market size was estimated at USD 17.95 billion in 2024 and is projected to grow at a CAGR of 8.3% from 2025 to 2030.

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 (EL)
  • 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
  • US
  • 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

Key Companies profiled:

• 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

Recent Developments

• In November 2023, Intertek announced its partnership with Emitech Group, a French independent testing engineering specialist.
• In June 2023, TÜV SÜD opened a new laboratory in Minnesota. It is ISO 17025 accredited for the biological chemical testing of medical devices. It is a part of the company’s commitment to providing high-quality medical device services.
• In April 2023, Nelson Labs announced that the company is ASCA-accredited testing laboratory by the U.S. FDA within the category of biocompatibility.

Order a free sample PDF of the Medical Device Testing Services Market Intelligence Study, published by Grand View Research.