Medical Device Testing Services Market Analysis

Global Medical Device Testing Services Market Overview

The Medical Device Testing Services Market Size valued at USD 8.5 Billion in 2022 and is projected to grow from USD 9.29 Billion in 2023 to USD 18.92 Billion by 2032, exhibiting a compound yearly growth rate (CAGR) of 9.30% during the forecast period (2023 - 2032). Stringent regulatory requirements and standards imposed on medical device manufacturers, the growing complexity of devices, and the need for risk mitigation are the key market drivers enhancing the growth of market.

Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review

Medical Device Testing Services Market Trends

• Stringent regulatory requirements and standards are driving the market growth.

Market CAGR for medical device testing services is being driven by the rising stringent regulatory requirements and standards. Medical devices are subject to rigorous testing and quality assurance processes to make sure they are safe and effective for patient use. Advances in medical device technology leading to the development of increasingly complex devices, such as implantable devices, diagnostic equipment and digital health solutions. Comprehensive testing is essential to ensure the safety, reliability and performance of these complex devices.

Regulatory bodies, like the US Food and the Drug Administration (FDA) in the US and European Medicine Agency (EMA) in Europe, mandate thorough testing to protect patient safety. As regulations evolve and become more stringent, manufacturers increasingly rely on testing services to meet compliance requirements. There is a growing trend toward the global harmonization of medical device regulations, like the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP). These initiatives encourage standardized testing and quality standards across different regions, driving the need for consistent testing services. Further, manufacturers and healthcare organizations seek to mitigate risks associated with medical devices, including recalls and adverse events. In order to bring medical devices to market, manufacturers must demonstrate compliance with regulatory requirements. Testing services provide the necessary evidence of safety and efficiency, facilitating market entry and regulatory approvals.

High-quality testing services help manufacturers maintain their reputation and credibility by ensuring that their products meet the highest standards. Ongoing innovation in medical device technology necessitates continuous testing and validation of new features and capabilities. After a medical device is on the market, ongoing surveillance and testing are required to monitor its performance, detect issues and make improvements. Further, medical device manufacturers often expand their market presence internationally. This expansion requires compliance with various regional and national regulations, driving the need for testing services that can address diverse regulatory requirements.

A growing focus on patient-centered healthcare emphasizes the importance of safe and effective medical devices. Rigorous testing ensures that devices meet the expectations of healthcare providers and patients. The primary objective of strict approval norms is to ensure the safety of the patients and users of medical devices. Additionally, adherence to strict approval norms helps minimize the likelihood of product recalls and legal liabilities for manufacturers. Thus driving the Medical Device Testing Services market revenue.

Medical Device Testing Services Market Segment Insights

Medical Device Testing Services Service Insights

The Medical Device Testing Services Market segmentation, based on service, includes Biocompatibility Tests, Chemistry Tests and Microbiology test and sterility Tests. The microbiology & sterility test segment dominates the market and accounts for 34.2% revenue share in 2022. The dominance of the category is due to their critical role in ensuring the safety and efficacy of medical devices. Regulatory bodies like the FDA and EMA require manufacturers to adhere to stringent microbiological and sterility testing standards. It has an essential role in patient safety, quality control and mitigation of risk and has a diverse application across diverse medical device categories. The second most popular service is biocompatibility testing, as it is an indispensable service that helps manufacturers assess the compatibility of their devices with the human body.

Medical Device Testing Services Phase Insights

The Medical Device Testing Services Market segmentation, based on phase, includes Preclinical and Clinical. The clinical category dominates the market, accounting for more than 68.8% of revenue in 2022. The regulatory bodies mandate extensive clinical testing for medical devices; in order to gain regulatory approval and market access, manufacturers are required to conduct clinical trials that assess the safety and the efficacy. The clinical phase provides patient safety assurance, efficacy validation, competitive advantage, innovation support, reimbursement and insurance coverage and long-term device performance. Further, the preclinical phase is expected to attain stable growth due to a growing number of companies investing in the R&D of new medical devices for rare diseases.

Figure 1: Medical Device Testing Services Market, by Phase, 2022 & 2032 (USD Billion)

Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review

Medical Device Testing Services Regional Insights

By region, the study gives market insights into the North America, Europe, Asia-Pacific and the Rest of the World. The North American Medical Device Testing Services market area dominates the market as the region has one of the most stringent and well-established regulatory environments for medical devices. There is a presence of a large medical industry and hub for medical device innovation and technological advancements in this region. North American region has an innovation culture, extensive clinical trial activity, market access opportunities, commitment to quality assurance, access to expertise and global reach of service providers.

Further, the prime countries studied in the market report are The US, Canada, Germany, France, the U.K., Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2: MEDICAL DEVICE TESTING SERVICES MARKET SHARE BY REGION 2022 (USD Billion)

Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe's Medical Device Testing Services market accounts for the second-largest market share as the region has a strong and well-established healthcare infrastructure with advanced hospitals, research centers and healthcare professionals. Further, the German Medical Device Testing Services market held largest market share, and the U.K. Medical Device Testing Services market was the fastest-growing market in the European region.

The Asia-Pacific Medical Device Testing Services Market is expected to rise at the rapid CAGR from 2023 to 2032. This is due to expanding healthcare infrastructure, increasing medical device manufacturing and increased regulatory compliance. Moreover, China’s Medical Device Testing Services market held the largest market revenue, and the Indian Medical Device Testing Services market was the fastest-growing market in the Asia-Pacific region.

Medical Device Testing Services Key Market Players & Competitive Insights

Leading market participants are investing hugely in research and development in order to spread their product lines, which will help the Medical Device Testing Services market grow even more. Market players are also undertaking a variety of strategic activities to spread their global footprint, with important market developments including contractual agreements, new product launches, mergers and acquisitions, higher investments, and collaboration with other organizations. To spread and survive in a more competitive and rising market climate, the Medical Device Testing Services industry must offer cost-effective items.

Manufacturing locally to minimize the operational costs is one of the key business tactics used by the manufacturers in the global Medical Device Testing Services industry to benefit the clients and increase the market sector. In recent years, the Medical Device Testing Services industry has provided some of the most significant advantages to the healthcare industry. Major participants in the Medical Device Testing Services market, including SGS S.A.; Labcorp (Toxikon, Inc); American Preclinical Services; Charles River Laboratories; Sterigenics International LLC; Element Minnetonka; North America Science Associates Inc.; Eurofins Scientific; Pace Analytical Services LLC; Intertek Group Plc, and others, are attempting to increase the market demand by investing in the research and development operations.

Charles River Laboratories International Inc. is a company that provides a broader range of products and services to support the pharmaceutical, biotechnology and healthcare industries in their research and drug development efforts. Founded in 1947, the company provides a wide range of preclinical research services, including in vivo studies, pharmacology, toxicology and efficacy testing. The company specializes in safety assessment services, which involve assessing the potential risks and safety profiles of new drugs and therapies. In February 2022, Charles River Laboratories, a leading provider of preclinical research services, announced a partnership with Kibur Medical, a leading provider of implantable microdevice technology. The partnership will enable Charles River Laboratories to offer its clients access to Kibur Medical’s IMD technology for preclinical in-vivo oncology studies.

LabCorp, a leading life sciences company that specializes in diagnostic testing, drug development and clinical trial services. Headquartered in Burlington, North Carolina, LabCorp plays a crucial role in healthcare by providing a wide range of laboratory testing and diagnostic services to patients, healthcare providers, pharmaceutical companies and researchers. In November 2021, LabCorp, a leading provider of clinical laboratory services, announced the acquisition of Toxikon, a leading provider of nonclinical toxicology testing services for medical devices and pharmaceuticals. The acquisition will enable LabCorp to expand its portfolio of medical device testing services to strengthen its position in the preclinical testing market.

Key Companies in the 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.

Medical Device Testing Services Industry Developments

August 2023: Eurofins BioPharma Product Testing and Huma announced a partnership to develop and deliver digital clinical trial solutions for medical devices. The partnership will leverage Eurofins' expertise in medical device testing and Huma's expertise in digital clinical trials to help medical device companies bring their products to market more quickly and efficiently.

April 2022: Eurofins and SGS, two leading providers of medical device testing services, announced a partnership to provide their clients a wide range of medical device testing services. The partnership will also enable Eurofins and SGS to expand their global reach.

March 2021: NAMSA announced the acquisition of APS, a leading provider of preclinical testing services for medical devices. The acquisition will enable NAMSA to expand its portfolio of preclinical testing services and strengthen its position in the preclinical testing market.

Medical Device Testing Services Market Segmentation

Medical Device Testing Services Service Outlook

• Biocompatibility Tests


• Chemistry Test


• Microbiology & Sterility Test

Medical Device Testing Services Phase Outlook

• Preclinical


• Clinical

Medical Device Testing Services Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America