The global medical device testing services market size was estimated at 6.9 billion in 2019 and is anticipated to expand at a CAGR of 9.4 % over the forecast period. Increasing complexity in product design, coupled with stringent regulatory norms, is anticipated to drive the market. All medical devices have a unique set of testing requirements enforced by various regulatory bodies such as the U.S. Food and Drug Administration and the China Food and Drug Administration.
Growing trend of outsourcing medical device testing services is also projected to drive the market. Emergence of personalized medicine, drug device combination, Artificial Intelligence (AI), and wearables, coupled with increasing focus on real-time patient monitoring, has resulted in a complex medical devices ecosystem. To match these parameters, devices now have to undergo stringent testing in accelerated conditions to obtain marketing approval. 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 device 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 the market growth. These are some of the most basic tests required for all medical devices.
A rising number of companies are contributing to the growth of this market. Structurally, the global medical device industry is led by a handful of major players and a large number of small- and medium-sized enterprises (SMEs). Escalating demand from SMEs, which lack in-house capabilities, will support the market.
The medical device testing services market is segmented based on service into biocompatibility tests, chemistry test, microbiology and sterility testing, and package validation. Microbiology and sterility testing services include bio-burden determination, Pyrogen and endotoxin testing, sterility test and validation, and anti-microbial activity testing.This segment held the dominant share in 2019 and is likely to retain its lead throughout the forecast period.
Biocompatibility testing services for medical devices account for a significant share in the market owing to the lower cost of these tests. Development of novel in-vitro methods is expected to replace some of the older in-vivo tests, thereby reducing the cost of biocompatibility tests. Chemistry testing services are a great tool to identify which biocompatibility tests should be carried out and this segment is expected to witness the fastest growth during the forecast period.
On the basis of phase, the market is segmented into preclinical and clinical. Medical device testing during the preclinical phase includes testing of antimicrobial wound dressings and medical coatings. The preclinical segment accounted for the largest market share in 2019. A significant rise in preclinical spending on pharmaceutical and medical device testing is the primary factor contributing to the growth of this segment.
Medical device testing services during the clinical trial phase are also expected to witness significant growth over the next few years. The device development process comprises numerous phases, which includes cleaning validation, sterilization testing and validation, package and shipping testing, and shelf life and accelerated aging test.
Asia Pacific dominated the market in 2019 and is expected to retain its lead throughout the forecast period. This can be attributed to increasing R&D activities in this region and growing adoption of new technologies in clinical trials. Rising need for long-term therapy by patients is also driving the regional market. Contract research organizations (CROs) are investing heavily in this region due to lower costs and easy availability of skilled labor.
North America held the second-largest share in 2019 and is expected to witness rapid growth during the forecast period. Increasing complexity in product designing and growing efforts toward cost-cutting are expected to be the major factors driving this regional market.
The global market is highly competitive. Some of the key players operating in the market are Toxikon, Inc.; SGS S.A.; Eurofins Scientific, LLC; Intertek Group plc; WuXi AppTec Group; Pace Analytical Services; North American Science Associates, Inc.; Sterigenics International LLC; Charles River Laboratories International, Inc.; and American Preclinical Services LLC.
Rapid adoption of advanced healthcare technology for improved healthcare is a key parameter affecting the competitive nature of the vendor landscape. Major players undertake mergers and acquisitions along with launch of new services in order to expand their share in the market and diversify their product portfolio.
Base year for estimation
Actual estimates/Historical data
2016 - 2018
2020 - 2027
Revenue in USD Million and CAGR from 2020 to 2027
North America, Europe, Asia Pacific, Latin America, Middle East & Africa
U.S., Canada, U.K., Germany, France, Italy, Spain, Netherlands, Belgium, Switzerland, Russia, Sweden, China, India, Japan, Australia, South Korea, Malaysia, Indonesia, Singapore, Philippines, Thailand, Mexico, Brazil, Argentina, Colombia, Chile, South Africa, Saudi Arabia, UAE, Israel, Egypt
Revenue forecast, company share, competitive landscape, growth factors and trends
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis on latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global medical device testing services market report on the basis of service, phase, and region:
Service Outlook (Revenue, USD Million, 2016 - 2027)
Microbiology & Sterility Testing
Pyrogen and Endotoxin Testing
Sterility Test and Validation
Anti-microbial Activity Testing
Phase Outlook (Revenue, USD Million, 2016 - 2027)
Antimicrobial Wound Dressings
Regional Outlook (Revenue, USD Million, 2016 - 2027)
Middle East & Africa
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With Covid-19 infections rising globally, the apprehension regarding a shortage of essential life-saving devices and other essential medical supplies in order to prevent the spread of this pandemic and provide optimum care to the infected also widens. In addition, till a pharmacological treatment is developed, ventilators act as a vital treatment preference for the COVID-19 patients, who may require critical care. Moreover, there is an urgent need for a rapid acceleration in the manufacturing process for a wide range of test-kits (antibody tests, self-administered, and others). The report will account for Covid19 as a key market contributor.