The global medical device testing services market is anticipated to grow at a compound annual growth rate of 11.7% from 2019 to 2027, reaching $14.66 billion, according to a new report from

Innovative product developments, collaborations, mergers and acquisitions, and the stringent medical device approval process will boost market growth during the forecast period, researchers project. Also, advancements in the medical device sector are buoying the global medical device testing services market. Impeding growth, however, are factors such as interruptions in contractual obligations.

Moreover, “medical device testing needs strong experience of the domain, native and national legislations, and information about the devices, infrastructure, and ability to support testing,” ResearchAndMarkets.comexperts say. And since the healthcare market is continuously advancing—and introducing technologies that significantly improve patient care—the need to test devices is more important than ever.

After all, without adequate testing, the patient consequences can be severe. Last year, in fact, the U.S. FDA reported that it identified more than 80,000 medical device-related patient injuries since 2008. 

However, numerous problems inhibit medical devices from undertaking the standard formulary agency review process applied to drugs, ResearchAndMarkets.comexperts say. In recent years, approximately 30% of respondents experienced a significant supply shortage or disruption that was mostly due to supply shortages, quality issues in manufacturing, and delays in regulatory approvals.

Finally, the global medical device testing services market is segmented by service and phase. On a service basis, the market is divided into biocompatibility tests, chemistry tests, microbiology and sterility testing, and package validation. And on a phase basis, the market is grouped into preclinical and clinical medical device testing.

In 2018, the microbiology and sterility testing market accounted for more than half of the medical device testing services sector—53.6%—while the preclinical phase segment held 68% market share.