The worldwide market for medical device testing services is projected to grow significantly, reaching approximately US$ 14,660.1 million by 2027, up from US$ 5,505.4 million in 2018. This growth represents a compound annual growth rate (CAGR) of 11.7% from 2019 to 2027.
The expansion of this market is driven by several factors, including innovative product development, strategic partnerships, mergers and acquisitions, and the increasingly stringent regulatory requirements for medical device approvals. Additionally, advancements within the medical device sector are expected to positively influence market demand throughout the forecast period. Nevertheless, the market's growth may be hindered by challenges such as disruptions in contractual agreements.
Testing medical devices requires extensive expertise in the field, a thorough understanding of both local and national regulations, as well as comprehensive knowledge about the devices themselves, the necessary infrastructure, and the capacity to facilitate testing. The healthcare and medical device sectors are highly dynamic, characterized by ongoing advancements and innovative solutions. Over the past few decades, improvements in medical device technology have greatly enhanced patient care efficiency. According to the FDA, over 80,000 incidents related to medical device injuries have been reported since 2008. In recent years, medical device manufacturers and healthcare professionals have noted that spinal cord stimulators have been beneficial for patients suffering from pain disorders, making them one of the fastest-growing products in the $400 billion medical device market. Consequently, the rising number of product recalls and the increasing demand for high-quality products are driving the need for comprehensive medical device testing services, thereby propelling market growth.
However, several challenges prevent medical devices from undergoing the same standard formulary agency review process that is applied to pharmaceuticals. In recent years, around thirty percent of industry respondents reported experiencing significant supply shortages or disruptions, primarily due to manufacturing quality issues, supply chain shortages, and delays in regulatory approvals.
The global medical device testing services market is categorized based on Service and Phase. In terms of service, the market is divided into biocompatibility testing, chemistry testing, microbiology and sterility testing, and package validation. By Phase, the market is classified into preclinical and clinical stages. In 2018, microbiology and sterility testing accounted for the largest share of the medical device testing services market, holding 53.55% of the market share by service. Meanwhile, the preclinical segment dominated the Phase category, capturing a substantial market share of 68.17% in the same year.
Key primary and secondary sources utilized in this report include the Food and Drug Administration, the World Health Organization, the International Trade Administration (ITA), the Federal Commission for Protection against Sanitary Risk (COFEPRIS), the Medicines and Healthcare products Regulatory Agency (MHRA), and the Federal Institute for Drugs and Medical Devices.