The medical device analytical testing outsourcing market is projected to generate $10,904.8 million revenue by 2030, advancing at a CAGR of 9.8% during 2021–2030. In 2021, the hospitals category accounted for the largest revenue share, of more than 84%, based on end use. This can be attributed to the increase in the patient traffic, rise in the chronic illness prevalence, and rise in the budget allocation of hospital administrations to get their devices tested and validated for safety and effectiveness.
Furthermore, due to the technical improvements and the availability of highly dependable medical equipment, there has been a rise in the use of medical devices. Therefore, the existence of well-established healthcare infrastructure also provides significant market prospects.
In addition, with this, the demand for bioburden testing is expected to rise significantly throughout the forecast period. Outsourcing organizations may perform bioburden testing for locations exposed to patients, as well as the interior sections of medical devices and their packaging material, based on customer requirements. Outsourcing partners provide risk assessment reports and other ancillary services in addition to analyzing the load of live microorganisms on the surface of medical devices.
The prevalence of diabetes is rapidly increasing on a global level. According to government sources, diabetes was the cause of 1.5 million deaths worldwide in 2019. Moreover, approximately 48% of the fatalities occurred before the age of 70. Furthermore, diabetes affected around 34 million people in the U.S., according to the Diabetes Statistics Report 2020.
The fast-increasing incidence of diabetes may be credited for the lucrative medical device analytical testing outsourcing market’s growth potential in the coming years, as it will increase the demand for blood glucose monitoring equipment. The growing demand for such devices is leading to their high-volume manufacturing, which is, in turn, propelling the requirement for analytical testing services.
North America was the second-largest market in 2021, with a share of approximately 27%. The rapid increase in medical device production, to cater to the high demand for quality healthcare is projected to drive the market growth in the continent. Furthermore, the development of low-cost medical equipment is expected to have a favorable impact on the market throughout the forecast period.
Moreover, the rising frequency of cardiovascular disorders in North America is increasing the need for medical equipment. According to a survey, around 647,000 individuals die in the U.S. each year as a result of cardiovascular disorders. Hence, numerous firms in North America are engaged in manufacturing medical devices in accordance with the validation requirements, in order to meet client expectations.
Players in the market have been involved in mergers to remain competitive. For instance, in May 2021, EAG Laboratories announced the expansion of its medical device testing capabilities with a new 20,000-square-foot laboratory in the U.S.
Key Players operating in the medical device analytical testing outsourcing market are EAG Laboratories, Envigo, WuXi AppTec Co. Ltd., The Smithers Group Inc., Pace Analytical Services LLC, North American Science Associates Inc., Charles River Laboratories International Inc., Medistri SA, and BDC Laboratories.