The global ultrasound devices market is expected to register a compound annual growth rate of about 4% between 2018 and 2023, according to a new report from Dublin-based Research and Markets. Previous estimates predict the ultrasound devices market will swell to $3.86 billion by 2021.
According to the new report, the growth of the market is to be driven largely by government and private funding for research and development of ultrasound imaging technologies. The long-term goal of these initiatives is to develop innovative, disruptive, safe, non-invasive ultrasound technologies that enable or enhance interventional therapies for the treatment of diseases, injuries, abnormalities, and other conditions.
Technological advancements and rising incidences of chronic diseases are some of the other factors that are expected contribute to the market growth. The types of ultrasound interventional therapies noted by the market analysts include ultrasound thrombolysis, high-intensity-focused ultrasound, and sonophoresis.
Potentially hampering the growth of the ultrasound device markets, the analysts say, are stringent requirements set by various regulatory bodies around the globe, such as the U.S. FDA.
The FDA’s Center for Devices and Radiological Health is responsible for regulating firms that manufacture, repackage, re-label, and import medical devices and radiation-emitting electronic products, including ultrasound equipment. As per the Code of Federal Regulation 21 CFR Part 807, manufacturers and initial distributors of ultrasound equipment must register with FDA and the registrations must be submitted electronically unless a waiver has been granted by the federal agency.
Hence, the authors of the new report urge manufacturers to closely follow all the steps set by FDA, from equipment registration to the submission of a premarket notification. The same applies for premarket approval, investigational device exemption, quality system regulation, labeling and medical device reporting, they warn.
Additionally, a lack of skilled labor is also expected to restrain growth in the global ultrasound devices market growth, which is nevertheless anticipated to continue to be dominated by North America.