ELECTROTHERAPY SYSTEM MARKET ANALYSIS

Market Challenges And Opportunities

Global Electrotherapy System Market - Driver

Increasing approval of the electrotherapy system by regulatory bodies

Key players operating in the market are focused on getting approval for the new technology electrotherapy system by the regulatory bodies, which is expected to drive the global electrotherapy system market over the forecast period. For instance, on March 2, 2023, Neuro20 Technologies Corp., a wearable medical device manufacturing company, received the  U.S. Food and Drug Administration (FDA) pre-market approval for its Neuro20 PRO System. The Neuro20 PRO System is the Whole-Body Electrical Muscle Stimulator Suit, Software and Operating System involuntarily contracts 42 muscles independently or by any combination of co-contraction, with control specificity for each muscle for 1 to 10 patients at a time.

Rapidly rising incidence of spinal injuries

Increasing number of incidence of spinal injuries due to rising geriatric population and hectic day to day life schedule is expected to drive the global electrotherapy system market over the forecast period. For instance, in December 2021, according to the data published by the National Spinal Cord Injury Statistical Center, it was found that there are approximately 18,000 new cases of spinal cord injury each year in the U.S. and about 282,000 persons are estimated to be living with spinal cord injury in the year 2022 in the U.S. Furthermore, according to the same source it was also estimated that in the year 2022, approximately 299,000 persons, with a range from 253,000 to 378,000 persons in the U.S. are living with spinal cord injury.

Global Electrotherapy System Market : Restraint

Stringent regulatory compliance for electrotherapy products

The major factors that hinder the growth of the global electrotherapy system market is the stringent regulatory compliance for electrotherapy products and product recalls. For instance, in August 2022, according to data published by the National Center for Biotechnology Information (NCBI), stringent rules for developing new devices are set by regulatory authorities such as the U.S. Food and Drug Administration, the European Medicines Agency, among others, owing to which the development of new medical device has become a lengthy process, which involves coordination between drug sponsors, clinical researchers, and regulatory authorities and more time is required to verify drug safety. Furthermore, in August 2022, according to data published by the National Center for Biotechnology Information (NCBI), increasing cost of performing clinical trials has become hurdle for the approval of new drugs. The reason behind rising cost of performing clinical trial includes increasing comparator drugs (an investigational or marketed product (active control) or placebo (inactive control) used as a reference in a clinical trial), increasing clinical procedures, higher failure risk, and so on. Thus, the rising cost may lead to negative effect on drug manufacturers to manufacture fewer new drugs and perform research and development activities. The above restraint can be solved by following the Current Good Manufacturing Practice (CGMP) rules for manufacturing the electrotherapy devices.

• Stringent regulatory compliance for electrotherapy products