Software as a Medical Device Market to Top $5.4B in 10 Years

The global software as a medical device (SaMD) market is primed for explosive growth over the next decade.

Fact.Mr estimates the market’s value at $1.1 billion this year and expects it to swell 16.7% annually to reach $5.4 billion by 2032 as the integration of artificial intelligence (AI), and advanced technology surges in the healthcare sector. Growth drivers include the introduction of AI-based software applications and the advancement of technology. Moreover, SaMD enhances medical device effectiveness and existing treatment programs, resulting in faster and higher-quality data collection and improved health outcomes. The ability to easily seek user input on host devices also contributes to shorter market time, faster product revisions, and faster innovation. As these solutions are faster and less expensive to upgrade than hardware solutions, demand in the United States, United Kingdom, and other developed regions is expected to surge.
 
The increasing use of Internet of things (IoT) in healthcare and government efforts to improve the infrastructure also are likely to drive the market’s expansion. However, growth could be hampered by the prevalence of cybercrime and a lack of cybersecurity, which may impact consumer confidence. The market also could be affected by SaMD’s intangible character, which allows for many copies and wide distribution.
 
Regionally, Asia Pacific SaMD market will experience significant growth as a result of quick regulatory changes in medical devices and favorable policies across China and India. Furthermore, adequate government rules for developers regarding the design of diagnostics and medical devices also are expected to boost the market. Japan’s SaMD is forecast to grow 17.8% annually over the next decade.

The North American SaMD sector is forecast to expand 15.8% annually through 2032, with the U.S. dominating market share (90.2%). 
 
The SaMD sector was dominated by PCs and laptops, in terms of device type. The segment is likely to maintain its dominance during the projection period due to technological advancements in laptop designs that enable the installation of smart sensors, which is transforming the compatibility between these devices and the SaMD.
 
Based on software technology, the artificial intelligence (AI) segment grew more than 35% over the past decade. The chronic illness and disease management application market will grow by 5.2x through 2032.

Based on application, screening and diagnosis will maintain a 53.4% market share this year.

To maintain their position, key SaMD players are adopting organic growth techniques such as new developments and launches. They also are focusing on increasing their capacity as well as their worldwide presence, employing both organic and inorganic growth strategies including acquisitions and partnerships.
 
For instance, iCAD Inc. earlier this year introduced a new webinar series, ProFound Insights, ProFound Impact, which will features client success stories. Hyperfine Inc.—manufacturer of Swoop, the first FDA-cleared portable magnetic resonance imaging (MRI) system—recruited Queen’s University and Kingston Health Sciences Centre to deploy a Swoop system as part of their health services for six towns in the James Bay and Hudson Bay Area.
 
In December 2020, MaxQ AI Ltd. developed a second-generation ACCIPIO clinical platform for the healthcare sector in order to help physicians give “smarter care” through improved clinical workflow.
 
Key companies in the SaMD market include GE Healthcare, iCAD Inc., Hyperfine Research, Star Tietronix Software Inc., S3 Connected Health, Ideagen, BrightInsight Inc., Inzentiz, Zühlke Group, and Orthogonal.