Software as a Medical Device (SaMD) Market By Deployment Type (Cloud Based, On Premise) , By Application (Screening and Diagnosis, Monitoring and Alerting, Chronic Disease Management, Digital Therapeutics, Others) By End User (Hospitals and Clinics, Home Care Settings, Others) : Global Opportunity Analysis and Industry Forecast, 2024-2033
(SaMD) Software as a Medical Device Market
The (SaMD) software as a medical device market was valued at $19.5 million in 2023 and is projected to reach $96.2 million by 2033, growing at a CAGR of 17.3% from 2024 to 2033.
Software as a medical device (SaMD) is dedicated software designed for medical use through which functions are performed without the requirement of a hardware medical device. SaMD aids in managing patient health data, diagnosing health conditions, and recommending treatments. The software is highly versatile and accessible as it is easily accessible on general-purpose computing platforms such as smartphones and tablets. A key characteristic of SaMD is its potential to independently accomplish medical objectives, thereby accelerating the scope and efficiency of modern healthcare systems.
Increase in the adoption of telehealth and remote patient monitoring is a major driver of the (SaMD) software as a medical device market. In addition, support from several regulatory bodies such as the Food and Drug Administration and the European Union is boosting the demand for SaMD. To improve the healthcare providers’ assistance, the incorporation of Clinical Decision Support Systems (CDSS) is an emerging trend in the market. The capabilities of CDSS help in making evidence-based clinical decisions, thereby enhancing diagnostic accuracy and optimizing treatment procedures.
However, the integration of existing medical records and healthcare data into SaMD is a time-consuming and costly process, hence hampering the development of the (SaMD) software as a medical device market. Furthermore, usage of the software is subject to rigorous regulatory compliance by the U.S. Food and Drug Administration (FDA), which presents significant challenges for the SaMD developers. The regulatory requirements of FDA include premarket approval, strict quality check, post-market surveillance, cybersecurity requirements, and specific software modifications & updates. All these requirements ensure the reliability and efficacy of SaMD, thus preventing compromise with critical health data and patient records.
Segment ReviewThe (SaMD) software as a medical device market is segmented into deployment type, application, end user, and region. On the basis of deployment type, the market is bifurcated into cloud based and on premise. Depending on application, it is divided into screening & diagnosis, monitoring & alerting, chronic disease management, digital therapeutics, and others. As per end user, it is classified into hospitals & clinics, home care settings, and others. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.
Key FindingsOn the basis of deployment type, the cloud-based segment dominates the (SaMD) software as a medical device market.
Depending on application, the screening & diagnosis segment accounts for a high market share.
As per end user, the hospitals & clinics segment acquires a high stake in the market.
Region wise, North America is the highest revenue generator in the (SaMD) software as a medical device market.
Competition AnalysisThe major players operating in the global (SaMD) software as a medical device market include MindMaze , Siemens, Biofourmis, BrightInsight, Inc., 4S Information Systems Ltd, Viz.ai, Inc., F. Hoffmann-La Roche Ltd, Koninklijke Philips N.V., Orthogonal, and Zühlke Engineering AG. These players have adopted various key developmental strategies such as business expansion, new product launches, and partnerships to strengthen their foothold in the market.
Key Market SegmentsBy Deployment TypeCloud Based
On Premise
By ApplicationScreening and Diagnosis
Monitoring and Alerting
Chronic Disease Management
Digital Therapeutics
Others
By End UserHospitals and Clinics
Home Care Settings
Others
By RegionNorth America
U.S.
Canada
Mexico
Europe
Germany
France
UK
Italy
Spain
Rest of Europe
Asia-Pacific
Japan
China
India
Australia
South Korea
Rest of Asia-Pacific
LAMEA
Brazil
Saudi Arabia
South Africa
Rest of LAMEA
Key Market Players
MindMaze
Siemens
Biofourmis
BrightInsight, Inc.
4S Information Systems Ltd,
Viz.ai, Inc.
F. Hoffmann-La Roche Ltd
Koninklijke Philips N.V.,
Orthogonal
Zühlke Engineering AG