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Software As A Medical Device (SaMD) Market Forecast: What Value Will The Market Reach By 2030?
The market for software as a medical device (samd) has seen considerable expansion in recent years. It is projected to grow from $38.02 billion in 2025 to $47.26 billion in 2026 at a compound annual growth rate (CAGR) of 24.3%. Historically, this expansion has been driven by factors such as the widespread adoption of telemedicine, increasing smartphone penetration, substantial digital health funding, enhanced regulatory clarity, and a growing demand for remote care solutions.
The software as a medical device (samd) market size is anticipated to undergo significant growth over the next few years. It is projected to expand to $120.54 billion in 2030, demonstrating a compound annual growth rate (CAGR) of 26.4%. This expansion during the forecast period is propelled by factors such as the broadening of virtual care, software-driven diagnostics, the development of cloud healthcare platforms, outcome-based reimbursement systems, and updates in hospital software. Noteworthy trends expected in this period encompass the increased use of clinical decision support software, the rise of remote diagnostic applications, more robust regulatory validation for medical software, the adoption of subscription-based samd business models, and improved integration with electronic health records.
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Software As A Medical Device (SaMD) Market Growth Catalysts And Demand Drivers
The increasing prevalence of chronic diseases is anticipated to drive the future expansion of the software as a medical device (SaMD) market. These are enduring health conditions, such as diabetes, heart disease, and arthritis, that typically advance slowly and demand continuous medical attention and lifestyle modifications for symptom control and complication prevention. The rise in chronic diseases is largely attributable to unhealthy lifestyles, including poor diet, physical inactivity, and smoking, which heighten the risk of conditions like diabetes, heart disease, and obesity. Software as a medical device (SaMD) assists in managing chronic illnesses by facilitating constant monitoring of patient health metrics, enabling early detection of complications. It further enhances treatment outcomes by delivering personalized insights and supporting remote care, thereby lessening the need for frequent hospital visits. For example, the National Health Service, a UK-based government department, stated in June 2024 that 3,615,330 individuals registered with a general practitioner (GP) were diagnosed with non-diabetic hyperglycemia or pre-diabetes (a condition with elevated blood sugar levels, not high enough to be classified as diabetes) in 2023, reflecting an 18% increase from 3,065,825 cases in 2022. Hence, the growing incidence of chronic diseases is a key factor propelling the growth of the software as a medical device (SaMD) market.
Software As A Medical Device (SaMD) Market Segment Outlook: Which Categories Are Growing Fastest?
The software as a medical device (samd) market covered in this report is segmented –
1) By Device Type: Wearable Device, PCs And Laptop, Smartphone And Tablets
2) By Deployment Method: Cloud-Based, On-Premise
3) By Application: Diagnostic, Clinical Management
Subsegments:
1) By Wearable Devices: Smartwatches With Health Monitoring Functions, Fitness Trackers, Wearable ECG And Blood Pressure Monitors
2) By PCs And Laptops: Medical Diagnostic Software, Clinical Decision Support Software, Telemedicine Platforms
3) By Smartphone And Tablets: Mobile Health (mHealth) Apps, Remote Patient Monitoring Software, Diagnostic Imaging Apps
Software As A Medical Device (SaMD) Market Trends Shaping Long-Term Demand
Leading companies operating within the software as a medical device (SaMD) market are increasingly focusing on introducing advanced software, such as SOMNUM, to achieve a competitive advantage. SOMNUM is a sleep disease analysis software that integrates the latest AI research trends with diagnostic algorithms based on multi-channel sleep biosignal data rather than video images. For instance, in September 2023, HoneyNaps Co. Ltd., a South Korea-based software company, obtained approval from the United States Food and Drug Administration (USFDA) for its SOMNUM software. It utilizes deep learning-based AI to perform real-time analysis of various sleep biosignals, including electroencephalograms, electrooculograms, electromyograms, electrocardiograms, respiratory airflow and effort, and oxygen saturation. The software is engineered to provide more accurate and sophisticated readings than conventional methods, and it can reduce the analysis of patient sleep data to under five minutes.
Software As A Medical Device (SaMD) Market Top Companies Driving Competitive Growth
Major companies operating in the software as a medical device (samd) market are Apple Inc., Abbott Laboratories, Siemens Healthcare GmbH, GE HealthCare Technologies Inc., Roche Diagnostics, Cerner Corporation, Philips Medical Systems Ltd., Dexcom Inc., Carl Zeiss Meditec AG, Nihon Kohden Corporation, Viz.ai Inc., S3 Connected Health, Arterys Inc., BrightInsight Inc., Agfa HealthCare Corp., iSchemaView Inc., VitalConnect Inc., Volpara Health Technologies, Greenfinch Technology Ltd., MaxQ AI Ltd., IDx Technologies Inc.
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Software As A Medical Device (SaMD) Market Global Footprint: Which Region Leads The Industry?
North America was the largest region in the software as a medical device (SaMD) market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the software as a medical device (samd) market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
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