Global Software As A Medical Device (SaMD) Market Anticipated To Grow To $120.53 Billion By 2030 At 26.4% CAGR
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How Will The Market Size Of The Software As A Medical Device (SaMD) Market Progress Through 2030?
The market size for software as a medical device (samd) has experienced rapid expansion in recent years. This market is projected to grow from $38.02 billion in 2025 to $47.26 billion in 2026, achieving a compound annual growth rate (CAGR) of 24.3%. The historical growth can be attributed to factors such as telemedicine adoption, smartphone penetration, increased digital health funding, regulatory clarity, and a growing demand for remote care.
The market size for software as a medical device (samd) is projected to experience substantial growth in the coming years. It is anticipated to expand to $120.54 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 26.4%. This expected growth during the forecast period can be attributed to the increasing adoption of virtual care, developments in software-driven diagnostics, the proliferation of cloud healthcare platforms, the shift towards outcome-based reimbursement, and the modernization of hospital software. Prominent trends for the forecast period include the broader deployment of clinical decision support software, the rising popularity of remote diagnostic applications, stricter regulatory validation for medical software, the development of subscription-based samd business models, and improved integration with electronic health records.
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Which Major Factors Are Contributing To The Development Of The Software As A Medical Device (SaMD) Market?
A rise in chronic diseases is anticipated to fuel the expansion of the software as a medical device (SaMD) market in the future. These are enduring health conditions, including diabetes, heart disease, and arthritis, which typically advance gradually and necessitate continuous medical care and lifestyle adjustments to manage symptoms and avert complications. The surge in chronic diseases is primarily attributed to unhealthy lifestyle choices, such as inadequate diet, lack of physical activity, and smoking, which elevate the likelihood of developing conditions like diabetes, heart disease, and obesity. Software as a medical device (SaMD) supports the management of chronic conditions through constant tracking of patient health data, facilitating the prompt identification of issues. This technology enhances treatment results by offering tailored information and facilitating remote patient care, thereby decreasing the necessity for numerous hospital visits. As an illustration, in June 2024, the National Health Service, a UK government department, reported that 3,615,330 individuals registered with a general practitioner (GP) received a diagnosis of non-diabetic hyperglycemia or pre-diabetes (a state of elevated blood sugar not yet categorized as diabetes) in 2023. This represented an 18% rise from 3,065,825 instances recorded in 2022. Consequently, the growing occurrence of chronic diseases is propelling the expansion of the software as a medical device (SaMD) market.
What Key Segment Areas Are Included In The Software As A Medical Device (SaMD) Market Assessment?
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
Which Trends Are Influencing The Expansion Of The Software As A Medical Device (SaMD) Market?
Major companies operating in the software as a medical device (SaMD) market are increasingly prioritizing the introduction of advanced software, such as SOMNUM, to gain a significant 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, secured approval from the United States Food and Drug Administration (USFDA) for SOMNUM software. This software 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 designed to provide more accurate and sophisticated readings than conventional methods, and it can shorten the analysis of patient sleep data to under five minutes.
Who Are The Major Companies Operating In The Software As A Medical Device (SaMD) Market?
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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What Is The Largest Regional Market In The Software As A Medical Device (SaMD) Market?
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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