The Business Research Company’s 2026 market reports feature enhanced tools like market attractiveness analysis, TAM assessment, and company scoring matrices, along with interactive dashboards, deeper supply chain insights, and startup coverage strengthening the depth, usability, and strategic value of insights.
What Level Of Market Value Growth Is Predicted For The Software As A Medical Device (SaMD) Market From 2026 To 2030?
The market for software as a medical device (samd) has experienced rapid expansion over recent years. Forecasts indicate it will expand from $38.02 billion in 2025 to $47.26 billion in 2026, demonstrating a compound annual growth rate (CAGR) of 24.3%. Historically, this growth is primarily due to factors such as telemedicine adoption, increasing smartphone penetration, significant digital health funding, clearer regulatory frameworks, and a rising demand for remote care solutions.
The software as a medical device (samd) market is projected to experience substantial expansion in the coming years. By 2030, its valuation is anticipated to reach $120.54 billion, demonstrating a compound annual growth rate (CAGR) of 26.4%. This projected growth during the forecast period is primarily fueled by factors such as the expansion of virtual care, the rise of software-driven diagnostics, the adoption of cloud healthcare platforms, outcome-based reimbursement models, and ongoing hospital software modernization. Key trends expected within this period encompass the wider deployment of clinical decision support software, the proliferation of remote diagnostic applications, enhanced regulatory approval for medical software, the emergence of subscription-based samd business models, and improved integration with electronic health records.
Access Your Free Sample Report For In-Depth Market Analysis:
What Key Drivers Are Fueling The Growth Of The Software As A Medical Device (SaMD) Market?
The rising occurrence of chronic illnesses 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, that typically advance gradually and necessitate continuous medical care and lifestyle adjustments to manage symptoms and avert complications. The growth in chronic diseases is primarily attributed to unhealthy habits like poor diet, lack of physical activity, and smoking, which heighten the likelihood of developing conditions such as diabetes, heart disease, and obesity. Software as a medical device (SaMD) assists in managing chronic conditions by facilitating the constant tracking of patient health data, leading to the prompt identification of complications. Moreover, it enhances treatment results through personalized insights and remote care support, thereby decreasing the necessity for numerous hospital visits. As an illustration, data from the National Health Service, a UK-based government department, revealed 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. This represented an 18% rise from 3,065,825 cases recorded in 2022. Consequently, the expanding prevalence of chronic illnesses is propelling the growth of the software as a medical device (SaMD) market.
How Is The Software As A Medical Device (SaMD) Market Organized By Segment Classification?
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
What Trends Are Influencing The Software As A Medical Device (SaMD) Market?
Leading entities within the software as a medical device (SaMD) sector are intensifying their efforts to launch sophisticated software solutions, like SOMNUM, to secure a market advantage. SOMNUM functions as a sleep disorder analysis program, incorporating contemporary AI research advancements with diagnostic algorithms derived from multi-channel sleep biosignal data, in contrast to relying on video imagery. An illustrative example is HoneyNaps Co. Ltd., a software firm from South Korea, which obtained approval for its SOMNUM software from the United States Food and Drug Administration (USFDA) in September 2023. This software leverages deep learning-powered AI to conduct real-time examinations of diverse sleep biosignals, such as electroencephalograms, electrooculograms, electromyograms, electrocardiograms, respiratory airflow and effort, and oxygen saturation. Designed to deliver superior accuracy and complexity in readings compared to traditional approaches, the software can also reduce the processing time for patient sleep data to less than five minutes.
Who Are The Industry Participants Involved 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.
Get The Full Software As A Medical Device (SaMD) Market Report:
Which Region Has The Greatest Market Share 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.
Request A Customized Software As A Medical Device (SaMD) Market Report For Competitive Insights:
Browse Through More Reports Similar to the Global Software As A Medical Device (SaMD) Market 2026, By The Business Research Company
Medical Equipment Market Report 2026
https://www.thebusinessresearchcompany.com/report/medical-equipment-global-market-report
Medical And Diagnostic Laboratory Services Market Report 2026
Medical Aesthetics Market Report 2026
https://www.thebusinessresearchcompany.com/report/medical-aesthetics-global-market-report
Get in touch with us:
The Business Research Company: https://www.thebusinessresearchcompany.com/
Americas +1 310-496-7795
Asia +44 7882 955267 & +91 8897263534
Europe +44 7882 955267
Email us at info@tbrc.info
Follow us on:
LinkedIn: https://in.linkedin.com/company/the-business-research-company
YouTube: https://www.youtube.com/channel/UC24_fI0rV8cR5DxlCpgmyFQ
Global Market Model: https://www.thebusinessresearchcompany.com/global-market-model