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Emerging Trends to Reshape the Software As A Medical Device (SaMD) Market: AI-Powered Software Gain A Traction In The Market as a Key Influencer

07-17-2025 12:33 PM CET | Health & Medicine

Press release from: The Business Research Company

Software As A Medical Device (SaMD) Market Size

Software As A Medical Device (SaMD) Market Size

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Software As A Medical Device (SaMD) Market Size Valuation Forecast: What Will the Market Be Worth by 2025?
In recent years, the market size of Software as a Medical Device (SaMD) has seen exponential growth. It is expected to expand from $29802.38 billion in 2024 to $36884.09 billion in 2025, reflecting a compound annual growth rate (CAGR) of 23.8%. Factors contributing to growth in the historic period include globalization, increased complexity of problems, market dynamics, joint research and development expenses, and sustainability objectives.

Software As A Medical Device (SaMD) Market Size Forecast: What's the Projected Valuation by 2029?
The upcoming years are anticipated to usher in remarkable expansion for the Software as a Medical Device (SaMD) market, which is forecasted to reach a market size of $84269.39 billion in 2029, growing at a compound annual growth rate (CAGR) of 22.9%. Factors contributing to this projected growth during the forecast period include regulatory modifications, concerns pertaining to cybersecurity, utilization of AI and data analytics, responses to global health crises, and the application of blockchain for enhancing trust and transparency. Other significant trends predicted for the forecast period encompass ecosystem collaborations, rapid tech-related obsolescence, digital transformation, exposure to emerging technologies, the urgency for innovation, and technological progress.

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What Are the Drivers Transforming the Software As A Medical Device (SaMD) Market?
The increasing integration of IoT in the medical field is anticipated to push the growth of the software as a medical device (SaMD) market forward. IoT in this context encompasses all medical equipment and software that can interface with internet-based computer networks for healare information technology system access. A key use of IoT in healare involves remote patient monitoring, which leverages connected devices and sensors to check on patients' health statuses and gather data from afar. The synergy of IoT-based telemedicine in the healare sector constitutes an innovative approach with the ability to transform healare delivery, leading to proactive interventions, personalized care, enhanced patient results, and higher privacy levels. For instance, Medicon Publications, a US-based international publisher of open access journals, reported in May 2023 that 80% of Americans approved the usage of remote patient monitoring in 2021, and it's projected that the number of patients utilizing remote patient monitoring technologies and services will hit 30 million by 2024. Therefore, such an increased acceptance of IoT in the medical field strengthens the growth of the software as a medical device (SaMD) market.

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What Long-Term Trends Will Define the Future of the Software As A Medical Device (SaMD) Market?
The rise of AI-driven software is a notable trend in the Software as a Medical Device (SaMD) market. To maintain a competitive edge, key players in the SaMD market are introducing advanced AI-based software. For example, Genomic Vision, a bio-tech company based in France, unveiled FiberSmart, an AI-powered software, in May 2023. This revolutionary software is built to automatically identify and quantify fluorescent signals on combed DNA molecules. It offers the capability to study DNA replication kinetics - the procedure of copying DNA. This technology can align and differentiate DNA molecules, simplifying the detection and quantification of fluorescent signals. FiberSmart also features AI-powered identification and quantification, a user-friendly design, and flexibility and scalability. In particular, it has proven highly effective as it works well with Genomic Vision's range of scanners.

Which Segments in the Software As A Medical Device (SaMD) Market Offer the Most Profit Potential?
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

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Which Firms Dominate the Software As A Medical Device (SaMD) Market by Market Share and Revenue in 2025?
Major companies operating in the software as a medical device (SaMD) market include Apple Inc., McKesson Corporation, Thermo Fisher Scientific Inc., Abbott Laboratories, Siemens Healare GmbH, GE Healare Technologies Inc., Roche Diagnostics, 3M Health Care, Cerner Corporation, Illumina Inc., Philips Medical Systems Ltd., Dexcom Inc., Sysmex Corporation, Carl Zeiss Meditec AG, Nihon Kohden Corporation, Zhlke Group, Viz ai Inc., Paragon Biosciences LLC, S3 Connected Health, Arterys Inc., BrightInsight Inc., Agfa Healare Corp., iSchemaView Inc., VitalConnect Inc., Volpara Health Technologies, Tietronix Software Inc., Velentium LLC, Greenfinch Technology Ltd., MaxQ AI Ltd., IDx Technologies Inc.

Which Regions Offer the Highest Growth Potential 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 2024. 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, Western Europe, Eastern Europe, North America, South America, Middle East, Africa

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4. Consultants & Analysts - To support market entry, expansion strategies, and client advisory work.

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