Software As A Medical Device (SaMD) Market Trends 2025-2034: Insights into Growth and Strategic Opportunities Ahead
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How Will the Software As A Medical Device (SaMD) Market’s Growth Rate Evolve Over the Forecast Period to 2034?
The software as a medical device (SaMD) market has witnessed exponential expansion in recent years. It is expected to increase from $29,802.38 billion in 2024 to $36,884.09 billion in 2025, with a CAGR of 23.8%. Growth in the past was influenced by globalization, evolving market dynamics, increasing complexity of challenges, shared R&D costs, and sustainability initiatives.
The software as a medical device (SaMD) market is projected to see exponential growth, reaching $84,269.39 billion by 2029, growing at a CAGR of 22.9%. Factors contributing to this expansion include regulatory changes, cybersecurity challenges, AI-driven analytics, global health crises response, and the adoption of blockchain for transparency. Key trends will encompass ecosystem partnerships, rapid technological advancements, digital transformation, improved access to emerging technologies, and innovation-driven market dynamics.
Which Drivers Are Expected to Have the Greatest Impact on the Market’s Growth?
The escalating adoption of IoT within the healthcare industry is expected to enhance the growth of the software as a medical device (SaMD) market in the future. IoT in healthcare refers to medical tools and software that connect to online networks to access healthcare IT systems. One of the main applications of IoT in healthcare is remote patient monitoring, which uses connected devices and sensors to observe patients’ health and gather data from a distance. Additionally, IoT-based telemedicine is integrated into the healthcare sector, presenting an innovative technology that has the potential to transform healthcare delivery through proactive interventions, personalized care, improved patient outcomes, and increased privacy. For example, in May 2023, Medicon Publications, a US-based international publisher of open-access journals, reported that in 2021, 80% of Americans supported remote patient monitoring, with 30 million patients in the US expected to use these technologies and services by 2024. Thus, the rising integration of IoT in healthcare is driving the growth of the software as a medical device (SaMD) market.
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Who Are the Influential Players Reshaping the Software As A Medical Device (SaMD) Market Landscape?
Major companies operating in the software as a medical device (SaMD) market include:
• Apple Inc._x000D_
• McKesson Corporation_x000D_
• Thermo Fisher Scientific Inc._x000D_
• Abbott Laboratories_x000D_
• Siemens Healthcare GmbH_x000D_
What New and Evolving Trends Are Having a Lasting Impact on the Software As A Medical Device (SaMD) Market?
AI-powered software is a significant trend in the software as a medical device (SaMD) market. Leading companies in this market are focusing on developing innovative AI-driven software solutions to maintain their market presence. For example, in May 2023, Genomic Vision, a France-based biotechnology company, introduced FiberSmart, an AI-powered software designed to automate the detection and quantification of fluorescent signals on combed DNA molecules. This advanced technology facilitates the analysis of DNA replication kinetics, simplifying the alignment and separation of DNA molecules while improving the accuracy of fluorescent signal detection. Additionally, FiberSmart offers AI-powered quantification, a user-friendly interface, and scalability. It is fully compatible with Genomic Vision’s suite of scanners and has undergone successful testing and validation.
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Which Key Segments Define the Structure of the Software As A Medical Device (SaMD) Market and Their Growth 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
Which Geographic Locations Are Critical to the Growth of 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
What Are the Key Characteristics That Define the Software As A Medical Device (SaMD) Market?
Software as a medical device (SaMD) refers to software-designed devices intended to be used for medical purposes without needing a physical medical device. It is a term used to classify software applications or programs that have a medical function and are used in diagnosing, treating, or monitoring medical conditions.
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