Software as a Medical Device (SaMD) Global Market Report 2024

The (samd) software as a medical device market size has grown exponentially in recent years. It will grow from $24.29 billion in 2023 to $30.4 billion in 2024 at a compound annual growth rate (CAGR) of 25.2%. The historical period's growth can be ascribed to factors such as globalization, increasing complexity of challenges, market dynamics, shared research and development costs, and sustainability goals.

The (samd) software as a medical device market size is expected to see exponential growth in the next few years. It will grow to $74.86 billion in 2028 at a compound annual growth rate (CAGR) of 25.3%. The forecasted period's growth is linked to regulatory changes, cybersecurity concerns, advancements in AI and data analytics, responses to global health crises, and the utilization of blockchain for trust and transparency. Key trends in the forecast period encompass ecosystem partnerships, swift technological obsolescence, digital transformation, access to new technologies, the imperative for innovation, and technological advancements.

The anticipated growth in the software as a medical device (SaMD) market is driven by the increasing adoption of IoT in the healthcare sector. IoT in healthcare refers to medical tools and software that can connect to online computer networks to access healthcare information technology systems. A crucial application of IoT in healthcare is remote patient monitoring, which involves using connected devices and sensors to remotely monitor patients' health status and collect relevant data. The integration of IoT-based telemedicine in the healthcare sector is considered innovative, offering the potential to revolutionize healthcare delivery by enabling proactive interventions, personalized care, improved patient outcomes, and enhanced privacy. Notably, a report by Medicon Publications in May 2023 indicated that 80% of Americans favored remote patient monitoring in 2021, and an estimated 30 million patients in the US are expected to utilize remote patient monitoring technologies and services by 2024. Additionally, data from the Centers for Disease Control and Prevention in October 2022 revealed that 37.0% of individuals utilized telemedicine in 2021, with higher prevalence among women (42.0%) than men (31.7%). Hence, the increasing adoption of IoT in healthcare is a key factor propelling the growth of the SaMD market.

The factor contributing to the growth of the software as a medical device (SaMD) market is the rise in chronic diseases. Chronic diseases are long-term health conditions that persist for three months or more, and SaMD plays a crucial role in managing these conditions by enabling remote monitoring, personalized treatment plans, and timely interventions through advanced healthcare solutions. According to the World Health Organization (WHO) in September 2023, chronic diseases account for 74% of all global deaths, with 41 million deaths annually. These include 17.9 million deaths from cardiovascular diseases, 9.3 million from cancer, 4.1 million from chronic respiratory diseases, and 2.0 million from diabetes. The increasing prevalence of chronic diseases underscores the significance of SaMD in addressing healthcare challenges, further driving the growth of the SaMD market.

The software as a medical device (SaMD) market is witnessing a significant trend with the increasing popularity of AI-powered software. Leading companies in the SaMD market are actively developing innovative AI-driven software solutions to maintain their market positions. For example, in May 2023, the French biotechnology company Genomic Vision launched FiberSmart, an AI-powered software designed for the automated detection and quantification of fluorescent signals on combed DNA molecules. This technology facilitates the analysis of DNA replication kinetics, streamlining the process of detecting and quantifying fluorescent signals. FiberSmart features AI-powered detection and quantification, a user-friendly interface, and scalability. It is compatible with Genomic Vision's suite of scanners and has undergone successful testing and validation.

Major players in the SaMD market are increasingly focusing on introducing advanced software, such as SOMNUM, to gain a competitive advantage. SOMNUM is a sleep disease analysis software that incorporates the latest AI research trends and diagnostic algorithms based on multi-channel sleep biosignal data, surpassing traditional video-image-based methods. In September 2023, HoneyNaps Co., Ltd., a South Korea-based software company, received approval from the United States Food and Drug Administration (USFDA) for SOMNUM software. This deep learning-based AI software offers real-time analysis of various sleep biosignals, including electroencephalograms, electrooculograms, electromyograms, electrocardiograms, respiratory airflow and effort, and oxygen saturation. SOMNUM provides more accurate and sophisticated readings than conventional methods, enabling the analysis of patient sleep data in under five minutes.

In June 2022, Greenlight Guru, a US-based software company, acquired Smart-Trial for an undisclosed amount. This strategic move is aimed at expanding Greenlight Guru's offerings, enhancing its capabilities, extending market reach, and generating additional revenue. Smart-Trial, based in Denmark, specializes in designing software for medical devices.


Major companies operating in the (samd) software as a medical device market report are Apple Inc., McKesson Corporation, Thermo Fisher Scientific Inc., Abbott Laboratories, Siemens Healthcare GmbH, GE HealthCare 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 HealthCare Corp., iSchemaView Inc., VitalConnect Inc., Volpara Health Technologies, Tietronix Software Inc., Velentium LLC, Greenfinch Technology Ltd., MaxQ AI Ltd., IDx Technologies Inc.

North America was the largest region in the software as a medical device (SaMD) market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the (samd) software as a medical device market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the (samd) software as a medical device market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Spain, Canada.

The primary categories of devices in SaMD include wearable devices, PCs, laptops, smartphones, and tablets. Wearable devices are electronic equipment placed on or within the human body, facilitating communication with other devices to transmit or collect data. These devices can be deployed through cloud-based or on-premise solutions and find applications in diagnostic and clinical management.

The (SaMD) software as a medical device market research report is one of a series of new reports that provides (SaMD) software as a medical device market statistics, including (SaMD) software as a medical device industry global market size, regional shares, competitors with a (SaMD) software as a medical device market share, detailed (SaMD) software as a medical device market segments, market trends and opportunities, and any further data you may need to thrive in the (SaMD) software as a medical device industry. This (SaMD) software as a medical device market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The SaMD (software as a medical device) market consists of revenues earned by entities by providing diagnostic assistance, treatment planning and guidance, monitoring and remote patient management services. The market value includes the value of related goods sold by the service provider or included within the service offering. The SaMD (software as a medical device) market also includes sales of clinical decision support systems, digital diagnostics and screening tools, personal health and wellness apps, radiology imaging software, and diabetic management apps, which are used in providing SaMD (software as a medical device) services. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).


The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.