Software as a Medical Device (SaMD) Market Size, Share, Growth, and Industry Analysis, By Type (Cloud-based and On-Premise), By Application (Screening and Diagnosis, Monitoring and Alerting, Chronic Disease Management, and Other), Regional Insights and Forecast From 2025 To 2033

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SOFTWARE AS A MEDICAL DEVICE (SaMD) MARKET OVERVIEW

The global software as a medical device (SaMD) market size was USD 1.43 billion in 2024, with a projected to USD 29.22 billion by 2033 at a CAGR of 39.8% CAGR during the forecast period from 2025 to 2033.

Software as a medical device is an app intended to provide one or more medical purposes without being physically connected to the body using any medical devices. These solutions can be used for various technology platforms, such as medical devices, commercial standardized systems, virtual networks, and so on. The different characteristics of these devices make them more conventional medical devices, leading to innovation in digital healthcare and maintaining patient safety. 

The rise of this industry is accredited to the rapidly increasing adoption of the Internet of Things (IoT) and connected devices for the healthcare industry as well as the multiple advantages of SaMD. However, on the downside, hackers have a chance to exploit, which ultimately impacts the industry's development.

COVID-19 IMPACT

Market Growth Accelerated by Pandemic Due to Need for Remote Healthcare

The global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden growth reflected by the rise in CAGR is attributable to the market’s growth and demand returning to pre-pandemic levels.

The effects of the COVID-19 pandemic have been observed in the market worldwide. In the initial phases, the demand for this software dropped significantly due to the closing down and slowing of the production sector. It had a direct impact on the market. The pandemic caused short-term disruptions due to workforce availability. 

The pandemic gave rise to a larger demand for this software. The pandemic has brought the concept of online service delivery and telehealth to the forefront for reaching and assisting patients virtually tending to the breach in the provision of care services and more access to health care. 

LATEST TRENDS

Technological advancements to propel market growth

The utilization of AI and machine learning algorithms in SaMD development is getting sufficient attention. AI-enabled SaMD systems have proved the ability to work successfully in different medical fields, such as recognizing skin cancer and interpreting medical images. The new era of technology and regulation is resulting in the expansion of the SaMD market where this technology is transforming healthcare using personalized, remote, and efficient care delivery mechanism

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SOFTWARE AS A MEDICAL DEVICE (SaMD) MARKET SEGMENTATION

By Type

Based on the type, the market can be categorized into cloud-based and on-premise.

• On-premise: On-premise software runs on an individual or organization's computers on the premises rather than in a remote facility. It works independently without relying on an internet connection.

• Cloud-based: Cloud-based software does not need installation. They can be accessed anywhere with the availability of the internet.

By Application

Based on the application, the market can be categorized into screening and diagnosis, monitoring and alerting, chronic disease management, and others.

• Screening and Diagnosis: SaMD can process data such as images and genetic data for analyzing the risks of possible diseases and early detection of skin cancer or heart conditions.

• Monitoring and Alerting: The SMD monitors patients with chronic conditions through wearable devices. The system can review data and take measures for health care providers or patients in case of abnormal findings.

• Chronic Disease Management: SaMD solutions are applicable for prolonged chronic illness. They serve as a reminder for medications, monitor health data, and provide tailored advice for patients to facilitate the improvement of their health.

DRIVING FACTORS

Use of SaMD on technological platforms for accessible healthcare to expand the market  

One of the key factors in the software as a medical device (SaMD) market growth is the use of SaMD on technological platforms for accessible healthcare. Telemedicine and remote patient monitoring are increasingly used by healthcare professionals who rely more on technology. They give medical professionals online access to medical records and help them communicate with their patients in real-time. They also help them to connect with other healthcare professionals online. PCs and laptops allow healthcare experts to give medical care to people in remote or health-deprived areas. Healthcare providers could reach out to a broader patient population by delivering care with the help of technology and, thus, providing more accessible services to those in need.

User-friendly solutions to boost the demand

The unique and user-friendly software solutions help doctors in diagnosis, treatment, and patient care. Through conducting research and development, establishing collaborations with healthcare professionals, and obtaining approvals from regulators, the companies contribute to the introduction of SaMD in medical organizations. The application of more advanced technologies and integrated solutions provided by them help SaMD expand and be a relevant part of healthcare in the modern age.

RESTRAINING FACTOR

Security Concerns to Impede Market Growth

The data privacy concerns in this software impede market growth. Data breaches and viruses can lead to the loss of sensitive data. Cyberattackers can interfere with the operation of software and compromise data. It is important to overcome these challenges to realize a good market development pace.

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SOFTWARE AS A MEDICAL DEVICE (SaMD) MARKET REGIONAL INSIGHTS

North America to Dominate the Market Due to the Widespread Use of Medical Technology

The market is primarily segregated into Europe, Latin America, Asia Pacific, North America, and the Middle East & Africa.

Due to the widespread use of medical technology, North America has emerged as the most dominant region in the software as a medical device (SaMD) market share. The region can provide various resources which brings the opportunity to think of more opportunities to enlarge the business. Technological advancement is the root of this dominance, which makes the region independent in innovating and applying the latest innovations. The various companies and more advanced technologies of this region, further, add to the growth in this sector as well. As a result, North America stands out as a key player, setting the standard for efficient, technologically advanced, and environmentally friendly platforms on the global stage.

KEY INDUSTRY PLAYERS

Key Players Provide Diverse Portfolio for Innovations

Major industry players have a role in developing the market by offering a variety of products. These significant players revamp the industries' standards by providing a broad array of customers with new creative options. This is because these brands have the realm of global market attention and thus they will cater to the different customer needs of different markets. The inclusion of both revolutionary advances and a wide market base is what makes them stand out among the other brands.

List of Top Software as a Medical Device (SaMD) Companies

• MindMaze (Switzerland)
• Medtronic (U.S)
• Siemens Healthcare (Germany)
• Arterys (U.S)
• Digital Diagnostics (U.S)
• Allscripts (U.S) 
• Adherium (Australia)

INDUSTRIAL DEVELOPMENT

December 2023: After receiving the “ISO 13485” certificate, ADHOCON has announced itself as a Contract Legal Manager (CLM) for SaMD and AI in healthcare. The company provides services in the development, manufacture, distribution, and support of SaMD. it specializes in healthcare and AI software solutions.

REPORT COVERAGE

This report is based on historical analysis and forecast calculation that aims to help readers understand the global software as a medical device (SaMD) market from multiple angles, which also provides sufficient support to readers’ strategy and decision-making. Also, this study comprises a comprehensive analysis of SWOT and provides insights for future developments within the market. It examines varied factors that contribute to the market growth by discovering the dynamic categories and potential areas of innovation whose applications may influence its trajectory in the upcoming years. This analysis considers recent trends and historical turning points, providing a holistic understanding of the market’s competitors and identifying capable areas for growth. 

This research report examines market segmentation by using quantitative and qualitative methods to provide a thorough analysis that also evaluates the influence of strategic and financial perspectives on the market. Additionally, the report's regional assessments consider the dominant supply and demand forces that impact market growth. The competitive landscape is detailed meticulously, including shares of significant market competitors. The report incorporates unconventional research techniques, methodologies, and key strategies tailored for the anticipated time frame. Overall, it offers valuable and comprehensive insights into the market dynamics professionally and understandably.