Software as a Medical Device (SaMD) Market Size to Reach USD 7,125.7 Million in 2032
The Software as a Medical Device (SaMD) Market size was USD 2,048.8 Million in 2024 and is expected to register a revenue CAGR of 17.2% during the forecast period
February 8th, 2025 – Rapid implementation of software as a medical device (SaMD) in point-of-care (PoC) diagnostics driving market revenue growth in the Software as a Medical Device (SaMD) market. Hospitals, clinics, and healthcare professionals use SaMD to rapidly access and analyze patients’ medical histories and current test findings.
Electronic health records (EHRs) and other point-of-care (PoC) systems serve as a digital toolset for delivering essential patient information. Internet access has considerably accelerated the growth of connected point-of-care (PoC), notably for In vitro diagnostics (IVD) testing. According to the International Telecommunication Union (ITU), 67% of the world population, or 5.4 billion people have access to internet.
Federal organizations such as the United States Food and Drug Administration (FDA) and the European Medical Association (EMA) have set defined guidelines for AI and machine learning integration across healthcare platforms, which are predicted to drive growth throughout the projected period. For example, the US FDA has introduced the AI/ML SaMD Action Plan, while the European Union (EU) has established the AI Act.
These advancements have accelerated generative AI discoveries in drug discovery, personalized healthcare, predictive analytics, and early illness diagnosis. In December 2024, The Food and Drug Administration (FDA) issued new recommendations aimed at streamlining the approval process for medical devices incorporating artificial intelligence (AI).
However, Concerns over data security are also predicted to impede market revenue development. Software deployment is largely reliant on large volumes of data to produce diagnostic results. The breach of individual and patient healthcare data may have an impact on a company’s reputation. According to the FBI, the Internet Crime Complaint Centre (IC3) received 1,193 reports from organizations in critical infrastructure sectors affected by ransomware attacks.
Key Highlights:
- The mobile apps segment is expected to register the fastest revenue growth over the forecast period. Mobile apps are revolutionizing healthcare delivery by enabling individual patients to get personalized assistance, real-time tracking, and therapeutic treatments via mobile devices. Additionally, FDA clearance is expected to drive the segment’s growth. For example, on January 27th, 2025, PanopticAI received 510(k) clearance from the US Food and Drug Administration (FDA) for their contactless vital sign monitoring software.
- The hospitals & clinics segment contributed a significant revenue share in 2024. Hospitals and clinics rely heavily on software as a medical device (SaMD) to constantly monitor and assess data from hospitalized patients. SaMD systems are widely used in hospitals and clinics to provide key functions such as patient monitoring, diagnostic decision support, chronic illness management, and remote patient care.
- North America registered the highest market share in the Software as a Medical Device (SaMD) Market. The rising prevalence of chronic ailments is fuelling market revenue growth in this region. Software as a Medical Device (SaMD) is widely used to treat chronic illnesses by analysing numerous data points obtained from electronic health records.
- According to research conducted by the Centres for Condition Control and Prevention (CDC) of the United States Department of Health and Human Services, approximately 129 million Americans have at least one serious chronic ailment, including heart disease, cancer, diabetes, obesity, or hypertension.
- Some major companies in the global Software as a Medical Device (SaMD) Market report include Medtronic PLC, GE HealthCare, Samsung Medison Co., Ltd., Click Therapeutics, Inc., Median Technologies SA, Capgemini SE, Hyperfine, Inc., Medisafe, BioT Healthcare Ltd., VUNO Inc, Siemens AG, Koninklijke Philips N.V., Monitor Corporation, WellSky Corporation, PanopticAI Ltd., AccurKardia, Inc., Nanowear Inc., AgileMD, Inc and Others.
- In October 25th 2024, WellSky Corporation completed its acquisition of Bonafide. This acquisition supports WellSky to grow its footprint in the DME/HME sector by providing a comprehensive software platform that helps providers manage their operations in a compliant, efficient, and lucrative way.
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Navistrat Analytics has segmented the Software as a Medical Device (SaMD) Market in the areas of type, deployment, technology, application, end-use, and region:
- Type Outlook (Revenue, USD Million; 2022-2032)
- Standalone Software
- Mobile Apps
- Web-based Platforms
- Wearables
- Deployment Outlook (Revenue, USD Million; 2022-2032)
- Cloud-based
- On-Premise
- Hybrid
- Technology Outlook (Revenue, USD Million; 2022-2032)
- Artificial Intelligence & Machine Learning (AI/ML)
- Internet of Medical Things (IoMT)
- Big Data Analytics
- Blockchain
- Others
- Application Outlook (Revenue, USD Million; 2022-2032)
- Diagnosis & Screening
- Radiology & Imaging Analysis
- Pathology & Laboratory Analysis
- Genetic Testing & Molecular Diagnostics
- Monitoring & Disease Management
- Chronic Disease Monitoring
- Neurological Disorders Monitoring
- Respiratory Monitoring
- Therapeutic Applications
- Pain Management Software
- Virtual Rehabilitation & Physical Therapy
- Remote Patient Monitoring (RPM) & Telehealth
- Wearable-connected Health Platforms
- Telemedicine Software
- Home-based Patient Monitoring
- Others
- Diagnosis & Screening
- End-Use Outlook (Revenue, USD Million; 2022-2032)
- Hospitals & Clinics
- Diagnostic Imaging Centers
- Homecare Settings
- Research Institutions & Universities
- Pharmaceutical & Biotechnology Companies
- Individuals
- Regional Outlook (Revenue, USD Million; 2022-2032)
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- France
- U.K.
- Italy
- Spain
- Benelux
- Nordic Countries
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- South Korea
- Oceania
- ASEAN Countries
- Rest of APAC
- Latin America
- Brazil
- Rest of LATAM
- Middle East & Africa
- GCC Countries
- South Africa
- Israel
- Turkey
- Rest of MEA
- North America