Introduction
The Global Software as a Medical Device (SaMD) market size is expected to reach a market value of approximately USD 1.53 billion by 2024, with a projected revenue increase at a CAGR of 14.3% from 2025 to 2032. According to the International Medical Device Regulators Forum (IMDRF), software as a medical device, or SaMD, is a software intended for one or more medical purposes that performs those purposes without being part of a hardware medical device. SaMD is essential in modern healthcare. It has a broad range of applications across platforms like desktop software, cloud services, and mobile apps, ranging from diagnostic tools and illness management solutions to treatment monitoring systems. The rising incidence of chronic diseases, the need for remote patient monitoring, and developments in digital health technologies like artificial intelligence and machine learning are major growth drivers. Market growth is also supported by the growing use of smartphones and other connected devices, as well as the move toward preventive and personalised care.
Key Highlights
Market Dynamics
Rising Incidence of Chronic Diseases Led to a Growing Demand for Advanced Medical Solutions
The primary factors driving the growth of the market are the rise of Software as a Medical Device (SaMD) due to increasing chronic diseases, including diabetes, cardiovascular conditions, respiratory ailments, and cancer. According to American Heart Association Research published in the year of 2024, Cardiovascular disease (CVD) is listed as the underlying cause of death and accounted for 931,578 deaths in the United States in 2021. SaMD solutions help patients in such scenarios by providing strong support for the long-term care, ongoing monitoring, and early medical treatments that are necessary for these illnesses. For instance, cardiac monitoring software that detects arrhythmias in real-time or diabetes management apps that monitor blood sugar levels and suggest insulin dosages offer patients and medical professionals relevant information that improves outcomes and lowers readmission rates to hospitals. Such growing advancements in medical software provide consumers a chance to stay ahead of the major problems and help in their well-being. Thus, this has led to increasing demand for various advanced medical solutions, mostly in developed and developing countries.
Advancements in Digital Technologies, Such as Artificial Intelligence and Machine Learning, are Paving a New Path for the Market Growth
SaMD solutions can manage large amounts of health data, identify complex trends, and perform very accurate predictive analyses. This is particularly significant in fields like medical imaging, where AI-powered SaMD may more quickly and precisely identify early indicators of diseases like cancer or neurological abnormalities than standard methods. Personalised medicine is also utilising machine learning algorithms to customise therapy recommendations based on genetic profiles, real-time monitoring, and unique patient data. Additionally, SaMD-integrated chatbots and virtual assistants driven by AI are improving patient involvement and self-management, particularly in the treatment of chronic diseases.
Global Software as a Medical Device (SaMD) Market Segmentation
By Device Type / Application
Diagnostic Software holds the largest segment of the SaMD market, which is nearly 52.8% of the total market share. This lead is due to the extensive use of AI-powered diagnostic technologies, including radiology image analysis, ECG interpretation, and cancer detection software. The growing demand for precise and efficient diagnostic solutions has brought this category to the highest level of the SaMD market.
Monitoring Software is expected to be the fastest-growing category of the SaMD market between 2025 and 2030. This growth is being driven by the increasing use of remote patient monitoring technologies, wearable integrations, and real-time vital sign tracking. The trend to telehealth and home-based care, particularly in light of global health issues, has increased demand for monitoring software that allows for continuous patient oversight outside of traditional clinical settings. This tendency is likely to considerably contribute to the segment's rapid growth during the forecast period.
By Technology
Cloud computing has the highest share of the Software as a Medical Device (SaMD) market, owing to its extensive implementation in healthcare settings. Its capacity to provide scalable data storage, real-time access, and smooth system integration makes it a popular choice among hospitals, clinics, and digital health platforms. Cloud infrastructure, whether in public, private, or hybrid models, enables critical activities including remote patient monitoring, data analytics, and telemedicine services. Its scalability and flexibility have made cloud technology the foundation of many SaMD solutions.
AI and Machine Learning (ML) are expected to be the fastest-growing technologies in the SaMD industry between 2025 and 2030. These technologies are transforming healthcare by providing predictive analytics, customised treatment methods, and improved diagnostic accuracy. The integration of AI and ML into SaMDs is expected to improve patient outcomes and operational efficiency, resulting in significant growth in this market during the forecast period.
By Therapeutic Area
Diabetes management leads the Software as a Medical Device industry, due to the increased usage of digital technologies for continuous glucose monitoring, insulin dose assistance, and lifestyle tracking. These solutions have considerably increased patient engagement and glycaemic management, making diabetes care the most visible therapeutic application in the SaMD landscape.
Advancements in AI-powered diagnostic tools, individualised treatment planning, and remote monitoring technologies are transforming cancer care. Oncology is expected to be the fastest-growing therapeutic area in the SaMD market between 2025 and 2030, and the growing desire for early detection and personalised therapy is driving rapid adoption of SaMD applications in oncology.
By Deployment Mode
Cloud-based deployment is dominating the SaMD market in 2024. The growth of this segment can be attributed to the cloud systems providing scalable infrastructure, seamless software updates, and easy access from numerous devices and places. This mode is particularly versatile because it can support public, private, and hybrid cloud models, meeting a wide range of security, regulatory, and operational concerns in healthcare. Cloud-based SaMD enables remote patient monitoring, telehealth, and large-scale data analytics, all of which are crucial in today's healthcare ecosystems.
Mobile-based deployment is expected to be the fastest-growing segment of the Software as a Medical Device industry. The increasing number of users of cell phones and wearable devices has significantly raised the involvement of patients and enabled real-time health monitoring outside of traditional clinical settings. Mobile SaMD applications have become crucial tools for managing chronic diseases, providing mental health care, and tracking wellness. The combination of ease and intuitive user interfaces is propelling their rapid adoption, particularly in consumer-focused healthcare delivery.
By End User
Hospitals and clinics currently account for the largest share of the SaMD market. It encompasses both inpatient and outpatient settings, where SaMD technologies help with diagnosis, treatment planning, patient monitoring, and clinical decision support. Healthcare practitioners rely largely on these tools to increase service efficiency, prevent errors, and handle difficult cases.
Mobile health applications, wellness and fitness apps, enable individuals to manage their health more proactively outside of clinical settings. This acts as a major driver for the growth of the direct-to-consumer segment, which is predicted to be the fastest-growing in the SaMD market. This expansion is being driven by increased smartphone usage, greater health awareness, and demand for modified, convenient healthcare.
Global Software As a Medical Device (SaMD) Market Regional Analysis
North America has the largest share of the global Software as a Medical Device (SaMD) market. This dominance is driven by a well-developed healthcare ecosystem, widespread use of innovative digital health technology, and an effective regulatory framework. The presence of prominent SaMD firms, as well as major investments in AI and telehealth technologies, helps to boost the region's position.
Asia-Pacific is predicted to be the fastest-growing region in the SaMD market over the forecast period. Rapid healthcare digital transformation, increased government support for technology integration, and expanding demand for remote care solutions all contribute to this expansion. Key markets, including China, India, and Japan, are rapidly adopting mobile health platforms and AI-powered diagnostic tools.
Europe's steady expansion is driven by established healthcare infrastructure and increased demand for customised therapy. South America is starting to develop with increasing mobile health usage despite certain infrastructure challenges. The Middle East and Africa are gradually developing due to healthcare modernisation and increased investment in digital health projects.
Prominent Players in the Market:
Prominent companies in the SaMD market include Philips N.V., Siemens Healthineers, Medtronic, GE Healthcare, F. Hoffmann-La Roche Ltd, Apple Inc., Illumina Inc., which are focusing on extending their AI-based diagnostic capabilities and cloud-integrated platforms to enhance patient outcomes and streamline workflows. Companies such as Abbott and Dexcom are revolutionising diabetes care with continuous glucose monitoring and real-time data systems. Butterfly Network and Eko Health are two emerging companies developing mobile imaging and smart diagnostic devices. Partnerships, product innovation, and regulatory compliance are critical to their efforts to increase market presence and growth.
Recent developments
Sept 2024, Medtronic announced the commercial launch of several software, hardware, and imaging innovations, as well as a collaboration with Siemens Healthineers to explore opportunities to expand access to advanced pre- and post-operative imaging technologies for spine care at the North American Spine Society's (NASS) 39th Annual Meeting in Chicago
Research Methodology
At Stats and Research, we adopt a rigorous, data-driven methodology to ensure our market research reports provide accurate, reliable, and actionable insights. Our structured approach combines both qualitative and quantitative research techniques, utilizing advanced data analytics, statistical modelling, and market intelligence tools to offer well-rounded perspectives on the market.
Our research process follows four key stages:
1. Research and Data Collection
Our data collection is based on a comprehensive, three-pillar approach:
Primary Research: We directly engage with industry leaders, executives, product managers, investors, distributors, regulatory bodies, and end-users. This is done through structured interviews, surveys, and consultations to gather real-time insights.
Secondary Research: We examine secondary data sources like company financials, government reports, regulatory filings, investor presentations, whitepapers, trade association reports, and industry publications to build a foundational understanding of the market.
Product or Services Mapping: We analyze product portfolios, service offerings, and revenue breakdowns across global, regional, and local levels. This helps us assess market share, product penetration, and competitive positioning, identifying industry trends and growth opportunities.
Key Data Sources:
Government and International Databases: OECD, FAO, IMF, World Bank, WTO, National Statistics Bureaus, etc.
Industry Journals & Publications: Technium, Science, MDPI, MarketLine, ResearchGate, etc.
Company Reports: Annual reports, press releases, investor briefings, regulatory disclosures, etc.
Trade Associations & Market Intelligence Databases: Insights from financial institutions, manufacturing groups, and professional bodies.
This comprehensive approach ensures that our findings are grounded in credible and verified data sources.
2. Data Pre-Processing and Standardization
In this stage, we focus on ensuring data accuracy and consistency through:
Data Refinement: We identify and resolve gaps, inconsistencies, and anomalies in the collected data to ensure its completeness and reliability.
Standardization: Data is converted into uniform formats and measurement units, enabling seamless comparison across regions, products, and segments.
This meticulous preparation ensures that the data used in our analysis is clean, validated, and optimized for precise market analysis.
3. Market Estimation and Forecasting
Our market estimation model combines both Top-Down and Bottom-Up approaches to ensure a well-rounded and validated market assessment:
Top-Down Approach: We begin with macro-level estimations of market size, breaking it down by region, industry segment, and product category, using key economic indicators and market dynamics.
Bottom-Up Approach: We aggregate data from individual companies, product categories, and regional markets to ensure micro-level accuracy in our estimates.
Each forecast model is customized to the specific characteristics of the market, guaranteeing precision in future projections.
4. Quality Assurance and Validation
To ensure the highest level of data accuracy and reliability, our research undergoes multiple layers of validation:
Data Triangulation: We cross-verify insights from both primary and secondary sources to ensure consistency and reliability.
Expert Review Panels: We collaborate with industry professionals and market analysts to validate our findings and methodologies.
Client & Stakeholder Feedback: We ensure that the research findings align with the needs and expectations of our clients and stakeholders.
Plausibility & Consistency Checks: We perform historical data validation and time-series tests to ensure the logical consistency of our market estimates.
This rigorous validation process guarantees that our insights are credible, precise, and actionable.
Conclusion
By combining structured data collection, robust estimation methods, and comprehensive validation, our methodology ensures that we deliver high-quality, accurate market insights tailored to meet the specific needs of our clients.
Market Taxonomy
Regional Coverage
1. Executive Summary
1.1. Market Definition
1.2. Market Introduction
1.3. Segmental Analysis (%), 2024
2. Research Methodology
2.1. Data Collection Process
2.2. Data Collection Methodology
2.3. Primary and Secondary Research
2.4. List of Sources
3. Market Forecast
3.1. Market Value Projection 2025 - 2032 (USD Bn) and Y - o - Y Growth (%)
3.2. Incremental $ Opportunity
4. Software as a Medical Device (SaMD) Market Analysis By Device Type
4.1. Introduction
4.2. Historical Market Size Analysis 2022 - 2024 and Forecast 2025 - 2032 Analysis, By Device Type (USD Bn)
4.2.1. Monitoring Software
4.2.1.1. Remote Patient Monitoring
4.2.1.2. Vital Signs Monitoring
4.2.1.3. Wearable Integration
4.2.1.4. Glucose Monitoring
4.2.1.5. Sleep Monitoring
4.2.1.6. Respiratory Monitoring
4.2.1.7. Post - operative Recovery Monitoring
4.2.2. Diagnostic Software
4.2.2.1. Radiology Image Analysis
4.2.2.2. ECG Interpretation
4.2.2.3. Diagnostic Decision Support
4.2.2.4. Cancer Detection & Screening
4.2.2.5. Infectious Disease Diagnostics
4.2.3. Therapeutic Software
4.2.3.1. Cognitive Behavioural Therapy (CBT)
4.2.3.2. Virtual Physical Therapy
4.2.3.3. Diabetes Management Algorithms
4.2.3.4. Pain Management
4.2.3.5. Medication Adherence Support
4.2.3.6. Insulin Dose Calculators
4.2.4. Chronic Disease Management
4.2.4.1. Hypertension
4.2.4.2. Asthma
4.2.4.3. Cardiovascular Disease Management
4.2.4.4. Diabetes Management Platforms
4.2.4.5. Other Long - term Condition Trackers
4.2.5. Others
4.2.5.1. Sleep Disorders
4.2.5.2. Ophthalmology
4.2.5.3. Oncology Support Software
4.2.5.4. Womens Health Tracking
4.3. Market Attractiveness Analysis By Device Type
5. Software as a Medical Device (SaMD) Market Analysis By Technology
5.1. Introduction
5.2. Historical Market Size Analysis 2022 - 2024 and Forecast 2025 - 2032 Analysis, By Technology (USD Bn)
5.2.1. Artificial Intelligence (AI) & Machine Learning (ML)
5.2.1.1. Predictive Analytics
5.2.1.2. Natural Language Processing (NLP)
5.2.1.3. Image Recognition & Interpretation
5.2.1.4. Clinical Decision Support Systems (CDSS)
5.2.2. Cloud Computing
5.2.2.1. Public Cloud
5.2.2.2. Private Cloud
5.2.2.3. Hybrid Cloud
5.2.3. Big Data & Analytics
5.2.3.1. Real - Time Data Processing
5.2.3.2. Patient Risk Stratification
5.2.3.3. Predictive Analytics
5.2.3.4. Clinical Decision Support
5.2.4. Internet of Things (IoT)
5.2.4.1. Wearable Integration
5.2.4.2. Smart Medical Devices
5.2.4.3. Remote Patient Monitoring Systems
5.2.4.4. Smart Hospital Infrastructure
5.2.5. Blockchain
5.3. Market Attractiveness Analysis By Technology
6. Software as a Medical Device (SaMD) Market Analysis By Deployment Mode
6.1. Introduction
6.2. Historical Market Size Analysis 2022 - 2024 and Forecast 2025 - 2032 Analysis, By Deployment Mode (USD Bn)
6.2.1. Cloud - Based
6.2.1.1. Public Cloud
6.2.1.2. Private Cloud
6.2.1.3. Hybrid Cloud
6.2.2 On - Premise
6.2.3. Web - Based
6.2.4 Mobile - Based
6.3. Market Attractiveness Analysis By Deployment Mode
7. Software as a Medical Device (SaMD) Market Analysis By Therapeutic Area
7.1. Introduction
7.2. Historical Market Size Analysis 2022 - 2024 and Forecast 2025 - 2032 Analysis, By Therapeutic Area (USD Bn)
7.2.1 Cardiology
7.2.1.1 Arrhythmia Detection & Monitoring
7.2.1.2 Heart Rate Variability Analysis
7.2.1.3. ECG Interpretation & Alerts
7.2.1.4. Cardiac Rehabilitation Apps
7.2.1.5. Blood Pressure Monitoring
7.2.1.6. Other Cardiological Applications
7.2.2. Neurology
7.2.2.1. Seizure Detection
7.2.2.2. Stroke Detection & Recovery Monitoring
7.2.2.3. Multiple Sclerosis Tracking
7.2.2.4. Cognitive Function Assessment
7.2.2.5. Parkinson's Disease Monitoring
7.2.2.6. Others Neurological Applications
7.2.3. Radiology
7.2.3.1. MRI/CT Image Interpretation
7.2.3.2. X - Ray Analysis
7.2.3.3. Mammography Software
7.2.3.4. 3D Imaging & Segmentation
7.2.3.5. Computer - Aided Diagnosis (CAD)
7.2.3.6. Others Radiological Applications
7.2.4. Diabetes Management
7.2.4.1. Continuous Glucose Monitoring (CGM) Integration
7.2.4.2. Dosing Calculators
7.2.4.3. Diet & Nutrition Trackers
7.2.4.4. Hypoglycemia Alerts
7.2.4.5. Lifestyle Coaching Tools
7.2.4.6. Risk Stratification and Complication Prevention
7.2.5. Mental Health
7.2.5.1. Cognitive Behavioral Therapy (CBT) Apps
7.2.5.2. Mood & Emotion Tracking
7.2.5.3. Depression & Anxiety Screening Tools
7.2.5.4. Sleep Disorder Tracking
7.2.5.5. Remote Monitoring by Clinicians
7.2.6. Respiratory
7.2.6.1. COPD Monitoring & Alerts
7.2.6.2. Asthma Action Plans
7.2.6.3. Pulmonary Function Assessment
7.2.6.4. Others Respiratory Applications
7.2.7. Oncology
7.2.7.1. Tumour Progression Tracking
7.2.7.2. Personalized Treatment Planning
7.2.7.3. Medication Adherence for Chemo/Radiotherapy
7.2.7.4. Others Oncological Applications
7.2.8. Dermatology
7.2.8.1. Acne & Psoriasis Monitoring
7.2.8.2. UV Exposure Tracking
7.2.8.3. Others Dermatological Applications
7.2.9. Ophthalmology
7.2.9.1. Retinal Scan Interpretation
7.2.9.2. Vision Therapy Apps
7.2.9.3. Others Ophthalmological Applications
7.2.10. Gastroenterology
7.2.10.1. Liver Health Monitoring
7.2.10.2. Diet & Bowel Movement Logs
7.2.10.3. GI Motility Assessment
7.2.10.4. Other Gastroenterological Applications
7.3. Market Attractiveness Analysis By Therapeutic Area
8. Software as a Medical Device (SaMD) Market Analysis By End User
8.1. Introduction
8.2. Historical Market Size Analysis 2022 - 2024 and Forecast 2025 - 2032 Analysis, By End User (USD Bn)
8.2.1. Hospitals & Clinics
8.2.2.1. Inpatient
8.2.2.2. Outpatient
8.2.2. Homecare Settings
8.2.3. Diagnostic Centres
8.2.4. Patients (Direct - to - Consumer)
8.2.5.1. Mobile Health Apps
8.2.5.2. Wellness & Fitness Apps
8.2.5. Research & Academic Institutes
8.3. Market Attractiveness Analysis By End User
9. Software as a Medical Device (SaMD) Market Analysis By Region
9.1. Introduction
9.2. Historical Market Size (USD Bn) Analysis 2022 - 2024 By Region
9.3. Market Attractiveness Analysis By Region
10. North America Software as a Medical Device (SaMD) Market Analysis
10.1. Introduction
10.2. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Device Type (USD Bn)
10.3. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Technology (USD Bn)
10.4. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Deployment Mode (USD Bn)
10.5. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Therapeutic Area (USD Bn)
10.6. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By End User (USD Bn)
10.7. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Country (USD Bn)
10.7.1. U.S.
10.7.2. Canada
10.7.3. Mexico
10.7.4. Puerto Rico
10.7.5. Rest of North America
11. Europe Software as a Medical Device (SaMD) Market Analysis
11.1. Introduction
11.2. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Device Type (USD Bn)
11.3. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Technology (USD Bn)
11.4. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Deployment Mode (USD Bn)
11.5. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Therapeutic Area (USD Bn)
11.6. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By End User (USD Bn)
11.7. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Country (USD Bn)
11.7.1. Germany
11.7.2. Italy
11.7.3. France
11.7.4. UK
11.7.5. Russia
11.7.6. Spain
11.7.7. Switzerland
11.7.8. Belgium
11.7.9. The Netherlands
11.7.10. Rest of Europe
12. Asia - Pacific Software as a Medical Device (SaMD) Market Analysis
12.1. Introduction
12.2. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Device Type (USD Bn)
12.3. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Technology (USD Bn)
12.4. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Deployment Mode (USD Bn)
12.5. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Therapeutic Area (USD Bn)
12.6. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By End User (USD Bn)
12.7. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Country (USD Bn)
12.7.1. China
12.7.2. India
12.7.3. Japan
12.7.4. South Korea
12.7.5. Singapore
12.7.6. New Zealand
12.7.7. Australia
12.7.8. Rest of Asia - Pacific
13. South America Software as a Medical Device (SaMD) Market Analysis
13.1. Introduction
13.2. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Device Type (USD Bn)
13.3. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Technology (USD Bn)
13.4. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Deployment Mode (USD Bn)
13.5. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Therapeutic Area (USD Bn)
13.6. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By End User (USD Bn)
13.7. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Country (USD Bn)
13.7.1. Brazil
13.7.2. Argentina
13.7.3. Columbia
13.7.4. Peru
13.7.5. Chile
13.7.6. Rest of South America
14. Middle East and Africa (MEA) Software as a Medical Device (SaMD) Market Analysis
14.1. Introduction
14.2. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Device Type (USD Bn)
14.3. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Technology (USD Bn)
14.4. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Deployment Mode (USD Bn)
14.5. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Therapeutic Area (USD Bn)
14.6. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By End User (USD Bn)
14.7. Historic Market Value 2022 - 2024, and Forecast 2025 - 2032, By Country (USD Bn)
14.7.1. Saudi Arabia
14.7.2. UAE
14.7.3. Oman
14.7.4. Qatar
14.7.5. Algeria
14.7.6. Morocco
14.7.7. Libya
14.7.8. South Africa
14.7.9. Turkey
14.7.10. Rest of MEA
15. Market Structure Analysis
15.1. Company Market Share (%) Analysis, 2024
15.2. Tier Structure Analysis, 2024
15.3. Company Strategies Analysis
15.4. SWOT Analysis
16. Competition Analysis
16.1. Competition Dashboard
16.2. Company Profiles (15 Companies)
16.2.1. Philips N.V.
16.2.1.1. Overview
16.2.1.2. Product/Services Portfolio
16.2.1.3. Financial Overview
16.2.1.4. Recent Developments
16.2.1.5. Key Company Strategies
16.2.2. Siemens Healthineers AG
16.2.3. Medtronic
16.2.4. GE Healthcare
16.2.5. AliveCor Inc.
16.2.6. Abbott
16.2.7. Dexcom Inc.
16.2.8. F. Hoffmann - La Roche Ltd
16.2.9. Apple Inc.
16.2.10. Glooko Inc.
16.2.11. Illumina Inc.
16.2.12. Eko Health Inc.
16.2.13. Kaia Health
16.2.14. iRhythm Inc.
16.2.15. ResMed
17. Economic Scenario: Impacts on the Software as a Medical Device (SaMD) Market
17.1. Economic Impact on the Software as a Medical Device (SaMD) Market
17.2. Macro - Economic Indicators
18. Market Background
18.1. Key Market Takeaways
18.2. Regulatory Landscape
18.3. Forecast Factors: Relevance and Impact
18.4. Market Dynamics
18.4.1. Drivers
18.4.2. Restraints
18.4.3. Opportunities
18.4.4. Trends
18.4.5. Challenges
18.5. PESTLE Analysis
18.6. Porter's Five Force Analysis
18.7. Technology Roadmap
18.8. Premium Insights
19. Analysis and Recommendations
20. Research Methodology
21. Assumptions & Acronyms
List Of Figures:
Figure 01: Software as a Medical Device (SaMD) Market Share Analysis (%), By Device Type, (2024)
Figure 02: Software as a Medical Device (SaMD) Market Share Analysis (%), By Technology, (2024)
Figure 03: Software as a Medical Device (SaMD) Market Share Analysis (%), by Deployment Mode, (2024)
Figure 04: Software as a Medical Device (SaMD) Market Share Analysis (%), by Therapeutic Area, (2024)
Figure 05: Software as a Medical Device (SaMD) Market Share Analysis (%), by End User, (2024)
Figure 06: Software as a Medical Device (SaMD) Market Value 2025 - 2032 (USD Bn) and Y - o - Y Growth (2025 - 2032)
Figure 07: Software as a Medical Device (SaMD) Market Incremental $ Opportunity (USD Bn), 2025 - 2032
Figure 08: Software as a Medical Device (SaMD) Market: Market Attractiveness Analysis, By Device Type
Figure 09: Software as a Medical Device (SaMD) Market: Market Attractiveness Analysis, By Technology
Figure 10: Software as a Medical Device (SaMD) Market: Market Attractiveness Analysis, by Deployment Mode
Figure 11: Software as a Medical Device (SaMD) Market: Market Attractiveness Analysis, by Therapeutic Area
Figure 12: Software as a Medical Device (SaMD) Market: Market Attractiveness Analysis, by End User
Figure 13: Software as a Medical Device (SaMD) Market Share Analysis (%), by Region, 2022(H), 2025(E) & 2032(F)
Figure 14: Software as a Medical Device (SaMD) Market, Y - O - Y Growth, by Region, 2025(E) 2032(F)
Figure 15: Software as a Medical Device (SaMD) Market: Market Attractiveness Analysis, by Region
Figure 16: North America Software as a Medical Device (SaMD) Market Share Analysis (%), By Device Type, (2024)
Figure 17: North America Market Share Analysis (%), By Technology, (2024)
Figure 18: North America Software as a Medical Device (SaMD) Market Share Analysis (%), by Deployment Mode, (2024)
Figure 19: North America Software as a Medical Device (SaMD) Market Share Analysis (%), by Therapeutic Area, (2024)
Figure 20: North America Software as a Medical Device (SaMD) Market Share Analysis (%), by End User, (2024)
Figure 21: North America Software as a Medical Device (SaMD) Market Value Forecast 2025 & 2032 (USD Bn)
Figure 22: Europe Software as a Medical Device (SaMD) Market Share Analysis (%), By Device Type, (2024)
Figure 23: Europe Market Share Analysis (%), By Technology, (2024)
Figure 24: Europe Software as a Medical Device (SaMD) Market Share Analysis (%), by Deployment Mode, (2024)
Figure 25: Europe Software as a Medical Device (SaMD) Market Share Analysis (%), by Therapeutic Area, (2024)
Figure 26: Europe Software as a Medical Device (SaMD) Market Share Analysis (%), by End User, (2024)
Figure 27: Europe Software as a Medical Device (SaMD) Market Value Forecast 2025 & 2032 (USD Bn)
Figure 28: Asia - Pacific Software as a Medical Device (SaMD) Market Share Analysis (%), By Device Type, (2024)
Figure 29: Asia - Pacific Market Share Analysis (%), By Technology, (2024)
Figure 30: Asia - Pacific Software as a Medical Device (SaMD) Market Share Analysis (%), by Deployment Mode, (2024)
Figure 31: Asia - Pacific Software as a Medical Device (SaMD) Market Share Analysis (%), by Therapeutic Area, (2024)
Figure 32: Asia - Pacific Software as a Medical Device (SaMD) Market Share Analysis (%), by End User, (2024)
Figure 33: Asia - Pacific Software as a Medical Device (SaMD) Market Value Forecast 2025 & 2032 (USD Bn)
Figure 34: South America Software as a Medical Device (SaMD) Market Share Analysis (%), By Device Type, (2024)
Figure 35: South America Market Share Analysis (%), By Technology, (2024)
Figure 36: South America Software as a Medical Device (SaMD) Market Share Analysis (%), by Deployment Mode, (2024)
Figure 37: South America Software as a Medical Device (SaMD) Market Share Analysis (%), by Therapeutic Area, (2024)
Figure 38: South America Software as a Medical Device (SaMD) Market Share Analysis (%), by End User, (2024)
Figure 39: South America Software as a Medical Device (SaMD) Market Value Forecast 2025 & 2032 (USD Bn)
Figure 40: Middle East and Africa Software as a Medical Device (SaMD) Market Share Analysis (%), By Device Type, (2024)
Figure 41: Middle East and Africa Market Share Analysis (%), By Technology, (2024)
Figure 42: Middle East and Africa Software as a Medical Device (SaMD) Market Share Analysis (%), by Deployment Mode, (2024)
Figure 43: Middle East and Africa Software as a Medical Device (SaMD) Market Share Analysis (%), by Therapeutic Area, (2024)
Figure 44: Middle East and Africa Software as a Medical Device (SaMD) Market Share Analysis (%), by End User, (2024)
Figure 45: Middle East and Africa Software as a Medical Device (SaMD) Market Value Forecast 2025 & 2032 (USD Bn)
Figure 46: Software as a Medical Device (SaMD) Market, Company Market Share (%) Analysis, 2023
Figure 47: Software as a Medical Device (SaMD) Market, Tier Structure Analysis, 2023
List Of Tables:
Table 01: Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Device Type, 2022(H) 2032(F)
Table 02: Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Technology, 2022(H) 2032(F)
Table 03: Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Deployment Mode, 2022(H) 2032(F)
Table 04: Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Therapeutic Area, 2022(H) 2032(F)
Table 05: Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By End User, 2022(H) 2032(F)
Table 06: Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Region, 2022(H) 2032(F)
Table 07: North America Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Device Type, 2022(H) 2032(F)
Table 08: North America Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Technology, 2022(H) 2032(F)
Table 09: North America Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Deployment Mode, 2022(H) 2032(F)
Table 10: North America Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Therapeutic Area, 2022(H) 2032(F)
Table 11: North America Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By End User, 2022(H) 2032(F)
Table 12: North America Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Country, 2022(H) 2032(F)
Table 13: Europe Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Device Type, 2022(H) 2032(F)
Table 14: Europe Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Technology, 2022(H) 2032(F)
Table 15: Europe Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Deployment Mode, 2022(H) 2032(F)
Table 16: Europe Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Therapeutic Area, 2022(H) 2032(F)
Table 17: Europe Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By End User, 2022(H) 2032(F)
Table 18: Europe Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Country, 2022(H) 2032(F)
Table 19: Asia - Pacific Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Device Type, 2022(H) 2032(F)
Table 20: Asia - Pacific Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Technology, 2022(H) 2032(F)
Table 21: Asia - Pacific Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Deployment Mode, 2022(H) 2032(F)
Table 22: Asia - Pacific Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Therapeutic Area, 2022(H) 2032(F)
Table 23: Asia - Pacific Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By End User, 2022(H) 2032(F)
Table 24: Asia - Pacific Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Country, 2022(H) 2032(F)
Table 25: South America Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Device Type, 2022(H) 2032(F)
Table 26: South America Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Technology, 2022(H) 2032(F)
Table 27: South America Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Deployment Mode, 2022(H) 2032(F)
Table 28: South America Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Therapeutic Area, 2022(H) 2032(F)
Table 29: South America Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By End User, 2022(H) 2032(F)
Table 30: South America Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Country, 2022(H) 2032(F)
Table 31: Middle East and Africa Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Device Type, 2022(H) 2032(F)
Table 32: Middle East and Africa Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Technology, 2022(H) 2032(F)
Table 33: Middle East and Africa Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Deployment Mode, 2022(H) 2032(F)
Table 34: Middle East and Africa Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Therapeutic Area, 2022(H) 2032(F)
Table 35: Middle East and Africa Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By End User, 2022(H) 2032(F)
Table 36: Middle East and Africa Software as a Medical Device (SaMD) Market Value (USD Bn) and Forecast, By Country, 2022(H) 2032(F)
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