Software as a Medical Device Market Size, Share and Trends Report 2026 to 2035

Report Id: 3423 Pages: 180 Last Updated: 29 January 2026 Format: PDF / PPT / Excel / Power BI
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Segmentation of Software-as-a-Medical Device Market:

Software-as-a-Medical Device Market by Deployment Type-

  • Cloud-Based
  • On-Premises

Software-as-a-Medical Device Market

Software-as-a-Medical Device Market by Device Type-

  • Smartphones
  • Wearable Devices
  • Laptop / Desktops

Software-as-a-Medical Device Market by Application-

  • Screening & Diagnosis
  • Chronic Conditions & Disease Management
  • Monitoring & Altering
  • Digital Therapeutics

Software-as-a-Medical Device Market by Software Technology-

  • Artificial Intelligence
  • Machine Learning

Software-as-a-Medical Device Market by End-user-

  • Hospitals and Clinics
  • Home Healthcare
  • Research Institutes
  • Others

Software-as-a-Medical Device Market By Region-

  • North America-
    • The US
    • Canada
  • Europe-
    • Germany
    • The UK
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific-
    • China
    • Japan
    • India
    • South Korea
    • South East Asia
    • Rest of Asia Pacific
  • Latin America-
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  •  Middle East & Africa-
    • GCC Countries
    • South Africa
    • Rest of Middle East and Africa

Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions

Chapter 2. Executive Summary

Chapter 3. Global Software as a Medical Device Market Snapshot

Chapter 4. Global Software as a Medical Device Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends 
4.5. Investment and Funding Analysis 
4.6. Porter's Five Forces Analysis
4.7. Incremental Opportunity Analysis (US$ MN), 2026-2035
4.8. Global Software as a Medical Device Market Penetration & Growth Prospect Mapping (US$ Mn), 2025-2035
4.9. Competitive Landscape & Market Share Analysis, By Key Player (2025)
4.10. Use/impact of AI on Software as a Medical Device Industry Trends 

Chapter 5. Software as a Medical Device Market Segmentation 1: By Type of Deployment, Estimates & Trend Analysis
5.1. Market Share by Type of Deployment, 2025 & 2035
5.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2022 to 2035 for the following Type of Deployment:

5.2.1. Cloud Based
5.2.2. On-Premises

Chapter 6. Software as a Medical Device Market Segmentation 2: By Type of Device, Estimates & Trend Analysis
6.1. Market Share by Type of Device, 2025 & 2035
6.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2022 to 2035 for the following Type of Device:

6.2.1. Smartphone
6.2.2. Laptop / Desktop
6.2.3. Wearable Devices

Chapter 7. Software as a Medical Device Market Segmentation 3: By Type of Software Technology, Estimates & Trend Analysis
7.1. Market Share by Type of Software Technology, 2025 & 2035
7.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2022 to 2035 for the following Type of Software Technology:

7.2.1. Artificial Intelligence
7.2.2. Machine Learning

Chapter 8. Software as a Medical Device Market Segmentation 4: By End-User, Estimates & Trend Analysis
8.1. Market Share by End-User, 2025 & 2035
8.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2022 to 2035 for the following End-User:

8.2.1. Home Healthcare
8.2.2. Hospitals and Clinics
8.2.3. Research Institutes
8.2.4. Other End Users

Chapter 9. Software as a Medical Device Market Segmentation 5: By Application Areas, Estimates & Trend Analysis
9.1. Market Share by Application Areas, 2025 & 2035
9.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2022 to 2035 for the following Application Areas:

9.2.1. Screening & Diagnosis
9.2.2. Monitoring & Altering
9.2.3. Chronic Conditions & Disease Management
9.2.4. Digital Therapeutics

Chapter 10. Software as a Medical Device Market Segmentation 6: Regional Estimates & Trend Analysis
10.1. Global Software as a Medical Device Market, Regional Snapshot 2025 & 2035
10.2. North America

10.2.1. North America Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Country, 2022-2035

10.2.1.1. US
10.2.1.2. Canada

10.2.2. North America Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Deployment, 2022-2035
10.2.3. North America Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Device, 2022-2035
10.2.4. North America Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Software Technology, 2022-2035
10.2.5. North America Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2022-2035
10.2.6. North America Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Application Areas, 2022-2035

10.3. Europe

10.3.1. Europe Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Country, 2022-2035

10.3.1.1. Germany
10.3.1.2. U.K.
10.3.1.3. France
10.3.1.4. Italy
10.3.1.5. Spain
10.3.1.6. Rest of Europe

10.3.2. Europe Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Deployment, 2022-2035
10.3.3. Europe Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Device, 2022-2035
10.3.4. Europe Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Software Technology, 2022-2035
10.3.5. Europe Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2022-2035
10.3.6. Europe Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Application Areas, 2022-2035

10.4. Asia Pacific

10.4.1. Asia Pacific Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Country, 2022-2035

10.4.1.1. India 
10.4.1.2. China
10.4.1.3. Japan
10.4.1.4. Australia
10.4.1.5. South Korea
10.4.1.6. Hong Kong
10.4.1.7. Southeast Asia
10.4.1.8. Rest of Asia Pacific

10.4.2. Asia Pacific Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Deployment, 2022-2035
10.4.3. Asia Pacific Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Device, 2022-2035
10.4.4. Asia Pacific Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts By Type of Software Technology, 2022-2035
10.4.5. Asia Pacific Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts By End-User, 2022-2035
10.4.6. Asia Pacific Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Application Areas, 2022-2035

10.5. Latin America

10.5.1. Latin America Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Country, 2022-2035

10.5.1.1. Brazil
10.5.1.2. Mexico
10.5.1.3. Rest of Latin America

10.5.2. Latin America Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Deployment, 2022-2035
10.5.3. Latin America Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Device, 2022-2035
10.5.4. Latin America Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Software Technology, 2022-2035
10.5.5. Latin America Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2022-2035
10.5.6. Latin America Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Application Areas, 2022-2035

10.6. Middle East & Africa

10.6.1. Middle East & Africa Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by country, 2022-2035

10.6.1.1. GCC Countries
10.6.1.2. Israel
10.6.1.3. South Africa
10.6.1.4. Rest of Middle East and Africa

10.6.2. Middle East & Africa Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Deployment, 2022-2035
10.6.3. Middle East & Africa Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Device, 2022-2035
10.6.4. Middle East & Africa Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Type of Software Technology, 2022-2035
10.6.5. Middle East & Africa Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2022-2035
10.6.6. Middle East & Africa Software as a Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Application Areas, 2022-2035

Chapter 11. Competitive Landscape
11.1. Major Mergers and Acquisitions/Strategic Alliances
11.2. Company Profiles
 
11.2.1. Apple

11.2.1.1. Business Overview
11.2.1.2. Key Product/Service 
11.2.1.3. Financial Performance
11.2.1.4. Geographical Presence
11.2.1.5. Recent Developments with Business Strategy

11.2.2. Arterys
11.2.3. BenevolentAI (by Odyssey)
11.2.4. Biobeats Medical
11.2.5. Cambridge Cognition
11.2.6. Fitbit
11.2.7. IDx Technologies
11.2.8. Imagen Technologies
11.2.9. iSchemaView (RAPID)
11.2.10. Johnson & Johnson
11.2.11. MaxQ AI
11.2.12. Mogrify
11.2.13. Philips
11.2.14. PEAR Therapeutics
11.2.15. Roche
11.2.16. Qlarity Imaging (by Paragon Biosciences)
11.2.17. S3 Connected Health
11.2.18. Samsung
11.2.19. Siemens Healthineers
11.2.20. Tietronix Software
11.2.21. Velentium

Research Design and Approach

This study employed a multi-step, mixed-method research approach that integrates:

  • Secondary research
  • Primary research
  • Data triangulation
  • Hybrid top-down and bottom-up modelling
  • Forecasting and scenario analysis

This approach ensures a balanced and validated understanding of both macro- and micro-level market factors influencing the market.

Secondary Research

Secondary research for this study involved the collection, review, and analysis of publicly available and paid data sources to build the initial fact base, understand historical market behaviour, identify data gaps, and refine the hypotheses for primary research.

Sources Consulted

Secondary data for the market study was gathered from multiple credible sources, including:

  • Government databases, regulatory bodies, and public institutions
  • International organizations (WHO, OECD, IMF, World Bank, etc.)
  • Commercial and paid databases
  • Industry associations, trade publications, and technical journals
  • Company annual reports, investor presentations, press releases, and SEC filings
  • Academic research papers, patents, and scientific literature
  • Previous market research publications and syndicated reports

These sources were used to compile historical data, market volumes/prices, industry trends, technological developments, and competitive insights.

Secondary Research

Primary Research

Primary research was conducted to validate secondary data, understand real-time market dynamics, capture price points and adoption trends, and verify the assumptions used in the market modelling.

Stakeholders Interviewed

Primary interviews for this study involved:

  • Manufacturers and suppliers in the market value chain
  • Distributors, channel partners, and integrators
  • End-users / customers (e.g., hospitals, labs, enterprises, consumers, etc., depending on the market)
  • Industry experts, technology specialists, consultants, and regulatory professionals
  • Senior executives (CEOs, CTOs, VPs, Directors) and product managers

Interview Process

Interviews were conducted via:

  • Structured and semi-structured questionnaires
  • Telephonic and video interactions
  • Email correspondences
  • Expert consultation sessions

Primary insights were incorporated into demand modelling, pricing analysis, technology evaluation, and market share estimation.

Data Processing, Normalization, and Validation

All collected data were processed and normalized to ensure consistency and comparability across regions and time frames.

The data validation process included:

  • Standardization of units (currency conversions, volume units, inflation adjustments)
  • Cross-verification of data points across multiple secondary sources
  • Normalization of inconsistent datasets
  • Identification and resolution of data gaps
  • Outlier detection and removal through algorithmic and manual checks
  • Plausibility and coherence checks across segments and geographies

This ensured that the dataset used for modelling was clean, robust, and reliable.

Market Size Estimation and Data Triangulation

Bottom-Up Approach

The bottom-up approach involved aggregating segment-level data, such as:

  • Company revenues
  • Product-level sales
  • Installed base/usage volumes
  • Adoption and penetration rates
  • Pricing analysis

This method was primarily used when detailed micro-level market data were available.

Bottom Up Approach

Top-Down Approach

The top-down approach used macro-level indicators:

  • Parent market benchmarks
  • Global/regional industry trends
  • Economic indicators (GDP, demographics, spending patterns)
  • Penetration and usage ratios

This approach was used for segments where granular data were limited or inconsistent.

Hybrid Triangulation Approach

To ensure accuracy, a triangulated hybrid model was used. This included:

  • Reconciling top-down and bottom-up estimates
  • Cross-checking revenues, volumes, and pricing assumptions
  • Incorporating expert insights to validate segment splits and adoption rates

This multi-angle validation yielded the final market size.

Forecasting Framework and Scenario Modelling

Market forecasts were developed using a combination of time-series modelling, adoption curve analysis, and driver-based forecasting tools.

Forecasting Methods

  • Time-series modelling
  • S-curve and diffusion models (for emerging technologies)
  • Driver-based forecasting (GDP, disposable income, adoption rates, regulatory changes)
  • Price elasticity models
  • Market maturity and lifecycle-based projections

Scenario Analysis

Given inherent uncertainties, three scenarios were constructed:

  • Base-Case Scenario: Expected trajectory under current conditions
  • Optimistic Scenario: High adoption, favourable regulation, strong economic tailwinds
  • Conservative Scenario: Slow adoption, regulatory delays, economic constraints

Sensitivity testing was conducted on key variables, including pricing, demand elasticity, and regional adoption.

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Frequently Asked Questions

Software as a Medical Device Market Size is valued at USD 34.05 Bn in 2025 and is predicted to reach USD 182.22 Bn by the year 2035

Software as a Medical Device Market is expected to grow at a 18.8% CAGR during the forecast period for 2026 to 2035

Apple, Biobeats Medical, Mogrify, Imagen Technologies, iSchemaView (RAPID), Philips, Cambridge Cognition, Fitbit, IDx Technologies, Johnson & Johnson, MaxQ AI, Arterys, BenevolentAI (by Odyssey), Siemens Healthineers, Tietronix Software, PEAR Therapeutics, Roche, Qlarity Imaging (by Paragon Biosciences), S3 Connected Health, Samsung, Velentium and Other.

Software as a Medical Device Market is segmented in Deployment Type (Cloud-Based and On-Premises), Device Type (Smartphones, Wearable Devices, and Laptop / Desktops), Application (Screening & Diagnosis, Chronic Conditions & Disease Management, Monitoring & Altering, and Digital Therapeutics), Software Technology (Artificial Intelligence and Machine Learning), End-user (Hospitals and Clinics, Home Healthcare, Research Institutes, and Others) and Other.

North America region is leading the Software as a Medical Device Market

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