PUBLISHER: Prescient & Strategic Intelligence | PRODUCT CODE: 1909326
PUBLISHER: Prescient & Strategic Intelligence | PRODUCT CODE: 1909326
AI-enabled Medical Devices Market Size & Share Analysis - Trends, Drivers, Competitive Landscape, and Forecasts (2026 - 2032)
The AI-enabled medical devices market is witnessing rapid expansion as healthcare providers increasingly adopt artificial intelligence to enhance diagnostic accuracy, clinical efficiency, and patient outcomes. The market is valued at USD 18.8 billion in 2025 and is projected to reach USD 133.2 billion by 2032, growing at a strong CAGR of 32.3% during the study period from 2019 to 2032. Rising demand for data-driven decision-making, automation in healthcare workflows, and real-time clinical insights is driving accelerated adoption of AI-powered medical technologies.
AI-enabled medical devices are being widely integrated across imaging, diagnostics, patient monitoring, and therapeutic applications. These devices leverage machine learning algorithms, advanced analytics, and large datasets to support early disease detection, personalized treatment planning, and improved operational efficiency. Continuous advancements in computing power, software capabilities, and regulatory clarity are further strengthening market growth.
North America represents the largest regional market, supported by advanced healthcare infrastructure, high technology adoption, and strong investment in medical innovation, while the Asia-Pacific region is emerging as the fastest-growing market due to expanding healthcare digitization, rising patient volumes, and increasing investment in AI-driven medical solutions. As artificial intelligence becomes integral to modern healthcare delivery, the AI-enabled medical devices market is expected to maintain exceptional growth momentum throughout the forecast period.
Key Insights
The AI-enabled medical devices market is valued at USD 18.8 billion in 2025 and is expected to reach USD 133.2 billion by 2032, reflecting exceptional long-term growth driven by widespread adoption of artificial intelligence in healthcare.
The market is projected to grow at a CAGR of 32.3% during 2019-2032, supported by rapid technological advancements and increasing clinical reliance on AI-powered tools.
Growing demand for accurate, real-time diagnostics and predictive analytics is strengthening adoption of AI-enabled medical devices.
North America accounts for the largest share of the global market, driven by strong healthcare infrastructure, high R&D spending, and early adoption of advanced medical technologies.
The Asia-Pacific region is the fastest-growing market, supported by expanding healthcare access, rapid digital transformation, and increasing investment in AI-driven healthcare solutions.
Integration of AI with medical imaging and diagnostic devices is improving detection accuracy and clinical decision-making.
Increasing use of AI-enabled monitoring and therapeutic devices is enhancing patient management and treatment outcomes.
Advancements in machine learning algorithms and data analytics are expanding the capabilities and applications of AI-powered medical devices.
Regulatory progress and growing clinical validation are strengthening confidence in AI-enabled healthcare technologies.
Continuous investment in healthcare innovation, artificial intelligence, and medical device development is expected to sustain long-term growth in the AI-enabled medical devices market.
Table of Contents
Chapter 1. Research Scope
- 1.1. Research Objectives
- 1.2. Market Definition
- 1.3. Analysis Period
- 1.4. Market Size Breakdown by Segments
- 1.4.1. Market Size Breakdown, by Component
- 1.4.2. Market Size Breakdown, by Technology
- 1.4.3. Market Size Breakdown, by Device Type
- 1.4.4. Market Size Breakdown, by Therapeutic Area
- 1.4.5. Market Size Breakdown, by End Use
- 1.4.6. Market Size Breakdown, by Region
- 1.4.7. Market Size Breakdown, by Country
- 1.5. Market Data Reporting Unit
- 1.5.1. Revenue
- 1.6. Key Stakeholders
Chapter 2. Research Methodology
- 2.1. Secondary Research
- 2.1.1. Paid
- 2.1.2. Unpaid
- 2.1.3. P&S Intelligence Database
- 2.2. Primary Research
- 2.3. Market Size Estimation
- 2.4. Data Triangulation
- 2.5. Currency Conversion Rates
- 2.6. Assumptions for the Study
- 2.7. Notes and Caveats
Chapter 3. Executive Summary
Chapter 4. Market Indicators
Chapter 5. Industry Outlook
- 5.1. Industry Background
- 5.2. Market Dynamics
- 5.2.1. Trends
- 5.2.2. Drivers
- 5.2.3. Restraints/Challenges
- 5.2.4. Emerging Economies and Key Opportunities
- 5.2.5. Impact Analysis of Drivers/Restraints
- 5.3. Sociopolitical Impact
- 5.4. Porter's Five Forces Analysis
- 5.4.1. Bargaining Power of Buyers
- 5.4.2. Bargaining Power of Suppliers
- 5.4.3. Threat of New Entrants
- 5.4.4. Intensity of Rivalry
- 5.4.5. Threat of Substitutes
- 5.5. Lifecycle Analysis
- 5.6. Innovation and Technology Trends
- 5.7. Economic and Regulatory Impact
- 5.8. Market Entry Strategies
Chapter 6. Competitive Landscape
- 6.1. List of Market Players and their Offerings
- 6.2. Market Share of Key Players (2025)
- 6.2.1. Global
- 6.2.2. North America
- 6.2.3. Europe
- 6.2.4. Asia-Pacific
- 6.2.5. Latin America
- 6.2.6. Middle East and Africa
- 6.3. Competitive Benchmarking of Key Players
- 6.4. Product Benchmarking of Key Players
- 6.5. Recent Strategic Developments by Key Players
- 6.6. Company Leadership Matrix
Chapter 7. Global Market
- 7.1. Overview
- 7.2. Market Revenue, by Component (2019-2032)
- 7.3. Market Revenue, by Technology (2019-2032)
- 7.4. Market Revenue, by Device Type (2019-2032)
- 7.5. Market Revenue, by Therapeutic Area (2019-2032)
- 7.6. Market Revenue, by End Use (2019-2032)
- 7.7. Market Revenue, by Region (2019-2032)
Chapter 8. North America Market
- 8.1. Overview
- 8.2. Market Revenue, by Component (2019-2032)
- 8.3. Market Revenue, by Technology (2019-2032)
- 8.4. Market Revenue, by Device Type (2019-2032)
- 8.5. Market Revenue, by Therapeutic Area (2019-2032)
- 8.6. Market Revenue, by End Use (2019-2032)
- 8.7. Market Revenue, by Country (2019-2032)
Chapter 9. Europe Market
- 9.1. Overview
- 9.2. Market Revenue, by Component (2019-2032)
- 9.3. Market Revenue, by Technology (2019-2032)
- 9.4. Market Revenue, by Device Type (2019-2032)
- 9.5. Market Revenue, by Therapeutic Area (2019-2032)
- 9.6. Market Revenue, by End Use (2019-2032)
- 9.7. Market Revenue, by Country (2019-2032)
Chapter 10. Asia-Pacific Market
- 10.1. Overview
- 10.2. Market Revenue, by Component (2019-2032)
- 10.3. Market Revenue, by Technology (2019-2032)
- 10.4. Market Revenue, by Device Type (2019-2032)
- 10.5. Market Revenue, by Therapeutic Area (2019-2032)
- 10.6. Market Revenue, by End Use (2019-2032)
- 10.7. Market Revenue, by Country (2019-2032)
Chapter 11. Latin America Market
- 11.1. Overview
- 11.2. Market Revenue, by Component (2019-2032)
- 11.3. Market Revenue, by Technology (2019-2032)
- 11.4. Market Revenue, by Device Type (2019-2032)
- 11.5. Market Revenue, by Therapeutic Area (2019-2032)
- 11.6. Market Revenue, by End Use (2019-2032)
- 11.7. Market Revenue, by Country (2019-2032)
Chapter 12. Middle East and Africa Market
- 12.1. Overview
- 12.2. Market Revenue, by Component (2019-2032)
- 12.3. Market Revenue, by Technology (2019-2032)
- 12.4. Market Revenue, by Device Type (2019-2032)
- 12.5. Market Revenue, by Therapeutic Area (2019-2032)
- 12.6. Market Revenue, by End Use (2019-2032)
- 12.7. Market Revenue, by Country (2019-2032)
Chapter 13. U.S. Market
- 13.1. Overview
- 13.2. Economic Indicators
- 13.3. Demographics and Population Insights
- 13.4. Growth Drivers
- 13.5. Challenges and Barriers
- 13.6. Competitive Strategies
- 13.7. Emerging Players
- 13.8. Market Size and Forecast
- 13.8.1. Market Revenue, by Component (2019-2032)
- 13.8.2. Market Revenue, by Technology (2019-2032)
- 13.8.3. Market Revenue, by Device Type (2019-2032)
- 13.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 13.8.5. Market Revenue, by End Use (2019-2032)
Chapter 14. Canada Market
- 14.1. Overview
- 14.2. Economic Indicators
- 14.3. Demographics and Population Insights
- 14.4. Growth Drivers
- 14.5. Challenges and Barriers
- 14.6. Competitive Strategies
- 14.7. Emerging Players
- 14.8. Market Size and Forecast
- 14.8.1. Market Revenue, by Component (2019-2032)
- 14.8.2. Market Revenue, by Technology (2019-2032)
- 14.8.3. Market Revenue, by Device Type (2019-2032)
- 14.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 14.8.5. Market Revenue, by End Use (2019-2032)
Chapter 15. Germany Market
- 15.1. Overview
- 15.2. Economic Indicators
- 15.3. Demographics and Population Insights
- 15.4. Growth Drivers
- 15.5. Challenges and Barriers
- 15.6. Competitive Strategies
- 15.7. Emerging Players
- 15.8. Market Size and Forecast
- 15.8.1. Market Revenue, by Component (2019-2032)
- 15.8.2. Market Revenue, by Technology (2019-2032)
- 15.8.3. Market Revenue, by Device Type (2019-2032)
- 15.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 15.8.5. Market Revenue, by End Use (2019-2032)
Chapter 16. U.K. Market
- 16.1. Overview
- 16.2. Economic Indicators
- 16.3. Demographics and Population Insights
- 16.4. Growth Drivers
- 16.5. Challenges and Barriers
- 16.6. Competitive Strategies
- 16.7. Emerging Players
- 16.8. Market Size and Forecast
- 16.8.1. Market Revenue, by Component (2019-2032)
- 16.8.2. Market Revenue, by Technology (2019-2032)
- 16.8.3. Market Revenue, by Device Type (2019-2032)
- 16.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 16.8.5. Market Revenue, by End Use (2019-2032)
Chapter 17. France Market
- 17.1. Overview
- 17.2. Economic Indicators
- 17.3. Demographics and Population Insights
- 17.4. Growth Drivers
- 17.5. Challenges and Barriers
- 17.6. Competitive Strategies
- 17.7. Emerging Players
- 17.8. Market Size and Forecast
- 17.8.1. Market Revenue, by Component (2019-2032)
- 17.8.2. Market Revenue, by Technology (2019-2032)
- 17.8.3. Market Revenue, by Device Type (2019-2032)
- 17.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 17.8.5. Market Revenue, by End Use (2019-2032)
Chapter 18. Italy Market
- 18.1. Overview
- 18.2. Economic Indicators
- 18.3. Demographics and Population Insights
- 18.4. Growth Drivers
- 18.5. Challenges and Barriers
- 18.6. Competitive Strategies
- 18.7. Emerging Players
- 18.8. Market Size and Forecast
- 18.8.1. Market Revenue, by Component (2019-2032)
- 18.8.2. Market Revenue, by Technology (2019-2032)
- 18.8.3. Market Revenue, by Device Type (2019-2032)
- 18.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 18.8.5. Market Revenue, by End Use (2019-2032)
Chapter 19. Spain Market
- 19.1. Overview
- 19.2. Economic Indicators
- 19.3. Demographics and Population Insights
- 19.4. Growth Drivers
- 19.5. Challenges and Barriers
- 19.6. Competitive Strategies
- 19.7. Emerging Players
- 19.8. Market Size and Forecast
- 19.8.1. Market Revenue, by Component (2019-2032)
- 19.8.2. Market Revenue, by Technology (2019-2032)
- 19.8.3. Market Revenue, by Device Type (2019-2032)
- 19.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 19.8.5. Market Revenue, by End Use (2019-2032)
Chapter 20. China Market
- 20.1. Overview
- 20.2. Economic Indicators
- 20.3. Demographics and Population Insights
- 20.4. Growth Drivers
- 20.5. Challenges and Barriers
- 20.6. Competitive Strategies
- 20.7. Emerging Players
- 20.8. Market Size and Forecast
- 20.8.1. Market Revenue, by Component (2019-2032)
- 20.8.2. Market Revenue, by Technology (2019-2032)
- 20.8.3. Market Revenue, by Device Type (2019-2032)
- 20.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 20.8.5. Market Revenue, by End Use (2019-2032)
Chapter 21. India Market
- 21.1. Overview
- 21.2. Economic Indicators
- 21.3. Demographics and Population Insights
- 21.4. Growth Drivers
- 21.5. Challenges and Barriers
- 21.6. Competitive Strategies
- 21.7. Emerging Players
- 21.8. Market Size and Forecast
- 21.8.1. Market Revenue, by Component (2019-2032)
- 21.8.2. Market Revenue, by Technology (2019-2032)
- 21.8.3. Market Revenue, by Device Type (2019-2032)
- 21.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 21.8.5. Market Revenue, by End Use (2019-2032)
Chapter 22. Japan Market
- 22.1. Overview
- 22.2. Economic Indicators
- 22.3. Demographics and Population Insights
- 22.4. Growth Drivers
- 22.5. Challenges and Barriers
- 22.6. Competitive Strategies
- 22.7. Emerging Players
- 22.8. Market Size and Forecast
- 22.8.1. Market Revenue, by Component (2019-2032)
- 22.8.2. Market Revenue, by Technology (2019-2032)
- 22.8.3. Market Revenue, by Device Type (2019-2032)
- 22.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 22.8.5. Market Revenue, by End Use (2019-2032)
Chapter 23. South Korea Market
- 23.1. Overview
- 23.2. Economic Indicators
- 23.3. Demographics and Population Insights
- 23.4. Growth Drivers
- 23.5. Challenges and Barriers
- 23.6. Competitive Strategies
- 23.7. Emerging Players
- 23.8. Market Size and Forecast
- 23.8.1. Market Revenue, by Component (2019-2032)
- 23.8.2. Market Revenue, by Technology (2019-2032)
- 23.8.3. Market Revenue, by Device Type (2019-2032)
- 23.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 23.8.5. Market Revenue, by End Use (2019-2032)
Chapter 24. Australia Market
- 24.1. Overview
- 24.2. Economic Indicators
- 24.3. Demographics and Population Insights
- 24.4. Growth Drivers
- 24.5. Challenges and Barriers
- 24.6. Competitive Strategies
- 24.7. Emerging Players
- 24.8. Market Size and Forecast
- 24.8.1. Market Revenue, by Component (2019-2032)
- 24.8.2. Market Revenue, by Technology (2019-2032)
- 24.8.3. Market Revenue, by Device Type (2019-2032)
- 24.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 24.8.5. Market Revenue, by End Use (2019-2032)
Chapter 25. Brazil Market
- 25.1. Overview
- 25.2. Economic Indicators
- 25.3. Demographics and Population Insights
- 25.4. Growth Drivers
- 25.5. Challenges and Barriers
- 25.6. Competitive Strategies
- 25.7. Emerging Players
- 25.8. Market Size and Forecast
- 25.8.1. Market Revenue, by Component (2019-2032)
- 25.8.2. Market Revenue, by Technology (2019-2032)
- 25.8.3. Market Revenue, by Device Type (2019-2032)
- 25.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 25.8.5. Market Revenue, by End Use (2019-2032)
Chapter 26. Mexico Market
- 26.1. Overview
- 26.2. Economic Indicators
- 26.3. Demographics and Population Insights
- 26.4. Growth Drivers
- 26.5. Challenges and Barriers
- 26.6. Competitive Strategies
- 26.7. Emerging Players
- 26.8. Market Size and Forecast
- 26.8.1. Market Revenue, by Component (2019-2032)
- 26.8.2. Market Revenue, by Technology (2019-2032)
- 26.8.3. Market Revenue, by Device Type (2019-2032)
- 26.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 26.8.5. Market Revenue, by End Use (2019-2032)
Chapter 27. Saudi Arabia Market
- 27.1. Overview
- 27.2. Economic Indicators
- 27.3. Demographics and Population Insights
- 27.4. Growth Drivers
- 27.5. Challenges and Barriers
- 27.6. Competitive Strategies
- 27.7. Emerging Players
- 27.8. Market Size and Forecast
- 27.8.1. Market Revenue, by Component (2019-2032)
- 27.8.2. Market Revenue, by Technology (2019-2032)
- 27.8.3. Market Revenue, by Device Type (2019-2032)
- 27.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 27.8.5. Market Revenue, by End Use (2019-2032)
Chapter 28. South Africa Market
- 28.1. Overview
- 28.2. Economic Indicators
- 28.3. Demographics and Population Insights
- 28.4. Growth Drivers
- 28.5. Challenges and Barriers
- 28.6. Competitive Strategies
- 28.7. Emerging Players
- 28.8. Market Size and Forecast
- 28.8.1. Market Revenue, by Component (2019-2032)
- 28.8.2. Market Revenue, by Technology (2019-2032)
- 28.8.3. Market Revenue, by Device Type (2019-2032)
- 28.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 28.8.5. Market Revenue, by End Use (2019-2032)
Chapter 29. U.A.E. Market
- 29.1. Overview
- 29.2. Economic Indicators
- 29.3. Demographics and Population Insights
- 29.4. Growth Drivers
- 29.5. Challenges and Barriers
- 29.6. Competitive Strategies
- 29.7. Emerging Players
- 29.8. Market Size and Forecast
- 29.8.1. Market Revenue, by Component (2019-2032)
- 29.8.2. Market Revenue, by Technology (2019-2032)
- 29.8.3. Market Revenue, by Device Type (2019-2032)
- 29.8.4. Market Revenue, by Therapeutic Area (2019-2032)
- 29.8.5. Market Revenue, by End Use (2019-2032)
Chapter 30. Company Profiles
Chapter 31. Appendix
- 31.1. Sources and References
- 31.2. Related Reports
