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Europe Artificial Intelligence/Machine Learning Medical Device Market: Analysis and Forecast, 2022-2032

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    Report

  • 106 Pages
  • January 2024
  • Region: Europe
  • BIS Research
  • ID: 5927573
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The Europe artificial intelligence/machine learning medical device market was valued at $1.01 billion in 2022 and is expected to reach $7.93 billion by 2032, witnessing a CAGR of 22.95% during the forecast period 2022-2032. The market is driven by various factors, including the extensive presence of companies providing AI solutions, increasing demand in radiology and cardiology sectors, a surge in the need for wearable sensors, and numerous government initiatives.

Market Introduction

The Europe market for Artificial Intelligence/Machine Learning (AI/ML) Medical Devices is experiencing significant growth, fueled by the integration of advanced technologies in the healthcare sector. A flourishing ecosystem of companies offering AI/ML solutions is driving innovation in medical devices across the region. Notably, there is a rising demand for AI/ML applications in medical imaging, diagnostics, and personalized medicine. The fields of radiology and cardiology are witnessing a substantial uptick in the adoption of AI/ML, leading to improved diagnostic precision and treatment planning. The increasing popularity of wearable sensors is also contributing to the market's expansion. Government initiatives across European countries aimed at promoting the incorporation of AI/ML technologies in healthcare are crucial factors fostering the growth of this market. With a commitment to technological advancements and healthcare innovation, the Europe AI/ML Medical Device Market is poised for continued evolution in reshaping medical diagnostics and patient care.

Market Segmentation

Segmentation 1: by Country

  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Rest-of-Europe

How can this report add value to an organization?

Growth/Marketing Strategy: The Europe artificial intelligence/machine learning medical device market has seen major development by key players operating in the market, such as business expansion, partnership, collaboration, and joint ventures. Partnerships, alliances, business expansions, and regulatory activities accounted for the maximum number of key developments.

Competitive Strategy: The Europe artificial intelligence/machine learning medical device market is highly fragmented, including established companies and startups. Key players in the Europe artificial intelligence/machine learning medical device market analyzed and profiled in the study involve established and emerging players that offer different AI-enabled medical devices. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.

Key Companies Profiled

  • CellaVision AB
  • Koninklijke Philips N.V.
  • Medtronic plc
  • Siemens Healthineers AG
  • AI4MedImaging Medical Solutions S.A.
  • AZmed SAS
  • Smart Soft Healthcare AD


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Table of Contents

Executive SummaryScope of the StudyResearch Methodology
1 Markets
1.1 Global Market Outlook
1.1.1 Product Definition
1.1.2 Inclusion and Exclusion Criteria
1.1.3 Key Findings
1.1.4 Market Scenario
1.1.4.1 Realistic Growth Scenario
1.1.4.2 Optimistic Growth Scenario
1.1.4.3 Pessimistic/Conservative Growth Scenario
1.2 Industry Outlook
1.2.1 Market Overview
1.2.2 Key Trends
1.2.2.1 Updations of Government Regulations to Accommodate the Development and Regulation of AI-enabled SaMD
1.2.2.2 Most AI-Enabled Medical Devices Aid in Clinical Decision-Making but do not Provide the Final Diagnosis Themselves
1.2.2.3 Very Few AI-Enabled Medical Devices Have to Undergo the Rigorous PMA Process: Rest Get 510(k) Clearance
1.2.3 Opportunity Assessment
1.2.4 Business Models
1.2.5 Recommendations for Key Players
1.2.6 Patent Analysis
1.2.6.1 Awaited Technological Developments
1.2.6.2 Patent Filing Trend (by Country)
1.2.6.3 Patent Filing Trend (by Year)
1.2.7 Funding Scenario
1.2.8 Product Benchmarking
1.2.9 End User Perception
1.3 Impact of COVID-19 on the Artificial Intelligence/Machine Learning Medical Device
1.3.1 Pre-COVID-19 Phase
1.3.2 During COVID-19
1.3.2.1 Impact of COVID-19 on Clinical Settings and Clinical Decision-Making
1.3.3 Post-COVID-19 Phase
1.4 Business Dynamics
1.4.1 Impact Analysis
1.4.2 Business Drivers
1.4.2.1 Presence of a Large Ecosystem of Companies Offering AI Solutions Targeting the Diverse Range of Applications of AI in the Healthcare
1.4.2.2 Growing Demand in the Field of Radiology and Cardiology Increasing Adoption of AI-Enabled Solutions due to Their Ability to Shorten Waiting Times and Reduce Burden on Healthcare System
1.4.2.3 Growing Demand for Wearable Sensors to Increase Adoption of AI-Enabled Medical Devices for Home-Based Care
1.4.2.4 Large Number of Government Initiatives Advancing the Research and Development of AI-Enabled Medical Devices
1.4.3 Business Restraints
1.4.3.1 Lack of Transparency and Concerns around Data Sharing Leading to Cybersecurity Concerns and Hindering Adoption of AI in Healthcare
1.4.3.2 Challenges Related to Identification and Minimization of Bias in AI Algorithms Leading to Concerns Surrounding the Reliability of Diagnosis and Thus Hindering the Use of AI-Enabled Solutions
1.4.4 Business Opportunities
1.4.4.1 Applications across a Wide Range of Clinical Areas Present Opportunities for Further Research and Development
1.4.4.2 Potential of AI to Shorten Wait Times and Reduce Disease Burden on the Healthcare System, Especially in Low- and Middle-Income Countries (LMICs)
2 Europe
2.1 Europe Artificial Intelligence/Machine Learning Medical Device Market
2.1.1 Regulatory Framework
2.1.2 Technology Adoption
2.1.3 Key Findings and Opportunity Assessment
2.1.4 Market Dynamics
2.1.4.1 Impact Analysis
2.1.5 Market Sizing and Forecast
2.1.5.1 Europe Artificial Intelligence/Machine Learning Medical Device Market (by Country)
2.1.5.1.1 Germany
2.1.5.1.1.1 Market Dynamics
2.1.5.1.1.2 Market Size and Forecast
2.1.5.1.2 France
2.1.5.1.2.1 Market Dynamics
2.1.5.1.2.2 Market Size and Forecast
2.1.5.1.3 Italy
2.1.5.1.3.1 Market Dynamics
2.1.5.1.3.2 Market Size and Forecast
2.1.5.1.4 U.K.
2.1.5.1.4.1 Market Dynamics
2.1.5.1.4.2 Market Size and Forecast
2.1.5.1.5 Spain
2.1.5.1.5.1 Market Dynamics
2.1.5.1.5.2 Market Size and Forecast
2.1.5.1.6 Rest-of-Europe
2.1.5.1.6.1 Market Dynamics
2.1.5.1.6.2 Market Size and Forecast
3 Markets - Competitive Benchmarking & Company Profiles
3.1 Competitive Benchmarking
3.1.1 Key Strategies and Developments
3.1.1.1.1 Regulatory and Legal Activities
3.1.1.1.2 Funding Activities
3.1.1.1.3 New Offerings
3.1.1.1.4 Mergers and Acquisitions
3.1.1.1.5 Partnerships, Collaborations, and Business Expansions
3.2 Company Profiles
3.2.1 CellaVision AB
3.2.1.1 Company Overview
3.2.1.2 Role of CellaVision AB in the Artificial Intelligence/Machine Learning Medical Device Market
3.2.1.3 Financials
3.2.1.4 Analyst Perception
3.2.2 Koninklijke Philips N.V.
3.2.2.1 Company Overview
3.2.2.2 Role of Koninklijke Philips N.V. in the Artificial Intelligence/Machine Learning Medical Device Market
3.2.2.3 Financials
3.2.2.4 Key Developments
3.2.2.5 Analyst Perception
3.2.3 Medtronic plc
3.2.3.1 Company Overview
3.2.3.2 Role of Medtronic plc in the Artificial Intelligence/Machine Learning Medical Device Market
3.2.3.3 Financials
3.2.3.4 Recent Developments
3.2.3.5 Analyst Perspectives
3.2.4 Siemens Healthineers AG
3.2.4.1 Company Overview
3.2.4.2 Role of Siemens Healthineers AG in the Artificial Intelligence/Machine Learning Medical Device Market
3.2.4.3 Financials
3.2.4.4 Analyst Perception
3.3 Company Snapshots
3.3.1 AI4MedImaging Medical Solutions S.A.
3.3.1.1 Company Overview
3.3.1.2 Role of AI4MedImaging Medical Solutions S.A. in the Artificial Intelligence/Machine Learning Medical Device Market
3.3.1.3 Key Developments
3.3.2 AZmed SAS
3.3.2.1 Company Overview
3.3.2.2 Role of AZmed SAS in the Artificial Intelligence/Machine Learning Medical Device Market
3.3.2.3 Key Developments
3.3.3 Smart Soft Healthcare AD
3.3.3.1 Company Overview
3.3.3.2 Role of Smart Soft Healthcare AD in the Artificial Intelligence/Machine Learning Medical Device Market
3.3.3.3 Key Developments
List of Figures
Figure 1: Artificial Intelligence/Machine Learning Medical Device Market, Healthcare Workflow on Introduction of AI/ML-Enabled Medical Devices
Figure 2: Artificial Intelligence/Machine Learning Medical Device Market, Impact Analysis
Figure 3: Artificial Intelligence/Machine Learning Medical Device Market (by Region), $Million, 2022 and 2032
Figure 4: Artificial Intelligence/Machine Learning Medical Device Market: Research Methodology
Figure 5: Primary Research Methodology
Figure 6: Bottom-Up Approach (Segment-Wise Analysis)
Figure 7: Top-Down Approach (Segment-Wise Analysis)
Figure 8: Artificial Intelligence/Machine Learning Medical Device Market Size and Growth Potential (Realistic Growth Scenario), $Million, 2021-2032
Figure 9: Artificial Intelligence/Machine Learning Medical Device Market Size and Growth Potential (Optimistic Growth Scenario), $Million, 2021-2032
Figure 10: Artificial Intelligence/Machine Learning Medical Device Market Size and Growth Potential (Pessimistic Growth Scenario), $Million, 2021-2032
Figure 11: Artificial Intelligence/Machine Learning Medical Device Market, Relevancy of AI in Healthcare
Figure 12: Artificial Intelligence/Machine Learning Medical Device Market, AI’s Role in Assisting the Various Stakeholders in Healthcare Settings
Figure 13: Artificial Intelligence/Machine Learning Medical Device Market, Different Types of AI/ML Algorithms in Healthcare
Figure 14: Artificial Intelligence/Machine Learning Medical Device Market Key Trends, Market Shift, 2022-2032
Figure 15: Artificial Intelligence/Machine Learning Medical Device Market, Changes in Traditional Healthcare Business Models due to Integration of AI in Medical Devices
Figure 16: Artificial Intelligence/Machine Learning Medical Device Market, Recommendations for Key Players
Figure 17: Artificial Intelligence/Machine Learning Medical Device Market, Patent Analysis (by Country), January 2018-January 2023
Figure 18: Artificial Intelligence/Machine Learning Medical Device Market, Patent Analysis (by Year), January 2018-January 2023
Figure 19: Artificial Intelligence/Machine Learning Medical Device Market Product Benchmarking
Figure 20: Artificial Intelligence/Machine Learning Medical Device Market, End User Perception
Figure 21: General Procedure of Artificial Intelligence (AI)-Based Applications to Identify COVID-19 Symptoms
Figure 22: Artificial Intelligence/Machine Learning Medical Device Market, Impact Analysis
Figure 23: Diverse Range of AI Applications in Medical Field
Figure 24: Regulatory Approvals for AI-Enabled Solutions, 2019-2022
Figure 25: Artificial Intelligence/Machine Learning Medical Device Market, Applications of Wearable Sensors in Healthcare
Figure 26: Artificial Intelligence/Machine Learning Medical Device Market Share (by Region), 2022-2032
Figure 27: Artificial Intelligence/Machine Learning Medical Device Market, Number of CE Marked AI/ML-Enabled Medical Devices, 2015-2019
Figure 28: Medical Artificial Intelligence/Machine Learning Medical Device Market Guidelines for Determining the Trustworthiness of an AI-Enabled Device as per EU Standards
Figure 29: Europe Artificial Intelligence/Machine Learning Medical Device Market, Incremental Opportunity (by Country), $Million, 2022-2032
Figure 30: Europe Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 31: Europe Artificial Intelligence/Machine Learning Medical Device Market (by Country), % Share, 2021 and 2032
Figure 32: Germany Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 33: France Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 34: Italy Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 35: U.K. Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 36: Spain Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 37: Rest-of-Europe Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 38: Artificial Intelligence/Machine Learning Medical Device Number of Key Developments and Strategies, January 2018-January 2023
Figure 39: Regulatory and Legal Activities, January 2018-January 2023
Figure 40: Funding Activities, January 2018-January 2023
Figure 41: New Offerings, January 2018-January 2023
Figure 42: Mergers and Acquisitions, January 2018-January 2023
Figure 43: Partnerships, Alliances, and Business Expansions, January 2018-January 2023
Figure 44: CellaVision AB: Overall Product Portfolio
Figure 45: CellaVision AB: Overall Financials, $Million, 2019-2021
Figure 46: CellaVision AB: Net Revenue (by Region), $Million, 2019-2021
Figure 47: CellaVision AB: R&D Expenditure, $Million, 2019-2021
Figure 48: Koninklijke Philips N.V.: Overall Product Portfolio
Figure 49: Koninklijke Philips N.V.: Overall Financials, $Million, 2019-2021
Figure 50: Koninklijke Philips N.V.: Net Revenue (by Segment), $Million, 2019-2021
Figure 51: Koninklijke Philips N.V.: Revenue (by Region), $Million, 2019-2021
Figure 52: Koninklijke Philips N.V.: R&D Expenditure, $Million, 2019-2021
Figure 53: Medtronic plc: Overall Product Portfolio
Figure 54: Medtronic plc: Overall Financials, $Million, 2020-2022
Figure 55: Medtronic plc: Net Revenue (by Segment), $Million, 2020-2022
Figure 56: Medtronic plc: Net Revenue (by Region), $Million, 2020-2022
Figure 57: Medtronic plc: R&D Expenditure, $Million, 2020-2022
Figure 58: Siemens Healthineers AG: Overall Product Portfolio
Figure 59: Siemens Healthineers AG: Overall Financials, $Million, 2020-2022
Figure 60: Siemens Healthineers AG: Net Revenue (by Segment), $Million, 2020-2022
Figure 61: Siemens Healthineers AG: Net Revenue (by Region), $Million, 2020-2022
Figure 62: Siemens Healthineers AG: R&D Expenditure, $Million, 2020-2022
Figure 63: AI4MedImaging Medical Solutions S.A.: Overall Product Portfolio
Figure 64: AZmed SAS: Overall Product Portfolio
Figure 65: Smart Soft Healthcare AD: Overall Product Portfolio
List of Tables
Table 1: Artificial Intelligence/Machine Learning Medical Device Market, Key Developments Analysis, January 2018-February 2023
Table 2: Key Questions Answered in the Report
Table 3: Parameters for Realistic, Optimistic, and Pessimistic Growth Scenarios in Artificial Intelligence/Machine Learning Medical Device Market
Table 4: Funding Scenarios in Artificial Intelligence/Machine Learning Medical Device Market, January 2018-January 2023
Table 5: Artificial Intelligence/Machine Learning Medical Device Market, Applications of AI-Enabled Medical Devices in Several Clinical Areas
Table 6: Europe Artificial Intelligence/Machine Learning Medical Device Market, Impact Analysis

Companies Mentioned

  • CellaVision AB
  • Koninklijke Philips N.V.
  • Medtronic plc
  • Siemens Healthineers AG
  • AI4MedImaging Medical Solutions S.A.
  • AZmed SAS
  • Smart Soft Healthcare AD

Table Information