Report Scope:
In this report, the market has been segmented based on product type and geography. The report provides an overview of the software as a medical device market and analyzes market trends. Using 2021 as the base year, the report provides estimated market data for the forecast period, 2022-2027. Revenue forecasts for this period are segmented based on product type and geography. Market values have been estimated based on the total revenue of SaMD manufacturers and key vendors.
The report covers the market for software as a medical device across different regions and countries. It also highlights major trends, opportunities, restraints that affect the market of SaMD. The report estimates the global market for SaMD in 2021 and provides projections for the expected market size through 2027.
The scope of the study includes software as a medical devices and operating platforms such as desktops/laptops, smartphones/tablets, and wearable devices.
Report Includes:
- A brief general outlook of the global market for software as a medical device (SaMD)
- Analyses of the global market trends, with historic revenue data for 2019-2021, estimates for 2022, and projections of compound annual growth rates (CAGRs) through 2027
- Understanding of the upcoming market opportunities for SaMD products market and digital health solutions, and areas of focus to forecast the market into various segments and sub-segments
- Estimation of the actual market size and revenue forecast for software as a medical device market, and corresponding market share analysis by product type and region
- Review of the impact of COVID-19 pandemic on the medical devices market
- Market share analysis of leading medical device manufacturers, their research priorities, technology advancements, and market development strategies
- Company profiles of the leading industry players, including Abbott Laboratories, Arterys, DexCom Inc. and Hyperfine Inc.
Summary:
The global market for software as a medical device (SaMD) was estimated to be $REDACTED in 2021. It is projected the SaMD market will grow at a CAGR of REDACTED% and is forecast to reach $REDACTED by 2027. Increasing venture capital funding in SaMD technology, growing demand for SaMD application in accurate diagnosis, disease prevention are some of the key factors driving the growth of the SaMD market. However, cybersecurity concerns and unsettled regulatory environment across regions such as North America and Europe are hindering market growth. Apart from drivers and restraints, increasing adoption of SaMD; the advent of artificial intelligence (AI), machine learning (ML) and the Internet of Things (IoT); and a rising number of SaMD start-ups will create huge opportunities for vendors in the market.
In this report, the global SaMD market has been segmented into desktops/laptops, smartphones/tablets and wearable devices. The desktop/laptop segment currently dominates the market and was valued at $REDACTED in 2021. It is estimated the desktop/laptop market will grow at a CAGR of REDACTED% and will reach $REDACTED by 2027.
By geography, the software as a medical device market has been segmented into North America, Europe, Asia-Pacific, and RoW. The North American region is currently the dominant market. In 2021, total revenue from the North American SaMD market reached $REDACTED, which is around REDACTED% of the global market. The presence of major companies, robust technology infrastructure, surge in demand for digital health and high adoption of advanced technologies, such as AI, IoT and cloud-based healthcare services, are some of the key factors driving the North American market.
Software as a Medical Device: Global Market Outlook
Table of Contents
Chapter 1 Market Outlook
1.1 Market Snapshot
Chapter 2 Executive Summary
Chapter 3 Market Definitions and Background
3.1 Overview
3.2 Definitions and Background
3.2.1 Difference Between Medical Device Software and SaMD
3.2.2 SaMD Utilizing Artificial Intelligence and Machine Learning (AI/ML)
3.2.3 Examples of Software that are not Software as a Medical Device
3.2.4 Five Applications of Software as a Medical Device
3.3 Regulation of Software as a Medical Device (SaMD)
3.3.1 Historic Foundations
3.3.2 Outlook of Regulatory Process in 2021
3.3.3 Future Scenario
3.4 International SaMD Regulations
3.4.1 SaMD Regulation in the EU
3.4.2 SaMD Regulation in the U.S.
Chapter 4 Market Dynamics
4.1 Market Drivers
4.2 Market Trends
4.3 Market Opportunities
4.4 Market Restraints
Chapter 5 Market Breakdown by Product
5.1 Introduction
5.2 SaMD: Desktops/Laptops
5.3 SaMD: Smartphone/Tablets
5.4 SaMD: Wearable Devices
Chapter 6 Market Breakdown by Region
6.1 Global Software as a Medical Device Market Size by Region
6.1.1 North America
6.1.2 Europe
6.1.3 Asia-Pacific
6.1.4 Rest of the World
Chapter 7 COVID-19 Impact on the SaMD Market
7.1 Introduction
7.2 Impact of COVID-19 on MedTech Industry
7.3 COVID-19 Impact on SaMD Market
Chapter 8 Competitive Landscape
8.1 Industry Scenario
8.2 Company Shares
8.3 Competitive Analysis
Chapter 9 Company Profiles
9.1 SaMD Manufacturers, Developers and Vendors
ABBOTT LABORATORIES
ARTERYS
DEXCOM INC.
FUJIFILM HOLDINGS CORP.
GENERAL ELECTRIC CO.
HYPERFINE, INC.
ICAD INC.
KONINKLIJKE PHILIPS N.V.
MEDTRONIC PLC
MITAC INTERNATIONAL CORP.
OMEGA MEDICAL IMAGING LLC
SIEMENS HEALTHINEERS
Chapter 10 Project Scope and Methodology
10.1 Scope of Report
10.2 Methodology
10.3 Analyst's Credentials
10.4 Related BCC Research Reports
List of Tables
Summary Table : Global Software as a Medical Device Market, by Region, Through 2027
Table 1 : Global Software as a Medical Device Market, by Product, Through 2027
Table 2 : Global SaMD Desktop/Laptop Market, by Region, Through 2027
Table 3 : Global SaMD Smartphone/Tablet Market, by Region, Through 2027
Table 4 : Global SaMD Wearable Device Market, by Region, Through 2027
Table 5 : Global Software as a Medical Device Market, by Region, Through 2027
Table 6 : North American Software as a Medical Device Market, by Country, Through 2027
Table 7 : European Software as a Medical Device Market, by Country, Through 2027
Table 8 : Asia-Pacific Software as a Medical Device Market, by Country, Through 2027
Table 9 : Rest of the World Software as a Medical Device Market, Through 2027
Table 10 : Arterys: Product Portfolio
Table 11 : Fujifilm Holdings Corp.: Product Portfolio
Table 12 : General Electric Co.: Product portfolio
Table 13 : Hyperfine Inc.: Product portfolio
Table 14 : iCAD INC.: Product Portfolio
Table 15 : Koninklijke Philips N.V.: Product Portfolio
Table 16 : Medtronic: Product Portfolio
Table 17 : Siemens Healthineers: Product Portfolio
List of Figures
Summary Figure : Global Market Share for Software as a Medical Device, by Region, 2021
Figure 1 : Global Sofware as a Medical Device Market, by Product, 2019-2027
Figure 2 : Global Sofware as a Medical Device Market Share, by Product, 2021
Figure 3 : Global SaMD Desktop/Laptop Market, by Region, 2019-2027
Figure 4 : Global SaMD Desktop/Laptop Market Market Share, by Region, 2021
Figure 5 : Global SaMD Smartphone/Tablet Market, by Region, 2019-2027
Figure 6 : Global SaMD Smartphone/Tablet Market Share, by Region, 2021
Figure 7 : Global SaMD Wearable Device Market, by Region, 2019-2027
Figure 8 : Global SaMD Wearable Device Market Share, by Region, 2021
Figure 9 : Global SaMD Market, by Region
Figure 10 : Global Software as a Medical Device Market Share, by Region, 2021
Figure 11 : North American Software as a Medical Device Market Share, by Country, 2021
Figure 12 : European Software as a Medical Device Market Share, by Country, 2021
Figure 13 : Asia-Pacific Software as a Medical Device Market Share, by Country, 2021
Figure 14 : Global Software as a Medical Device Market Share, by Company, 2021
Figure 15 : Global SaMD Desktop/Laptop Market Share, by Company, 2021
Figure 16 : Global SaMD Smartphone/Tablet Market Share, by Company, 2021
Figure 17 : Global SaMD Wearable Device Market Share, by Company, 2021
Figure 18 : Abbott: Annual Revenue, 2018-2021
Figure 19 : Abbott: Revenue Share, by Business Segment, 2021
Figure 20 : Dexcom Inc.: Annual Revenue, 2019-2021
Figure 21 : Fujifilm Holdings Corp.: Annual Revenue, 2019-2021
Figure 22 : General Electric Co.: Healthcare Segment, Annual Revenue, 2018-2021
Figure 23 : General Electric Co.: Healthcare Segment, Revenue Share, by Division, 2021
Figure 24 : Koninklijke Philips N.V.: Annual Revenue, 2018-2021
Figure 25 : Koninklijke Philips N.V.: Revenue Share, by Business Segment, 2021
Figure 26 : Medtronic: Annual Revenue, 2019-2021
Figure 27 : Medtronic: Revenue Share, by Business Segment, 2021
Figure 28 : Medtronic: Revenue Share, by Geography, 2021
Figure 29 : Siemens Healthineers: Annual Revenue, 2019-2021
Figure 30 : Siemens Healthineers: Revenue Share, by Business Segment, 2021
Figure 31 : Siemens Healthineers: Revenue Share, by Geography, 2021
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