Product Code: MDS080A
Highlights:
This report provides a comprehensive analysis of the global market for software as a medical device. It presents the current and historical market revenue data estimation based on the product type, and by region. The report examines new and emerging trends and their impact on current and future market dynamics.
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.
Table of Contents
Chapter 1 Market Outlook
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