(SaMD) software as a medical device refers to software intended to be used for medical purposes without being part of a hardware medical device. SaMD can perform a wide range of functions, from providing information for clinical decision-making to directly diagnosing or treating medical conditions.
The (SaMD) software as medical device market consists of sales of (SaMD) software as a medical device by entities (organizations, partnerships and sole proprietors) that develop healthcare software that can help with diagnosis, management and treatment of medical conditions. It can automate some aspects of care, improve quality and save time.
The global (SaMD) software as a medical device market was valued at $8,058.3 million in 2018 which grew till 2023 at a compound annual growth rate (CAGR) of more than 24.0%
Increased Demand For Remote Monitoring In Healthcare
Increased demand for remote monitoring in healthcare services drove the growth of the (SaMD) software as a medical device market during the historic period. Remote monitoring in healthcare refers to the use of technology to monitor patients' health status and vital signs outside of traditional clinical settings, such as hospitals or clinics. SaMD platforms serve as the backbone of remote patient monitoring (RPM) programs, aggregating and analyzing patient-generated health data (PGHD) from various sources, such as wearable devices, smart sensors and mobile health apps. These platforms offer data analytics, trend analysis and predictive modeling capabilities to identify potential health issues, trigger alerts and facilitate clinical decision-making in real-time. According to the American Medical Association's (US-based professional association) Digital Health Research Survey of 1,300 physicians to investigate physician motivations and requirements for integrating remote health tools into their practices, the use of remote monitoring devices more than doubled from 12% in 2016 to 30% in 2022. Therefore, increased demand for remote monitoring in healthcare services supported the growth of the (SaMD) software as a medical device market.
Introduction Of Advanced Software With Improved Analysis Capabilities
Companies operating in the (SaMD) software as a medical device market are increasing their focus on introducing advanced software with improved analysis capabilities to gain a competitive edge in the market. For example, in September 2023, HoneyNaps Co., Ltd., a South Korea-based software company, received approval from the United States Food and Drug Administration (USFDA) for SOMNUM software. It uses deep learning-based AI to perform real-time analysis of various sleep biosignals, including electroencephalograms, electrooculograms, electromyograms, electrocardiograms, respiratory airflow and effort and oxygen saturation. The software is designed to provide more accurate and sophisticated readings than conventional methods and it can shorten the analysis of patient sleep data to under five minutes.
The global (SaMD) software as a medical device market is fairly fragmented, with a large number of players operating in the market. The top ten competitors in the market made up to 25.2% of the total market in 2022.
(SaMD) Software as a Medical Device Market Opportunities And Strategies To 2033 from The Business Research Company provides the strategists; marketers and senior management with the critical information they need to assess the global (SaMD) software as a medical device market as it emerges from the COVID-19 shut down.
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Where is the largest and fastest-growing market for (SaMD) software as a medical device? How does the market relate to the overall economy; demography and other similar markets? What forces will shape the market going forward? The (SaMD) software as a medical device market global report from The Business Research Company answers all these questions and many more.
The report covers market characteristics; size and growth; segmentation; regional and country breakdowns; competitive landscape; market shares; trends and strategies for this market. It traces the market's history and forecasts market growth by geography. It places the market within the context of the wider (SaMD) software as a medical device market; and compares it with other markets.
The report covers the following chapters
- Introduction and Market Characteristics: Brief introduction to the segmentations covered in the market, definitions and explanations about the segment by device type, by deployment method and by application.
- Key Trends: Highlights the major trends shaping the global market. This section also highlights likely future developments in the market.
- Macroeconomic Scenario: The report provides an analysis of the impact of the COVID-19 pandemic, impact of the Russia-Ukraine war and impact of rising inflation on global and regional markets, providing strategic insights for businesses in the (SaMD) software as medical device market.
- Global Market Size And Growth: Global historic (2018-2023) and forecast (2023-2028, 2033F) market values and drivers and restraints that support and control the growth of the market in the historic and forecast periods.
- Regional And Country Analysis: Historic (2018-2023) and forecast (2023-2028, 2033F) market values and growth and market share comparison by region and country.
- Market Segmentation: Contains the market values (2018-2023) (2023-2028, 2033F) and analysis for each segment by device type, by deployment method and by application in the market. Historic (2018-2023) and forecast (2023-2028) and (2028-2033) market values and growth and market share comparison by region market.
- Regional Market Size And Growth: Regional market size (2023), historic (2018-2023) and forecast (2023-2028, 2033F) market values and growth and market share comparison of countries within the region. This report includes information on all the regions Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa and major countries within each region.
- Competitive Landscape: Details on the competitive landscape of the market, estimated market shares and company profiles of the leading players.
- Other Major And Innovative Companies: Details on the company profiles of other major and innovative companies in the market.
- Competitive Benchmarking Briefs on the financials comparison between major players in the market.
- Competitive Dashboard: Briefs on competitive dashboard of major players.
- Key Mergers And Acquisitions: Information on recent mergers and acquisitions in the market covered in the report. This section gives key financial details of mergers and acquisitions, which have shaped the market in recent years.
- Market Opportunities And Strategies- Describes market opportunities and strategies based on findings of the research, with information on growth opportunities across countries, segments and strategies to be followed in those markets.
- Conclusions And Recommendations- This section includes recommendations for (SaMD) software as a medical device providers in terms of product/service offerings geographic expansion, marketing strategies and target groups next five years.
- Appendix: This section includes details on the NAICS codes covered, abbreviations and currencies codes used in this report
Scope
Markets Covered:
- 1) By Device: Devices; PCS; Laptop; Smartphone; Tablets
- 2) By Deployment: Cloud-Based; On-Premise
- 3) By Application: Diagnostic; Clinical Management
- Companies Mentioned: DexCom, Inc.; Koninklijke Philips N.V.; GE HealthCare Technologies Inc; Siemens Healthineers AG; FUJIFILM Holdings Corporation
- Countries: China; Australia; India; Indonesia; Japan; South Korea; USA; Canada; Brazil; France; Germany; UK; Italy; Spain; Russia
- Regions: Asia-Pacific; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
- Time-series: Five years historic and ten years forecast.
- Data: Ratios of market size and growth to related markets; GDP proportions; expenditure per capita; (SaMD) software as a medical device indicators comparison.
- Data segmentations: country and regional historic and forecast data; market share of competitors; market segments.
- Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.