Global Software as a Medical Device (SaMD) Market Growth (Status and Outlook) 2025-2031

Publication ID:

LPI01250078

Publication Date:

January 8, 2025

Pages:

Publisher:

LPI

Countries:

Global [1]

USD 3,660.00

Pharmaceutical Manufacturing [2]

Healthcare [3]

Pharma & Healthcare [4]

Description:

The global Software as a Medical Device (SaMD) market size is predicted to grow from US$ 1803 million in 2025 to US$ 6222 million in 2031; it is expected to grow at a CAGR of 22.9% from 2025 to 2031.
SaMD is software that performs one or more medical functions. While the software may be embedded in a piece of hardware (as is often the case) it's the software itself that performs the medical function. The international medical device regulators forum (IMDRF), of which the US FDA is a member, describes SaMD as software that may work on general-purpose (non-medical) computing platforms; may be used in combination with other products including medical devices; and may interface with other medical devices or other general-purpose hardware and software that provide input to SaMD.
Global key players of Software as a Medical Device (SaMD) include MindMaze, Medtronic, iSchemaView, Viz.AI., Arterys, etc. The top five players hold a share about 18%.
The 鈥淪oftware as a Medical Device (SaMD) Industry Forecast鈥� looks at past sales and reviews total world Software as a Medical Device (SaMD) sales in 2024, providing a comprehensive analysis by region and market sector of projected Software as a Medical Device (SaMD) sales for 2025 through 2031. With Software as a Medical Device (SaMD) sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Software as a Medical Device (SaMD) industry.
This Insight Report provides a comprehensive analysis of the global Software as a Medical Device (SaMD) landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on Software as a Medical Device (SaMD) portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms鈥� unique position in an accelerating global Software as a Medical Device (SaMD) market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Software as a Medical Device (SaMD) and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Software as a Medical Device (SaMD).
This report presents a comprehensive overview, market shares, and growth opportunities of Software as a Medical Device (SaMD) market by product type, application, key players and key regions and countries.
Segmentation by Type:
Cloud-based
On Premise
Segmentation by Application:
Screening and Diagnosis
Monitoring and Alerting
Chronic Disease Management
Other
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
MindMaze
Medtronic
iSchemaView
Viz.AI.
Arterys
Digital Diagnostics
Siemens Healthcare
Allscripts
Adherium

Please Note - This is an on demand report and will be delivered in 2 business days (48 hours) post payment.

Table Of Contents:

1 Scope of the Report
1.1 Market Introduction
1.2 Years Considered
1.3 Research Objectives
1.4 Market Research Methodology
1.5 Research Process and Data Source
1.6 Economic Indicators
1.7 Currency Considered
1.8 Market Estimation Caveats
2 Executive Summary
2.1 World Market Overview
2.1.1 Global Software as a Medical Device (SaMD) Market Size (2020-2031)
2.1.2 Software as a Medical Device (SaMD) Market Size CAGR by Region (2020 VS 2024 VS 2031)
2.1.3 World Current & Future Analysis for Software as a Medical Device (SaMD) by Country/Region (2020, 2024 & 2031)
2.2 Software as a Medical Device (SaMD) Segment by Type
2.2.1 Cloud-based
2.2.2 On Premise
2.3 Software as a Medical Device (SaMD) Market Size by Type
2.3.1 Software as a Medical Device (SaMD) Market Size CAGR by Type (2020 VS 2024 VS 2031)
2.3.2 Global Software as a Medical Device (SaMD) Market Size Market Share by Type (2020-2025)
2.4 Software as a Medical Device (SaMD) Segment by Application
2.4.1 Screening and Diagnosis
2.4.2 Monitoring and Alerting
2.4.3 Chronic Disease Management
2.4.4 Other
2.5 Software as a Medical Device (SaMD) Market Size by Application
2.5.1 Software as a Medical Device (SaMD) Market Size CAGR by Application (2020 VS 2024 VS 2031)
2.5.2 Global Software as a Medical Device (SaMD) Market Size Market Share by Application (2020-2025)
3 Software as a Medical Device (SaMD) Market Size by Player
3.1 Software as a Medical Device (SaMD) Market Size Market Share by Player
3.1.1 Global Software as a Medical Device (SaMD) Revenue by Player (2020-2025)
3.1.2 Global Software as a Medical Device (SaMD) Revenue Market Share by Player (2020-2025)
3.2 Global Software as a Medical Device (SaMD) Key Players Head office and Products Offered
3.3 Market Concentration Rate Analysis
3.3.1 Competition Landscape Analysis
3.3.2 Concentration Ratio (CR3, CR5 and CR10) & (2023-2025)
3.4 New Products and Potential Entrants
3.5 Mergers & Acquisitions, Expansion
4 Software as a Medical Device (SaMD) by Region
4.1 Software as a Medical Device (SaMD) Market Size by Region (2020-2025)
4.2 Global Software as a Medical Device (SaMD) Annual Revenue by Country/Region (2020-2025)
4.3 Americas Software as a Medical Device (SaMD) Market Size Growth (2020-2025)
4.4 APAC Software as a Medical Device (SaMD) Market Size Growth (2020-2025)
4.5 Europe Software as a Medical Device (SaMD) Market Size Growth (2020-2025)
4.6 Middle East & Africa Software as a Medical Device (SaMD) Market Size Growth (2020-2025)
5 Americas
5.1 Americas Software as a Medical Device (SaMD) Market Size by Country (2020-2025)
5.2 Americas Software as a Medical Device (SaMD) Market Size by Type (2020-2025)
5.3 Americas Software as a Medical Device (SaMD) Market Size by Application (2020-2025)
5.4 United States
5.5 Canada
5.6 Mexico
5.7 Brazil
6 APAC
6.1 APAC Software as a Medical Device (SaMD) Market Size by Region (2020-2025)
6.2 APAC Software as a Medical Device (SaMD) Market Size by Type (2020-2025)
6.3 APAC Software as a Medical Device (SaMD) Market Size by Application (2020-2025)
6.4 China
6.5 Japan
6.6 South Korea
6.7 Southeast Asia
6.8 India
6.9 Australia
7 Europe
7.1 Europe Software as a Medical Device (SaMD) Market Size by Country (2020-2025)
7.2 Europe Software as a Medical Device (SaMD) Market Size by Type (2020-2025)
7.3 Europe Software as a Medical Device (SaMD) Market Size by Application (2020-2025)
7.4 Germany
7.5 France
7.6 UK
7.7 Italy
7.8 Russia
8 Middle East & Africa
8.1 Middle East & Africa Software as a Medical Device (SaMD) by Region (2020-2025)
8.2 Middle East & Africa Software as a Medical Device (SaMD) Market Size by Type (2020-2025)
8.3 Middle East & Africa Software as a Medical Device (SaMD) Market Size by Application (2020-2025)
8.4 Egypt
8.5 South Africa
8.6 Israel
8.7 Turkey
8.8 GCC Countries
9 Market Drivers, Challenges and Trends
9.1 Market Drivers & Growth Opportunities
9.2 Market Challenges & Risks
9.3 Industry Trends
10 Global Software as a Medical Device (SaMD) Market Forecast
10.1 Global Software as a Medical Device (SaMD) Forecast by Region (2026-2031)
10.1.1 Global Software as a Medical Device (SaMD) Forecast by Region (2026-2031)
10.1.2 Americas Software as a Medical Device (SaMD) Forecast
10.1.3 APAC Software as a Medical Device (SaMD) Forecast
10.1.4 Europe Software as a Medical Device (SaMD) Forecast
10.1.5 Middle East & Africa Software as a Medical Device (SaMD) Forecast
10.2 Americas Software as a Medical Device (SaMD) Forecast by Country (2026-2031)
10.2.1 United States Market Software as a Medical Device (SaMD) Forecast
10.2.2 Canada Market Software as a Medical Device (SaMD) Forecast
10.2.3 Mexico Market Software as a Medical Device (SaMD) Forecast
10.2.4 Brazil Market Software as a Medical Device (SaMD) Forecast
10.3 APAC Software as a Medical Device (SaMD) Forecast by Region (2026-2031)
10.3.1 China Software as a Medical Device (SaMD) Market Forecast
10.3.2 Japan Market Software as a Medical Device (SaMD) Forecast
10.3.3 Korea Market Software as a Medical Device (SaMD) Forecast
10.3.4 Southeast Asia Market Software as a Medical Device (SaMD) Forecast
10.3.5 India Market Software as a Medical Device (SaMD) Forecast
10.3.6 Australia Market Software as a Medical Device (SaMD) Forecast
10.4 Europe Software as a Medical Device (SaMD) Forecast by Country (2026-2031)
10.4.1 Germany Market Software as a Medical Device (SaMD) Forecast
10.4.2 France Market Software as a Medical Device (SaMD) Forecast
10.4.3 UK Market Software as a Medical Device (SaMD) Forecast
10.4.4 Italy Market Software as a Medical Device (SaMD) Forecast
10.4.5 Russia Market Software as a Medical Device (SaMD) Forecast
10.5 Middle East & Africa Software as a Medical Device (SaMD) Forecast by Region (2026-2031)
10.5.1 Egypt Market Software as a Medical Device (SaMD) Forecast
10.5.2 South Africa Market Software as a Medical Device (SaMD) Forecast
10.5.3 Israel Market Software as a Medical Device (SaMD) Forecast
10.5.4 Turkey Market Software as a Medical Device (SaMD) Forecast
10.6 Global Software as a Medical Device (SaMD) Forecast by Type (2026-2031)
10.7 Global Software as a Medical Device (SaMD) Forecast by Application (2026-2031)
10.7.1 GCC Countries Market Software as a Medical Device (SaMD) Forecast
11 Key Players Analysis
11.1 MindMaze
11.1.1 MindMaze Company Information
11.1.2 MindMaze Software as a Medical Device (SaMD) Product Offered
11.1.3 MindMaze Software as a Medical Device (SaMD) Revenue, Gross Margin and Market Share (2020-2025)
11.1.4 MindMaze Main Business Overview
11.1.5 MindMaze Latest Developments
11.2 Medtronic
11.2.1 Medtronic Company Information
11.2.2 Medtronic Software as a Medical Device (SaMD) Product Offered
11.2.3 Medtronic Software as a Medical Device (SaMD) Revenue, Gross Margin and Market Share (2020-2025)
11.2.4 Medtronic Main Business Overview
11.2.5 Medtronic Latest Developments
11.3 iSchemaView
11.3.1 iSchemaView Company Information
11.3.2 iSchemaView Software as a Medical Device (SaMD) Product Offered
11.3.3 iSchemaView Software as a Medical Device (SaMD) Revenue, Gross Margin and Market Share (2020-2025)
11.3.4 iSchemaView Main Business Overview
11.3.5 iSchemaView Latest Developments
11.4 Viz.AI.
11.4.1 Viz.AI. Company Information
11.4.2 Viz.AI. Software as a Medical Device (SaMD) Product Offered
11.4.3 Viz.AI. Software as a Medical Device (SaMD) Revenue, Gross Margin and Market Share (2020-2025)
11.4.4 Viz.AI. Main Business Overview
11.4.5 Viz.AI. Latest Developments
11.5 Arterys
11.5.1 Arterys Company Information
11.5.2 Arterys Software as a Medical Device (SaMD) Product Offered
11.5.3 Arterys Software as a Medical Device (SaMD) Revenue, Gross Margin and Market Share (2020-2025)
11.5.4 Arterys Main Business Overview
11.5.5 Arterys Latest Developments
11.6 Digital Diagnostics
11.6.1 Digital Diagnostics Company Information
11.6.2 Digital Diagnostics Software as a Medical Device (SaMD) Product Offered
11.6.3 Digital Diagnostics Software as a Medical Device (SaMD) Revenue, Gross Margin and Market Share (2020-2025)
11.6.4 Digital Diagnostics Main Business Overview
11.6.5 Digital Diagnostics Latest Developments
11.7 Siemens Healthcare
11.7.1 Siemens Healthcare Company Information
11.7.2 Siemens Healthcare Software as a Medical Device (SaMD) Product Offered
11.7.3 Siemens Healthcare Software as a Medical Device (SaMD) Revenue, Gross Margin and Market Share (2020-2025)
11.7.4 Siemens Healthcare Main Business Overview
11.7.5 Siemens Healthcare Latest Developments
11.8 Allscripts
11.8.1 Allscripts Company Information
11.8.2 Allscripts Software as a Medical Device (SaMD) Product Offered
11.8.3 Allscripts Software as a Medical Device (SaMD) Revenue, Gross Margin and Market Share (2020-2025)
11.8.4 Allscripts Main Business Overview
11.8.5 Allscripts Latest Developments
11.9 Adherium
11.9.1 Adherium Company Information
11.9.2 Adherium Software as a Medical Device (SaMD) Product Offered
11.9.3 Adherium Software as a Medical Device (SaMD) Revenue, Gross Margin and Market Share (2020-2025)
11.9.4 Adherium Main Business Overview
11.9.5 Adherium Latest Developments
12 Research Findings and Conclusion

License Types:

Single User License (PDF)

This license allows for use of a publication by one person.
This person may print out a single copy of the publication.
This person can include information given in the publication in presentations and internal reports by providing full copyright credit to the publisher.
This person cannot share the publication (or any information contained therein) with any other person or persons.
Unless a Enterprise License is purchased, a Single User License must be purchased for every person that wishes to use the publication within the same organization.
Customers who infringe these license terms are liable for a Global license fee.

听

Site License (PDF)*

This license allows for use of a publication by all users within one corporate location, e.g. a regional office.
These users may print out a single copy of the publication.
These users can include information given in the publication in presentations and internal reports by providing full copyright credit to the publisher.
These users cannot share the publication (or any information contained therein) with any other person or persons outside the corporate location for which the publication is purchased.
Unless a Enterprise License is purchased, a Site User License must be purchased for every corporate location by an organization that wishes to use the publication within the same organization.
Customers who infringe these license terms are liable for a Global license fee.

听

Global License (PDF)*

This license allows for use of a publication by unlimited users within the purchasing organization e.g. all employees of a single company.
Each of these people may use the publication on any computer, and may print out the report, but may not share the publication (or any information contained therein) with any other person or persons outside of the organization.
These employees of purchasing organization can include information given in the publication in presentations and internal reports by providing full copyright credit to the publisher.

*If Applicable.

91制片厂