Global Software as a Medical Device (SaMD) Industry Growth and Trends Forecast to 2031

Summary

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.

According to APO Research, The global Software as a Medical Device (SaMD) market was estimated at US$ million in 2025 and is projected to reach a revised size of US$ million by 2031, witnessing a CAGR of xx% during the forecast period 2026-2031.

North American market for Software as a Medical Device (SaMD) is estimated to increase from $ million in 2025 to reach $ million by 2031, at a CAGR of % during the forecast period of 2026 through 2031.

Asia-Pacific market for Software as a Medical Device (SaMD) is estimated to increase from $ million in 2025 to reach $ million by 2031, at a CAGR of % during the forecast period of 2026 through 2031.

Europe market for Software as a Medical Device (SaMD) is estimated to increase from $ million in 2025 to reach $ million by 2031, at a CAGR of % during the forecast period of 2026 through 2031.

The major global companies of Software as a Medical Device (SaMD) include MindMaze, Medtronic, Viz.AI., Siemens Healthcare, iSchemaView, Arterys, Adherium, Digital Diagnostics and Allscripts, etc. In 2024, the world's top three vendors accounted for approximately % of the revenue.

Report Scope

This report aims to provide a comprehensive presentation of the global market for Software as a Medical Device (SaMD), with both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding Software as a Medical Device (SaMD).

The Software as a Medical Device (SaMD) market size, estimations, and forecasts are provided in terms of revenue ($ millions), considering 2024 as the base year, with history and forecast data for the period from 2020 to 2031. This report segments the global Software as a Medical Device (SaMD) market comprehensively. Regional market sizes, concerning products by Type, by Application, and by players, are also provided. For a more in-depth understanding of the market, the report provides profiles of the competitive landscape, key competitors, and their respective market ranks. The report also discusses technological trends and new product developments.

Key Companies & Market Share Insights

In this section, the readers will gain an understanding of the key players competing. This report has studied the key growth strategies, such as innovative trends and developments, intensification of product portfolio, mergers and acquisitions, collaborations, new product innovation, and geographical expansion, undertaken by these participants to maintain their presence. Apart from business strategies, the study includes current developments and key financials. The readers will also get access to the data related to global revenue, gross margin by manufacturers for the period 2020-2025. This all-inclusive report will certainly serve the clients to stay updated and make effective decisions in their businesses.

Software as a Medical Device (SaMD) Segment by Company

MindMaze
Medtronic
Viz.AI.
Siemens Healthcare
iSchemaView
Arterys
Adherium
Digital Diagnostics
Allscripts

Software as a Medical Device (SaMD) Segment by Type

Cloud-based
On Premise

Software as a Medical Device (SaMD) Segment by Application

Screening and Diagnosis
Monitoring and Alerting
Chronic Disease Management
Other

Software as a Medical Device (SaMD) Segment by Region

North America
United States
Canada
Mexico
Europe
Germany
France
U.K.
Italy
Russia
Spain
Netherlands
Switzerland
Sweden
Poland
Asia-Pacific
China
Japan
South Korea
India
Australia
Taiwan
Southeast Asia
South America
Brazil
Argentina
Chile
Middle East & Africa
Egypt
South Africa
Israel
Türkiye
GCC Countries

Key Drivers & Barriers

High-impact rendering factors and drivers have been studied in this report to aid the readers to understand the general development. Moreover, the report includes restraints and challenges that may act as stumbling blocks on the way of the players. This will assist the users to be attentive and make informed decisions related to business. Specialists have also laid their focus on the upcoming business prospects.

Reasons to Buy This Report

1. This report will help the readers to understand the competition within the industries and strategies for the competitive environment to enhance the potential profit. The report also focuses on the competitive landscape of the global Software as a Medical Device (SaMD) market, and introduces in detail the market share, industry ranking, competitor ecosystem, market performance, new product development, operation situation, expansion, and acquisition. etc. of the main players, which helps the readers to identify the main competitors and deeply understand the competition pattern of the market.
2. This report will help stakeholders to understand the global industry status and trends of Software as a Medical Device (SaMD) and provides them with information on key market drivers, restraints, challenges, and opportunities.
3. This report will help stakeholders to understand competitors better and gain more insights to strengthen their position in their businesses. The competitive landscape section includes the market share and rank (in value), competitor ecosystem, new product development, expansion, and acquisition.
4. This report stays updated with novel technology integration, features, and the latest developments in the market
5. This report helps stakeholders to gain insights into which regions to target globally
6. This report helps stakeholders to gain insights into the end-user perception concerning the adoption of Software as a Medical Device (SaMD).
7. This report helps stakeholders to identify some of the key players in the market and understand their valuable contribution.

Chapter Outline

Chapter 1: Introduces the report scope of the report, executive summary of global and regional market size and CAGR for the history and forecast period (2020-2025, 2026-2031). It offers a high-level view of the current state of the market and its likely evolution in the short to mid-term, and long term.
Chapter 2: Provides the analysis of various market segments by type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 3: Provides the analysis of various market segments by application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 4: Introduces the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by manufacturers in the industry, and the analysis of relevant policies in the industry.
Chapter 5: Detailed analysis of Software as a Medical Device (SaMD) companies' competitive landscape, revenue, market share and ranking, latest development plan, merger, and acquisition information, etc.
Chapter 6: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product introduction, revenue, recent development, etc.
Chapter 7, 8, 9, 10 and 11: North America, Europe, Asia Pacific, South America, Middle East & Africa, revenue by country.
Chapter 12: Concluding Insights of the report

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