Software as a Medical Device Market By Deployment Type , By Application By End User : Global Opportunity Analysis and Industry Forecast, 2024-2033

Description

(SaMD) Software as a Medical Device Market

The (SaMD) software as a medical device market was valued at $19.5 million in 2023 and is projected to reach $96.2 million by 2033, growing at a CAGR of 17.3% from 2024 to 2033.

Software as a medical device (SaMD) is dedicated software designed for medical use through which functions are performed without the requirement of a hardware medical device. SaMD aids in managing patient health data, diagnosing health conditions, and recommending treatments. The software is highly versatile and accessible as it is easily accessible on general-purpose computing platforms such as smartphones and tablets. A key characteristic of SaMD is its potential to independently accomplish medical objectives, thereby accelerating the scope and efficiency of modern healthcare systems.

Increase in the adoption of telehealth and remote patient monitoring is a major driver of the (SaMD) software as a medical device market. In addition, support from several regulatory bodies such as the Food and Drug Administration and the European Union is boosting the demand for SaMD. To improve the healthcare providers' assistance, the incorporation of Clinical Decision Support Systems (CDSS) is an emerging trend in the market. The capabilities of CDSS help in making evidence-based clinical decisions, thereby enhancing diagnostic accuracy and optimizing treatment procedures.

However, the integration of existing medical records and healthcare data into SaMD is a time-consuming and costly process, hence hampering the development of the (SaMD) software as a medical device market. Furthermore, usage of the software is subject to rigorous regulatory compliance by the U.S. Food and Drug Administration (FDA), which presents significant challenges for the SaMD developers. The regulatory requirements of FDA include premarket approval, strict quality check, post-market surveillance, cybersecurity requirements, and specific software modifications & updates. All these requirements ensure the reliability and efficacy of SaMD, thus preventing compromise with critical health data and patient records.

Segment Review

The (SaMD) software as a medical device market is segmented into deployment type, application, end user, and region. On the basis of deployment type, the market is bifurcated into cloud based and on premise. Depending on application, it is divided into screening & diagnosis, monitoring & alerting, chronic disease management, digital therapeutics, and others. As per end user, it is classified into hospitals & clinics, home care settings, and others. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

Key Findings

On the basis of deployment type, the cloud-based segment dominates the (SaMD) software as a medical device market.

Depending on application, the screening & diagnosis segment accounts for a high market share.

As per end user, the hospitals & clinics segment acquires a high stake in the market.

Region wise, North America is the highest revenue generator in the (SaMD) software as a medical device market.

Competition Analysis

The major players operating in the global (SaMD) software as a medical device market include MindMaze , Siemens, Biofourmis, BrightInsight, Inc., 4S Information Systems Ltd, Viz.ai, Inc., F. Hoffmann-La Roche Ltd, Koninklijke Philips N.V., Orthogonal, and Zuhlke Engineering AG. These players have adopted various key developmental strategies such as business expansion, new product launches, and partnerships to strengthen their foothold in the market.

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Possible Customization with this report (with additional cost and timeline, please talk to the sales executive to know more)

Regulatory Guidelines
Additional company profiles with specific to client's interest
Additional country or region analysis- market size and forecast
Expanded list for Company Profiles
Historic market data
Key player details (including location, contact details, supplier/vendor network etc. in excel format)

Key Market Segments

By Deployment Type

Cloud Based
On Premise

By Application

Screening and Diagnosis
Monitoring and Alerting
Chronic Disease Management
Digital Therapeutics
Others

By End User

Hospitals and Clinics
Home Care Settings
Others

By Region

North America
- U.S.
- Canada
- Mexico
Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest of Europe
Asia-Pacific
- Japan
- China
- India
- Australia
- South Korea
- Rest of Asia-Pacific
LAMEA
- Brazil
- Saudi Arabia
- South Africa
- Rest of LAMEA

Key Market Players:

MindMaze
Siemens
Biofourmis
BrightInsight, Inc.
4S Information Systems Ltd,
Viz.ai, Inc.
F. Hoffmann-La Roche Ltd
Koninklijke Philips N.V.,
Orthogonal
Zuhlke Engineering AG

Product Code: A323957

CHAPTER 1: INTRODUCTION

1.1. Report Description
1.2. Key Market Segments
1.3. Key Benefits
1.4. Research Methodology
- 1.4.1. Primary Research
- 1.4.2. Secondary Research
- 1.4.3. Analyst Tools and Models

CHAPTER 2: EXECUTIVE SUMMARY

2.1. CXO Perspective

CHAPTER 3: MARKET LANDSCAPE

3.1. Market Definition and Scope
3.2. Key Findings
- 3.2.1. Top Investment Pockets
- 3.2.2. Top Winning Strategies
3.3. Porter's Five Forces Analysis
- 3.3.1. Bargaining Power of Suppliers
- 3.3.2. Threat of New Entrants
- 3.3.3. Threat of Substitutes
- 3.3.4. Competitive Rivalry
- 3.3.5. Bargaining Power among Buyers
3.4. Market Dynamics
- 3.4.1. Drivers
- 3.4.2. Restraints
- 3.4.3. Opportunities

CHAPTER 4: SOFTWARE AS A MEDICAL DEVICE (SAMD) MARKET, BY DEPLOYMENT TYPE

4.1. Market Overview
- 4.1.1 Market Size and Forecast, By Deployment Type
4.2. Cloud Based
- 4.2.1. Key Market Trends, Growth Factors and Opportunities
- 4.2.2. Market Size and Forecast, By Region
- 4.2.3. Market Share Analysis, By Country
4.3. On Premise
- 4.3.1. Key Market Trends, Growth Factors and Opportunities
- 4.3.2. Market Size and Forecast, By Region
- 4.3.3. Market Share Analysis, By Country

CHAPTER 5: SOFTWARE AS A MEDICAL DEVICE (SAMD) MARKET, BY APPLICATION

5.1. Market Overview
- 5.1.1 Market Size and Forecast, By Application
5.2. Screening And Diagnosis
- 5.2.1. Key Market Trends, Growth Factors and Opportunities
- 5.2.2. Market Size and Forecast, By Region
- 5.2.3. Market Share Analysis, By Country
5.3. Monitoring And Alerting
- 5.3.1. Key Market Trends, Growth Factors and Opportunities
- 5.3.2. Market Size and Forecast, By Region
- 5.3.3. Market Share Analysis, By Country
5.4. Chronic Disease Management
- 5.4.1. Key Market Trends, Growth Factors and Opportunities
- 5.4.2. Market Size and Forecast, By Region
- 5.4.3. Market Share Analysis, By Country
5.5. Digital Therapeutics
- 5.5.1. Key Market Trends, Growth Factors and Opportunities
- 5.5.2. Market Size and Forecast, By Region
- 5.5.3. Market Share Analysis, By Country
5.6. Others
- 5.6.1. Key Market Trends, Growth Factors and Opportunities
- 5.6.2. Market Size and Forecast, By Region
- 5.6.3. Market Share Analysis, By Country

CHAPTER 6: SOFTWARE AS A MEDICAL DEVICE (SAMD) MARKET, BY END USER

6.1. Market Overview
- 6.1.1 Market Size and Forecast, By End User
6.2. Hospitals And Clinics
- 6.2.1. Key Market Trends, Growth Factors and Opportunities
- 6.2.2. Market Size and Forecast, By Region
- 6.2.3. Market Share Analysis, By Country
6.3. Home Care Settings
- 6.3.1. Key Market Trends, Growth Factors and Opportunities
- 6.3.2. Market Size and Forecast, By Region
- 6.3.3. Market Share Analysis, By Country
6.4. Others
- 6.4.1. Key Market Trends, Growth Factors and Opportunities
- 6.4.2. Market Size and Forecast, By Region
- 6.4.3. Market Share Analysis, By Country

CHAPTER 7: SOFTWARE AS A MEDICAL DEVICE (SAMD) MARKET, BY REGION

7.1. Market Overview
- 7.1.1 Market Size and Forecast, By Region
7.2. North America
- 7.2.1. Key Market Trends and Opportunities
- 7.2.2. Market Size and Forecast, By Deployment Type
- 7.2.3. Market Size and Forecast, By Application
- 7.2.4. Market Size and Forecast, By End User
- 7.2.5. Market Size and Forecast, By Country
- 7.2.6. U.S. Software as a Medical Device (SaMD) Market
  - 7.2.6.1. Market Size and Forecast, By Deployment Type
  - 7.2.6.2. Market Size and Forecast, By Application
  - 7.2.6.3. Market Size and Forecast, By End User
- 7.2.7. Canada Software as a Medical Device (SaMD) Market
  - 7.2.7.1. Market Size and Forecast, By Deployment Type
  - 7.2.7.2. Market Size and Forecast, By Application
  - 7.2.7.3. Market Size and Forecast, By End User
- 7.2.8. Mexico Software as a Medical Device (SaMD) Market
  - 7.2.8.1. Market Size and Forecast, By Deployment Type
  - 7.2.8.2. Market Size and Forecast, By Application
  - 7.2.8.3. Market Size and Forecast, By End User
7.3. Europe
- 7.3.1. Key Market Trends and Opportunities
- 7.3.2. Market Size and Forecast, By Deployment Type
- 7.3.3. Market Size and Forecast, By Application
- 7.3.4. Market Size and Forecast, By End User
- 7.3.5. Market Size and Forecast, By Country
- 7.3.6. Germany Software as a Medical Device (SaMD) Market
  - 7.3.6.1. Market Size and Forecast, By Deployment Type
  - 7.3.6.2. Market Size and Forecast, By Application
  - 7.3.6.3. Market Size and Forecast, By End User
- 7.3.7. France Software as a Medical Device (SaMD) Market
  - 7.3.7.1. Market Size and Forecast, By Deployment Type
  - 7.3.7.2. Market Size and Forecast, By Application
  - 7.3.7.3. Market Size and Forecast, By End User
- 7.3.8. UK Software as a Medical Device (SaMD) Market
  - 7.3.8.1. Market Size and Forecast, By Deployment Type
  - 7.3.8.2. Market Size and Forecast, By Application
  - 7.3.8.3. Market Size and Forecast, By End User
- 7.3.9. Italy Software as a Medical Device (SaMD) Market
  - 7.3.9.1. Market Size and Forecast, By Deployment Type
  - 7.3.9.2. Market Size and Forecast, By Application
  - 7.3.9.3. Market Size and Forecast, By End User
- 7.3.10. Spain Software as a Medical Device (SaMD) Market
  - 7.3.10.1. Market Size and Forecast, By Deployment Type
  - 7.3.10.2. Market Size and Forecast, By Application
  - 7.3.10.3. Market Size and Forecast, By End User
- 7.3.11. Rest of Europe Software as a Medical Device (SaMD) Market
  - 7.3.11.1. Market Size and Forecast, By Deployment Type
  - 7.3.11.2. Market Size and Forecast, By Application
  - 7.3.11.3. Market Size and Forecast, By End User
7.4. Asia-Pacific
- 7.4.1. Key Market Trends and Opportunities
- 7.4.2. Market Size and Forecast, By Deployment Type
- 7.4.3. Market Size and Forecast, By Application
- 7.4.4. Market Size and Forecast, By End User
- 7.4.5. Market Size and Forecast, By Country
- 7.4.6. Japan Software as a Medical Device (SaMD) Market
  - 7.4.6.1. Market Size and Forecast, By Deployment Type
  - 7.4.6.2. Market Size and Forecast, By Application
  - 7.4.6.3. Market Size and Forecast, By End User
- 7.4.7. China Software as a Medical Device (SaMD) Market
  - 7.4.7.1. Market Size and Forecast, By Deployment Type
  - 7.4.7.2. Market Size and Forecast, By Application
  - 7.4.7.3. Market Size and Forecast, By End User
- 7.4.8. India Software as a Medical Device (SaMD) Market
  - 7.4.8.1. Market Size and Forecast, By Deployment Type
  - 7.4.8.2. Market Size and Forecast, By Application
  - 7.4.8.3. Market Size and Forecast, By End User
- 7.4.9. Australia Software as a Medical Device (SaMD) Market
  - 7.4.9.1. Market Size and Forecast, By Deployment Type
  - 7.4.9.2. Market Size and Forecast, By Application
  - 7.4.9.3. Market Size and Forecast, By End User
- 7.4.10. South Korea Software as a Medical Device (SaMD) Market
  - 7.4.10.1. Market Size and Forecast, By Deployment Type
  - 7.4.10.2. Market Size and Forecast, By Application
  - 7.4.10.3. Market Size and Forecast, By End User
- 7.4.11. Rest of Asia-Pacific Software as a Medical Device (SaMD) Market
  - 7.4.11.1. Market Size and Forecast, By Deployment Type
  - 7.4.11.2. Market Size and Forecast, By Application
  - 7.4.11.3. Market Size and Forecast, By End User
7.5. LAMEA
- 7.5.1. Key Market Trends and Opportunities
- 7.5.2. Market Size and Forecast, By Deployment Type
- 7.5.3. Market Size and Forecast, By Application
- 7.5.4. Market Size and Forecast, By End User
- 7.5.5. Market Size and Forecast, By Country
- 7.5.6. Brazil Software as a Medical Device (SaMD) Market
  - 7.5.6.1. Market Size and Forecast, By Deployment Type
  - 7.5.6.2. Market Size and Forecast, By Application
  - 7.5.6.3. Market Size and Forecast, By End User
- 7.5.7. Saudi Arabia Software as a Medical Device (SaMD) Market
  - 7.5.7.1. Market Size and Forecast, By Deployment Type
  - 7.5.7.2. Market Size and Forecast, By Application
  - 7.5.7.3. Market Size and Forecast, By End User
- 7.5.8. South Africa Software as a Medical Device (SaMD) Market
  - 7.5.8.1. Market Size and Forecast, By Deployment Type
  - 7.5.8.2. Market Size and Forecast, By Application
  - 7.5.8.3. Market Size and Forecast, By End User
- 7.5.9. Rest of LAMEA Software as a Medical Device (SaMD) Market
  - 7.5.9.1. Market Size and Forecast, By Deployment Type
  - 7.5.9.2. Market Size and Forecast, By Application
  - 7.5.9.3. Market Size and Forecast, By End User

CHAPTER 8: COMPETITIVE LANDSCAPE

8.1. Introduction
8.2. Top Winning Strategies
8.3. Product Mapping of Top 10 Player
8.4. Competitive Dashboard
8.5. Competitive Heatmap
8.6. Top Player Positioning, 2023

CHAPTER 9: COMPANY PROFILES

9.1. MindMaze
- 9.1.1. Company Overview
- 9.1.2. Key Executives
- 9.1.3. Company Snapshot
- 9.1.4. Operating Business Segments
- 9.1.5. Product Portfolio
- 9.1.6. Business Performance
- 9.1.7. Key Strategic Moves and Developments
9.2. Siemens
- 9.2.1. Company Overview
- 9.2.2. Key Executives
- 9.2.3. Company Snapshot
- 9.2.4. Operating Business Segments
- 9.2.5. Product Portfolio
- 9.2.6. Business Performance
- 9.2.7. Key Strategic Moves and Developments
9.3. Biofourmis
- 9.3.1. Company Overview
- 9.3.2. Key Executives
- 9.3.3. Company Snapshot
- 9.3.4. Operating Business Segments
- 9.3.5. Product Portfolio
- 9.3.6. Business Performance
- 9.3.7. Key Strategic Moves and Developments
9.4. BrightInsight, Inc.
- 9.4.1. Company Overview
- 9.4.2. Key Executives
- 9.4.3. Company Snapshot
- 9.4.4. Operating Business Segments
- 9.4.5. Product Portfolio
- 9.4.6. Business Performance
- 9.4.7. Key Strategic Moves and Developments
9.5. 4S Information Systems Ltd,
- 9.5.1. Company Overview
- 9.5.2. Key Executives
- 9.5.3. Company Snapshot
- 9.5.4. Operating Business Segments
- 9.5.5. Product Portfolio
- 9.5.6. Business Performance
- 9.5.7. Key Strategic Moves and Developments
9.6. Viz.ai, Inc.
- 9.6.1. Company Overview
- 9.6.2. Key Executives
- 9.6.3. Company Snapshot
- 9.6.4. Operating Business Segments
- 9.6.5. Product Portfolio
- 9.6.6. Business Performance
- 9.6.7. Key Strategic Moves and Developments
9.7. F. Hoffmann-La Roche Ltd
- 9.7.1. Company Overview
- 9.7.2. Key Executives
- 9.7.3. Company Snapshot
- 9.7.4. Operating Business Segments
- 9.7.5. Product Portfolio
- 9.7.6. Business Performance
- 9.7.7. Key Strategic Moves and Developments
9.8. Koninklijke Philips N.V.,
- 9.8.1. Company Overview
- 9.8.2. Key Executives
- 9.8.3. Company Snapshot
- 9.8.4. Operating Business Segments
- 9.8.5. Product Portfolio
- 9.8.6. Business Performance
- 9.8.7. Key Strategic Moves and Developments
9.9. Orthogonal
- 9.9.1. Company Overview
- 9.9.2. Key Executives
- 9.9.3. Company Snapshot
- 9.9.4. Operating Business Segments
- 9.9.5. Product Portfolio
- 9.9.6. Business Performance
- 9.9.7. Key Strategic Moves and Developments
9.10. Zuhlke Engineering AG
- 9.10.1. Company Overview
- 9.10.2. Key Executives
- 9.10.3. Company Snapshot
- 9.10.4. Operating Business Segments
- 9.10.5. Product Portfolio
- 9.10.6. Business Performance
- 9.10.7. Key Strategic Moves and Developments