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Software as a Medical Device (SaMD) Market - Forecasts from 2023 to 2028

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  • 125 Pages
  • June 2023
  • Region: Global
  • Knowledge Sourcing Intelligence LLP
  • ID: 5351025

The software as a medical device (SaMD) market is estimated to grow at a CAGR of 51.88% during the forecast period.

The software as a medical device (SaMD) market is estimated to grow exponentially during the forecast period. This growth can be attributed to the increasing demand for digital health solutions, driven by the need for remote patient monitoring and telehealth. The COVID-19 pandemic has accelerated the adoption of virtual care, creating a conducive environment for SaMD applications. Regulatory bodies worldwide are recognizing the potential of SaMD and implementing initiatives to streamline the regulatory process. For instance, the FDA's Digital Health Pre-Cert Program aims to facilitate innovation and market access for SaMD.

Additionally, integrating artificial intelligence (AI) and machine learning algorithms in SaMD development has garnered attention. AI-powered SaMD systems have demonstrated impressive performance in various medical domains, including detecting skin cancer and analyzing medical imaging data. These advancements in technology and regulatory support are driving the growth of the SaMD market, revolutionizing healthcare delivery, and paving the way for personalized, remote, and efficient patient care.

The software as a medical device (SaMD) market is driven by the rising adoption of IoT in healthcare.

The software as a medical device market is expected to witness healthy growth over the forecast period with the growing adoption of IoT in healthcare. Some of the applications of IoT in healthcare include continuous monitoring of blood pressure, heartbeat, body temperature, respiration rate, an ongoing collection of certain parameters in case of chronic illnesses, and providing remote assistance, among other applications. The growing adoption of these IoT devices is driven by the increasing prevalence of chronic diseases worldwide and the growing geriatric population suffering from various age-associated disorders, especially in remote monitoring of patients, fueling the market growth as well. Additionally, the increasing investments in IoT are continuing to fuel the innovations in the field of healthcare, which include the innovations such as AI and big data analytics and are thus having a significant impact on fueling the growth of global software as a medical device market.

Furthermore, with the growing consumer preferences for sophisticated wearables, the popularity of connected devices in healthcare is increasing with the rise in customers' disposable income worldwide during the forecast period. Additionally, governments worldwide are increasingly embracing the integration of Internet of Things (IoT) technologies into healthcare management. For example, the U.S. Department of Health and Human Services (HHS) has demonstrated this commitment by procuring Salesforce Service Cloud for Customer Support, MicroStrategy Platform Analytics for Analytics and BI, and Salesforce Sales Cloud for Sales Automation, CRM, and Sales Engagement. These investments and the active engagement of relevant IT decision-makers and key stakeholders reflect a concerted effort to leverage IoT's potential in enhancing healthcare operations and service delivery.

Market Developments:

In March 2020, Biofourmis, a Boston-based digital therapeutics leader, landed $100 million to develop, commercialize, and expand its AI-powered therapeutics platform.
In November 2021, HoneyNaps, a healthcare startup, announced the launch of "SOMNUM," a medical computer software to diagnose, predict, and prevent diseases by automatically analyzing data measured by Polysomnography using artificial intelligence algorithms.

The PCs/Laptops segment will witness robust growth during the forecast period.

Software as a medical device is widely used across a broad range of technological platforms, including PCs and Laptops. Increasing accessible healthcare and the growing demand for personalized treatment are the prime factors driving this growth during the forecast period. With the rise of telemedicine and remote patient monitoring, healthcare providers rely more on technology to deliver care. They enable healthcare professionals to access medical records, communicate with patients, and consult other healthcare providers in real-time. They also allow patients to access medical information, share with healthcare providers, and participate in telemedicine visits. Using PCs or laptops in the SaMD market also enables healthcare providers to offer care to patients in remote or underserved areas. This is particularly important for patients who may not have access to healthcare due to geographical barriers, such as those living in rural areas. By using technology to deliver care, healthcare providers can extend their reach and offer more accessible care to needy patients.

Americas accounted for a major share of the software as a medical device (SaMD) market, especially in the United States.

By geography, the software as a medical device (SaMD) market has been segmented into the Americas, Europe, the Middle East and Africa, and the Asia Pacific.

The growing adoption of advanced technologies in the medical & healthcare sector for better diagnosis and treatment is positively impacting the demand for software as a medical device (SAMD) in the United States. The growing internet and smartphone penetration is also boosting the SAMD demand. Such software can be installed in smartphones, allowing them to view images obtained from MRI medical devices. According to the Consumer Technology Association, 2020 smartphone shipments in the US stood at 166 million units, representing a 2% increase compared to 2019. Favorable government policies to boost the country's business activities further contribute to the SaMD market's growth. Recently, in November 2021, the FDA published a new guideline describing the important factors in evaluating the safety and effectiveness of device software.

Market Segmentation:


  • PCs/Laptops
  • Smartphones/Tablets
  • Wearable Devices


  • Diagnostics
  • Clinical Management


  • Cloud
  • On-premise


  • Americas
  • United States
  • Others
  • Europe, Middle East and Africa
  • United Kingdom
  • Germany
  • France
  • Others
  • Asia Pacific
  • Japan
  • China
  • Others

Table of Contents

1. Introduction
1.1 Market Overview
1.2. Covid-19 Scenario
1.3. Market Definition
1.4. Scope of The Study
1.5. Currency
1.6. Assumptions
1.7. Base, And Forecast Years Timeline
2. Research Methodology
2.1. Research Design
2.2. Secondary Sources
2.3. Validation
3. Key Findings
4. Market Dynamics
4.1. Segmentation
4.2. Drivers
4.2.1. Rising adoption Of IoT in healthcare
4.2.2. Developments in regulations of Software as a Medical Device
4.2.3. Concerns regarding misdiagnosis in healthcare
4.3. Restraints
4.3.1. Concerns regarding data security and privacy
4.3.2. Strict regulatory procedures for the development and approval of medical devices
4.4. Market Opportunities
4.4.1. Innovations in healthcare
4.4.2. Growing trend of home healthcare
4.4.3. Rising investments by the market players
4.5. Porter’s Five Forces Analysis
4.5.1. Bargaining Power of Suppliers
4.5.2. Bargaining Power of Buyers
4.5.3. Threat of New Entrants
4.5.4. Threat of Substitutes
4.5.5. Competitive Rivalry in the Industry
4.6. Product Pipeline
4.7. Industry Regulations
4.8. Life Cycle Analysis - Regional Snapshot
4.9. Market Attractiveness
5. Software as a Medical Device Market By Device Type
5.1. Introduction
5.2. PCs/Laptops
5.3. Smartphones/Tablets
5.4. Wearable Devices
6. Software as a Medical Device Market By Application
6.1. Introduction
6.1. Diagnostics
6.2. Clinical Management
7. Software as a Medical Device Market By Deployment
7.1. Introduction
7.1. Cloud
7.2. On-Premise
8. Software as a Medical Device Market By Geography
8.1. Introduction
8.2. Americas
8.2.1. United States
8.2.2. Others
8.3. Europe, Middle East and Africa
8.3.1. United Kingdom
8.3.2. Germany
8.3.3. France
8.3.4. Others
8.4. Asia Pacific
8.4.1. Japan
8.4.2. China
8.4.3. Others
9. Competitive Environment And Analysis
9.1. Major Players and Strategy Analysis
9.2. Mergers, Acquisitions, Agreements, and Collaborations
9.3. Vendor Competitiveness Matrix
10. Company Profiles
10.1. Arterys Inc.
10.1.1. Overview
10.1.2. Products and Services
10.1.3. Recent Developments
10.2. Qlarity Imaging Llc
10.2.1. Overview
10.2.2. Products and Services
10.2.3. Recent Developments
10.3. Viz.Ai, Inc.
10.3.1. Overview
10.3.2. Products and Services
10.3.3. Recent Developments
10.4. Imagen Technologies
10.4.1. Overview
10.4.2. Products and Services
10.4.3. Key Developments
10.5. Apple, Inc.
10.5.1. Overview
10.5.2. Products and Services
10.5.3. Financials
10.5.4. Key Developments
10.6. iSchemaView, Inc.
10.6.1. Overview
10.6.2. Products and Services
10.6.3. Key Developments
10.7. Digital Diagnostics Inc.
10.7.1. Overview
10.7.2. Products and Services
10.7.3. Recent Developments
10.8. Maxq Ai, Ltd.
10.8.1. Overview
10.8.2. Products and Services
10.8.3. Recent Developments
10.9. Greenfinch Technology
10.9.1. Overview
10.9.2. Products and Services
10.9.3. Recent Developments
10.10. Siemens Healthineers AG
10.10.1. Overview
10.10.2. Products and Services
10.10.3. Financials
10.10.4. Recent Developments
10.11. Koninklijke Philips N.V.
10.11.1. Overview
10.11.2. Products and Services
10.11.3. Financials

Companies Mentioned

  • Arterys Inc
  • Qlarity Imaging LLC
  • Viz.AI, Inc
  • Imagen Technologies
  • Apple Inc
  • Ischemaview Inc
  • Digital Diagnostics Inc
  • MaxQ AI, Ltd
  • Greenfinch Technology
  • Siemens Healthineers AG
  • Koninklijke Philips N.V