+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

Software as a Medical Device (SaMD) Market - Forecasts from 2021 to 2026

  • PDF Icon


  • 107 Pages
  • June 2021
  • Region: Global
  • Knowledge Sourcing Intelligence LLP
  • ID: 5351025
The Software as a Medical Device (SaMD) market is projected to grow at a CAGR of 69.30% during the forecast period of 2019-2026.

Software as a Medical Device (SaMD), according to the definition by the International Medical Device Regulators Forum (IMDRF) is “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. It is software, which performs one or more medical functions. The software performs the medical functions. The software intends to treat diagnose, cure, mitigate or prevent diseases. SaMD is largely used with non-medical computing platforms connected to virtual networks or other general-use hardware. The Software as a Medical Device market is projected to witness staggering growth during the forecast period owing to the rapid product launches and rising adoption of the Internet of Things (IoT) and connected devices in the healthcare sector. Furthermore, ease in regulations for the certification of the SaMD will further boost the market. Additionally, rising investments by the companies for SaMD will provide ample opportunities for the market players to flourish during the given forecast period. The emergence of the Internet of Things (IoT) has largely impacted the healthcare development sector. IoT has integrated the conversion of digital platforms into medical devices which has resulted in making the devices more beneficial for all levels of treatment, such as in-patient treatment to population health condition monitoring. There have been recent investments in the healthcare sector in IoT and software development owing to the several advantages they offer. According to Forbes, nearly 87% of healthcare organizations across the globe have adopted IoT services by 2019. Moreover, several laws have been enacted and implemented across the globe, which is further expected to drive the market growth of the SaMD during the forecast period. For instance, the Health Information Technology for Economic and Clinical Health (HITECH) Act, 2009 was implemented in North America, to promote the adoption and meaningful use of health information technology. Furthermore, SaMD software taps the consumer end by providing fertility application services. This software helps users control conception or deal with reproductive outcomes. Further, the software also allows a smartphone user to directly look at images from an MRI scan or a computer-aided detection software to provide image post-processing which helps to detect breast cancer. The multiple uses of software as a medical device in diverse applications are bound to expand the market growth in the years to come.

By device type, the PCs and Laptops segment dominates the market owing to their advanced computing capabilities and integration with advanced sensor technologies to provide higher efficiency and better performance. The growing number of product launches coupled with favoring regulatory policies is increasing the competition in the market, which is anticipated to propel the market growth opportunities for manufacturers and vendors in the coming years. Currently, new smart sensor laptops are changing the way users can work, in simple words, the combination of sensing technology and laptops/PCs can handle the computing capabilities of advanced healthcare applications and software to monitor daily activities. The growing adoption of smartphones for various applications in the healthcare industry is expected to drive the smartphone segment. By deployment, Cloud-based SaMD is projected to hold a significant share owing to the rising popularity and greater functionality and scope in comparison to on premise-based devices. It is also anticipated to show multiple growth opportunities in the coming years owing to the increasing penetration of IoT in healthcare. Furthermore, cloud-based software also allows for accelerated performance on lower-tier hardware, which many healthcare technology giants are taking advantage of to develop high-performance devices through innovations and their research and development. For example, Singapore-based Biofourmis, recently received FDA clearance for its cloud-based AI software RhythmAnalytics, a part of its digital therapeutics program.

Geographically, North America is projected to hold the largest market share owing to several companies are getting FDA clearances for their software coupled with the burgeoning investment in the healthcare industry by major countries such as the U.S. and Canada. The growth will be followed by Europe Middle East, and Africa, while the Asia Pacific is projected to grow with the highest compound annual growth rate (CAGR) over the forecast period of 2020-2025 owing to the growing demand for SaMD keeping in view the high geriatric population of Japan, in addition to the growing health awareness among individuals where the educated individuals of emerging economies such as China and India are keenly concerned about keeping track of their health management.

Growth Factors
  • Rising adoption of IoT in healthcare

The increasing adoption of IoT in the healthcare sector coupled with the recent developments in regulations in the healthcare industry is expected to significantly influence the growth of the Software as a Medical Device market over the coming years. Some of the applications of IoT in healthcare include continuous monitoring of the blood pressure, heartbeat, body temperature, respiration rate, continuous collection of certain parameters in case of chronic illnesses, and providing remote assistance among other applications. Hence, the adoption of IoT in healthcare, globally will drive the market growth during the forecast period.

  • Privacy of health data of the user

The privacy of health data of the patients such as their details, confidential information, family history, sensitive medical history, etc. may be at stake as a data breach is highly prevalent in the industry. There are no stringent laws for data privacy, which may make the users apprehensive about adopting the software as a medical device technology, this may, in turn, limit the overall growth of the market during the forecast period.

Impact of COVID-19

The Covid-19 pandemic resulted in a mass shortage of vacant beds in hospitals, worldwide. The patients suffering from chronic illness were advised against visiting hospitals physically for treatment due to the fear of being infected. This trend encouraged the aggressive use of software as a medical device across the globe, to ensure no patient suffers due to a shortage of healthcare infrastructure. Thus, the pandemic greatly accelerated the growth of the software as a medical device market.

Competitive Insights

Prominent/major key market players in the Software As A Medical Device Market include Arterys Inc., Qlarity Imaging LLC, Viz.ai, Inc., Imagen Technologies, Inc., Apple, Inc., iSchemaView, inc. (RAPID), IDx Technologies Inc., MaxQ AI, Ltd. Greenfinch Technology, Siemens Healthineers AG, and Koninklijke Philips N.V. The players in the Software As A Medical Device Market are implementing various growth strategies to gain a competitive advantage over their competitors in this market. For Instance, In December 2020 MaxQ AI, Ltd. launched a second-generation ACCIPIO clinical platform for the healthcare industry to enhance physicians to provide “smarter care” with enhanced clinical workflow. In addition, in May 2020, Arterys Inc. raised $28 million to accelerate the delivery of medical artificial intelligence to practices around the world. They received the seventh USA FDA clearance, in the latest round of Series C investment from a syndicate led by Benslie Investment Group and Temasek Holdings, with participation by Fosun, Revelation Partners, Emergent Medical Partners, and Varian Medical Systems. Major market players in the market have been covered along with their relative competitive strategies in this report and the report mentions recent deals and investments of different market players over the last few years. The company profiles section details the business overview, financial performance (public companies) for the past few years, key products and services being offered along with the recent deals and investments of these important players in the Software As A Medical Device Market.


By Device Type
  • PCs/Laptop
  • Smartphone/tablets
  • Wearable Device

By Application
  • Diagnostic
  • Clinical Management

By Deployment Method
  • On-Premise
  • Cloud

By Geography
  • Americas
  • USA
  • Others
  • Europe Middle East and Africa
  • UK
  • Germany
  • France
  • Others
  • Asia Pacific
  • Japan
  • China
  • Others

Table of Contents

1. Introduction
1.1. Market Definition
1.2. Market Segmentation
2. Research Methodology
2.1. Research Data
2.2. Assumptions
3. Executive Summary
3.1. Research Highlights
4. Market Dynamics
4.1. Market Drivers
4.2. Market Restraints
4.3. Porters Five Forces Analysis
4.3.1. Bargaining Power of Suppliers
4.3.2. Bargaining Power of Buyers
4.3.3. The threat of New Entrants
4.3.4. Threat of Substitutes
4.3.5. Competitive Rivalry in the Industry
4.4. Industry Value Chain Analysis
5. Software As A Medical Device Market Analysis, By Device Type
5.1. Introduction
5.2. PCs/Laptop
5.3. Smartphone/tablets
5.4. Wearable Device
6. Software As A Medical Device Market Analysis, By Application
6.1. Introduction
6.2. Diagnostic
6.3. Clinical Management
7. Software As A Medical Device Market Analysis, By Deployment Method
7.1. Introduction
7.2. On-Premise
7.3. Cloud
8. Software As A Medical Device Market Analysis, 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 Intelligence
11.1. Competitive Benchmarking and Analysis
11.2. Recent Investment and Deals
11.3. Strategies of Key Players
10. Company Profiles
10.1. Arterys Inc.
10.2. Qlarity Imaging LLC
10.3. Viz.ai, Inc
10.4. Imagen Technologies
10.5. Apple, Inc.
10.6. iSchemaView, inc.(RAPID)
10.7. IDx Technologies Inc.
10.8. MaxQ AI, Ltd.
10.9. Greenfinch Technology
10.10. Siemens Healthineers AG
10.11. Koninklijke Philips N.V.

Companies Mentioned

  • Arterys Inc.
  • Qlarity Imaging LLC
  • Viz.ai, Inc.
  • Imagen Technologies, Inc.
  • Apple, Inc.
  • iSchemaView, inc.(RAPID)
  • IDx Technologies Inc.
  • MaxQ AI, Ltd.
  • Greenfinch Technology
  • Siemens Healthineers AG
  • Koninklijke Philips N.V