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Software as a Medical Device Market to Surpass US$ 5.4 Billion by 2032 as Integration of Internet of Things in Healthcare Sector Surges
[October 25, 2022]

Software as a Medical Device Market to Surpass US$ 5.4 Billion by 2032 as Integration of Internet of Things in Healthcare Sector Surges

AI-Based Software as a Medical Device to Register Over 35% CAGR through 2022 & Beyond

The latest report on the software as a medical device market conducted by Fact.MR uncovers critical trends and opportunities across various key segments in terms of device type, software technology, application, and region between 2022 and 2032. The report emphasizes on providing exclusive insights into the market to assist key players in making well-knitted strategies to gain a competitive edge.

NEW YORK, Oct. 25, 2022 /PRNewswire/ -- The global software as a medical device (SaMD) market is expected to reach US$ 1.1 billion in 2022, registering 16.7% CAGR during the forecast period (2022-2032). Sales in the market are projected to surpass US$ 5.4 billion by 2032 as integration of artificial intelligence, and advanced technology is surging in healthcare sector.

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Increasing use of Internet of things (IoT) in the healthcare industry and government efforts to improve the infrastructure are likely to drive the growth in software as a medical device market. Further, monitoring blood pressure, respiration rate, continual collecting of particular metrics in case of chronic conditions, and offering remote support are some of the functions of IoT in healthcare. As a result, the adoption of IoT in the healthcare industry will boost the expansion over the forecast period.

Software as a medical device enhances the effectiveness of medical devices and existing treatment programs, resulting in faster and higher-quality data collection and improved health outcomes. As these solutions are faster and less expensive to upgrade than hardware solutions, the demand in the U.S., the U.K., and other developed regions is expected to surge.

Ability to easily seek user input on host devices also contributes to shorter market time, faster product revisions, and faster innovation. As a result, the benefits provided by these solutions are projected to propel the growth in software as a medical device market over the decade.

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Regionally, Asia Pacific software as a medical device market will witness significant growth as a result of quick regulatory changes in medical devices and favorable policies across China and India. Furthermore, adequate government rules for developers regarding the design of diagnostics and medical devices are expected to boost the market.

The market for software as a medical device was dominated by PCs and laptops, in terms of device type. The segment is likely to maintain its dominance during the projection period due to technological advancements in laptop designs that enable the installation of smart sensors, which is transforming the compatibility between these devices and the SaMD.

Key Takeaways:

  • North America software as a medical device market is expected to register 15.8% CAGR between 2022 and 2032.
  • Based on software technology, the artificial intelligence (AI) segment grew at a CAGR of more than 35% over the past decade.
  • The U. S is expected to account for a demand share of 90.2% in North America software as a medical device market.
  • Japan software as a medical device market is predicted to grow at a CAGR of 17.8% over the upcoming decade.
  • Chronic illness and disease management application market will grow by 5.2x between 2022 and 2032.
  • Based on application, screening and diagnosis will hold a market share f 53.4% in 2022.

Growth Drivers:

  • Introduction of AI-based software applications and the advancement of technology will drive the growth in software as a medical device market.
  • The adoption of software as medical devices has substantially enhanced market growth due to the simplicity of handling and faster decision-making.


  • Expansion is likely to be hampered by increasing instances of cybercrime and a lack of cybersecurity, which may impede earning consumer confidence.
  • Growth of software as a medical device is hampered by their intangible character, which allows for many copies and wide distribution.

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Competitive Landscape:

To maintain their position, key players in the software as a medical device market are adopting organic growth techniques such as new developments and launches. Players in the market are focusing on increasing their capacity as well as their worldwide presence, employing both organic and inorganic growth strategies including acquisitions and partnerships.

For instance,

  • In 2022, iCAD, Inc., a global medical technology company offering novel cancer detection and therapeutic solutions, announced today the introduction of a new webinar series, ProFound Insights, ProFound Impact, which will feature client success stories throughout the year.
  • In 2022, Hyperfine, Inc., the manufacturer of Swoop, the first FDA-cleared portable magnetic resonance imaging (MRI) systemTM, is pleased to announce that Queen's University and Kingston Health Sciences Centre will deploy a Swoop system as part of their health services for six towns in the James Bay and Hudson Bay Area.
  • In December 2020, MaxQ AI, Ltd. has developed a second-generation ACCIPIO clinical platform for the healthcare sector in order to help physicians give "smarter care" through improved clinical workflow.

Key Companies Profiled by Fact.MR

  • GE Healthcare
  • iCAD Inc.
  • Hyperfine Research
  • Star
  • Tietronix Software, Inc.
  • S3 Connected Health
  • Ideagen
  • BrightInsight, Inc
  • Inzentiz
  • Zühlke Group
  • Orthogonal

More Valuable Insights on Software as a Medical Device Market

In the latest study, Fact.MR offers a detailed study on global software as a medical device market for the forecast period of 2022 to 2032. This study also highlights key drivers promoting the sales of software as a medical device through detailed segmentation as follows:

By Device Type:

  • Smartphones
  • Laptops/Desktops
  • Wearable Devices

By Software Technology:

  • Artificial Intelligence
  • Machine Learning

By Application:

  • Screening and Diagnosis
  • Monitoring and Alerting
  • Chronic Condition & Disease Management
  • Digital Therapeutics

By Region:

  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia & Oceania
  • MEA

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Key Questions Covered in the Software as a Medical Device Market Report

  • What is the projected value of the software as a medical device market in 2022?
  • At what rate will the global software as a medical device market grow until 2032?
  • Which are the factors hampering the growth in the software as a medical device market?
  • Which region is expected to lead in the global software as a medical device market during 2022-2032?
  • Which are the factors driving the software as a medical device market during the forecast period?

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About Fact.MR

Fact.MR is a market research and consulting agency with deep expertise in emerging market intelligence. Spanning a wide range – from automotive & industry 4.0 to healthcare, technology, chemical and materials, to even the most niche categories. We are committed to deliver insights that help businesses gain deeper understanding of their target markets. We understand that making sense of the vast labyrinth of data can be overwhelming for businesses. That's why focus on offering insights that can actually make a difference to bottom-lines.

Specialties: Competition Tracking, Customized Research, Syndicated Research, Investment Research, Social Media Research, Business Intelligence, Industry Analysis, Thought Leadership.


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