Software as a Medical Device Market

Software as a Medical Device Market Analysis, By Device Type (Smartphones, Laptops/Desktops, Wearable Devices), By Software Technology (Artificial Intelligence, Machine Learning), By application, By Region - Global Market Insights 2022 to 2032

Analysis of Software as a Medical Device market covering 30 + countries including analysis of US, Canada, UK, Germany, France, Nordics, GCC countries, Japan, Korea and many more

Software as a Medical Device Market Outlook (2022-2032)

The global software as a medical device market currently accounts for a valuation of US$ 1.1 billion and is expected to boom at a CAGR of 16.7% to reach US$ 5.4 billion by the end of 2032.

Revenue from the software as a medical device (SaMD) market accounts for around 1% share of the global medical devices market.

Report Attributes


Software as a Medical Device Market Size (2021A)

US$ 994.5 Million

Estimated Market Value (2022E)

US$ 1.1 Billion

Forecasted Market Value (2032F)

US$ 5.4 Billion

Global Market Growth Rate (2022-2032)

~16.7% CAGR

North America Market Share (2021)


North America Market Growth Rate (2022-2032)

~15.8% CAGR

Japan Market Growth Rate (2022-2032)

~17.8% CAGR

Market Share of Top 5 Companies


Key Companies Profiled

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

Know thy Competitors

Competitive landscape highlights only certain players
Complete list available upon request

Sales Analysis of Software as Medical Devices (2017-2021) Vs. Market Forecasts (2022-2032)

The software as a medical device market is in the growing phase in its product lifecycle. The medical industry is fueling the demand for artificial intelligence and machine learning, which has also been pushing the introduction of software as medical devices in the market. Software as medical devices support treatment options, diagnosis, sharing of health records, data storing, and handling workflows, which leads to more efficient clinical practices.

Initiatives by government authorities for software and evolving technologies for patient health have increased of late.

  • For instance, in the middle of 2017, the FDA introduced and implemented its digital health innovation action plan, which sparked a discussion across the world.

Market players have grabbed this opportunity and have started working on this development. As such, the software as a medical device market increased at a compound annual growth rate of 12% from 2017 to 2021.

Moreover, it is anticipated that emerging regulations for digital health and efforts towards cybersecurity by government authorities will positively affect market growth. Also, growing patient dependence on digital health will drive the use of software as medical devices.

Fact.MR suggests that the global SMD market will reach a valuation of US$ 5.4 billion by 2032-end.

  • Short Term (2022-2025): Lack of approvals and risk of cybersecurity across regions will lead to the slow growth of the software as a medical device industry. Incremental opportunity of US$ 784.4 million will be offered from 2022 to 2025.
  • Medium Term (2025-2028): Rising need for self-monitoring and trust in software as a medical device will enhance its use, with the market growing 1.6X from 2025 to 2028.
  • Long Term (2028-2032): Investments and advancements in digital health will escalate market growth over the long run. Fact.MR estimates an incremental opportunity of US$ 2.9 billion between 2028 and 2032.

The global market for software as medical devices registered a CAGR of 12% between 2017 and 2021, according to Fact.MR, a market research and competitive intelligence provider. The study suggests that the market will surge in the years ahead at 16.7% CAGR between 2022 and 2032.

Software as a medical device market forecast by Fact.MR

Market share analysis of software as medical device based on application and region. Under the application segment, screening and diagnosis dominate with 53.4% market share in 2022.

Why is the Future Leaning towards Software as Medical Devices?

“Rising Technology & AI Trend Will Drive Healthcare Industry”

Artificial intelligence is the future of the healthcare industry, which is directly proportional to the growth of the software as a medical device market. It is believed that AI can bring enhancements to any process in healthcare delivery and operations. The use of AI technology is also a cost-saving factor for the healthcare industry.

According to Fact.MR analysis, AI software applications can reduce yearly U.S. healthcare costs by more than US$ 150 billion by 2026. The AI-associate healthcare market expanded at a CAGR of more than 35% over the past few years.

Hence, this growing technology and the introduction of AI-based software applications will spur the growth of the software as a medical device market.

“Huge Benefits of Software as Medical Devices for Diagnostic Purposes”

Software as medical devices are not only used for diagnosis but also help make users smarter so that they make health-related decisions on their own. These devices also benefit in consolidating vast medical data of a particular patient on a single platform, which is helpful for physicians to make fast decisions. Hence, the ease of handling and faster decision-making due to the use of software as medical devices have escalated market growth substantially.

Additionally, rising chronic diseases that require continuous monitoring are creating the need for software as medical systems. Patients suffering from chronic diseases can independently monitor their daily health without the need for a healthcare practitioner. Hence, expanding applications of software as medical devices are driving market growth.

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What Do Software as a Medical Device Manufacturers Need to Be Aware Of?

“Post Market Surveillance Could Be Challenging for Industry Players”

Every software technique comes with associated risks that need continuous monitoring even after launching in the market. As software as medical devices are directly connected with patients’ health, market players should constantly monitor patient-related issues to uphold the safety level.

Additionally, due to their intangible nature, software as medical devices can have several duplicated copies and are broadly spread, which are not controllable by market players. Furthermore, rising cases of cybercrime, as well as lack of cybersecurity, may limit gaining user trust. These factors may have a negative impact on the overall growth of the SaMD market.

Country-wise Insights

What Makes the United States a Leading Market for Software as Medical Devices?

Medical technology improvements in the U.S. are facilitated by developments in AI. In healthcare, software is becoming more significant and prevalent. Software developed for medical purposes and non-medical purposes (e.g., financial, administrative) is being widely used in the American healthcare sector as a result of the availability of numerous technology platforms (smartphones, personal computers, network servers, etc.), as well as increasing ease of access and distribution (e.g., cloud, Internet).

Medical devices hold a significant position in healthcare and health-related products. According to the Fact.MR study, from 2020 and 2021, the U.S. Food and Drug Administration (FDA) regulated more than 19,000 firms that produced an estimated 200,000 different medical devices. In 2019, it was estimated that US$ 199 billion was spent on medical equipment, up from US$ 36 billion in 1983.

Thus, considering the above facts, the United States accounts for a market share of 90.2% in North America and is expected to continue its dominance over the coming years as well.

Why is the Japan Software as a Medical Device Market Growing the Fastest?

With a well-funded and well-organized universal healthcare system, a population that is ageing rapidly, a propensity for new technology, and a significant importation of medical devices, Japan is the ideal location for market players to launch cutting-edge MedTech products.

The Japanese medical technology industry is valued at US$ 30 billion in 2020, ranking it fourth globally. Half of the market was made up of imported medical technologies and devices, with up to 80% (ophthalmic) of those items coming from abroad.

The Japanese MedTech ecosystem is well organized, and the government actively promotes collaborations with international academics or businesses by way of funding. Private or public bio clusters can also be a huge help when it comes to entering Japan and investigating the market's possibilities for Japanese software used in medical devices.

Owing to this, the Japan software as a medical device market is expected to gain 150 BPS and expand at a CAGR of 17.8% over the assessment period.

Category-wise Insights

Why are Software as Medical Devices Widely Preferred in Chronic Condition & Disease Management Applications?

The issue of complicated chronic illnesses will shape the future of healthcare. The 20th and 21st centuries both saw an epidemiological shift, in which, the eradication of many infectious diseases was countered by a gradual rise in chronic non-communicable diseases (NCDs), many of which were linked to significant changes in lifestyles. Therefore, there is a pressing need for the improved management of chronic illnesses.

  • According to current estimates, more than half of adults across the world suffer from at least one chronic illness, and up to one-third have multiple chronic conditions (MCCs).
  • Non-communicable diseases (NCDs) account for roughly three-fourths of yearly global fatalities, proving the rapidly expanding health burden.
  • Moreover, between the ages of 30 and 69, an estimated 15 million people die prematurely from NCD every year.

Thus, chronic condition and disease management applications will act as a boon for society, surpassing a market valuation of US$ 131 million at the end of 2021. Furthermore, the growing need for the continuous monitoring of chronic disease is expected to amplify the chronic condition and disease management application market by 5.2X by the end of 2032.

How is the Wearable Device Trend Complementing Market Expansion?

Wearable devices were created by manufacturers in response to consumer and medical professional demand for the continuous monitoring of health and vital signs. Wearables and other connected devices will need to be able to access shifting networks as data services continue to develop if they are to keep consumers linked to their health and medical information.

Wearables are being adopted by end users more frequently for fitness, health, and medical reasons, in addition to fashion. The medical sector contends with new dangers and safety issues posed by the newest wearable technology while taking into account how certification and testing can assist in ensuring compliance and market acceptability. Market participants will benefit from a larger customer base as a result of this.

The global wearable devices market was valued at US$ 117.8 billion in 2021 and is expected to reach US$ 271.4 billion by 2026, expanding at a CAGR of 18.2% over the period of 2021-2026. This will parallelly drive the wearable devices segment of the SaMD market.

Competitive Landscape

Prominent software as a medical device companies are GE Healthcare, iCAD Inc., Hyperfine Research, Star, Tietronix Software, Inc., S3 Connected Health, Ideagen, BrightInsight, Inc, Inzentiz, Zühlke Group, and Orthogonal.

Major players in the software as a medical device market are adopting organic growth strategies such as product innovations and launches to sustain their position in the market. Product approval across different geographical legislations is a bottleneck to the entrance of emerging players into the market.

Industry players are concentrating on capacity expansion as well as enhancement of their global reach, using both organic and inorganic growth tactics such as acquisitions and collaborations.

  • In July 2021, Star, a global technology company, announced the acquisition of Pro 4 People, a leading player in MedTech solutions. The acquisition helped Star expand its existing offerings.
  • In August 2019, FutureNeuro, in a partnership with S3 Connected Health, adopted the co-design approach for epilepsy treatment by using software technological solutions.

Fact.MR has provided detailed information about the price points of key manufacturers of software as medical devices positioned across regions, sales growth, and speculative technological expansion, in the recently published report

Segmentation of Software as a Medical Device Industry Research

  • 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

- FAQs -

At present, the global software as a medical device market is valued at US$ 1.1 billion.

Worldwide demand for software as a medical device is set to bloat at 16.7% CAGR and reach US$ 5.4 billion by 2032.

Between 2017 and 2021, sales of software as medical devices increased at 12% CAGR.

North America accounted for 32.7% share of the global SaMD market in 2021.

Laptops/desktops lead the software as a medical device types with 58.7% market share.

Software as a Medical Device Market

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