Software as a Medical Device Market

Software as a Medical Device Market Outlook (2024 to 2034)

The global software as a medical device market is calculated to reach US$ 6.1 billion by the end of 2034, up from US$ 1.8 billion in 2024. Revenue in this market is projected to increase at a CAGR of 13% from 2024 to 2034.

The healthcare sector is embracing artificial intelligence and machine learning in a big way, thereby accelerating the introduction of software as medical devices. These software solutions support various aspects, including treatment options, diagnosis, health record sharing, data storage, and workflow management, resulting in enhanced clinical efficiency.

Recent initiatives by government bodies to promote software and emerging technologies for patient care are gaining momentum. Regulations governing digital health and government efforts in cybersecurity are projected to positively influence market growth. With patients increasingly relying on digital health solutions, the utilization of software as medical devices is projected to rise.

Integration of IoT in healthcare is poised to propel market expansion. Smart devices such as sensors, smartphones, and wearable technology collect crucial data, subsequently enhancing the user experience. The landscape of software as a medical device is aligning towards substantial market expansion, in tandem with the proliferation of wearable devices and smartphone production.

Report Attribute	Detail
Software as a Medical Device Market Size (2024E)	US$ 1.8 Billion
Projected Market Value (2034F)	US$ 6.1 Billion
Global Market Growth Rate (2024 to 2034)	13% CAGR
China Market Value (2034F)	US$ 700 Million
Canada Market Growth Rate (2024 to 2034)	13.5% CAGR
North America Market Share (2024E)	23.9%
East Asia Market Value (2034F)	US$ 1.4 Billion
Key Companies Profiled	GE Healthcare; iCAD Inc.; Hyperfine Research; Star; Tietronix Software, Inc.; S3 Connected Health; Ideagen; BrightInsight, Inc.; Inzentiz; Zühlke Group; Orthogonal.

How is Adoption of Software as a Medical Device Shaping the Future of Healthcare?

“Introduction of AI-driven Software Applications Expediting Decision-Making in Healthcare”

Artificial intelligence is the future of healthcare, and its adoption is projected to drive market expansion over the forecast period. It is widely acknowledged that AI has the potential to enhance every facet of healthcare delivery and operations. In addition, the utilization of AI technology presents a cost-saving advantage for the healthcare sector.

These technological advancements and the introduction of AI-driven software applications are poised to fuel software as a medical device market growth. Software as a medical device solution not only aids in diagnosis but also empowers users to make informed health-related decisions independently. Moreover, these devices facilitate the consolidation of extensive medical data for individual patients onto a unified platform, streamlining decision-making for physicians. The ease of use and expedited decision-making afforded by software as medical devices have significantly contributed to market expansion.

The increasing prevalence of chronic diseases necessitates continuous monitoring. This gives rise to the demand for medical software systems. Patients afflicted with chronic conditions can self-monitor their daily health status without constant intervention from healthcare professionals.

Which Issues Must Market Players Consider While Providing Solutions?

“Increasing Prevalence of Cybercrime and Insufficient Cybersecurity Measures”

Every software solution carries inherent risks that require ongoing monitoring even post-launch in the SaMD market. As it directly interfaces with patient health, industry stakeholders must vigilantly oversee patient-related concerns to maintain safety standards. Due to their intangible nature, software as medical devices can proliferate with several duplicate copies, making them challenging to regulate for market players. The increasing prevalence of cybercrime and insufficient cybersecurity measures are anticipated to undermine user trust, potentially impeding the overall growth of the medical software market.

Country-wise Insights

Fact.MR, a market research and competitive intelligence provider, asserts through its updated report analysis that North America is calculated to hold 24.3% of the global software as a medical device market share by 2034. Providers of software as a medical device solutions have significantly broadened their global presence, extending to various regions such as Southeast Asia, Central and South America, and Australia.

Which Software as a Medical Device Market Trends are Significant in the United States?

“Increasing Significance of Software in Healthcare and Rising Number of FDA Approvals for Devices”

Attribute	United States
Market Value (2024E)	US$ 200 Million
Growth Rate (2024 to 2034)	13.5% CAGR
Projected Value (2034F)	US$ 700 Million

The United States is poised to account for a market share of 90.2% in North America in 2024 and is projected to continue its leading position over the coming years as well. Medical technology improvements in the United States are facilitated by advancements 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 several 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.

• From 2020 and 2021, the United States 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.

Which Factors Make Japan an Ideal Market for Launching Cutting-Edge MedTech Products?

“Well-funded and Well-Organized Universal Healthcare System and Focus on Innovation”

Attribute	Japan
Market Value (2024E)	US$ 100 Million
Growth Rate (2024 to 2034)	13.5% CAGR
Projected Value (2034F)	US$ 400 Million

With a well-funded and well-organized universal healthcare system, an increasing aging population, the need for technological innovation, and significant imports of medical devices, Japan is the ideal location for market players to launch cutting-edge MedTech products.

The MedTech ecosystem in Japan 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 helping hand when it comes to entering Japan and investigating the market possibilities for Japanese software used in medical devices.

Category-wise Insights

The market is segmented into smartphones, laptops/desktops, and wearable devices by device type. Out of these three segments, smartphones are projected to occupy a leading market share of 44% by 2034.

How is Increasing Adoption of Digital Health Solutions via Smartphones Proving Beneficial?

“Integration of AI and Machine Learning Enhancing Predictive and Analytical Capabilities”

Attribute	Smartphones
Segment Value (2024E)	US$ 700 Million
Growth Rate (2024 to 2034)	14.1% CAGR
Projected Value (2034F)	US$ 2.7 Billion

Increasing adoption of digital health solutions via smartphones and their ease of use are contributing to the software as a medical device market size. Smartphones’ advanced computing capabilities and sensors can host a variety of medical applications, ranging from fitness trackers to sophisticated diagnostic tools. Integration of AI and machine learning in these applications is enhancing their predictive and analytical capabilities by making them more appealing to users.

Growing awareness and acceptance of these digital health solutions among consumers, healthcare professionals, and regulatory bodies are also playing a significant role in boosting smartphone sales in this market. Ongoing advancements in mobile technology and the deployment of 5G are expected to further drive this growth by enabling more complex and reliable medical applications on smartphones.

How Does Expansion of Screening & Diagnosis Segment Contribute to Healthcare?

“Critical Role of Screening in Early Detection and Management of Various Health Conditions”

Attribute	Screening & Diagnosis
Segment Value (2024E)	US$ 800 Million
Growth Rate (2024 to 2034)	12% CAGR
Projected Value (2034F)	US$ 2.5 Billion

Expansion of the screening & diagnosis segment is attributed to the critical role these applications play in the early detection and management of various health conditions. They leverage advanced algorithms and vast databases to analyze medical data, enabling accurate and timely diagnosis. These applications range from simple tools for checking crucial signs to complex software capable of interpreting radiological images.

Increasing prevalence of chronic diseases and the growing need for efficient diagnostic solutions are driving the demand for these applications. The convenience and cost-effectiveness of using software for screening and diagnosis, as opposed to traditional methods are further contributing to their leading market share. As the digitalization of healthcare continues, the significance of these applications is projected to increase further during the forecast period.

Competitive Landscape

Key players in the software as a medical device industry are aiming to develop new technologies that effectively cater to the growing need for software as a medical device solutions.

• In 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.

Key Segments of Software as a Medical Device Market Research

• By Device Type :

  • Smartphones
  • Laptops/Desktops
  • Wearable Devices

• By Software Technology :

  • Artificial Intelligence
  • Machine Learning

• By Application :

  • Screening & Diagnosis
  • Monitoring & Altering
  • Chronic Conditions & Disease Management
  • Digital Therapeutics

• By Region :

  • North America
  • Latin America
  • Eastern Europe
  • Western Europe
  • East Asia
  • South Asia & Pacific
  • Middle East & Africa