SaMD Market Size
| Study Period | 2022 - 2030 |
| Base Year For Estimation | 2024 |
| Forecast Data Period | 2025 - 2030 |
| CAGR | 18.92% |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players*Disclaimer: Major Players sorted in no particular order |
SaMD Market Analysis
The SaaMD Market is expected to register a CAGR of 18.92% during the forecast period.
- Driven by technological advancements, regulatory changes, and a growing demand for personalized healthcare solutions, SaMD is rapidly evolving. The integration of artificial intelligence and machine learning into SaMD is enhancing its capabilities, making it more efficient and effective. Additionally, regulatory bodies are updating guidelines to ensure the safety and efficacy of these software solutions, further driving innovation in the sector. As healthcare providers and patients increasingly seek tailored healthcare options, the demand for advanced SaMD continues to rise, pushing the boundaries of medical technology.
- The rising adoption of Software as a Medical Device (SaMD) is largely due to its versatility across diverse technology platforms, including medical device platforms and virtual networks. SaMD underscores the expanding opportunities for medical device companies, emphasizing the potential of innovative technologies to advance the future of healthcare positively.
- SaMD includes diverse software applications such as mobile health apps, clinical decision support systems, electronic health records, and platforms for remote patient monitoring. These applications play a pivotal role in clinical decision-making, expediting the discovery and treatment of numerous medical conditions. SaMD is utilized to analyze data for screening and diagnosing medical conditions, monitoring patients, alerting both patients and healthcare providers to health issues, and even managing chronic diseases.
- Furthermore, the integration of Machine Learning (ML) and Artificial Intelligence (AI) into Software as a Medical Device (SaMD) is transforming the functionality of medical software. These technologies enable the software to learn from real-world data, enhancing its diagnostic and treatment capabilities over time. This innovation improves patient care and facilitates more adaptive and responsive healthcare solutions.
- Despite the vast potential of Software as a Medical Device (SaMD), its broad adoption encounters multiple hurdles. A key challenge lies in guaranteeing the safety and dependability of these software applications. Ensuring compliance with regulatory standards, addressing cybersecurity threats, and managing the integration with existing healthcare systems are additional obstacles that need to be overcome for SaMD to achieve widespread implementation.
SaMD Market Trends
Screening and Diagnosis to Register Significant Growth
- The screening and diagnosis segment is poised to play a pivotal role in the growth of the SaMD market. This surge can be attributed to technological advancements, particularly the integration of AI and ML. These technologies facilitate more accurate and timely assessments of patient conditions, a crucial factor for effective treatment planning.
- SaMD developers are leveraging AI, machine learning, and data analytics to craft more effective solutions. These technologies enable developers to analyze vast amounts of data, identify patterns, and make informed decisions, ultimately enhancing the functionality and reliability of software as a medical device.
- In September 2023, The US Food and Drug Administration (FDA) has granted approval for the inaugural over-the-counter (OTC) hearing aid software that is compatible with Apple AirPods Pro headphones. This innovative capability, set to be added to the AirPods Pro 2 via a software update, will enable the earbuds to serve as customised hearing aids. The primary goal of this feature is to assist users with mild-to-moderate hearing impairments.
- As chronic diseases become more prevalent and the demand for early diagnosis rises, the need for advanced screening and diagnostic tools intensifies. This trend underscores the importance of investing in innovative medical technologies to enhance patient outcomes and streamline healthcare services. NHS Digital reported that, as of December 2023, the average patient count per GP practice in England reached about 10,000, a notable increase from roughly 8,400 in 2018. This significant rise highlights the growing pressure on healthcare providers to adopt efficient diagnostic solutions to manage the increasing patient load effectively.
- SaMD solutions provide real-time tracking of medical conditions, assisting in the early detection of symptoms. These solutions also monitor chronic illnesses, such as diabetes and bronchial asthma, alerting users to any unexpected developments. SaMD software works hand-in-hand with medical techniques to streamline treatment strategies. For example, by analyzing digital mammogram images, SaMD can assess the likelihood of breast cancer, thereby aiding physicians in formulating treatment plans or suggesting further examinations.
Asia-Pacific to Witness Major Growth
- As the healthcare landscape in the Asia Pacific (APAC) region undergoes rapid evolution, there's an increasing demand for innovative solutions. Artificial Intelligence (AI) emerges as a key player, poised to unlock opportunities that can elevate patient care and optimize healthcare outcomes in the studied market.
- With to the increasing prevalence of diseases like cardiovascular disorders, diabetes, and infectious diseases, coupled with a heightened focus from market players to expand their presence in emerging countries, the region is expected to witness substantial growth in the software as a medical device market. This growth is driven by advancements in technology, regulatory support, and the rising adoption of digital health solutions. Additionally, the increasing investment in healthcare infrastructure and the growing awareness about the benefits of software as a medical device further contribute to the market's expansion.
- As of December 2023, the Ministry of Health, Labour and Welfare of Japan (MHLW) reported that about 84% of hospital beds designated for long-term care patients were occupied. This high occupancy rate reflects aging population and the prevalence of chronic illnesses. Additionally, psychiatric patients had an occupancy rate of approximately 81%.
- Countries in the region are taking initiatives to support the adoption of SaMD. In October 2024, Acer Medical, a Taiwan-based company, announced that its AI-driven software, VeriOsteo OP, which screens for bone mineral density abnormalities, has received a medical device certificate from Indonesia's Ministry of Health. This milestone follows the company's prior achievement with VeriSee DR, an AI diagnostic tool for diabetic retinopathy, which was the first product to obtain registration approval.
- Further, in September 2024, the Asia Pacific Medical Technology Association (APACMed) hosted the Asia Pacific MedTech Forum in Singapore. Themed 'THE DEC-AI-DE OF INTELLIGENT HEALTHCARE SYSTEMS', APACMed has been both reactively and proactively addressing challenges in digital health and AI. Through publishing industry position papers and engaging with regulatory authorities, APACMed has successfully driven policy changes, including updated SaMD guidance from Singapore's HSA and Australia's TGA.
SaMD Industry Overview
The Software as a Medical Device (SaMD) market is characterized by fragmentation, with a multitude of small to medium-sized firms, none commanding a dominant market share. This scenario cultivates fierce competition, with many players vying for both customers and market prominence. Furthermore, the competitive landscape is being reshaped by strategic partnerships, acquisitions, and mergers.
SaMD Market Leaders
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Zühlke Engineering AG
-
Koninklijke Philips N.V
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Siemens Healthcare Private Limited
-
Medtronic plc
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GE Healthcare
- *Disclaimer: Major Players sorted in no particular order
SaMD Market News
- August 2024: Skanray, a global MedTech company focused on R&D and manufacturing, specializes in diagnostic imaging, critical care, and surgical/OT solutions. They've partnered with Tata Elxsi to develop advanced surgical imaging core technology and software platforms. This collaboration seeks to transform diagnosis and treatment by harnessing advanced technology modules, ensuring they are predictable, accurate, and consistent. Tata Elxsi will spearhead a software-centric diagnostic approach, catering to all imaging, critical care, and surgical systems within the Skanray portfolio. This ensures interoperability, compatibility, and multi-modal functionality. Furthermore, the platform will integrate cutting-edge technologies and efficiencies from AI and GenAI.
- March 2024: GE HealthCare has unveiled its latest innovation, the Prostate Volume Assist (PVA), an AI-driven software feature designed to elevate urological imaging and treatment. By automating the generation of prostate volume measurements, a key element in diagnosing and managing prostate diseases, this AI-enabled feature promises to streamline a traditionally manual process. Set for a global rollout, the software will be integrated into the bkActiv, bk3000/5000, and bkSpecto active imaging systems.
- November 2023: L&T Technology Services Limited (LTTS), a global povider in pure-play engineering services, has teamed up with NVIDIA to craft software-defined architectures for endoscopy-focused medical devices. This collaboration aims to boost product image quality and scalability. This cutting-edge solution addresses industry challenges, including the availability, cost, and reliance on custom proprietary hardware. The resulting architecture serves as a versatile platform, enabling real-time decision-making for medical professionals.
SaMD Industry Segmentation
Software as a Medical Device (SaMD) refers to software that delivers medical functions independently of any hardware. SaMD enhances the speed of diagnosing, managing, and treating medical conditions and diseases. By automating certain care aspects, it not only elevates the quality of care but also conserves valuable time.
Software as a Medical Device Market is segmented by deployment type (cloud, on-premise), by application (screening and diagnosis, monitoring and alerting, and chronic disease management) by end user industry (hospitals and clinics, and home care arrangements) by geography (North America, Europe, Asia-Pacific, Latin America and Middle East and Africa).
The report offers market forecasts and size in value (USD) for all the above segments.
| By Deployment Type | Cloud |
| On-Premise | |
| By Appplication | Screening and Diagnosis |
| Monitoring and Alerting | |
| Chronic Disease Management | |
| By End user Industry | Hospitals and Clinics |
| Home Care Arrangements | |
| By Geography | North America |
| Europe | |
| Asia | |
| Australia and New Zealand | |
| Latin America | |
| Middle East and Africa |
| Cloud |
| On-Premise |
| Screening and Diagnosis |
| Monitoring and Alerting |
| Chronic Disease Management |
| Hospitals and Clinics |
| Home Care Arrangements |
| North America |
| Europe |
| Asia |
| Australia and New Zealand |
| Latin America |
| Middle East and Africa |
SaaMD Market Research Faqs
What is the current SaaMD Market size?
The SaaMD Market is projected to register a CAGR of 18.92% during the forecast period (2025-2030)
Who are the key players in SaaMD Market?
Zühlke Engineering AG, Koninklijke Philips N.V, Siemens Healthcare Private Limited, Medtronic plc and GE Healthcare are the major companies operating in the SaaMD Market.
Which is the fastest growing region in SaaMD Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in SaaMD Market?
In 2025, the North America accounts for the largest market share in SaaMD Market.
What years does this SaaMD Market cover?
The report covers the SaaMD Market historical market size for years: 2022, 2023 and 2024. The report also forecasts the SaaMD Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
SaaMD Industry Report
Statistics for the 2025 SaaMD market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. SaaMD analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
