Software as Medical Device Market Overview, Growth, Trends, Analysis, Research Report (2021-2031)

The software as medical device market size is projected to reach US$ 93.08 billion by 2031 from US$ 30.17 billion in 2023. The market is expected to register a CAGR of 15.1% during 2023–2031. The increasing number of wearable medical devices is likely to remain a key trend in the market.

Software as Medical Device Market Analysis

In recent years, software as a Medical Device (SaMD) has become a vital tool in the healthcare arsenal, and its growth is likely to accelerate in 2023. Factors like SaMD and other digital solutions are reshaping patient-provider interactions and revealing the power of data sharing, collection, and tracking. Other factors like the increasing prevalence of Virtual First Care, or V1C to the forefront, allowing healthcare providers to deliver care without risking physical contact. Thus, making remote diseases manageable.

Software as Medical Device Market Overview

Mexico is focused on advancing healthcare digitalization by encouraging more incorporation of software-based digital solutions in its infrastructure. The country is growing at an unprecedented rate. Within the past few decades, the Mexican government has put forth an ambitious initiative to improve the overall quality of healthcare by implementing digital tools in its healthcare settings. The development in overall digital healthcare in the country will also likely promote the market's growth and offer a conducive scenario over the years to come. Furthermore, Mexico’s geriatric population of 60 years and above would increase from 6.3% in 2010 to 23% by 2050. Thus, such factors as the rising geriatric population are expected to increase demand in the coming decade.

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Software as Medical Device Market: Strategic Insights

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Software as Medical Device Market Drivers and Opportunities

FDA Issues New Draft Guidance on SaMD to Favor Market

A recently released draft guidance update is clarifying and streamlining the process. According to the new guidance document, the Software as a Medical Device was classified into Clinical Decision Support Software (CDSS) and Patient Decision Support Software (PDS) for both the patients and caregivers. These classification rules consider several factors, including the degree of invasiveness in the body, duration of contact, body system affected, and local versus systemic effects. The draft guidance update is also an indication of increased SaMD development.

Developing regions with Emerging Economies

With the rise in the economy and per capita income of the people in emerging economies, the growth for enhanced medical services is also increasing. The growth of the medical industry is experienced due to the increasing automatization of healthcare services. The global market players consider the region for their business expansions in the emerging nations, which is further expected to grow the Software as Medical Device (SaMD) market during the forecast period. According to the Kingdom’s Communications and Information Technology Commission (CITC), it is estimated that most (54%) Saudi consumers use technology to manage their health, 40% use health apps on mobile devices, and the rest 14% use wearable technology.

Software as Medical Device Market Report Segmentation Analysis

Key segments that contributed to the derivation of the software as medical device market analysis are device type, application, and deployment type.

• Based on device type, the software as medical device market is divided into PCs/laptop, smartphones/tablets, and wearable devices. The PCs/laptop segment held a larger market share in 2023.
• By application, the market is segmented into screening and diagnosis, monitoring and alerting, and disease management. The screening and diagnostics segment held the largest share of the market in 2023.
• In terms of deployment type, the market is bifurcated into cloud and on-premises. The cloud segment held the largest share of the market in 2023.

Software as Medical Device Market Share Analysis by Geography

The geographic scope of the Software as Medical Device market report is mainly divided into five regions: North America, Asia Pacific, Europe, Middle East & Africa, and South & Central America.

North America has dominated the market. The penetration of artificial intelligent, machine learning, Natural Language Processing (NLP) and its application in digital healthcare is likely to be accountable for the dominance of the market. Furthermore, presence of key market leaders contribution novel solutions for diagnostic and remote supervising of patients through smartphone and laptop based software solutions are also creating a rise in demand for these solutions as they are easy to operate, understand and analyse health conditions thereby creating a rise their demand. Asia Pacific is anticipated to grow with the highest CAGR in the coming years.

Software as Medical Device Market Regional Insights

The regional trends and factors influencing the Software as Medical Device Market throughout the forecast period have been thoroughly explained by the analysts at Insight Partners. This section also discusses Software as Medical Device Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.

Software as Medical Device Market Market Report Scope

Market Players Density: Understanding Its Impact on Business Dynamics

The Software as Medical Device Market market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

Market players density refers to the distribution of firms or companies operating within a particular market or industry. It indicates how many competitors (market players) are present in a given market space relative to its size or total market value.

Major Companies operating in the Software as Medical Device Market are:

1. Velentium LLC
2. Tietronix Software, Inc.
3. S3 Connected Health
4. Zühlke Group
5. Science Group
6. Inzentiz

Disclaimer: The companies listed above are not ranked in any particular order.

Software as Medical Device Market News and Recent Developments

The software as medical device market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A few of the developments in the software as medical device market are listed below:

• CompliancePath and Ideagen have entered into a Product Validation partnership to extend their on-going validation accelerator program to include all life science-related software products. (Source: CompliancePath, Press Release, April 2020)
• US-based STAT Health company introduced a 24/7 in-ear wearable general wellness product that measures blood flow to. (Source: STAT Health, Press Release, June 2023)

Software as Medical Device Market Report Coverage and Deliverables

The “Software as Medical Device Market Size and Forecast (2021–2031)” report provides a detailed analysis of the market covering below areas:

• Software as Medical Device market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
• Software as Medical Device market trends as well as market dynamics such as drivers, restraints, and key opportunities
• Detailed PEST/Porter’s Five Forces and SWOT analysis
• Software as Medical Device market analysis covering key market trends, global and regional framework, major players, regulations, and recent market developments
• Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the Software as Medical Device market
• Detailed company profiles