Software as a Medical Device Market: Current Analysis and Forecast (2024-2032)

Report Description

Global Software as a Medical Device Market Size & Forecast

The Software as a Medical Device Market was valued at USD 5,588.56 million in 2023 and is expected to grow at a strong CAGR of around 10.71% during the forecast period (2024-2032) owing to the increasing prevalence of chronic disease and rising adoption of digital healthcare system across the globe.

Global Software as a Medical Device Market Analysis

Software as a Medical Device (SaMD) refers to software designed for one or more medical purposes to operate independently, without being a part of any hardware medical device. SaMD applications include diagnosis, monitoring or management of health conditions. It operates on general-purpose computing platforms, which means it does not need to be integrated into a physical medical device to fulfill its medical role. It can run on various platforms, such as mobile applications and cloud-based systems, that further enhance accessibility and usability in healthcare settings.

The Global Software as a Medical Device market was valued at USD 5,588.56 million in 2023 and is expected to grow at a strong CAGR of around 10.71% during the forecast period (2024-2032). One of the key factors that have been attributed to growth is the increasing number of chronic diseases leading to higher demand for SaMD solutions to assist healthcare professionals in providing appropriate treatment. For instance, as per the World Health Organization (WHO), around 41 million people die each year due to chronic diseases. Metabolic risk factors such as increased blood pressure, obesity and hyperglycemia are the leading cause of death among this major population. To combat the growing chronic diseases, WHO has also suggested emphasis on preventive measures such as early detection, timely screening and effective treatment measures. SaMD has the potential to provide accurate and rapid diagnosis, which is an important factor for efficient disease management process. This has increased the demand for SaMD solutions among healthcare providers as well as patients, leading to the tremendous growth of the software as a medical device market.

Global Software as a Medical Device Market Trends

This section discusses the key market trends that are influencing the various segments of the global software as a medical device market as identified by our team of research experts.

Rising Demand for AI-based SaMD

Technological advancements such as Artificial Intelligence (AI) have played a major role in driving the growth of SaMD market in the healthcare sector. Integration of AI in the medical software industry such as in SaMD, ease the disease management process by providing early and accurate diagnosis and efficient disease treatment plans in short duration of time. These potential benefits of AI-based SaMD solution assist healthcare professionals in quick data gathering and data interpretation and save time. This leads to huge demand for AI-based SaMD products among healthcare professionals. Moreover, AI-based SaMD helps the patients with remote disease monitoring, which has further enabled the patients to self-monitor their diseases using their digital devices such as smartphones or wearables. Food and Drug Administration (FDA) emphasis on integrating AI with SaMD to enhance the potential of these medical software in improving the healthcare delivery service quality. For instance, in March 2024, FDA published an article on how artificial intelligence and medical products are working together efficiently and contributing to elevating the overall healthcare industry. This article focuses on the importance and benefits of developing AI-based SaMD action plans to provide improved patient care.

North America is Expected to Hold Major Market Share During Forecast Period

North America Software as a Medical Device market holds a significant market share in 2023. Some of the factors attributed to the growth are increasing number of aging population, rising prevalence of chronic diseases, well-developed healthcare infrastructure, along with higher number of companies operating in the region such as Qure.ai, Imagen Technologies, Inc., etc. Additionally, the region has also focused on consistently developing innovative SaMD solutions for various medical purposes, that has led to increasing number of FDA approvals within the region. For instance, In January 2024, Qure.ai, a U.S-based leading global manufacturer of medical imaging solutions, announced its recent FDA clearance for AI-enabled SaMD solutions for radiography and medical imaging analysis. These products are highly efficient in detecting cancer. These frequent US FDA approvals are driving growth of North America SaMD market. With the expansion of the SaMD solution in the region as well as collaboration among the leading market players in the region, the market is anticipated to rise in the forthcoming years.

Global Software as a Medical Device Industry Overview

The global software as a medical device market is competitive and fragmented, with the presence of several global and international market players. The key players are adopting different growth strategies to enhance their market presence, such as partnerships, agreements, collaborations, new product launches, geographical expansions, and mergers and acquisitions. Some of the major players operating in the market are Siemens Healthineers, GE HealthCare Technologies Inc., Koninklijke Philips N.V., Aptar Digital Health, Qure.ai Technologies Private Limited, Imagen Technologies, Inc., Digital Diagnostics Inc., Viz.ai, HeartFlow, Inc. and Hologic, Inc.

Global Software as a Medical Device Market News

In 2024- Samsung Medison, which is a global medical equipment company announced that it has signed an agreement to acquire 100% of the shares of Sonio SAS, which is a fetal ultrasound AI software company.

In 2024- Aptar Digital Health, which is a global leader in digital health solutions such as Software as a Medical Device (SaMD) announced successful acquisition of Healint, which is a digital health company known for their digital health solutions.

In 2024- GE HealthCare announced that it has signed an agreement to acquire MIM Software, which is a worldwide provider of medical imaging analysis and artificial intelligence solutions for applications such as radiation oncology, molecular radiotherapy, diagnostic imaging, and urology.

Global Software as a Medical Device Market Report Coverage

Reasons to buy this report:

• The study includes market sizing and forecasting analysis validated by authenticated key industry experts.
• The report presents a quick review of overall industry performance at one glance.
• The report covers an in-depth analysis of prominent industry peers with a primary focus on key business financials, product portfolios, expansion strategies, and recent developments.
• Detailed examination of drivers, restraints, key trends, and opportunities prevailing in the industry.
• The study comprehensively covers the market across different segments.
• Deep dive regional level analysis of the industry.

Customization Options:

The global software as a medical device market can further be customized as per the requirement or any other market segment. Besides this, UMI understands that you may have your own business needs; hence, feel free to connect with us to get a report that completely suits your requirements.

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Research Methodology

Research Methodology for the Software as a Medical Device Market Analysis (2024-2032)

Analyzing the historical market, estimating the current market, and forecasting the future market of the global software as a medical device market were the three major steps undertaken to create and analyze the adoption of software as a medical device in major regions globally. Exhaustive secondary research was conducted to collect the historical market numbers and estimate the current market size. Secondly, to validate these insights, numerous findings and assumptions were taken into consideration. Moreover, exhaustive primary interviews were also conducted with industry experts across the value chain of the global software as a medical device market. Post assumption and validation of market numbers through primary interviews, we employed a top-down/bottom-up approach to forecasting the complete market size. Thereafter, market breakdown and data triangulation methods were adopted to estimate and analyze the market size of segments and sub-segments of the industry. Detailed methodology is explained below:

Analysis of Historical Market Size

Step 1: In-Depth Study of Secondary Sources:

A detailed secondary study was conducted to obtain the historical market size of the global software as a medical device market through company internal sources such as annual reports & financial statements, performance presentations, press releases, etc., and external sources including journals, news & articles, government publications, competitor publications, sector reports, third-party database, and other credible publications.

Step 2: Market Segmentation:

After obtaining the historical market size of the global software as a medical device market, we conducted a detailed secondary analysis to gather historical market insights and share for different segments & sub-segments for major regions. Major segments are included in the report as by deployment, by application and by therapeutic area. Further regional/country-level analyses were conducted to evaluate the overall adoption of testing models in that region.

Step 3: Factor Analysis:

After acquiring the historical market size of different segments and sub-segments, we conducted a detailed factor analysis to estimate the current market size of the global software as a medical device market. Further, we conducted factor analysis using dependent and independent variables such as by deployment, by application and by therapeutic area in the global software as a medical device market. A thorough analysis was conducted for demand and supply-side scenarios considering top partnerships, mergers and acquisitions, business expansion, and product launches in the software as a medical device market sector across the globe.

Current Market Size Estimate & Forecast

Current Market Sizing: Based on actionable insights from the above 3 steps, we arrived at the current market size, key players in the global software as a medical device market, and market shares of the segments. All the required percentage shares split and market breakdowns were determined using the above-mentioned secondary approach and verified through primary interviews.

Estimation & Forecasting: For market estimation and forecast, weights were assigned to different factors, including drivers & trends, restraints, and opportunities available for the stakeholders. After analyzing these factors, relevant forecasting techniques, i.e., the top-down/bottom-up approach, were applied to arrive at the market forecast for 2032 for different segments and sub-segments across the major markets globally. The research methodology adopted to estimate the market size encompasses:

• The industry’s market size, in terms of revenue (USD) and the adoption rate of the software as a medical device market across the major markets domestically.
• All percentage shares, splits, and breakdowns of market segments and sub-segments.
• Key players in the global software as a medical device market in terms of products offered. Also, the growth strategies adopted by these players to compete in the fast-growing market.

Market Size and Share Validation

Primary Research: In-depth interviews were conducted with the Key Opinion Leaders (KOLs), including Top Level Executives (CXO/VPs, Sales Head, Marketing Head, Operational Head, Regional Head, Country Head, etc.) across major regions. Primary findings were then summarized, and statistical analysis was performed to prove the stated hypothesis. Inputs from primary research were consolidated with secondary findings, hence turning information into actionable insights.

Split of Primary Participants in Different Regions

Market Engineering

The data triangulation technique was employed to complete the overall market estimation and to arrive at precise statistical numbers for each segment and sub-segment of the global software as a medical device market. Data was split into several segments and sub-segments after studying various parameters and trends by deployment, by application and by therapeutic area in the global software as a medical device market.

The main objective of the Global Software as a Medical Device Market Study

The current & future market trends of the global software as a medical device market were pinpointed in the study. Investors can gain strategic insights to base their discretion for investments on the qualitative and quantitative analysis performed in the study. Current and future market trends determined the overall attractiveness of the market at a regional level, providing a platform for the industrial participant to exploit the untapped market to benefit from a first-mover advantage. Other quantitative goals of the studies include:

• Analyze the current and forecast market size of the global software as a medical device market in terms of value (USD). Also, analyze the current and forecast market size of different segments and sub-segments.
• Segments in the study include areas by deployment, by application and by therapeutic area.
• Define and analyze the regulatory framework for global software as a medical device industry.
• Analyze the value chain involved with the presence of various intermediaries, along with analyzing customer and competitor behaviors of the industry.
• Analyze the current and forecast market size of the global Software as a medical device market for the major regions.
• Major countries of regions studied in the report include North America (The US, Canada, and Rest of North America), Europe (The UK, France, Germany, Italy, Spain, Rest of Europe), Asia-pacific (China, Japan, India, Rest of the Asia-pacific), Rest of the World
• Company profiles of the global software as a medical device market and the growth strategies adopted by the market players to sustain in the fast-growing market.
• Deep dive regional level analysis of the industry

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