Software as a Medical Device Market Growth Report to 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
Market Size Value in US$ 18,488.00 Million in 2019 Market Size Value by US$ 86,451.62 Million by 2027 Growth rate CAGR of 21.9% from 2020-2027 Forecast Period 2020-2027 Base Year 2020
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Software as Medical Device Market: Strategic Insights
| Market Size Value in | US$ 18,488.00 Million in 2019 |
| Market Size Value by | US$ 86,451.62 Million by 2027 |
| Growth rate | CAGR of 21.9% from 2020-2027 |
| Forecast Period | 2020-2027 |
| Base Year | 2020 |
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Mrinal will walk you through a 15-minute call to present the report’s content and answer all queries if you have any.
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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 Report Scope
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
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Device Type , Application , Deployment Type , and Geography
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
North America held the largest market for Software as Medical Device. The growth of the region is attributed to continuous rise in the use of Software as Medical Device, innovations in software designs, and increasing awareness among people regarding the benefits for digital healthcare applications.
The driving factors are increasing adoption of Internet of Things (IoT) & connected devices in healthcare and the advantages offered by Software as Medical Device (SaMD).
Increasing number of wearable medical devices is likely to remain key trends in the market.
S3 Connected Health, BrightInsight, Inc. and CompliancePath are among the top players operating in the Software as Medical Device market.
The software as medical device market size is projected to reach US$ 93.08 billion by 2031.
The market is expected to register a CAGR of 15.1% during 2023–2031.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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