预计到 2031 年,软件医疗器械市场规模将从 2023 年的 301.7 亿美元增至 930.8 亿美元。预计 2023-2031 年期间,该市场的复合年增长率将达到 15.1%。可穿戴医疗设备数量的增加可能仍是市场的主要趋势。
软件作为医疗器械市场分析
近年来,软件即医疗设备 (SaMD) 已成为医疗保健领域的重要工具,其增长很可能在 2023 年加速。SaMD 和其他数字解决方案等因素正在重塑患者与提供者之间的互动,并揭示数据共享、收集和跟踪的力量。其他因素,如虚拟急救 (V1C) 的日益普及,也成为焦点,使医疗保健提供者能够在不冒身体接触风险的情况下提供护理。从而使远程疾病变得可控。
软件作为医疗器械市场概述
墨西哥致力于推动医疗数字化,鼓励在其基础设施中更多地纳入基于软件的数字解决方案。该国正以前所未有的速度发展。在过去的几十年里,墨西哥政府提出了一项雄心勃勃的计划,通过在医疗环境中实施数字工具来提高医疗的整体质量。该国整体数字医疗的发展也可能促进市场的增长,并在未来几年提供有利的前景。此外,到 2050 年,墨西哥 60 岁及以上的老年人口将从 2010 年的 6.3% 增加到 23%。因此,老年人口增加等因素预计将在未来十年增加需求。
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软件作为医疗器械市场的驱动因素和机遇
FDA 发布 SaMD 新指南草案以利于市场
最近发布的指导草案更新正在澄清和简化这一流程。根据新的指导文件,医疗器械软件被分为临床决策支持软件 (CDSS) 和患者决策支持软件 (PDS),供患者和护理人员使用。这些分类规则考虑了几个因素,包括侵入身体的程度、接触时间、受影响的身体系统以及局部与全身影响。指导草案更新也表明 SaMD 的发展有所增加。
新兴经济体的发展中地区
随着新兴经济体经济和人均收入的增长,医疗服务需求也在增长。医疗服务自动化程度的提高推动了医疗行业的增长。全球市场参与者考虑在新兴国家拓展业务,预计在预测期内,软件即医疗设备 (SaMD) 市场将进一步增长。根据沙特通信和信息技术委员会 (CITC) 的数据,估计大多数 (54%) 沙特消费者使用技术来管理他们的健康,40% 使用移动设备上的健康应用程序,其余 14% 使用可穿戴技术。
软件作为医疗器械市场报告细分分析
有助于得出软件作为医疗器械市场分析的关键部分是设备类型、应用和部署类型。
- 根据设备类型,医疗设备软件市场分为 PC/笔记本电脑、智能手机/平板电脑和可穿戴设备。2023 年,PC/笔记本电脑领域占据了更大的市场份额。
- 根据应用,市场分为筛查和诊断、监测和警报以及疾病管理。筛查和诊断领域在 2023 年占据了最大的市场份额。
- 就部署类型而言,市场分为云和本地部署。2023 年,云部分占据了最大的市场份额。
医疗设备软件市场份额按地区分析
医疗器械软件市场报告的地理范围主要分为五个地区:北美、亚太、欧洲、中东和非洲、南美和中美。
北美占据了市场主导地位。人工智能、机器学习、自然语言处理 (NLP) 的渗透及其在数字医疗中的应用可能是造成市场主导地位的原因。此外,主要市场领导者通过智能手机和笔记本电脑的软件解决方案为患者诊断和远程监控提供新颖的解决方案,这也导致对这些解决方案的需求增加,因为它们易于操作、理解和分析健康状况,从而导致需求增加。预计亚太地区将在未来几年以最高的复合年增长率增长。
软件作为医疗器械市场区域洞察
Insight Partners 的分析师已详细解释了预测期内影响软件即医疗器械市场的区域趋势和因素。本节还讨论了北美、欧洲、亚太地区、中东和非洲以及南美和中美洲的软件即医疗器械市场细分和地理位置。
- 获取软件作为医疗器械市场的区域特定数据
软件作为医疗器械市场报告范围
报告属性 | 细节 |
---|---|
2023 年的市场规模 | 301.7亿美元 |
2031 年市场规模 | 930.8亿美元 |
全球复合年增长率(2023 - 2031) | 15.1% |
史料 | 2021-2022 |
预测期 | 2024-2031 |
涵盖的领域 | 按设备类型
|
覆盖地区和国家 | 北美
|
市场领导者和主要公司简介 |
|
市场参与者密度:了解其对商业动态的影响
由于消费者偏好的不断变化、技术进步以及对产品优势的认识不断提高等因素,最终用户需求不断增加,推动了软件即医疗设备市场快速增长。随着需求的增加,企业正在扩大其产品范围,进行创新以满足消费者需求,并利用新兴趋势,从而进一步推动市场增长。
市场参与者密度是指在特定市场或行业内运营的企业或公司的分布情况。它表明在给定市场空间中,相对于其规模或总市场价值,有多少竞争对手(市场参与者)存在。
在医疗器械软件市场运营的主要公司有:
- 威伦蒂姆有限责任公司
- Tietronix 软件公司
- S3 互联健康
- 祖尔克集团
- 科学组
- 因岑蒂兹
免责声明:上面列出的公司没有按照任何特定顺序排列。
- 获取软件作为医疗器械市场顶级关键参与者的概述
软件作为医疗器械市场新闻和最新发展
通过收集一手和二手研究后的定性和定量数据来评估软件作为医疗器械市场,其中包括重要的公司出版物、协会数据和数据库。以下列出了软件作为医疗器械市场的一些发展情况:
- CompliancePath 和 Ideagen 已建立产品验证合作伙伴关系,以扩展其正在进行的验证加速器计划,以涵盖所有与生命科学相关的软件产品。(来源:CompliancePath,新闻稿,2020 年 4 月)
- 总部位于美国的 STAT Health 公司推出了一款 24/7 入耳式可穿戴一般健康产品,可测量血液流量。(来源:STAT Health,新闻稿,2023 年 6 月)
软件作为医疗器械市场报告覆盖范围和交付成果
“软件即医疗设备市场规模和预测(2021-2031)”报告对市场进行了详细分析,涵盖以下领域:
- 医疗设备软件市场规模及预测,涵盖范围涵盖的所有关键细分市场的全球、区域和国家层面
- 软件作为医疗器械的市场趋势以及市场动态,如驱动因素、限制因素和关键机遇
- 详细的 PEST/波特五力分析和 SWOT 分析
- 软件作为医疗器械市场分析涵盖关键市场趋势、全球和区域框架、主要参与者、法规和最新市场发展
- 行业格局和竞争分析,涵盖市场集中度、热图分析、知名参与者以及软件作为医疗器械市场的最新发展
- 详细的公司简介
- Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
- PEST and SWOT Analysis
- Market Size Value / Volume - Global, Regional, Country
- Industry and Competitive Landscape
- Excel Dataset
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
This text is related
to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
This text is related
to country scope.
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.
Trends and growth analysis reports related to Technology, Media and Telecommunications : READ MORE..
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 and advised several client 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 organization 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 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/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.
- 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.
- 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.
- 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.
- 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.