软件作为医疗器械市场、软件作为医疗器械市场规模、软件作为医疗器械市场份额、软件作为医疗器械市场预测、软件作为医疗器械市场增长、软件作为医疗器械市场分析市场分析和预测(按规模、份额、增长、趋势)复合年增长率为 15.1%

  • Report Code : TIPRE00010198
  • Category : Medical Device
  • No. of Pages : 150
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Software as a Medical Device Market Growth Report to 2031

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作为医疗设备的软件市场规模预计将从 2023 年的 301.7 亿美元增至 2031 年的 930.8 亿美元。预计 2023 年至 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然是市场的主要趋势。

软件作为医疗设备市场分析

近年来,软件即医疗设备 (SaMD) 已成为医疗保健库中的重要工具,其增长可能会在 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,并揭示医疗保健的力量。数据共享、收集和跟踪。其他因素包括虚拟急救或 V1C 的日益普及,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。因此,使远程疾病变得易于管理。

软件即医疗设备市场概述

墨西哥致力于通过鼓励在其基础设施中更多地采用基于软件的数字解决方案来推进医疗保健数字化。该国正在以前所未有的速度增长。在过去的几十年里,墨西哥政府提出了一项雄心勃勃的举措,通过在医疗保健环境中实施数字工具来提高医疗保健的整体质量。该国整体数字医疗保健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,墨西哥60岁及以上的老年人口将从2010年的6.3%增加到2050年的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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软件即医疗设备市场:

软件作为医疗设备市场
  • Software as Medical Device Market
    年均复合增长率(2023 - 2031)
    15.1%
  • 2023 年市场规模
    301.7 亿美元
  • 2031 年市场规模
    930.8 亿美元

市场动态

增长动力
  • FDA 发布关于 SaMD 的新指南草案以支持市场
未来的趋势
  • SaMD的优势
机会
  • 发展中地区和新兴经济体

关键人物;主力;重要一员

  • Velentium有限责任公司 LLC
  • 泰创软件公司 Software, Inc.
  • S3 互联健康
  • 祖尔克集团
  • 科学组
  • 因岑蒂斯
  • 剑桥咨询公司
  • BrightInsight 公司
  • 合规路径
  • 捷普公司

区域概况

Software as Medical Device Market
  • 北美
  • 欧洲
  • 亚太
  • 南美洲和中美洲
  • 中东和非洲

市场细分

Software as Medical Device Market设备类型
  • 个人电脑/笔记本电脑
  • 智能手机/平板电脑
  • 可穿戴设备
Software as Medical Device Market应用
  • 筛选
  • 诊断
  • 监控
  • 警报
  • 疾病管理
Software as Medical Device Market部署类型
  • 本地部署
  • 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。

软件作为医疗器械市场的驱动力和机遇

FDA 发布关于 SaMD 的新指南草案以支持市场

最近发布的指南草案更新正在澄清和简化该流程。根据新的指导文件,作为医疗器械的软件分为供患者和护理人员使用的临床决策支持软件(CDSS)和患者决策支持软件(PDS)。这些分类规则考虑了几个因素,包括对身体的侵入程度、接触持续时间、受影响的身体系统以及局部与全身影响。指南草案的更新也表明 SaMD 的开发有所增加。

发展中地区和新兴经济体

随着新兴经济体经济和人民人均收入的上升,强化医疗服务的增长也在不断加大。由于医疗保健服务的自动化程度不断提高,医疗行业不断发展。全球市场参与者考虑在新兴国家扩展业务,预计该地区将在预测期内进一步增长软件即医疗设备(SaMD)市场。据沙特通信和信息技术委员会 (CITC) 估计,大多数 (54%) 沙特消费者使用技术来管理自己的健康,40% 在移动设备上使用健康应用程序,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

有助于开发医疗设备市场分析软件的关键部分是设备类型、应用程序和部署类型。

  • 根据设备类型,医疗设备软件市场分为个人电脑/笔记本电脑、智能手机/平板电脑和可穿戴设备。 2023 年,个人电脑/笔记本电脑细分市场将占据更大的市场份额。
  • 按应用划分,市场分为筛查和诊断、监测和警报以及疾病管理。 2023 年,筛查和诊断领域占据最大市场份额。
  • 就部署类型而言,市场分为云和本地。 2023 年,云细分市场占据最大市场份额。

软件医疗设备市场份额按地理位置分析

软件即医疗器械市场报告的地理范围主要分为五个区域:北美、亚太地区、欧洲、中东和非洲以及南美洲和中美洲。

北美市场占据主导地位。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保健中的应用可能是市场主导地位的原因。此外,主要市场领导者的存在通过智能手机和基于笔记本电脑的软件解决方案贡献了用于诊断和远程监督患者的新颖解决方案,这也导致了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,从而导致了对这些解决方案的需求增加他们的需求。预计亚太地区未来几年将以最高的复合年增长率增长。

软件作为医疗设备市场报告范围

报告属性细节
2023年市场规模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%
历史数据2021-2022
预测期2024-2031
涵盖的细分市场按设备类型
  • 个人电脑/笔记本电脑
  • 智能手机/平板电脑
  • 可穿戴设备
按申请
  • 筛选
  • 诊断
  • 监控
  • 警报
  • 疾病管理
按部署类型
  • 本地部署
覆盖地区和国家北美
  • 我们
  • 加拿大
  • 墨西哥
欧洲
  • 英国
  • 德国
  • 法国
  • 俄罗斯
  • 意大利
  • 欧洲其他地区
亚太
  • 中国
  • 印度
  • 日本
  • 澳大利亚
  • 亚太其他地区
南美洲和中美洲
  • 巴西
  • 阿根廷
  • 南美洲和中美洲其他地区
中东和非洲
  • 南非
  • 沙特阿拉伯
  • 阿联酋
  • 中东和非洲其他地区
市场领导者和主要公司简介
  • Velentium有限责任公司
  • 泰创软件公司
  • S3 互联健康
  • 祖尔克集团
  • 科学组
  • 因岑蒂斯
  • 剑桥咨询公司
  • BrightInsight 公司
  • 合规路径
  • 捷普公司
  • 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。

软件作为医疗设备市场新闻和最新发展

作为医疗器械市场的软件是通过收集初级和二级研究后的定性和定量数据来评估的,其中包括重要的公司出版物、协会数据和数据库。下面列出了医疗设备软件市场的一些发展:

  • 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)
  • 美国 STAT Health 公司推出了一款 24/7 的入耳式可穿戴一般健康产品,可测量血流量。 (来源:STAT Health,新闻稿,2023 年 6 月)

软件作为医疗设备市场报告的覆盖范围和可交付成果

《软件医疗器械市场规模和预测(2021-2031)》报告对涵盖以下领域的市场进行了详细分析:

  • 软件医疗器械市场规模以及全球、区域和国家层面涵盖的所有关键细分市场的预测
  • 软件医疗器械市场趋势以及市场动态,例如驱动因素、限制因素和关键机遇
  • 详细的 PEST/波特五力分析和 SWOT 分析
  • 软件医疗器械市场分析,涵盖主要市场趋势、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、知名参与者以及医疗器械软件市场的最新发展
  • 详细的公司简介
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


Which region dominated the Software as Medical Device market in 2023?

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.

What are the driving factors impacting the Software as Medical Device market?

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).

What are the future trends of the Software as Medical Device market?

Increasing number of wearable medical devices is likely to remain key trends in the market.

Which are the leading players operating in the Software as Medical Device market?

S3 Connected Health, BrightInsight, Inc. and CompliancePath are among the top players operating in the Software as Medical Device market.

What would be the estimated value of the Software as Medical Device market by 2031?

The software as medical device market size is projected to reach US$ 93.08 billion by 2031.

What is the expected CAGR of the Software as Medical Device market?

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.

  1. 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.

  1. 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:

Research Methodology

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.

  1. 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.

  1. 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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