欧洲医疗器械警戒软件市场规模预计将从 2023 年的 1.439 亿美元增至 2031 年的 2.8023 亿美元。预计 2023-2031 年期间该市场的复合年增长率将达到 8.7%。未来几年,作为医疗器械的软件可能会为市场带来一系列新的关键趋势。
欧洲医疗器械警戒软件市场分析
法规遵从性不断提高、医疗技术不断进步以及医疗器械日益复杂,推动着欧洲医疗器械警戒软件市场的发展。医疗器械警戒系统的主要目标是通过最大限度地降低医疗器械不良事件再次发生的可能性,提高对患者、医护人员和公众健康和安全的保护。这可以通过多种机制实现。医疗器械警戒需要收集、评估、理解和应对与使用医疗器械相关的风险的新信息。这些风险主要是不良事件、与其他物质或设备的相互作用、禁忌症、假冒、故障和技术缺陷。
欧洲医疗器械警戒软件市场概况
医疗器械警戒软件的主要目的是支持医疗器械的上市后监督,确保其在整个生命周期内持续安全有效。上市后监督对于确保产品不会发生不良事件或其他问题至关重要。应尽快识别和解决长期使用可能产生的任何意外影响的风险。上市后监督的目标是确保产品保持安全有效,同时持续监测其益处和风险。
医疗器械警戒软件的功能包括有关故障的事件报告、根据医疗器械报告收集所有相关数据、分配特殊制造商报告编号以及履行所有文书工作和记录保存要求;存储事件数据、分析设备归因以及评估和调查报告以快速轻松地检索数据;并创建大量报告提交给该地区的各个监管机构。
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欧洲医疗器械警戒软件市场:
复合年增长率(2023 - 2031)8.7%- 2023 年市场规模
1.439 亿美元 - 市场规模 2031
2.8023 亿美元
市场动态
- “与医疗器械相关的严格监管要求
- 医疗技术的进步
- 医疗器械的复杂性增加”
- 软件作为医疗设备
- 医疗保健领域的数字化转型
- 不断增长的医疗器械市场
关键参与者
- 甲骨文公司
- AB 立方体 SAS
- 萨珍系统私人有限公司
- AssurX公司
- UL 解决方案公司
- 霍尼韦尔国际公司
- PTC公司
- 英特尔公司
- 最大应用
- Xybion数字公司
区域概况
- 欧洲
市场细分
- 诊断
- 治疗
- 外科
- 研究
- 云
- 本地部署
- 临床研究组织
- 业务流程外包
- 原始设备制造商
- 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。
欧洲医疗器械警戒软件市场驱动因素和机遇
医疗器械的复杂性不断增加
医疗器械软件是现代医疗保健系统的重要组成部分。医疗器械市场需要软件解决方案来管理用户界面、患者数据、法规和产品复杂性。采用这些解决方案可以降低开发医疗器械及其软件时的风险,并有助于加速软件开发和部署。它还可以监督医疗保健领域的风险管理。随着医疗器械市场的扩大,平衡硬件、软件和法规的挑战也随之增加。在医疗保健行业中,需求管理工具和医疗器械警戒软件与医疗器械开发及其生命周期管理密切相关。因此,为了应对医疗器械的复杂性,对医疗器械警戒软件的需求正在增长。
医疗技术的进步带来了更好的诊断和治疗,可以更早、更准确地诊断、更有效的治疗并确保患者的安全。随着数字系统的集成、现代和紧凑的医疗设备设计以及对软件系统的依赖,医疗设备迅速发展。这在监控、报告和确保医疗设备安全方面产生了复杂性。此外,遵守更严格的法规要求鼓励医疗设备制造商采用先进的软件解决方案,以应对医疗设备复杂性增加带来的挑战。
医疗保健领域的数字化转型
欧洲的数字医疗行业推动了各种数字技术的使用,以改善医疗设施。利用数字技术进行信息和通信来管理疾病、避免健康风险和促进患者安全,推动了欧洲医疗保健行业的数字化。欧洲当局始终致力于为公民提供更好的服务。为此,他们不断参与投资活动。例如,欧盟4Health计划在2021-2027年期间的预算超过59亿美元(53亿欧元),旨在建立更强大、更具弹性和更易于访问的卫生系统。这项投资促进了医疗保健系统的数字化以及药品、医疗器械和危机相关产品的可及性。自2023年12月以来,大多数新项目已经开始实施,拨款的目标是帮助欧盟国家实施未来的欧洲健康数据空间(EHDS)。此类投资可以促进符合监管标准并提高患者安全性的医疗器械警戒软件的创新、开发和采用。采用警戒软件可以增强卫生系统在 COVID-19 等健康危机期间的恢复能力。它可以提供更快的报告并分析医疗设备性能数据。在紧急情况下,它可以支持更快的决策和风险管理。因此,欧洲医疗保健系统的数字化推动了医疗保健各个方面的重大进步,为该行业更有效地提供更好的健康结果创造了潜力。这一因素使得采用解决方案能够最大限度地降低质量风险,并缩短上市时间和遵守法规,进一步促进了欧洲对医疗器械警戒软件的需求。
欧洲医疗器械警戒软件市场报告细分分析
有助于得出欧洲医疗器械警戒软件市场分析的关键部分是应用、部署模式和最终用途垂直领域。
- 根据应用,市场分为诊断、治疗、外科、研究和其他。诊断领域在 2023 年占据了欧洲医疗器械警戒软件市场的最大份额。
- 根据部署模式,市场分为云和本地。2023 年,云部分占据了欧洲医疗设备警戒软件市场的较大份额。
- 根据最终用途垂直领域,市场分为 CRO、BPO、OEM 和其他。2023 年,原始设备制造商 (OEM) 部门占据欧洲最大的医疗器械警戒软件市场份额。
欧洲医疗器械警戒软件市场份额(按地区)分析
欧洲医疗器械警戒软件市场分为德国、法国、英国、俄罗斯、西班牙和欧洲其他地区。2023 年,德国占据市场主导地位,其次是法国和英国。
涉及英国医疗器械的不良事件必须报告给药品和保健产品管理局 (MHRA)。MHRA 负责监管英国医疗器械市场。一旦医疗器械投放英国市场,制造商就有义务在英国发生涉及其器械的某些类型的事件时向 MHRA 提交警戒报告。制造商还必须在必要时采取适当的安全措施。制造商必须确保其器械在使用期间符合适用的安全和性能标准。医疗器械制造商、英国负责人或位于北爱尔兰的授权代表必须向 MHRA 报告与医疗器械有关的事件和上市后警戒报告。此类警戒系统报告和监测要求推动了对医疗器械警戒软件的需求,以实现有效的报告和上市后监测。
欧洲医疗器械警戒软件市场报告范围
报告属性 | 细节 |
---|---|
2023 年的市场规模 | 1.439 亿美元 |
2031 年市场规模 | 2.8023亿美元 |
全球复合年增长率(2023 - 2031) | 8.7% |
史料 | 2021-2022 |
预测期 | 2024-2031 |
涵盖的领域 | 按应用
|
覆盖地区和国家 | 欧洲
|
市场领导者和主要公司简介 |
|
- 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。
欧洲医疗器械警戒软件市场新闻和最新发展
欧洲医疗器械警戒软件市场通过收集一级和二级研究后的定性和定量数据进行评估,其中包括重要的公司出版物、协会数据和数据库。欧洲医疗器械警戒软件市场的一些发展情况如下:
- Oracle 宣布了其 AI 支持的 Oracle Argus 和 Safety One Intake 解决方案的新功能,以帮助生命科学组织满足不断变化的监管要求和不断增加的不良事件案例工作量。借助旨在提高生产力、改善数据隐私和增强报告功能的新增强功能,用户可以更有效地应对动态的、特定于国家的法规和要求,并加快从临床试验到上市后监测的安全案例管理的可靠性和透明度。(来源:Oracle Corporation,新闻稿,2024 年 7 月)
- Ab Cube Company 在 AB Cube Galaxy 中推出了四款新的下一代 AI 警戒应用程序。这些新模块为核心 SafetyEasy Suite 提供了强大的增强功能,可实现快速、高效和可扩展的多警戒操作。该公司的新 AI 驱动模块采用了先进的自然语言处理 (NLP) 技术,允许客户复制和粘贴其 ICSR 的逐字记录,然后将其自动转换为 SafetyEasy Suite 中的案例 - 将案例接收工作量减少了 70%。(来源:Ab Cube Company,新闻稿,2024 年 6 月)
欧洲医疗器械警戒软件市场报告覆盖范围和交付成果
“欧洲医疗器械警戒软件市场规模和预测(2021-2031 年)”对市场进行了详细分析,涵盖以下领域:
- 欧洲医疗器械警戒软件市场规模以及区域和国家层面所有关键细分市场的预测
- 欧洲医疗器械警戒软件市场趋势,以及驱动因素、限制因素和关键机遇等市场动态
- 详细的 PEST 和 SWOT 分析
- 欧洲医疗器械警戒软件市场分析涵盖主要市场趋势、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、知名参与者以及欧洲医疗器械警戒软件市场的最新发展
- 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
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to country scope.
Frequently Asked Questions
The Europe medical device vigilance software market was estimated to be US$ 143.90 million in 2023 and is expected to grow at a CAGR of 8.7% during the forecast period 2024 - 2031.
Stringent regulatory requirements related to medical devices, rise in medical technology, and increased complexity of medical devices are the major factors that propel the Europe medical device vigilance software market.
Software as a Medical Device is anticipated to play a significant role in the Europe medical device vigilance software market in the coming years.
The key players holding majority shares in the Europe medical device vigilance software market are AB Cube S.A.S.; AssurX, Inc.; Oracle Corporation; Sparta Systems (Honeywell International Inc.); and Sarjen Systems Pvt. Ltd.
The Europe medical device vigilance software market is expected to reach US$ 280.23 million by 2031.
The incremental growth expected to be recorded for the Europe medical device vigilance software market during the forecast period is US$ 136.33 million.
Trends and growth analysis reports related to Technology, Media and Telecommunications : READ MORE..
The List of Companies - Europe Medical Device Vigilance Software Market
- Oracle Corp
- AB Cube S.A.S.
- Sarjen Systems Pvt. Ltd
- AssurX, Inc.
- UL Solutions Inc
- Honeywell International Inc
- PTC Inc
- Intel Corp
- Max Application
- Xybion Digital Inc.
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.