欧洲药物警戒和药物安全软件市场概况、增长、趋势、分析、研究报告(2023-2031 年)

  • Report Code : TIPRE00022771
  • Category : Technology, Media and Telecommunications
  • Status : Published
  • No. of Pages : 205
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2023 年欧洲药物警戒和药物安全软件市场规模为 5237 万美元,预计到 2031 年将达到 8466 万美元;预计 2023-2031 年复合年增长率为 6.2%。基于云的药物警戒和药物安全软件很可能在未来几年为市场带来新的关键趋势。

欧洲药物警戒和药品安全软件市场分析

药物警戒和药物安全软件可确保快速检测和评估与药物相关的不良反应。通过增强安全监控和自动化数据收集和分析,该软件可加快识别潜在安全问题,从而快速干预以降低风险。这种主动方法可提高法规遵从性、患者安全性和整体公共卫生结果。此外,借助高级分析和实时监控功能,药物警戒和药物安全软件为优化药物安全监控提​​供了强大的框架。人工智能和预测分析与药物警戒和药物安全软件的集成增强了在潜在安全风险升级为严重问题之前识别它们的能力。这些先进技术有助于分析大量结构化和非结构化数据,以检测即将到来的安全信号和趋势,从而触发主动风险缓解策略。因此,由于各种优势,欧洲对药物警戒和药物安全软件的需求正在增加。

欧洲药物警戒和药品安全软件市场概况

药物警戒是通过确保药品的安全性和有效性来维护公共健康的科学。药物警戒和药物安全软件是解决手动数据输入错误、大量安全数据和各种其他挑战的重要工具。从临床试验到上市后监测,该软件在整个药物开发生命周期中都不可或缺。药物警戒和药物安全软件有助于减少不良事件处理时间,并通过早期信号检测提高患者安全性。随着法规的发展和欧洲合作的加强,采用药物警戒和药物安全软件是有利的,这对制药公司和监管机构来说是必不可少的。2022 年,药品检查合作计划 (PIC/S) 更新了其药物警戒指南,以遵守国际标准,强调了强大的药物警戒和药物安全软件的重要性。此外,该软件通过促进创建全面的安全报告和向监管机构提交文件来确保符合监管标准,这有助于公司避免受到处罚并维护其声誉。

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欧洲药物警戒和药物安全软件市场:

欧洲药物警戒和药品安全软件市场
  • Europe Pharmacovigilance and Drug Safety Software Market
    复合年增长率(2023 - 2031)
    6.2%
  • 2023 年市场规模
    5237 万美元
  • 市场规模 2031
    8466 万美元

市场动态

增长动力
  • 药物不良反应发生率上升
  • 药物警戒的全球化
  • 药物开发速度激增
未来趋势
  • 基于云的药物警戒
  • 药品安全软件
机会
  • 软件与人工智能、机器学习的集成
  • 自然语言处理

关键人物

  • 欧洲阿里斯
  • ICON plc Syneos Health
  • 埃森哲
  • 艾昆纬
  • 简柏特
  • 认知
  • Paraxel 国际公司
  • 美国实验室控股公司
  • 最大应用
  • Clinevo技术公司

区域概况

Europe Pharmacovigilance and Drug Safety Software Market
  • 欧洲

市场细分

Europe Pharmacovigilance and Drug Safety Software Market奉献
  • 软件
  • 服务
Europe Pharmacovigilance and Drug Safety Software Market部署
  • 本地
Europe Pharmacovigilance and Drug Safety Software Market企业规模
  • 大型企业
  • 中小企业
Europe Pharmacovigilance and Drug Safety Software Market形式
  • 标准
  • 定制
  • 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。

欧洲药物警戒和药物安全软件市场驱动因素和机遇

药物不良反应发生率上升

在欧洲,药物不良反应 (ADR) 可能是导致死亡和疾病的重要原因。由于所有药物都有可能产生药物不良反应,因此每次开药时都需要进行风险收益分析。ADR 仍然是现代医疗保健面临的挑战,尤其是考虑到欧洲治疗学日益复杂、人口老龄化和多重疾病发病率上升。药物警戒软件使医疗保健提供者和制药公司能够系统地收集、分析和报告与 ADR 相关的数据,并克服与之相关的挑战。

药物不良反应是欧洲死亡率上升的主要原因。根据欧盟药品管理局 (EUDA) 的报告,就药物过量而言,2021 年欧盟的死亡率约为每百万 15 至 64 岁人口 18.3 人死亡。此外,2021 年欧盟至少发生了 6,166 起因非法药物过量而导致的死亡事件(2020 年为 5,796 起)。如果包括挪威和土耳其,死亡人数将达到约 6,677 人(2020 年为 6,434 人)。

随着越来越多的不良反应被报告和确认,制药公司、医疗保健提供者和监管机构面临着改进药物安全监测和报告流程的更大压力。这需要采用药物警戒和药物安全软件来收集、分析和管理不断增长的安全数据量。该软件有助于简化检测、评估和预防不良反应的过程,从而缩短响应时间并提高风险评估的准确性。因此,药物不良反应发生率的上升推动了欧洲药物警戒和药物安全软件市场的增长。

软件与 AI、ML 和 NLP 的集成

人工智能 (AI)、机器学习 (ML)、自然语言处理 (NLP) 和其他技术正在改变资源密集型的药物警戒工作量,确保采取更明智、更高效的方法。药物警戒和药物安全软件平台大多配备了先进的分析和人工智能功能,可增强对安全信号的检测。这些工具可以分析大量数据,识别传统方法可能忽略的相关性和模式。人工智能驱动的预测分析还可以预测潜在的安全问题,让公司采取主动措施。机器学习模型可用于预测与药物消费相关的潜在不良事件。例如,药物警戒活动使用机器学习筛选大量数据集,检测可能表明存在药物不良反应风险的模式。机器学习算法特别擅长处理非结构化数据(如社交媒体和患者记录),以预测安全问题。

人工智能系统正逐步用于推进实时药物安全监测。这种主动监测包括临床试验数据、扫描医学文献和不良事件 (AE) 患者登记册;它还可以提高 ADR 检测的准确性和速度。此外,利用 NLP,人工智能系统可以从大量文本数据集中提取相关信息,例如药物名称和症状,从而实现准确、快速的不良事件报告。这加速了未知或新药物安全问题的识别,从而显著促进了药物警戒工作的进步。包括 ArisGlobal 在内的多家公司都提供基于人工智能的药物警戒和药物安全软件。因此,药物警戒和药物安全软件与人工智能、机器学习和 NLP 的整合预计将在预测期内为市场增长创造丰厚的机会。

欧洲药物警戒和药品安全软件市场报告细分分析

有助于得出欧洲药物警戒和药物安全软件市场分析的关键部分是产品、组织规模、部署、形式、功能和最终用户。

  • 根据组织规模,欧洲药物警戒和药物安全软件市场分为大型企业和中小型企业。大型企业部门在 2023 年占据了市场主导地位。
  • 就产品而言,市场分为软件和服务。2023 年,软件领域占据了更大的市场份额。
  • 根据部署情况,欧洲药物警戒和药物安全软件市场分为云和本地。2023 年,云部分占据了市场主导地位
  • 根据形式,欧洲药物警戒和药物安全软件市场分为标准和定制。2023 年,标准部分占据了市场主导地位。
  • 根据功能,欧洲药物警戒和药物安全软件市场细分为案例管理、信号和风险管理、质量和合规性、审计支持和培训合规性、问题跟踪和不良事件跟踪、临床安全管理和临床试验安全、医学写作、医疗保健分析等。信号和风险管理部门在 2023 年占据了最大的市场份额。
  • 根据最终用户,欧洲药物警戒和药物安全软件市场分为制药和生物技术公司、合同研究组织、业务流程外包公司和其他药物警戒服务提供商。制药和生物技术公司部门在 2023 年占据了市场主导地位。

欧洲药物警戒和药物安全软件市场份额按地区分析

欧洲药物警戒和药物安全软件市场分为法国、德国、意大利、西班牙、英国和欧洲其他地区。欧洲对药物警戒和药物安全软件的需求不断增长,这归因于多种因素,包括监管要求、药品审批的增加、对患者安全的日益重视以及技术的进步。欧盟的药物警戒系统是世界上最先进的系统之一。欧洲药品管理局 (EMA) 和其他监管机构正在实施严格的药物警戒要求,这使得采用先进的软件解决方案成为必要。例如,欧盟药物警戒指令 (2010/84/EU) 和随后的法规 (EU) No 1235/2010 对监测药物不良反应 (ADR) 制定了更严格的规则。公司必须实时报告安全数据,这大大增加了对能够处理大量数据的高效软件系统的需求。

欧洲药物警戒和药物安全软件市场报告范围

报告属性细节
2023 年的市场规模5237万美元
2031 年市场规模8466万美元
全球复合年增长率(2023 - 2031)6.2%
史料2021-2022
预测期2024-2031
涵盖的领域通过奉献
  • 软件
  • 服务
按部署
  • 本地
按企业规模
  • 大型企业
  • 中小企业
按形式
  • 标准
  • 定制
覆盖地区和国家欧洲
  • 法国
  • 德国
  • 意大利
  • 西班牙
  • 英国
  • 欧洲其他地区
市场领导者和主要公司简介
  • 欧洲阿里斯
  • ICON plc Syneos Health
  • 埃森哲
  • 艾昆纬
  • 简柏特
  • 认知
  • Paraxel 国际公司
  • 美国实验室控股公司
  • 最大应用
  • Clinevo技术公司
  • 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。

欧洲药物警戒和药物安全软件市场新闻和最新发展

欧洲药物警戒和药物安全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。欧洲药物警戒和药物安全软件市场的一些关键发展如下所列:

  • 全球药物开发技术解决方案市场领导者 ArisGlobal 宣布,专门从事肿瘤学和血液学、泌尿学和自身免疫性疾病领域的德国制药商 Medac 选择 LifeSphere Safety 来实现其药物安全流程的现代化。精确、针对患者和人群的分析对于最大限度地降低患者的治疗风险至关重要,这有助于实现最佳的治疗效果。(来源:ArisGlobal,新闻稿,2023 年 5 月)
  • IQVIA 是一家为生命科学行业提供先进分析、技术解决方案和临床研究服务的全球领先供应商,该公司宣布与 Argenx 建立战略合作关系,通过创新和集成技术支持的药物警戒 (PV) 安全服务和解决方案,为患有罕见自身免疫性疾病的患者提供治疗。(来源:IQVIA,新闻稿,2023 年 1 月)

欧洲药物警戒和药物安全软件市场报告覆盖范围和交付成果

“欧洲药物警戒和药物安全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:

  • 欧洲药物警戒和药物安全软件市场规模以及范围内涵盖的所有主要细分市场的国家/地区预测
  • 欧洲药物警戒和药物安全软件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 和 SWOT 分析
  • 欧洲药物警戒和药物安全软件市场分析,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药物警戒和药物安全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
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


What is the estimated market size for the Europe pharmacovigilance and drug safety software market in 2023?

The Europe pharmacovigilance and drug safety software market was estimated to be US$ 52.37 million in 2023 and is expected to grow at a CAGR of 6.2% during the forecast period 2023 - 2031.

What are the future trends of the Europe pharmacovigilance and drug safety software market?

Cloud-based pharmacovigilance and drug safety software, which is anticipated to play a significant role in the Europe pharmacovigilance and drug safety software market in the coming years.

What are the driving factors impacting the Europe pharmacovigilance and drug safety software market?

Rise in incidences of adverse drug reactions, globalization of pharmacovigilance, surge in drug development rates are the major factors that propel the Europe pharmacovigilance and drug safety software market.

Which are the key players holding the major market share of the Europe pharmacovigilance and drug safety software market?

The key players holding majority shares in the Europe pharmacovigilance and drug safety software market are ArisEurope, ICON plc, Syneos Health, Accenture, IQVIA, Genpact, Cognizant, Paraxel International Corporation, Laboratory Corporation of America Holdings, Max Application, Clinevo Technologies, Qinecsa Solutions, AB Cube, and Veeva Systems.

What is the incremental growth of the Europe pharmacovigilance and drug safety software market during the forecast period?

The incremental growth expected to be recorded for the Europe pharmacovigilance and drug safety software market during the forecast period is US$ 32.29 million.

What will be the market size of the Europe pharmacovigilance and drug safety software market by 2031?

The Europe pharmacovigilance and drug safety software market is expected to reach US$ 84.66 million by 2031.

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The List of Companies - Europe Pharmacovigilance and Drug Safety Software Market

  • ArisGlobal LLC 
  • Max Application
  • Oracle Corp 
  • Veeva Systems Inc 
  • IQVIA Holdings Inc 
  • ICON Plc 
  • Cognizant Technology Solutions Corp 
  • Accenture Plc
  • Syneos Health Inc
  • Genpact Ltd.
  • AB Cube S.A.S.
  • Laboratory Corp of America Holdings
  • Parexel International Corp
  • Qinecsa Solutions
  • Clinevo Technologies
  •  
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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.