药物警戒和药物安全软件市场规模预计将从 2023 年的 2.1439 亿美元增至 2031 年的 3.593 亿美元。预计该市场在 2023-2031 年的复合年增长率为 6.7%。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。
药物警戒和药品安全软件市场分析
人工智能和机器学习等技术与药物警戒和药物安全软件的不断融合,使药物安全任务自动化,推动着市场的发展。一些关键参与者正在整合这些先进技术,以实现制药行业工作流程的自动化。例如,2024 年 1 月,人工智能驱动的科学安全和文献信息工作流程提供商 PubHive Ltd. 推出了集中式产品特性摘要 (SmPC) 管理软件,该软件为生命科学公司提供人工智能驱动的药物警戒工作流程。该公司向临床研究组织 (CRO) 及其药物警戒和药物安全部门提供软件。这种基于人工智能的解决方案简化和精简了流程,有助于满足合规性,并使药物警戒团队能够更快、更有效地工作。
药物警戒和药品安全软件市场概况
药物警戒和药物安全软件是解决手动数据输入错误和管理大量安全数据等各种挑战的重要工具。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公司之间合作的加强,采用药物警戒和药物安全软件将成为制药公司和监管机构的当务之急。2022 年,药品检验合作计划 (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,2024 年 3 月,美国食品药品管理局 (FDA) 提供了指导,规定提交与药品相关的严重和疑似不良事件的新药试验 (IND) 安全报告。这些报告以 PDF 文件格式提交,采用电子通用技术文档 (eCTD)。此外,该软件还有助于创建全面的安全报告并提交给监管机构,从而确保遵守监管标准,帮助公司避免受到处罚并维护其声誉。
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药物警戒和药物安全软件市场:
复合年增长率(2023 - 2031)6.7%- 2023 年市场规模
2.1439 亿美元 - 市场规模 2031
3.593 亿美元
市场动态
- 药物不良反应发生率上升
- 药物警戒的全球化
- 药物开发支出激增
- 基于云的药物警戒
- 药品安全软件
- 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 集团
- Syneos 健康
- 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
区域概况
- 北美
- 欧洲
- 亚太
- 南美洲和中美洲
- 中东和非洲
市场细分
- 软件
- 服务
- 云
- 本地
- 大型企业
- 中小企业
- 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。
药物警戒和药物安全软件市场驱动因素和机遇
药品不良反应发生率上升利好市场
由于慢性病的患病率不断上升,全球范围内的药物不良反应 (ADR) 病例不断增加。由于所有药物都有可能出现药物不良反应,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,尤其是考虑到治疗学日益复杂、人口老龄化以及全球多重疾病的增加。药物警戒软件使医疗保健提供者和制药公司能够收集、系统地分析和报告与 ADR 相关的数据,并克服与之相关的挑战。全球范围内 ADR 的日益流行推动了对药物警戒和药物安全软件的需求。根据美国食品药品监督管理局不良事件报告系统 (FAERS) 中提供的 ADR 数据库,2022 年报告了超过 125 万例严重不良反应病例,以及超过 175,000 例死亡病例。
药物不良反应是全球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,死亡人数总数约为 6,677 人(2020 年为 6,434 人)。
随着大环内酯类抗生素的使用和维生素 K 摄入量的增加,茶碱和呼吸抑制的暴露量增加,从而导致不良反应。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更大的压力,需要改进药物安全监测和报告流程。药物警戒和药物安全软件有助于避免过量用药带来的风险。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全球药物警戒和药物安全软件市场的增长。
药物警戒的全球化
药物警戒是监测和评估药物不良反应的过程,是有效药物监管体系、临床实践和公共卫生计划的重要组成部分。药物警戒的全球化促进了利益相关者之间的合作,包括监管机构、医疗保健提供者和制药公司。例如,欧洲药品管理局 (EMA) 越来越重视与国际药品监管机构的合作,重点关注药品安全、检查和就共同关心的问题交换信息等领域。这种协作环境增强了数据共享,并提高了对药物安全性的整体了解。随着公司寻求利用这些全球网络,对可在全球范围内运行的集成药物警戒解决方案的需求变得越来越重要。
全球各国政府正在与各自国家的监管机构合作开展药物警戒计划。监管机构了解药物警戒在确保药物安全方面的重要性。例如,在北美,美国 FDA 制定指南、法律和法规来开展多项实践,例如适用于生物医学产品的良好临床实践计划 (GCP) 和良好药物警戒实践计划 (GVP)。此外,2024 年 9 月,印度药典委员会和中央药品标准控制组织发布了其药物警戒指南 2.0 版,并颁布了诸如延长报告非严重不良反应事件的截止日期和修改记录保存要求等变更。此外,马来西亚国家药品监管机构发布了其关于生物等效性和药物警戒检查指南的第二修订版。该机构提供了有关药品检查流程和与药品评估相关的评估范围的更多信息。菲律宾食品药品管理局(FDA)还发布了详细行动,以回应有关新药产品注册的反馈,并提供有关人类使用的活性药物成分(API)的信息。
药物警戒和药品安全软件市场报告细分分析
有助于得出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。
药物警戒和药物安全软件市场份额按地区分析
药物警戒和药物安全软件市场分为五大区域:北美、欧洲、亚太地区 (APAC)、中东和非洲 (MEA) 以及南美和中美。2023 年,北美占据市场主导地位,其次是欧洲和亚太地区。
由于 IQVIA、Oracle Corporation 等各种市场参与者的存在,北美的药物警戒和药物安全软件市场正在经历巨大的增长,他们不断致力于药物警戒和药物安全软件的进步。 2024 年 7 月,Oracle Corporation 推出了基于 AI 的 Oracle Argus 平台作为 Safety One Intake 解决方案。 该解决方案可帮助生命科学组织满足日益增长的监管要求并减轻不良事件病例数量的增加。 这个新的药物警戒平台旨在提高生产力、改善数据隐私并增强报告能力。 因此,该地区市场参与者的此类产品创新正在推动药物警戒和药物安全软件市场的增长。
药物警戒和药品安全软件市场报告范围
报告属性 | 细节 |
---|---|
2023 年的市场规模 | 2.1439亿美元 |
2031 年市场规模 | 3.593亿美元 |
全球复合年增长率(2023 - 2031) | 6.7% |
史料 | 2021-2022 |
预测期 | 2024-2031 |
涵盖的领域 | 通过奉献
|
覆盖地区和国家 | 北美
|
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。
药物警戒和药物安全软件市场新闻和最新发展
药物警戒和药物安全软件市场通过收集一手和二手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。以下列出了药物警戒和药物安全软件市场的一些关键发展:
- 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,从而支持最佳的治疗结果。(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)
药物警戒和药物安全软件市场报告范围和交付成果
“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:
- 药物警戒和药物安全软件市场规模及预测,涵盖范围内所有关键细分市场的全球、区域和国家层面
- 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
- 药物警戒和药物安全软件市场分析,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
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- Industry and Competitive Landscape
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Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
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Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
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Frequently Asked Questions
Integration of cloud-based platforms that offers real-time access to data from anywhere across the globe, enabling pharmaceutical companies to respond swiftly to emerging safety concerns.
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 are among the key players operating in the global pharmacovigilance and drug safety software market.
The pharmacovigilance and drug safety software market was valued at US$ 214.39 billion in 2023 and is anticipated to grow at a CAGR of 6.7% over the forecast period.
The rising cases of adverse drug reactions (ADRs) worldwide owing to the increasing prevalence of chronic diseases drives the market growth.
Asia Pacific is anticipated to grow at the fastest CAGR over the forecast period.
The software segment led the pharmacovigilance and drug safety software market with a significant share in 2023.
The pharmacovigilance and drug safety software market are expected to reach US$ 359.30 million by 2031 and is expected to register a CAGR of 6.7% during 2023–2031.
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The List of Companies - 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.
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.