市场调查报告书
商品编码
1466073
药物安全检测和药物安全软体市场:按产品、临床试验、分销和最终用户 - 全球预测 2024-2030Pharmacovigilance & Drug Safety Software Market by Product (Adverse Event Reporting Software, Drug Safety Audits Software, Fully Integrated Software), Clinical Trial (Phase I, Phase II, Phase III), Distribution, End User - Global Forecast 2024-2030 |
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预计2023年药物安全检测与药物安全软体市场规模为5.521亿美元,2024年将达6.2931亿美元,2030年将达到14.2924亿美元,复合年增长率为14.55%。
药物安全检测和药物安全软体包括各种旨在监测、评估、了解和预防副作用和其他药物相关问题的数位平台。这些软体解决方案被製药和生物技术公司、合约研究委外研发机构(CRO)、监管机构以及对药物开发过程和上市后监管至关重要的其他公司采用。其主要目标是确保遵守全球监管标准、简化报告流程并改善病患安全结果。在随着新药开发而不断扩张的製药业中,对药物安全检测和药物安全软体的需求不断增加。数位技术的日益普及以及由于资料量不断增加而对高效资料管理系统的需求正在推动市场成长。与药物安全检测和药物安全软体相关的资料安全和隐私问题正在阻碍市场成长。增加对高级分析功能的投资,将原始资料转化为可操作的见解,以实现更好的风险管理、高效的工作流程管理和直观的UI/UX 设计,即使是非技术用户也易于使用,预计将创造市场成长机会。
主要市场统计 | |
---|---|
基准年[2023] | 5.521 亿美元 |
预测年份 [2024] | 62931万美元 |
预测年份 [2030] | 1,429.24 百万美元 |
复合年增长率(%) | 14.55% |
产品:增加药物安全审核软体的使用,以确保遵守药物安全检测法规
不利事件报告软体对于系统记录和管理与药物使用相关的不利事件(AE) 至关重要。该软体使製药公司、监管机构和医疗保健提供者能够记录和报告副作用,这是许多司法管辖区的监管要求。这些系统通常具有标记潜在不利事件、自动化报告流程并确保符合 FDA 和 EMA 等全球标准的功能。药物安全审核软体旨在确保遵守药物安全检测法规。透过追踪审核生命週期,此类软体支援药物安全检测审核的实施、报告和跟踪,使公司更容易保持合规性并为监管检查做好准备。完全整合的药物安全检测软体系统描述了从 AE资料收集到监管提交的端到端药物安全解决方案。这些系统通常在一个平台上包含案例处理、讯号检测、风险管理和报告功能,因此无需使用多个系统。药物安全检测中的问题追踪软体有助于有效管理和解决安全问题。这些系统对製造商至关重要,使他们能够围绕 AE 案例调查、根本原因分析和纠正措施规划来完成复杂的工作流程。
最终使用者:药物安全检测和药物安全软体为合约研究机构提供临床试验资料处理和进阶彙报功能的潜力
业务流程外包 (BPO) 公司向製药和生技公司提供第三方服务,包括药物安全检测活动。这些公司需要强大的药品安全软体来有效管理不同的客户资料并遵守各种监管标准。合约研究组织以合约形式向製药业提供研究服务,包括临床试验管理和药物安全检测。由于製药和生物技术公司处于药物开发的最前沿,因此它们本质上对整个产品生命週期的药物安全和药物安全检测负责。药物安全检测服务提供者专门为其他医疗保健营业单位提供药物安全监测和报告服务,通常提供适合大容量资料交易和多客户端环境的专业药物安全检测软体。
区域洞察
严格的法规和先进的医疗基础设施正在推动该地区(横跨北美和南美)对药物安全检测和药物安全软体的强劲需求。美洲在采用技术、投资研发以及执行法规以确保药品安全方面处于领先地位。加拿大也紧跟其后,建立了强大的卫生系统,并更加重视药物安全检测。欧盟 (EU) 透过 EMA(欧洲药品管理局)制定统一法规,使其成为药物安全检测(PV) 和药物安全软体不断增长的市场。欧盟国家越来越多地采用 PV 软体解决方案,以遵守 EMA 规定的药物不良反应 (ADR) 报告、风险管理计划要求和药物安全检测审核策略。在中东和非洲地区,由于医疗保健标准的提高以及政府为更有效地监管药物所做的努力,一些国家的药物安全检测成长率正在加快,采用程度各不相同。亚太地区由中国、印度和日本等主要经济体组成,正迅速崛起为光伏软体解决方案的主要市场。医疗保健支出的增加、药品安全意识的提高以及製药业的成长都有助于该地区药物安全检测软体市场的扩张。
FPNV定位矩阵
FPNV 定位矩阵对于评估药物安全检测和药物安全软体市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限。最前线 (F)、探路者 (P)、利基 (N) 和重要 (V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对药物安全检测和药物安全软体市场中供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该细分市场竞争特征的宝贵见解,包括在研究基准年观察到的累积、碎片化主导地位和合併特征等因素。详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:包括新产品发布、开拓地区、最新发展和投资的详细资讯。
4. 竞争评估和情报:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况和製造能力进行全面评估。
5. 产品开发与创新:包括对未来技术、研发活动以及突破性产品开发的见解。
1.药物安全检测和药物安全软体市场的市场规模和预测是多少?
2.在药物安全检测和药物安全软体市场的预测期内,我们应该考虑投资哪些产品和应用?
3.药物安全检测和药物安全软体市场的技术趋势和法规结构是什么?
4.药物安全检测和药物安全软体市场主要供应商的市场占有率是多少?
5. 进入药物安全检测和药物安全软体市场的适当型态和战略手段是什么?
[188 Pages Report] The Pharmacovigilance & Drug Safety Software Market size was estimated at USD 552.10 million in 2023 and expected to reach USD 629.31 million in 2024, at a CAGR 14.55% to reach USD 1,429.24 million by 2030.
The pharmacovigilance & drug safety software encompasses a range of digital platforms designed to monitor, assess, understand, and prevent adverse effects or other drug-related problems. These software solutions are employed by pharmaceutical and biotechnology companies, contract research organizations (CROs), regulatory agencies, and others integral to the drug development process and post-marketing surveillance. The primary aim is to ensure compliance with global regulatory standards, streamline reporting processes, and improve patient safety outcomes. The expanding pharmaceutical industry with the rising development of novel drugs is raising the need for pharmacovigilance & drug safety software. The growing adoption of digital technologies with the need for efficient data management systems in the face of growing data volumes is driving the market growth. Data security and privacy issues associated with pharmacovigilance and drug safety software hamper the market growth. Rising investments in advanced analytics capabilities to transform raw data into actionable insights for better risk management and creating intuitive UI/UX designs that enable efficient workflow management and ease of use, even for non-technical users, are expected to create opportunities for market growth.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 552.10 million |
Estimated Year [2024] | USD 629.31 million |
Forecast Year [2030] | USD 1,429.24 million |
CAGR (%) | 14.55% |
Product: Growing usage of drug safety audit software to ensure compliance with pharmacovigilance regulations
Adverse event reporting software is essential for the systematic recording and managing of adverse events (AEs) related to drug usage. This software enables pharmaceutical companies, regulatory agencies, and healthcare providers to document and report adverse reactions, which is a regulatory requirement in many jurisdictions. These systems often come with features for flagging potential adverse events, automating the reporting process, and ensuring compliance with global standards such as those set by the FDA and EMA. Drug safety audit software is designed to ensure compliance with pharmacovigilance regulations. By tracking the audit lifecycle, this type of software supports the conduct, reporting, and follow-up of pharmacovigilance audits, thus making it easier for companies to remain compliant and prepare for regulatory inspections. Fully integrated pharmacovigilance software systems offer end-to-end drug safety solutions, from AE data capture to regulatory submission. These systems often include features for case processing, signal detection, risk management, and reporting in one platform, eliminating the need for multiple systems. Issue tracking software in pharmacovigilance helps manage and resolve safety issues efficiently. These systems are critical for manufacturers, enabling them to navigate complex workflows around AE case investigation, root cause analysis, and corrective action planning.
End User: Potential of pharmacovigilance & drug safety software among contract research organizations for handling clinical trial data and offering advanced reporting capabilities
Business process outsourcing (BPO) firms offer third-party services to pharmaceutical and biotechnology companies, including pharmacovigilance activities. These firms require robust drug safety software to manage their clients' diverse data efficiently and comply with various regulatory standards. Contract research organizations provide research services to the pharmaceutical industry on a contractual basis, including clinical trial management and pharmacovigilance. Pharmaceutical & biotechnology companies are at the forefront of drug development and, thus, inherently responsible for drug safety and pharmacovigilance throughout the product lifecycle. Pharmacovigilance service providers specialize in drug safety monitoring and report services for other healthcare entities and typically require specialized pharmacovigilance software adapted to high-volume data transactions and multi-client environments.
Regional Insights
Encompassing both North and South America, the region demonstrates a significant demand for pharmacovigilance & drug safety software largely driven by stringent regulations and a sophisticated healthcare infrastructure. The Americas leads in terms of adoption of technology, investment in R&D, and implementation of regulations to ensure drug safety. Canada follows with a robust healthcare system and a growing focus on pharmacovigilance. The European Union, with its harmonized regulations through the EMA (European Medicines Agency), presents a growing market for pharmacovigilance (PV) & drug safety software. EU countries have seen increasing adoption of PV software solutions to comply with adverse drug reaction (ADR) reporting, risk management plan requirements, and pharmacovigilance audit strategies as mandated by the EMA. The MEA region shows varied levels of adoption, with certain countries exhibiting increased growth in pharmacovigilance due to rising healthcare standards and government initiatives to regulate drugs more effectively. Comprising major economies such as China, India, and Japan, the Asia Pacific region is rapidly emerging as a key market for PV software solutions with the rising healthcare spending, increasing awareness about drug safety, and growing pharmaceutical sectors contributing to the expansion of the pharmacovigilance software market in this region.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Pharmacovigilance & Drug Safety Software Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Pharmacovigilance & Drug Safety Software Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Pharmacovigilance & Drug Safety Software Market, highlighting leading vendors and their innovative profiles. These include 4C Pharma Solutions, AB Cube S.A.S., Accenture PLC, Anju Software, Inc., ArisGlobal LLC, Certara, Inc., Clarivate, Clinevo Technologies Private Limited, Cloudbyz, Inc., Cognizant Technology Solutions Corporation, Ennov SAS, Ergomed PLC, Extedo GmbH, Freyr Software Services Pvt. Ltd., Indegene Inc., Infosys Limited, IQVIA Inc., NUVO Consultancy, Oracle Corporation, PureSoftware Limited, Sarjen Systems Private Limited, Sparta Systems, Inc., Tepsivo Oy, TriNetX, LLC, United BioSource LLC, and Wipro Limited.
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Pharmacovigilance & Drug Safety Software Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Pharmacovigilance & Drug Safety Software Market?
3. What are the technology trends and regulatory frameworks in the Pharmacovigilance & Drug Safety Software Market?
4. What is the market share of the leading vendors in the Pharmacovigilance & Drug Safety Software Market?
5. Which modes and strategic moves are suitable for entering the Pharmacovigilance & Drug Safety Software Market?