2024 年至 2031 年药物安全检测和药物安全软体市场（按功能、部署模式、最终用户和地区划分）

药物安全检测与药物安全软体市场 - 2024-2031

药物安全检测和药品安全软体市场需求不断成长。随着药品和医疗设备日益复杂，需要先进的软体系统来有效监控和管理潜在风险。随着新药的推出，确保病患安全变得越来越重要，因此需要使用强大的软体工具来检测和处理发生的不利事件。预计2024年市场规模将超过93.3亿美元，到2031年将达到200.1亿美元。

全球监管机构对药品安全监测提出了更高的要求，迫使製药公司部署符合不断变化的法规和标准的复杂软体系统。这些监管压力催生了对有效可靠的药物安全检测和药品安全软体解决方案的迫切需求，以确保合规性并降低法律风险。对经济高效的药物安全检测和药品安全软体的需求日益增长，将推动市场在2024年至2031年间以11.04%的复合年增长率成长。

药物安全检测与药物安全软体市场：定义/概述

药物安全检测和药物安全软体是专门用于监测、评估和管理药品整个生命週期安全性的系统。这些工具有助于收集和分析不利事件报告，从而能够在潜在药物危害出现时立即识别和处理。该软体透过自动化向卫生当局的报告流程、追踪安全讯号以及维护完整的安全资料库，促进法规遵循。使用者包括製药公司、临床研究组织和监管机构，帮助他们发现和降低风险，改善药物安全性，并增强病患安全。

技术突破将显着推动药物安全检测和药物安全软体的发展。人工智慧和机器学习的应用预计将提升这些系统的预测能力，从而实现更准确的风险评估和更快的安全讯号检测。

此外，数据分析和即时监控技术的进步预计将提升软体管理来自电子健康记录和社交媒体等多种资讯来源的大量数据的能力。随着监管要求的变化和个体化医疗需求的增加，软体将能够管理复杂的安全评估并支援先进的药物安全检测流程，从而为患者带来更安全的治疗结果。

药物不良反应（ADR）发生率的不断上升将如何推动药物安全检测和药物安全软体市场的发展？

药物安全检测和药物安全软体市场在製药和生物技术领域呈现显着成长。药物不良反应 (ADR) 数量的增加是药物安全检测和药物安全软体市场的主要驱动力。根据《药理学与药物治疗学杂誌》报道，ADR 约占美国所有住院病例的 5%。 FDA 的不利事件通报系统 (FAERS) 加剧了这种日益严重的担忧，该系统在 2019 年收到了超过 200 万份不利事件报告。 ADR 的不断增加使得开发能够成功管理和分析大量药物安全资料的现代药物安全检测系统成为必要，从而产生了对强大软体解决方案的需求。

药物开发和临床试验的成长推动了药物安全检测和药物安全软体市场的发展。根据世界卫生组织国际临床研究註册平台 (ICTRP) 的数据，截至 2021 年，全球已註册超过 60 万项临床试验，收集了大量安全数据。这些不断增长的数据需要有效的管理和分析，从而导致对专业药物安全检测软体的需求不断增长。此类工具对于处理这些试验期间产生的复杂且大量的安全数据至关重要，从而推动了此类先进软体解决方案的市场成长。

资料隐私和安全问题将如何阻碍药物安全检测和药物安全软体市场的成长？

对资料隐私和安全的担忧可能会阻碍药物安全检测和药物安全软体市场的成长。由于这些系统处理敏感的患者资料和不利事件报告，因此保持强大的资料保护并遵守 GDPR 和 HIPAA 等法规至关重要。资料安全和隐私外洩可能导致监管处罚、法律责任和信任丧失，从而阻碍公司采用和全面实施其软体解决方案。在公司寻求遵守严格的资料保护法规的同时，成功解决这些隐私和安全问题的需求可能会限制市场的成长。

高昂的实施成本可能会阻碍药物安全检测和药品安全软体市场的成长。购买、配置和整合这些先进软体解决方案的初始投资可能是一项沉重的负担，尤其对于中小型企业和资金有限的企业而言。高昂的成本可能会阻碍潜在用户投资完整的药物安全检测系统，减缓该产业的发展。持续的维护和支援成本增加了财务负担，儘管长期来看，这些系统能够提高药品安全性和法规遵从性，但企业仍难以证明投资的合理性。

目录

第一章 引言

• 市场定义
• 市场区隔
• 调查方法

第二章执行摘要

• 主要发现
• 市场概况
• 市集亮点

第三章 市场概况

• 市场规模和成长潜力
• 市场趋势
• 市场驱动因素
• 市场限制
• 市场机会
• 波特五力分析

第四章药物安全检测和药品安全软体市场（依软体类型）

• 不利事件通报软体
• 讯号侦测与管理软体
• 风险管理软体
• 合规管理软体
• 讯号情报软体
• 电子资料撷取 (EDC) 软体

第五章药物安全检测与药物安全软体市场（依交付模式）

• 本地解决方案
• 云端基础的解决方案

第六章药物安全检测与药品安全软体市场（依最终使用者）

• 製药和生物技术公司
• CRO（委外研发机构）
• 医疗设备公司
• 监管和卫生部门

第七章区域分析

• 北美洲
• 美国
• 加拿大
• 墨西哥
• 欧洲
• 英国
• 德国
• 法国
• 义大利
• 亚太地区
• 中国
• 日本
• 印度
• 澳洲
• 拉丁美洲
• 巴西
• 阿根廷
• 智利
• 中东和非洲
• 南非
• 沙乌地阿拉伯
• 阿拉伯聯合大公国

第八章市场动态

• 市场驱动因素
• 市场限制
• 市场机会
• COVID-19 市场影响

第九章 竞争态势

• 主要企业
• 市占率分析

第十章：公司简介

• Ennov Solutions Inc.
• Extedo GmbH
• United BioSource Corporation
• Ab Cube
• ArisGlobal
• Oracle Corporation
• Sarjen Systems Pvt Ltd
• Sparta Systems Inc.

第十一章 市场展望与机会

• 新兴技术
• 未来市场趋势
• 投资机会

第十二章 附录

• 简称列表
• 来源和参考文献

Pharmacovigilance and Drug Safety Software Market - 2024-2031

The growing demand for pharmacovigilance and drug safety software market. The complexity of pharmaceuticals and medical equipment needs advanced software systems for properly monitoring and managing potential risks. As new medicines emerge, ensuring patient safety becomes increasingly important, necessitating the use of strong software tools to detect and address adverse events as they occur. The market size surpass USD 9.33 Billion valued in 2024 to reach a valuation of around USD 20.01 Billion by 2031.

Regulatory agencies around the world are imposing larger requirements for medication safety monitoring, requiring pharmaceutical companies to implement complex software systems that comply with changing regulations and standards. This regulatory pressure has created a critical requirement for effective and dependable pharmacovigilance and drug safety software solutions to ensure compliance and reduce legal risks. The rising demand for cost-effective and efficient pharmacovigilance and drug safety software is enabling the market grow at a CAGR of 11.04% from 2024 to 2031.

Pharmacovigilance and Drug Safety Software Market: Definition/ Overview

Pharmacovigilance and drug safety software are specialized systems that monitor, evaluate, and manage the safety of pharmaceutical goods throughout their lifecycle. These tools make it easier to gather and analyze adverse event reports, ensuring that any possible drug dangers are identified and treated as soon as they arise. The software facilitates regulatory compliance by automating reporting processes to health authorities, tracking safety signals, and keeping complete safety databases. Its applications include pharmaceutical firms, clinical research organizations, and regulatory authorities, where it aids in risk detection and reduction, medication safety profile improvement, and patient safety enhancement.

Technological breakthroughs are poised to propel pharmacovigilance and drug safety software forward significantly. The incorporation of artificial intelligence and machine learning is projected to improve these systems' predictive capacities, allowing for more accurate risk assessment and faster detection of safety signals.

Furthermore, advances in data analytics and real-time monitoring are projected to increase the software's ability to manage enormous amounts of data from many sources, such as electronic health records and social media. As regulatory requirements change and demand for customized medicine increases, the software will adapt to manage complex safety evaluations and support advanced pharmacovigilance processes, resulting in safer therapeutic results for patients.

How will the Increasing Incidence of Adverse Drug Reactions (ADRs) Drive the Pharmacovigilance And Drug Safety Software Market?

The pharmaceutical and biotechnology companies' segment is experiencing significant expansion in the pharmacovigilance and drug safety software market. The rising number of adverse drug reactions (ADRs) is a major driver in the pharmacovigilance and drug safety software market. The journal of pharmacology & pharmacotherapeutics reports that ADRs account for about 5% of all hospital admissions in the United States. This increasing concern is heightened by the FDA's Adverse Event Reporting System (FAERS), which received over 2 million adverse event reports in 2019. The growing incidence of ADRs necessitates the development of modern pharmacovigilance systems capable of successfully managing and analyzing massive volumes of drug safety data, resulting in a requirement for strong software solutions.

The growth of medication development and clinical trials is propelling the pharmacovigilance and drug safety software market. According to the WHO International Clinical Studies Registry Platform (ICTRP), there are over 600,000 registered clinical studies worldwide as of 2021, resulting in an enormous collection of safety data. This growing data needs effective management and analysis, resulting in an increased demand for specialized pharmacovigilance software. Such tools are essential for dealing with the complicated and extensive safety data generated during these studies, driving market growth for these advanced software solutions.

How Do the Data Privacy and Security Concerns Hamper the Growth of the Pharmacovigilance And Drug Safety Software Market?

Data privacy and security concerns may impede the growth of the pharmacovigilance and drug safety software market. Due to these systems handling sensitive patient data and adverse event reports, maintaining strong data protection and compliance with rules like GDPR and HIPAA is critical. Any shortcomings in data security or privacy breaches can result in regulatory penalties, legal liabilities, and a loss of confidence, inhibiting enterprises from adopting or fully implementing software solutions. The requirement to address these privacy and security issues successfully may restrict market growth as businesses attempt to meet tight data protection rules.

The high cost of installation may impede the growth of the pharmacovigilance and drug safety software market. The initial investment in obtaining, configuring, and integrating these advanced software solutions can be significant, especially for smaller firms or those with limited finances. The high cost may dissuade potential adopters from investing in full pharmacovigilance systems, resulting in slower industry growth. Continuing maintenance and support costs add to the financial burden, making it difficult for companies to justify the investment, despite the long-term benefits of improved drug safety and regulatory compliance.

Category-Wise Acumens

What are the Factors that Surge the Demand for the Pharmacovigilance And Drug Safety Software Market?

Adverse Event Reporting Software (AERS) is rapidly expanding in the pharmacovigilance and drug safety software market. Mitigating safety risks will drive the adverse event reporting software section of the pharmacovigilance and drug safety software market. Effective adverse event reporting is critical for detecting and managing safety hazards associated with pharmaceuticals. As regulatory bodies and organizations highlight the need for real-time, accurate reporting to promote patient safety and ensure compliance with severe requirements, there is a higher demand for specialist software that can streamline and optimize the reporting process. This emphasis on safety risk minimization drives the creation of the adverse event reporting software industry, which provides essential tools for monitoring and addressing potential drug-related concerns.

The ability to capture, track, and evaluate adverse events related to pharmaceuticals and medical devices is a major driver of the adverse event reporting software segment in the pharmacovigilance and drug safety software market. This feature offers full monitoring of drug safety and regulatory compliance by methodically collecting adverse events, tracking their course, and analyzing patterns to identify potential safety concerns. As the demand for accurate and efficient reporting develops, driven by severe regulatory regulations and the need to protect patient health, businesses are increasing their investment in software that improves these capabilities, fueling the growth of this market segment.

Which Factors Enhance the Use of Pharmacovigilance And Drug Safety Software Market?

Ensured drug safety and efficacy will drive the pharmaceutical and biotechnology category of the pharmacovigilance and drug safety software market. These companies must rigorously monitor and manage their products' safety and effectiveness in order to meet regulatory standards and preserve patient health. They invest in cutting-edge software solutions that enable full safety monitoring, real-time data analysis, and regulatory compliance support. This emphasis on maintaining high safety and efficacy standards increases demand for specialized pharmacovigilance software, which drives growth in these categories.

The pharmaceutical and biotechnology segments of the pharmacovigilance and drug safety software market will be driven by increased drug complexity, stronger regulations, and significant legal and financial consequences. As medications become increasingly complicated, the demand for precise and comprehensive safety monitoring grows. Stricter rules place increased responsibility on these corporations to maintain drug safety, and the potential legal and financial consequences of noncompliance highlight the significance of strong pharmacovigilance systems. This combination of variables forces pharmaceutical and biotechnology businesses to invest in modern software solutions to efficiently control risks, resulting in increased growth in these market segments.

Country/Region-wise Acumens

Will the Advancement in Technologies Fuel the Pharmacovigilance And Drug Safety Software Market in North America?

North America dominates the pharmacovigilance and drug safety software market. Advanced technological capabilities are propelling the pharmacovigilance and drug safety software market in North America. As the number of adverse event reports in the area rises-from 2 million in 2018 to more than 3 million in 2022, according to the US FDA-the need for comprehensive and effective pharmacovigilance systems grows. North America's leadership in the global pharmacovigilance market, which is expected to reach USD 12.48 Billion by 2030, is supported by efforts such as the FDA's Sentinel Initiative and the growing use of AI and ML technologies. These developments allow for more effective monitoring, analysis, and management of safety data, positioning advanced technology as a significant driver of regional market growth.

The expansion of the North American pharmacovigilance and drug safety software market is being driven by R&D. The FDA reported a 27% rise in investigational new drug (IND) applications between 2018 and 2022, indicating a growing demand for improved drug safety monitoring systems. The significant expenditure by biopharmaceutical companies in R&D, which surpassed USD 102.3 Billion in 2021, demonstrates the need for improved pharmacovigilance skills. The 60% increase in adverse event reports between 2018 and 2022 underscores the importance of effective software solutions. Pharmaceutical businesses are increasingly using AI and machine learning technology to handle and evaluate the spike in safety data. The industry's emphasis on innovation and patient safety, supported by robust R&D operations, is a major driver of this market in North America.

Will the Increasing Healthcare Expenditure in the Asia-Pacific Region Propel the Pharmacovigilance And Drug Safety Software Market?

The Asia-Pacific region is experiencing the most rapid growth in the pharmacovigilance and drug safety software markets. The growing healthcare expenditure in the Asia-Pacific region is considerably driving the growth of the pharmacovigilance and drug safety software industry. As healthcare spending in the Western Pacific region, which includes much of Asia, increased from 6.6% of GDP in 2000 to 7.5% in 2020, there was a higher concentration on health investments. This growth in spending is matched by a surge in adverse drug reaction (ADR) reports, with China seeing a 64% increase from 2018 to 2022 and India's ADR reporting tripling during the same period. Japan likewise saw a 30% spike in ADR reports.

The rapidly expanding pharmaceutical and biotechnology sectors in Asia-Pacific are pushing up demand for pharmacovigilance and drug safety software. In China, drug applications under review increased by 80.9% between 2018 and 2022, while India's pharmaceutical market is expected to reach USD 120-130 Billion by 2030, with a 45% rise in new medicine approvals between 2018 and 2022. Japan also observed a 25% increase in new drug applications and a 35% increase in post-marketing safety reports during the same time period. These developments highlight the growing demand for complex medication safety monitoring systems. According to a 2023 DIA poll, 82% of pharmaceutical and biotech businesses in the region intend to boost their investment in pharmacovigilance technologies, with 65% concentrating on incorporating AI and machine learning into their drug safety processes, which will fuel market growth.

Competitive Landscape

The pharmacovigilance and drug safety software market is a dynamic and competitive space, characterized by a diverse range of players vying for market share. These players are on the run for solidifying their presence through the adoption of strategic plans such as collaborations, mergers, acquisitions, and political support.

The organizations are focusing on innovating their product line to serve the vast population in diverse regions. Some of the prominent players operating in the pharmacovigilance and drug safety software market include:

• Oracle Corporation
• IQVIA
• ArisGlobal LLC
• SAS Institute, Inc.
• Sparta Systems, Inc.
• Online Business Applications, Inc.
• Ennov
• Sarjen Systems Pvt. Ltd.
• EXTEDO
• GmbH
• Linical Accelovance
• OpenText Corporation
• Umbra Global LLC
• AB Cube
• PharmaLex GmbH
• Veeva Systems, Inc.
• Saranas Data Systems, Inc.
• DLRC LTD
• Virtify, Inc.

Latest Developments

• In October 2022, PegBio selected Litesphere MultiVigilance, AnsGlobal's leading pharmacovigilance platform, to convert their pharmacovigilance from Contract Research Organization (CRO) services to in-house procedures.
• In July 2022, Dotmatics announced the launch of its Small Molecule Drug Discovery Solution, a comprehensive scientific R&D platform with pre-configured workflows and improved data management capabilities.

Pharmacovigilance and Drug Safety Software Market, By Category

• Functionality:
• Adverse Event Reporting Software
• Signal Management Software
• Drug Safety Audits Software
• Issue Tracking Software
• Deployment Mode:
• On-premise
• Cloud-based
• End User:
• Pharma and Biotech Companies
• Contract Research Organizations (CROS)
• Business Process Outsourcing (BPO) Firms
• Region:
• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Pharmacovigilance And Drug Safety Software Market, By Type of Software

• Adverse Event Reporting Software
• Signal Detection and Management Software
• Risk Management Software
• Compliance Management Software
• Signal Intelligence Software
• Electronic Data Capture (EDC) Software

5. Pharmacovigilance And Drug Safety Software Market, By Delivery Mode

• On-Premises Solutions
• Cloud-Based Solutions

6. Pharmacovigilance And Drug Safety Software Market, By End-User

• Pharmaceutical and Biotechnology Companies
• Contract Research Organizations (CROs)
• Medical Device Companies
• Regulatory Authorities and Health Agencies

7. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

8. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

9. Competitive Landscape

• Key Players
• Market Share Analysis

10. Company Profiles

• Ennov Solutions Inc.
• Extedo GmbH
• United BioSource Corporation
• Ab Cube
• ArisGlobal
• Oracle Corporation
• Sarjen Systems Pvt Ltd
• Sparta Systems Inc.

11. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

12. Appendix

• List of Abbreviations
• Sources and References