首頁 > 市場調查報告書 > 製藥

醫藥品法規環境

市場調查報告書

商品編碼

1846062

2024 年至 2031 年藥物安全檢測和藥物安全軟體市場（按功能、部署模式、最終用戶和地區分類）

Pharmacovigilance And Drug Safety Software Market By Functionality, Deployment Mode, End-User (Pharma and Biotech Companies, Contract Research Organizations ), & Region for 2024-2031

出版日期: 2025年09月05日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

藥物安全檢測與藥物安全軟體市場 - 2024-2031

藥物安全檢測和藥品安全軟體市場需求不斷成長。隨著藥品和醫療設備日益複雜，需要先進的軟體系統來有效監控和管理潛在風險。隨著新藥的推出，確保病患安全變得越來越重要，因此需要使用強大的軟體工具來檢測和處理發生的不利事件。預計2024年市場規模將超過93.3億美元，到2031年將達到200.1億美元。

全球監管機構對藥品安全監測提出了更高的要求，迫使製藥公司部署符合不斷變化的法規和標準的複雜軟體系統。這些監管壓力催生了對有效可靠的藥物安全檢測和藥品安全軟體解決方案的迫切需求，以確保合規性並降低法律風險。對經濟高效的藥物安全檢測和藥品安全軟體的需求日益成長，將推動市場在2024年至2031年間以11.04%的複合年成長率成長。

藥物安全檢測與藥物安全軟體市場：定義/概述

藥物安全檢測和藥物安全軟體是專門用於監測、評估和管理藥品整個生命週期安全性的系統。這些工具有助於收集和分析不利事件報告，從而能夠在潛在藥物危害出現時立即識別和處理。該軟體透過自動化向衛生當局的報告流程、追蹤安全訊號以及維護完整的安全資料庫，促進法規遵循。使用者包括製藥公司、臨床研究組織和監管機構，幫助他們發現和降低風險，改善藥物安全性，並增強病患安全。

技術突破將顯著推動藥物安全檢測和藥物安全軟體的發展。人工智慧和機器學習的應用預計將提升這些系統的預測能力，從而實現更準確的風險評估和更快的安全訊號檢測。

此外，數據分析和即時監控技術的進步預計將提升軟體管理來自電子健康記錄和社交媒體等多種資訊來源的大量數據的能力。隨著監管要求的變化和個體化醫療需求的增加，軟體將能夠管理複雜的安全評估並支援先進的藥物安全檢測流程，從而為患者帶來更安全的治療結果。

藥物不良反應（ADR）發生率的不斷上升將如何推動藥物安全檢測和藥物安全軟體市場的發展？

藥物安全檢測和藥物安全軟體市場在製藥和生物技術領域呈現顯著成長。藥物不良反應 (ADR) 數量的增加是藥物安全檢測和藥物安全軟體市場的主要驅動力。根據《藥理學與藥物治療學雜誌》報道，ADR 約占美國所有住院病例的 5%。 FDA 的不利事件通報系統 (FAERS) 加劇了這種日益嚴重的擔憂，該系統在 2019 年收到了超過 200 萬份不利事件報告。 ADR 的不斷增加使得開發能夠成功管理和分析大量藥物安全資料的現代藥物安全檢測系統成為必要，從而產生了對強大軟體解決方案的需求。

藥物開發和臨床試驗的成長推動了藥物安全檢測和藥物安全軟體市場的發展。根據世界衛生組織國際臨床研究註冊平台 (ICTRP) 的數據，截至 2021 年，全球已註冊超過 60 萬項臨床試驗，收集了大量安全數據。這些不斷成長的數據需要有效的管理和分析，從而導致對專業藥物安全檢測軟體的需求不斷成長。此類工具對於處理這些試驗期間產生的複雜且大量的安全數據至關重要，從而推動了此類先進軟體解決方案的市場成長。

資料隱私和安全問題將如何阻礙藥物安全檢測和藥物安全軟體市場的成長？

對資料隱私和安全的擔憂可能會阻礙藥物安全檢測和藥物安全軟體市場的成長。由於這些系統處理敏感的患者資料和不利事件報告，因此保持強大的資料保護並遵守 GDPR 和 HIPAA 等法規至關重要。資料安全和隱私外洩可能導致監管處罰、法律責任和信任喪失，從而阻礙公司採用和全面實施其軟體解決方案。在公司尋求遵守嚴格的資料保護法規的同時，成功解決這些隱私和安全問題的需求可能會限制市場的成長。

高昂的實施成本可能會阻礙藥物安全檢測和藥品安全軟體市場的成長。購買、配置和整合這些先進軟體解決方案的初始投資可能是一項沉重的負擔，尤其對於中小型企業和資金有限的企業而言。高昂的成本可能會阻礙潛在用戶投資完整的藥物安全檢測系統，減緩該產業的發展。持續的維護和支援成本增加了財務負擔，儘管長期來看，這些系統能夠提高藥品安全性和法規遵從性，但企業仍難以證明投資的合理性。

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.