市場調查報告書
商品編碼
1466073
藥物安全檢測和藥物安全軟體市場:按產品、臨床試驗、分銷和最終用戶 - 全球預測 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 |
※ 本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。
預計2023年藥物安全檢測與藥物安全軟體市場規模為5.521億美元,2024年將達6.2931億美元,2030年將達到14.2924億美元,複合年成長率為14.55%。
藥物安全檢測和藥物安全軟體包括各種旨在監測、評估、了解和預防副作用和其他藥物相關問題的數位平台。這些軟體解決方案被製藥和生物技術公司、合約研究委外研發機構(CRO)、監管機構以及對藥物開發過程和上市後監管至關重要的其他公司採用。其主要目標是確保遵守全球監管標準、簡化報告流程並改善病患安全結果。在隨著新藥開發而不斷擴張的製藥業中,對藥物安全檢測和藥物安全軟體的需求不斷增加。數位技術的日益普及以及由於資料量不斷增加而對高效資料管理系統的需求正在推動市場成長。與藥物安全檢測和藥物安全軟體相關的資料安全和隱私問題正在阻礙市場成長。增加對高級分析功能的投資,將原始資料轉化為可操作的見解,以實現更好的風險管理、高效的工作流程管理和直覺的UI/UX 設計,即使是非技術用戶也易於使用,預計將創造市場成長機會。
主要市場統計 | |
---|---|
基準年[2023] | 5.521 億美元 |
預測年份 [2024] | 62931萬美元 |
預測年份 [2030] | 1,429.24 百萬美元 |
複合年成長率(%) | 14.55% |
產品:增加藥物安全審核軟體的使用,以確保遵守藥物安全檢測法規
不利事件報告軟體對於系統記錄和管理與藥物使用相關的不利事件(AE) 至關重要。該軟體使製藥公司、監管機構和醫療保健提供者能夠記錄和報告副作用,這是許多司法管轄區的監管要求。這些系統通常具有標記潛在不利事件、自動化報告流程並確保符合 FDA 和 EMA 等全球標準的功能。藥物安全審核軟體旨在確保遵守藥物安全檢測法規。透過追蹤審核生命週期,此類軟體支援藥物安全檢測審核的實施、報告和追蹤,使公司更容易保持合規性並為監管檢查做好準備。完全整合的藥物安全檢測軟體系統描述了從 AE資料收集到監管提交的端到端藥物安全解決方案。這些系統通常在一個平台上包含案例處理、訊號檢測、風險管理和報告功能,因此無需使用多個系統。藥物安全檢測中的問題追蹤軟體有助於有效管理和解決安全問題。這些系統對製造商至關重要,使他們能夠圍繞 AE 案例調查、根本原因分析和糾正措施規劃來完成複雜的工作流程。
最終使用者:藥物安全檢測和藥物安全軟體為合約研究機構提供臨床試驗資料處理和進階彙報功能的潛力
業務流程外包 (BPO) 公司向製藥和生技公司提供第三方服務,包括藥物安全檢測活動。這些公司需要強大的藥品安全軟體來有效管理不同的客戶資料並遵守各種監管標準。合約研究組織以合約形式向製藥業提供研究服務,包括臨床試驗管理和藥物安全檢測。由於製藥和生物技術公司處於藥物開發的最前沿,因此它們本質上對整個產品生命週期的藥物安全和藥物安全檢測負責。藥物安全檢測服務提供者專門為其他醫療保健營業單位提供藥物安全監測和報告服務,通常提供適合大容量資料交易和多客戶端環境的專業藥物安全檢測軟體。
區域洞察
嚴格的法規和先進的醫療基礎設施正在推動該地區(橫跨北美和南美)對藥物安全檢測和藥物安全軟體的強勁需求。美洲在採用技術、投資研發以及執行法規以確保藥品安全方面處於領先地位。加拿大也緊跟其後,建立了強大的衛生系統,並更加重視藥物安全檢測。歐盟 (EU) 透過 EMA(歐洲藥品管理局)制定統一法規,使其成為藥物安全檢測(PV) 和藥物安全軟體不斷成長的市場。歐盟國家擴大採用 PV 軟體解決方案,以遵守 EMA 規定的藥物不良反應 (ADR) 報告、風險管理計劃要求和藥物安全檢測審核策略。在中東和非洲地區,由於醫療保健標準的提高以及政府為更有效地監管藥物所做的努力,一些國家的藥物安全檢測成長率正在加快,採用程度各不相同。亞太地區由中國、印度和日本等主要經濟體組成,正迅速崛起為光伏軟體解決方案的主要市場。醫療保健支出的增加、藥品安全意識的提高以及製藥業的成長都有助於該地區藥物安全檢測軟體市場的擴張。
FPNV定位矩陣
FPNV 定位矩陣對於評估藥物安全檢測和藥物安全軟體市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限。最前線 (F)、探路者 (P)、利基 (N) 和重要 (V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對藥物安全檢測和藥物安全軟體市場中供應商的現狀進行深入而深入的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該細分市場競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、碎片化主導地位和合併特徵等因素。詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:包括新產品發布、開拓地區、最新發展和投資的詳細資訊。
4. 競爭評估和情報:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況和製造能力進行全面評估。
5. 產品開發與創新:包括對未來技術、研發活動以及突破性產品開發的見解。
1.藥物安全檢測和藥物安全軟體市場的市場規模和預測是多少?
2.在藥物安全檢測和藥物安全軟體市場的預測期內,我們應該考慮投資哪些產品和應用?
3.藥物安全檢測和藥物安全軟體市場的技術趨勢和法規結構是什麼?
4.藥物安全檢測和藥物安全軟體市場主要供應商的市場佔有率是多少?
5. 進入藥物安全檢測和藥物安全軟體市場的適當型態和戰略手段是什麼?
[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 | |
---|---|
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?