市場調查報告書
商品編碼
1401916
到 2030 年藥物警戒和藥物安全軟體市場預測:按功能、交付方式、最終用戶和地區進行的全球分析Pharmacovigilance and Drug Safety Software Market Forecasts to 2030 - Global Analysis By Functionality, By Mode of Delivery (On-Premise and On-Demand/Cloud-Based ) End User and By Geography |
根據 Stratistics MRC 的數據,2023 年全球藥物警戒和藥物安全軟體市場規模為 2.026 億美元,預測期內複合年成長率為 8.8%,預計到 2030 年將達到 3.658 億美元。
藥物警戒涉及監測、評估和確保藥品上市核准後的安全性。藥品安全軟體是指透過收集、管理和分析與藥品相關的不利事件資料來協助此過程的專業技術。這些軟體解決方案簡化了報告,促進遵守監管要求,實現有效的訊號檢測,並有助於持續評估和增強藥物安全性。
根據美國國家護理研究所的數據,2018 年美國登記了 170 萬新癌症病例。
藥品變得越來越複雜
隨著藥物配方變得更加複雜,包括生技藥品、個體化藥物和聯合治療,不利事件的風險也隨之增加。先進的藥物警戒軟體透過實現全面監測、訊號檢測和簡化的不利事件報告,在管理這種複雜性方面發揮著至關重要的作用。該軟體能夠處理大型且複雜的資料集,加上其分析功能,可確保增強藥物警戒、法規遵循和主動風險管理。因此,隨著藥物複雜性的增加,對複雜藥物警戒和藥物安全軟體解決方案的需求也在增加。
實施成本高
與軟體整合、客製化、資料遷移和員工培訓相關的初期成本可能很高。這些成本,包括許可費和基礎設施投資,可能會導致預算緊張,特別是對於資源有限的小型製藥公司和醫療保健營業單位。此外,一些組織不願採用先進的藥物警戒軟體解決方案,因為持續的維護和升級進一步增加了總擁有成本,進一步限制了市場成長。
藥物核准和臨床試驗的增加
隨著製藥業的擴張和全球臨床試驗的激增,對強力的安全措施和高效資料管理的需求日益增加。先進的軟體解決方案簡化了不利事件報告、訊號偵測和風險評估,以支援快速核准和嚴格的安全合規性。業界對加速藥物開發、提高病人安全和滿足不斷變化的法規的關注推動了對這些軟體工具的需求,使之成為創新和採用的主要市場,帶來了機會。
對藥物警戒軟體的好處缺乏認知
對藥物警戒軟體的好處缺乏認知是市場的主要威脅。由於製藥和醫療保健營業單位對軟體簡化不利事件監測、加強藥物安全協議和加速監管合規的能力了解有限,阻礙了其採用。此外,由於缺乏認知,軟體無法發揮其在降低風險、提高病人安全和最佳化藥物開發流程方面的潛力。
COVID-19 大流行對藥物警戒和藥物安全軟體市場產生了重大影響。全球對快速疫苗開發和藥物核准的需求活性化了監管監督和藥物警戒活動。對強大的安全監控系統、不利事件追蹤和簡化的報告機制的需求激增,加速了先進軟體解決方案的採用。此外,疫情期間的遠距工作環境凸顯了對雲端基礎和遠端存取平台的需求,為創新、擴充性和人工智慧驅動的藥物警戒軟體解決方案打開了市場。這種轉變已經加速。
製藥和生物技術公司部門預計將在預測期內成為最大的部門
由於在研發和藥品製造方面的大量投資,製藥和生物技術公司預計將主導藥物警戒和藥物安全軟體市場。這些公司優先考慮監管合規性和病人安全,這需要強大的藥物警戒系統。隨著業界面臨日益增加的藥物警戒和嚴格監管要求的壓力,這些公司擴大採用先進的軟體解決方案。這些技術正在推動製藥和生物技術市場的發展,因為它們對於不利事件報告、訊號檢測和風險管理、確保藥品安全、合規性和效率至關重要。
按需/雲端基礎的(SaaS) 產業預計在預測期內複合年成長率最高
在藥物警戒和藥物安全軟體市場中,按需/雲端基礎的(SaaS) 領域預計將表現出最高的複合年成長率。這種快速成長是由業界對彈性、擴充性且經濟高效的解決方案日益偏好所推動的。基於雲端基礎的平台提供可訪問性、即時協作並降低基礎設施成本,以滿足製藥公司不斷變化的需求。隨著對簡化資料管理、快速部署和遠端存取的需求不斷增加,SaaS 模型脫穎而出並正在推動顯著成長。
預計北美將在預測期內獲得最大的市場佔有率。該地區的優勢在於其強大的醫療基礎設施、大量的技術投資以及要求嚴格藥物安全措施的嚴格法規結構。知名製藥公司的存在及其實施先進軟體解決方案的意願進一步增強了北美的優勢。該地區專注於確保患者安全、合規性和高效的不利事件管理,已成為推動藥物警戒軟體解決方案成長和採用的關鍵地點。
預計在預測期內,亞太地區的藥物警戒和藥物安全軟體市場將出現最高成長。這種快速成長是由該地區製藥和生物技術行業的擴張以及醫療保健基礎設施的快速進步所推動的。此外,臨床試驗外包的增加、研發投資的增加以及對醫療保健數位化的興趣日益濃厚,正在推動對強大的藥物警戒解決方案的需求。隨著人們對加強藥品安全的日益重視,亞太地區已成為市場擴張顯著的關鍵地區。
According to Stratistics MRC, the Global Pharmacovigilance and Drug Safety Software Market is accounted for $202.6 million in 2023 and is expected to reach $365.8 million by 2030 growing at a CAGR of 8.8% during the forecast period. Pharmacovigilance involves monitoring, assessing, and ensuring the safety of pharmaceutical products post-market approval. Drug Safety Software refers to specialized technology aiding in this process by collecting, managing, and analyzing adverse event data associated with medications. These software solutions streamline reporting, facilitate compliance with regulatory requirements, and enable efficient signal detection, contributing to the continual evaluation and enhancement of drug safety profiles.
According to the National Care Institute 1.7 million new cases of cancer were registered in the U.S. in 2018.
Growing complexity of drugs
As drug formulations become more intricate, involving biologics, personalized medicines, and combination therapies, the risk of adverse events intensifies. Advanced pharmacovigilance software plays a pivotal role in managing this complexity by enabling comprehensive monitoring, signal detection, and streamlined adverse event reporting. The software's capacity to handle vast and intricate data sets, coupled with its analytical capabilities, ensures enhanced drug safety surveillance, regulatory compliance, and proactive risk management. Consequently, the growing complexity of drugs propels the demand for sophisticated pharmacovigilance and drug safety software solutions.
High implementation costs
The initial expenses associated with software integration, customization, data migration, and staff training can be substantial. These costs, which include licensing fees and infrastructure investments, can strain budgets, particularly for smaller pharmaceutical companies or healthcare entities with limited resources. Moreover, ongoing maintenance and upgrades further contribute to the total cost of ownership, deterring some organizations from adopting advanced pharmacovigilance software solutions, which further limits the market growth.
Increasing drug approvals and clinical trials
With an expanding pharmaceutical landscape and a burgeoning number of clinical trials globally, there's a heightened need for robust safety measures and efficient data management. Advanced software solutions offer streamlined adverse event reporting, signal detection, and risk assessment, supporting quicker approvals and ensuring stringent safety compliance. The demand for these software tools is propelled by the industry's focus on accelerating drug development, enhancing patient safety, and complying with evolving regulatory mandates, presenting a ripe opportunity for innovation and adoption within this market.
Lack of awareness regarding the benefits of pharmacovigilance software
The lack of awareness regarding the advantages of pharmacovigilance software poses a significant threat to the market. Limited understanding among pharmaceutical companies and healthcare entities about the software's capability to streamline adverse event monitoring, enhance drug safety protocols, and expedite regulatory compliance impedes its adoption. Additionally, insufficient awareness hampers the realization of its potential in reducing risks, improving patient safety and optimizing drug development processes.
The COVID-19 pandemic significantly influenced the pharmacovigilance and drug safety software markets. The global urgency for rapid vaccine development and drug approvals prompted heightened regulatory scrutiny and increased pharmacovigilance activities. This surge in demand for robust safety monitoring systems, adverse event tracking, and streamlined reporting mechanisms amplified the adoption of advanced software solutions. Additionally, remote work setups during the pandemic emphasized the need for cloud-based and remote-accessible platforms, accelerating the market's shift towards innovative, scalable, and AI-powered pharmacovigilance software solutions.
The pharmaceuticals & biotechnology companies segment is expected to be the largest during the forecast period
The pharmaceuticals and biotechnology companies segment is anticipated to dominate the pharmacovigilance and drug safety software market due to its substantial investment in research, development, and drug manufacturing. These companies prioritize regulatory compliance and patient safety, necessitating robust pharmacovigilance systems. As the industry faces escalating pressure for enhanced drug safety monitoring and stringent regulatory requirements, these entities increasingly adopt advanced software solutions. These technologies streamline adverse event reporting, signal detection, and risk management, which are crucial in ensuring drug safety, compliance, and efficiency, consequently propelling the pharmaceutical and biotechnology market.
The on-demand/cloud-based (SaaS) segment is expected to have the highest CAGR during the forecast period
The on-demand/cloud-based (SaaS) segment is projected to exhibit the highest CAGR in the pharmacovigilance and drug safety software market. This surge is fueled by the industry's growing preference for flexible, scalable, and cost-effective solutions. Cloud-based platforms offer accessibility, real-time collaboration, and reduced infrastructure costs, aligning well with the evolving needs of pharmaceutical companies. As the demand intensifies for streamlined data management, rapid deployment, and remote accessibility, the SaaS model stands out, driving its remarkable growth.
North America is poised to secure the largest market share during the forecast period. This prominence is attributed to the region's robust healthcare infrastructure, substantial investments in technology, and stringent regulatory frameworks mandating stringent drug safety measures. The presence of prominent pharmaceutical companies and a proactive approach toward adopting advanced software solutions further contribute to North America's dominance. With a heightened focus on ensuring patient safety, compliance, and efficient adverse event management, the region emerges as a pivotal hub driving the growth and adoption of pharmacovigilance software solutions.
The Asia Pacific region is anticipated to witness the highest growth in the pharmacovigilance and drug safety software market during the forecast period. This upsurge is fueled by the region's expanding pharmaceutical and biotechnology sectors and rapid advancements in healthcare infrastructure. Additionally, increased outsourcing of clinical trials, rising investments in research and development, and a growing focus on healthcare digitization drive the demand for robust pharmacovigilance solutions. With a mounting emphasis on enhancing drug safety, the Asia-Pacific region emerges as a pivotal region for significant market expansion.
Some of the key players in Pharmacovigilance And Drug Safety Software Market include Accelovance, ArisGlobal LLC, Cognizant, DXC Technology, Ennov, EXTEDO, FMD K&L Inc., ICON plc, IQVIA, Novartis AG, Oracle Corporation, Parexel International Corporation, Sarjen Systems Pvt. Ltd., SAS Institute Inc., Sparta Systems, Veeva Systems and Wingspan Technology, Inc.
In October 2023, Ennov is pleased to announce a strategic partnership with ION Pharma. This alliance marks the beginning of a collaborative effort that merges over two decades of expertise in electronic Quality Management Systems (eQMS) with the shared goal of advancing patient outcomes in the Life Sciences sector.
In October 2023, IQVIA, a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry announced a strategic collaboration with argenx to advance treatment to patients with rare autoimmune diseases through innovative and integrated technology-enabled pharmacovigilance (PV) safety services and solutions.
In April 2023, Ennov, a leading provider of regulated content and data management software for the Life Sciences industry, is happy to announce that it has acquired UK-based Samarind from its parent company Instem.