市场调查报告书
商品编码
1401916
到 2030 年药物警戒和药物安全软体市场预测:按功能、交付方式、最终用户和地区进行的全球分析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 |
根据 Stratistics MRC 的数据,2023 年全球药物警戒和药物安全软体市场规模为 2.026 亿美元,预测期内复合年增长率为 8.8%,预计到 2030 年将达到 3.658 亿美元。
药物警戒涉及监测、评估和确保药品上市核准后的安全性。药品安全软体是指透过收集、管理和分析与药品相关的不利事件资料来协助此过程的专业技术。这些软体解决方案简化了报告,促进遵守监管要求,实现有效的讯号检测,并有助于持续评估和增强药物安全性。
根据美国国家护理研究所的数据,2018 年美国登记了 170 万新癌症病例。
药品变得越来越复杂
随着药物配方变得更加复杂,包括生技药品、个体化药物和联合治疗,不利事件的风险也随之增加。先进的药物警戒软体透过实现全面监测、讯号检测和简化的不利事件报告,在管理这种复杂性方面发挥着至关重要的作用。该软体能够处理大型且复杂的资料集,加上其分析功能,可确保增强药物警戒、法规遵循和主动风险管理。因此,随着药物复杂性的增加,对复杂药物警戒和药物安全软体解决方案的需求也在增加。
实施成本高
与软体整合、客製化、资料迁移和员工培训相关的初期成本可能很高。这些成本,包括许可费和基础设施投资,可能会导致预算紧张,特别是对于资源有限的小型製药公司和医疗保健营业单位。此外,一些组织不愿采用先进的药物警戒软体解决方案,因为持续的维护和升级进一步增加了总拥有成本,进一步限制了市场成长。
药物核准和临床试验的增加
随着製药业的扩张和全球临床试验的激增,对强有力的安全措施和高效资料管理的需求日益增加。先进的软体解决方案简化了不利事件报告、讯号侦测和风险评估,以支援快速核准和严格的安全合规性。业界对加速药物开发、提高病人安全和满足不断变化的法规的关注推动了对这些软体工具的需求,使之成为创新和采用的主要市场,带来了机会。
对药物警戒软体的好处缺乏认识
对药物警戒软体的好处缺乏认识是市场的主要威胁。由于製药和医疗保健营业单位对软体简化不利事件监测、加强药物安全协议和加速监管合规的能力了解有限,阻碍了其采用。此外,由于缺乏认识,软体无法发挥其在降低风险、提高病人安全和优化药物开发流程方面的潜力。
COVID-19 大流行对药物警戒和药物安全软体市场产生了重大影响。全球对快速疫苗开发和药物核准的需求活性化了监管监督和药物警戒活动。对强大的安全监控系统、不利事件追踪和简化的报告机制的需求激增,加速了先进软体解决方案的采用。此外,疫情期间的远距工作环境凸显了对云端基础和远端存取平台的需求,为创新、扩充性和人工智慧驱动的药物警戒软体解决方案打开了市场。这种转变已经加速。
製药和生物技术公司部门预计将在预测期内成为最大的部门
由于在研发和药品製造方面的大量投资,製药和生物技术公司预计将主导药物警戒和药物安全软体市场。这些公司优先考虑监管合规性和病人安全,这需要强大的药物警戒系统。随着业界面临日益增加的药物警戒和严格监管要求的压力,这些公司越来越多地采用先进的软体解决方案。这些技术正在推动製药和生物技术市场的发展,因为它们对于不利事件报告、讯号检测和风险管理、确保药品安全、合规性和效率至关重要。
按需/云端基础的(SaaS) 产业预计在预测期内复合年增长率最高
在药物警戒和药物安全软体市场中,按需/云端基础的(SaaS) 领域预计将表现出最高的复合年增长率。这种快速成长是由业界对弹性、扩充性且经济高效的解决方案日益偏好所推动的。基于云端基础的平台提供可访问性、即时协作并降低基础设施成本,以满足製药公司不断变化的需求。随着对简化资料管理、快速部署和远端存取的需求不断增加,SaaS 模型脱颖而出并正在推动显着成长。
预计北美将在预测期内获得最大的市场占有率。该地区的优势在于其强大的医疗基础设施、大量的技术投资以及要求严格药物安全措施的严格法规结构。知名製药公司的存在及其实施先进软体解决方案的意愿进一步增强了北美的优势。该地区专注于确保患者安全、合规性和高效的不利事件管理,已成为推动药物警戒软体解决方案成长和采用的关键地点。
预计在预测期内,亚太地区的药物警戒和药物安全软体市场将出现最高成长。这种快速增长是由该地区製药和生物技术行业的扩张以及医疗保健基础设施的快速进步所推动的。此外,临床试验外包的增加、研发投资的增加以及对医疗保健数位化的兴趣日益浓厚,正在推动对强大的药物警戒解决方案的需求。随着人们对加强药品安全的日益重视,亚太地区已成为市场扩张显着的关键地区。
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.