![]() |
市场调查报告书
商品编码
1820217
药物警戒市场规模、份额、趋势及预测(按服务提供者、产品生命週期、类型、製程流程、治疗领域、最终用途和地区),2025 年至 2033 年Pharmacovigilance Market Size, Share, Trends and Forecast by Service Provider, Product Life Cycle, Type, Process Flow, Therapeutic Area, End Use, and Region, 2025-2033 |
2024年,全球药物警戒市场规模达85亿美元。展望未来, IMARC Group预测,到2033年,该市场规模将达到163亿美元,2025年至2033年的复合年增长率为7.5%。目前,北美占据市场主导地位,占有33.7%的份额。由于药品复杂性不断提高、全球监管趋严、人工智慧和巨量资料应用日益普及、多重用药和药物滥用导致的不良反应增多,以及製药公司加大临床和上市后安全管理外包力度,该市场正在不断扩张。
药物警戒市场的发展受到药品不良反应 (ADR) 日益增加、上市后药品监测需求不断增长以及全球监管要求日益严格的推动。此外,人工智慧 (AI) 和巨量资料分析技术的日益普及,增强了讯号检测和药物安全评估,从而提高了效率并促进了市场成长。例如,欧洲药品管理局 (EMA) 将于 2024 年发布在药物警戒中使用人工智慧的工具和指南,表明其愿意利用技术改进药物安全监测。此外,製药和生物技术行业的成长推动了对药物开发过程中全面安全监测的需求,进一步促进了市场的扩张。此外,慢性病的激增和新药的上市也刺激了对强大的药物警戒系统的需求,为市场提供了动力。此外,将药物警戒活动外包给专业公司可以在保持合规性的同时降低营运成本,从而促进市场成长。
美国药物警戒市场受到该国庞大製药业的强劲推动,该行业开展了大量需要全面安全监测的临床试验。同时,生物相似药和个人化医疗的兴起增加了药物安全评估的复杂性,从而刺激了市场需求。同时,政府推动药物安全监测的倡议,例如美国食品药物管理局 (FDA) 的“哨兵计划”,正在促进市场成长。同时,以患者为中心的方法日益融合,强调了安全性评估的真实世界资料收集,从而增强了药物警戒的市场份额。此外,监管机构和製药公司之间的合作增强了合规性和监测系统,从而支持了市场成长。此外,远距医疗和数位健康工具的迅速普及促进了药品不良反应 (ADR) 的远距报告和监测,推动了市场向前发展。
科技进步改变药物警戒运作
药物警戒市场前景凸显了自动化和智慧驱动的工作流程在重塑产业格局中的作用。人工智慧、机器学习 (ML)、自然语言处理 (NLP) 和巨量资料分析等技术正在将传统的药物警戒模式转变为敏捷且数据丰富的生态系统。这些工具透过快速、大规模地处理大量资料集,增强了核心功能,尤其是不良反应 (ADR) 监测、讯号检测和监管报告。根据最近的市场研究,全球机器学习产业规模在 2024 年将达到 310 亿美元,药物警戒将成为其成长最快的应用之一。高影响力的合作正在树立新的标竿:赛诺菲和德勤的 ConvergeHEALTH Safety 平台利用人工智慧简化病例接收,而 ArisGlobal 与美国食品药品监督管理局 (FDA) FAERS II 系统的整合则增强了电子安全提交。 Saama Technologies 的 ASAP 解决方案借鉴了 FDA 的 Sentinel 通用资料模型和 TreeScan 方法,进一步推进了即时风险检测。
政府监管与现实世界证据强化市场扩张
从目前药物警戒市场概况中可以清楚看出,全球监管审查力道正在加强。美国食品药物管理局 (USFDA)、欧洲药品管理局 (EMA)、美国药品註册服务中心 (CDSCO) 和澳洲药品管理局 (TGA) 等机构正在提高警惕,并发布了严格的安全报告要求,尤其是在新药和复杂疗法产量不断增长的背景下。美国奥罗宾多製药公司 (Aurobindo Pharma USA) 因亚硝胺污染物召回喹那普利和氢氯噻嗪片,凸显了更严格的检测标准变得不可妥协。这些事件促使药厂加强内部系统,并寻求外部药物警戒合作伙伴。对上市后监测的日益依赖也凸显了药物不良反应 (ADR) 监测的关键作用,尤其是在药物滥用和多重用药现像日益增加的环境下。如今,监管机构的预期重点是试验阶段和真实世界用药资料,这些数据可以记录患者随时间推移的疗效。 《药物安全与监管前沿》的一项研究强调了真实世界证据 (RWE) 在更新临床环境之外的药物风险概况方面的价值。
药物复杂性导致药厂对药物警戒服务的需求不断上升
最新的药物警戒市场趋势表明,製药公司对专业安全监测服务的需求激增。这项转变背后的核心驱动因素之一是新药生产日益复杂,尤其是在生物製剂、基因疗法和个人化医疗领域。随着疾病负担的增加(尤其是慢性病和共病),患者经常需要同时服用多种药物,这增加了药物交互作用和意外不良反应的可能性。为了应对这种复杂性,药厂正在将药物警戒任务外包给专业的服务提供者。这些公司提供可扩展的基础设施、经验丰富的分析师以及获取区域监管情报的管道。 IQVIA 与 NRx Pharmaceuticals 在医疗资讯和药物警戒方面的策略伙伴关係,体现了外包如何从削减成本发展到提升绩效。这一趋势也反映了药物警戒市场报告中的另一个关键见解:内部资源往往捉襟见肘。外包使组织能够专注于核心创新,同时确保在全球市场维持端到端的药物安全监测。
复杂的临床试验和多种药物联合用药推动市场发展
临床试验的数量和复杂性不断增加是药物警戒市场预测的主要成长引擎。根据最近的市场资料,2023 年启动了超过 22,000 项新试验,其中许多试验采用自适应方案、分散式元素和以患者为中心的设计。这些趋势凸显了对能够跨多个地区即时运作的敏捷主动安全系统的需求。此外,心血管疾病、糖尿病和癌症等慢性疾病的增加意味着患者经常接受多种药物治疗,即同时使用多种治疗药物。这增加了显着的安全风险,使得药物不良反应 (ADR) 监测比以往任何时候都更重要。技术驱动的合作伙伴关係是这项变革的核心。 Cognizant 与分散临床试验 (DCT) 平台的领导者 Medable 的合作,在每个试验接触点引入了简化的安全监测。同样,Viedoc 和 LINK Medical 的合作伙伴关係旨在支援协作功能测试,并透过整合的药物警戒工具提高试验效率。
The global pharmacovigilance market size was valued at USD 8.5 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 16.3 Billion by 2033, exhibiting a CAGR of 7.5% from 2025-2033. North America currently dominates the market, holding a share of 33.7%. The market is expanding due to rising drug complexity, strict global regulations, growing use of AI and big data, increased adverse drug reactions from polypharmacy and substance abuse, and greater outsourcing by pharmaceutical firms to manage clinical and post-marketing safety.
The pharmacovigilance market is driven by the growing prevalence of adverse drug reactions (ADRs), increasing demand for post-market drug monitoring, and stricter regulatory requirements worldwide. In addition, the rising adoption of artificial intelligence (AI) and big data analytics enhances signal detection and drug safety evaluation, improving efficiency and aiding the market growth. For instance, in 2024 European Medicines Agency (EMA) released tools and guidelines for using AI in pharmacovigilance, hereby showing a willingness to use technology to improve drug safety monitoring. Additionally, the growth of the pharmaceutical and biotechnology industries drives the demand for thorough safety monitoring during drug development, further contributing to the market's expansion. Besides this, the surge in chronic diseases and new drug launches boosts the demand for robust pharmacovigilance systems, providing an impetus to the market. Furthermore, outsourcing pharmacovigilance activities to specialized firms reduces operational costs while maintaining compliance, thus catalyzing the market growth.
The United States pharmacovigilance market is strongly driven by the country's extensive pharmaceutical industry, which conducts numerous clinical trials requiring thorough safety monitoring. In line with this, the rise of biosimilars and personalized medicine increases the complexity of drug safety assessments, boosting the market demand. Concurrently, government initiatives promoting drug safety surveillance, such as the Food and Drug Administration's (FDA) Sentinel Initiative, are fostering the market growth. In confluence with this, the growing integration of patient-centric approaches emphasizes real-world data collection for safety evaluations, strengthening the pharmacovigilance market share. Also, collaborations between regulatory bodies and pharmaceutical companies enhance compliance and monitoring systems, supporting the market growth. Apart from this, the rapid adoption of telemedicine and digital health tools fosters remote reporting and monitoring of ADRs, propelling the market forward.
Technological Advancements Transforming Pharmacovigilance Operations
The pharmacovigilance market outlook highlights the role of automation and intelligence-driven workflows in redefining the landscape. Technologies such as AI, machine learning (ML), natural language processing (NLP), and big data analytics are transforming traditional pharmacovigilance models into agile, data-rich ecosystems. These tools are enhancing core functions-especially ADR monitoring, signal detection, and regulatory reporting-by processing massive datasets at speed and scale. According to recent market research, the global ML industry reached USD 31 billion in 2024, with pharmacovigilance emerging as one of its fastest-growing applications. High-impact collaborations are setting new benchmarks: Sanofi and Deloitte's ConvergeHEALTH Safety platform uses AI to streamline case intake, while ArisGlobal's integration with the USFDA's FAERS II system has enhanced electronic safety submissions. Saama Technologies' ASAP solution further advances real-time risk detection, drawing on the FDA's Sentinel Common Data Model and TreeScan methodology.
Government Regulation and Real-World Evidence Reinforce Market Expansion
A clear takeaway from the current pharmacovigilance market overview is the intensification of global regulatory scrutiny. Agencies like the USFDA, EMA, CDSCO, and TGA are increasing their vigilance, issuing strict mandates around safety reporting, especially in light of the rising production of novel drugs and complex therapies. Aurobindo Pharma USA's recall of Quinapril and Hydrochlorothiazide tablets-due to nitrosamine contaminants-highlights how stricter testing standards are becoming non-negotiable. These episodes are driving pharmaceutical firms to reinforce internal systems and seek external pharmacovigilance partners. The growing reliance on post-marketing surveillance has also spotlighted the critical role of ADR monitoring, particularly in an environment of increased drug abuse and polypharmacy. Regulatory expectations are now focused on both trial phases and real-world usage data that captures patient outcomes over time. A study in Frontiers in Drug Safety and Regulation emphasized the value of real-world evidence (RWE) in updating drug risk profiles beyond the clinical setting.
Rising Pharma Demand for Pharmacovigilance Services Amid Drug Complexity
The latest pharmacovigilance market trends point to a surge in demand from pharmaceutical companies for specialized safety monitoring services. One of the core drivers behind this shift is the growing complexity of novel drug production, especially in biologics, gene therapies, and personalized medicine. With disease burdens rising-particularly chronic and comorbid conditions-patients are often prescribed multiple drugs simultaneously, increasing the chances of interactions and unexpected adverse reactions. To manage this complexity, pharma companies are outsourcing pharmacovigilance tasks to expert service providers. These firms offer scalable infrastructure, experienced analysts, and access to regional regulatory intelligence. IQVIA's strategic partnership with NRx Pharmaceuticals for medical information and pharmacovigilance illustrates how outsourcing has evolved from cost-cutting to performance enhancement. This trend also reflects another key insight from the pharmacovigilance market report: internal resources are often overstretched. Outsourcing enables organizations to focus on core innovation while ensuring end-to-end drug safety monitoring is maintained across global markets.
Complex Clinical Trials and Polypharmacy Fuel Market Momentum
The increasing number and complexity of clinical trials are major growth engines for the pharmacovigilance market forecast. According to recent market data, over 22,000 new trials were launched in 2023, with many featuring adaptive protocols, decentralized elements, and patient-centric designs. These trends underscore the need for agile and proactive safety systems that can function in real-time across multiple geographies. Moreover, the rise of chronic diseases-like cardiovascular conditions, diabetes, and cancer-means that patients often undergo polypharmacy, i.e., simultaneous use of multiple therapeutic agents. This adds significant layers of safety risk, making ADR monitoring more vital than ever. Tech-driven partnerships are at the heart of this evolution. Cognizant's collaboration with Medable-a leader in decentralized clinical trial (DCT) platforms-has introduced streamlined safety monitoring at every trial touchpoint. Likewise, Viedoc and LINK Medical's partnership was built to support collaborative feature testing and improve trial productivity through integrated pharmacovigilance tools.
Contract outsourcing is the most popular segment and holds 61.2% market share since it is more affordable and productive in terms of compliance with regulatory requirements and risk monitoring. The pharmacovigilance outsourcing trend has become common with more pharmaceutical and biotechnology companies opting to outsource the processes as a way of avoiding operational costs and focusing on business strengths such as product research and marketing. The increasing stringency of the safety requirements for drugs across the world also increases the need for contract service organizations that have niche competence in the regulation's affairs and other safety assessment techniques. These providers use advanced technologies such as AI and big data analytics to enhance the outcomes of adverse event identification and notification. Also, the increase in the number of clinical trials, new drug launches, and growth in the biosimilars segment supports the growth of this segment. Both contract service providers and pharmaceutical firms are continuously building up their capabilities through more strategic collaborations, making this segment more dominant in the pharmacovigilance market.
Phase IV or the post-marketing surveillance phase has the biggest market share of 76.5% in the pharmacovigilance market as the monitoring of drug safety after approval is crucial. The dominance of the segment is due to the regulatory requirements for constant safety assessments and risk management procedures. Higher numbers of ADRs observed after approval add to the need for Phase IV to ascertain long-term safety. The pharmaceutical business and increasing number of drugs launches again broaden this segment as firms have to follow safety surveillance standards. Furthermore, new Phase IV activities that combine RWE and big data analytics enable efficient and compliant safety assessments. The ability to outsource Phase IV pharmacovigilance services to specialized service providers that offer cost-effective and compliant post-market surveillance is another factor driving segment growth.
The global pharmacovigilance market is led by the spontaneous reporting method with a share of 31.9% due to its high usage in identifying ADRs at a relatively low cost and time. The growth of this segment is due to the compliance standards on healthcare professionals and pharma companies, to report ADRs to central repositories such as the FAERS. This approach to data collection is quicker and means that safety issues can be identified very quickly. Greater public awareness and patient promotion to report ADRs directly also expand the size of this segment. The use of sophisticated technologies like ML and NLP advanced data analysis from spontaneous reports, signals, and risks. With the steady rise in the consumption of drugs all over the world, the need for monitoring the safety of these drugs through spontaneous reporting systems enhances the growth of this segment.
Signal detection constitutes the largest segment of the pharmacovigilance market with a market share of 38.2% because it plays a central role in detecting and managing safety concerns that may exist about a drug during its development and after launch. The foundation of this process lies in the collection of real-time data from clinical trials, electronic health records (EHRs), and patient records, gathered through adverse event logging. Modern technologies particularly ML algorithms increase the efficiency of adverse event analysis thus enhancing the improvement of drug safety. The increased compliance with regulatory frameworks enhances adverse event review and reporting to meet the required time and quality standards of reporting to the regulatory authorities. Signal detection is anticipated to record strong growth due to the rising uptake of big data analytics as well as the integration of RWE alongside growth in drug development projects and public awareness of drug safety.
The pharmacovigilance market is led by oncology as it has the largest market share of 27.8%. Oncology has the highest number of clinical trials and approved drugs as a therapeutic area. The increasing occurrence of cancer all over the world, estimated to be 29,564,943 cases in 2040, fosters the development of oncology drugs and the comprehensiveness of safety measures. Personalized medicine and immunotherapies increase the complexity of adverse event reporting by targeted therapies, and for this reason, necessitate the use of pharmacovigilance processes. The US FDA pressure on the highly secure oncology treatment adds to the market intensity. Also, expensive, and long oncology trials stress the need to have optimum risk management approaches and post-market vigilance to safeguard the patient from any harm while meeting legal compliance requirements. Due to this directed focus on oncology pharmacovigilance, the development of data analytics and AI signal detection innovation is further fueled and market expansion is sustained.
The largest segment in the pharmacovigilance market is occupied by pharmaceutical companies with a share of 44.2% because of their significant responsibilities within drug development and safety. They spend a lot of money on pharmacovigilance to meet set regulatory requirements and reduce the potential consequences of ADRs. The increasing numbers of new chemical entities and clinical trials contribute to the escalating demand for sound pharmacovigilance practices. In personal medicine and other biologic products, tracking and risk assessment become difficult; hence, pharmaceutical companies use robust instruments like AI for signal detection. Further, the global engagements between pharmaceutical firms and other regulatory authority organizations improve compliance and data sharing. The continuously rising public concern over drug safety and the shift towards RWE continue to cause pharmaceutical companies to be the most significant drivers of the pharmacovigilance market growth.
North America holds the largest share of the pharmacovigilance market at 33.7%, driven by advanced healthcare infrastructure, including the 6,120 hospitals and 916,752 staffed beds in the U.S. along with stringent regulatory frameworks established by the FDA. The region benefits from significant investments in drug safety programs and the widespread adoption of technology for adverse event reporting and data analysis. The rising prevalence of chronic diseases and an aging population are driving the increase in drug consumption, which in turn heightens the demand for effective pharmacovigilance practices. Moreover, the region leads in the integration of AI and big data for signal detection and real-time monitoring, improving efficiency and compliance. Robust collaboration between pharmaceutical companies and research institutions also plays a key role in supporting drug safety initiatives, driving ongoing market growth. The growing focus on patient safety and rising awareness about ADRs solidify North America's leadership in the pharmacovigilance market.
United States Pharmacovigilance Market Analysis
The United States accounted for a share of 83.40% in the North America pharmacovigilance market in 2024. The US pharmacovigilance market is driven by a combination of stringent regulatory frameworks, technological advancements, and increasing healthcare awareness. The FDA enforces robust pharmacovigilance requirements, fostering the demand for comprehensive adverse event reporting and monitoring systems. With rising concerns over medication safety and side effects, there is a growing need for post-market surveillance, further propelling market growth. According to the US Department of Health and Human Services, an estimated 129 million people in the US suffer from at least one major chronic disease, such as heart disease, cancer, diabetes, obesity, or hypertension, which drives the demand for continuous drug safety monitoring. Technological advancements like AI, ML, and automation are improving drug safety monitoring by increasing both efficiency and accuracy in the detection of adverse events. The integration of EHRs and wearable devices also contributes to real-time safety data collection, enabling faster response to potential risks. Additionally, increasing collaborations between pharmaceutical companies and third-party service providers for pharmacovigilance outsourcing optimize operational costs and ensure compliance with global safety standards. The focus on personalized medicine and the growth of biologics further intensifies the need for robust pharmacovigilance practices in the US market.
Europe Pharmacovigilance Market Analysis
The pharmacovigilance market in Europe is highly driven by an effective regulatory framework set down by the EMA and individual country agencies. The uptake of the EU Pharmacovigilance Directive (2010/84/EU) has provided more impetus to the expected safety monitoring and reporting by the pharmaceutical industries. With concern for patient safety, estimations of pharmacovigilance services have gained importance as adverse event reporting and risk management plans are a substantial part of drug development and post-marketing surveillance. The threat level of diseases including cancer, diabetes, and respiratory illnesses amongst others, along with the growing elderly population creates the need for constant safety evaluation of drugs. According to reports, on January 1, 2023, the EU population of 448.8 million, and more than one-fifth of the people are 65 years and above, thus requiring better pharmacovigilance to address the aging population. Furthermore, the application of modern technologies, including big data, AI, and EHRs, as a consequence, contributes to the pharmacovigilance improvement and early identification of ADRs. The European market is also following the overall trend towards outsourcing pharmacovigilance services to specialized contract research organizations (CROs), thus supporting the market growth.
Asia Pacific Pharmacovigilance Market Analysis
The pharmacovigilance market in the Asia-Pacific (APAC) region is expanding rapidly, driven by the region's growing pharmaceutical industry and increasing drug consumption. The prevalence of chronic diseases and the rising need for effective post-market surveillance are key factors fueling this growth. The demand for pharmacovigilance services is particularly prominent due to the increasing focus on drug safety and the need for risk management. As reported by PubMed Central, the prevalence of knee pain among older Asian populations varies significantly, with rates ranging from 11% to 56% in China, 33% in Japan, 38% in Korea, and 61% in Vietnam, underscoring the importance of monitoring treatments in aging populations. Emerging markets like China and India are witnessing significant investments in healthcare infrastructure, improving the collection and analysis of pharmacovigilance data. Moreover, the rising trend of clinical trials in the region further necessitates robust pharmacovigilance systems. Technological advancements, such as EHRs, are enhancing the monitoring of ADRs, further boosting market growth in the region.
Latin America Pharmacovigilance Market Analysis
The Latin American pharmacovigilance market is driven by an increasing demand for regulatory compliance and drug safety monitoring, primarily due to the region's expanding pharmaceutical sector and rising healthcare awareness. According to PubMed Central, in Brazil, an estimated 928,000 deaths annually are attributed to chronic diseases, highlighting the need for effective pharmacovigilance systems to manage medication risks in such populations. Key factors contributing to market growth include the implementation of stricter regulatory guidelines by national agencies such as ANVISA in Brazil and COFEPRIS in Mexico. Moreover, the growing adoption of advanced technologies for drug monitoring and the outsourcing of pharmacovigilance services are major factors driving the market.
Middle East and Africa Pharmacovigilance Market Analysis
The pharmacovigilance market in the Middle East and Africa (MEA) is influenced by regulatory improvements, increasing healthcare infrastructure, and rising awareness of drug safety. According to PubMed Central, in the UAE, the prevalence of self-reported chronic diseases is 23.0%, with obesity, diabetes, and asthma/allergies being the most common (12.5%, 4.2%, and 3.2%, respectively). This high prevalence of chronic conditions drives the demand for robust pharmacovigilance systems to ensure patient safety. The region's pharmaceutical market is expanding, and with rising healthcare infrastructure and the growth of clinical trials, the need for comprehensive drug safety monitoring continues to rise across MEA.
The pharmacovigilance market is experiencing heightened competition, with leading players concentrating on technological innovations and strategic partnerships to improve their service offerings. There is a growing trend toward leveraging AI and ML for automated adverse event detection and predictive analytics. Companies are expanding their global presence by outsourcing pharmacovigilance services to emerging markets, aiming to reduce operational costs while maintaining high standards. Strategic partnerships with clinical research organizations and healthcare providers are becoming common to streamline data collection and analysis. Additionally, the integration of RWE and patient-reported outcomes into safety assessments is gaining momentum, reflecting the industry's commitment to improving drug safety and regulatory compliance. These activities underline the dynamic evolution of the market landscape.