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市场调查报告书
商品编码
1930062
全球药物警戒市场:市场规模、占有率、成长率、产业分析、按类型、应用和地区划分的考量因素以及未来预测(2025-2034)Pharmacovigilance Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2025-2034 |
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预计2025年全球药物警戒(PV)市场规模将达到93.5亿美元,到2026年将达到105.4亿美元。预计2034年将进一步成长至315.6亿美元,预测期内复合年增长率(CAGR)为14.69%。北美地区凭藉强大的製药产业、高额的医疗保健支出、先进的基础设施和严格的监管环境,在2025年将以40.84%的市场占有率引领市场。包括 IQVIA Inc.、Laboratory Corporation of America Holdings、埃森哲、Cognizant、Ergomed Group、Parexel International Corporation、ICON plc. 和 Quanticate 在内的市场主要参与者正专注于技术创新、人工智慧应用、合作伙伴关係和地域扩张。
药物警戒 (PV) 是指监测、评估和预防药物不良反应 (ADR),以确保药物的安全性和有效性。它涉及收集和分析来自医疗保健提供者、患者和监管机构在临床前、临床和上市后阶段的数据。不断增加的不良反应报告、新药上市以及临床试验投资正在推动全球对药物警戒服务和软体的需求。例如,澳洲在 2021-2022 年共收到 125,873 例药物不良反应 (ADR) 报告,凸显了加强药物安全监测的必要性。
市场驱动因素
提高药物不良反应意识和公共倡议:医疗保健提供者、患者和政府机构意识的提高是市场的主要驱动因素。诸如乌普萨拉监测中心的年度社交媒体活动和 2023 年药物安全週等活动提高了公众对药物不良反应报告的理解,从而促进了药物警戒 (PV) 服务的普及。
药厂外包趋势:许多药厂选择将药物警戒服务外包给专业供应商,以提高营运效率、降低成本并获得专业解决方案。这一趋势在 2024 年得到了体现,当时 ProPharma 集团收购了 Clinres Farmacija,扩大了在欧洲的上市后监管和药物警戒服务。外包提高了上市药物监测的灵活性、合规性和效率。
技术创新与人工智慧整合:人工智慧 (AI) 在药物警戒领域的应用日益广泛,能够快速检测和评估不良事件。例如,2023 年 4 月,Parexel International 与 Partex 合作,在药物发现和开发过程中运用人工智慧解决方案,以提升监管决策和营运效率。人工智慧的引入使药物安全监测人员能够专注于更高价值的任务,从而提高药物安全监测的整体有效性。
市场限制因子
资金和专业人员短缺:儘管市场需求旺盛,但资金有限和训练有素的药物安全监测专业人员的匮乏限制了市场扩张,尤其是在非洲等地区。资源匮乏导致报告、监测和监管合规的延误,影响了市场有效性。
市场区隔
按服务类型划分:服务领域占领先地位,预计到 2026 年将达到 91.43% 的市场占有率,主要受临床试验需求、外包趋势和上市后监测的推动。软体领域成长最快,这得益于自动化、人工智慧、云端平台以及合作项目,例如埃森哲为安斯泰来製药于 2022 年开发的基于云端的 IT 平台。
以部署方式划分:外包领域位居榜首,预计到 2026 年将达到 57.03% 的市占率。这使得製药公司能够有效地适应不断变化的法规并降低营运成本。内部营运仍然很重要,但由于专业知识和资源限制,面临挑战。
按最终用户划分:製药和生物技术公司预计到 2026 年将占 62.51% 的市场占有率,他们将利用药物警戒服务来确保新药的监管合规性和安全性监测。合约研究组织 (CRO) 是第二大终端用户群体,为製药公司提供经济高效的临床试验和安全性解决方案。
主要参与者
主要参与者包括 IQVIA Inc.、Laboratory Corporation of America Holdings、Parexel International Corporation、埃森哲、Cognizant、Ergomed Group、Thermo Fisher Scientific、ICON plc. 和 Quanticate。 Ergomed 收购 Panacea(2024 年)以及埃森哲与 Salesforce 开展基于人工智慧的合作(2023 年)等策略性举措正在增强其市场地位和服务能力。
The global pharmacovigilance (PV) market was valued at USD 9.35 billion in 2025 and is projected to reach USD 10.54 billion in 2026, eventually expanding to USD 31.56 billion by 2034, reflecting a CAGR of 14.69% during the forecast period. North America dominated the market in 2025 with a 40.84% share, driven by a strong pharmaceutical industry, high healthcare expenditure, advanced infrastructure, and a stringent regulatory environment. Key players in the market include IQVIA Inc., Laboratory Corporation of America Holdings, Accenture, Cognizant, Ergomed Group, Parexel International Corporation, ICON plc., and Quanticate, focusing on technological innovations, AI adoption, partnerships, and geographic expansion.
Pharmacovigilance involves monitoring, assessing, and preventing adverse drug reactions (ADRs) to ensure the safety and efficacy of medications. It spans preclinical, clinical, and post-marketing stages, collecting and analyzing data from healthcare providers, patients, and regulatory authorities. Increasing ADR reporting, rising drug launches, and investments in clinical trials are driving demand for PV services and software globally. For example, Australia reported 125,873 adverse event notifications in 2021-22, highlighting the need for robust drug safety monitoring.
Market Drivers
Rising ADR Awareness and Public Initiatives: Growing awareness among healthcare providers, patients, and governments has significantly fueled the market. Campaigns such as Uppsala Monitoring Centre's annual social media initiatives and MedSafety Week in 2023 educate the public about ADR reporting, leading to increased adoption of PV services.
Outsourcing Trend by Pharmaceutical Companies: Many pharmaceutical firms prefer outsourcing PV services to specialized providers to streamline operations, reduce costs, and access expert solutions. In 2024, ProPharma Group acquired Clinres Farmacija to expand post-marketing regulatory and PV services in Europe, reflecting this trend. Outsourcing enhances flexibility, regulatory compliance, and efficiency in monitoring marketed drugs.
Technological Innovations and AI Integration: Artificial intelligence is increasingly applied in PV for faster detection and assessment of adverse events. For instance, in April 2023, Parexel International collaborated with Partex to leverage AI-powered solutions in drug discovery and development, improving regulatory decision-making and workflow efficiency. AI adoption also helps PV professionals focus on value-added tasks, enhancing the overall efficacy of drug safety monitoring.
Market Restraints
Funding and Skilled Workforce Shortages: Despite high demand, limited funding and a shortage of trained PV professionals constrain market expansion, particularly in regions like Africa. Insufficient resources delay reporting, monitoring, and compliance with regulations, impacting market effectiveness.
Market Segmentation
By Type: The services segment dominated with a 91.43% share in 2026, driven by clinical trials, outsourcing trends, and the demand for post-marketing surveillance. The software segment is the fastest-growing, supported by automation, AI, cloud platforms, and collaborations, such as Accenture's 2022 cloud-based IT platform for Astellas Pharma.
By Deployment: The outsourced segment led in 2026 with 57.03% share, enabling pharmaceutical companies to adapt to evolving regulations efficiently and reduce operational costs. In-house operations remain significant but face challenges due to limited expertise and resources.
By End-User: Pharmaceutical & biotechnology companies accounted for 62.51% of the market in 2026, leveraging PV services for regulatory compliance and safety monitoring of new drugs. CROs represent the second-largest end-user segment, providing cost-effective clinical trial and safety solutions to pharmaceutical companies.
Key Industry Players
Leading companies include IQVIA Inc., Laboratory Corporation of America Holdings, Parexel International Corporation, Accenture, Cognizant, Ergomed Group, Thermo Fisher Scientific, ICON plc., and Quanticate. Strategic initiatives such as Ergomed's acquisition of Panacea (2024) and Accenture's AI-driven collaboration with Salesforce (2023) enhance market presence and service capabilities.
Conclusion
The global pharmacovigilance market is expected to grow from USD 9.35 billion in 2025 to USD 31.56 billion by 2034, driven by increasing ADR reporting, pharmaceutical outsourcing trends, AI adoption, and growing clinical trials. North America leads the market, while Asia Pacific exhibits the fastest growth. Services dominate due to outsourcing and clinical demand, and software adoption is rising rapidly with technological innovation. Strategic collaborations, AI-powered platforms, and public awareness campaigns will continue to fuel market expansion, ensuring improved drug safety, regulatory compliance, and public health outcomes globally.
Segmentation By Type
By Deployment
By End User
By Region