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市场调查报告书
商品编码
1914550
药物警戒市场-全球产业规模、份额、趋势、机会及预测(按临床试验阶段、方法、服务供应商、流程、治疗领域、最终用户、地区和竞争格局划分,2021-2031年)Pharmacovigilance Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Clinical Trial Phase, By Method, By Service Provider, By Process Flow, By Therapeutic Area, By End-User, By Region & Competition, 2021-2031F |
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全球药物监测市场预计将从2025年的82.1亿美元显着成长至2031年的153.7亿美元,复合年增长率(CAGR)为11.02%。药物监测是一个专注于检测、评估、理解和预防不利事件及相关问题的科学领域,其主要驱动力是全球药品消费量的增长以及需要长期用药的慢性病患病率的上升。此外,世界各地卫生监管机构实施的严格监管要求迫使製药公司建立严密的安全监测体系,这也成为推动该产业扩张的根本动力。
| 市场概览 | |
|---|---|
| 预测期 | 2027-2031 |
| 市场规模:2025年 | 82.1亿美元 |
| 市场规模:2031年 | 153.7亿美元 |
| 复合年增长率:2026-2031年 | 11.02% |
| 成长最快的细分市场 | 合约外包 |
| 最大的市场 | 北美洲 |
儘管市场前景广阔,但由于管理快速成长的安全资料量成本高且复杂,该市场仍面临许多挑战。数据量的爆炸性增长给现有资源带来了巨大压力,并需要建立强大的基础设施。例如,欧洲药品管理局 (EMA) 报告称,2024 年向 EudraVigilance 提交的不利事件报告超过 170 万份,这凸显了各机构为确保合规性而必须准确收集和分析的资讯量之庞大。
慢性病盛行率的上升以及由此导致的药品消费量增加是全球药物警戒市场的主要驱动因素。随着肿瘤、糖尿病和心血管疾病等疾病的全球负担加重,用药量也随之增加,这需要对不利事件进行严格监测。世界卫生组织(世卫组织)于2024年2月发布的《2024年全球癌症现状报告》也印证了这一趋势,该报告预测2022年将新增2000万例癌症病例,这意味着需要长期药物治疗的患者数量正在不断增长。疾病发生率的上升迫使製药公司扩大药物警戒力度,以有效追踪用于治疗慢性病的复杂治疗方法的安全性。
此外,临床试验和药物研发的扩张正在推动市场成长,因为其产生大量安全数据,这些数据在核准前必须进行处理。製药公司正大力投资创新技术以满足尚未满足的医疗需求,也增加了临床试验和上市后监管的需求。根据欧洲製药工业协会联合会(EFPIA)2024年6月发布的报告《2024年製药业数据概览》,预计2023年欧洲的研发支出将达到500亿欧元。为了因应随之而来的法律规范,各监管机构正在加强自身能力。 2024年,美国食品药物管理局(FDA)申请了72亿美元的2025财年预算,用于加强其安全项目和公共卫生基础设施。
安全数据的指数级增长对全球药物警戒市场的扩张构成了重大障碍。随着不利事件报告呈指数级增长,製药公司被迫将大量资金用于维持基本的合规性,而非投资于创新。检验和处理如此庞大的资讯量既复杂又高成本,对企业造成了沉重的财务负担,尤其是对中小企业而言。这些中小企业往往缺乏足够的预算柔软性来承担严格的安全监测所需的高昂营运成本,这有效地限制了它们的市场参与度,并阻碍了整个产业的成长。
资源密集型环境因必须管理的庞大资讯量而进一步加剧,而这些资讯量之大正是避免监管处罚的必要条件。不断加速的资料涌入迫使各组织优先考虑即时处理能力,而非长期策略发展。据乌普萨拉监测中心称,2024年全球VigiBase系统平均每週收到约5万份新的个案安全报告。如此庞大的数据涌入凸显了相关人员被迫不断扩展基础设施才能满足报告要求,最终阻碍了更广泛的市场机会和盈利。
人工智慧 (AI) 和机器学习的融合正在从根本上重塑全球药物警戒市场,将安全营运从被动的合规转向主动的风险管理。面对不利事件报告的激增,製药公司正越来越多地利用预测演算法和自然语言处理技术来自动化诸如病例接收、疗效检查和叙述生成等劳动密集型任务。这项技术进步使安全团队能够专注于复杂的获益-风险评估,而不是手动输入数据,从而提高讯号检测的速度和准确性。根据皮斯托亚联盟 (Pistoia Alliance) 于 2025 年 9 月发布的《未来实验室 2025 报告》,60% 的受访者将人工智慧和机器学习列为未来两年最重要的技术投资重点,凸显了该行业对数位转型的坚定承诺。
同时,由于需要在不承担固定成本的情况下应对复杂的监管环境和不断变化的资源需求,将部分工作策略性外包给合约研究组织 (CRO) 正逐渐成为主流趋势。尤其是规模较小的公司,它们利用 CRO 的专业基础设施来确保全球合规性和扩充性,从而有效地将固定营运成本转化为可变支出。依赖外部合作伙伴使生物製药公司能够获得先进的药物警戒平台和全球安全网络,而这些平台和网络如果自行建造则成本极其高昂。根据临床研究组织协会 (ACRO) 2025 年 7 月的报告显示,其成员公司在 2024 年的收入预计将达到 980 亿美元,这反映了目前外包给第三方供应商的工作规模之大。
The Global Pharmacovigilance Market is projected to experience substantial growth, rising from USD 8.21 Billion in 2025 to USD 15.37 Billion by 2031, reflecting a compound annual growth rate of 11.02%. Defined as the scientific discipline focused on detecting, assessing, understanding, and preventing adverse effects or medicine-related issues, the market is primarily driven by increasing global pharmaceutical consumption and the growing prevalence of chronic diseases that require long-term medication. Additionally, stringent regulatory requirements enforced by health authorities worldwide mandate that pharmaceutical companies maintain rigorous safety surveillance systems, serving as a fundamental driver for the industry's expansion.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 8.21 Billion |
| Market Size 2031 | USD 15.37 Billion |
| CAGR 2026-2031 | 11.02% |
| Fastest Growing Segment | Contract Outsourcing |
| Largest Market | North America |
Despite these growth prospects, the market faces a significant hurdle due to the high costs and complexity involved in managing the rapidly increasing volume of safety data. This surge in data places immense pressure on existing resources and necessitates the development of robust infrastructure. For instance, the European Medicines Agency reported that in 2024, over 1.7 million adverse drug reaction reports were submitted to EudraVigilance, underscoring the massive scale of information that organizations must accurately capture and analyze to ensure regulatory compliance.
Market Driver
The escalating prevalence of chronic diseases and the resulting increase in medication consumption serve as key catalysts for the Global Pharmacovigilance Market. As the global burden of conditions like oncology, diabetes, and cardiovascular disorders rises, the volume of administered drugs increases, necessitating strict monitoring for adverse events. Highlighting this trend, the World Health Organization's 'Global Status Report on Cancer 2024', released in February 2024, estimated there were 20 million new cancer cases in 2022, indicating a growing patient population that requires long-term pharmacological treatment. This rise in disease incidence compels pharmaceutical entities to expand their pharmacovigilance operations to effectively track the safety profiles of complex therapies used in chronic care.
Furthermore, the expansion of clinical trials and drug research and development accelerates market growth by generating vast amounts of safety data that must be processed before authorization. Pharmaceutical companies are investing heavily in innovation to meet unmet medical needs, heightening the demand for surveillance during both clinical and post-marketing phases. According to the European Federation of Pharmaceutical Industries and Associations' June 2024 report, 'The Pharmaceutical Industry in Figures 2024', R&D expenditure in Europe was projected to reach €50,000 million in 2023. To manage the regulatory oversight associated with this investment, agencies are also enhancing their capabilities; the US Food and Drug Administration requested a budget of $7.2 billion for fiscal year 2025 in 2024 to strengthen safety programs and public health infrastructure.
Market Challenge
The rapid increase in safety data volume poses a significant barrier to the Global Pharmacovigilance Market's expansion. As adverse event reports multiply exponentially, pharmaceutical companies are forced to divert substantial capital toward maintaining basic compliance rather than investing in innovation. The complexity and high expense of validating and processing this influx create a severe financial strain, particularly for small and medium-sized enterprises. These smaller entities often lack the budgetary flexibility to absorb the soaring operational costs required for rigorous safety surveillance, effectively limiting their participation in the market and hampering overall industry growth.
This resource-intensive environment is further exacerbated by the sheer scale of information that must be managed to avoid regulatory penalties. The relentless acceleration of data intake compels organizations to prioritize immediate processing capabilities over long-term strategic development. According to the Uppsala Monitoring Centre, the global VigiBase system received an average of approximately 50,000 new individual case safety reports per week in 2024. This magnitude of data influx highlights the immense pressure on industry stakeholders, who must continuously expand their infrastructure solely to keep pace with reporting requirements, thereby stifling broader market opportunities and profitability.
Market Trends
The integration of Artificial Intelligence and Machine Learning is fundamentally reshaping the Global Pharmacovigilance Market by shifting safety operations from reactive compliance to proactive risk management. Facing an exponential rise in adverse event reports, pharmaceutical companies are increasingly utilizing predictive algorithms and natural language processing to automate labor-intensive tasks such as case intake, validity checks, and narrative generation. This technological advancement allows safety teams to focus on complex benefit-risk assessments rather than manual data entry, improving the speed and accuracy of signal detection. According to the Pistoia Alliance's 'Lab of the Future 2025 Report' from September 2025, 60% of respondents identified AI and machine learning as their top technology investment for the next two years, underscoring the sector's commitment to digital transformation.
Simultaneously, strategic outsourcing to Contract Research Organizations (CROs) has emerged as a dominant trend, driven by the need to navigate complex regulatory landscapes and manage fluctuating resource demands without incurring fixed overheads. Small and medium-sized enterprises, in particular, are leveraging the specialized infrastructure of CROs to ensure global compliance and scalability, effectively converting fixed operational costs into variable expenses. This reliance on external partners enables bio-pharmaceutical firms to access advanced vigilance platforms and global safety networks that would be prohibitively expensive to build in-house. As reported by the Association of Clinical Research Organizations in July 2025, member companies generated an estimated $98 billion in revenue in 2024, reflecting the substantial scale of operations now entrusted to third-party providers.
Report Scope
In this report, the Global Pharmacovigilance Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Pharmacovigilance Market.
Global Pharmacovigilance Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: