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市場調查報告書
商品編碼
1930062
全球藥物警戒市場:市場規模、佔有率、成長率、產業分析、按類型、應用和地區劃分的考量因素以及未來預測(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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預計2025年全球藥物警戒(PV)市場規模將達到93.5億美元,到2026年將達到105.4億美元。預計2034年將進一步成長至315.6億美元,預測期內複合年增長率(CAGR)為14.69%。北美地區憑藉強大的製藥產業、高額的醫療保健支出、先進的基礎設施和嚴格的監管環境,在2025年將以40.84%的市場佔有率引領市場。包括 IQVIA Inc.、Laboratory Corporation of America Holdings、埃森哲、Cognizant、Ergomed Group、Parexel International Corporation、ICON plc. 和 Quanticate 在內的市場主要參與者正專注於技術創新、人工智慧應用、合作夥伴關係和地域擴張。
藥物警戒 (PV) 是指監測、評估和預防藥物不良反應 (ADR),以確保藥物的安全性和有效性。它涉及收集和分析來自醫療保健提供者、患者和監管機構在臨床前、臨床和上市後階段的數據。不斷增加的不良反應報告、新藥上市以及臨床試驗投資正在推動全球對藥物警戒服務和軟體的需求。例如,澳洲在 2021-2022 年共收到 125,873 例藥物不良反應 (ADR) 報告,凸顯了加強藥物安全監測的必要性。
市場驅動因素
提高藥物不良反應意識和公共倡議:醫療保健提供者、患者和政府機構意識的提高是市場的主要驅動因素。諸如烏普薩拉監測中心的年度社交媒體活動和 2023 年藥物安全週等活動提高了公眾對藥物不良反應報告的理解,從而促進了藥物警戒 (PV) 服務的普及。
藥廠外包趨勢:許多藥廠選擇將藥物警戒服務外包給專業供應商,以提高營運效率、降低成本並獲得專業解決方案。這一趨勢在 2024 年得到了體現,當時 ProPharma 集團收購了 Clinres Farmacija,擴大了在歐洲的上市後監管和藥物警戒服務。外包提高了上市藥物監測的靈活性、合規性和效率。
技術創新與人工智慧整合:人工智慧 (AI) 在藥物警戒領域的應用日益廣泛,能夠快速檢測和評估不良事件。例如,2023 年 4 月,Parexel International 與 Partex 合作,在藥物發現和開發過程中運用人工智慧解決方案,以提升監管決策和營運效率。人工智慧的引入使藥物安全監測人員能夠專注於更高價值的任務,從而提高藥物安全監測的整體有效性。
市場限制因子
資金和專業人員短缺:儘管市場需求旺盛,但資金有限和訓練有素的藥物安全監測專業人員的匱乏限制了市場擴張,尤其是在非洲等地區。資源匱乏導致報告、監測和監管合規的延誤,影響了市場有效性。
市場區隔
按服務類型劃分:服務領域佔領先地位,預計到 2026 年將達到 91.43% 的市場佔有率,主要受臨床試驗需求、外包趨勢和上市後監測的推動。軟體領域成長最快,這得益於自動化、人工智慧、雲端平台以及合作項目,例如埃森哲為安斯泰來製藥於 2022 年開發的基於雲端的 IT 平台。
以部署方式劃分:外包領域位居榜首,預計到 2026 年將達到 57.03% 的市佔率。這使得製藥公司能夠有效地適應不斷變化的法規並降低營運成本。內部營運仍然很重要,但由於專業知識和資源限制,面臨挑戰。
按最終用戶劃分:製藥和生物技術公司預計到 2026 年將佔 62.51% 的市場佔有率,他們將利用藥物警戒服務來確保新藥的監管合規性和安全性監測。合約研究組織 (CRO) 是第二大終端用戶群體,為製藥公司提供經濟高效的臨床試驗和安全性解決方案。
主要參與者
主要參與者包括 IQVIA Inc.、Laboratory Corporation of America Holdings、Parexel International Corporation、埃森哲、Cognizant、Ergomed Group、Thermo Fisher Scientific、ICON plc. 和 Quanticate。 Ergomed 收購 Panacea(2024 年)以及埃森哲與 Salesforce 開展基於人工智慧的合作(2023 年)等策略性舉措正在增強其市場地位和服務能力。
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