![]() |
市場調查報告書
商品編碼
2108155
藥物安全檢測(PV) 市場分析及預測(至 2035 年):按類型、產品、服務、技術、組件、應用、流程、部署、最終用戶和解決方案分類Pharmacovigilance (PV) Market Analysis and Forecast to 2035: Type, Product, Services, Technology, Component, Application, Process, Deployment, End User, Solutions |
||||||
全球藥物安全檢測(PV) 市場預計將從 2025 年的 89 億美元成長到 2035 年的 151 億美元,複合年成長率 (CAGR) 為 5.6%。藥物安全檢測市場集中度適中,由於監管機構的廣泛採用,自願報告仍然是主要的監測方法。然而,主動安全監測,例如隊列事件監測和有針對性的自願報告,正在持續成長。市場正在擴大採用人工智慧驅動的藥物安全檢測平台、基於雲端的安全資料庫以及藥物安全服務的外包,以提高不利事件的檢測和監管合規性。戰略合作夥伴關係正在加速藥物藥物安全檢測營運的數位轉型。例如,2025 年 1 月,IQVIA 宣布與 NVIDIA 建立策略合作夥伴關係,旨在推動醫療級人工智慧的發展,並透過自動化整個藥物生命週期中複雜的藥物安全檢測、臨床和醫療安全工作流程,增強人工智慧驅動的藥物安全能力。
以產品細分市場來看,預計到2025年,服務細分市場將佔藥物安全檢測市場最大的佔有率。這主要是因為製藥和生物技術公司擴大將藥物安全營運外包給專業的藥物安全檢測服務供應商。不利事件病例處理、醫學審查、總結報告、訊號檢測、風險管理和法規遵循等服務正被廣泛外包,以提高營運效率、降低成本並確保符合不斷變化的全球法規。臨床試驗數量的增加、生物製藥和專科藥物獲批數量的成長以及上市後監測要求的加強,進一步推動了對藥物安全檢測服務的需求。此外,全球合約研究組織 (CRO) 和業務流程外包服務供應商的擴張也持續鞏固了該細分市場在市場中的主導地位。
| 市場區隔 | |
|---|---|
| 類型 | 自願報告、強化不利事件報告、有針對性的自願報告、隊列事件監測、電子健康記錄 (EHR) 挖掘等。 |
| 產品 | 軟體、服務及其他 |
| 服務 | 外包、內部處理和其他 |
| 科技 | 基於人工智慧、基於雲端、本地部署、巨量資料等。 |
| 成分 | 軟體、硬體及其他 |
| 目的 | 製藥、生技、醫療設備及其他 |
| 過程 | 案例資料管理、訊號檢測、風險管理等。 |
| 實作方法 | 本地部署、雲端部署、混合部署及其他 |
| 最終用戶 | 製藥公司、生物技術公司、合約研究組織 (CRO) 等。 |
| 解決方案 | 不利事件報告、藥物安全審計、風險管理系統等。 |
從技術角度來看,在預測期內,人工智慧(AI)細分市場預計將實現最快成長,這主要得益於人工智慧和機器學習技術在藥物警戒工作流程自動化和藥物安全監測改進方面的應用日益廣泛。以人工智慧為基礎的解決方案能夠加速不利事件病例處理、智慧訊號檢測、文獻篩檢、重複資料識別和監管報告,同時減少人工工作量和營運成本。製藥公司正在擴大人工智慧的應用範圍,以更準確、更快速地管理不斷成長的真實世界數據和不利事件數據。對數位化藥物警戒平台的投資增加、預測分析的日益普及以及監管機構對人工智慧驅動的安全監測的接受度不斷提高,預計將在整個預測期內加速該細分市場的成長。
2025年,北美在藥物安全檢測市場佔領先地位,這得益於大型製藥和生物技術公司的存在、嚴格的藥物安全法規以及先進的醫療保健基礎設施。美國憑藉其廣泛的臨床研究活動、眾多藥物獲批以及監管機構強制執行的上市後監測要求,佔了最大的區域市場佔有率。人工智慧驅動的藥物安全檢測平台的普及、藥物安全營運外包的增加以及全球合約研究組織(CRO)的強大影響力,進一步鞏固了該地區的主導地位。加拿大也透過擴大藥物研發、致力於遵守法規以及投資數位醫療技術,為市場做出了貢獻。
預計亞太地區將在預測期內實現最快成長,這主要得益於製藥生產的擴張、臨床試驗活動的增加以及藥物安全檢測服務外包至成本效益更高的市場。印度、中國、日本和韓國等國家正在藥物研發、監管現代化和數位醫療基礎設施方面進行大量投資,對先進的藥物藥物安全檢測解決方案產生了強勁的需求。雲端藥物安全平台的日益普及、生技藥品和生物相似藥的快速發展、更嚴格的監管報告要求以及合約研究組織(CRO)的快速擴張,預計將加速全部區域的市場成長。
擴大人工智慧藥物安全檢測平台的應用範圍:
在藥物安全檢測市場,人工智慧 (AI)、機器學習和雲端技術正迅速應用於不利事件病例處理、訊號檢測、文獻篩檢和監管報告的自動化。 AI驅動的藥物安全檢測平台提高了藥物安全監測的速度、準確性和一致性,同時減少了人工工作量和營運成本。製藥公司和合約研究組織 (CRO) 正日益將預測分析和真實世界數據整合到其藥物藥物安全檢測營運中,以加強風險評估和監管合規性。數位轉型計畫的擴展和對智慧藥物安全平台投資的增加,正在加速AI驅動的藥物安全檢測解決方案在全球的應用。
監管機構更重視藥品安全和上市後監測:
藥物安全檢測市場的主要驅動力是全球監管機構日益嚴格的要求,這些要求旨在對整個產品生命週期內的藥物安全性進行持續監測。 FDA、EMA、MHRA 和 PMDA 等監管機構正在加強對不利事件報告、訊號檢測和風險管理的要求,以提高病患安全。複雜生物製藥、專科藥物、生物相似藥和先進療法的核准數量不斷增加,促使安全資料量龐大,對高效藥物安全檢測系統的需求也日益成長。此外,臨床試驗的擴展、藥物安全檢測服務外包的增加以及基於風險的法規結構的日益普及,都持續推動全球對先進藥物安全解決方案的需求。
The global Pharmacovigilance (PV) market is projected to grow from $8.9 billion in 2025 to $15.1 billion by 2035, at a compound annual growth rate (CAGR) of 5.6%. The Pharmacovigilance (PV) Market is moderately consolidated, with spontaneous reporting remaining the leading surveillance method due to widespread regulatory adoption, while cohort event monitoring and targeted spontaneous reporting continue to expand for active safety surveillance. The market is witnessing growing adoption of AI-enabled pharmacovigilance platforms, cloud-based safety databases, and outsourced drug safety services to improve adverse event detection and regulatory compliance. Strategic collaborations are accelerating digital transformation across pharmacovigilance operations. For instance, in January 2025, IQVIA announced a strategic collaboration with NVIDIA to advance Healthcare-grade AI and automate complex pharmacovigilance, clinical, and medical safety workflows across the drug lifecycle, strengthening AI-driven drug safety capabilities.
Based on Product, the Services segment dominated the Pharmacovigilance Market in 2025 due to the increasing outsourcing of drug safety operations by pharmaceutical and biotechnology companies to specialized pharmacovigilance service providers. Services such as adverse event case processing, medical review, aggregate reporting, signal detection, risk management, and regulatory compliance are widely outsourced to improve operational efficiency, reduce costs, and ensure compliance with evolving global regulations. The growing number of clinical trials, increasing approvals of complex biologics and specialty drugs, and rising post-marketing surveillance requirements have further strengthened demand for pharmacovigilance services. Additionally, the expansion of global CROs and business process outsourcing providers continues to support the segment's market leadership.
| Market Segmentation | |
|---|---|
| Type | Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring, EHR Mining, Others |
| Product | Software, Services, Others |
| Services | Contract Outsourcing, In-house, Others |
| Technology | AI-based, Cloud-based, On-premise, Big Data, Others |
| Component | Software, Hardware, Others |
| Application | Pharmaceuticals, Biotechnology, Medical Devices, Others |
| Process | Case Data Management, Signal Detection, Risk Management, Others |
| Deployment | On-premise, Cloud, Hybrid, Others |
| End User | Pharmaceutical Companies, Biotechnology Companies, Contract Research Organizations, Others |
| Solutions | Adverse Event Reporting, Drug Safety Audits, Risk Management Systems, Others |
Based on Technology, the AI-based segment is projected to register the fastest growth during the forecast period owing to the increasing adoption of artificial intelligence and machine learning technologies to automate pharmacovigilance workflows and improve drug safety monitoring. AI-based solutions enable faster adverse event case processing, intelligent signal detection, literature screening, duplicate identification, and regulatory reporting while reducing manual workload and operational costs. Pharmaceutical companies are increasingly deploying AI to manage growing volumes of real-world evidence and adverse event data with greater accuracy and speed. Rising investments in digital pharmacovigilance platforms, expanding use of predictive analytics, and increasing regulatory acceptance of AI-enabled safety monitoring are expected to accelerate segment growth throughout the forecast period.
North America dominated the Pharmacovigilance Market in 2025, supported by the presence of leading pharmaceutical and biotechnology companies, stringent drug safety regulations, and advanced healthcare infrastructure. The United States accounts for the largest regional share due to extensive clinical research activities, high volumes of drug approvals, and mandatory post-marketing surveillance requirements enforced by regulatory agencies. The widespread adoption of AI-enabled pharmacovigilance platforms, increasing outsourcing of drug safety operations, and strong presence of global contract research organizations (CROs) further strengthen the region's leadership. Canada also contributes through expanding pharmaceutical research, regulatory compliance initiatives, and investments in digital healthcare technologies.
Asia-Pacific is projected to register the fastest growth during the forecast period, driven by expanding pharmaceutical manufacturing, increasing clinical trial activity, and rising outsourcing of pharmacovigilance services to cost-efficient markets. Countries such as India, China, Japan, and South Korea are investing heavily in drug development, regulatory modernization, and digital healthcare infrastructure, creating strong demand for advanced pharmacovigilance solutions. Growing adoption of cloud-based drug safety platforms, increasing biologics and biosimilar development, rising regulatory reporting requirements, and the rapid expansion of contract research organizations (CROs) are expected to accelerate market growth across the region.
Increasing Adoption of AI-Driven Pharmacovigilance Platforms:
The pharmacovigilance market is witnessing rapid adoption of artificial intelligence (AI), machine learning, and cloud-based technologies to automate adverse event case processing, signal detection, literature screening, and regulatory reporting. AI-powered pharmacovigilance platforms improve the speed, accuracy, and consistency of drug safety monitoring while reducing manual effort and operational costs. Pharmaceutical companies and contract research organizations (CROs) are increasingly integrating predictive analytics and real-world data into pharmacovigilance workflows to strengthen risk assessment and regulatory compliance. Growing digital transformation initiatives and rising investments in intelligent drug safety platforms are accelerating the adoption of AI-enabled pharmacovigilance solutions globally.
Growing Regulatory Focus on Drug Safety and Post-Marketing Surveillance:
The pharmacovigilance market is primarily driven by increasingly stringent global regulatory requirements for continuous drug safety monitoring throughout the product lifecycle. Regulatory authorities such as the FDA, EMA, MHRA, and PMDA are strengthening adverse event reporting, signal detection, and risk management requirements to improve patient safety. Rising approvals of complex biologics, specialty drugs, biosimilars, and advanced therapies are generating larger volumes of safety data, increasing the need for efficient pharmacovigilance systems. Furthermore, expanding clinical trials, growing outsourcing of pharmacovigilance services, and increasing adoption of risk-based regulatory frameworks continue to drive sustained demand for advanced drug safety solutions worldwide.
Our research scope provides comprehensive market data, insights, and analysis across a variety of critical areas. We cover Local Market Analysis, assessing consumer demographics, purchasing behaviors, and market size within specific regions to identify growth opportunities. Our Local Competition Review offers a detailed evaluation of competitors, including their strengths, weaknesses, and market positioning. We also conduct Local Regulatory Reviews to ensure businesses comply with relevant laws and regulations. Industry Analysis provides an in-depth look at market dynamics, key players, and trends. Additionally, we offer Cross-Segmental Analysis to identify synergies between different market segments, as well as Production-Consumption and Demand-Supply Analysis to optimize supply chain efficiency. Our Import-Export Analysis helps businesses navigate global trade environments by evaluating trade flows and policies. These insights empower clients to make informed strategic decisions, mitigate risks, and capitalize on market opportunities.