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市場調查報告書

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1820217

藥物警戒市場規模、佔有率、趨勢及預測（按服務提供者、產品生命週期、類型、製程流程、治療領域、最終用途和地區），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

出版日期: 2025年09月01日 | 出版商:

IMARC | 英文 138 Pages | 商品交期: 2-3個工作天內

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簡介目錄圖表

2024年，全球藥物警戒市場規模達85億美元。展望未來， IMARC Group預測，到2033年，該市場規模將達到163億美元，2025年至2033年的複合年成長率為7.5%。目前，北美佔據市場主導地位，佔有33.7%的佔有率。由於藥品複雜性不斷提高、全球監管趨嚴、人工智慧和巨量資料應用日益普及、多重用藥和藥物濫用導致的不良反應增多，以及製藥公司加大臨床和上市後安全管理外包力度，該市場正在不斷擴張。

藥物警戒市場的發展受到藥品不良反應 (ADR) 日益增加、上市後藥品監測需求不斷成長以及全球監管要求日益嚴格的推動。此外，人工智慧 (AI) 和巨量資料分析技術的日益普及，增強了訊號檢測和藥物安全評估，從而提高了效率並促進了市場成長。例如，歐洲藥品管理局 (EMA) 將於 2024 年發佈在藥物警戒中使用人工智慧的工具和指南，表明其願意利用技術改進藥物安全監測。此外，製藥和生物技術行業的成長推動了對藥物開發過程中全面安全監測的需求，進一步促進了市場的擴張。此外，慢性病的激增和新藥的上市也刺激了對強大的藥物警戒系統的需求，為市場提供了動力。此外，將藥物警戒活動外包給專業公司可以在保持合規性的同時降低營運成本，從而促進市場成長。

美國藥物警戒市場受到該國龐大製藥業的強勁推動，該行業開展了大量需要全面安全監測的臨床試驗。同時，生物相似藥和個人化醫療的興起增加了藥物安全評估的複雜性，從而刺激了市場需求。同時，政府推動藥物安全監測的舉措，例如美國食品藥物管理局 (FDA) 的“哨兵計劃”，正在促進市場成長。同時，以患者為中心的方法日益融合，強調了安全性評估的真實世界資料收集，從而增強了藥物警戒的市場佔有率。此外，監管機構和製藥公司之間的合作增強了合規性和監測系統，從而支持了市場成長。此外，遠距醫療和數位健康工具的迅速普及促進了藥品不良反應 (ADR) 的遠距報告和監測，推動了市場向前發展。

藥物警戒市場趨勢：

科技進步改變藥物警戒運作

藥物警戒市場前景凸顯了自動化和智慧驅動的工作流程在重塑產業格局中的作用。人工智慧、機器學習 (ML)、自然語言處理 (NLP) 和巨量資料分析等技術正在將傳統的藥物警戒模式轉變為敏捷且數據豐富的生態系統。這些工具透過快速、大規模地處理大量資料集，增強了核心功能，尤其是不良反應 (ADR) 監測、訊號檢測和監管報告。根據最近的市場研究，全球機器學習產業規模在 2024 年將達到 310 億美元，藥物警戒將成為其成長最快的應用之一。高影響力的合作正在樹立新的標竿：賽諾菲和德勤的 ConvergeHEALTH Safety 平台利用人工智慧簡化病例接收，而 ArisGlobal 與美國食品藥品監督管理局 (FDA) FAERS II 系統的整合則增強了電子安全提交。 Saama Technologies 的 ASAP 解決方案借鑒了 FDA 的 Sentinel 通用資料模型和 TreeScan 方法，進一步推進了即時風險檢測。

政府監管與現實世界證據強化市場擴張

從目前藥物警戒市場概況中可以清楚看出，全球監管審查力道正在加強。美國食品藥物管理局 (USFDA)、歐洲藥品管理局 (EMA)、美國藥品註冊服務中心 (CDSCO) 和澳洲藥品管理局 (TGA) 等機構正在提高警惕，並發布了嚴格的安全報告要求，尤其是在新藥和複雜療法產量不斷成長的背景下。美國奧羅賓多製藥公司 (Aurobindo Pharma USA) 因亞硝胺污染物召回喹那普利和氫氯噻嗪片，凸顯了更嚴格的檢測標準變得不可妥協。這些事件促使藥廠加強內部系統，並尋求外部藥物警戒合作夥伴。對上市後監測的日益依賴也凸顯了藥物不良反應 (ADR) 監測的關鍵作用，尤其是在藥物濫用和多重用藥現像日益增加的環境下。如今，監管機構的預期重點是試驗階段和真實世界用藥資料，這些數據可以記錄患者隨時間推移的療效。《藥物安全與監管前沿》的一項研究強調了真實世界證據 (RWE) 在更新臨床環境之外的藥物風險概況方面的價值。

藥物複雜性導致藥廠對藥物警戒服務的需求不斷上升

最新的藥物警戒市場趨勢表明，製藥公司對專業安全監測服務的需求激增。這項轉變背後的核心促進因素之一是新藥生產日益複雜，尤其是在生物製劑、基因療法和個人化醫療領域。隨著疾病負擔的增加（尤其是慢性病和共病），患者經常需要同時服用多種藥物，這增加了藥物交互作用和意外不良反應的可能性。為了應對這種複雜性，藥廠正在將藥物警戒任務外包給專業的服務提供者。這些公司提供可擴展的基礎設施、經驗豐富的分析師以及獲取區域監管情報的管道。 IQVIA 與 NRx Pharmaceuticals 在醫療資訊和藥物警戒方面的策略夥伴關係，體現了外包如何從削減成本發展到提升績效。這一趨勢也反映了藥物警戒市場報告中的另一個關鍵見解：內部資源往往捉襟見肘。外包使組織能夠專注於核心創新，同時確保在全球市場維持端到端的藥物安全監測。

複雜的臨床試驗和多種藥物聯合用藥推動市場發展

臨床試驗的數量和複雜性不斷增加是藥物警戒市場預測的主要成長引擎。根據最近的市場資料，2023 年啟動了超過 22,000 項新試驗，其中許多試驗採用自適應方案、分散式元素和以患者為中心的設計。這些趨勢凸顯了對能夠跨多個地區即時運作的敏捷主動安全系統的需求。此外，心血管疾病、糖尿病和癌症等慢性疾病的增加意味著患者經常接受多種藥物治療，即同時使用多種治療藥物。這增加了顯著的安全風險，使得藥物不良反應 (ADR) 監測比以往任何時候都更重要。技術驅動的合作夥伴關係是這項變革的核心。 Cognizant 與分散臨床試驗 (DCT) 平台的領導者 Medable 的合作，在每個試驗接觸點引入了簡化的安全監測。同樣，Viedoc 和 LINK Medical 的合作夥伴關係旨在支援協作功能測試，並透過整合的藥物警戒工具提高試驗效率。

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.

Pharmacovigilance Market Trends:

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.

Pharmacovigilance Industry Segmentation:

Analysis by Service Provider:

In-house
Contract Outsourcing

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.

Analysis by Product Life Cycle:

Pre-clinical
Phase I
Phase II
Phase III
Phase IV

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.

Analysis by Type:

Spontaneous Reporting
Intensified ADR Reporting
Targeted Spontaneous Reporting
Cohort Event Monitoring
EHR Mining

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.

Analysis by Process Flow:

Case Data Management
- Case Logging
- Case Data Analysis
- Medical Reviewing and Reporting
Signal Detection
- Adverse Event Logging
- Adverse Event Analysis
- Adverse Event Review and Reporting
Risk Management System
- Risk Evaluation System
- Risk Mitigation System

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.

Analysis by Therapeutic Area:

Oncology
Neurology
Cardiology
Respiratory Systems
Others

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.

Analysis by End Use:

Pharmaceuticals Companies
Biotechnology Companies
Medical Device Companies
Others

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.

Analysis by Region:

North America
- United States
- Canada
Asia-Pacific
- China
- Japan
- India
- South Korea
- Australia
- Indonesia
- Others
Europe
- Germany
- France
- United Kingdom
- Italy
- Spain
- Russia
- Others
Latin America
- Brazil
- Mexico
- Others
Middle East and Africa

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.

Key Regional Takeaways:

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.

Competitive Landscape:

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.

The pharmacovigilance market research report provides a comprehensive analysis of the competitive landscape with detailed profiles of all major companies, including:

Accenture plc
ArisGlobal LLC
BioClinica Inc. (Cinven Partners LLP)
Capgemini
Cognizant
International Business Machines Corporation
ICON plc.
IQVIA Inc.
ITClinical
Parexel International Corporation
Wipro Limited

Key Questions Answered in This Report

1.What is pharmacovigilance?
2.How big is the pharmacovigilance market?
3.What is the expected growth rate of the global pharmacovigilance market during 2025-2033?
4.What are the key factors driving the global pharmacovigilance market?
5.What is the leading segment of the global pharmacovigilance market based on service provider?
6.What is the leading segment of the global pharmacovigilance market based on product life cycle?
7.What is the leading segment of the global pharmacovigilance market based on type?
8.What is the leading segment of the global pharmacovigilance market based on process flow?
9.What is the leading segment of the global pharmacovigilance market based on therapeutic area?
10.What is the leading segment of the global pharmacovigilance market based on end use?
11.What are the key regions in the global pharmacovigilance market?
12.Who are the key players/companies in the global pharmacovigilance market?

1 Preface

2 Scope and Methodology

2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
- 2.3.1 Primary Sources
- 2.3.2 Secondary Sources
2.4 Market Estimation
- 2.4.1 Bottom-Up Approach
- 2.4.2 Top-Down Approach
2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

4.1 Overview
4.2 Key Industry Trends

5 Global Pharmacovigilance Market

5.1 Market Overview
5.2 Market Performance
5.3 Impact of COVID-19
5.4 Market Forecast

6 Market Breakup by Service Provider

6.1 In-house
- 6.1.1 Market Trends
- 6.1.2 Market Forecast
6.2 Contract Outsourcing
- 6.2.1 Market Trends
- 6.2.2 Market Forecast

7 Market Breakup by Product Life Cycle

7.1 Pre-clinical
- 7.1.1 Market Trends
- 7.1.2 Market Forecast
7.2 Phase I
- 7.2.1 Market Trends
- 7.2.2 Market Forecast
7.3 Phase II
- 7.3.1 Market Trends
- 7.3.2 Market Forecast
7.4 Phase III
- 7.4.1 Market Trends
- 7.4.2 Market Forecast
7.5 Phase IV
- 7.5.1 Market Trends
- 7.5.2 Market Forecast

8 Market Breakup by Type

8.1 Spontaneous Reporting
- 8.1.1 Market Trends
- 8.1.2 Market Forecast
8.2 Intensified ADR Reporting
- 8.2.1 Market Trends
- 8.2.2 Market Forecast
8.3 Targeted Spontaneous Reporting
- 8.3.1 Market Trends
- 8.3.2 Market Forecast
8.4 Cohort Event Monitoring
- 8.4.1 Market Trends
- 8.4.2 Market Forecast
8.5 EHR Mining
- 8.5.1 Market Trends
- 8.5.2 Market Forecast

9 Market Breakup by Process Flow

9.1 Case Data Management
- 9.1.1 Market Trends
- 9.1.2 Major Types
  - 9.1.2.1 Case Logging
  - 9.1.2.2 Case Data Analysis
  - 9.1.2.3 Medical Reviewing and Reporting
- 9.1.3 Market Forecast
9.2 Signal Detection
- 9.2.1 Market Trends
- 9.2.2 Major Types
  - 9.2.2.1 Adverse Event Logging
  - 9.2.2.2 Adverse Event Analysis
  - 9.2.2.3 Adverse Event Review and Reporting
- 9.2.3 Market Forecast
9.3 Risk Management System
- 9.3.1 Market Trends
- 9.3.2 Major Types
  - 9.3.2.1 Risk Evaluation System
  - 9.3.2.2 Risk Mitigation System
- 9.3.3 Market Forecast

10 Market Breakup by Therapeutic Area

10.1 Oncology
- 10.1.1 Market Trends
- 10.1.2 Market Forecast
10.2 Neurology
- 10.2.1 Market Trends
- 10.2.2 Market Forecast
10.3 Cardiology
- 10.3.1 Market Trends
- 10.3.2 Market Forecast
10.4 Respiratory Systems
- 10.4.1 Market Trends
- 10.4.2 Market Forecast
10.5 Others
- 10.5.1 Market Trends
- 10.5.2 Market Forecast

11 Market Breakup by End Use

11.1 Pharmaceuticals Companies
- 11.1.1 Market Trends
- 11.1.2 Market Forecast
11.2 Biotechnology Companies
- 11.2.1 Market Trends
- 11.2.2 Market Forecast
11.3 Medical Device Companies
- 11.3.1 Market Trends
- 11.3.2 Market Forecast
11.4 Others
- 11.4.1 Market Trends
- 11.4.2 Market Forecast

12 Market Breakup by Region

12.1 North America
- 12.1.1 United States
  - 12.1.1.1 Market Trends
  - 12.1.1.2 Market Forecast
- 12.1.2 Canada
  - 12.1.2.1 Market Trends
  - 12.1.2.2 Market Forecast
12.2 Asia-Pacific
- 12.2.1 China
  - 12.2.1.1 Market Trends
  - 12.2.1.2 Market Forecast
- 12.2.2 Japan
  - 12.2.2.1 Market Trends
  - 12.2.2.2 Market Forecast
- 12.2.3 India
  - 12.2.3.1 Market Trends
  - 12.2.3.2 Market Forecast
- 12.2.4 South Korea
  - 12.2.4.1 Market Trends
  - 12.2.4.2 Market Forecast
- 12.2.5 Australia
  - 12.2.5.1 Market Trends
  - 12.2.5.2 Market Forecast
- 12.2.6 Indonesia
  - 12.2.6.1 Market Trends
  - 12.2.6.2 Market Forecast
- 12.2.7 Others
  - 12.2.7.1 Market Trends
  - 12.2.7.2 Market Forecast
12.3 Europe
- 12.3.1 Germany
  - 12.3.1.1 Market Trends
  - 12.3.1.2 Market Forecast
- 12.3.2 France
  - 12.3.2.1 Market Trends
  - 12.3.2.2 Market Forecast
- 12.3.3 United Kingdom
  - 12.3.3.1 Market Trends
  - 12.3.3.2 Market Forecast
- 12.3.4 Italy
  - 12.3.4.1 Market Trends
  - 12.3.4.2 Market Forecast
- 12.3.5 Spain
  - 12.3.5.1 Market Trends
  - 12.3.5.2 Market Forecast
- 12.3.6 Russia
  - 12.3.6.1 Market Trends
  - 12.3.6.2 Market Forecast
- 12.3.7 Others
  - 12.3.7.1 Market Trends
  - 12.3.7.2 Market Forecast
12.4 Latin America
- 12.4.1 Brazil
  - 12.4.1.1 Market Trends
  - 12.4.1.2 Market Forecast
- 12.4.2 Mexico
  - 12.4.2.1 Market Trends
  - 12.4.2.2 Market Forecast
- 12.4.3 Others
  - 12.4.3.1 Market Trends
  - 12.4.3.2 Market Forecast
12.5 Middle East and Africa
- 12.5.1 Market Trends
- 12.5.2 Market Breakup by Country
- 12.5.3 Market Forecast

13 SWOT Analysis

13.1 Overview
13.2 Strengths
13.3 Weaknesses
13.4 Opportunities
13.5 Threats

14 Value Chain Analysis

15 Porters Five Forces Analysis

15.1 Overview
15.2 Bargaining Power of Buyers
15.3 Bargaining Power of Suppliers
15.4 Degree of Competition
15.5 Threat of New Entrants
15.6 Threat of Substitutes

16 Price Analysis

17 Competitive Landscape

17.1 Market Structure
17.2 Key Players
17.3 Profiles of Key Players
- 17.3.1 Accenture plc
  - 17.3.1.1 Company Overview
  - 17.3.1.2 Product Portfolio
  - 17.3.1.3 Financials
  - 17.3.1.4 SWOT Analysis
- 17.3.2 ArisGlobal LLC
  - 17.3.2.1 Company Overview
  - 17.3.2.2 Product Portfolio
- 17.3.3 BioClinica Inc. (Cinven Partners LLP)
  - 17.3.3.1 Company Overview
  - 17.3.3.2 Product Portfolio
  - 17.3.3.3 SWOT Analysis
- 17.3.4 Capgemini
  - 17.3.4.1 Company Overview
  - 17.3.4.2 Product Portfolio
- 17.3.5 Cognizant
  - 17.3.5.1 Company Overview
  - 17.3.5.2 Product Portfolio
  - 17.3.5.3 Financials
  - 17.3.5.4 SWOT Analysis
- 17.3.6 International Business Machines Corporation
  - 17.3.6.1 Company Overview
  - 17.3.6.2 Product Portfolio
  - 17.3.6.3 Financials
  - 17.3.6.4 SWOT Analysis
- 17.3.7 ICON plc.
  - 17.3.7.1 Company Overview
  - 17.3.7.2 Product Portfolio
  - 17.3.7.3 Financials
  - 17.3.7.4 SWOT Analysis
- 17.3.8 IQVIA Inc.
  - 17.3.8.1 Company Overview
  - 17.3.8.2 Product Portfolio
  - 17.3.8.3 Financials
  - 17.3.8.4 SWOT Analysis
- 17.3.9 ITClinical
  - 17.3.9.1 Company Overview
  - 17.3.9.2 Product Portfolio
- 17.3.10 Parexel International Corporation
  - 17.3.10.1 Company Overview
  - 17.3.10.2 Product Portfolio
  - 17.3.10.3 SWOT Analysis
- 17.3.11 Wipro Limited
  - 17.3.11.1 Company Overview
  - 17.3.11.2 Product Portfolio
  - 17.3.11.3 Financials
  - 17.3.11.4 SWOT Analysis

簡介目錄圖表

List of Figures

Figure 1: Global: Pharmacovigilance Market: Major Drivers and Challenges
Figure 2: Global: Pharmacovigilance Market: Sales Value (in Billion USD), 2019-2024
Figure 3: Global: Pharmacovigilance Market Forecast: Sales Value (in Billion USD), 2025-2033
Figure 4: Global: Pharmacovigilance Market: Breakup by Service Provider (in %), 2024
Figure 5: Global: Pharmacovigilance Market: Breakup by Product Life Cycle (in %), 2024
Figure 6: Global: Pharmacovigilance Market: Breakup by Type (in %), 2024
Figure 7: Global: Pharmacovigilance Market: Breakup by Process Flow (in %), 2024
Figure 8: Global: Pharmacovigilance Market: Breakup by Therapeutic Area (in %), 2024
Figure 9: Global: Pharmacovigilance Market: Breakup by End Use (in %), 2024
Figure 10: Global: Pharmacovigilance Market: Breakup by Region (in %), 2024
Figure 11: Global: Pharmacovigilance (In-house) Market: Sales Value (in Million USD), 2019 & 2024
Figure 12: Global: Pharmacovigilance (In-house) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 13: Global: Pharmacovigilance (Contract Outsourcing) Market: Sales Value (in Million USD), 2019 & 2024
Figure 14: Global: Pharmacovigilance (Contract Outsourcing) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 15: Global: Pharmacovigilance (Pre-clinical) Market: Sales Value (in Million USD), 2019 & 2024
Figure 16: Global: Pharmacovigilance (Pre-clinical) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 17: Global: Pharmacovigilance (Phase I) Market: Sales Value (in Million USD), 2019 & 2024
Figure 18: Global: Pharmacovigilance (Phase I) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 19: Global: Pharmacovigilance (Phase II) Market: Sales Value (in Million USD), 2019 & 2024
Figure 20: Global: Pharmacovigilance (Phase II) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 21: Global: Pharmacovigilance (Phase III) Market: Sales Value (in Million USD), 2019 & 2024
Figure 22: Global: Pharmacovigilance (Phase III) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 23: Global: Pharmacovigilance (Phase IV) Market: Sales Value (in Million USD), 2019 & 2024
Figure 24: Global: Pharmacovigilance (Phase IV) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 25: Global: Pharmacovigilance (Spontaneous Reporting) Market: Sales Value (in Million USD), 2019 & 2024
Figure 26: Global: Pharmacovigilance (Spontaneous Reporting) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 27: Global: Pharmacovigilance (Intensified ADR Reporting) Market: Sales Value (in Million USD), 2019 & 2024
Figure 28: Global: Pharmacovigilance (Intensified ADR Reporting) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 29: Global: Pharmacovigilance (Targeted Spontaneous Reporting) Market: Sales Value (in Million USD), 2019 & 2024
Figure 30: Global: Pharmacovigilance (Targeted Spontaneous Reporting) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 31: Global: Pharmacovigilance (Cohort Event Monitoring) Market: Sales Value (in Million USD), 2019 & 2024
Figure 32: Global: Pharmacovigilance (Cohort Event Monitoring) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 33: Global: Pharmacovigilance (EHR Mining) Market: Sales Value (in Million USD), 2019 & 2024
Figure 34: Global: Pharmacovigilance (EHR Mining) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 35: Global: Pharmacovigilance (Case Data Management) Market: Sales Value (in Million USD), 2019 & 2024
Figure 36: Global: Pharmacovigilance (Case Data Management) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 37: Global: Pharmacovigilance (Signal Detection) Market: Sales Value (in Million USD), 2019 & 2024
Figure 38: Global: Pharmacovigilance (Signal Detection) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 39: Global: Pharmacovigilance (Risk Management System) Market: Sales Value (in Million USD), 2019 & 2024
Figure 40: Global: Pharmacovigilance (Risk Management System) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 41: Global: Pharmacovigilance (Oncology) Market: Sales Value (in Million USD), 2019 & 2024
Figure 42: Global: Pharmacovigilance (Oncology) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 43: Global: Pharmacovigilance (Neurology) Market: Sales Value (in Million USD), 2019 & 2024
Figure 44: Global: Pharmacovigilance (Neurology) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 45: Global: Pharmacovigilance (Cardiology) Market: Sales Value (in Million USD), 2019 & 2024
Figure 46: Global: Pharmacovigilance (Cardiology) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 47: Global: Pharmacovigilance (Respiratory Systems) Market: Sales Value (in Million USD), 2019 & 2024
Figure 48: Global: Pharmacovigilance (Respiratory Systems) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 49: Global: Pharmacovigilance (Other Therapeutic Areas) Market: Sales Value (in Million USD), 2019 & 2024
Figure 50: Global: Pharmacovigilance (Other Therapeutic Areas) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 51: Global: Pharmacovigilance (Pharmaceuticals Companies) Market: Sales Value (in Million USD), 2019 & 2024
Figure 52: Global: Pharmacovigilance (Pharmaceuticals Companies) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 53: Global: Pharmacovigilance (Biotechnology Companies) Market: Sales Value (in Million USD), 2019 & 2024
Figure 54: Global: Pharmacovigilance (Biotechnology Companies) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 55: Global: Pharmacovigilance (Medical Device Companies) Market: Sales Value (in Million USD), 2019 & 2024
Figure 56: Global: Pharmacovigilance (Medical Device Companies) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 57: Global: Pharmacovigilance (Other End Uses) Market: Sales Value (in Million USD), 2019 & 2024
Figure 58: Global: Pharmacovigilance (Other End Uses) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 59: North America: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 60: North America: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 61: United States: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 62: United States: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 63: Canada: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 64: Canada: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 65: Asia-Pacific: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 66: Asia-Pacific: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 67: China: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 68: China: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 69: Japan: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 70: Japan: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 71: India: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 72: India: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 73: South Korea: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 74: South Korea: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 75: Australia: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 76: Australia: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 77: Indonesia: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 78: Indonesia: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 79: Others: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 80: Others: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 81: Europe: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 82: Europe: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 83: Germany: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 84: Germany: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 85: France: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 86: France: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 87: United Kingdom: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 88: United Kingdom: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 89: Italy: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 90: Italy: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 91: Spain: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 92: Spain: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 93: Russia: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 94: Russia: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 95: Others: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 96: Others: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 97: Latin America: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 98: Latin America: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 99: Brazil: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 100: Brazil: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 101: Mexico: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 102: Mexico: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 103: Others: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 104: Others: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 105: Middle East and Africa: Pharmacovigilance Market: Sales Value (in Million USD), 2019 & 2024
Figure 106: Middle East and Africa: Pharmacovigilance Market: Breakup by Country (in %), 2024
Figure 107: Middle East and Africa: Pharmacovigilance Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 108: Global: Pharmacovigilance Industry: SWOT Analysis
Figure 109: Global: Pharmacovigilance Industry: Value Chain Analysis
Figure 110: Global: Pharmacovigilance Industry: Porter's Five Forces Analysis

List of Tables

Table 1: Global: Pharmacovigilance Market: Key Industry Highlights, 2024 and 2033
Table 2: Global: Pharmacovigilance Market Forecast: Breakup by Service Provider (in Million USD), 2025-2033
Table 3: Global: Pharmacovigilance Market Forecast: Breakup by Product Life Cycle (in Million USD), 2025-2033
Table 4: Global: Pharmacovigilance Market Forecast: Breakup by Type (in Million USD), 2025-2033
Table 5: Global: Pharmacovigilance Market Forecast: Breakup by Process Flow (in Million USD), 2025-2033
Table 6: Global: Pharmacovigilance Market Forecast: Breakup by Therapeutic Area (in Million USD), 2025-2033
Table 7: Global: Pharmacovigilance Market Forecast: Breakup by End Use (in Million USD), 2025-2033
Table 8: Global: Pharmacovigilance Market Forecast: Breakup by Region (in Million USD), 2025-2033
Table 9: Global: Pharmacovigilance Market: Competitive Structure
Table 10: Global: Pharmacovigilance Market: Key Players

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