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醫藥品法規環境

藥物警戒市場規模、佔有率和成長分析（按生命週期、類型、部署類型、最終用戶和地區分類）－2026-2033年產業預測

市場調查報告書

商品編碼

1899665

藥物警戒市場規模、佔有率和成長分析（按生命週期、類型、部署類型、最終用戶和地區分類）－2026-2033年產業預測

PharmaCovigilance Market Size, Share, and Growth Analysis, By Life Cycle (Pre-clinical, Phase I), By Type (Spontaneous Reporting, Intensified ADR Reporting), By Deployment, By End User, By Region - Industry Forecast 2026-2033

出版日期: 2025年12月24日 | 出版商:

SkyQuest | 英文 219 Pages | 商品交期: 3-5個工作天內

價格

簡介目錄

預計到 2024 年，藥物警戒市場規模將達到 80.1 億美元，到 2025 年將達到 85.5 億美元，到 2033 年將達到 144.8 億美元，在預測期（2026-2033 年）內，複合年成長率為 6.8%。

全球藥物警戒市場正經歷顯著成長，這主要得益於對病人安全的日益重視、監管環境的變化以及製藥業的擴張。這一成長主要源於對藥物安全監測需求的不斷成長，尤其是在藥物研發日益複雜且創新治療方法層出不窮的情況下。日益嚴格的全球監管迫使製藥公司實施嚴格的藥物警戒措施以符合相關要求，從而進一步推動了市場擴張。此外，慢性病發生率的上升和藥物使用量的增加也凸顯了藥物警戒在減少不利事件的重要性。建立有效的藥物警戒監測和管理系統對於保護病患健康、降低醫療成本和最大限度減少法律風險至關重要，這凸顯了其在促進改善醫療效果方面的重要作用。

藥物警戒市場促進因素

藥物警戒市場的發展主要受全球藥物不良反應（ADR）發生率不斷上升的驅動。隨著藥物使用範圍的擴大，意外不利事件的發生機率也隨之增加。藥物警戒，包括對藥物不良反應的監測和報告，對於早期發現、風險評估以及採取有效措施保障病人安全至關重要。對綜合藥物警戒服務和解決方案日益成長的需求，與有效控制藥物不良反應的迫切需求直接相關。這一趨勢是推動藥物警戒市場擴張的主要因素。

藥物警戒市場限制因素

全球藥物警戒市場面臨的主要挑戰之一是發展中地區意識不足和基礎設施落後。這些地區對藥物警戒重要性的認知不足，導致難以建立全面的監測系統。此外，法規結構不完善和資源有限也阻礙了藥物警戒實務的有效實施。基礎設施匱乏、訓練有素的專業人員短缺以及資料管理系統效率低下，進一步阻礙了這些地區的市場成長。因此，這些因素構成了阻礙藥物警戒舉措進展和最佳化的障礙，而這些措施對於確保藥品的安全性和有效性至關重要。

藥物警戒市場趨勢

受藥品消費量和研發量成長的推動，藥物警戒市場正經歷強勁成長。儘管這帶來了許多益處，但也引發了人們對藥物不良反應和病人安全的擔憂。針對藥品中有害雜質事件（尤其是大規模召回）的監管力度加大，推動了對全面監測和通報系統的需求。藥廠日益認知到藥物警戒服務對於遵守監管要求和維護藥品安全標準的重要性。產業領導者為加強藥物警戒能力所做的共同努力，凸顯了將病患安全和合規性置於優先地位的策略轉變，從而推動了市場擴張。

北美洲
- 美國
- 加拿大
歐洲
- 德國
- 西班牙
- 法國
- 英國
- 義大利
- 其他歐洲地區
亞太地區
- 中國
- 印度
- 日本
- 韓國
- 亞太其他地區
拉丁美洲
- 巴西
- 其他拉丁美洲地區
中東和非洲
- 海灣合作理事會國家
- 南非
- 其他中東和非洲地區

競爭資訊

前五大公司對比
主要企業的市場定位（2025 年）
主要市場參與者所採取的策略
近期市場趨勢
公司市佔率分析（2025 年）
主要企業公司簡介
- 公司詳情
- 產品系列分析
- 依業務板塊進行公司股票分析
- 2023-2025年營收年比比較

主要企業簡介

Accenture（Ireland）
IQVIA Inc.（United States）
Cognizant（United States）
IBM Corporation（United States）
Capgemini（France）
ITClinical（Portugal）
ICON plc（Ireland）
TAKE Solutions Limited（India）
Parexel International Corporation（United States）
Wipro（India）
United BioSource LLC（United States）
BioClinica Inc.（Clario）（United States）
ClinChoice（formerly FMD K&L）（United States）
Linical Americas（United States）
Science 37 Holdings, Inc.（United States）
LEO Pharma（Denmark）
argenx（Belgium）
Purisys（United States）

結論與建議

簡介目錄

Product Code: SQMIG35J2052

PharmaCovigilance Market size was valued at USD 8.01 Billion in 2024 and is poised to grow from USD 8.55 Billion in 2025 to USD 14.48 Billion by 2033, growing at a CAGR of 6.8% during the forecast period (2026-2033).

The global pharmacovigilance market is witnessing substantial growth, propelled by heightened emphasis on patient safety, evolving regulatory landscapes, and the expansion of the pharmaceutical sector. A prime catalyst for this growth is the increasing necessity for drug safety monitoring, particularly as drug development becomes more intricate and innovative therapies emerge. Tightened regulations globally are compelling pharmaceutical companies to adopt stringent pharmacovigilance practices to comply with requirements, further fueling market expansion. Additionally, the rising burden of chronic diseases and augmented medication use underscore the critical role of pharmacovigilance in mitigating adverse drug reactions. Effective systems to monitor and manage these events are vital for safeguarding patient health, reducing healthcare expenditures, and minimizing legal risks, thereby underscoring their significance in fostering improved healthcare outcomes.

Top-down and bottom-up approaches were used to estimate and validate the size of the PharmaCovigilance market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

PharmaCovigilance Market Segments Analysis

Global PharmaCovigilance Market is segmented by Life Cycle, Type, Deployment, End User and region. Based on Life Cycle, the market is segmented into Pre-clinical, Phase I, Phase II, Phase III and Phase IV. Based on Type, the market is segmented into Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring and EHR Mining. Based on Deployment, the market is segmented into In-house and Contract Outsourcing. Based on End User, the market is segmented into Contract Research Organizations (CROs), Pharmaceutical & Biotechnology Companies and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the PharmaCovigilance Market

The pharmacovigilance market is propelled by the rising occurrence of adverse drug reactions (ADRs) worldwide. As the use of pharmaceutical products grows, the likelihood of experiencing unforeseen adverse events also rises. The role of pharmacovigilance is essential as it encompasses the monitoring and reporting of ADRs, which allows for early detection, risk assessment, and effective measures to ensure patient safety. The increasing need for comprehensive pharmacovigilance services and solutions is directly linked to the urgent requirement to manage the prevalence of ADRs effectively. This dynamic is a key factor influencing the expansion of the pharmacovigilance market.

Restraints in the PharmaCovigilance Market

A significant challenge facing the pharmacovigilance market globally is the insufficient awareness and infrastructure in developing regions. These areas struggle to establish comprehensive pharmacovigilance systems due to a lack of understanding regarding the importance of such measures. Additionally, inadequate regulatory frameworks and limited resources hinder the effective implementation of pharmacovigilance practices. The absence of essential infrastructure, a shortage of trained professionals, and ineffective data management systems further obstruct the market's growth in these regions. Consequently, these factors create barriers that prevent the advancement and optimization of pharmacovigilance initiatives essential for ensuring drug safety and efficacy.

Market Trends of the PharmaCovigilance Market

The PharmaCovigilance market is experiencing robust growth driven by an increase in drug consumption and development, which, while beneficial, raises concerns about adverse drug reactions and patient safety. The heightened scrutiny from regulatory bodies in response to incidents of harmful impurities in medications, exemplified by high-profile recalls, has intensified the demand for comprehensive monitoring and reporting systems. Pharmaceutical companies are increasingly recognizing the critical importance of pharmacovigilance services to navigate regulatory landscapes and uphold drug safety standards. Collaborative efforts among industry leaders to enhance pharmacovigilance capabilities underscore a strategic shift towards prioritizing patient safety and compliance, propelling the market's expansion.

Introduction

Objectives of the Study
Scope of the Report
Definitions

Research Methodology

Information Procurement
Secondary & Primary Data Methods
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Global Market Outlook
Supply & Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Overview
Market Size
Market Dynamics
- Drivers & Opportunities
- Restraints & Challenges
Porters Analysis
- Competitive rivalry
- Threat of substitute
- Bargaining power of buyers
- Threat of new entrants
- Bargaining power of suppliers

Key Market Insights

Key Success Factors
Degree of Competition
Top Investment Pockets
Market Ecosystem
Market Attractiveness Index, 2025
PESTEL Analysis
Macro-Economic Indicators
Value Chain Analysis
Pricing Analysis
Regulatory Landscape
Case Studies
Technological Advancement
Trade Analysis

Global PharmaCovigilances Market Size by Life Cycle & CAGR (2026-2033)

Market Overview
Pre-clinical
Phase I
Phase II
Phase III
Phase IV

Global PharmaCovigilances Market Size by Type & CAGR (2026-2033)

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

Global PharmaCovigilances Market Size by Deployment & CAGR (2026-2033)

Market Overview
In-house
Contract Outsourcing

Global PharmaCovigilances Market Size by End User & CAGR (2026-2033)

Market Overview
Contract Research Organizations (CROs)
Pharmaceutical & Biotechnology Companies
Others

Global PharmaCovigilances Market Size & CAGR (2026-2033)

North America (Life Cycle, Type, Deployment, End User)
- US
- Canada
Europe (Life Cycle, Type, Deployment, End User)
- Germany
- Spain
- France
- UK
- Italy
- Rest of Europe
Asia Pacific (Life Cycle, Type, Deployment, End User)
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Latin America (Life Cycle, Type, Deployment, End User)
- Brazil
- Rest of Latin America
Middle East & Africa (Life Cycle, Type, Deployment, End User)
- GCC Countries
- South Africa
- Rest of Middle East & Africa

Competitive Intelligence

Top 5 Player Comparison
Market Positioning of Key Players, 2025
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2025
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2023-2025)

Key Company Profiles

Accenture (Ireland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
IQVIA Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Cognizant (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
IBM Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Capgemini (France)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
ITClinical (Portugal)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
ICON plc (Ireland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
TAKE Solutions Limited (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Parexel International Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Wipro (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
United BioSource LLC (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
BioClinica Inc. (Clario) (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
ClinChoice (formerly FMD K&L) (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Linical Americas (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Science 37 Holdings, Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
LEO Pharma (Denmark)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
argenx (Belgium)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Purisys (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments