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医药品法规环境

药物警戒市场规模、份额和成长分析（按生命週期、类型、部署类型、最终用户和地区划分）－2026-2033年产业预测

市场调查报告书

商品编码

1899665

药物警戒市场规模、份额和成长分析（按生命週期、类型、部署类型、最终用户和地区划分）－2026-2033年产业预测

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个工作天内

价格

简介目录

预计到 2024 年，药物警戒市场规模将达到 80.1 亿美元，到 2025 年将达到 85.5 亿美元，到 2033 年将达到 144.8 亿美元，在预测期（2026-2033 年）内，复合年增长率为 6.8%。

全球药物警戒市场正经历显着成长，这主要得益于对病人安全的日益重视、监管环境的变化以及製药业的扩张。这一增长主要源于对药物安全监测需求的不断增长，尤其是在药物研发日益复杂且创新治疗方法层出不穷的情况下。日益严格的全球监管迫使製药公司实施严格的药物警戒措施以符合相关要求，从而进一步推动了市场扩张。此外，慢性病发生率的上升和药物使用量的增加也凸显了药物警戒在减少不利事件的重要性。建立有效的药物警戒监测和管理系统对于保护病患健康、降低医疗成本和最大限度减少法律风险至关重要，这凸显了其在促进改善医疗效果方面的重要作用。

药物警戒市场驱动因素

药物警戒市场的发展主要受全球药物不良反应（ADR）发生率不断上升的驱动。随着药物使用范围的扩大，意外不利事件的发生机率也随之增加。药物警戒，包括对药物不良反应的监测和报告，对于早期发现、风险评估以及采取有效措施保障病人安全至关重要。对综合药物警戒服务和解决方案日益增长的需求，与有效控制药物不良反应的迫切需求直接相关。这一趋势是推动药物警戒市场扩张的主要因素。

药物警戒市场限制因素

全球药物警戒市场面临的主要挑战之一是发展中地区意识不足和基础设施落后。这些地区对药物警戒重要性的认识不足，导致难以建立全面的监测系统。此外，法规结构不完善和资源有限也阻碍了药物警戒实务的有效实施。基础设施匮乏、训练有素的专业人员短缺以及资料管理系统效率低下，进一步阻碍了这些地区的市场成长。因此，这些因素构成了阻碍药物警戒倡议进展和优化的障碍，而这些措施对于确保药品的安全性和有效性至关重要。

药物警戒市场趋势

受药品消费量和研发量成长的推动，药物警戒市场正经历强劲成长。儘管这带来了许多益处，但也引发了人们对药物不良反应和病人安全的担忧。针对药品中有害杂质事件（尤其是大规模召回）的监管力度加大，推动了对全面监测和通报系统的需求。药厂日益认识到药物警戒服务对于遵守监管要求和维护药品安全标准的重要性。产业领导者为加强药物警戒能力所做的共同努力，凸显了将病患安全和合规性置于优先地位的策略转变，从而推动了市场扩张。

北美洲
- 美国
- 加拿大
欧洲
- 德国
- 西班牙
- 法国
- 英国
- 义大利
- 其他欧洲地区
亚太地区
- 中国
- 印度
- 日本
- 韩国
- 亚太其他地区
拉丁美洲
- 巴西
- 其他拉丁美洲地区
中东和非洲
- 海湾合作委员会国家
- 南非
- 其他中东和非洲地区

竞争资讯

前五大公司对比
主要企业的市场定位（2025 年）
主要市场参与者所采取的策略
近期市场趋势
公司市占率分析（2025 年）
主要企业公司简介
- 公司详情
- 产品系列分析
- 依业务板块进行公司股票分析
- 2023-2025年营收年比比较

主要企业简介

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）

结论与建议

简介目录

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