日本药物警戒市场报告（按服务提供者、产品生命週期、类型、流程、治疗领域、最终用途和地区划分）2025 年至 2033 年

2024年，日本药物警戒市场规模达5.027亿美元。展望未来， IMARC Group预计到2033年，该市场规模将达到9.761亿美元，2025-2033年期间的复合年增长率（CAGR）为7.70%。巨量资料分析、人工智慧和机器学习工具的需求日益增长，这些工具透过实现更有效率的讯号检测和风险评估，彻底改变了药物警戒，推动着市场的发展。

药物警戒是医疗保健和药物监管的一个重要面向。它涉及对药物（包括处方药、疫苗和非处方药）相关不良反应和安全问题的系统性监测、评估和报告。药物警戒的主要目标是确保这些产品在整个生命週期内的安全性和有效性。医疗保健专业人员、製药公司和监管机构在过程中通力合作。他们收集并分析患者和医疗保健提供者报告的不良事件和副作用资料。如果出现潜在的安全问题，可能会采取适当的措施，例如更新产品标籤、发出警告，甚至召回产品，以保护公众健康。药物警戒有助于识别先前未知或罕见的不良反应，确保市场上的药物对病人安全。这种持续的监测和风险评估有助于持续提高药物安全性和医疗保健的整体品质。

日本药物警戒市场趋势：

日本的药物警戒市场正经历强劲成长，这主要得益于几个相互关联的驱动因素。首先，该地区对医疗服务的需求不断增长，导致药品消费增加，加剧了对药品安全进行警惕监测的需求。此外，慢性病盛行率的上升以及新的复杂疗法的引入进一步推动了药物警戒市场的扩张。此外，日本的监管机构正在加强对药品安全的监管，并对製药公司施加了严格的报告要求。这使得药物警戒活动必须外包给专业服务提供者，从而推动了市场成长。同时，医疗专业人员和病患对不良事件通报重要性的认知不断提高，也促使药物警戒工作力道加大。此外，人工智慧和巨量资料分析等技术的进步透过提高不良事件检测的效率和准确性，彻底改变了药物警戒，预计将在预测期内推动日本市场的发展。

日本药物警戒市场细分：

服务提供者洞察：

• 内部
• 合约外包

产品生命週期洞察：

• 临床前
• 第一阶段
• 第二阶段
• 第三阶段
• 第四阶段

类型洞察：

• 自发性报告
• 强化ADR报告
• 针对性的自发性报告
• 群组事件监控
• EHR挖掘

流程洞察：

• 病例资料管理
  • 案例记录
  • 案例数据分析
  • 医疗审查和报告
• 讯号检测
  • 不良事件记录
  • 不良事件分析
  • 不良事件审查和报告
• 风险管理系统
  • 风险评估系统
  • 风险缓解系统

治疗领域洞察：

• 肿瘤学
• 神经病学
• 心臟病学
• 呼吸系统
• 其他的

最终用途洞察：

• 製药公司
• 生技公司
• 医疗器材公司
• 其他的

竞争格局：

市场研究报告也对竞争格局进行了全面的分析。报告涵盖了市场结构、关键参与者定位、最佳制胜策略、竞争仪錶板和公司评估象限等竞争分析。此外，报告还提供了所有主要公司的详细资料。

本报告回答的关键问题：

• 日本药物警戒市场迄今表现如何？未来几年将如何表现？
• COVID-19 对日本药物警戒市场有何影响？
• 根据服务提供者，日本药物警戒市场是如何分類的？
• 根据产品生命週期，日本药物警戒市场是如何分類的？
• 日本药物警戒市场依类型分为哪些类型？
• 日本药物警戒市场依流程如何划分？
• 日本药物警戒市场如何依治疗领域划分？
• 日本药物警戒市场如何根据最终用途划分？
• 日本药物警戒市场的价值链分为哪些阶段？
• 日本药物警戒的主要驱动因素和挑战是什么？
• 日本药物警戒市场的结构是怎么样的？主要参与者是谁？
• 日本药物警戒市场的竞争程度如何？

本报告回答的关键问题：

• 日本药物警戒市场迄今表现如何？未来几年将如何表现？
• COVID-19 对日本药物警戒市场有何影响？
• 根据服务提供者，日本药物警戒市场是如何分類的？
• 根据产品生命週期，日本药物警戒市场是如何分類的？
• 日本药物警戒市场依类型分为哪些类型？
• 日本药物警戒市场依流程如何划分？
• 日本药物警戒市场如何依治疗领域划分？
• 日本药物警戒市场如何根据最终用途划分？
• 日本药物警戒市场的价值链分为哪些阶段？
• 日本药物警戒的主要驱动因素和挑战是什么？
• 日本药物警戒市场的结构是怎么样的？主要参与者是谁？
• 日本药物警戒市场的竞争程度如何？

目录

第一章：前言

第二章：范围与方法

• 研究目标
• 利害关係人
• 资料来源
  • 主要来源
  • 次要来源
• 市场评估
  • 自下而上的方法
  • 自上而下的方法
• 预测方法

第三章：执行摘要

第四章：日本药物警戒市场－简介

• 概述
• 市场动态
• 产业趋势
• 竞争情报

第五章：日本药物警戒市场格局

• 历史与当前市场趋势（2019-2024）
• 市场预测（2025-2033）

第六章：日本药物警戒市场-细分：依服务提供者

• 内部
  • 概述
• 合约外包
  • 概述

第七章：日本药物警戒市场-细分：依产品生命週期

• 临床前
  • 概述
• 第一阶段
  • 概述
• 第二阶段
  • 概述
• 第三阶段
  • 概述
• 第四阶段
  • 概述

第 8 章：日本药物警戒市场 - 细分：按类型

• 自发性报告
  • 概述
• 强化ADR报告
  • 概述
• 针对性的自发性报告
  • 概述
• 群组事件监控
  • 概述
• EHR挖掘
  • 概述

第九章：日本药物警戒市场-细分：依流程

• 病例资料管理
  • 概述
  • 市场区隔
    • 案例记录
    • 案例数据分析
    • 医疗审查和报告
• 讯号检测
  • 概述
  • 市场区隔
    • 不良事件记录
    • 不良事件分析
    • 不良事件审查和报告
• 风险管理系统
  • 概述
  • 市场区隔
    • 风险评估系统
    • 风险缓解系统

第十章：日本药物警戒市场 - 细分：依治疗领域

• 肿瘤学
  • 概述
• 神经病学
  • 概述
• 心臟病学
  • 概述
• 呼吸系统
  • 概述
• 其他的

第 11 章：日本药物警戒市场 - 分裂：最终用途别

• 製药公司
  • 概述
• 生技公司
  • 概述
• 医疗器材公司
  • 概述
• 其他的

第 12 章：日本药物警戒市场 - 竞争格局

• 概述
• 市场结构
• 市场参与者定位
• 最佳获胜策略
• 竞争仪錶板
• 公司评估象限

第十三章：关键参与者简介

• Company A
• Business Overview
• Services Offered
• Business Strategies
• SWOT Analysis
• Major News and Events
• Company B
• Business Overview
• Services Offered
• Business Strategies
• SWOT Analysis
• Major News and Events
• Company C
• Business Overview
• Services Offered
• Business Strategies
• SWOT Analysis
• Major News and Events
• Company D
• Business Overview
• Services Offered
• Business Strategies
• SWOT Analysis
• Major News and Events
• Company E
• Business Overview
• Services Offered
• Business Strategies
• SWOT Analysis
• Major News and Events

第 14 章：日本药物警戒市场 - 产业分析

• 驱动因素、限制因素和机会
  • 概述
  • 驱动程式
  • 限制
  • 机会
• 波特五力分析
  • 概述
  • 买家的议价能力
  • 供应商的议价能力
  • 竞争程度
  • 新进入者的威胁
  • 替代品的威胁
• 价值链分析

第 15 章：附录

Japan pharmacovigilance market size reached USD 502.7 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 976.1 Million by 2033, exhibiting a growth rate (CAGR) of 7.70% during 2025-2033. The increasing demand for big data analytics, artificial intelligence, and machine learning tools, which has revolutionized pharmacovigilance by enabling more efficient signal detection and risk assessment, is driving the market.

Pharmacovigilance is a crucial aspect of healthcare and drug regulation. It involves the systematic monitoring, assessment, and reporting of adverse effects and safety concerns associated with pharmaceutical products, including prescription medications, vaccines, and over-the-counter drugs. The primary goal of pharmacovigilance is to ensure the safety and effectiveness of these products throughout their lifecycle. Healthcare professionals, pharmaceutical companies, and regulatory agencies collaborate in this process. They collect and analyze data on adverse events and side effects reported by patients and healthcare providers. If a potential safety concern arises, appropriate actions, such as product labeling updates, warnings, or even product recalls, may be taken to protect public health. Pharmacovigilance helps identify previously unknown or rare adverse effects, ensuring that drugs on the market remain safe for patients. This ongoing monitoring and risk assessment contribute to the continuous improvement of drug safety and the overall quality of healthcare.

Japan Pharmacovigilance Market Trends:

The pharmacovigilance market in Japan is experiencing robust growth, primarily due to several interconnected drivers. Firstly, the escalating regional demand for healthcare services has led to an increased consumption of medicines, amplifying the need for vigilant monitoring of drug safety. Additionally, the rising prevalence of chronic diseases and the introduction of new and complex therapies have further fueled the expansion of the pharmacovigilance market. Moreover, regulatory agencies in Japan are tightening their oversight of drug safety, imposing stringent reporting requirements on pharmaceutical companies. This has necessitated the outsourcing of pharmacovigilance activities to specialized service providers, driving market growth. Simultaneously, the growing awareness among healthcare professionals and patients about the importance of adverse event reporting has led to increased pharmacovigilance efforts. Moreover, advancements in technology, including artificial intelligence and big data analytics, which have revolutionized pharmacovigilance by enhancing the efficiency and accuracy of adverse event detection, are expected to drive the market in Japan during the forecast period.

Japan Pharmacovigilance Market Segmentation:

Service Provider Insights:

• In-house
• Contract Outsourcing

Product Life Cycle Insights:

• Pre-clinical
• Phase I
• Phase II
• Phase III
• Phase IV

Type Insights:

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

Process Flow Insights:

• 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

Therapeutic Area Insights:

• Oncology
• Neurology
• Cardiology
• Respiratory Systems
• Others

End Use Insights:

• Pharmaceuticals Companies
• Biotechnology Companies
• Medical Device Companies
• Others

Competitive Landscape:

The market research report has also provided a comprehensive analysis of the competitive landscape. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided.

Key Questions Answered in This Report:

• How has the Japan pharmacovigilance market performed so far and how will it perform in the coming years?
• What has been the impact of COVID-19 on the Japan pharmacovigilance market?
• What is the breakup of the Japan pharmacovigilance market on the basis of service provider?
• What is the breakup of the Japan pharmacovigilance market on the basis of product life cycle?
• What is the breakup of the Japan pharmacovigilance market on the basis of type?
• What is the breakup of the Japan pharmacovigilance market on the basis of process flow?
• What is the breakup of the Japan pharmacovigilance market on the basis of therapeutic area?
• What is the breakup of the Japan pharmacovigilance market on the basis of end use?
• What are the various stages in the value chain of the Japan pharmacovigilance market?
• What are the key driving factors and challenges in the Japan pharmacovigilance?
• What is the structure of the Japan pharmacovigilance market and who are the key players?
• What is the degree of competition in the Japan pharmacovigilance market?

Table of Contents

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 Japan Pharmacovigilance Market - Introduction

• 4.1 Overview
• 4.2 Market Dynamics
• 4.3 Industry Trends
• 4.4 Competitive Intelligence

5 Japan Pharmacovigilance Market Landscape

• 5.1 Historical and Current Market Trends (2019-2024)
• 5.2 Market Forecast (2025-2033)

6 Japan Pharmacovigilance Market - Breakup by Service Provider

• 6.1 In-house
  • 6.1.1 Overview
  • 6.1.2 Historical and Current Market Trends (2019-2024)
  • 6.1.3 Market Forecast (2025-2033)
• 6.2 Contract Outsourcing
  • 6.2.1 Overview
  • 6.2.2 Historical and Current Market Trends (2019-2024)
  • 6.2.3 Market Forecast (2025-2033)

7 Japan Pharmacovigilance Market - Breakup by Product Life Cycle

• 7.1 Pre-clinical
  • 7.1.1 Overview
  • 7.1.2 Historical and Current Market Trends (2019-2024)
  • 7.1.3 Market Forecast (2025-2033)
• 7.2 Phase I
  • 7.2.1 Overview
  • 7.2.2 Historical and Current Market Trends (2019-2024)
  • 7.2.3 Market Forecast (2025-2033)
• 7.3 Phase II
  • 7.3.1 Overview
  • 7.3.2 Historical and Current Market Trends (2019-2024)
  • 7.3.3 Market Forecast (2025-2033)
• 7.4 Phase III
  • 7.4.1 Overview
  • 7.4.2 Historical and Current Market Trends (2019-2024)
  • 7.4.3 Market Forecast (2025-2033)
• 7.5 Phase IV
  • 7.5.1 Overview
  • 7.5.2 Historical and Current Market Trends (2019-2024)
  • 7.5.3 Market Forecast (2025-2033)

8 Japan Pharmacovigilance Market - Breakup by Type

• 8.1 Spontaneous Reporting
  • 8.1.1 Overview
  • 8.1.2 Historical and Current Market Trends (2019-2024)
  • 8.1.3 Market Forecast (2025-2033)
• 8.2 Intensified ADR Reporting
  • 8.2.1 Overview
  • 8.2.2 Historical and Current Market Trends (2019-2024)
  • 8.2.3 Market Forecast (2025-2033)
• 8.3 Targeted Spontaneous Reporting
  • 8.3.1 Overview
  • 8.3.2 Historical and Current Market Trends (2019-2024)
  • 8.3.3 Market Forecast (2025-2033)
• 8.4 Cohort Event Monitoring
  • 8.4.1 Overview
  • 8.4.2 Historical and Current Market Trends (2019-2024)
  • 8.4.3 Market Forecast (2025-2033)
• 8.5 EHR Mining
  • 8.5.1 Overview
  • 8.5.2 Historical and Current Market Trends (2019-2024)
  • 8.5.3 Market Forecast (2025-2033)

9 Japan Pharmacovigilance Market - Breakup by Process Flow

• 9.1 Case Data Management
  • 9.1.1 Overview
  • 9.1.2 Historical and Current Market Trends (2019-2024)
  • 9.1.3 Market Segmentation
    • 9.1.3.1 Case Logging
    • 9.1.3.2 Case Data Analysis
    • 9.1.3.3 Medical Reviewing and Reporting
  • 9.1.4 Market Forecast (2025-2033)
• 9.2 Signal Detection
  • 9.2.1 Overview
  • 9.2.2 Historical and Current Market Trends (2019-2024)
  • 9.2.3 Market Segmentation
    • 9.2.3.1 Adverse Event Logging
    • 9.2.3.2 Adverse Event Analysis
    • 9.2.3.3 Adverse Event Review and Reporting
  • 9.2.4 Market Forecast (2025-2033)
• 9.3 Risk Management System
  • 9.3.1 Overview
  • 9.3.2 Historical and Current Market Trends (2019-2024)
  • 9.3.3 Market Segmentation
    • 9.3.3.1 Risk Evaluation System
    • 9.3.3.2 Risk Mitigation System
  • 9.3.4 Market Forecast (2025-2033)

10 Japan Pharmacovigilance Market - Breakup by Therapeutic Area

• 10.1 Oncology
  • 10.1.1 Overview
  • 10.1.2 Historical and Current Market Trends (2019-2024)
  • 10.1.3 Market Forecast (2025-2033)
• 10.2 Neurology
  • 10.2.1 Overview
  • 10.2.2 Historical and Current Market Trends (2019-2024)
  • 10.2.3 Market Forecast (2025-2033)
• 10.3 Cardiology
  • 10.3.1 Overview
  • 10.3.2 Historical and Current Market Trends (2019-2024)
  • 10.3.3 Market Forecast (2025-2033)
• 10.4 Respiratory Systems
  • 10.4.1 Overview
  • 10.4.2 Historical and Current Market Trends (2019-2024)
  • 10.4.3 Market Forecast (2025-2033)
• 10.5 Others
  • 10.5.1 Historical and Current Market Trends (2019-2024)
  • 10.5.2 Market Forecast (2025-2033)

11 Japan Pharmacovigilance Market - Breakup by End Use

• 11.1 Pharmaceuticals Companies
  • 11.1.1 Overview
  • 11.1.2 Historical and Current Market Trends (2019-2024)
  • 11.1.3 Market Forecast (2025-2033)
• 11.2 Biotechnology Companies
  • 11.2.1 Overview
  • 11.2.2 Historical and Current Market Trends (2019-2024)
  • 11.2.3 Market Forecast (2025-2033)
• 11.3 Medical Device Companies
  • 11.3.1 Overview
  • 11.3.2 Historical and Current Market Trends (2019-2024)
  • 11.3.3 Market Forecast (2025-2033)
• 11.4 Others
  • 11.4.1 Historical and Current Market Trends (2019-2024)
  • 11.4.2 Market Forecast (2025-2033)

12 Japan Pharmacovigilance Market - Competitive Landscape

• 12.1 Overview
• 12.2 Market Structure
• 12.3 Market Player Positioning
• 12.4 Top Winning Strategies
• 12.5 Competitive Dashboard
• 12.6 Company Evaluation Quadrant

13 Profiles of Key Players

• 13.1 Company A
  • 13.1.1 Business Overview
  • 13.1.2 Services Offered
  • 13.1.3 Business Strategies
  • 13.1.4 SWOT Analysis
  • 13.1.5 Major News and Events
• 13.2 Company B
  • 13.2.1 Business Overview
  • 13.2.2 Services Offered
  • 13.2.3 Business Strategies
  • 13.2.4 SWOT Analysis
  • 13.2.5 Major News and Events
• 13.3 Company C
  • 13.3.1 Business Overview
  • 13.3.2 Services Offered
  • 13.3.3 Business Strategies
  • 13.3.4 SWOT Analysis
  • 13.3.5 Major News and Events
• 13.4 Company D
  • 13.4.1 Business Overview
  • 13.4.2 Services Offered
  • 13.4.3 Business Strategies
  • 13.4.4 SWOT Analysis
  • 13.4.5 Major News and Events
• 13.5 Company E
  • 13.5.1 Business Overview
  • 13.5.2 Services Offered
  • 13.5.3 Business Strategies
  • 13.5.4 SWOT Analysis
  • 13.5.5 Major News and Events

14 Japan Pharmacovigilance Market - Industry Analysis

• 14.1 Drivers, Restraints, and Opportunities
  • 14.1.1 Overview
  • 14.1.2 Drivers
  • 14.1.3 Restraints
  • 14.1.4 Opportunities
• 14.2 Porters Five Forces Analysis
  • 14.2.1 Overview
  • 14.2.2 Bargaining Power of Buyers
  • 14.2.3 Bargaining Power of Suppliers
  • 14.2.4 Degree of Competition
  • 14.2.5 Threat of New Entrants
  • 14.2.6 Threat of Substitutes
• 14.3 Value Chain Analysis

15 Appendix