Japan Pharmacovigilance Market Report by Service Provider, Product Life Cycle, Type, Process Flow, Therapeutic Area, End Use, and Region 2025-2033

Description

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?

Product Code: SR112025A19290

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