세계의 약물감시 시장 보고서 : 서비스 제공업체별, 제품 수명주기별, 유형별, 공정 흐름별, 치료 영역별, 최종 용도별, 지역별(2024-2032년)

The global pharmacovigilance market size reached US$ 7.9 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 15.9 Billion by 2032, exhibiting a growth rate (CAGR) of 7.8% during 2024-2032. The increasing prevalence of adverse drug reactions (ADRs), coupled with the launch of favorable policies by government bodies to generate awareness about the proper usage of medicines and conduct clinical trials, is primarily stimulating the pharmacovigilance market growth.

Global Pharmacovigilance Market Analysis:

Major Market Drivers: The elevating incidences of various lifestyle diseases, including cardiac disorders, hypertension, diabetes, etc., are augmenting the usage of drugs across the globe. Consequently, there is an elevating need for pharmacovigilance (PV) to detect previously unknown adverse effects, recognize changes in the frequency or severity, assess the risks and benefits of drugs to determine required actions, etc. This, in turn, is providing significant opportunities in the pharmacovigilance market outlook.

Key Market Trends: One of the key pharmacovigilance market trends includes the development of advanced platforms to ensure automated adverse drug reactions (ADR) reporting. Furthermore, key players are also focusing on enhancing manufacturing operations and streamlining R&D activities, owing to the competitive environment. Besides this, the rising number of clinical trials is expected to fuel the pharmacovigilance market in the forecasted period.

Competitive Landscape: Some of the prominent pharmacovigilance market key players are Accenture plc, ArisGlobal LLC, BioClinica Inc. (Cinven Partners LLP), Capgemini, Cognizant, International Business Machines Corporation, ICON plc., IQVIA Inc., ITClinical, Parexel International Corporation, and Wipro Limited, among many others.

Challenges and Opportunities: According to the pharmacovigilance market analysis, some of the challenges, including stringent regulatory requirements by government bodies, the rising complexities in managing and deriving meaningful insights from a vast amount of data, and the increasing need for balancing comprehensive drug safety monitoring with the pressure to control costs, are hindering the growth of the pharmacovigilance industry across the globe. However, fostering strategic collaborations to ensure the safety of drugs and safeguard public health is expected to propel the pharmacovigilance market share in the coming years.

Global Pharmacovigilance Market Trends:

The Development of Continuous Technological Advancements

The increasing integration of novel technologies, such as machine learning (ML), natural language processing (NLP), artificial intelligence (AI), big data analytics, etc., is enhancing the pharmacovigilance processes. In line with this, these technologies are gaining extensive traction, as they help in identifying adverse events, risk assessments, enabling efficient signal detection, etc., which is expected to fuel the market growth over the forecasted period. For instance, Sanofi and Deloitte collaborated on ConvergeHEALTH Safety, a next-generation artificial intelligence (AI) software-as-a-service adverse events case intake platform that transformed pharmacovigilance (PV) processes and addressed some of the industry's most pressing operational safety issues. In line with this, ArisGlobal introduced the go-live of the USFDA Adverse Event Reporting System (FAERS II), an electronic safety reporting platform powered by LifeSphere MultiVigilance, which propelled the market growth. Furthermore, Saama Technologies Inc. developed the new Active Safety Analytics for Pharma (ASAP) products. ASAP is one of the first validated pharmacovigilance solutions to leverage the TreeScan methodology and the United States Food and Drug Administration's (FDA) Sentinel Common Data Model for detecting safety signals.

Stringent Regulations Implemented by Government Bodies

Government authorities across the globe are implementing strict rules in clinical trials and generating awareness regarding the proper utilization of medicines, which is stimulating the usage of pharmacovigilance services. For example, according to a study published in Frontiers in Drug Safety and Regulation, the significance of post-marketing medication evaluation is important for characterizing drug safety profiles in real-world settings. Such studies are further increasing the importance of pharmacovigilance, thereby stimulating the market growth. Moreover, Aurobindo Pharma USA reformulated Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, owing to the presence of N-Nitroso-Quinapril and Nitrosamine Drug Substance Related Impurity (NDSRI). Consequently, the inflating need for medical information among regulatory authorities is expected to fuel the market growth over the forecasted period.

The Rising Adoption of Pharmacovigilance Services by Pharmaceutical Companies

Pharmacovigilance services are extensively adopted by key pharmaceutical companies across the globe, owing to benefits, such as better outcomes over shorter periods and increasing internal resource flexibility. For example, according to the Vaccine Adverse Event Reporting System, 10 cases of anaphylaxis were detected after the administration of a reported 4,041,396 first doses of the Moderna COVID-19 vaccine (2.5 cases per million doses). Consequently, the growing need for pharmacovigilance services is also stimulating the market growth. In addition to this, key industry players are also entering into strategic collaborations, which will continue to propel the pharmacovigilance market over the forecasted period. For example, IQVIA entered into a strategic collaboration with NRx Pharmaceuticals to offer medical information and pharmacovigilance services in preparation for potential regulatory actions.

The Growing Number of Advanced Clinical Trial Phases

To enhance the efficacy of clinical trials, major prominent players are developing advanced clinical trials, which are stimulating the global market for pharmacovigilance. For example, Cognizant entered into a partnership with Medable Inc. to jointly deliver clinical research solutions based on Medable's software-as-a-service platform for decentralized clinical trials. In line with this, according to the pharmacovigilance market overview, Viedoc and LINK Medical entered into a partnership established by Viedoc. The collaboration was designed to enhance trial efficiency for LINK Medical and its clients. The partnership allowed for the exchange of needs, experience, ideas, etc., and the testing of new features.

Pharmacovigilance Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global pharmacovigilance market report, along with forecasts at the global, regional, and country levels from 2024-2032. Our report has categorized the market based on service provider, product life cycle, type, process flow, therapeutic area, and end use.

Breakup by Service Provider:

In-house

Contract Outsourcing

The report has provided a detailed breakup and analysis of the market based on the service provider. This includes in-house and contract outsourcing.

Breakup by Product Life Cycle:

Pre-clinical

Phase I

Phase II

Phase III

Phase IV

A detailed breakup and analysis of the market based on the product life cycle has also been provided in the report. This includes pre-clinical, Phase I, Phase II, Phase III, and Phase IV.

Breakup by Type:

Spontaneous Reporting

Intensified ADR Reporting

Targeted Spontaneous Reporting

Cohort Event Monitoring

EHR Mining

The report has provided a detailed breakup and analysis of the market based on the type. This includes spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, and EHR Mining.

Breakup 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

The report has provided a detailed breakup and analysis of the market based on the process flow. This includes case data management (case logging, case data analysis, medical reviewing and reporting), signal detection (adverse event logging, adverse event analysis, and adverse event review and reporting, and risk management system (risk evaluation system and risk mitigation system).

Breakup by Therapeutic Area:

Oncology

Neurology

Cardiology

Respiratory Systems

Others

The report has provided a detailed breakup and analysis of the market based on the therapeutic area. This includes oncology, neurology, cardiology, respiratory systems, and others.

Breakup by End Use:

Pharmaceuticals Companies

Biotechnology Companies

Medical Device Companies

Others

The report has provided a detailed breakup and analysis of the market based on the end-use. This includes pharmaceuticals companies, biotechnology companies, medical device companies, and others.

Breakup 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

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa.

Competitive Landscape:

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the pharmacovigilance top companies are listed below:

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

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Global Pharmacovigilance Market News:

March 2024: The American Society of Pharmacovigilance (ASP), along with several partners, is focused on advancing drug safety via minimizing ADEs, the fourth leading cause of death in the United States.

February 2024: The Indian Pharmacopoeia Commission (IPC) released the Draft Pharmacovigilance Guidance Document for pharmaceutical products for its latest Version 2.0. The Commission also offered suggestions from Marketing Authorization Holders (MAHs) on the draft document.

February 2024: The US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) launched the standardization of Risk Evaluation and Mitigation Strategies (REMS) data to facilitate its use.

Key Questions Answered in This Report:

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

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 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