Global Pharmacovigilance Market Size, Share, Opportunities, And Trends By Clinical Trial Phase (Preclinical, Phase I, Phase II, Phase III, Phase IV), By Service Provider (Contract Outsourcing, In-House), By End User (Pharmaceutical, Biotechnology Companies, Medical Device Manufacturers, Others), And By Geography - Forecasts From 2025 To 2030

The global pharmacovigilance market is expected to grow at a compound annual growth rate of 10.53% over the forecast period to reach a market size of US$11.041 billion in 2030 from US$7.071 billion in 2025.

Pharmacovigilance, also known as drug safety, is the science and activities involved with the detection, evaluation, comprehension, and prevention of adverse effects or other medicine or vaccine-related problems. All medicines and vaccines are submitted to rigorous testing for safety and efficacy in clinical trials before they are licenced for use.

The major driving factors of this market include rising drug consumption and drug development rates, rising rates of adverse drug reactions and drug toxicity, and an increasing tendency to outsource pharmacovigilance services. The rising prevalence of lifestyle-related diseases, such as diabetes, hypertension, and cardiovascular diseases (CVDs), as a result of sedentary lifestyles, a lack of physical activity, changing lifestyle patterns, and poor diets, leading to increased drug consumption, indicating a high demand for drug monitoring and fuelling the market growth.

According to the World Health Organization (WHO), 17.9 million people died from CVDs in 2019, accounting for 32% of all global deaths. About 85 % of these fatalities were caused by a heart attack or a stroke. Globally, an estimated 1.28 billion individuals aged 30-79 years have hypertension, with the majority(2/3rd) residing in low- and middle-income nations. Furthermore, diabetes is directly responsible for an anticipated 1.5 million fatalities in 2019.

On the other hand, factors such as high data security risk, a lack of global regulatory harmonization, and a lack of data standards for adverse event collection are expected to pose challenges to the global pharmacovigilance market.

What are the pharmacovigilance market growth drivers?

• An increased prevalence of ADRs is anticipated to drive the global pharmacovigilance market.

The global pharmacovigilance market is expected to grow due to the rise in Adverse Drug Reactions (ADRs). Factors contributing to this growth include rising drug utilization, diverse patient populations, stringent regulatory requirements, drug safety concerns, advanced monitoring technologies, globalization of clinical trials, patient-centric approach, market expansion in developing regions, collaboration between pharmaceutical companies and pharmacovigilance service providers, and post-marketing surveillance activities. Regulatory authorities worldwide require robust pharmacovigilance activities to ensure drug safety, and advanced monitoring technologies like data analytics and artificial intelligence are enhancing the ability to detect and monitor ADRs more effectively.

According to the Centers for Disease Control and Prevention, about 6.7 percent of hospitalized patients experience a severe ADR, with a mortality rate of 0.32 percent. If these figures are assumed to be true, then there are about 2,216,000 severe ADRs in hospitalized patients per year, which results in over 106,000 deaths. If these statistics are assumed to be true, then ADRs are the fourth-largest cause of death, followed by pulmonary illness, diabetes, AIDS, pneumonia, accidents, and automobile accidents. Therefore, the rising global prevalence of ADRs will increase demand in the pharmacovigilance market.

Major challenges hindering the growth of the pharmacovigilance market:

• Inconsistent reporting of adverse reactions could hinder the global pharmacovigilance market

Pharmacovigilance is concerned with drug quality, dosage mistakes, and adverse drug responses that influence the healthcare system by impacting a large patient population. An adverse reaction does not necessarily occur during a visit to the healthcare center. It may occur several hours after the medication has been administered. Patients failing to report adverse reactions leads to inconsistency in diagnosis and research, which can be life-threatening. Furthermore, administering medicines for extended periods to a large population might result in adverse reactions that have not previously been detected in scientific studies.

For instance, Fresenius Kabi USA recalled Dexmedetomidine HCL in 0.9 % Sodium Chloride Injection in 2020 owing to lidocaine cross-contamination, which could have resulted in a potentially fatal allergic reaction. In 2021, due to the presence of nitrosamine and N-nitroso-varenicline at or above the FDA’s interim permissible consumption limit, Pfizer voluntarily recalled all batches of its Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level. Long-term use of N-nitroso-varenicline may be linked to elevated cancer risk in humans, although there is no immediate danger to individuals using this drug.

Geographical outlooks of the pharmacovigilance market:

• North America region is expected to grow significantly.

The global pharmacovigilance market is expected to be dominated by the North American region. The number of drug abuse and associated adverse drug reactions in the United States has increased significantly. According to the U.S. Department of Health and Human Services, ADRs account for an estimated one-third of all hospital adverse events and affect about 2 million hospital stays each year in inpatient settings. Increasing hospital stays from 1.7 to 4.6 days.

ADEs in outpatient settings account for about 3.5 million doctor visits each year, as well as an estimated 1 million emergency room visits and over 125,000 hospitalizations. The pharmacovigilance system in the United States is transitioning from a passive to a proactive role in the healthcare system as a result of the high costs of in-house pharmacovigilance operations being outsourced to contract research organizations.

Key developments in the pharmacovigilance market:

• October 2024: EVERSANA partnered with Oracle to further enhance its pharmacovigilance and drug safety services. The collaboration includes the leveraging of Oracle Argus Cloud, a solution that provides AI-enabled automation and workflow optimization for the management of growing caseload and potential regulatory pressures. EVERSANA also launched a global patient support model: multilingual medical information contact centres operating 24/7 across North America, Europe, India, and Japan. This initiative ensured timely access to essential information for patients and healthcare service providers.
• February 2024: PrimeVigilance, part of the Ergomed Group, has strengthened its global presence by acquiring Panacea Pharma Projects Limited. This acquisition is strategic in strengthening pharmacovigilance and regulatory services offered by PrimeVigilance to clients. After the acquisition, Panacea will adopt the name PrimeVigilance to integrate into the company's identity, enhancing service provision and operational efficiency. This is a catalyst for growth and adding quality to client support in this highly regulated environment of the pharmaceutical industry and reinforces PrimeVigilance's market position.

Pharmacovigilance Market Scope:

Report Metric	Details
Market Size Value in 2025	US$7.071 billion
Market Size Value in 2030	US$11.041 billion
Growth Rate	CAGR of 10.53%
Study Period	2020 to 2030
Historical Data	2020 to 2023
Base Year	2024
Forecast Period	2025 – 2030
Forecast Unit (Value)	USD Billion
Segments Covered	Clinical Trial Phase Service Provider End-User Geography
Companies Covered	Cognizant Sciformix (Covance) IQVIA APCER Life Sciences, Inc. Navitas Life Sciences
Regions Covered	North America, South America, Europe, Middle East and Africa, Asia Pacific
Customization Scope	Free report customization with purchase

Market Segmentation:

• By Clinical Trial Phase
  • Preclinical
  • Phase I
  • Phase II
  • Phase III
  • Phase IV
• By Service Provider
  • Contract Outsourcing
  • In-house
• By End-User
  • Pharmaceuticals
  • Biotechnology Companies
  • Medical Device Manufacturers
  • Others
• By Geography
  • North America
    • USA
    • Canada
    • Mexico
  • South America
    • Brazil
    • Argentina
    • Others
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • UAE
    • South Africa
    • Others
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Taiwan
    • Thailand
    • Indonesia
    • Others

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1. INTRODUCTION

1.1. Market Overview

1.2. Market Definition

1.3. Scope of the Study

1.4. Market Segmentation

1.5. Currency

1.6. Assumptions

1.7. Base and Forecast Years Timeline

1.8. Key Benefits to the Stakeholder

2. RESEARCH METHODOLOGY  

2.1. Research Design

2.2. Research Processes

3. EXECUTIVE SUMMARY

3.1. Key Findings

4. MARKET DYNAMICS

4.1. Market Drivers

4.2. Market Restraints

4.3. Porter’s Five Forces Analysis

4.3.1. Bargaining Power of Suppliers

4.3.2. Bargaining Power of Buyers

4.3.3. Threat of New Entrants

4.3.4. Threat of Substitutes

4.3.5. Competitive Rivalry in the Industry

4.4. Industry Value Chain Analysis

4.5. Analyst View

5. GLOBAL PHARMACOVIGILANCE MARKET BY CLINICAL TRIAL PHASE

5.1. Introduction

5.2. Preclinical

5.2.1. Market Opportunities and Trends

5.2.2. Growth Prospects

5.2.3. Geographic Lucrativeness

5.3. Phase I

5.3.1. Market Opportunities and Trends

5.3.2. Growth Prospects

5.3.3. Geographic Lucrativeness

5.4. Phase II

5.4.1. Market Opportunities and Trends

5.4.2. Growth Prospects

5.4.3. Geographic Lucrativeness

5.5. Phase III

5.5.1. Market Opportunities and Trends

5.5.2. Growth Prospects

5.5.3. Geographic Lucrativeness

5.6. Phase IV

5.6.1. Market Opportunities and Trends

5.6.2. Growth Prospects

5.6.3. Geographic Lucrativeness

6. GLOBAL PHARMACOVIGILANCE MARKET BY SERVICE PROVIDER

6.1. Introduction

6.2. Contract Outsourcing

6.2.1. Market Opportunities and Trends

6.2.2. Growth Prospects

6.2.3. Geographic Lucrativeness

6.3. In-house

6.3.1. Market Opportunities and Trends

6.3.2. Growth Prospects

6.3.3. Geographic Lucrativeness

7. GLOBAL PHARMACOVIGILANCE MARKET BY END-USER

7.1. Introduction

7.2. Pharmaceuticals

7.2.1. Market Opportunities and Trends

7.2.2. Growth Prospects

7.2.3. Geographic Lucrativeness

7.3. Biotechnology Companies

7.3.1. Market Opportunities and Trends

7.3.2. Growth Prospects

7.3.3. Geographic Lucrativeness

7.4. Medical Device Manufacturers

7.4.1. Market Opportunities and Trends

7.4.2. Growth Prospects

7.4.3. Geographic Lucrativeness

7.5. Others

7.5.1. Market Opportunities and Trends

7.5.2. Growth Prospects

7.5.3. Geographic Lucrativeness

8. GLOBAL PHARMACOVIGILANCE MARKET BY GEOGRAPHY

8.1. Introduction

8.2. North America

8.2.1. By Clinical Trial Phase

8.2.2. By Service Provider

8.2.3. By End-User

8.2.4. By Country

8.2.4.1. USA

8.2.4.1.1. Market Opportunities and Trends

8.2.4.1.2. Growth Prospects

8.2.4.2. Canada

8.2.4.2.1. Market Opportunities and Trends

8.2.4.2.2. Growth Prospects

8.2.4.3. Mexico

8.2.4.3.1. Market Opportunities and Trends

8.2.4.3.2. Growth Prospects

8.3. South America

8.3.1. By Clinical Trial Phase

8.3.2. By Service Provider

8.3.3. By End-User

8.3.4. By Country 

8.3.4.1. Brazil

8.3.4.1.1. Market Opportunities and Trends

8.3.4.1.2. Growth Prospects

8.3.4.2. Argentina

8.3.4.2.1. Market Opportunities and Trends

8.3.4.2.2. Growth Prospects

8.3.4.3. Others

8.3.4.3.1. Market Opportunities and Trends

8.3.4.3.2. Growth Prospects

8.4. Europe

8.4.1. By Clinical Trial Phase

8.4.2. By Service Provider

8.4.3. By End-User

8.4.4. By Country

8.4.4.1. Germany

8.4.4.1.1. Market Opportunities and Trends

8.4.4.1.2. Growth Prospects

8.4.4.2. France

8.4.4.2.1. Market Opportunities and Trends

8.4.4.2.2. Growth Prospects

8.4.4.3. United Kingdom

8.4.4.3.1. Market Opportunities and Trends

8.4.4.3.2. Growth Prospects

8.4.4.4. Italy

8.4.4.4.1. Market Opportunities and Trends

8.4.4.4.2. Growth Prospects

8.4.4.5. Spain

8.4.4.5.1. Market Opportunities and Trends

8.4.4.5.2. Growth Prospects

8.4.4.6. Others

8.4.4.6.1. Market Opportunities and Trends

8.4.4.6.2. Growth Prospects

8.5. Middle East and Africa

8.5.1. By Clinical Trial Phase

8.5.2. By Service Provider

8.5.3. By End-User

8.5.4. By Country

8.5.4.1. Saudi Arabia

8.5.4.1.1. Market Opportunities and Trends

8.5.4.1.2. Growth Prospects

8.5.4.2. UAE

8.5.4.2.1. Market Opportunities and Trends

8.5.4.2.2. Growth Prospects

8.5.4.3. South Africa

8.5.4.3.1. Market Opportunities and Trends

8.5.4.3.2. Growth Prospects

8.5.4.4. Others

8.5.4.4.1. Market Opportunities and Trends

8.5.4.4.2. Growth Prospects

8.6. Asia Pacific

8.6.1. By Clinical Trial Phase

8.6.2. By Service Provider

8.6.3. By End-User

8.6.4. By Country

8.6.4.1. China

8.6.4.1.1. Market Opportunities and Trends

8.6.4.1.2. Growth Prospects

8.6.4.2. India

8.6.4.2.1. Market Opportunities and Trends

8.6.4.2.2. Growth Prospects

8.6.4.3. Japan

8.6.4.3.1. Market Opportunities and Trends

8.6.4.3.2. Growth Prospects

8.6.4.4. South Korea

8.6.4.4.1. Market Opportunities and Trends

8.6.4.4.2. Growth Prospects

8.6.4.5. Taiwan

8.6.4.5.1. Market Opportunities and Trends

8.6.4.5.2. Growth Prospects

8.6.4.6. Thailand

8.6.4.6.1. Market Opportunities and Trends

8.6.4.6.2. Growth Prospects

8.6.4.7. Indonesia

8.6.4.7.1. Market Opportunities and Trends

8.6.4.7.2. Growth Prospects

8.6.4.8. Others

8.6.4.8.1. Market Opportunities and Trends

8.6.4.8.2. Growth Prospects

9. COMPETITIVE ENVIRONMENT AND ANALYSIS

9.1. Major Players and Strategy Analysis

9.2. Market Share Analysis

9.3. Mergers, Acquisitions, Agreements, and Collaborations

9.4. Competitive Dashboard

10. COMPANY PROFILES

10.1. Cognizant

10.2. Sciformix (Covance)

10.3. IQVIA

10.4. APCER Life Sciences, Inc.

10.5. Navitas Life Sciences

10.6. BioClinica

10.7. Accenture

10.8. ArisGlobal

10.9. Capgemini

10.10. FMD K&L Inc.

Cognizant

Sciformix (Covance)

IQVIA

APCER Life Sciences, Inc.

Navitas Life Sciences

BioClinica

Accenture

ArisGlobal

Capgemini

FMD K&L Inc.