Pharmacovigilance Market Size (2024 - 2029)

The pharmacovigilance market is anticipated to experience significant growth, driven by increasing drug consumption and development rates, as well as a rising incidence of adverse drug reactions and drug toxicity. The market's expansion is further supported by the growing trend of outsourcing pharmacovigilance services and the need for comprehensive monitoring systems, particularly in the context of novel vaccinations and post-authorization safety monitoring. Additionally, the increasing burden of lifestyle-related diseases and the importance of post-marketing medication evaluation underscore the critical role of pharmacovigilance in ensuring drug safety. Collaborations between pharmaceutical companies and software providers are also expected to enhance market growth, despite challenges such as data security risks and regulatory inconsistencies.

Market Size of Pharmacovigilance Industry

Pharmacovigilance Market Summary
Study Period 2019 - 2029
Market Size (2024) USD 8.45 Billion
Market Size (2029) USD 13.13 Billion
CAGR (2024 - 2029) 9.23 %
Fastest Growing Market Asia Pacific
Largest Market North America

Major Players

Pharmacovigilance Market Major Players

*Disclaimer: Major Players sorted in no particular order

Pharmacovigilance Market Analysis

The Pharmacovigilance Market size is estimated at USD 8.45 billion in 2024, and is expected to reach USD 13.13 billion by 2029, growing at a CAGR of 9.23% during the forecast period (2024-2029).

The evolving threat of COVID-19 infection adversely affected communities, industries, businesses, and lives worldwide. Medical monitoring and safety reporting are essential as several potential therapies are being used to treat a coronavirus-induced infection. For instance, an article published in September 2021 reported that the unprecedented speed with which vaccines are being developed has created new issues, such as post-authorization safety monitoring and vaccine safety communication. Comprehensive pharmacovigilance and active monitoring systems are required to quickly, effectively, and safely use novel vaccinations in varied populations. Thus, the rising incidence of adverse drug reactions and safety issues is anticipated to accelerate the demand for pharmacovigilance services amid the pandemic.

The key factors propelling this market's growth are increasing drug consumption and development rates, growing incidence rates of adverse drug reactions and drug toxicity, and an increasing trend of outsourcing pharmacovigilance services.

The increasing incidence of lifestyle-related diseases, such as diabetes, hypertension, and cardiac disorders, as a result of sedentary lifestyles, lack of physical activity, changing lifestyle patterns, and poor diets, leads to increased consumption of drugs, which indicates the high demand for drug monitoring and is expected to fuel the growth of the market. For instance, as per the 2022 statistics published by IDF, approximately 537 million adults (20-79 years) were living with diabetes across the globe in 2021 and this number is expected to increase to 643 million by 2030 and 783 million by 2045.

Additionally, as per the 2022 statistics published by the American Cancer Society, approximately 1.9 million new cancer cases are expected to be diagnosed in the United States in 2022. Thus, the increasing burden of a diverse range of diseases among all age groups globally drives the demand for therapeutic drugs in the treatment of these disorders. With the growing drug consumption, the need for regular monitoring of drugs has also augmented, eventually boosting the pharmacovigilance market.

Furthermore, according to a study published in Frontiers in Drug Safety and Regulation, in February 2022, the significance of post-marketing medication evaluation in better characterizing drug safety profiles in real-world settings and bridging the data gap left by pre-marketing research is critical. Such studies will further imply the importance of pharmacovigilance, thereby driving market growth.

Moreover, rising collaborations between pharmaceutical companies and software providers in the market are further expected to propel market growth. For instance, in November 2021, Deloitte and Sanofi collaborated on ConvergeHEALTH Safety, a next-generation artificial intelligence (AI) software-as-a-service adverse events case intake platform that will transform pharmacovigilance (PV) and address some of the industry's most pressing operational safety issues.

However, factors such as high risk associated with data security, lack of global regulatory harmonization, and lack of data standardization for adverse event collection, may hinder the growth of the pharmacovigilance market over the forecast period.

Pharmacovigilance Industry Segmentation

Pharmacovigilance is the science and group of activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Pharmacovigilance focuses on ADR (adverse drug reactions) and drug toxicity. The pharmacovigilance market comprises all types of adverse events reporting conducted during clinical trials in hospitals, pharmacies, and other healthcare sectors. The Pharmacovigilance Market is segmented by Clinical Trial Phase (Preclinical, Phase I, Phase II, Phase III, and Phase IV), Service Provider (In-house and Contract Outsourcing), Type of Reporting (Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring, and EHR Mining), End User (Hospitals, Pharmaceutical Companies, and Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD billion) for the above segments.

By Clinical Trial Phase
Preclinical
Phase I
Phase II
Phase III
Phase IV
By Service Provider
In-house
Contract Outsourcing
By Type of Reporting
Spontaneous Reporting
Intensified ADR Reporting
Targeted Spontaneous Reporting
Cohort Event Monitoring
EHR Mining
By End User
Hospitals
Pharmaceutical Companies
Other End Users
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle-East and Africa
GCC
South Africa
Rest of Middle-East and Africa
South America
Brazil
Argentina
Rest of South America
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Pharmacovigilance Market Size Summary

The pharmacovigilance market is poised for significant growth, driven by the increasing consumption and development of drugs, alongside a rising incidence of adverse drug reactions and drug toxicity. The market is further propelled by the trend of outsourcing pharmacovigilance services, which is becoming more prevalent as pharmaceutical companies seek to enhance their operational efficiency and focus on core activities. The demand for pharmacovigilance services is also fueled by the growing prevalence of lifestyle-related diseases, such as diabetes and cardiac disorders, which necessitate regular drug monitoring. The COVID-19 pandemic has underscored the importance of comprehensive pharmacovigilance systems, particularly in the context of vaccine safety monitoring and communication, thereby accelerating market demand.

North America holds a significant share of the pharmacovigilance market and is expected to maintain its strong position in the coming years. The region's market is transitioning from a passive to a proactive role, especially as pharmacovigilance activities are increasingly outsourced to contract research organizations. This shift is driven by the need to address medication errors, which have become a leading cause of death in the United States. The market is characterized by moderate competition, with major players like Accenture, IBM Corporation, and Cognizant actively engaging in product development and strategic collaborations to enhance their market presence. These companies are leveraging advanced technologies and partnerships to improve drug safety monitoring and regulatory compliance, thereby driving the growth of the pharmacovigilance market.

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Pharmacovigilance Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Increasing Drug Consumption and Drug Development Rates

      2. 1.2.2 Growing Incidence Rates of Adverse Drug Reaction and Drug Toxicity

      3. 1.2.3 Increasing Trend of Outsourcing Pharmacovigilance Services

    3. 1.3 Market Restraints

      1. 1.3.1 High Risk Associated with Data Security

      2. 1.3.2 Lack of Global Regulatory Harmonization and Lack of Data Standardization for Adverse Event Collection

    4. 1.4 Porter's Five Forces Analysis

      1. 1.4.1 Threat of New Entrants

      2. 1.4.2 Bargaining Power of Buyers/Consumers

      3. 1.4.3 Bargaining Power of Suppliers

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

  2. 2. MARKET SEGMENTATION (Market Size by Value - USD Billion)

    1. 2.1 By Clinical Trial Phase

      1. 2.1.1 Preclinical

      2. 2.1.2 Phase I

      3. 2.1.3 Phase II

      4. 2.1.4 Phase III

      5. 2.1.5 Phase IV

    2. 2.2 By Service Provider

      1. 2.2.1 In-house

      2. 2.2.2 Contract Outsourcing

    3. 2.3 By Type of Reporting

      1. 2.3.1 Spontaneous Reporting

      2. 2.3.2 Intensified ADR Reporting

      3. 2.3.3 Targeted Spontaneous Reporting

      4. 2.3.4 Cohort Event Monitoring

      5. 2.3.5 EHR Mining

    4. 2.4 By End User

      1. 2.4.1 Hospitals

      2. 2.4.2 Pharmaceutical Companies

      3. 2.4.3 Other End Users

    5. 2.5 Geography

      1. 2.5.1 North America

        1. 2.5.1.1 United States

        2. 2.5.1.2 Canada

        3. 2.5.1.3 Mexico

      2. 2.5.2 Europe

        1. 2.5.2.1 Germany

        2. 2.5.2.2 United Kingdom

        3. 2.5.2.3 France

        4. 2.5.2.4 Italy

        5. 2.5.2.5 Spain

        6. 2.5.2.6 Rest of Europe

      3. 2.5.3 Asia-Pacific

        1. 2.5.3.1 China

        2. 2.5.3.2 Japan

        3. 2.5.3.3 India

        4. 2.5.3.4 Australia

        5. 2.5.3.5 South Korea

        6. 2.5.3.6 Rest of Asia-Pacific

      4. 2.5.4 Middle-East and Africa

        1. 2.5.4.1 GCC

        2. 2.5.4.2 South Africa

        3. 2.5.4.3 Rest of Middle-East and Africa

      5. 2.5.5 South America

        1. 2.5.5.1 Brazil

        2. 2.5.5.2 Argentina

        3. 2.5.5.3 Rest of South America

Pharmacovigilance Market Size FAQs

The Pharmacovigilance Market size is expected to reach USD 8.45 billion in 2024 and grow at a CAGR of 9.23% to reach USD 13.13 billion by 2029.

In 2024, the Pharmacovigilance Market size is expected to reach USD 8.45 billion.

Pharmacovigilance Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)