Pharmacovigilance Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

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 report offers the value (in USD billion) for the above segments.

Market Snapshot

Pharmacovigilance Market Forecast
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia Pacific
Largest Market: North America
CAGR: 8.65 %

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Market Overview

The pharmacovigilance market is expected to register a CAGR of 8.65 % during the forecast period (2022-2027).

The evolving threat of COVID-19 infection is adversely affecting communities, industries, businesses, and lives around the world. Medical monitoring and safety reporting are essential as several potential therapies are being used in the treatment of coronavirus-induced infection. For instance, the article published in September 2021, titled "Impact of COVID-19 pandemic on pharmacovigilance" 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. For the quick, effective, and safe use of novel vaccinations in varied populations, comprehensive pharmacovigilance and active monitoring systems are required. 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 drug 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 International Diabetes Federation in 2021, approximately 537 million adults (20-79 years) were living with diabetes across the globe in 2021. The total number of diabetics is expected to rise to 643 million by 2030 and 783 million by 2045, with 3 out of every 4 adults living in low-and middle-income countries. In addition, as per the American Cancer Society, in 2020, approximately 1.8 million new cancer cases were reported, and approximately 606,520 cancer deaths were reported in the United States. 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 the study published in Frontiers in Drug Safety and Regulation, titled "A New Era of Pharmacovigilance: Future Challenges and Opportunities" 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 the 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, owing to 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.

Scope of the Report

As per the scope of this report, pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The focus of pharmacovigilance is 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
Phase I
Phase II
Phase III
Phase IV
By Service Provider
Contract Outsourcing
By Type of Reporting
Spontaneous Reporting
Intensified ADR Reporting
Targeted Spontaneous Reporting
Cohort Event Monitoring
EHR Mining
By End User
Pharmaceutical Companies
Other End Users
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle-East and Africa
South Africa
Rest of Middle-East and Africa
South America
Rest of South America

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Key Market Trends

Pharmaceutical Companies Segment is Expected to Hold a Major Market Share

Pharmaceutical companies segment by end users is expected to hold a major market share and it is projected to do the same over the forecast period.

In recent years, drugs are being consumed and developed at significantly higher rates. The intake of drugs for longer periods by a large population can lead to adverse effects not seen in clinical trials. For instance, in November 2020, Dexmedetomidine HCL in 0.9% Sodium Chloride Injection by Fresenius Kabi USA was recalled due to cross-contamination of lidocaine, which could result in a potentially life-threatening allergic reaction. Thus, the growing need for medical information by the regulatory authorities is also anticipated to fuel the growth of this segment.

The rising adoption of pharmacovigilance services by pharmaceutical companies is propelling the segment's growth over the forecast period. For instance, in September 2021, IQVIA entered into a transformative collaboration with NRx Pharmaceuticals to provide pharmacovigilance services and medical information in preparation for potential regulatory actions.

Furthermore, according to the study published in Frontiers in Drug Safety and Regulation, titled "A New Era of Pharmacovigilance: Future Challenges and Opportunities" in February 2022, eco-pharmacovigilance has become an important issue in recent years, and it's critical for lowering the risk of pharmaceutical pollutants polluting the environment. Pharmaceutical companies may therefore adopt pharmacovigilance services to reduce environmental pollution, thereby driving the market's growth.

Such developments among pharmaceutical companies are anticipated to boost the segment's growth over the analysis period.


North America is Expected to Hold a Significant Market Share and is Expected to do the Same during the Forecast Period

North America holds a major market share for pharmacovigilance and is expected to continue its stronghold for a few more years.

Due to the shifting of the high cost of in-house pharmacovigilance activities to contract research organizations (CROs), the pharmacovigilance approach in the United States is moving from a passive to a proactive role in the healthcare system. As per the Institute of Medicine report, titled "Top 10 Patient Safety Concerns For 2020" by Christopher Cheney, published in March 2020, nearly 98,000 Americans died annually due to medication errors. Estimates of annual patient deaths due to medication errors have since risen steadily to 440,000 lives, which makes medication errors the country's third-leading cause of death. Therefore, there is a need to modify the current protocols for quick communication between healthcare providers and the Food and Drug Administration. Since pharmacovigilance plays a vital role in drug assessment and prevention of adverse effects, the demand for such services is likely to increase in the near future.

Furthermore, the key players are also involved in product launches and strategic collaborations to strengthen their market positions. For instance, in December 2021, ArisGlobal launched the go-live of the United States Food and Drug Administration Adverse Event Reporting System (FAERS II), an electronic safety reporting platform powered by LifeSphere MultiVigilance. In addition, in October 2020, Saama Technologies Inc. launched the new Active Safety Analytics for Pharma (ASAP) products. ASAP is one of the first validated pharmacovigilance solutions to leverage the United States Food and Drug Administration’s (FDA) Sentinel Common Data Model and the TreeScan methodology for detecting safety signals.

Hence, all these factors are propelling the market growth in North America over the forecast period.

Pharmacovigilance Market Size

Competitive Landscape

The pharmacovigilance market is moderately competitive and consists of several major players. In terms of market share, a few of the major players currently dominate the market. The key participants are involved in continuous product development, collaborations, partnerships, and alliances to augment market penetration. Some of the key market players in this market include Accenture, IBM Corporation, Wipro, Cognizant, and Capgemini, among others.

Recent Developments

  • In February 2022, 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 February 2022, LINK Medical and Viedoc entered into a partnership that has been established by Viedoc and is designed to improve trial efficiency for LINK Medical and its clients. The partnership allows for a continuous exchange of experience, needs, and ideas, as well as testing of new features.

Table of Contents


    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Drug Consumption and Drug Development Rates

      2. 4.2.2 Growing Incidence Rates of Adverse Drug Reaction and Drug Toxicity

      3. 4.2.3 Increasing Trend of Outsourcing Pharmacovigilance Services

    3. 4.3 Market Restraints

      1. 4.3.1 High Risk Associated with Data Security

      2. 4.3.2 Lack of Global Regulatory Harmonization and Lack of Data Standardization for Adverse Event Collection

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

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

    1. 5.1 By Clinical Trial Phase

      1. 5.1.1 Preclinical

      2. 5.1.2 Phase I

      3. 5.1.3 Phase II

      4. 5.1.4 Phase III

      5. 5.1.5 Phase IV

    2. 5.2 By Service Provider

      1. 5.2.1 In-house

      2. 5.2.2 Contract Outsourcing

    3. 5.3 By Type of Reporting

      1. 5.3.1 Spontaneous Reporting

      2. 5.3.2 Intensified ADR Reporting

      3. 5.3.3 Targeted Spontaneous Reporting

      4. 5.3.4 Cohort Event Monitoring

      5. 5.3.5 EHR Mining

    4. 5.4 By End User

      1. 5.4.1 Hospitals

      2. 5.4.2 Pharmaceutical Companies

      3. 5.4.3 Other End Users

    5. 5.5 Geography

      1. 5.5.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.5.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.5.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.5.4 Middle-East and Africa

        1. GCC

        2. South Africa

        3. Rest of Middle-East and Africa

      5. 5.5.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Accenture

      2. 6.1.2 ArisGlobal

      3. 6.1.3 BioClinica

      4. 6.1.4 Capgemini

      5. 6.1.5 Cognizant

      6. 6.1.6 IBM Corporation

      7. 6.1.7 ICON PLC

      8. 6.1.8 IQVIA

      9. 6.1.9 ITClinical

      10. 6.1.10 Laboratory Corporation of America Holdings

      11. 6.1.11 Linical Accelovance

      12. 6.1.12 PAREXEL International Corporation

      13. 6.1.13 United BioSource Corporation

      14. 6.1.14 TAKE Solutions Ltd

      15. 6.1.15 Wipro Ltd

    2. *List Not Exhaustive

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Global Pharmacovigilance Market market is studied from 2019 - 2027.

The Global Pharmacovigilance Market is growing at a CAGR of 8.65% over the next 5 years.

Asia Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

Cognizant, Capgemini, Accenture, Wipro Limited, IBM are the major companies operating in Global Pharmacovigilance Market.

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