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

Published: | Mordor Intelligence Pvt Ltd | 125 Pages | Delivery time: 2-3 business days


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Pharmacovigilance Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)
Published: January 17, 2022
Mordor Intelligence Pvt Ltd
Content info: 125 Pages
Delivery time: 2-3 business days
  • Description
  • Table of Contents

The pharmacovigilance market was valued at approximately USD 5.6 billion in 2020, and it is expected to reach 8.6 billion by 2026, registering a CAGR of nearly 7.54% during the forecast period, 2021-2026.

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. The medications like Lopinavir/Ritonavir, hydroxychloroquine (HCQ), and Remdesivir are being repurposed to treat coronavirus infection. The chances of suspected adverse drug reactions for some of these medicines have already been submitted to the individual case safety reports database named VigiBase, managed by Uppsala Monitoring Centre (UMC). Thus, the rising incidence of adverse drug reactions is anticipated to accelerate the demand for pharmacovigilance services amid pandemics.

The key factors propelling this market are increasing drug consumption and drug development rates, growing incidence rates of adverse drug reactions and drug toxicity, and 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 activities, changing lifestyle patterns, and poor diets, leads to increased consumption of drugs, which indicates the high demand for drug monitoring and fuels the growth of the market. For instance, cardiovascular disorders have a high burden globally. For instance, as per the estimates of the Heart Disease and Stroke Statistics 2019, around 116.4 million, or 46% of adults, in the United States were estimated to have hypertension.

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 and 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.

Rising government efforts to improve management in pharmacovigilance practices are also likely to boost the market growth. For instance, in 2018, the Ministry of AYUSH launched a new Central Sector scheme for promoting pharmacovigilance of Ayurveda, Siddha, Unani, and Homoeopathy (ASU&H) drugs. The scheme is aimed at developing the culture of documenting adverse effects and undertake safety monitoring of Ayurveda, Siddha, Unani, and Homoeopathy drugs and surveillance of misleading advertisements appearing in the print and electronic media. Such initiatives are estimated to propel the market growth in the upcoming years.

However, owing to the factors such as high risk associated with data security, lack of global regulatory harmonization, and lack of data standardization for adverse event collection, the growth of the pharmacovigilance market is expected to get hindered.

Key Market Trends

Pharmaceutical Companies are Expected to Hold the Highest Market Share

In the end-user segment of the pharmacovigilance market, pharmaceutical companies are believed to have the largest market size. The coronavirus pandemic has led to a significant number of deaths around the world, which has made pharmaceuticals' safety reporting and monitoring highly necessary in the context of potential treatment therapies.

The role of pharmaceutical companies is to invest in the R&D of new compounds, have the commitment to bring a new drug to the market to enhance patients' health and quality of life, maintain strict governance to conduct clinical trials, and engage in product development activities and relations with patients and healthcare professionals in accordance with ethical and legal principles.

Outsourcing the pharmacovigilance process is implemented by pharma companies to avoid fixed overhead costs and high upfront investments, secure additional capacity, and increase resource flexibility. Outsourcing pharmacovigilance proves to be a cost-effective endeavor for small and medium-sized companies.

In recent years, drugs are being consumed and developed at significantly high rates. The intake of drugs for longer periods by a large population can lead to adverse effects not seen in the clinical trials. For instance, in 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.

Furthermore, recent advancements in cancer treatments, such as targeted therapy, have some serious adverse effects and can compromise a patient's quality of life. For example, from 2014 to 2018, monoclonal antibodies were ranked among the top ten entries for spontaneous adverse drug reaction reports, with approximately 406,352 records. Constantly emerging technologies and changing reporting systems in pharmacovigilance are driving the segment.

As of 2020, a major pharmaceutical company, Astra, has over 100 permanent, experienced staff in pharmacovigilance within its R&D organization in Sweden and the United Kingdom and a similar number in local operating companies worldwide. This development has been driven by the increased recognition of the role of pharmacovigilance, the investigation and marketing of a wider range of diverse medicinal products, and more stringent and detailed regulatory requirements. Such developments among pharmaceutical companies are helping the pharmacovigilance market grow.

North America Dominates the Market and is Expected to do the Same in the Forecast Period

North America currently dominates the market for pharmacovigilance and is expected to continue its stronghold for a few more years. Due to the shifting of high costs of in-house pharmacovigilance activities to CROs, the pharmacovigilance system in the United States is moving from a passive to a proactive role in the healthcare system. As per the Institute of Medicine report published in March 2020, nearly 98,000 Americans were dying annually due to medication errors. Estimates of annual patient deaths due to medication errors have since risen steadily to 440,000 lives, which make medication errors the country's third-leading cause of death. Therefore, a need to modify the current protocols for quick communication between healthcare providers and the FDA needs to be addressed.

Due to the recent COVID-19 pandemic, scientists, clinicians, and the FDA are pivoting quickly to push drugs into clinical trials for the treatment of COVID-19. Thus, due to the pandemic situation, there has been a speed up in the identification of potential treatment options for COVID-19 and finding a way to slow or decrease the morbidity and mortality rate. Thus, in this scenario, the pharmacovigilance data plays an important role.

Also, the key health authorities, including the US FDA, released guidance for stakeholders, providing guidance on the conduct of clinical trials and post-marketing surveillance during the COVID-19 pandemic. Although these agencies acknowledge the challenges involved, safety reporting activities are expected to continue as usual, as patients' safety is the top priority. Therefore, the above-mentioned factors are driving the growth of the market.

Furthermore, the key players are also involved in product launches and strategic collaborations to strengthen their market positions. For instance, in 2019, Accenture launched INTIENT, a technology platform that improves the continuity and flow of data across life sciences enterprises, supporting the delivery of innovative treatments for patients. Hence, all these factors are propelling the market growth.

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. Companies like Accenture, IBM Corporation, Wipro, Cognizant, and Capgemini hold substantial market shares in the pharmacovigilance market. The market is competitive in nature, with key participants involved in continuous product developments, collaborations, partnerships, and alliances to augment market penetration. For instance, in December 2019, Accenture and UCB announced a collaboration to accelerate data processing and help in improving patient safety, thereby widening their businesses in their respective markets.

Additional Benefits:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support
Product Code: 57011



  • 1.1 Study Deliverables
  • 1.2 Study Assumptions
  • 1.3 Scope of the Study




  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Increasing Drug Consumption and Drug Development Rates
    • 4.2.2 Growing Incidence Rates of Adverse Drug Reaction and Drug Toxicity
    • 4.2.3 Increasing Trend of Outsourcing Pharmacovigilance Services
  • 4.3 Market Restraints
    • 4.3.1 High Risk Associated with Data Security
    • 4.3.2 Lack of Global Regulatory Harmonization and Lack of Data Standardization for Adverse Event Collection
  • 4.4 Porter's Five Forces Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry


  • 5.1 By Clinical Trial Phase
    • 5.1.1 Preclinical
    • 5.1.2 Phase I
    • 5.1.3 Phase II
    • 5.1.4 Phase III
    • 5.1.5 Phase IV
  • 5.2 Service Provider
    • 5.2.1 In-house
    • 5.2.2 Contract Outsourcing
  • 5.3 By Type of Reporting
    • 5.3.1 Spontaneous Reporting
    • 5.3.2 Intensified ADR Reporting
    • 5.3.3 Targeted Spontaneous Reporting
    • 5.3.4 Cohort Event Monitoring
    • 5.3.5 EHR Mining
  • 5.4 By End User
    • 5.4.1 Hospitals
    • 5.4.2 Pharmaceutical Companies
    • 5.4.3 Other End Users
  • 5.5 Geography
    • 5.5.1 North America
      • United States
      • Canada
      • Mexico
    • 5.5.2 Europe
      • Germany
      • United Kingdom
      • France
      • Italy
      • Spain
      • Rest of Europe
    • 5.5.3 Asia-Pacific
      • China
      • Japan
      • India
      • Australia
      • South Korea
      • Rest of Asia-Pacific
    • 5.5.4 Middle-East and Africa
      • GCC
      • South Africa
      • Rest of Middle-East and Africa
    • 5.5.5 South America
      • Brazil
      • Argentina
      • Rest of South America


  • 6.1 Company Profiles
    • 6.1.1 Accenture
    • 6.1.2 ArisGlobal
    • 6.1.3 BioClinica
    • 6.1.4 Capgemini
    • 6.1.5 Cognizant
    • 6.1.6 FMD K&L Inc.
    • 6.1.7 Foresight Group International AG
    • 6.1.8 IBM Corporation
    • 6.1.9 ICON PLC
    • 6.1.10 IQVIA
    • 6.1.11 ITClinical
    • 6.1.12 Laboratory Corporation of America Holdings
    • 6.1.13 Linical Accelovance
    • 6.1.14 PAREXEL International Corporation
    • 6.1.15 United BioSource Corporation
    • 6.1.16 TAKE Solutions Ltd
    • 6.1.17 Wipro Ltd