Pharmacovigilance Market Size
| 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 |
| Market Concentration | Medium |
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 Market Trends
The Pharmaceutical Companies Segment is Expected to Hold a Major Market Share
Pharmaceutical companies are expected to hold a major market share and are projected to do the same over the forecast period.
In recent years, drugs have been consumed and developed at significantly higher rates. The intake of drugs for longer periods by a large population can put patients at risk of experiencing unwanted and sometimes dangerous side effects. For instance, in October 2022, Aurobindo Pharma USA recalled Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg from the US market due to the presence of Nitrosamine Drug Substance Related Impurity (NDSRI) and N-Nitroso-Quinapril. Thus, the growing need for medical information by 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, 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.
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.
Since pharmacovigilance activities are being shifted to contract research organizations (CROs) due to high costs, 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, 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 USFDA 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.
Pharmacovigilance Industry Overview
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.
Pharmacovigilance Market Leaders
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Cognizant
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Capgemini
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Accenture
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Wipro Limited
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IBM
*Disclaimer: Major Players sorted in no particular order
Pharmacovigilance Market News
- 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 established by Viedoc and 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 the testing of new features.
Pharmacovigilance Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
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. MARKET SEGMENTATION (Market Size by Value - USD Billion)
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 By 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
5.5.1.1 United States
5.5.1.2 Canada
5.5.1.3 Mexico
5.5.2 Europe
5.5.2.1 Germany
5.5.2.2 United Kingdom
5.5.2.3 France
5.5.2.4 Italy
5.5.2.5 Spain
5.5.2.6 Rest of Europe
5.5.3 Asia-Pacific
5.5.3.1 China
5.5.3.2 Japan
5.5.3.3 India
5.5.3.4 Australia
5.5.3.5 South Korea
5.5.3.6 Rest of Asia-Pacific
5.5.4 Middle-East and Africa
5.5.4.1 GCC
5.5.4.2 South Africa
5.5.4.3 Rest of Middle-East and Africa
5.5.5 South America
5.5.5.1 Brazil
5.5.5.2 Argentina
5.5.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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 IBM Corporation
6.1.7 ICON PLC
6.1.8 IQVIA
6.1.9 ITClinical
6.1.10 Laboratory Corporation of America Holdings
6.1.11 Linical Accelovance
6.1.12 PAREXEL International Corporation
6.1.13 United BioSource Corporation
6.1.14 TAKE Solutions Ltd
6.1.15 Wipro Ltd
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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 | ||||||||
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Pharmacovigilance Market Research FAQs
How big is the Pharmacovigilance Market?
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.
What is the current Pharmacovigilance Market size?
In 2024, the Pharmacovigilance Market size is expected to reach USD 8.45 billion.
Who are the key players in Pharmacovigilance Market?
Cognizant, Capgemini, Accenture, Wipro Limited and IBM are the major companies operating in the Pharmacovigilance Market.
Which is the fastest growing region in Pharmacovigilance Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Pharmacovigilance Market?
In 2024, the North America accounts for the largest market share in Pharmacovigilance Market.
What years does this Pharmacovigilance Market cover, and what was the market size in 2023?
In 2023, the Pharmacovigilance Market size was estimated at USD 7.67 billion. The report covers the Pharmacovigilance Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Pharmacovigilance Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Pharmacovigilance Industry Report
Statistics for the 2024 Pharmacovigilance market share, size and revenue growth rate, created by Mordor Intelligenceā¢ Industry Reports. Pharmacovigilance analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
Pharmacovigilance Market Report Snapshots
