In the dynamic landscape of global healthcare, the importance of pharmacovigilance cannot be overstated. Monitoring the safety and efficacy of pharmaceuticals has emerged as a key necessity, driven by burgeoning drug consumption and development rates, increased instances of adverse drug reactions, and a rising trend of outsourcing pharmacovigilance services. Accommodating these needs, our market report offers prime insights into the pharmacovigilance market, its growth factors, and its potential business opportunities.
The rising incidence of various lifestyle-related diseases, combined with a burdening plague of diseases amongst different age groups globally, drives substantial demand for therapeutic drugs and consequential drug monitoring. In this context, our report provides an advantageous overview of the market, addressing these comprehensive concerns. Furthemore, the study investigates existing and potential collaborations between pharmaceutical companies and software providers, expected to drive market growth. Equipped with such knowledge, senior executives can make informed decisions regarding their engagement with this rapidly growing industry, increasing their competitiveness and ensuring superior patient safety.
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 SharePharmaceutical 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 PeriodNorth 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 Market Competitor AnalysisThe 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.
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Table of Contents
1.2 Scope of the Study
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
5.1.2 Phase I
5.1.3 Phase II
5.1.4 Phase III
5.1.5 Phase IV
5.2 By Service Provider
5.2.2 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
5.4.2 Pharmaceutical Companies
5.4.3 Other End Users
5.5.1 North America
184.108.40.206 United States
220.127.116.11 United Kingdom
18.104.22.168 Rest of Europe
22.214.171.124 South Korea
126.96.36.199 Rest of Asia-Pacific
5.5.4 Middle-East and Africa
188.8.131.52 South Africa
184.108.40.206 Rest of Middle-East and Africa
5.5.5 South America
220.127.116.11 Rest of South America
6.1.6 IBM Corporation
6.1.7 ICON PLC
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
A selection of companies mentioned in this report includes:
- IBM Corporation
- ICON PLC
- Laboratory Corporation of America Holdings
- Linical Accelovance
- PAREXEL International Corporation
- United BioSource Corporation
- TAKE Solutions Ltd
- Wipro Ltd