The pharmacovigilance and drug safety software market was valued at US$ 1.97 billion in 2021 and is expected to reach US$ 3.29 billion by 2031. The market is expected to register a CAGR of 5.9% in 2023–2031. Artificial intelligence in pharmacovigilance will likely remain a key pharmacovigilance and drug safety software market trend.
Pharmacovigilance (PV) plays an essential role in the healthcare system through assessment, monitoring, and finding drug interactions and their effects in humans. Pharmacovigilance helps companies monitor adverse drug reaction events during the trial and post-marketing periods. Key factors driving the market are rising adverse drug reaction incidences and the globalization of pharmacovigilance, which have been boosting the market over the years. However, expensive technology is likely to have a negative impact on market growth in the coming years.
The rise in a high volume of pharmacovigilance data and ADR events during recent years across the globe is a prime contributing factor to the rising demand for sophisticated pharmacovigilance and drug safety software. The industry players operating in the market of pharmacovigilance (PV) and drug safety market include AB Cube, United BioSource LLC, ARISGLOBAL LLC, Sparta Systems, Inc., Oracle Corporation, Sarjen Systems Pvt. Ltd., EXTEDO, ENNOV, Max Application, and Anju Software, Inc. The players operating in the pharmacovigilance (PV) and drug safety software market have been focusing on various organic and inorganic growth strategies during the previous years.
Pharmacovigilance, which refers to the procedures for tracking and assessing adverse drug responses, is an essential part of clinical practice, public health initiatives, and efficient drug control systems. The volume of data processed increased due to the reported number of Adverse Drug Reactions (ADRs) within the existing Uppsala Monitoring Center-coordinated global network of pharmacovigilance facilities. Pharmacovigilance is becoming increasingly common in many nations, and it is an essential and crucial component of clinical research. However, at the turn of the millennium, pharmacovigilance faces significant challenges in the aspect of better safety and monitoring of drugs.
The emerging Asian Pacific markets are creating significant opportunities for key market players to expand their businesses. It will likely be a prime factor contributing to market growth in the coming years. Most players concentrate on developing markets such as India and China, owing to the presence of many clinical research organization and business process outsourcing firms in countries.
Various players from the pharmaceutical industry have been investing a significant amount of their revenue in research and development activities to develop better medicines to be used in the healthcare industry. Asia Pacific is foreseen to register the fastest growth during the forecast period. The presence of key pharmaceutical companies in the region contributes to APAC's market growth. These activities in the region are increasing the demand for pharmacovigilance and drug safety software’s.
Key segments that contributed to the derivation of the pharmacovigilance and drug safety software market analysis are disorder and service provider.
The geographic scope of the pharmacovigilance and drug safety software market report is mainly divided into five regions: North America, Asia Pacific, Europe, Middle East & Africa, and South America/South & Central America.
The United States offers significant growth opportunities in the Pharmacovigilance (PV) and drug safety software market, which is expected to drive the market’s growth considerably. The Institute of Medicine reported in 2000 that from 44,000 to 98,000 deaths occur annually from medical errors, and an estimated 7,000 deaths occur due to Adverse Drug Reactions (ADRs).
According to the U.S Food and Drugs Admiration, a study conducted in the hospital on hospitalized patient populations has placed much higher estimates on the overall incidence of serious Adverse Drug Reactions (ADRs). These studies estimate that 6.7% of hospitalized patients have a serious adverse drug reaction with a fatality rate of 0.32%. According to this study data, it estimates that there are more than 2,216,000 serious ADRs in hospitalized patients, causing over 106,000 deaths annually, which indicates that ADRs are the 4th leading cause of death ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents, and automobile deaths.
Report Attribute | Details |
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Market size in 2023 | US$ 214.39 Million |
Market Size by 2031 | US$ 359.30 Million |
Global CAGR (2023 - 2031) | 6.7% |
Historical Data | 2021-2022 |
Forecast period | 2024-2031 |
Segments Covered |
By Offering
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Regions and Countries Covered | North America
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Market leaders and key company profiles |
The pharmacovigilance and drug safety software market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. The following is a list of developments in the market for speech and language disorders and strategies:
Dotmatics, the leader in scientific software for research and development that links data, science, and decision-making, has released a new platform for scientific research and development called Small Molecule Drug Discovery Solution. It features enhanced data management features and pre-configured workflows. The solution makes innovation easier for businesses by using best practices developed over the company's more than 15 years of supporting small molecule drug research. (Source: Dotmatics, Press Release, 2022)
The “Pharmacovigilance and Drug Safety Software Market Size and Forecast (2021–2031)” report provides a detailed analysis of the market covering below areas:
Integration of cloud-based platforms that offers real-time access to data from anywhere across the globe, enabling pharmaceutical companies to respond swiftly to emerging safety concerns.
ArisEurope, ICON plc, Syneos Health, Accenture, IQVIA, Genpact, Cognizant, Paraxel International Corporation, Laboratory Corporation of America Holdings, Max Application, Clinevo Technologies, Qinecsa Solutions, AB Cube, and Veeva Systems are among the key players operating in the global pharmacovigilance and drug safety software market.
The pharmacovigilance and drug safety software market was valued at US$ 214.39 billion in 2023 and is anticipated to grow at a CAGR of 6.7% over the forecast period.
The rising cases of adverse drug reactions (ADRs) worldwide owing to the increasing prevalence of chronic diseases drives the market growth.
Asia Pacific is anticipated to grow at the fastest CAGR over the forecast period.
The software segment led the pharmacovigilance and drug safety software market with a significant share in 2023.
The pharmacovigilance and drug safety software market are expected to reach US$ 359.30 million by 2031 and is expected to register a CAGR of 6.7% during 2023–2031.