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 and Drug Safety Software Market Analysis

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.

Pharmacovigilance and Drug Safety Software Market Overview

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.

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Pharmacovigilance and Drug Safety Software Market: Strategic Insights

Pharmacovigilance and Drug Safety Software Market

• 
  CAGR (2023 - 2031)

  5.9%
• Market Size 2021
  US$ 1.97 Billion
• Market Size 2031
  US$ 3.29 Billion

Market Dynamics

GROWTH DRIVERS

• Globalization Of Pharmacovigilance

FUTURE TRENDS

• Artificial intelligence in pharmacovigilance

OPPORTUNITIES

• Growth Opportunities in Developing Countries

Key Players

• IQVIA
• Accenture
• Cognizant
• Laboratory Corporation of America Holdings
• IBM
• ArisGlobal
• ICON Plc.
• Capgemini
• Oracle

Regional Overview

• North America
• Europe
• Asia-Pacific
• South and Central America
• Middle East and Africa

Market Segmentation

Software Type

• Adverse Event Reporting Software
• Drug Safety Audits Software
• Issue Tracking Software
• Fully Integrated Software

Delivery Mode

• On-premise
• Cloud-based

End User

• Pharmaceutical and Biotech Companies
• Contract Research Organizations

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Pharmacovigilance and Drug Safety Software Market Drivers and Opportunities

Globalization Of Pharmacovigilance

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.

Growth Opportunities in Developing Countries– An Opportunity in Pharmacovigilance and Drug Safety Software Market

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.

Pharmacovigilance and Drug Safety Software Market Report Segmentation Analysis

Key segments that contributed to the derivation of the pharmacovigilance and drug safety software market analysis are disorder and service provider.

• Based on software type, the pharmacovigilance and drug safety software market is segmented into adverse event reporting software, drug safety audits software, issue tracking software, fully integrated software. The adverse event reporting software segment held a larger market share in 2023.
• By delivery mode, the pharmacovigilance and drug safety software market is segmented into on-premise, cloud-based. The on-premise segment held the largest share of the market in 2023.
• By End Users, the pharmacovigilance and drug safety software market is classified into pharmaceutical and biotech companies, contract research organizations (CROs), business process outsourcing (BPO) firms, pharmacovigilance service providers. The contract research organizations (CROs) segment held the largest share of the market in 2023.

Pharmacovigilance and Drug Safety Software Market Share Analysis by Geography

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.

Pharmacovigilance and Drug Safety Software Market Report Scope

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Pharmacovigilance and Drug Safety Software Market News and Recent Developments

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:

• To move their pharmacovigilance from Contract Research Organization (CRO) services to in-house practices using this cutting-edge pharmacovigilance software, PegBio chose ArisGlobal's flagship product, LifeSphere MultiVigilance. (PegBio: Pearl, Press Release, 2022).

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)

Pharmacovigilance and Drug Safety Software Market Report Coverage and Deliverables

The “Pharmacovigilance and Drug Safety Software Market Size and Forecast (2021–2031)” report provides a detailed analysis of the market covering below areas:

• Market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
• Market dynamics such as drivers, restraints, and key opportunities
• Key future trends
• Detailed PEST/Porter’s Five Forces and SWOT analysis
• Global and regional market analysis covering key market trends, major players, regulations, and recent market developments
• Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments
• Detailed company profiles