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Pharmacovigilance and Drug Safety Software Market Size and Forecast (2021–2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By 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 (CROs), Business Process Outsourcing (BPO) Firms, Pharmacovigilance Service Providers ), and Geography

Report Code : 

TIPHC00002557

No. of Pages : 150
Published Month : May 2024
Category : Technology, Media and Telecommunications

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.

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

Report Attribute Details
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
  • Software
  • Services
By Deployment
  • Cloud
  • On Premises
By Enterprise Size
  • Large Enterprises
  • SMEs
By Form
  • Standard
  • Customized
Regions and Countries Covered North America
  • US
  • Canada
  • Mexico
Europe
  • UK
  • Germany
  • France
  • Russia
  • Italy
  • Rest of Europe
Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
South and Central America
  • Brazil
  • Argentina
  • Rest of South and Central America
Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa
Market leaders and key company profiles
  • ArisEurope
  • ICON plc
  • Syneos Health
  • Accenture
  • IQVIA
  • Genpact
  • Cognizant
  • Paraxel International Corporation
  • Laboratory Corporation of America Holdings
  • Max Application
  • 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

    The List of Companies - Pharmacovigilance and Drug Safety Software Market

    1. ArisGlobal LLC     
    2. Max Application    
    3. Oracle Corp         
    4. Veeva Systems Inc           
    5. IQVIA Holdings Inc           
    6. ICON Plc             
    7. Cognizant Technology Solutions Corp       
    8. Accenture Plc      
    9. Syneos Health Inc
    10. Genpact Ltd.     
    • Save and reduce time carrying out entry-level research by identifying the growth, size, leading players and segments in the pharmacovigilance and drug safety software market.
    • Highlights key business priorities in order to assist companies to realign their business strategies
    • The key findings and recommendations highlight crucial progressive industry trends in the pipe relining market, thereby allowing players across the value chain to develop effective long-term strategies
    • Develop/modify business expansion plans by using substantial growth offering developed and emerging markets
    • Scrutinize in-depth global market trends and outlook coupled with the factors driving the market, as well as those hindering it
    • Enhance the decision-making process by understanding the strategies that underpin commercial interest with respect to client products, segmentation, pricing and distribution
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    Frequently Asked Questions

    What are the future trends of the pharmacovigilance and drug safety software market?

    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.