GVR Report cover Pharmacovigilance and Drug Safety Software Market Size, Share & Trends Report

Pharmacovigilance and Drug Safety Software Market Size, Share & Trends Analysis Report By Functionality, By Delivery Mode, By End Use (Pharmaceutical & Biotech Companies, CROs, BPOs), And Segment Forecasts, 2018 - 2024

  • Published Date: May 2018
  • Report ID: GVR-1-68038-144-3
  • Number of Pages: 93
  • Format: Electronic (PDF)
  • Historical Data: 2013 - 2015

Report Overview

The global pharmacovigilance (PV) & drug safety software market size was estimated at USD 124.6 million in 2016 and is expected to exhibit a CAGR of 6.5% over the forecast period. Increasing incidence of adverse drug reactions (ADR) is expected to propel the demand for pharmacovigilance (PV) software in the coming years.

U.S. pharmacovigilance and drug safety software market size

PV and drug safety software solutions are accessible anywhere and at any time thanks to growing Internet penetration. Increasing globalization in pharmacovigilance with widespread availability of the Internet is expected to boost usage rates. In addition, a growing health information functionality market will strengthen the usage of PV software over the forecast period, as it improves patient health and reduces medical expenditures.

Moreover, increasing pressure to follow safety guidelines set by government authorities such as the European Medicines Agency and the U.S. FDA is contributing toward growing adoption of pharmacovigilance systems. Many pharmaceutical companies are moving toward outsourcing pharmacovigilance activities to curb operational costs.

Manufacturers are gradually shifting from being fully integrated pharmaceutical companies to sharing costs by collaborating with service providers. Services outsourced range from medical writing and clinical trial data collection to medical reporting and other PV services. Outsourcing helps increase internal resource flexibility, improves timelines, and results in better outcomes.

Functionality Insights

ADR reporting tools dominated the market in 2015 due to related benefits such as data entry and management with minimum errors. Pharmacovigilance software has transformed the traditional way of ADR reporting and management. Introduction of advanced data integration solutions and cost-effective nature of this PV system is anticipated to spur demand.

The fully integrated software segment is expected to show lucrative growth in the coming years owing to increasing need to avert errors in database management. These solutions are used to track individual case safety reports and avoid data redundancy through elimination of errors.

Delivery Mode Insights

On-premise software accounted for the largest revenue share in the pharmacovigilance software market owing to increasing adoption by large pharmaceutical companies. This type of delivery mode involves installation of services and solutions on computers within organization premises. Nevertheless, it can be accessed from remote locations, thereby providing the benefit of reduced costs due to power consumption and system maintenance.

Global pharmacovigilance and drug safety software market share

Introduction of cloud computing and its rapid adoption by healthcare IT providers is expected to slow the growth of the on-premise segment over the forecast period. On the other hand, on-demand services such as cloud-based solutions are expected to gain popularity in the coming years. Increasing adoption of these platforms by pharmaceutical companies and contract research organizations is driving the segment. Remote access to data, real-time data tracking, and a simpler complex physical ecosystem are notable benefits associated with cloud-based systems.

End-use Insights

PV software solutions are widely accepted by pharma and biotech companies to facilitate clinical trial programs and reduce the burden on medical expenditure. PV outsourcing is a growing trend in the pharmaceutical industry and as a result, manufacturers are striving to identify various ways to contain costs and minimize operational expenses by gradually shifting from being fully-integrated pharmaceutical companies to sharing costs through collaborations with service providers. This is expected to strengthen the growth of contract research firms that perform these activities for pharmaceutical companies.

The CROs segment is expected to exhibit profitable growth during the forecast period due to increasing trend of outsourcing. PV service providers, in an attempt to ensure sustainability, are providing customized end-to-end solutions to meet consumer needs. These firms are also incorporating integrated technologies, such as electronic data capture and hosting of PV warehousing to aggregate cross industry data, which enables risk evaluation. Furthermore, service providers are now operating via flexible and variable pricing structures to achieve operational excellence through constant product updates, which is expected to boost usage rates over the coming years.

Regional Insights

In terms of region, North America led the market in 2015 and is anticipated to continue this trend over the foreseeable future. Owing to government-aided initiatives favoring the adoption of PV software systems, the regional market is expected to show significant growth through 2024. For instance, the Open FDA initiative provides scientists and application developers access to its massive database through open search-based programs, which is anticipated to boost usage rates over the forecast period. Mini-Sentinel is a project started by the U.S. FDA to promote active surveillance systems, which provide statistically relevant data in lesser time. Initiatives such as these strengthen the growth of the regional market.

Companies in Asia Pacific provide substantial cost-saving advantages, with savings ranging from 50% to 80% of the cost as compared to developed nations. This leads to rising volume of clinical trials being conducted in this region. Rise in demand for and occurrence of clinical trials has led to increasing focus on pharmacovigilance and drug safety software. Along with India and China, Singapore, South Korea, and Taiwan have been recognized as outsourcing hubs in Asia. Increasing number of adverse drug reactions, rising awareness about public safety, and stringent government regulations are some factors expected to drive market growth.

Pharmacovigilance & Drug Safety Software Market Share Insights

The market is competitive in nature due to the presence of many healthcare information functionality companies, such as Wipro, TCS, and Cognizant, focusing on establishment of separate clinical research data management and pharmacovigilance divisions. Some of the players dominating this industry are Oracle Corporation; ArisGlobal; AB Cube; Max Delivery; Relsys; Sparta Systems, Inc.; United BioSource Corporation; EXTEDO GmbH; and Ennov Solutions, Inc.

Introduction of technologically advanced and user-friendly software systems such as cloud-based pharmacovigilance platforms is anticipated to drive market growth in the coming years. The role of social media as a useful tool for businesses has also greatly impacted the market. Although the healthcare industry is restricted by regulatory protocols, the utility of social media holds significant promise for market growth.

Pharmacovigilance And Drug Safety Software MarketReport Scope

Report Attribute


Market size value in 2020

USD 160.14 million

Revenue forecast in 2024

USD 207.7 million

Growth Rate

CAGR of 6.5% from 2016 to 2024

Base year for estimation


Historical data

2013 – 2015

Forecast period

2016 – 2024

Quantitative units

Revenue in USD million and CAGR from 2016 to 2024

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Functionality, delivery mode, end use, region

Regional scope

North America; Europe; APAC; Latin America; MEA

Country scope

U.S.; Canada; U.K.; Germany; Japan; China; India; Brazil; Mexico; South Africa

Key companies profiled

Wipro; TCS; Cognizant; Oracle Corporation; ArisGlobal; AB Cube; Max Delivery; Relsys; Sparta Systems, Inc.; United BioSource Corporation; EXTEDO GmbH; Ennov Solutions, Inc.

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope.

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Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2013 to 2024. For the purpose of this study, Grand View Research has segmented the global pharmacovigilance & drug safety software market report on the basis of functionality, delivery mode, end use, and region:

  • Functionality Outlook (Revenue, USD Million, 2013 - 2024)

    • ADR Reporting

    • Drug Safety Audits

    • Issue Tracking

    • Fully Integrated Software

  • Delivery Mode Outlook (Revenue, USD Million, 2013 - 2024)

    • On-premise

    • On-demand

  • End-use Outlook (Revenue, USD Million, 2013 - 2024)

    • Pharma & biotech companies

    • CROs

    • BPOs

    • Others

  • Regional Outlook (Revenue, USD Million, 2013 - 2024)

    • North America

      • The U.S.

      • Canada

    • Europe

      • The U.K.

      • Germany

    • Asia Pacific

      • Japan

      • China

      • India

    • Latin America

      • Mexico

      • Brazil

    • Middle East & Africa

      • South Africa

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