Global Pharmacovigilance and Drug Safety Software Market Report and Forecast 2023-2031

Global Pharmacovigilance and Drug Safety Software Market Report and Forecast 2023-2031


Global Pharmacovigilance and Drug Safety Software Market Outlook


The value of the global pharmacovigilance and drug safety software market was USD 7.80 billion in 2022, driven by the increasing incidence of adverse drug reactions across the globe. The market value is anticipated to grow at a CAGR of 8.98% during the forecast period of 2023-2031 to reach a value of USD 16.90 billion by 2031.

Pharmacovigilance and Drug Safety Software: Introduction

Pharmacovigilance and drug safety software is a computer-based system used by pharmaceutical companies to monitor and analyse the safety of drugs in the market. The software collects, analyses, and evaluates data related to the adverse effects of drugs, identifies potential risks, and suggests measures to manage and mitigate those risks. It helps in ensuring the safety and efficacy of drugs, improving patient outcomes, and complying with regulatory requirements. The software can also generate reports and alerts based on the analysed data, enabling healthcare professionals and regulators to take informed decisions about the use of drugs.

Pharmacovigilance and Drug Safety Software: Application and Uses

Pharmacovigilance and drug safety software are used in the healthcare industry to monitor and track the safety of drugs and medications. The software is designed to help healthcare professionals and regulatory agencies identify and evaluate adverse events, including side effects, drug interactions, and other safety issues related to medications. The application and uses of pharmacovigilance and drug safety software include:
  • Adverse Event Reporting: Pharmacovigilance software is used to track adverse events and report them to regulatory agencies as required.
  • Signal Detection: The software can be used to identify new signals or trends in safety data, such as increased rates of adverse events for a particular drug.
  • Risk Management: Pharmacovigilance software is used to manage and mitigate risks associated with drugs and medications.
  • Clinical Trial Safety Monitoring: The software can be used to monitor safety data during clinical trials and help ensure that trials are conducted safely and ethically.
  • Post-Marketing Surveillance: Pharmacovigilance software is used to monitor safety data after a drug is approved and on the market.
  • Regulatory Compliance: The software is designed to help healthcare organizations comply with regulatory requirements related to drug safety and pharmacovigilance.
Overall, pharmacovigilance and drug safety software are critical tools for ensuring the safety and efficacy of drugs and medications, and are used throughout the healthcare industry to improve patient safety and outcomes.

Global Pharmacovigilance and Drug Safety Software Market Segmentations


Market Breakup by Functionality
  • Adverse Event Reporting Software
  • Drug Safety Audits Software
  • Issue Tracking Software
  • Fully Integrated Software
Market Breakup by Mode of Delivery
  • On-Premises Delivery
  • On-Demand/Cloud Based (SaaS) Delivery
Market Breakup by End User
  • Pharma and Biotech Companies
  • Contract Research Organizations (CROs)
  • Business Process Outsourcing (BPO) Firms
  • Others
Market Breakup by Region

North America
  • United States of America
  • Canada
Europe
  • United Kingdom
  • Germany
  • France
  • Italy
  • Others
Asia Pacific
  • China
  • Japan
  • India
  • ASEAN
  • Australia
  • Others
Latin America
  • Brazil
  • Argentina
  • Mexico
  • Others
Middle East and Africa
  • Saudi Arabia
  • United Arab Emirates
  • Nigeria
  • South Africa
  • Others

Global Pharmacovigilance and Drug Safety Software Market Scenario


The market is expected to grow significantly during the forecast period owing to the increasing incidence of adverse drug reactions and the growing emphasis on patient safety and risk management are some of the key factors driving the growth of this market.

The market is also being driven by the increasing demand for pharmacovigilance and drug safety software solutions among pharmaceutical and biotechnology companies, contract research organizations, and regulatory authorities. In addition, the increasing use of artificial intelligence and machine learning in pharmacovigilance and drug safety software is expected to fuel the growth of this market.

Based on the mode of delivery, the cloud-based segment is expected to witness significant growth during the forecast period due to its advantages such as easy access to data, reduced cost of ownership, and improved scalability. On the basis of end-users, the pharmaceutical and biotechnology company segment is expected to hold the largest share of the market owing to the increasing need for pharmacovigilance and drug safety software solutions in these companies.

Geographically, North America is expected to dominate the global pharmacovigilance and drug safety software market owing to the presence of a large number of pharmaceutical and biotechnology companies and stringent regulatory requirements. However, the Asia Pacific region is expected to witness significant growth during the forecast period due to the increasing number of clinical trials being conducted in this region and the increasing focus on patient safety and risk management.

Overall, the pharmacovigilance and drug safety software market is expected to experience steady growth during the forecast period due to the increasing demand for pharmacovigilance and drug safety solutions and the growing emphasis on patient safety and risk management.

Key Players in the Global Pharmacovigilance and Drug Safety Software Market

The report gives an in-depth analysis of the key players involved in the global pharmacovigilance and drug safety software market. The companies included in the market are as follows:
  • IQVIA
  • Accenture
  • Cognizant
  • Laboratory Corporation of America Holdings
  • IBM
  • ARIS Global
  • ICON Plc.
  • Capgemini
  • Oracle
  • Parexel International Corporation
  • Ab Cube
  • Extedo GmbH
  • Ennov Solutions Inc.


1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Pharmacovigilance and Drug Safety Software Market Overview
3.1 Global Pharmacovigilance and Drug Safety Software Market Historical Value (2016-2022)
3.2 Global Pharmacovigilance and Drug Safety Software Market Forecast Value (2023-2031)
4 Global Pharmacovigilance and Drug Safety Software Market Landscape
4.1 Global Pharmacovigilance and Drug Safety Software Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 Global Pharmacovigilance and Drug Safety Software Product Landscape
4.2.1 Analysis by Functionality
4.2.2 Analysis by Mode of Mode of Delivery
4.2.3 Analysis by End User
5 Global Pharmacovigilance and Drug Safety Software Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.3 Porter’s Five Forces Model
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 Global Pharmacovigilance and Drug Safety Software Market Segmentation
6.1 Global Pharmacovigilance and Drug Safety Software Market by Functionality
6.1.1 Market Overview
6.1.2 Adverse Event Reporting Software
6.1.3 Drug Safety Audits Software
6.1.4 Issue Tracking Software
6.1.5 Fully Integrated Software
6.2 Global Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
6.2.1 Market Overview
6.2.2 On-Premises Delivery
6.2.3 On-Demand/Cloud Based (SaaS) Delivery
6.3 Global Pharmacovigilance and Drug Safety Software Market by End User
6.3.1 Market Overview
6.3.2 Pharma and Biotech Companies
6.3.3 Contract Research Organizations (CROs)
6.3.4 Business Process Outsourcing (BPO) Firms
6.3.5 Others
6.4 Global Pharmacovigilance and Drug Safety Software Market by Region
6.4.1 Market Overview
6.4.2 North America
6.4.3 Europe
6.4.4 Asia Pacific
6.4.5 Latin America
6.4.6 Middle East and Africa
7 North America Pharmacovigilance and Drug Safety Software Market
7.1 Market Share by Country
7.2 United States of America
7.3 Canada
8 Europe Pharmacovigilance and Drug Safety Software Market
8.1 Market Share by Country
8.2 United Kingdom
8.3 Germany
8.4 France
8.5 Italy
8.6 Others
9 Asia Pacific Pharmacovigilance and Drug Safety Software Market
9.1 Market Share by Country
9.2 China
9.3 Japan
9.4 India
9.5 ASEAN
9.6 Australia
9.7 Others
10 Latin America Pharmacovigilance and Drug Safety Software Market
10.1 Market Share by Country
10.2 Brazil
10.3 Argentina
10.4 Mexico
10.5 Others
11 Middle East and Africa Pharmacovigilance and Drug Safety Software Market
11.1 Market Share by Country
11.2 Saudi Arabia
11.3 United Arab Emirates
11.4 Nigeria
11.5 South Africa
11.6 Others
12 Patent Analysis
12.1 Analysis by Type of Patent
12.2 Analysis by Publication year
12.3 Analysis by Issuing Authority
12.4 Analysis by Patent Age
12.5 Analysis by CPC Analysis
12.6 Analysis by Patent Valuation
12.7 Analysis by Key Players
13 Grants Analysis
13.1 Analysis by year
13.2 Analysis by Amount Awarded
13.3 Analysis by Issuing Authority
13.4 Analysis by Grant Application
13.5 Analysis by Funding Institute
13.6 Analysis by NIH Departments
13.7 Analysis by Recipient Organization
14 Funding Analysis
14.1 Analysis by Funding Instances
14.2 Analysis by Type of Funding
14.3 Analysis by Funding Amount
14.4 Analysis by Leading Players
14.5 Analysis by Leading Investors
14.6 Analysis by Geography
15 Partnership and Collaborations Analysis
15.1 Analysis by Partnership Instances
15.2 Analysis by Type of Partnership
15.3 Analysis by Leading Players
15.4 Analysis by Geography
16 Regulatory Framework
16.1 Regulatory Overview
16.1.1 US FDA
16.1.2 EU EMA
16.1.3 INDIA CDSCO
16.1.4 JAPAN PMDA
16.1.5 Others
17 Supplier Landscape
17.1 IQVIA
17.1.1 Financial Analysis
17.1.2 Product Portfolio
17.1.3 Demographic Reach and Achievements
17.1.4 Mergers and Acquisitions
17.1.5 Certifications
17.2 Accenture
17.2.1 Financial Analysis
17.2.2 Product Portfolio
17.2.3 Demographic Reach and Achievements
17.2.4 Mergers and Acquisitions
17.2.5 Certifications
17.3 Cognizant
17.3.1 Financial Analysis
17.3.2 Product Portfolio
17.3.3 Demographic Reach and Achievements
17.3.4 Mergers and Acquisitions
17.3.5 Certifications
17.4 Laboratory Corporation of America Holdings
17.4.1 Financial Analysis
17.4.2 Product Portfolio
17.4.3 Demographic Reach and Achievements
17.4.4 Mergers and Acquisitions
17.4.5 Certifications
17.5 IBM
17.5.1 Financial Analysis
17.5.2 Product Portfolio
17.5.3 Demographic Reach and Achievements
17.5.4 Mergers and Acquisitions
17.5.5 Certifications
17.6 ARIS Global
17.6.1 Financial Analysis
17.6.2 Product Portfolio
17.6.3 Demographic Reach and Achievements
17.6.4 Mergers and Acquisitions
17.6.5 Certifications
17.7 ICON Plc.
17.7.1 Financial Analysis
17.7.2 Product Portfolio
17.7.3 Demographic Reach and Achievements
17.7.4 Mergers and Acquisitions
17.7.5 Certifications
17.8 Capgemini
17.8.1 Financial Analysis
17.8.2 Product Portfolio
17.8.3 Demographic Reach and Achievements
17.8.4 Mergers and Acquisitions
17.8.5 Certifications
17.9 Oracle
17.9.1 Financial Analysis
17.9.2 Product Portfolio
17.9.3 Demographic Reach and Achievements
17.9.4 Mergers and Acquisitions
17.9.5 Certifications
17.10 Parexel International Corporation
17.10.1 Financial Analysis
17.10.2 Product Portfolio
17.10.3 Demographic Reach and Achievements
17.10.4 Mergers and Acquisitions
17.10.5 Certifications
17.11 Ab Cube
17.11.1 Financial Analysis
17.11.2 Product Portfolio
17.11.3 Demographic Reach and Achievements
17.11.4 Mergers and Acquisitions
17.11.5 Certifications
17.12 Extedo GmbH
17.12.1 Financial Analysis
17.12.2 Product Portfolio
17.12.3 Demographic Reach and Achievements
17.12.4 Mergers and Acquisitions
17.12.5 Certifications
17.13 Ennov Solutions Inc.
17.13.1 Financial Analysis
17.13.2 Product Portfolio
17.13.3 Demographic Reach and Achievements
17.13.4 Mergers and Acquisitions
17.13.5 Certifications
18 Global Pharmacovigilance and Drug Safety Software Market - Distribution Model (Additional Insight)
18.1 Overview
18.2 Potential Distributors
18.3 Key Parameters for Distribution Partner Assessment
19 Key Opinion Leaders (KOL) Insights (Additional Insight)
20 Company Competitiveness Analysis (Additional Insight)
20.1 Very Small Companies
20.2 Small Companies
20.3 Mid-Sized Companies
20.4 Large Companies
20.5 Very Large Companies
21 Payment Methods (Additional Insight)
21.1 Government Funded
21.2 Private Insurance
21.3 Out-of-Pocket

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