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Pharmacovigilance and Drug Safety Software Market: Global Industry Analysis, Trends, Market Size, and Forecasts up to 2030

  • Report

  • 255 Pages
  • October 2023
  • Region: Global
  • Infinium Global Research
  • ID: 5898342
The report on the global pharmacovigilance and drug safety software market provides qualitative and quantitative analysis for the period from 2021-2030. The global pharmacovigilance and drug safety software market was valued at USD 188.14 million in 2022 and is expected to reach USD 311.98 million in 2030, with a CAGR of 5.55% during the forecast period 2023-2030. The study on pharmacovigilance and drug safety software market covers the analysis of the leading geographies such as North America, Europe, Asia Pacific, and RoW for the period of 2021-2030.

Pharmacovigilance, a critical aspect of drug safety, encompasses activities such as data collection, detection, assessment, monitoring, and prevention of adverse effects associated with pharmaceutical products. It is of paramount importance within the life science industry, where strict regulatory compliance is mandatory for drug development, manufacturing, and commercialization. Efficient and effective pharmacovigilance software solutions are essential to ensure the safety and efficacy of pharmaceutical products throughout their lifecycle. The scope of the pharmacovigilance and drug safety software market is broad and continues to grow due to increasing regulatory demands, technological advancements, globalization of drug development, and a growing emphasis on patient safety. This market encompasses pharmaceutical companies, healthcare providers, CROs, and other stakeholders who rely on advanced software solutions to monitor, analyze, and ensure the safety of pharmaceutical products throughout their lifecycle.

Government bodies like the European Medicines Evaluation Agency (EMEA) and the U.S. Food and Drug Administration (FDA) impose rigorous regulations for drug approval, with a primary focus on drug safety. The growing pressure from these regulatory agencies to develop innovative and safe drugs is propelling the growth of the pharmacovigilance and drug safety software market worldwide. Furthermore, the increasing incidence rate of Adverse Drug Reactions (ADRs) is expected to drive market growth. The adoption of pharmacovigilance software is rapidly increasing, especially among outsourcing firms, to ensure safe and effective drug manufacturing. However, a shortage of skilled professionals in the pharmacovigilance field is hindering market growth. Nevertheless, ongoing research and development efforts aimed at creating more effective software solutions and increasing awareness of the benefits of pharmacovigilance and drug safety software are likely to create numerous growth opportunities in the coming years.

From a geographical perspective, North America leads the pharmacovigilance and drug safety software market. This is primarily due to the widespread adoption of pharmacovigilance and drug safety software, a well-developed healthcare infrastructure, and a high demand for new and safe drugs in the region. Additionally, the Asia-Pacific region is experiencing the fastest growth in this market, driven by increased government investments in the pharmaceutical sector, rising demand for pharmacovigilance and drug safety software in hospitals and clinics, and other factors.

Report Findings

1) Drivers

  • The growing pressure from government agencies to develop novel and safe drugs is driving the growth of the pharmacovigilance and drug safety software market.
  • The growing occurrence of rates of Adverse Drug Reactions (ADRS) is anticipated to boost the growth of pharmacovigilance and drug safety software market.

2) Restraints

  • The lack of a skilled workforce in pharmacovigilance is hampering the growth of the pharmacovigilance and drug safety software market.

3) Opportunities

  • The ongoing research and development activity to develop effective software and growing awareness about the benefits of pharmacovigilance and drug safety software are projected to create various growth opportunities in the upcoming year.

Research Methodology

A) Primary Research

The primary research involves extensive interviews and analysis of the opinions provided by the primary respondents. The primary research starts with identifying and approaching the primary respondents.

The primary respondents approached include:

1. Key Opinion Leaders
2. Internal and External subject matter experts
3. Professionals and participants from the industry

The primary research respondents typically include:

1. Executives working with leading companies in the market under review
2. Product/brand/marketing managers
3. CXO level executives
4. Regional/zonal/country managers
5. Vice President level executives.

B) Secondary Research

Secondary research involves extensive exploring through the secondary sources of information available in both the public domain and paid sources. Each research study is based on over 500 hours of secondary research accompanied by primary research. The information obtained through the secondary sources is validated through the crosscheck on various data sources.

The secondary sources of the data typically include:

1. Company reports and publications
2. Government/institutional publications
3. Trade and associations journals
4. Databases such as WTO, OECD, World Bank, and among others.
5. Websites and publications by research agencies

Segments Covered

The global pharmacovigilance and drug safety software market is segmented on the basis of software, mode of delivery, and end user.

The Global Pharmacovigilance and Drug Safety Software Market by Software

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

The Global Pharmacovigilance and Drug Safety Software Market by Mode of Delivery

  • On-premise
  • Cloud-based

The Global Pharmacovigilance and Drug Safety Software Market by End User

  • Pharma & Biotech Companies
  • Contract Research Organizations (CROS)
  • Pharmacovigilance Service Providers
  • Business Process Outsourcing (BPO) Firms

Company Profiles

The companies covered in the report include:

  • IQVIA Inc
  • Oracle Corporation
  • Honeywell International Inc.
  • AB Cube S.A.S.
  • ArisGlobal
  • EXTEDO
  • Ennov
  • United BioSource LLC
  • Sarjen
  • Others

What does this Report Deliver?

1. Comprehensive analysis of the global as well as regional markets of the pharmacovigilance and drug safety software market.

2. Complete coverage of all the segments in the pharmacovigilance and drug safety software market to analyze the trends, developments in the global market and forecast of market size up to 2030.

3. Comprehensive analysis of the companies operating in the global pharmacovigilance and drug safety software market. The company profile includes analysis of product portfolio, revenue, SWOT analysis and latest developments of the company.

4. The Growth Matrix presents an analysis of the product segments and geographies that market players should focus to invest, consolidate, expand and/or diversify.

Table of Contents

Chapter 1. Preface
1.1. Report Description
1.2. Research Methods
1.3. Research Approaches
Chapter 2. Executive Summary
2.1. Pharmacovigilance and Drug Safety Software Market Highlights
2.2. Pharmacovigilance and Drug Safety Software Market Projection
2.3. Pharmacovigilance and Drug Safety Software Market Regional Highlights
Chapter 3. Global Pharmacovigilance and Drug Safety Software Market Overview
3.1. Introduction
3.2. Market Dynamics
3.2.1. Drivers
3.2.2. Restraints
3.2.3. Opportunities
3.3. Porter's Five Forces Analysis
3.4. Growth Matrix Analysis
3.4.1. Growth Matrix Analysis by Software
3.4.2. Growth Matrix Analysis by Mode of Delivery
3.4.3. Growth Matrix Analysis by End User
3.4.4. Growth Matrix Analysis by Region
3.5. Value Chain Analysis of Pharmacovigilance and Drug Safety Software Market
Chapter 4. Pharmacovigilance and Drug Safety Software Market Macro Indicator Analysis
Chapter 5. Company Profiles and Competitive Landscape
5.1. Competitive Landscape in the Global Pharmacovigilance and Drug Safety Software Market
5.2. Companies Profiles
5.2.1. IQVIA Inc
5.2.2. Oracle Corporation
5.2.3. Honeywell International Inc.
5.2.4. AB Cube S.A.S.
5.2.5. ArisGlobal
5.2.6. EXTEDO
5.2.7. Ennov
5.2.8. United BioSource LLC
5.2.9. Sarjen
5.2.10. Others
Chapter 6. Global Pharmacovigilance and Drug Safety Software Market by Software
6.1. Drug Adverse Event Reporting Software
6.2. Issue Tracking Software
6.3. Fully Integrated Software and Drug Safety Audits Software
Chapter 7. Global Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
7.1. On-premise
7.2. Cloud-based
Chapter 8. Global Pharmacovigilance and Drug Safety Software Market by End User
8.1. Pharma & Biotech Companies
8.2. Contract Research Organizations (CROS)
8.3. Pharmacovigilance Service Providers
8.4. Business Process Outsourcing (BPO) Firms
Chapter 9. Global Pharmacovigilance and Drug Safety Software Market by Region 2023-2030
9.1. North America
9.1.1. North America Pharmacovigilance and Drug Safety Software Market by Software
9.1.2. North America Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.1.3. North America Pharmacovigilance and Drug Safety Software Market by End User
9.1.4. North America Pharmacovigilance and Drug Safety Software Market by Country
9.1.4.1. The U.S. Pharmacovigilance and Drug Safety Software Market
9.1.4.1.1. The U.S. Pharmacovigilance and Drug Safety Software Market by Software
9.1.4.1.2. The U.S. Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.1.4.1.3. The U.S. Pharmacovigilance and Drug Safety Software Market by End User
9.1.4.2. Canada Pharmacovigilance and Drug Safety Software Market
9.1.4.2.1. Canada Pharmacovigilance and Drug Safety Software Market by Software
9.1.4.2.2. Canada Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.1.4.2.3. Canada Pharmacovigilance and Drug Safety Software Market by End User
9.1.4.3. Mexico Pharmacovigilance and Drug Safety Software Market
9.1.4.3.1. Mexico Pharmacovigilance and Drug Safety Software Market by Software
9.1.4.3.2. Mexico Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.1.4.3.3. Mexico Pharmacovigilance and Drug Safety Software Market by End User
9.2. Europe
9.2.1. Europe Pharmacovigilance and Drug Safety Software Market by Software
9.2.2. Europe Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.2.3. Europe Pharmacovigilance and Drug Safety Software Market by End User
9.2.4. Europe Pharmacovigilance and Drug Safety Software Market by Country
9.2.4.1. Germany Pharmacovigilance and Drug Safety Software Market
9.2.4.1.1. Germany Pharmacovigilance and Drug Safety Software Market by Software
9.2.4.1.2. Germany Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.2.4.1.3. Germany Pharmacovigilance and Drug Safety Software Market by End User
9.2.4.2. United Kingdom Pharmacovigilance and Drug Safety Software Market
9.2.4.2.1. United Kingdom Pharmacovigilance and Drug Safety Software Market by Software
9.2.4.2.2. United Kingdom Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.2.4.2.3. United Kingdom Pharmacovigilance and Drug Safety Software Market by End User
9.2.4.3. France Pharmacovigilance and Drug Safety Software Market
9.2.4.3.1. France Pharmacovigilance and Drug Safety Software Market by Software
9.2.4.3.2. France Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.2.4.3.3. France Pharmacovigilance and Drug Safety Software Market by End User
9.2.4.4. Italy Pharmacovigilance and Drug Safety Software Market
9.2.4.4.1. Italy Pharmacovigilance and Drug Safety Software Market by Software
9.2.4.4.2. Italy Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.2.4.4.3. Italy Pharmacovigilance and Drug Safety Software Market by End User
9.2.4.5. Rest of Europe Pharmacovigilance and Drug Safety Software Market
9.2.4.5.1. Rest of Europe Pharmacovigilance and Drug Safety Software Market by Software
9.2.4.5.2. Rest of Europe Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.2.4.5.3. Rest of Europe Pharmacovigilance and Drug Safety Software Market by End User
9.3. Asia Pacific
9.3.1. Asia Pacific Pharmacovigilance and Drug Safety Software Market by Software
9.3.2. Asia Pacific Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.3.3. Asia Pacific Pharmacovigilance and Drug Safety Software Market by End User
9.3.4. Asia Pacific Pharmacovigilance and Drug Safety Software Market by Country
9.3.4.1. China Pharmacovigilance and Drug Safety Software Market
9.3.4.1.1. China Pharmacovigilance and Drug Safety Software Market by Software
9.3.4.1.2. China Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.3.4.1.3. China Pharmacovigilance and Drug Safety Software Market by End User
9.3.4.2. Japan Pharmacovigilance and Drug Safety Software Market
9.3.4.2.1. Japan Pharmacovigilance and Drug Safety Software Market by Software
9.3.4.2.2. Japan Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.3.4.2.3. Japan Pharmacovigilance and Drug Safety Software Market by End User
9.3.4.3. India Pharmacovigilance and Drug Safety Software Market
9.3.4.3.1. India Pharmacovigilance and Drug Safety Software Market by Software
9.3.4.3.2. India Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.3.4.3.3. India Pharmacovigilance and Drug Safety Software Market by End User
9.3.4.4. South Korea Pharmacovigilance and Drug Safety Software Market
9.3.4.4.1. South Korea Pharmacovigilance and Drug Safety Software Market by Software
9.3.4.4.2. South Korea Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.3.4.4.3. South Korea Pharmacovigilance and Drug Safety Software Market by End User
9.3.4.5. Australia Pharmacovigilance and Drug Safety Software Market
9.3.4.5.1. Australia Pharmacovigilance and Drug Safety Software Market by Software
9.3.4.5.2. Australia Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.3.4.5.3. Australia Pharmacovigilance and Drug Safety Software Market by End User
9.3.4.6. Rest of Asia-Pacific Pharmacovigilance and Drug Safety Software Market
9.3.4.6.1. Rest of Asia-Pacific Pharmacovigilance and Drug Safety Software Market by Software
9.3.4.6.2. Rest of Asia-Pacific Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.3.4.6.3. Rest of Asia-Pacific Pharmacovigilance and Drug Safety Software Market by End User
9.4. RoW
9.4.1. RoW Pharmacovigilance and Drug Safety Software Market by Software
9.4.2. RoW Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.4.3. RoW Pharmacovigilance and Drug Safety Software Market by End User
9.4.4. RoW Pharmacovigilance and Drug Safety Software Market by Sub-region
9.4.4.1. Latin America Pharmacovigilance and Drug Safety Software Market
9.4.4.1.1. Latin America Pharmacovigilance and Drug Safety Software Market by Software
9.4.4.1.2. Latin America Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.4.4.1.3. Latin America Pharmacovigilance and Drug Safety Software Market by End User
9.4.4.2. Middle East Pharmacovigilance and Drug Safety Software Market
9.4.4.2.1. Middle East Pharmacovigilance and Drug Safety Software Market by Software
9.4.4.2.2. Middle East Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.4.4.2.3. Middle East Pharmacovigilance and Drug Safety Software Market by End User
9.4.4.3. Africa Pharmacovigilance and Drug Safety Software Market
9.4.4.3.1. Africa Pharmacovigilance and Drug Safety Software Market by Software
9.4.4.3.2. Africa Pharmacovigilance and Drug Safety Software Market by Mode of Delivery
9.4.4.3.3. Africa Pharmacovigilance and Drug Safety Software Market by End User

Companies Mentioned

  • IQVIA Inc
  • Oracle Corporation
  • Honeywell International Inc.
  • AB Cube S.A.S.
  • ArisGlobal
  • EXTEDO
  • Ennov
  • United BioSource LLC
  • Sarjen
  • Others

Table Information