Pharmacovigilance and Drug Safety Software Market Report Scope & Overview:

The Pharmacovigilance and Drug Safety Software Market Size was valued at USD 6.83 billion in 2022, and is expected to reach USD 14.86 billion by 2030, and grow at a CAGR of 10.2% over the forecast period 2023-2030.

To identify, evaluate, comprehend, and prevent harmful effects associated to medications, medical devices, and pharmaceutical products, pharmacovigilance and drug safety software is utilised. Health organisations all around the world use it to guarantee compliance with international regulations, hasten the development of science-based safety judgments, combine safety and risk management, and reduce pharmacovigilance costs. To address the specific business and product safety needs of health businesses, service providers now deliver adaptable, creative, and scalable variations.

Pharmacovigilance and Drug Safety Software Market Revenue Analysis

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Pharmacovigilance, commonly referred to as drug safety, is the branch of research that focuses on identifying, evaluating, and preventing adverse effects of pharmaceuticals. The primary functions of pharmacovigilance and drug safety software are the creation, classification, and review of pharmacovigilance data, which increases healthcare workers' knowledge and awareness. The capability of the software is categorized into four categories: issue tracking, drug safety audits, adverse event reporting, and fully integrated software.



  • Adverse Drug Reactions Are Now More Common.

  • Outsourcing Companies Are Using Pharmacovigilance Software More Frequently


  • Pharmacovigilance is not widely known


  • Increasing use of pharmaceutical monitoring software by outsourcing firms

  • the market is anticipated to grow due to the increased prevalence of chronic disorders.


  • Insufficiently qualified pharmacovigilance personnel


As a result of the COVID-19 epidemic, some businesses have introduced new issue tracking systems. For example, in May 2021, Dialog Solutions unveiled Drug Safety Triage, the pharmacovigilance literature monitoring system of the future. A new pharmacovigilance reporting platform for COVID-19 treatments was introduced in May 2020 by the Medicines and Healthcare Products Regulatory Agency under the name "Yellow Card COVID-19 reporting portal." In an effort to create a body of information about the safest ways to treat the disease, a new online reporting platform may monitor any negative effects resulting from the usage of any medicines used to treat COVID-19. As a result, the introduction of such a product can benefit the market sector in question. 

By Functionality

The market is divided into four segments: issue tracking software, adverse event reporting software, and fully integrated software. The market share leader is the fully Integrated Software sector.

By Delivery

Market segments include on-premises delivery mode and on-demand/cloud delivery mode. The most notable CAGR in the foreseeable future is expected to be in the on-demand/cloud-based delivery mode.

By End-User

Contract research organizations (CROS), business process outsourcing (BPO) companies, pharmaceutical and biotechnology companies, and other pharmacovigilance service providers make up the two halves of the industry. Business Process Outsourcing (BPO) Companies are predicted to hold the biggest market share, followed by Contract Research Organizations (CROS).


By Functionality

  • Adverse Event Reporting Software

  • Drug Safety Audits Software

  • Issue Tracking Software

  • Fully Integrated Software

By Delivery

  • On-Premise Delivery Mode

  • On-Demand/Cloud-Based

By End-User

  • Pharma and Biotech Companies

  • Contract Research Organizations (CROS)

  • Business Process Outsourcing (BPO) Firms

Pharmacovigilance and Drug Safety Software Market Segmentation Analysis

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The market for pharmaceutical vigilance and drug safety software is divided into four regions: North America, Europe, Asia-Pacific, and the rest of the world (RoW). The market for pharmacovigilance and drug safety software is anticipated to be dominated by North America. Asia-Pacific is anticipated to grow at a quicker pace over the estimated period due to rising expenditure in the research & development process and acceptance of solutions in the area.

Increasing regional competition in the Pharmacovigilance and Drug Safety Software Market is anticipated to fuel future market expansion. Additionally, it is anticipated that during the research period, leading vendors will increase their investments in product capabilities and company expansion.


  • North America

    • USA

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • The Netherlands

    • Rest of Europe

  • Asia-Pacific

    • Japan

    • south Korea

    • China

    • India

    • Australia

    • Rest of Asia-Pacific

  • The Middle East & Africa

    • Israel

    • UAE

    • South Africa

    • Rest of Middle East & Africa

  • Latin America

    • Brazil

    • Argentina

    • Rest of Latin America


The Major key players are Aris Global, Capgemini, Accenture, Cognizant, IBM, Laboratory Corporation of America Holdings, Oracle, ICON Plc., Parexel International Corporation, IQVIA and other players.

Accenture-Company Financial Analysis

Company Landscape Analysis

Pharmacovigilance and Drug Safety Software Market Report Scope:

Report Attributes Details
Market Size in 2022 US$ 6.83 Billion
Market Size by 2030 US$ 14.86 Billion
CAGR CAGR of 10.2% From 2023 to 2030
Base Year 2022
Forecast Period 2023-2030
Historical Data 2020-2021
Report Scope & Coverage Market Size, Segments Analysis, Competitive  Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook
Key Segments • By Functionality (Adverse Event Reporting Software, Drug Safety Audits Software, Issue Tracking Software, Fully Integrated Software)
• By Delivery (On-Premise Delivery Mode, On-Demand/Cloud-Based)
• By End-User (Pharma and Biotech Companies, Contract Research Organizations (CROS), Business Process Outsourcing (BPO) Firms)
Regional Analysis/Coverage North America (USA, Canada, Mexico), Europe
(Germany, UK, France, Italy, Spain, Netherlands,
Rest of Europe), Asia-Pacific (Japan, South Korea,
China, India, Australia, Rest of Asia-Pacific), The
Middle East & Africa (Israel, UAE, South Africa,
Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America)
Company Profiles Aris Global, Capgemini, Accenture, Cognizant, IBM, Laboratory Corporation of America Holdings, Oracle, ICON Plc., Parexel International Corporation, IQVIA.
DRIVERS • Adverse Drug Reactions Are Now More Common.
• Outsourcing Companies Are Using Pharmacovigilance Software More Frequently
RESTRAINTS • Pharmacovigilance is not widely known

Frequently Asked Questions

Ans: The Pharmacovigilance and Drug Safety Software market is expected to grow at a CAGR of 10.2% over the forecast period 2023-2030.

 Pharmacovigilance is not widely known are the restraints of the market.

 Pharmacovigilance and Drug Safety Software Market is divided into three segments and they are By Functionality, By Delivery, and By End-User 

 The market for pharmacovigilance and drug safety software is anticipated to be dominated by North America.

Ans: The Pharmacovigilance and Drug Safety Software Market size was valued at US$ 6.83 billion in 2022.

Table of Contents

1. Introduction

1.1 Market Definition

1.2 Scope

1.3 Research Assumptions

2. Research Methodology

3. Market Dynamics

3.1 Drivers

3.2 Restraints

3.3 Opportunities

3.4 Challenges

4. Impact Analysis

4.1 COVID-19 Impact Analysis

4.2 Impact of Ukraine- Russia war

4.3 Impact of ongoing Recession

4.3.1 Introduction

4.3.2 Impact on major economies US Canada Germany France United Kingdom China Japan South Korea Rest of the World

5. Value Chain Analysis

6. Porter’s 5 forces model

7.  PEST Analysis


8. Pharmacovigilance and Drug Safety Software Market Segmentation, By Functionality

8.1 Adverse Event Reporting Software

8.2 Drug Safety Audits Software

8.3 Issue Tracking Software

8.4 Fully Integrated Software

9. Pharmacovigilance and Drug Safety Software Market Segmentation, By Delivery

9.1 On-Premise Delivery Mode

9.2 On-Demand/Cloud-Based

10. Pharmacovigilance and Drug Safety Software Market Segmentation, By End-User

10.1 Pharma and Biotech Companies

10.2 Contract Research Organizations (CROS)

10.3 Business Process Outsourcing (BPO) Firms

11. Regional Analysis

11.1 Introduction

11.2 North America

11.2.1 USA

11.2.2 Canada

11.2.3 Mexico

11.3 Europe

11.3.1 Germany

11.3.2 UK

11.3.3 France

11.3.4 Italy

11.3.5 Spain

11.3.6 The Netherlands

11.3.7 Rest of Europe

11.4 Asia-Pacific

11.4.1 Japan

11.4.2 South Korea

11.4.3 China

11.4.4 India

11.4.5 Australia

11.4.6 Rest of Asia-Pacific

11.5 The Middle East & Africa

11.5.1 Israel

11.5.2 UAE

11.5.3 South Africa

11.5.4 Rest

11.6 Latin America

11.6.1 Brazil

11.6.2 Argentina

11.6.3 Rest of Latin America

12. Company Profiles

12.1 Aris Global

              12.1.1 Financial

12.1.2 Products/ Services Offered

12.1.3 SWOT Analysis

12.1.4 The SNS view

12.2 Capgemini

12.3 Accenture

12.4 Cognizant

12.5 IBM

12.6 Laboratory Corporation of America Holdings

12.7 Oracle

12.8 ICON Plc.

12.9 Parexel International Corporation

12.10 IQVIA

13. Competitive Landscape

13.1 Competitive Benchmark

13.2 Market Share Analysis

13.3 Recent Developments

14. Conclusion

An accurate research report requires proper strategizing as well as implementation. There are multiple factors involved in the completion of good and accurate research report and selecting the best methodology to compete the research is the toughest part. Since the research reports we provide play a crucial role in any company’s decision-making process, therefore we at SNS Insider always believe that we should choose the best method which gives us results closer to reality. This allows us to reach at a stage wherein we can provide our clients best and accurate investment to output ratio.

Each report that we prepare takes a timeframe of 350-400 business hours for production. Starting from the selection of titles through a couple of in-depth brain storming session to the final QC process before uploading our titles on our website we dedicate around 350 working hours. The titles are selected based on their current market cap and the foreseen CAGR and growth.


The 5 steps process:

Step 1: Secondary Research:

Secondary Research or Desk Research is as the name suggests is a research process wherein, we collect data through the readily available information. In this process we use various paid and unpaid databases which our team has access to and gather data through the same. This includes examining of listed companies’ annual reports, Journals, SEC filling etc. Apart from this our team has access to various associations across the globe across different industries. Lastly, we have exchange relationships with various university as well as individual libraries.

Secondary Research

Step 2: Primary Research

When we talk about primary research, it is a type of study in which the researchers collect relevant data samples directly, rather than relying on previously collected data.  This type of research is focused on gaining content specific facts that can be sued to solve specific problems. Since the collected data is fresh and first hand therefore it makes the study more accurate and genuine.

We at SNS Insider have divided Primary Research into 2 parts.

Part 1 wherein we interview the KOLs of major players as well as the upcoming ones across various geographic regions. This allows us to have their view over the market scenario and acts as an important tool to come closer to the accurate market numbers. As many as 45 paid and unpaid primary interviews are taken from both the demand and supply side of the industry to make sure we land at an accurate judgement and analysis of the market.

This step involves the triangulation of data wherein our team analyses the interview transcripts, online survey responses and observation of on filed participants. The below mentioned chart should give a better understanding of the part 1 of the primary interview.

Primary Research

Part 2: In this part of primary research the data collected via secondary research and the part 1 of the primary research is validated with the interviews from individual consultants and subject matter experts.

Consultants are those set of people who have at least 12 years of experience and expertise within the industry whereas Subject Matter Experts are those with at least 15 years of experience behind their back within the same space. The data with the help of two main processes i.e., FGDs (Focused Group Discussions) and IDs (Individual Discussions). This gives us a 3rd party nonbiased primary view of the market scenario making it a more dependable one while collation of the data pointers.

Step 3: Data Bank Validation

Once all the information is collected via primary and secondary sources, we run that information for data validation. At our intelligence centre our research heads track a lot of information related to the market which includes the quarterly reports, the daily stock prices, and other relevant information. Our data bank server gets updated every fortnight and that is how the information which we collected using our primary and secondary information is revalidated in real time.

Data Bank Validation

Step 4: QA/QC Process

After all the data collection and validation our team does a final level of quality check and quality assurance to get rid of any unwanted or undesired mistakes. This might include but not limited to getting rid of the any typos, duplication of numbers or missing of any important information. The people involved in this process include technical content writers, research heads and graphics people. Once this process is completed the title gets uploader on our platform for our clients to read it.

Step 5: Final QC/QA Process:

This is the last process and comes when the client has ordered the study. In this process a final QA/QC is done before the study is emailed to the client. Since we believe in giving our clients a good experience of our research studies, therefore, to make sure that we do not lack at our end in any way humanly possible we do a final round of quality check and then dispatch the study to the client.

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