Drug Safety Software Market: By Functionality (Case Data Collection and Management, Adverse Event Reporting and Analysis, Signal Detection and Safety Risk Assessment, and Others), By Mode of Delivery (Cloud-Based and On-Premises), By End User (Pharmaceutical and Biotechnology Companies, Contract Research Organizations, Business Process Outsourcing Firms, Pharmacovigilance Service Providers, and Others), and Geography

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Drug Safety Software Market size was valued at USD 201.6 million in 2023 and is anticipated to grow at a CAGR of 8.4% over 2024-2030. Drug Safety Software refers to a specialized category of software applications and tools designed to facilitate the management, monitoring, and reporting of pharmaceutical and biotechnology companies' drug safety data and regulatory compliance. Ensuring the safety of drugs and medications is a critical aspect of the pharmaceutical industry, as regulatory agencies around the world require thorough monitoring and reporting of adverse events associated with drugs from clinical trials through post-market surveillance.

Stringent regulatory requirements are a significant driver behind the growth of revenues in the drug safety software market. Regulatory agencies like the FDA and EMA impose rigorous standards and reporting obligations on pharmaceutical and biotechnology companies to monitor and ensure the safety of drugs throughout their lifecycle. This includes the collection, assessment, and reporting of adverse events and safety data. To meet these stringent requirements, pharmaceutical companies and regulatory bodies increasingly turn to advanced drug safety software solutions. Moreover, the growing pharmaceutical industry is a significant driver behind the sales of drug safety software. As the pharmaceutical sector expands globally, with increasing research and development efforts and a continuous stream of new drug candidates, the need for effective pharmacovigilance and safety monitoring becomes paramount. Pharmaceutical companies are under constant pressure to ensure the safety and efficacy of their products, from clinical trials through post-market surveillance. Drug safety software plays a pivotal role in this process by enabling efficient collection, analysis, and reporting of adverse events and safety data.

However, the initial costs associated with implementing drug safety software, including licensing, customization, training, and integration with existing systems, can be substantial, deterring some organizations, particularly smaller ones, from adoption. Meanwhile, factors such as increasing healthcare IT investments and outsourcing of pharmacovigilance activities create significant opportunities for the growth of the drug safety software market. Several key manufacturers are developing innovative solutions to cater to the pharmaceutical industry. For instance, in May 2023, JNPMEDI launched a new drug safety management solution, 'Maven Safety'.

Drug Safety Software Market Key Developments:      
  • In November 2022, Clinigen Limited acquired Drug Safety Navigator Inc. to add vital pharmacovigilance capabilities to its leading pharma services offering for pharmaceutical and biotech clients.
  • In February 2022, Stanley Capital Partners LLP acquired Drug Safety and Pharmacovigilance Services Solutions to broaden its service offerings.

Drug Safety Software Market Summary

Study Period

2024-2030

Base Year

2023

CAGR

8.4%

Largest Market

North America

Fastest Growing Market

North America
Drug Safety Software Market Dynamics

Escalating drug approval processes are significant drivers of growth of the drug safety software market revenues. As the number of approved drugs increases, the pharmacovigilance process becomes paramount. Hence, several key companies are developing innovative drug safety, otherwise known as pharmacovigilance software for monitoring and reporting the safety of a drug effectively. Moreover, the increasing volume of adverse event data further drives the demand for drug safety software in the market. The risk of adverse drug events rises with medicine errors and other reasons, which eventually increase the volume of the adverse event data. These complex data need to be effectively handled to provide safety to the patients. adverse event. Therefore, the government is investing hugely in pharmaceutical industries to adopt advanced software solutions including drug safety software, which ultimately drive the market growth.

Drug Safety Software Market Segmentation

By Functionality
  • Case Data Collection and Management
  • Adverse Event Reporting and Analysis
  • Signal Detection and Safety Risk Assessment
By Mode of Delivery
  • Cloud-based
  • On-premises
By End User
  • Pharmaceuticals & Biotechnology Companies
  • Contract Research Organizations
  • Business Process Outsourcing Firms
  • Pharmacovigilance Service Providers
  • Others

Frequently Asked Questions

The drug safety software market size was valued at USD 201.6 million in 2023

The globalization of clinical trials coupled with the rising incidence of adverse events is creating significant opportunities for companies to enhance their revenue over the forecast years.

IQVIA, Accenture, Cognizant, Sparta Systems, Inc., Laboratory Corporation of America Holdings, IBM, ICON Plc., Capgemini, Oracle, Parexel International Corporation, Ennov Solutions Inc., Extedo GmbH, United BioSource Corporation, Ab Cube, ArisGlobal are a few companies operating in drug safety software market.

The integration of artificial intelligence (AI) and machine learning (ML) into drug safety software and the rising adoption of cloud-based drug safety software stand out as significant trends within the drug safety software market.

Key Features of the Reports

  • The drug safety software market report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
1.Executive Summary
2.Global Drug Safety Software Market Introduction 
2.1.Global Drug Safety Software Market  - Taxonomy
2.2.Global Drug Safety Software Market  - Definitions
2.2.1.Functionality
2.2.2.Application
2.2.3.End User
2.2.4.Region
3.Global Drug Safety Software Market Dynamics
3.1. Drivers
3.2. Restraints
3.3. Opportunities/Unmet Needs of the Market
3.4. Trends
3.5. Product Landscape
3.6. New Product Launches
3.7. Impact of COVID 19 on Market
4.Global Drug Safety Software Market Analysis, 2019 - 2023 and Forecast 2024 - 2030
4.1.  Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
4.2.  Year-Over-Year (Y-o-Y) Growth Analysis (%) 
4.3.  Market Opportunity Analysis 
5.Global Drug Safety Software Market  By Functionality, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
5.1. Case Data Collection and Management
5.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.1.3. Market Opportunity Analysis 
5.2. Adverse Event Reporting and Analysis
5.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.2.3. Market Opportunity Analysis 
5.3. Signal Detection and Safety Risk Assessment
5.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.3.3. Market Opportunity Analysis 
6.Global Drug Safety Software Market  By Application, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
6.1. Cloud-based
6.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.1.3. Market Opportunity Analysis 
6.2. On-premises
6.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.2.3. Market Opportunity Analysis 
7.Global Drug Safety Software Market  By End User, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
7.1. Pharmaceuticals & Biotechnology Companies
7.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.1.3. Market Opportunity Analysis 
7.2. Contract Research Organizations
7.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.2.3. Market Opportunity Analysis 
7.3. Business Process Outsourcing Firms
7.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.3.3. Market Opportunity Analysis 
7.4. Pharmacovigilance Service Providers
7.4.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.4.3. Market Opportunity Analysis 
7.5. Others
7.5.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.5.3. Market Opportunity Analysis 
8.Global Drug Safety Software Market  By Region, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
8.1. North America
8.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.1.3. Market Opportunity Analysis 
8.2. Europe
8.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.2.3. Market Opportunity Analysis 
8.3. Asia Pacific (APAC)
8.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.3.3. Market Opportunity Analysis 
8.4. Middle East and Africa (MEA)
8.4.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.4.3. Market Opportunity Analysis 
8.5. Latin America
8.5.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.5.3. Market Opportunity Analysis 
9.North America Drug Safety Software Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
9.1. Functionality Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.1.1.Case Data Collection and Management
9.1.2.Adverse Event Reporting and Analysis
9.1.3.Signal Detection and Safety Risk Assessment
9.2.  Application Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.2.1.Cloud-based
9.2.2.On-premises
9.3.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.3.1.Pharmaceuticals & Biotechnology Companies
9.3.2.Contract Research Organizations
9.3.3.Business Process Outsourcing Firms
9.3.4.Pharmacovigilance Service Providers
9.3.5.Others
9.4.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.4.1.United States of America (USA)
9.4.2.Canada
10.Europe Drug Safety Software Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
10.1. Functionality Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.1.1.Case Data Collection and Management
10.1.2.Adverse Event Reporting and Analysis
10.1.3.Signal Detection and Safety Risk Assessment
10.2.  Application Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.2.1.Cloud-based
10.2.2.On-premises
10.3.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.3.1.Pharmaceuticals & Biotechnology Companies
10.3.2.Contract Research Organizations
10.3.3.Business Process Outsourcing Firms
10.3.4.Pharmacovigilance Service Providers
10.3.5.Others
10.4.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.4.1.Germany
10.4.2.France
10.4.3.Italy
10.4.4.United Kingdom (UK)
10.4.5.Spain
11.Asia Pacific (APAC) Drug Safety Software Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
11.1. Functionality Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.1.1.Case Data Collection and Management
11.1.2.Adverse Event Reporting and Analysis
11.1.3.Signal Detection and Safety Risk Assessment
11.2.  Application Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.2.1.Cloud-based
11.2.2.On-premises
11.3.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.3.1.Pharmaceuticals & Biotechnology Companies
11.3.2.Contract Research Organizations
11.3.3.Business Process Outsourcing Firms
11.3.4.Pharmacovigilance Service Providers
11.3.5.Others
11.4.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.4.1.China
11.4.2.India
11.4.3.Australia and New Zealand (ANZ)
11.4.4.Japan
11.4.5.Rest of APAC
12.Middle East and Africa (MEA) Drug Safety Software Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
12.1. Functionality Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.1.1.Case Data Collection and Management
12.1.2.Adverse Event Reporting and Analysis
12.1.3.Signal Detection and Safety Risk Assessment
12.2.  Application Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.2.1.Cloud-based
12.2.2.On-premises
12.3.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.3.1.Pharmaceuticals & Biotechnology Companies
12.3.2.Contract Research Organizations
12.3.3.Business Process Outsourcing Firms
12.3.4.Pharmacovigilance Service Providers
12.3.5.Others
12.4.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.4.1.GCC Countries
12.4.2.South Africa
12.4.3.Rest of MEA
13.Latin America Drug Safety Software Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
13.1. Functionality Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.1.1.Case Data Collection and Management
13.1.2.Adverse Event Reporting and Analysis
13.1.3.Signal Detection and Safety Risk Assessment
13.2.  Application Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.2.1.Cloud-based
13.2.2.On-premises
13.3.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.3.1.Pharmaceuticals & Biotechnology Companies
13.3.2.Contract Research Organizations
13.3.3.Business Process Outsourcing Firms
13.3.4.Pharmacovigilance Service Providers
13.3.5.Others
13.4.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.4.1.Brazil
13.4.2.Mexico
13.4.3.Rest of LA
14. Competition Landscape
14.1.  Market Player Profiles (Introduction, Brand/Product Sales, Financial Analysis, Product Offerings, Key Developments, Collaborations, M & A, Strategies, and SWOT Analysis) 
14.2.1.IQVIA
14.2.2.Accenture
14.2.3.Cognizant
14.2.4.Sparta Systems, Inc.
14.2.5.Laboratory Corporation of America Holdings
14.2.6.IBM
14.2.7.ICON Plc.
14.2.8.Capgemini
14.2.9.Oracle
14.2.10.Parexel International Corporation
14.2.11.Ennov Solutions Inc.
14.2.12.Extedo GmbH
15. Research Methodology 
16. Appendix and Abbreviations 
  • IQVIA
  • Accenture
  • Cognizant
  • Sparta Systems, Inc.
  • Laboratory Corporation of America Holdings
  • IBM
  • ICON Plc.
  • Capgemini
  • Oracle
  • Parexel International Corporation
  • Ennov Solutions Inc.
  • Extedo GmbH
  • United BioSource Corporation
  • Ab Cube
  • ArisGlobal

Adjacent Markets