Summary

Overview
Global Pharmacovigilance and Drug Safety Software Market reached US$ XX billion in 2022 and is expected to reach US$ XX billion by 2030 growing with a CAGR of XX% during the forecast period 2023-2030.
Pharmacovigilance and drug safety software are used to manage drug safety data worldwide. It plays a major role in identifying, reporting, and managing adverse drug reactions (ADRs) as it is the most critical and integral part of clinical research. The drug safety software maintains effective drug regulation systems, clinical practice, and public health programs. The utilization of solutions in pharmacovigilance and drug safety software across numerous outsourcing firms is rising to ensure safe and effective manufacturing.
Government and regulatory authorities worldwide are emphasizing the importance of drug safety and adverse event monitoring. For instance, according to the Centers for Disease Control and Prevention, 2022 issue, adverse drug events cause approximately 1.3 million emergency department visits annually, and about 350,000 patients each year require hospitalization for further treatment after emergency visits for adverse drug events.
The advancements and integration of AI (Artificial Intelligence) and NLP (Natural Language Technology), enhanced the drug safety software capabilities in signal detection and data analysis. Furthermore, rise in the adoption of interconnected software services, growing incidences of adverse drug effects, and growing pressure from government agencies to develop safe and reliable drugs for patients among other factors are expected to boost the global pharmacovigilance and ADR market growth in the forecast period.
Dynamics
Increasing Developments in Pharmacovigilance and Drug Safety Software is Expected to Drive the Market
Increasing development in pharmacovigilance and drug safety software is to upgrade already existing software. The developments include better detection of potential safety issues, improved reporting capabilities, and more efficient algorithms. The drug safety software is achieving more sophisticated specifications in monitoring, analyzing, and managing adverse drug reactions and safety data.
For instance, Merck KGaA has recently adopted ArisGlobal's E2B(R3) compliant solution and safety software suite. The company has upgraded from ARISg 5 to ARISg 7, which provides enhanced compliance features, new processes, and improved productivity. Merck KGaA has been actively involved in the ArisGlobal Industry Standard Practice initiative, leading to the development of better tools and standardized configurations which are now implemented in ARISg 7. The upgradation enhances the efficiency of the existing software which increases the usage by many individuals.
Growing Concerns Regarding ADRs (Adverse Drug Reactions) Are Expected to Drive the Market Growth
Growing concerns over adverse drug reactions are increasing as the side effects of several drugs are on the rise due to quality issues and the usage of illegal chemicals. These adverse drug reactions can lead to severe complications in many individuals. Secondary hospital visits became a new normal as the drugs prescribed cause unwanted complications that can be severe at times in a few people.
For instance, according to the Centers for Disease Control and Prevention, adverse drug events cause approximately 1.3 million emergency department visits annually. About 350,000 patients each year require hospitalization for further treatment after emergency visits for adverse drug events. Older adults are nearly seven times more likely to be hospitalized than younger ones. Few drugs like blood thinners (warfarin), diabetes medications such as insulin, prescription opioids, and seizure medications (phenytoin) are expected to cause adverse drug reactions that require secondary hospital visits.
Lack of Awareness among Healthcare Professionals is Expected to Hamper the Market Growth
Pharmacovigilance and drug safety activities are essential to ensure patient safety. However, lack of awareness, training, and underreporting of adverse drug reactions is expected to be major hindrances in the implementation of pharmacovigilance programs.
A recent article from National Center for Biotechnology Information stated that nearly 68% of doctors, 80% of nurses, and 81% of pharmacists were not aware of the national ADR reporting system of India alone. These numbers are expected severely affect several people who take medication without the knowledge of ADRs.
Segment Analysis
The global pharmacovigilance and drug safety software market is segmented based on mode of delivery, functionality, end-user and region.
Owing to Increase in Product Launches, Cloud Based Product Segment Accounted for Approximately 43.2% of the Pharmacovigilance and Drug Safety Software Market Share
Cloud-based platforms are on the rise as the demand for usage of cloud-based platforms has increased over the years. These platform gives an opportunity to small and medium-sized organizations to access the information present in the software. Drug surveillance is made reliable due to the storage of highly structured data in the software.
For instance, in 2023, United BioSource, LLC, the leading provider of evidence-based research for the biopharma industry, migrated its safety functions from on-premises to Oracle Argus Cloud Service, a trusted safety case management solution. Oracle Argus Cloud Service provides a powerful innovative, agile, and secure technology that can enable us to better manage all safety aspects of even our most complex trials. Using a cloud-based safety solution reduces operational complexities. These market developments increase the cloud-based platform usage by organizations, institutions, etc.
Geographical Penetration
North America Accounted for Approximately 41.3% of the Market Share in 2022, Owing to the Increasing Awareness Programs
The increasing awareness programs and conferences are driving the North America market. Also, North America has a robust information technology sector that has a strong focus on research and development activities related to new software and applications. The presence of key market players such as ArisGlobal LLC, IQVIA, Paraxel International Corporation, etc market shares ensures the North American market growth in the forecast period.
For instance, in 2021, According to Innovative Medicine Initiative, European Programme in Pharmacovigilance and Pharmacoepidemiology, expanded to North America as well other than Europe. The EU2P project aims to improve understanding of the risks and benefits of medicines in large groups of people worldwide. It brought together all the academic, industrial, and regulatory partners in those fields. These programs specifically target audience who can gain knowledge about pharmacovigilance and drug safety management.
Competitive Landscape
The major global players in the pharmacovigilance and drug safety software market include Ennov Solutions Inc., Oracle Corporation, ArisGlobal LLC, EXTEDO, Clinevo Technologies, IQVIA, AB Cube, ICON Plc, Paraxel International Corporation, and Accenture among others.
COVID-19 Impact Analysis
The pandemic had created an urgent need for real-time monitoring and analysis of adverse drugs, especially for COVID-19 drugs and vaccines. It has created a surge in demand for more efficient data analysis, collection, and processing capabilities. Drug safety software providers focused on improving the software to enhance accuracy due to the immediate need to analyze the safety of the drugs that were used for treating COVID-19. Thus, the COVID-19 pandemic has created a surge in market growth.
By Mode of Delivery
• On-Premise
• Cloud-based
• Others
By Functionality
• Issue Tracking Software
• Drug Safety Audit Software
• Adverse Event Reporting Software
• Others
By End User
• Contract Research Organizations (CROs)
• Biotechnological Companies
• Healthcare Providers
• Others
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o U.K.
o France
o Spain
o Italy
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o Australia
o Rest of Asia-Pacific
• Middle East and Africa
Key Developments
• In 2022, Aris Global, a leading provider of life science software with its end-to-end technology platform Lifesphere automated core drug development functions expanded the adoption of Life sphere safety by adding Pegbio Co., Ltd to its customer roster. It aims to bring operations in-house and control drug development through cloud and customized service, authority connection, and bilingual translational capabilities.
• In 2022, Clinigen, a global pharmaceutical services company acquires Drug Safety Navigator Inc. (DSN), a pharmacovigilance service provider that enables Clinigen to add vital pharmacovigilance services along with its leading pharma services to drive value for pharmaceutical and biotech clients.
• In 2022, Stanley Capital Partners LLP acquired MyMeds&Me through its portfolio company Drug Safety and Pharmacovigilance Services Solutions, which will boost the high-quality service offering delivered to clients. It helps in growing technology-enabled platforms and also broadening client-focused service offerings.
Why Purchase the Report?
• To visualize the global pharmacovigilance and drug safety software market segmentation based on mode of delivery, functionality, end-user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of pharmacovigilance and drug safety software market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.
The global pharmacovigilance and drug safety software market report would provide approximately 53 tables, 54 figures, and 195 Pages.
Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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Table of Contents

1. Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Definition and Overview
3. Executive Summary
3.1. Snippet by Mode of Delivery
3.2. Snippet by Functionality
3.3. Snippet by End User
3.4. Snippet by Region
4. Dynamics
4.1. Impacting Factors
4.1.1. Drivers
4.1.1.1. Increasing Developments in Pharmacovigilance and Drug Safety Software
4.1.1.2. Growing Concerns Regarding ADRs (Adverse Drug Reactions)
4.1.2. Restraints
4.1.2.1. Lack of Awareness among Healthcare Professionals
4.1.3. Opportunity
4.1.3.1. Rising Adoption of Cloud-based Technologies
4.1.4. Impact Analysis
5. Industry Analysis
5.1. Porter’s 5 Forces Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
6. COVID-19 Analysis
6.1. Analysis of COVID-19
6.1.1. Scenario Before COVID-19
6.1.2. Scenario During COVID-19
6.1.3. Scenario Post COVID-19
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During the Pandemic
6.5. Manufacturer’s Strategic Initiatives
6.6. Conclusion
7. By Mode of Delivery
7.1. Introduction
7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode of Delivery
7.1.2. Market Attractiveness Index, By Mode of Delivery
7.2. On-Premise
7.2.1. Introduction
7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Cloud-based
7.4. Others
8. By Functionality
8.1. Introduction
8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Functionality
8.1.2. Market Attractiveness Index, By Functionality
8.2. Issue Tracking Software
8.2.1. Introduction
8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Drug Safety Audit Software
8.4. Adverse Event Reporting Software
8.5. Others
9. By End User
9.1. Introduction
9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
9.1.2. Market Attractiveness Index, By End User
9.2. Contract Research Organisations (CROs)
9.2.1. Introduction
9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Biotechnological Companies
9.4. Healthcare Providers
9.5. Others
10. By Region
10.1. Introduction
10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
10.1.2. Market Attractiveness Index, By Region
10.2. North America
10.2.1. Introduction
10.2.2. Key Region-Specific Dynamics
10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode of Delivery
10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Functionality
10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.2.7.1. U.S.
10.2.7.2. Canada
10.2.7.3. Mexico
10.3. Europe
10.3.1. Introduction
10.3.2. Key Region-Specific Dynamics
10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode of Delivery
10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Functionality
10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.3.7.1. Germany
10.3.7.2. U.K.
10.3.7.3. France
10.3.7.4. Spain
10.3.7.5. Italy
10.3.7.6. Rest of Europe
10.4. South America
10.4.1. Introduction
10.4.2. Key Region-Specific Dynamics
10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode of Delivery
10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Functionality
10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.4.7.1. Brazil
10.4.7.2. Argentina
10.4.7.3. Rest of South America
10.5. Asia-Pacific
10.5.1. Introduction
10.5.2. Key Region-Specific Dynamics
10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode of Delivery
10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Functionality
10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.5.7.1. China
10.5.7.2. India
10.5.7.3. Japan
10.5.7.4. Australia
10.5.7.5. Rest of Asia-Pacific
10.6. Middle East and Africa
10.6.1. Introduction
10.6.2. Key Region-Specific Dynamics
10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode of Delivery
10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Functionality
10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
11. Competitive Landscape
11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis
12. Company Profiles
12.1. Ennova Solutions Inc
12.1.1. Company Overview
12.1.2. Product Portfolio and Description
12.1.3. Financial Overview
12.1.4. Key Developments
12.2. Oracle Corporation
12.3. ArisGlobal LLC
12.4. EXTEDO
12.5. Clinevo Technologies
12.6. IQVIA
12.7. AB Cube
12.8. ICON Plc
12.9. Paraxel International Corporation
12.10. Accenture
LIST NOT EXHAUSTIVE
13. Appendix
13.1. About Us and Services
13.2. Contact Us