Market Overview

Global Pharmacovigilance and Drug Safety Software Market reached US$ YYbillion in 2023and is expected to reach US$ YYbillion by 2031growing with a CAGR of YY% during the forecast period 2024-2031.

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.

Market 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.

Segment Analysis

  • 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 Organisations (CROs)
    • Biotechnological Companies
    • Healthcare Providers
    • Others
  • By Region
    • North America
      • U.S.
      • Canada
      • Mexico
    • Europe
      • Germany
      • U.K.
      • France
      • Spain
      • Italy
      • Rest of Europe
    • South America
      • Brazil
      • Argentina
      • Rest of South America
    • Asia-Pacific
      • China
      • India
      • Japan
      • Australia
      • 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 2024

  • Manufacturers/ Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies