Pharmacovigilance and Drug Safety Software Market Snapshot

“The Pharmacovigilance and Drug Safety Software Market is estimated to increase at a CAGR 6.67% from $ 196.35 Million in 2023 to $ 298.4 Million by 2030.”

Pharmacovigilance is the science of detecting, assessing, understanding, and avoiding adverse effects or other medicine/vaccine-related issues, requiring rigorous testing for safety and efficacy in clinical trials before approval.

The World Health Organisation defines pharmacovigilance, or drug safety, as the science and activities involving the detection, assessment, understanding, and prevention of adverse effects or drug-related problems.

Oracle Argus is a pharmacovigilance platform that aids pharmaceutical businesses and clinical trial organizations in making safer decisions, enhancing global compliance, and integrating risk management.

Pharmacovigilance is based on the exchange of Individual Case Safety Reports (ICSRs) between the original report's recipient and interested parties like Marketing Authorization Holders and Health Authorities.

The WEB-RADR initiative by the Innovative Medicines Initiative (IMI) explores the advantages and disadvantages of utilizing technology and social media in pharmacovigilance.

How is artificial intelligence applied in pharmacovigilance?

AI can analyze a patient's genetic profile to identify markers related to medication metabolism and adverse reactions, enabling healthcare providers to make informed decisions about the most suitable treatments for individual patients, reducing the risk of adverse outcomes.

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Some software used in pharmacovigilance include:

• Oracle Argus Safety.
• ARISg
• Oracle Adverse Event Reporting System (AERS)
• PvNET
• repClinical
• Vigilanz Dynamic Monitoring System.
• WebVDME Pharmacovigilance Signal detection and Signal management software.

1.Oracle Argus Safety

Companies are focusing on a comprehensive approach to product safety, starting with clinical development and continuing through post-marketing surveillance. Oracle Argus Safety is a platform designed to meet the life science industry's pharmacovigilance requirements, aiding in regulatory compliance, facilitating safety decisions, and unifying safety and risk management operations.

2. ARISg

ARISg is a widely used pharmacovigilance software application used by over 300 global pharmaceutical corporations to store vital drug safety data. It includes functionality for managing adverse event reporting and reactions for regulatory authorities worldwide. ARISg supports various pharmacovigilance processes, including CIOMS 1, MedWatch 3500A, and more, from case input to automatic generation of submission-ready adverse event reports.

3. Oracle AERS

Oracle AERS is a global solution that offers robust automation and productivity tools for managing global safety information. It enables the capture, management, reporting, and analysis of serious adverse event and product compliance cases for all medical items, including pharmaceuticals, medical devices, vaccines, biologics, and gene therapies.

4. PvNET

PvNET is a comprehensive pharmacovigilance system that goes beyond compliance, integrating Adverse Event reporting, Adverse Drug Reaction data management, and regulatory reporting of ICSR. It aids in integrating safety information from early development to post-marketing, enabling users to make key decisions. PvNET's drug safety has been audited against GMP standards, 21 CFR compliance, and ICH E2B.

5. repClinical

RepClinical is a secure web-based solution that aids in managing pharmacovigilance tasks efficiently and cost-effectively. It allows for the collection of adverse event data, preparation of regulatory reports, and exchange of ICSRs with various regulatory agencies and business partners.

Growth Drivers

• The number of adverse drug reactions (ADRs) of drugs has been increasing.
• The regulation of drug safety is being increased.
• The advancements in technology.
• The field of drug development and clinical trials is experiencing significant growth.

The demand for PV services is fueled by regulatory guidelines from the European Medicines Agency and the US FDA, which dictate clinical trial conduct and post-marketing vigilance. Advances in ADR databases and information systems have enabled reliable data reporting, thereby increasing the overall demand for PV services.

The Pharmacovigilance and Drug Safety Software Market is expected to grow due to rising adverse drug reactions, stringent government regulations, increased outsourcing of pharmacovigilance software, and chronic illness incidence.

The market's expansion may be hampered by a few obstacles and limitations. The market is projected to be constrained by elements like the growing complexity of drug safety laws and the shortage of qualified pharmacovigilance specialists.

Restraints

The increasing complexity of drug safety laws, coupled with misquoting and miscoding of side effects, is hindering market growth.

Pharmacovigilance and Drug Safety Software Market Segment Analysis

by Functionality

In 2022, the signal management sector led the pharmacovigilance drug safety software market with a 34.98% revenue share. Case processing, with the fastest predicted growth, is a key industry due to its focus on error prevention and data redundancy.

Major corporations offer integrated end-to-end solutions to improve services and gain market share. Case processing accounted for a significant portion of the market in 2022 due to the widespread use of ADR reporting tools and the evolving use of pharmacy monitoring software.

By Mode of Delivery

In 2022, the On Demand software segment led the pharmacovigilance drug safety software market, accounting for the largest revenue share. The market is expected to grow due to cloud computing's rapid adoption by healthcare IT providers.

In the future, on-demand solutions, including cloud-based S-a-a-S solutions, will become more common, driven by pharmaceutical corporations and contract research organizations. Cloud-based systems offer advantages like scalability, real-time data tracking, and remote access to data.

By End User

Pharma and biotech firms are increasingly adopting PV and drug safety software solutions to streamline clinical trial procedures and reduce healthcare costs. In 2022, this market category dominated the pharmacovigilance drug safety software market.

The pharmaceutical industry is experiencing a growing trend of outsourcing, with manufacturers shifting from fully integrated companies to sharing costs through partnerships with service providers. This is expected to support the expansion of contract research organizations.

Competitive Landscape of the Pharmacovigilance and Drug Safety Software Market Analysis

The industry is characterized by extensive research and technological advancements, with intense competition among market participants for investment in R&D to create new Drug Safety Software tools.

• IQVIA
• Accenture
• Cognizant
• Laboratory Corporation of America Holdings
• IBM
• ArisGlobal
• ICON Plc.
• Capgemini
• Oracle
• Parexel International Corporation

New Developments in Pharmacovigilance and Drug Safety Software Market

Sep 12, 2023- IQVIA Named a Leader in Pharmacovigilance Solutions in IDC MarketScape Report

IQVIA, a global provider of data, analytics, and technology solutions for the life sciences industry, has been named a Leader in the IDC Marketscape Worldwide Life Science R&D Pharmacovigilance Solutions 2022 Vendor Assessment.

IQVIA's suite of PV technologies and services, including its SaaS-based Vigilance Platform, helps customers gain deeper understanding, enhance decision-making, and discover new opportunities.

October 2022: PegBio selected LifeSphere MultiVigilance, a flagship product by ArisGlobal, to transition their pharmacovigilance from Contract Research Organization (CRO) services to in-house practices with this leading pharmacovigilance software.

July 2022: Dotmatics launched its Small Molecule Drug Discovery Solution, an integrated scientific R&D platform with pre-configured workflows and expanded data management capabilities.

Regional Analysis of Global Pharmacovigilance and Drug Safety Software Industry

The pharmacovigilance and drug safety software market in North America is expected to grow steadily due to government initiatives and research spending, driven by the increasing number of adverse drug reactions as a leading cause of hospitalizations and fatalities in the US.

The US government's Open FDA initiative and Mini-Sentinel are driving market expansion in North America, allowing scientists and developers to access its database using open search-based applications and delivering relevant statistical data faster to support active surveillance systems.

The Asia Pacific region is expected to experience the fastest projected CAGR due to cost savings, leading to increased clinical trials and a growing focus on pharmacovigilance and drug safety software.

Outsourcing hotspots in Asia include South Korea, Taiwan, Singapore, China, and India. Factors driving market growth include the increasing incidence of adverse medication reactions, public safety consciousness, and strict government restrictions.

The region's outsourcing hotspots include South Korea, Taiwan, Singapore, China, and India.

Segments Covered in the Pharmacovigilance and Drug Safety Software Market Report

by Functionality

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

By Mode of Delivery

• On-premise Delivery
• On-demand/Cloud-based (SaaS) Delivery

By End User

• Pharmaceutical and Biotechnology Companies
• Contract Research Organizations
• Business Process Outsourcing Firms
• and Other Pharmacovigilance Service Providers

Market by Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Rest of Europe
• Asia-Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Australia
  • Rest of Asia-Pacific
• Rest of the World
• Middle East
• Africa
• Latin America

Frequently Asked Questions

What are some applications of Pharmacovigilance and Drug Safety Software?

Adverse events reporting. Easily record, track, and investigate all adverse reactions in relation to the treatment of your products.

What is the expected growth rate of the Pharmacovigilance and Drug Safety Software market over the next 7 years?

The Pharmacovigilance and Drug Safety Software Market is estimated to increase at a CAGR 6.67% from $ 196.35 Million in 2023 to $ 298.4 Million by 2030.

Who are the major players in the Pharmacovigilance and Drug Safety Software market and what is their market share?

IQVIA,Accenture, Cognizant, Laboratory Corporation of America Holdings, IBM, ArisGlobal, ICON Plc., Capgemini, Oracle, Parexel International Corporation, are prominent players operating and dominating in the market.

Who are the top 3 Pharmacovigilance and Drug Safety Software Market Key Vendors?

IQVIA, Accenture, Cognizant, Laboratory Corporation of America Holdings, are key players in the Pharmacovigilance and Drug Safety Software market.

Which geographical areas dominate the worldwide market for Pharmacovigilance and Drug Safety Software?

North America region are emerging as the top regional markets for Pharmacovigilance and Drug Safety Software solutions.