Pharmacovigilance & Drug Safety Software Market by Product, Clinical Trial, Distribution, End User

Description

List of Tables

[188 Pages Report] The Pharmacovigilance & Drug Safety Software Market size was estimated at USD 552.10 million in 2023 and expected to reach USD 629.31 million in 2024, at a CAGR 14.55% to reach USD 1,429.24 million by 2030.

The pharmacovigilance & drug safety software encompasses a range of digital platforms designed to monitor, assess, understand, and prevent adverse effects or other drug-related problems. These software solutions are employed by pharmaceutical and biotechnology companies, contract research organizations (CROs), regulatory agencies, and others integral to the drug development process and post-marketing surveillance. The primary aim is to ensure compliance with global regulatory standards, streamline reporting processes, and improve patient safety outcomes. The expanding pharmaceutical industry with the rising development of novel drugs is raising the need for pharmacovigilance & drug safety software. The growing adoption of digital technologies with the need for efficient data management systems in the face of growing data volumes is driving the market growth. Data security and privacy issues associated with pharmacovigilance and drug safety software hamper the market growth. Rising investments in advanced analytics capabilities to transform raw data into actionable insights for better risk management and creating intuitive UI/UX designs that enable efficient workflow management and ease of use, even for non-technical users, are expected to create opportunities for market growth.

KEY MARKET STATISTICS
Base Year [2023]	USD 552.10 million
Estimated Year [2024]	USD 629.31 million
Forecast Year [2030]	USD 1,429.24 million
CAGR (%)	14.55%

Product: Growing usage of drug safety audit software to ensure compliance with pharmacovigilance regulations

Adverse event reporting software is essential for the systematic recording and managing of adverse events (AEs) related to drug usage. This software enables pharmaceutical companies, regulatory agencies, and healthcare providers to document and report adverse reactions, which is a regulatory requirement in many jurisdictions. These systems often come with features for flagging potential adverse events, automating the reporting process, and ensuring compliance with global standards such as those set by the FDA and EMA. Drug safety audit software is designed to ensure compliance with pharmacovigilance regulations. By tracking the audit lifecycle, this type of software supports the conduct, reporting, and follow-up of pharmacovigilance audits, thus making it easier for companies to remain compliant and prepare for regulatory inspections. Fully integrated pharmacovigilance software systems offer end-to-end drug safety solutions, from AE data capture to regulatory submission. These systems often include features for case processing, signal detection, risk management, and reporting in one platform, eliminating the need for multiple systems. Issue tracking software in pharmacovigilance helps manage and resolve safety issues efficiently. These systems are critical for manufacturers, enabling them to navigate complex workflows around AE case investigation, root cause analysis, and corrective action planning.

End User: Potential of pharmacovigilance & drug safety software among contract research organizations for handling clinical trial data and offering advanced reporting capabilities

Business process outsourcing (BPO) firms offer third-party services to pharmaceutical and biotechnology companies, including pharmacovigilance activities. These firms require robust drug safety software to manage their clients' diverse data efficiently and comply with various regulatory standards. Contract research organizations provide research services to the pharmaceutical industry on a contractual basis, including clinical trial management and pharmacovigilance. Pharmaceutical & biotechnology companies are at the forefront of drug development and, thus, inherently responsible for drug safety and pharmacovigilance throughout the product lifecycle. Pharmacovigilance service providers specialize in drug safety monitoring and report services for other healthcare entities and typically require specialized pharmacovigilance software adapted to high-volume data transactions and multi-client environments.

Regional Insights

Encompassing both North and South America, the region demonstrates a significant demand for pharmacovigilance & drug safety software largely driven by stringent regulations and a sophisticated healthcare infrastructure. The Americas leads in terms of adoption of technology, investment in R&D, and implementation of regulations to ensure drug safety. Canada follows with a robust healthcare system and a growing focus on pharmacovigilance. The European Union, with its harmonized regulations through the EMA (European Medicines Agency), presents a growing market for pharmacovigilance (PV) & drug safety software. EU countries have seen increasing adoption of PV software solutions to comply with adverse drug reaction (ADR) reporting, risk management plan requirements, and pharmacovigilance audit strategies as mandated by the EMA. The MEA region shows varied levels of adoption, with certain countries exhibiting increased growth in pharmacovigilance due to rising healthcare standards and government initiatives to regulate drugs more effectively. Comprising major economies such as China, India, and Japan, the Asia Pacific region is rapidly emerging as a key market for PV software solutions with the rising healthcare spending, increasing awareness about drug safety, and growing pharmaceutical sectors contributing to the expansion of the pharmacovigilance software market in this region.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Pharmacovigilance & Drug Safety Software Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Pharmacovigilance & Drug Safety Software Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Pharmacovigilance & Drug Safety Software Market, highlighting leading vendors and their innovative profiles. These include 4C Pharma Solutions, AB Cube S.A.S., Accenture PLC, Anju Software, Inc., ArisGlobal LLC, Certara, Inc., Clarivate, Clinevo Technologies Private Limited, Cloudbyz, Inc., Cognizant Technology Solutions Corporation, Ennov SAS, Ergomed PLC, Extedo GmbH, Freyr Software Services Pvt. Ltd., Indegene Inc., Infosys Limited, IQVIA Inc., NUVO Consultancy, Oracle Corporation, PureSoftware Limited, Sarjen Systems Private Limited, Sparta Systems, Inc., Tepsivo Oy, TriNetX, LLC, United BioSource LLC, and Wipro Limited.

Market Segmentation & Coverage

This research report categorizes the Pharmacovigilance & Drug Safety Software Market to forecast the revenues and analyze trends in each of the following sub-markets:

Product
- Adverse Event Reporting Software
- Drug Safety Audits Software
- Fully Integrated Software
- Issue Tracking Software

Clinical Trial
- Phase I
- Phase II
- Phase III
- Phase IV
- Pre-clinical

Distribution
- On-Cloud
- On-Premise

End User
- Business Process Outsourcing Firms
- Contract Research Organizations
- Pharma & Biotech Companies
- Pharmacovigilance Service Providers

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Pharmacovigilance & Drug Safety Software Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Pharmacovigilance & Drug Safety Software Market?

3. What are the technology trends and regulatory frameworks in the Pharmacovigilance & Drug Safety Software Market?

4. What is the market share of the leading vendors in the Pharmacovigilance & Drug Safety Software Market?

5. Which modes and strategic moves are suitable for entering the Pharmacovigilance & Drug Safety Software Market?

Product Code: MRR-030EE4851600

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Rising Incidence of ADR and Drug Toxicity
  - 5.1.1.2. Increasing Need to Reduce Time Spent Reviewing Medical Literature for Aggregate Reports and Articles
  - 5.1.1.3. Highly Regulated Pharmacovigilance Space
- 5.1.2. Restraints
  - 5.1.2.1. Expensive Deployment of Pharmacovigilance & Drug Safety Software
- 5.1.3. Opportunities
  - 5.1.3.1. Increasing Investment in Research and Development (R&D) by Healthcare Companies
  - 5.1.3.2. Integration of AI and Machine Learning Models in Pharmacovigilance & Drug Safety Software
- 5.1.4. Challenges
  - 5.1.4.1. Lack of Awareness, Training, and Underreporting of Adverse Drug Reactions (ADRs) in Developing Countries
5.2. Market Segmentation Analysis
- 5.2.1. Product: Growing usage of drug safety audit software to ensure compliance with pharmacovigilance regulations
- 5.2.2. End User: Potential of pharmacovigilance & drug safety software among contract research organizations for handling clinical trial data and offering advanced reporting capabilities
5.3. Market Trend Analysis
5.4. Cumulative Impact of Russia-Ukraine Conflict
5.5. Cumulative Impact of High Inflation
5.6. Porter's Five Forces Analysis
- 5.6.1. Threat of New Entrants
- 5.6.2. Threat of Substitutes
- 5.6.3. Bargaining Power of Customers
- 5.6.4. Bargaining Power of Suppliers
- 5.6.5. Industry Rivalry
5.7. Value Chain & Critical Path Analysis
5.8. Regulatory Framework Analysis
5.9. Client Customization

6. Pharmacovigilance & Drug Safety Software Market, by Product

6.1. Introduction
6.2. Adverse Event Reporting Software
6.3. Drug Safety Audits Software
6.4. Fully Integrated Software
6.5. Issue Tracking Software

7. Pharmacovigilance & Drug Safety Software Market, by Clinical Trial

7.1. Introduction
7.2. Phase I
7.3. Phase II
7.4. Phase III
7.5. Phase IV
7.6. Pre-clinical

8. Pharmacovigilance & Drug Safety Software Market, by Distribution

8.1. Introduction
8.2. On-Cloud
8.3. On-Premise

9. Pharmacovigilance & Drug Safety Software Market, by End User

9.1. Introduction
9.2. Business Process Outsourcing Firms
9.3. Contract Research Organizations
9.4. Pharma & Biotech Companies
9.5. Pharmacovigilance Service Providers

10. Americas Pharmacovigilance & Drug Safety Software Market

10.1. Introduction
10.2. Argentina
10.3. Brazil
10.4. Canada
10.5. Mexico
10.6. United States

11. Asia-Pacific Pharmacovigilance & Drug Safety Software Market

11.1. Introduction
11.2. Australia
11.3. China
11.4. India
11.5. Indonesia
11.6. Japan
11.7. Malaysia
11.8. Philippines
11.9. Singapore
11.10. South Korea
11.11. Taiwan
11.12. Thailand
11.13. Vietnam

12. Europe, Middle East & Africa Pharmacovigilance & Drug Safety Software Market

12.1. Introduction
12.2. Denmark
12.3. Egypt
12.4. Finland
12.5. France
12.6. Germany
12.7. Israel
12.8. Italy
12.9. Netherlands
12.10. Nigeria
12.11. Norway
12.12. Poland
12.13. Qatar
12.14. Russia
12.15. Saudi Arabia
12.16. South Africa
12.17. Spain
12.18. Sweden
12.19. Switzerland
12.20. Turkey
12.21. United Arab Emirates
12.22. United Kingdom

13. Competitive Landscape

13.1. Market Share Analysis, 2023
13.2. FPNV Positioning Matrix, 2023
13.3. Competitive Scenario Analysis
- 13.3.1. RxLogix Corporation Announces Landmark Partnership with the European Medicines Agency (EMA) for a Cutting-Edge Safety Solution
- 13.3.2. Launch by JNPMEDI of 'Maven Safety,' a drug safety management solution

14. Competitive Portfolio

14.1. Key Company Profiles
14.2. Key Product Portfolio