약물감시 및 의약품 안전성 소프트웨어 시장 : 제품, 임상시험, 유통, 최종 사용자별 - 세계 예측(2025-2030년)

The Pharmacovigilance & Drug Safety Software Market was valued at USD 552.10 million in 2023, expected to reach USD 629.31 million in 2024, and is projected to grow at a CAGR of 14.55%, to USD 1,429.24 million by 2030.

Pharmacovigilance and drug safety software plays a crucial role in the healthcare and pharmaceutical industries by ensuring the continual monitoring and assessment of drug safety, post-marketing. The necessity for this software arises from the increasing incidence of adverse drug reactions (ADRs) and stringent government regulations requiring systematic documentation and analysis. The application of this software spans drug development companies, CROs, pharmaceutical companies, and regulatory bodies, with the primary end-users being healthcare professionals and researchers focusing on patient safety and compliance. Market growth is driven by technological advancements such as AI and machine learning, which enhance data processing and predictive analytics capabilities. Increasing globalization and the surge in new drug discoveries further fuel the demand. Emerging opportunities exist in the integration of real-world data (RWD) for more accurate safety profiles and the development of cloud-based platforms to improve accessibility and collaboration across various stakeholders. However, challenges such as data privacy concerns, high implementation costs, and the complexity of regulatory compliance can hinder market growth. Furthermore, regional differences in regulations require flexible software solutions, adding layers of complexity. The industry is ripe for innovation, with the best areas being the enhancement of signal detection methodologies and the incorporation of blockchain technology to ensure data integrity. These innovations can provide competitive advantages by streamlining operations and enhancing transparency. While the market is growing, it remains competitive and fragmented, with numerous vendors offering similar solutions. Thus, differentiation through innovation and customization is key. Companies should focus on user-friendly interfaces and scalable solutions to cater to small and large enterprises alike, while continually lobbying for clearer regulatory guidelines to simplify compliance processes. By focusing on these critical areas, businesses can effectively navigate challenges and capitalize on the potential opportunities within the pharmacovigilance and drug safety software market.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Pharmacovigilance & Drug Safety Software Market

The Pharmacovigilance & Drug Safety Software Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Rising Incidence of ADR and Drug Toxicity
  • Increasing Need to Reduce Time Spent Reviewing Medical Literature for Aggregate Reports and Articles
  • Highly Regulated Pharmacovigilance Space
• Market Restraints
  • Expensive Deployment of Pharmacovigilance & Drug Safety Software
• Market Opportunities
  • Increasing Investment in Research and Development (R&D) by Healthcare Companies
  • Integration of AI and Machine Learning Models in Pharmacovigilance & Drug Safety Software
• Market Challenges
  • Lack of Awareness, Training, and Underreporting of Adverse Drug Reactions (ADRs) in Developing Countries

Porter's Five Forces: A Strategic Tool for Navigating the Pharmacovigilance & Drug Safety Software Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Pharmacovigilance & Drug Safety Software Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Pharmacovigilance & Drug Safety Software Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Pharmacovigilance & Drug Safety Software Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Pharmacovigilance & Drug Safety Software Market

A detailed market share analysis in the Pharmacovigilance & Drug Safety Software Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Pharmacovigilance & Drug Safety Software Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Pharmacovigilance & Drug Safety Software Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

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 Clinevo Technologies Private Limited, United BioSource LLC, Indegene Inc., IQVIA Inc., Accenture PLC, Freyr Software Services Pvt. Ltd., Tepsivo Oy, ArisGlobal LLC, Clarivate, PureSoftware Limited, Anju Software, Inc., TriNetX, LLC, Cognizant Technology Solutions Corporation, AB Cube S.A.S., Oracle Corporation, 4C Pharma Solutions, Wipro Limited, NUVO Consultancy, Infosys Limited, Cloudbyz, Inc., Ennov SAS, Certara, Inc., Sarjen Systems Private Limited, Sparta Systems, Inc., Ergomed PLC, and Extedo GmbH.

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:

• Based on Product, market is studied across Adverse Event Reporting Software, Drug Safety Audits Software, Fully Integrated Software, and Issue Tracking Software.
• Based on Clinical Trial, market is studied across Phase I, Phase II, Phase III, Phase IV, and Pre-clinical.
• Based on Distribution, market is studied across On-Cloud and On-Premise.
• Based on End User, market is studied across Business Process Outsourcing Firms, Contract Research Organizations, Pharma & Biotech Companies, and Pharmacovigilance Service Providers.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

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. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental
• 5.5. 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

Companies Mentioned

• 1. Clinevo Technologies Private Limited
• 2. United BioSource LLC
• 3. Indegene Inc.
• 4. IQVIA Inc.
• 5. Accenture PLC
• 6. Freyr Software Services Pvt. Ltd.
• 7. Tepsivo Oy
• 8. ArisGlobal LLC
• 9. Clarivate
• 10. PureSoftware Limited
• 11. Anju Software, Inc.
• 12. TriNetX, LLC
• 13. Cognizant Technology Solutions Corporation
• 14. AB Cube S.A.S.
• 15. Oracle Corporation
• 16. 4C Pharma Solutions
• 17. Wipro Limited
• 18. NUVO Consultancy
• 19. Infosys Limited
• 20. Cloudbyz, Inc.
• 21. Ennov SAS
• 22. Certara, Inc.
• 23. Sarjen Systems Private Limited
• 24. Sparta Systems, Inc.
• 25. Ergomed PLC
• 26. Extedo GmbH