시판 후 감시 소프트웨어 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the postmarketing surveillance software market size is expected to increase from USD 1.35 billion in 2025 to USD 1.56 billion in 2026 and reach USD 3.20 billion by 2031, growing at a CAGR of 15.5% over 2026-2031.

This report is Segmented by Component (Software Platform, Services), Deployment Mode (On-Premises, Cloud-Based), End-User (Pharmaceutical Companies, Biotechnology Firms, Medical Device Manufacturers, Cros & PV Service Providers, Regulatory Agencies), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Postmarketing Surveillance Software Market Trends and Insights

Increasing Volume of Real-World Data Availability

Surveillance platforms now directly receive data streams from hospitals, payers, and patients, significantly increasing the volume of analyzable adverse-event signals beyond traditional spontaneous reports. The FDA's 2025 guidance on real-world evidence, which eased the requirement for identifiable patient data in many submissions, has enabled the use of national registries and claims databases for routine safety analyses. Leading vendors have implemented automated extract-transform-load pipelines, pulling and normalizing both structured and unstructured records from electronic health-record networks in near real-time. A mid-cap biopharma highlighted the operational benefits of these richer data sources, reporting a 60% reduction in case-touch time after integrating claims feeds into its platform. However, data completeness remains a challenge, as wearable and registry information often include inconsistent dosage or timing details. While multiregional initiatives around ISO IDMP aim to enhance coding uniformity, full alignment is not expected before 2028.

AI-Enabled Signal Detection Improves Speed and Accuracy

Machine-learning models have outperformed traditional frequentist and Bayesian disproportionality statistics, achieving AUROC values nearing 0.97 in peer-reviewed studies. Sanofi's implementation of these models achieved 85% sensitivity and 75% specificity, reducing its signal-identification timeline by six months. Platforms like LifeSphere Advanced Signals have incorporated automated confounder adjustments, leading to a 40-50% reduction in false-positive workloads. In response, regulators have initiated internal pilots; for instance, FDA's Project Elsa uses supervised transformers to summarize narrative text, flagging potential case duplicates while maintaining human oversight. This advancement significantly enhances reviewer productivity, enabling physicians to focus on causality assessments rather than data management tasks.

Fragmented Global Data Standards Hinder Interoperability

Efforts to achieve ICH alignment have not fully resolved regional discrepancies in narrative fields, timeline requirements, and controlled terminologies. Europe's ISO IDMP implementation is significantly ahead of the Asia-Pacific region, requiring global sponsors to adapt data elements to various regional formats. Additionally, they must manage version control due to MedDRA's biannual updates. This duplication places a strain on validation resources and extends system upgrade timelines. The challenge is further compounded when local regulators introduce country-specific elements that go beyond ICH guidance. Until these adoption gaps are addressed, companies will need to allocate additional resources to support dual validation workflows.

Other drivers and restraints analyzed in the detailed report include:

1. Regulatory Mandates for Proactive Pharmacovigilance
2. Growing Complexity of Combination Products
3. High Capital Investment Costs for Legacy IT Stacks

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

In 2025, software platforms accounting for 64.15% of total expenditures. This trend underscores companies' preference for integrated solutions, combining case intake, regulatory reporting, and analytics. Highlighting the industry's evolution, Oracle's Safety One Argus release demonstrates vendors' advancements, embedding machine-learning extractors that autonomously capture 90% of structured case data, eliminating the need for manual re-keying. While services took the remaining market share, they are poised to outpace software platforms, projecting a robust 15.95% CAGR. This shift is driven by sponsors' preference for variable-cost operating models over maintaining in-house teams. Furthermore, the momentum in outsourcing not only accelerates upgrades but also allows service providers to deploy new AI modules across multiple clients simultaneously, effectively distributing validation costs.

Geography Analysis

In 2025, North America captured 42.65% of the postmarketing surveillance software market. The region leverages a first-mover advantage due to early FDA endorsements of AI and cloud validation frameworks. Additionally, its proximity to leading enterprise software vendors in the United States strengthens its market position. Domestic safety-software contracts often exceed annual values of USD 10 million, particularly when bundled with multi-year managed services, reflecting the substantial demand in North America.

Europe follows closely, supported by a significant installed base anchored in the EMA's EudraVigilance ecosystem. The stringent requirements of the General Data Protection Regulation increase compliance complexity, driving demand for detailed audit trails and localized data residency. Many multinational sponsors maintain dual databases-one designed for FDA regulations and another tailored to EMA standards. This dual approach drives frequent system upgrades as both agencies align their daily data-release schedules.

Asia-Pacific is the fastest-growing region, with a 16.45% CAGR. Countries such as Japan, China, and India are aligning with ICH standards. China is upgrading its National Adverse Drug Reaction Monitoring System to attract international trials, prompting local sponsors to adopt ICH-compliant safety systems with bilingual reporting capabilities. India's launch of an AI-driven ADR platform in 2024 demonstrates its commitment to digital surveillance, though its success depends on hospitals adopting electronic medical record systems. Smaller Southeast Asian markets typically rely on centralized outsourcing hubs in Singapore, where service providers manage safety obligations across ASEAN nations.

1. AB Cube
2. Aris Global
3. Axpharma
4. Bioclinica (Clario)
5. BioPharma PV
6. Capgemini
7. Ennov
8. EXTEDO
9. Indegene
10. IQVIA
11. Omniscient Safety
12. Oracle
13. PharmInvent
14. RXLogix
15. Safety First Consulting
16. SAS Institute
17. Sparta Systems (Honeywell)
18. TCS ADD Safety Platform
19. United BioSource (UBC)
20. Vigilare International

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Increasing Volume of Real-World Data Availability
  • 4.2.2 AI-Enabled Signal Detection Improves Speed & Accuracy
  • 4.2.3 Regulatory Mandates for Proactive Pharmacovigilance
  • 4.2.4 Growing Complexity of Combination Products
  • 4.2.5 Expansion of Post-Authorization Safety Studies in Emerging Markets
  • 4.2.6 Decentralized Clinical Trial Models Feeding Post-Market Platforms
• 4.3 Market Restraints
  • 4.3.1 Fragmented Global Data Standards Hinder Interoperability
  • 4.3.2 High Upfront Integration Costs for Legacy IT Stacks
  • 4.3.3 Shortage of Qualified Safety Informatics Personnel
  • 4.3.4 Cyber-Security Concerns Over Cloud-Hosted Safety Data
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Component
  • 5.1.1 Software Platform
  • 5.1.2 Services
• 5.2 By Deployment Mode
  • 5.2.1 On-premises
  • 5.2.2 Cloud-based
• 5.3 By End-user
  • 5.3.1 Pharmaceutical Companies
  • 5.3.2 Biotechnology Firms
  • 5.3.3 Medical Device Manufacturers
  • 5.3.4 CROs & PV Service Providers
  • 5.3.5 Regulatory Agencies
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 India
    • 5.4.3.3 Japan
    • 5.4.3.4 South Korea
    • 5.4.3.5 Australia
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 AB Cube
  • 6.3.2 ArisGlobal
  • 6.3.3 Axpharma
  • 6.3.4 Bioclinica (Clario)
  • 6.3.5 BioPharma PV
  • 6.3.6 Capgemini
  • 6.3.7 Ennov
  • 6.3.8 EXTEDO
  • 6.3.9 Indegene
  • 6.3.10 IQVIA
  • 6.3.11 Omniscient Safety
  • 6.3.12 Oracle
  • 6.3.13 PharmInvent
  • 6.3.14 RXLogix
  • 6.3.15 Safety First Consulting
  • 6.3.16 SAS Institute
  • 6.3.17 Sparta Systems (Honeywell)
  • 6.3.18 TCS ADD Safety Platform
  • 6.3.19 United BioSource (UBC)
  • 6.3.20 Vigilare International

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment