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Real World Evidence Solutions Market, Opportunity, Growth Drivers, Industry Trend Analysis and Forecast, 2025-2034

Publisher Global Market Insights
Published Oct 08, 2025
Length 187 Pages
SKU # GMI20513097

Description

The Global Real World Evidence Solutions Market was valued at USD 2.3 billion in 2024 and is estimated to grow at a CAGR of 16.2 % to reach USD 10.2 billion by 2034.

Market growth is driven by the rising need for real-time clinical insights, the growing demand for cost-effective drug development, and the expanding use of big data analytics in healthcare. RWE solutions are transforming pharmaceutical research, helping companies analyze patient outcomes, treatment efficacy, and safety using real-world data from electronic health records, insurance databases, and patient registries. The growing emphasis on evidence-based decision-making by healthcare providers, regulators, and payers is further fueling market growth. Moreover, advancements in AI and machine learning are enhancing the accuracy and predictive capabilities of RWE platforms, enabling faster clinical trial design and post-market surveillance.

The market is primarily segmented by component, with the services segment leading in 2024, generating USD 1.3 billion. This dominance is attributed to the increasing outsourcing of data management, analytics, and regulatory reporting to specialized service providers. The services segment plays a crucial role in assisting biopharma and medical device firms in real-world data integration, interpretation, and compliance management, reducing time-to-market and research costs.

In terms of end-use, the pharmaceutical and medical devices companies segment was valued at USD 1.3 billion in 2024, driven by the growing need to demonstrate drug effectiveness and safety beyond clinical trial environments. These companies are leveraging RWE solutions for label expansion, lifecycle management, and strategic decision-making to improve patient outcomes and regulatory compliance.

North America Real World Evidence Solutions Market dominated the global landscape, valued at USD 987.2 million in 2024, owing to the region’s advanced healthcare infrastructure, supportive regulatory frameworks, and widespread adoption of digital health technologies. The U.S. leads the region due to the presence of major pharmaceutical companies, strong government initiatives promoting RWE-based clinical research, and extensive use of electronic health records and claims databases. The region’s focus on precision medicine and patient-centric care continues to drive RWE adoption across healthcare ecosystems.

Key players operating in the Global Real World Evidence Solutions Market include IQVIA, Syneos Health, Oracle Corporation, Flatiron Health, ICON plc, and Medidata Solutions. Companies in the Real World Evidence Solutions Market are strengthening their presence through strategic partnerships, data integration capabilities, and AI-driven analytics innovations. Many are expanding collaborations with healthcare providers and payers to enhance data accessibility and improve real-world study quality. Key players are also investing in scalable cloud-based platforms to streamline data capture, storage, and interpretation while ensuring compliance with evolving data privacy regulations. Additionally, mergers and acquisitions are being leveraged to expand service portfolios and geographic reach.

Table of Contents

187 Pages
Chapter 1 Methodology
1.1 Industry coverage
1.2 Market scope and definitions
1.3 Research design
1.4 Market size estimates and calculations
1.4.1 Approach 1: Company revenue share analysis
1.4.2 Approach 2: Data mining approach
1.4.3 Key trends for market estimates
1.5 Forecast model
1.6 Primary research & validation
1.6.1 Primary sources
1.6.2 Data mining sources
1.6.2.1 Paid sources
1.6.2.2 Public sources
Chapter 2 Executive Summary
2.1 Industry 360 degree synopsis
2.2 Component trends
2.3 Application trends
2.4 Revenue model trends
2.5 Deployment model trends
2.6 End user trends
2.7 Regional trends
2.8 CXO perspectives: Strategic imperatives
Chapter 3 Industry Insights
3.1 Industry ecosystem
3.2 Industry impact forces
3.2.1 Growth drivers
3.2.1.1 Growing focus towards accelerating drug development and cost reduction
3.2.1.2 Growing demand for real-time safety and efficacy monitoring of drugs and medical devices
3.2.1.3 Increasing adoption of RWE Solutions for informed reimbursement decision-making
3.2.1.4 Increasing adoption of data analytics services in clinical decision making
3.2.2 Industry pitfalls and challenges
3.2.2.2 Shortage of skilled professionals
3.2.3 Market opportunities
3.2.3.1 Emerging therapeutic areas expansion beyond oncology
3.2.3.2 Focus on patient-generated health data integration
3.3 Growth potential analysis
3.3.1 By component
3.3.2 By application
3.3.3 By revenue model
3.3.4 By deployment model
3.3.5 By end user
3.4 Regulatory landscape
3.4.1 North America
3.4.2 Europe
3.4.3 Asia Pacific
3.4.4 Latin America
3.5 Technology landscape
3.5.1 Current technologies
3.5.1.1 Artificial intelligence and machine learning integration
3.5.1.2 Cloud computing and data infrastructure
3.5.1.3 Natural language processing (NLP) for clinical data extraction
3.5.2 Emerging technologies
3.5.2.1 Blockchain and distributed ledger technologies
3.5.2.2 Quantum computing applications
3.5.2.3 Federated learning and privacy-preserving analytics
3.6 Future market trends
3.6.1 Regulatory integration of RWE in drug development and market access
3.6.2 AI-driven real-world data analytics for precision medicine
3.6.3 AI-driven real-world data analytics for precision medicine
3.7 Innovation investment trends and R&D focus
3.7.1 Investment in AI-powered RWE platforms
3.8 Porter's analysis
3.9 PESTEL analysis
Chapter 4 Competitive Landscape, 2024
4.1 Introduction
4.1.1 IQVIA Holdings Inc.
4.1.2 IBM Corporation
4.1.3 United Health Group Incorporated
4.1.4 Flatiron Health Inc
4.2 Company market share analysis
4.2.1 Global company market share analysis
4.2.2 North America company market share analysis
4.2.3 Europe company market share analysis
4.2.4 Asia Pacific company market share analysis
4.3 Company matrix analysis
4.4 Competitive analysis of major market players
4.5 Competitive positioning matrix
4.6 Key developments
Chapter 5 Real World Evidence Solutions Market, By Component
5.1 Services
5.1.1 Data collection and integration
5.1.2 Study design and execution
5.1.2.1 Prospective observational studies
5.1.2.2 Retrospective database studies
5.1.2.3 Site-centric studies
5.1.2.4 Registry-based studies
5.1.2.5 Hybrid studies
5.1.3 Regulatory and market access support
5.1.4 Evidence network
5.1.5 Other services
5.2 Data sets
5.2.1 Disparate data sets
5.2.1.1 Clinical settings data
5.2.1.2 Claims data sets
5.2.1.3 Pharmacy data sets
5.2.1.4 Patient powered data sets
5.2.1.5 Registry-based data sets
5.2.2 Integrated data sets
Chapter 6 Real World Evidence Solutions Market, By Application
6.1 Drug development and approval
6.1.1 Oncology
6.1.2 Cardiovascular disease
6.1.3 Neurology
6.1.4 Immunology
6.1.5 Other therapeutic areas
6.2 Medical device development and approvals
6.3 Post-market surveillance
6.4 Market access and reimbursement/coverage decision-making
6.5 Clinical and regulatory decision-making
Chapter 7 Real World Evidence Solutions Market, By Revenue Model
7.1 Pay-per-use (value-based pricing)
7.2 Subscription
Chapter 8 Real World Evidence Solutions Market, By Deployment Model
8.1 On-premise
8.2 Cloud-based
Chapter 9 Real World Evidence Solutions Market, By End User
9.1 Pharmaceutical and medical device companies
9.2 Healthcare payers
9.3 Healthcare providers
9.4 Other end users
Chapter 10 Real World Evidence Solutions Market, By Region
10.1 North America
10.2 Europe
10.3 Asia Pacific
10.4 Latin America
10.5 Middle East and Africa
Chapter 11 Company Profiles
11.1 Aetion, Inc.
11.1.1 Financial data
11.1.2 Services landscape
11.1.3 Strategic outlook
11.1.4 SWOT analysis
11.2 Cytel Inc.
11.2.1 Financial data
11.2.2 Services landscape
11.2.3 Strategic outlook
11.2.4 SWOT analysis
11.3 Flatiron Health Inc
11.3.1 Financial data
11.3.2 Services landscape
11.3.3 Strategic outlook
11.3.4 SWOT analysis
11.4 Fortrea Holdings Inc
11.4.1 Financial data
11.4.2 Sales revenue, 2022-2024 (USD Million)
11.4.3 Service landscape
11.4.4 Strategic outlook
11.4.5 SWOT analysis
11.5 IBM Corporation
11.5.1 Financial data
11.5.2 Sales revenue, 2021-2024 (USD Million)
11.5.3 Services landscape
11.5.4 SWOT analysis
11.6 ICON plc
11.6.1 Financial data
11.6.1.1 Sales revenue, 2021-2024 (USD Million)
11.6.2 Service landscape
11.6.3 Strategic outlook
11.6.4 SWOT analysis
11.7 IQVIA Holdings Inc.
11.7.1 Financial data
11.7.1.1 Sales revenue, 2021-2024 (USD Million)
11.7.2 Service landscape
11.7.3 Strategic outlook
11.7.4 SWOT analysis
11.8 Medidata Solutions, Inc.
11.8.1 Financial data
11.8.2 Sales revenue, 2021-2024 (USD Million)
11.8.3 Services landscape
11.8.4 SWOT analysis
11.9 Merative
11.9.1 Financial data
11.9.2 Service landscape
11.9.3 SWOT analysis
11.10 Oracle Corporation
11.10.1 Financial data
11.10.1.1 Sales revenue, 2021-2024 (USD Million)
11.10.2 Service landscape
11.10.3 Strategic outlook
11.10.4 SWOT analysis
11.11 Parexel International Corporation
11.11.1 Financial data
11.11.2 Services landscape
11.11.3 Strategic outlook
11.11.4 SWOT analysis
11.12 Syneos Health Inc
11.12.1 Financial data
11.12.2 Service landscape
11.12.3 Strategic outlook
11.12.4 SWOT analysis
11.13 Tempus
11.13.1 Financial data
11.13.2 Services landscape
11.13.3 Strategic outlook
11.13.4 SWOT analysis
11.14 TriNetX
11.14.1 Financial data
11.14.2 Services landscape
11.14.3 Strategic outlook
11.14.4 SWOT analysis
11.15 Thermo Fisher Scientific, Inc.
11.15.1 Financial data
11.15.2 Sales revenue, 2021-2024 (USD Million)
11.15.3 Services landscape
11.15.4 Strategic outlook
11.15.5 SWOT analysis
11.16 UnitedHealth Group Incorporated
11.16.1 Financial data
11.16.1.1 Sales revenue, 2021-2024 (USD Million)
11.16.2 Service landscape
11.16.3 SWOT analysis

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