RWE(Real World Evidence) 솔루션 시장 규모, 점유율 및 동향 분석 보고서 : 컴포넌트별, 용도별, 최종 용도별, 치료 영역별, 지역별, 부문 예측(2025-2033년)

Real World Evidence Solutions Market Summary

The global real world evidence solutions market size was estimated at USD 2.81 billion in 2024 and is projected to reach USD 6.01 billion by 2033, growing at a CAGR of 8.94% from 2025 to 2033. This growth is attributed to the increase in R&D spending, rising applications of real-world evidence (RWE) in various fields, support from regulatory bodies for using real world evidence (RWE) solutions and growing volume of real-world data are anticipated to boost the market growth.

Growing regulatory acceptance of real-world evidence is a major driving factor for market expansion, as global agencies now provide clearer rules on when and how RWD can support approvals, label expansions, and post-market decisions. This increasing clarity reduces compliance uncertainty and motivates pharma and biotech to invest

in robust RWE platforms. Key regulatory initiatives enabling RWE adoption includes:

• FDA (U.S.) - Through the 21st Century Cures Act and dedicated RWE guidance, the FDA clearly defines how EHR, claims, and registry data can support regulatory submissions and how data quality and methodologies should be validated.
• EMA (EU) - EMA's DARWIN EU network, RWE Roadmap, and Data Quality Framework standardize RWD use across Europe, enabling consistent integration of RWE into lifecycle assessments.
• MHRA (UK) - MHRA provides practical guidance on RWD-based studies and RCTs using RWD, outlining acceptable sources, endpoints, and safety processes, supported by its RWE Scientific Dialogue pathway.
• PMDA (Japan) - PMDA emphasizes strong data reliability and analytic accuracy while increasingly accepting registry-based evidence for approvals and label updates, especially in rare and pediatric conditions.

Such regulatory efforts are strengthening industry's trust in real-world evidence approaches, thereby driving broader global uptake of RWE solutions.

The growing volume of real-world data is a key driver for the Real-World Evidence (RWE) solutions market, as the volume of health-related data continues to grow at a compound annual rate of 36%. Data from electronic health records, insurance claims, disease registries, wearables, and patient-reported outcomes is increasing in both scale and granularity. Advances in data integration, interoperability, and analytics enable RWE platforms to transform these vast datasets into meaningful, actionable insights. This allows pharmaceutical companies, payers, and healthcare providers to generate more accurate, representative, and timely evidence, supporting drug development, regulatory submissions, and value-based care initiatives.

Global Real World Evidence Solutions Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global real world evidence solutions market report based on component, application, end use, therapeutic area, and region.

• Component Outlook (Revenue, USD Million, 2021 - 2033)
• Services
• Data Sets
  • Clinical Settings Data
  • Claims Data
  • Pharmacy Data
  • Patient-Powered Data
• Application Outlook (Revenue, USD Million, 2021 - 2033)
• Drug Development & Approvals
• Medical Device Development & Approvals
• Reimbursement/Coverage and Regulatory Decision Making
• Post Market Safety & Adverse Events Monitoring
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Healthcare Companies (Pharmaceutical, Biopharmaceutical, Medical Device)
  • Clinical research
  • Commercial (inclusive of marketing, etc.)
  • HEOR
  • Others (market access, etc.)
• Healthcare Payers
• Healthcare Providers
• Others
• Therapeutic Area Outlook (Revenue, USD Million, 2021 - 2033)
• Oncology
• Cardiology
• Neurology
• Diabetes
• Psychiatry
• Respiratory
• Other Therapeutic Areas (Immunology, Gastroenterology, etc.)
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Component
  • 1.2.2. Application
  • 1.2.3. End Use
  • 1.2.4. Therapeutic Area
  • 1.2.5. Regional scope
  • 1.2.6. Estimates and forecasts timeline
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased database
  • 1.4.2. GVR's internal database
  • 1.4.3. Secondary sources
  • 1.4.4. Primary research
  • 1.4.5. Details of primary research
• 1.5. Information or Data Analysis
  • 1.5.1. Data analysis models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity flow analysis
• 1.8. List of Secondary Sources
• 1.9. List of Primary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
  • 2.2.1. Component and Application outlook
  • 2.2.2. End use and Therapeutic Area outlook
  • 2.2.3. Regional outlook
• 2.3. Competitive Insights

Chapter 3. Real World Evidence Solutions Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Related/ancillary market outlook
• 3.2. Market Dynamics
  • 3.2.1. Market driver analysis
    • 3.2.1.1. Regulatory Support for RWE Integration
    • 3.2.1.2. Rising Demand for Cost-effective Drug Development
    • 3.2.1.3. Growing Volume of Real-World Data
    • 3.2.1.4. Increasing Use of RWE in Clinical Trial Design
    • 3.2.1.5. Growing Emphasis on Personalized Medicine
    • 3.2.1.6. Strategic Collaborations Between Stakeholders
    • 3.2.1.7. Growing Demand for Drug Safety and Post-Market Surveillance
    • 3.2.1.8. Expansion of Healthcare Data Sources
  • 3.2.2. Market restraint analysis
    • 3.2.2.1. Lack of Access to Data
    • 3.2.2.2. Data privacy concerns
    • 3.2.2.3. Data Quality, Completeness, and Standardization Issues
    • 3.2.2.4. Regulatory Compliance Challenges
  • 3.2.3. Market Opportunity analysis
  • 3.2.4. Market Challenges analysis
• 3.3. Case Study Insights
  • 3.3.1. Case Study 1: Real-World Evidence Enables Regulatory Pathway for Label Expansion
  • 3.3.2. Case Study 2
  • 3.3.3. Case Study 3
  • 3.3.4. Case Study 4
  • 3.3.5. Case Study 5
• 3.4. Real World Evidence Solutions Market Analysis Tools
  • 3.4.1. Industry Analysis - Porter's Five Forces Analysis
    • 3.4.1.1. Supplier power
    • 3.4.1.2. Buyer power
    • 3.4.1.3. Substitution threat
    • 3.4.1.4. Threat of new entrant
    • 3.4.1.5. Competitive rivalry
  • 3.4.2. PESTEL Analysis
    • 3.4.2.1. Political
    • 3.4.2.2. Economic
    • 3.4.2.3. Social
    • 3.4.2.4. Technological
    • 3.4.2.5. Environmental
    • 3.4.2.6. Legal
  • 3.4.3. Pricing Model Analysis
    • 3.4.3.1. As per usage
    • 3.4.3.2. Pay per patient record
    • 3.4.3.3. Annual/monthly subscription

Chapter 4. Real World Evidence Solutions Market: Component Estimates & Trend Analysis

• 4.1. Global Real World Evidence Solutions Market: Component Dashboard
• 4.2. Global Real World Evidence Solutions Market: Component Movement Analysis
• 4.3. Global Real World Evidence Solutions Market by Component, Revenue (USD Million)
• 4.4. Services
  • 4.4.1. Services market estimates and forecasts 2021 to 2033 (USD Million)
• 4.5. Data sets Systems
  • 4.5.1. Multi agent systems market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.5.2. Clinical Settings Data
    • 4.5.2.1. Clinical Settings Data market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.5.3. Claims Data
    • 4.5.3.1. Claims Data market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.5.4. Pharmacy Data
    • 4.5.4.1. Pharmacy Data market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.5.5. Patient-Powered Data
    • 4.5.5.1. Patient Powered Data market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 5. Real World Evidence Solutions Market: Application Estimates & Trend Analysis

• 5.1. Global Real World Evidence Solutions Market: Application Dashboard
• 5.2. Global Real World Evidence Solutions Market: Application Movement Analysis
• 5.3. Global Real World Evidence Solutions Market Estimates and Forecasts, By Application, Revenue (USD Million)
• 5.4. Drug Development & Approvals
  • 5.4.1. Drug development & approval market estimates and forecasts 2021 to 2033 (USD Million)
• 5.5. Medical Device Development & Approvals
  • 5.5.1. Medical device development & approvals market estimates and forecasts 2021 to 2033 (USD Million)
• 5.6. Reimbursement/Coverage and Regulatory Decision Making
  • 5.6.1. Reimbursement/Coverage and Regulatory Decision Making market estimates and forecasts 2021 to 2033 (USD Million)
• 5.7. Post Market Safety & Adverse Events Monitoring
  • 5.7.1. Post Market Safety & Adverse Events Monitoring market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 6. Real World Evidence Solutions Market: End Use Estimates & Trend Analysis

• 6.1. Global Real World Evidence Solutions Market: End Use Dashboard
• 6.2. Global Real World Evidence Solutions Market: End Use Movement Analysis
• 6.3. Global Real World Evidence Solutions Market Estimates and Forecasts, By End Use, Revenue (USD Million)
• 6.4. Healthcare Companies (Pharmaceutical, Biopharmaceutical, Medical Device)
  • 6.4.1. Healthcare Companies (Pharmaceutical, Biopharmaceutical, Medical Device) market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.4.2. Clinical research
    • 6.4.2.1. Clinical research market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.4.3. Supervised Commercial (inclusive of marketing, etc.)
    • 6.4.3.1. Commercial (inclusive of marketing, etc.) market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.4.4. HEOR
    • 6.4.4.1. HEOR market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.4.5. Others (market access, etc.)
    • 6.4.5.1. Others (market access, etc.) market estimates and forecasts 2021 to 2033 (USD Million)
• 6.5. Processing Healthcare Payers
  • 6.5.1. Healthcare Payers market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.5.2. Healthcare Providers
    • 6.5.2.1. Healthcare Providers market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.5.3. Others
    • 6.5.3.1. Others market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 7. Real World Evidence Solutions Market: Therapeutic Area Estimates & Trend Analysis

• 7.1. Global Real World Evidence Solutions Market: Therapeutic Area Dashboard
• 7.2. Global Real World Evidence Solutions Market: Therapeutic Area Movement Analysis
• 7.3. Global Real World Evidence Solutions Market Estimates and Forecasts, By Therapeutic Area, Revenue (USD Million)
• 7.4. Oncology
  • 7.4.1. Oncology market estimates and forecasts 2021 to 2033 (USD Million)
• 7.5. Cardiology
  • 7.5.1. Cardiology market estimates and forecasts 2021 to 2033 (USD Million)
• 7.6. Neurology
  • 7.6.1. Neurology market estimates and forecasts 2021 to 2033 (USD Million)
• 7.7. Psychiatry
  • 7.7.1. Psychiatry market estimates and forecasts 2021 to 2033 (USD Million)
• 7.8. Respiratory
  • 7.8.1. Respiratory market estimates and forecasts 2021 to 2033 (USD Million)
• 7.9. Other Therapeutic Areas (Immunology, Gastroenterology, etc.)
  • 7.9.1. Other Therapeutic Areas (Immunology, Gastroenterology, etc.) market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 8. Real World Evidence Solutions Market: Regional Estimates & Trend Analysis by Component, Application, End use, and Therapeutic Area

• 8.1. Regional Dashboard
• 8.2. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
• 8.3. North America
  • 8.3.1. U.S.
    • 8.3.1.1. Key country dynamics
    • 8.3.1.2. Regulatory framework
    • 8.3.1.3. Competitive scenario
    • 8.3.1.4. U.S. market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.3.2. Canada
    • 8.3.2.1. Key country dynamics
    • 8.3.2.2. Regulatory framework
    • 8.3.2.3. Competitive scenario
    • 8.3.2.4. Canada market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.3.3. Mexico
    • 8.3.3.1. Key country dynamics
    • 8.3.3.2. Regulatory framework
    • 8.3.3.3. Competitive scenario
    • 8.3.3.4. Mexico market estimates and forecasts 2021 to 2033 (USD Million)
• 8.4. Europe
  • 8.4.1. UK
    • 8.4.1.1. Key country dynamics
    • 8.4.1.2. Regulatory framework
    • 8.4.1.3. Competitive scenario
    • 8.4.1.4. UK market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.4.2. Germany
    • 8.4.2.1. Key country dynamics
    • 8.4.2.2. Regulatory framework
    • 8.4.2.3. Competitive scenario
    • 8.4.2.4. Germany market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.4.3. France
    • 8.4.3.1. Key country dynamics
    • 8.4.3.2. Regulatory framework
    • 8.4.3.3. Competitive scenario
    • 8.4.3.4. France market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.4.4. Italy
    • 8.4.4.1. Key country dynamics
    • 8.4.4.2. Regulatory framework
    • 8.4.4.3. Competitive scenario
    • 8.4.4.4. Italy market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.4.5. Spain
    • 8.4.5.1. Key country dynamics
    • 8.4.5.2. Regulatory framework
    • 8.4.5.3. Competitive scenario
    • 8.4.5.4. Spain market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.4.6. Denmark
    • 8.4.6.1. Key country dynamics
    • 8.4.6.2. Regulatory framework
    • 8.4.6.3. Competitive scenario
    • 8.4.6.4. Denmark market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.4.7. Sweden
    • 8.4.7.1. Key country dynamics
    • 8.4.7.2. Regulatory framework
    • 8.4.7.3. Competitive scenario
    • 8.4.7.4. Sweden market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.4.8. Norway
    • 8.4.8.1. Key country dynamics
    • 8.4.8.2. Regulatory framework
    • 8.4.8.3. Competitive scenario
    • 8.4.8.4. Norway market estimates and forecasts 2021 to 2033 (USD Million)
• 8.5. Asia Pacific
  • 8.5.1. Japan
    • 8.5.1.1. Key country dynamics
    • 8.5.1.2. Regulatory framework
    • 8.5.1.3. Competitive scenario
    • 8.5.1.4. Japan market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.5.2. China
    • 8.5.2.1. Key country dynamics
    • 8.5.2.2. Regulatory framework
    • 8.5.2.3. Competitive scenario
    • 8.5.2.4. China market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.5.3. India
    • 8.5.3.1. Key country dynamics
    • 8.5.3.2. Regulatory framework
    • 8.5.3.3. Competitive scenario
    • 8.5.3.4. India market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.5.4. South Korea
    • 8.5.4.1. Key country dynamics
    • 8.5.4.2. Regulatory framework
    • 8.5.4.3. Competitive scenario
    • 8.5.4.4. South Korea market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.5.5. Thailand
    • 8.5.5.1. Key country dynamics
    • 8.5.5.2. Regulatory framework
    • 8.5.5.3. Competitive scenario
    • 8.5.5.4. Thailand market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.5.6. Australia
    • 8.5.6.1. Key country dynamics
    • 8.5.6.2. Regulatory framework
    • 8.5.6.3. Competitive scenario
    • 8.5.6.4. Australia market estimates and forecasts 2021 to 2033 (USD Million)
• 8.6. Latin America
  • 8.6.1. Brazil
    • 8.6.1.1. Key country dynamics
    • 8.6.1.2. Regulatory framework
    • 8.6.1.3. Competitive scenario
    • 8.6.1.4. Brazil market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.6.2. Argentina
    • 8.6.2.1. Key country dynamics
    • 8.6.2.2. Regulatory framework
    • 8.6.2.3. Competitive scenario
    • 8.6.2.4. Argentina market estimates and forecasts 2021 to 2033 (USD Million)
• 8.7. MEA
  • 8.7.1. South Africa
    • 8.7.1.1. Key country dynamics
    • 8.7.1.2. Regulatory framework
    • 8.7.1.3. Competitive scenario
    • 8.7.1.4. South Africa market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.7.2. Saudi Arabia
    • 8.7.2.1. Key country dynamics
    • 8.7.2.2. Regulatory framework
    • 8.7.2.3. Competitive scenario
    • 8.7.2.4. Saudi Arabia market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.7.3. Israel
    • 8.7.3.1. Key country dynamics
    • 8.7.3.2. Regulatory framework
    • 8.7.3.3. Competitive scenario
    • 8.7.3.4. Israel market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.7.4. UAE
    • 8.7.4.1. Key country dynamics
    • 8.7.4.2. Regulatory framework
    • 8.7.4.3. Competitive scenario
    • 8.7.4.4. UAE market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.7.5. Kuwait
    • 8.7.5.1. Key country dynamics
    • 8.7.5.2. Regulatory framework
    • 8.7.5.3. Competitive scenario
    • 8.7.5.4. Kuwait market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Company Market Position Analysis/ Company Market Share Analysis, 2024
• 9.2. Company Categorization
• 9.3. Strategy Mapping
• 9.4. Company Profiles/Listing
  • 9.4.1. IQVIA
    • 9.4.1.1. Overview
    • 9.4.1.2. Financial performance
    • 9.4.1.3. Product benchmarking
    • 9.4.1.4. Strategic initiatives
  • 9.4.2. Merative
    • 9.4.2.1. Overview
    • 9.4.2.2. Financial performance
    • 9.4.2.3. Product benchmarking
    • 9.4.2.4. Strategic initiatives
  • 9.4.3. PPD Inc. (now part of Thermo Fisher)
    • 9.4.3.1. Overview
    • 9.4.3.2. Financial performance
    • 9.4.3.3. Product benchmarking
    • 9.4.3.4. Strategic initiatives
  • 9.4.4. Parexel International Corporation
    • 9.4.4.1. Overview
    • 9.4.4.2. Financial performance
    • 9.4.4.3. Product benchmarking
    • 9.4.4.4. Strategic initiatives
  • 9.4.5. Icon Plc
    • 9.4.5.1. Overview
    • 9.4.5.2. Financial performance
    • 9.4.5.3. Product benchmarking
    • 9.4.5.4. Strategic initiatives
  • 9.4.6. Oracle
    • 9.4.6.1. Overview
    • 9.4.6.2. Financial performance
    • 9.4.6.3. Product benchmarking
    • 9.4.6.4. Strategic initiatives
  • 9.4.7. Syneos Health
    • 9.4.7.1. Overview
    • 9.4.7.2. Financial performance
    • 9.4.7.3. Product benchmarking
    • 9.4.7.4. Strategic initiatives
  • 9.4.8. Cegedim Health Data
    • 9.4.8.1. Overview
    • 9.4.8.2. Financial performance
    • 9.4.8.3. Product benchmarking
    • 9.4.8.4. Strategic initiatives
  • 9.4.9. Medpace
    • 9.4.9.1. Overview
    • 9.4.9.2. Financial performance
    • 9.4.9.3. Product benchmarking
    • 9.4.9.4. Strategic initiatives
  • 9.4.10. Optum Inc. (UnitedHealth Group)
    • 9.4.10.1. Overview
    • 9.4.10.2. Financial performance
    • 9.4.10.3. Product benchmarking
    • 9.4.10.4. Strategic initiatives
  • 9.4.11. SAS Institute Inc.
    • 9.4.11.1. Overview
    • 9.4.11.2. Financial performance
    • 9.4.11.3. Product benchmarking
    • 9.4.11.4. Strategic initiatives
  • 9.4.12. Cognizant
    • 9.4.12.1. Overview
    • 9.4.12.2. Financial performance
    • 9.4.12.3. Product benchmarking
    • 9.4.12.4. Strategic initiatives
  • 9.4.13. Aetion, Inc. (acquired by Datavant in May 2025)
    • 9.4.13.1. Overview
    • 9.4.13.2. Financial performance
    • 9.4.13.3. Product benchmarking
    • 9.4.13.4. Strategic initiatives
  • 9.4.14. Flatiron Health
    • 9.4.14.1. Overview
    • 9.4.14.2. Financial performance
    • 9.4.14.3. Product benchmarking
    • 9.4.14.4. Strategic initiatives
  • 9.4.15. Cytel Inc.
    • 9.4.15.1. Overview
    • 9.4.15.2. Financial performance
    • 9.4.15.3. Product benchmarking
    • 9.4.15.4. Strategic initiatives
  • 9.4.16. Trinity
    • 9.4.16.1. Overview
    • 9.4.16.2. Financial performance
    • 9.4.16.3. Product benchmarking
    • 9.4.16.4. Strategic initiatives
  • 9.4.17. NTT Data Inc.
    • 9.4.17.1. Overview
    • 9.4.17.2. Financial performance
    • 9.4.17.3. Product benchmarking
    • 9.4.17.4. Strategic initiatives