Dublin, Jan. 05, 2026 (GLOBE NEWSWIRE) -- The "Real World Evidence Solutions Market Size, Share & Trends Analysis Report by Component (Services, Data Sets), Application, End Use (Healthcare Payers, Healthcare Providers), Therapeutic Area (Oncology, Cardiology) and Region with Growth Forecasts, 2025-2033" report has been added to ResearchAndMarkets.com's offering.
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, the analyst has segmented the global real world evidence solutions market report based on component, application, end use, therapeutic area, and region.
Why should you buy this report?
- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 190 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value (USD) in 2024 | $2.81 Billion |
| Forecasted Market Value (USD) by 2033 | $6.01 Billion |
| Compound Annual Growth Rate | 8.9% |
| Regions Covered | Global |
Market Dynamics
Market driver analysis
- Regulatory Support for RWE Integration
- Rising Demand for Cost-effective Drug Development
- Growing Volume of Real-World Data
- Increasing Use of RWE in Clinical Trial Design
- Growing Emphasis on Personalized Medicine
- Strategic Collaborations Between Stakeholders
- Growing Demand for Drug Safety and Post-Market Surveillance
- Expansion of Healthcare Data Sources
Market restraint analysis
- Lack of Access to Data
- Data privacy concerns
- Data Quality, Completeness, and Standardization Issues
- Regulatory Compliance Challenges
Real World Evidence Solutions Market Analysis Tools
- Industry Analysis - Porter's Five Forces Analysis
- PESTEL Analysis
- Pricing Model Analysis
Companies Featured
- IQVIA
- Merative
- PPD Inc. (now part of Thermo Fisher)
- Parexel International Corporation
- NTT DATA, Inc.
- Icon Plc
- Oracle
- Syneos Health
- Cegedim Health Data
- Medpace
- Optum Inc. (UnitedHealth Group)
- SAS Institute Inc.
- Cognizant
- Aetion, Inc. (acquired by Datavant in May 2025)
- Flatiron Health
- Cytel Inc.
- Trinity
Component Outlook (Revenue, USD Million, 2021-2033)
- Services
- Data Sets
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)
- 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
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa (MEA)
For more information about this report visit https://www.researchandmarkets.com/r/1nl6b2
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