Press release
Real-World Evidence (RWE) Solutions Market to Reach USD 6.8 Billion by 2030
Real-World Evidence (RWE) Solutions Market
Pune, India - Exactitude Consultancy publishes its latest insights on the Real-World Evidence (RWE) Solutions Market, highlighting rapid global expansion fueled by rising regulatory acceptance, adoption of real-world data (RWD) in clinical development, and increased demand for post-market surveillance. As healthcare becomes more data-driven, RWE is reshaping drug development, safety analytics, market access, and value-based care.
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Key Takeaways
• Market Size (2030): USD 6.8 Billion
• CAGR (2025-2030): 13.4%
• Claims & EHR data remain the largest RWD source.
• Oncology and rare disease segments show highest RWE adoption.
• North America dominates; Asia Pacific emerges as the fastest-growing region.
Market Story: Why RWE Is Becoming Central to Pharma & Healthcare Decisions
Healthcare systems generate enormous volumes of real-world data-EHRs, insurance claims, wearables, lab reports, patient registries, digital health apps, genomics data, and social determinants of health (SDoH).
RWE solutions use AI, analytics, NLP, and cloud platforms to transform this unstructured data into evidence supporting:
• Drug development & trial design
• Post-marketing safety & pharmacovigilance
• Clinical decision-making & treatment effectiveness
• Label expansion applications
• Market access & pricing negotiations
• Value-based care contracts
• Regulatory submissions (FDA, EMA, PMDA increasingly accepting RWE)
With rising interest in decentralized trials and precision medicine, RWE is becoming an indispensable tool for life sciences companies.
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Market Segments
By Component
• Real-World Data Platforms (Largest Segment)
• Analytics & Insights Tools
• Data Integration & Management Software
• Cloud & AI-Enabled RWE Platforms
• Consulting, Custom RWE Studies & Services
By Data Source
• Electronic Health Records (EHRs)
• Medical Claims & Billing Data
• Patient Registries
• Wearables & Mobile Health Data
• Genomics & Biomarker Data
• Pharmacy Data
• Social & Behavioral Health Data
By Application
• Drug Development & Early Research
• Clinical Trial Optimization
• Market Access & Pricing Strategy
• Pharmacovigilance & Safety Monitoring
• Regulatory Submissions
• Treatment Pathway Analysis
• Health Economics & Outcomes Research (HEOR)
By End User
• Pharmaceutical & Biotechnology Companies
• Contract Research Organizations (CROs)
• Healthcare Providers
• Payers & Insurance Companies
• Regulatory Agencies
• Digital Health Platforms & AI Companies
By Region
• North America - Leading adoption backed by FDA's RWE Framework
• Europe - Strong RWE initiatives under EMA & national health systems
• Asia Pacific - Fastest CAGR due to digital health expansion
• Latin America - Increasing use in epidemiology & value-based programs
• Middle East & Africa - Emerging adoption with database modernization
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Recent Developments
• IQVIA launched advanced AI-driven RWE analytics for oncology & rare diseases.
• Optum expanded its integrated RWD platform for payer-provider analytics.
• Flatiron Health added new structured oncology datasets approved for regulatory use.
• TriNetX strengthened its global clinical research network for decentralized trials.
• Syneos Health & Clarivate collaborated on RWE solutions for faster drug-market access.
Expert Quote
"RWE is becoming a powerful decision-making engine across the drug lifecycle. With AI-enabled analytics and expanded regulatory acceptance, real-world evidence is driving faster development, safer therapies, and more transparent value-based care models,"
- Irfan Tamboli, Business Development Executive, Exactitude Consultancy
Key Drivers
• Growing availability of large-scale real-world datasets
• Increased regulatory acceptance for RWE submissions
• High adoption of AI & NLP for unstructured data processing
• Shift toward value-based care and outcomes-based reimbursement
• Demand for post-marketing surveillance and safety reporting
• Rapid expansion of wearables & digital health platforms
Forecast Outlook (2025-2030)
With a projected 13.4% CAGR, the RWE market is set to become a mainstream component of global healthcare and pharmaceutical decision-making by 2030. Growth will be fueled by AI-driven analytics, cloud RWE ecosystems, and expanding use in clinical development and regulatory pathways.
Regional Insights
• North America:
o Strongest adoption due to FDA support and rich RWD networks.
• Europe:
o EMA expanding RWE frameworks for safety & regulatory evidence.
• Asia Pacific:
o Fastest growth, driven by digital health systems and national registries.
Conclusion
The Real-World Evidence Solutions Market is transforming the future of healthcare and drug development. From regulatory filings to safety monitoring and market access, RWE is bringing transparency, accuracy, and speed to decision-making across the life sciences industry.
This report is also available in the following languages : Japanese (リアルワールドエビデンスソリューション市場), Korean (실제 세계 증거 솔루션 시장), Chinese (真实世界证据解决方案市场), French (Marché des solutions de données probantes en situation réelle), German (Markt für Real-World-Evidence-Lösungen), and Italian (Mercato delle soluzioni di prove del mondo reale), etc.
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Connect Us:
Irfan Tamboli
PHONE NUMBER +1 (704) 266-3234
EMAIL ADDRESS: sales@exactitudeconsultancy.com
About Us
Exactitude Consultancy is a market research & consulting services firm which helps its client to address their most pressing strategic and business challenges. Our market research helps clients to address critical business challenges and also helps make optimized business decisions with our fact-based research insights, market intelligence, and accurate data.
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