Clinical trials remain the gold standard for proving a therapy works, but they show only part of the picture. Real-world evidence (RWE) fills the rest by showing how treatments perform across everyday patients, settings, and timeframes. Grand View Research values the global real world evidence solutions market at USD 3.0 billion in 2025, rising to USD 3.3 billion in 2026 and USD 6.0 billion by 2033, a CAGR of 9.1%. North America led in 2025 with a 44.1% share, while Asia Pacific is expected to grow fastest.

Regulators are a big reason for this momentum. In December 2025, the U.S. FDA dropped its requirement that RWE submissions include identifiable patient-level data, so de-identified registries, claims, and EHR networks can now be considered case by case. The UK's MHRA launched an RWE Scientific Dialogue pilot in January 2025. Below, we look at what is holding the market back, what it is built on, who uses it, and who is leading it.

Systemic Challenges: The Data Problem Behind the Promise

The main obstacle is not a lack of data. Health data is growing at roughly 36% a year. The problem is that much of it is hard to use.

• Data quality and completeness. Real-world datasets often have missing values, inconsistent coding, and mixed formats across providers and countries.
• Fragmentation. Differences in clinical coding systems, disconnected EHRs, and varied care delivery practices make integration slow and costly. Combining claims and EHR data often requires heavy cleaning and normalization before the evidence is regulatory-grade.
• Regulatory scrutiny. The FDA and EMA both stress "fit-for-purpose," high-quality evidence. Poorly curated data can weaken a submission or a reimbursement case.
• Regional gaps. In Latin America, fragmented data governance and the absence of formal RWE guidelines limit progress. In the Middle East and Africa, fragmented health systems, limited local data generation, and trust in data remain hurdles, even as Saudi Arabia's SFDA advances a draft RWE framework.

The emerging fix is AI. Vendors such as IQVIA, SAS, Saama, and Veradigm are embedding AI and automation to map, clean, and standardize data, turning scattered sources into analysis-ready datasets. This is also one of the market's biggest opportunities.

Key Components & Data Sources

The market splits into two components:

1. Services (58.1% share in 2025). This is the largest segment, driven by pharma, biotech, and provider demand for outsourced RWE studies, analytics, and expertise.
2. Data sets. This segment is expected to grow at a significant rate as organizations seek to understand real-world compliance, epidemiology, and costs. It breaks down into:

• Clinical settings data (EMRs and hospital records)
• Claims data
• Pharmacy data
• Patient-powered data (patient-reported outcomes, wearables, and biometric devices)

Decentralized trials, digital therapeutics, and remote monitoring are adding longitudinal patient data, making these sources richer each year. Partnerships are also expanding access. In October 2025, HealthVerity and Claritas Rx combined de-identified claims, EMR, and lab data with specialty pharmacy and hub insights. In November 2025, Datavant and AWS launched a clean-room solution that lets life-science companies analyze multiple data sources without moving raw data.

Want the numbers behind these trends? Download a free sample of the Real World Evidence Solutions Market Report for market estimates, forecasts, and trend analysis.

Applications

• Drug development and approvals led in 2025 with a 28.7% share, as sponsors use RWE to speed development and support regulatory decisions. The FDA has also issued draft guidance on using RWD in medical device decisions.
• Medical device development and approvals.
• Reimbursement/coverage and regulatory decision-making is the fastest-growing application, as RWE frameworks for the full product lifecycle are only now being issued.
• Post-market safety and adverse event monitoring is gaining importance as therapies grow more complex. Adverse drug events are estimated to contribute to 250,000 to 300,000 deaths a year in the U.S.

Therapeutic areas

Oncology leads with about 23.1% of the market, reflecting RWE's role in lowering trial costs and improving approval odds. Cardiology is expected to grow significantly, and the market also covers neurology, diabetes, psychiatry, and respiratory care.

End users

• Healthcare companies (pharma, biopharma, and device makers) held the largest share in 2025, using RWE across clinical research, commercial, HEOR, and market access.
• Healthcare payers are the fastest-growing group. RWE already appears in around 16% of clinical findings cited by payers in specialty drug decisions, with EHR data the most cited source.
• Healthcare providers and other stakeholders round out the market.

Key Industry Players

The market is slightly fragmented. Integrated data and analytics leaders like IQVIA compete with technology and health-data firms such as Oracle and Optum, while CROs and niche data specialists add further competition. Innovation, partnership activity, and regulatory influence are all high.

Companies profiled in the report include:

• 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 (acquired by Datavant in May 2025)
• Flatiron Health
• Cytel Inc.
• Trinity

Recent moves show where competition is heading:

• Thermo Fisher launched the CoreVitas Obesity Registry in January 2026.
• Aetion listed its evidence platform on AWS Marketplace in March 2025.
• IQVIA expanded its partnership with Salesforce in April 2024.
• Parexel partnered with Palantir on AI-driven trials in April 2024.
• Atropos Health launched its Evidence Agent in October 2025, working with Stanford Health Care and Microsoft to bring RWE into clinical workflows.

The Bottom Line

RWE is moving from a supplementary tool to a core part of drug development, regulatory review, and reimbursement. The winners will be those who can turn fragmented data into trusted, regulator-ready evidence, and AI-driven integration is a big part of that.

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