Real-World Evidence Market size was estimated at USD 1.81 Bn in 2024, and the total Real-World Evidence Market revenue is projected to grow at a CAGR of 14.3 % from 2025 to 2032, reaching nearly USD 5.27 Bn.
Stellar Market Research published a report "Real-World Evidence Market and forecast (2025-2032)." The report is a comprehensive analysis of Real-World Evidence Market share, size, growth, trends, and forecast. The report also contains competitor analysis and regional analysis and gives attention to the recent market trend.
The Real-World Evidence (RWE) market uses real-life health data such as electronic health records, insurance claims, and patient applications to discover how medical treatments are perceived in use versus clinical trials. RWE can assist pharmaceutical manufacturers, healthcare organizations, and regulators make more informed decisions about efficacy, safety and value.
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Real-World Evidence Market Dynamics
Regulatory Acceptance and Encouragement
Regulatory agencies such as the U.S. FDA, European Medicines Agency (EMA), and others are increasingly endorsing the use of RWE in drug approval and monitoring. RWE can fill knowledge gaps left by standard clinical trials regarding rare diseases, long-term safety issues, and drug effectiveness in patient populations that may not have been adequately studied in the clinical trial context.
Integration of AI and Advanced Analytics
Utilizing artificial intelligence (AI), machine learning (ML), and natural language processing (NLP) enables more robust discovery of massive datasets, improving the accuracy, speed, and depth of learnings that we can acquire from real-world data.
Collaboration and Partnership
Collaboration among pharmaceutical companies, technology companies, hospitals, and insurance companies are creating integrated platforms to generate RWE. These ecosystems are facilitating data exchange, improving the quality of real-world research.
Real-World Evidence Market Segmentation
Based on Component
The RWE market is divided into two-segment: Data Sets and Services. Data sets are structured and unstructured healthcare data sources that include electronic health records, insurance claims, pharmacy records and patient-generated data. The services of the two segments of the RWE market have a greater market share due to the increasing demand for informed data interpretation and increasing utilization of AI-based data analysis, and RWE customized solutions for clinical studies and regulatory submissions.
Based on Application
RWE has many applications. Some of these include Drug Development & Approvals, Post-Market Safety & Surveillance, Market Access & Reimbursement, Clinical Decision Support, and Medical Device Evaluation. The most obvious area of RWE use is drug development and approvals given that RWE is becoming increasingly utilized by companies to help support and develop clinical trial design, strengthen regulatory submissions, and show evidence for real-world effectiveness.
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Real-World Evidence Market Regional Analysis
North America
North America is the largest region in the Real-World Evidence market. The region's advanced healthcare system, established electronic health records, associated advancements in pharmaceuticals from budget expenditures on R&D, and a high regulatory environment, most notably from the U.S. FDA which openly advocates for the adoption of RWE for drug release and post-marketing studies, offer unsurpassed access to real-world, revenue-generating sources.
Asia-Pacific
Asia-Pacific is the highest growth region in the RWE space. The region's growth is fueled by rapidly developing digital health infrastructure, the presence of very large and diverse patient populations, increased clinical research activity, and increasing investments in AI and health analytics in countries like China, India, Japan, and South Korea.
Real-World Evidence Market Competitive Landscape
Sanofi's Strategic Acquisitions: Sanofi in June 2025 announced that it would buy U.S.-based Blueprint Medicines Corporation for more than $9 billion in a bid to shore up its leadership in rare immunological diseases. This comes after previous acquisitions of Vigil Neuroscience worth $470 million and Inhibrx worth $2.2 billion, demonstrating Sanofi's interest in growing its immunology pipeline and using real-world data for drug development.
Concerto HealthAI's Acquisition of CancerLinQ: In December of 2023, Concerto HealthAI acquired CancerLinQ, previously part of the American Society of Clinical Oncology, a real-world data platform that aims to better the future of oncology care by utilizing real-world data and advanced analytics.
Recent Development
- In April 2024, Parexel announced a partnership with Palantir Technologies Inc. to utilize artificial intelligence (AI) to accelerate and improve the delivery of safe and effective clinical trials for biopharmaceutical clients globally.
- In August 2023, the U.S. Food and Drug Administration published a new report called "Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products" and recommendations were made in a framework with regards to the use of RWE for regulatory decision-making.
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