PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1927687
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1927687
RWE oncology market size was valued at US$ 790.10 Million in 2024, expanding at a CAGR of 14.90% from 2025 to 2032.
Real-World Evidence (RWE) in oncology involves the collection and analysis of health data from real-world settings such as electronic health records, patient registries, and insurance claims-to complement clinical trial findings. This evidence supports treatment effectiveness, safety monitoring, and personalized cancer care decisions. The market growth is driven by increasing cancer prevalence and the rising adoption of value-based healthcare models. According to the National Cancer Institute (NCI), an estimated 1.9 million new cancer cases were diagnosed in the U.S. in 2024, intensifying the need for real-world data to improve therapeutic outcomes. Advances in data analytics, AI integration, and regulatory acceptance are fostering RWE applications to accelerate oncology drug development and optimize patient management globally.
RWE Oncology Market- Market Dynamics
Growing adoption of real-world data to enhance oncology treatment outcomes
The rising global cancer burden and the need for personalized, evidence-based oncology care are driving demand for RWE solutions. According to the World Health Organization (WHO), cancer remains a leading cause of death globally, accounting for nearly 10 million deaths in 2024. This has intensified the focus on utilizing real-world data from electronic health records, cancer registries, and claims databases to complement clinical trials, improving treatment effectiveness and safety monitoring. Regulatory agencies like the U.S. FDA increasingly accept RWE to support drug approvals and label expansions, accelerating market adoption. Advances in AI and machine learning facilitate deeper insights from complex oncology data, enabling precision medicine. Furthermore, healthcare payers and providers emphasize value-based care models, leveraging RWE to optimize treatment protocols and reduce costs. Growing investments in health IT infrastructure, particularly in developed and emerging economies, further propel market growth opportunities worldwide.
The Global RWE Oncology Market is segmented on the basis of Component, Data Source Type, Therapeutic Area, Application, End User, and Region.
Based on Component, the market includes Data Sources, Analytics Software, and Services. Data Sources encompass electronic health records (EHRs), cancer registries, claims and billing data, patient-reported outcomes, and genomic databases, providing diverse real-world insights critical for oncology research. Analytics Software leverages AI and machine learning algorithms to analyze complex oncology datasets for treatment effectiveness, safety, and outcome prediction. Services include consulting, data management, and integration, which help healthcare stakeholders implement RWE solutions efficiently. According to the U.S. Office of the National Coordinator for Health Information Technology (ONC), adoption of certified EHR technology reached over 85% among hospitals in 2024, supporting data availability for RWE.
Based on Application, the market covers Drug Development & Clinical Trials, Treatment Optimization, Regulatory & Payer Decision Support, and Market Access & Reimbursement. Drug Development utilizes RWE to complement clinical trials, enabling accelerated approvals and label expansions. Treatment Optimization involves personalizing therapy based on patient data to improve outcomes. Regulatory & Payer Decision Support uses real-world insights for safety monitoring and coverage decisions. Market Access and Reimbursement benefit from RWE by demonstrating treatment value and cost-effectiveness, critical for payer negotiations and formulary inclusion.
RWE Oncology Market- Geographical Insights
The global RWE oncology market shows significant regional variation shaped by healthcare infrastructure, data availability, and regulatory frameworks. North America leads with over 1.9 million new cancer cases projected in the U.S. in 2024, according to the National Cancer Institute (NCI), fueling demand for real-world data to improve treatment outcomes. The FDA's Real-World Evidence Program further accelerates adoption in this region. Europe follows, with the European Cancer Information System reporting nearly 4 million new cancer cases annually, supporting RWE initiatives across major oncology hubs. Asia-Pacific is expected to experience the fastest growth, with China's National Cancer Center estimating 4.8 million new cancer diagnoses in 2023, driving investments in healthcare data infrastructure and digital oncology solutions. Emerging regions such as Latin America and the Middle East benefit from increasing cancer incidence and government efforts to enhance healthcare data collection, presenting new market opportunities.
U.S. RWE Oncology Market- Country Insights
The United States leads the global RWE oncology market, propelled by its advanced healthcare ecosystem, extensive oncology research, and strong regulatory support for real-world data integration. According to the National Cancer Institute (NCI), approximately 1.9 million new cancer cases are expected in the U.S. in 2024, driving urgent demand for enhanced treatment evaluation through real-world evidence. The FDA's Real-World Evidence Program facilitates faster approvals and improved post-market surveillance, strengthening the market's growth. Key players such as Flatiron Health, IQVIA, and Tempus Labs focus on leveraging vast clinical data, AI analytics, and partnerships with leading cancer centers. The U.S.'s robust health IT infrastructure, high healthcare spending exceeding $4.3 trillion in 2023 (CMS), and ongoing innovation in precision oncology make it the focal point for real-world evidence applications in oncology worldwide.
The rising emphasis on data-driven oncology treatment and real-world evidence utilization is intensifying competition among key market players. Major companies such as IQVIA, ICON plc, Syneos Health, Parexel, Covance, and Flatiron Health lead by leveraging advanced data analytics platforms, AI integration, and comprehensive oncology data registries. Common strategies include strategic acquisitions to enhance data capabilities, partnerships with pharmaceutical companies for tailored oncology solutions, and expanding global footprints to access diverse patient populations. Investment in cloud-based data management and real-time evidence generation tools is prevalent, enabling faster drug development and regulatory approvals. Additionally, companies are focusing on compliance with evolving data privacy regulations and offering customized solutions to meet oncology research demands, strengthening their competitive positions worldwide.
In May 2025, Datavant completed its acquisition of RWE specialist Aetion, combining data connectivity and advanced real world evidence analytics into a unified platform. The expanded ecosystem-spanning over 300 data partners across EHRs, claims, registries, and more-aims to help life sciences and healthcare organizations generate faster, scalable, and actionable evidence across the drug development lifecycle.
In April 2025, Atropos Health partnered with Ontada to integrate Ontada's community oncology real world data into the Atropos Evidence(TM) Network, enhancing RWE use cases for clinicians, researchers, and healthcare leaders. This collaboration aims to improve cancer care protocols, advance precision medicine, and accelerate development of new oncology treatments using high quality real world evidence.