The Global Real-World Evidence (RWE) in Healthcare Market is projected to grow from USD 18.91 billion in 2025 to USD 50.12 billion by 2032, at a CAGR of 13.3% from 2025-2032.
The Global Real-World Evidence (RWE) in Healthcare Market refers to the worldwide industry focused on collecting, analyzing, and utilizing real-world data from sources like electronic health records, insurance claims, patient registries, and wearable devices. RWE helps healthcare stakeholders—pharmaceutical companies, providers, and regulators—make informed decisions on drug development, treatment effectiveness, safety monitoring, and personalized care. Market growth is driven by increasing demand for data-driven insights, regulatory support, and advancements in analytics technologies.
The Global Real-World Evidence (RWE) in Healthcare Market is witnessing rapid growth due to the increasing adoption of digital health technologies, big data analytics, and artificial intelligence to process real-world data from diverse sources such as electronic health records, claims databases, and wearable devices. There is a rising emphasis on personalized medicine, post-market drug surveillance, and value-based healthcare, which drives demand for accurate and actionable insights. Collaborations between pharmaceutical companies, technology providers, and healthcare institutions are also shaping innovative RWE solutions.
Segmentation: The Global Real-World Evidence (RWE) in Healthcare Market is segmented, by Type (Clinical Setting Data, Claims Data, Pharmacy Data, Patient Powered Data, and Others), Application (Pharmaceutical and Medical Device Companies, Healthcare Payers, Healthcare Providers, and Others), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report provides the value (in USD million) for the above segments.
Market Drivers:
The increasing prevalence of chronic diseases such as diabetes, cardiovascular disorders, cancer, and respiratory illnesses is a major driver for the global real-world evidence (RWE) market in healthcare. For instance, in 2025, in 2025, 11.1% of adults lived with diabetes, with many unaware of their condition, and projections indicated a 46% increase by 2050. Over 90% had type 2 diabetes, driven by socio-economic and genetic factors, contributing to chronic disease prevalence and fueling demand for real-world evidence in healthcare.
Chronic conditions require long-term monitoring and management, creating a need for comprehensive real-world data on treatment effectiveness, patient adherence, and long-term safety outside controlled clinical trials. RWE solutions enable healthcare providers, payers, and pharmaceutical companies to analyze large, diverse patient populations in everyday clinical settings. With healthcare systems aiming to reduce costs while improving patient outcomes, the demand for actionable insights from RWE platforms is accelerating, thereby driving market growth significantly.
The transition from volume-based to value-based healthcare models is another key market driver. Healthcare systems and payers are increasingly seeking evidence of real-world effectiveness, cost-efficiency, and improved patient outcomes rather than relying solely on clinical trial data.
Concurrently, regulatory agencies worldwide are providing frameworks and guidance for incorporating RWE into drug approvals, post-market surveillance, and policy decisions. For instance, Reveleer and Mathematica released the March 2025 State of Technology in Value-Based Care Report, highlighting that while confidence in technology supporting value-based care was high, execution lagged due to fragmented data strategies, uneven AI adoption, and limited staff training. This situation underscored the growing need for real-world evidence, driving regulatory support and adoption, and accelerating growth in the global real-world evidence healthcare market. These developments encourage pharmaceutical companies, medical device manufacturers, and healthcare providers to invest in RWE solutions to support regulatory submissions and optimize patient care strategies. The combined effect of policy support and value-based care initiatives is a strong boost to market adoption.
Market Restraint:
Despite the potential of RWE, the market faces significant challenges related to data quality, standardization, and integration. Real-world data often comes from heterogeneous sources such as electronic health records, insurance claims, registries, and wearable devices, each with different formats, definitions, and levels of completeness. Inconsistent methodologies and lack of universal standards reduce confidence in RWE outcomes, making adoption slower. Additionally, integrating diverse datasets into a unified system can be technically complex and costly, particularly for organizations with legacy systems. These challenges constrain scalability and widespread deployment of RWE solutions, limiting the overall market growth potential.
RWE adoption positively impacts healthcare outcomes and costs by enabling evidence-based decision-making, improving patient safety, and optimizing treatment protocols. It facilitates faster drug development and regulatory approvals while reducing the reliance on costly clinical trials. For patients, this leads to more effective, personalized treatments and better health management. Economically, it helps healthcare systems allocate resources efficiently, decreases avoidable hospitalizations, and supports insurers in designing value-driven coverage, improving overall societal health and economic productivity.
Segmental Analysis:
The claims data segment within the global real world evidence (RWE) market is poised for robust expansion over the forecast period. Claims data—which includes insurance billing information, reimbursement records and payment streams—is increasingly valued because it offers longitudinal, population wide insight into treatment patterns, costs and outcomes outside the clinical trial setting. Compared with narrower clinical datasets, claims provide large scale, payer relevant information that supports health economic outcomes research, value based care initiatives and regulatory decisions. As payers and health systems demand greater transparency around cost effectiveness and real world utilisation, the demand for claims based real world evidence rises. Accordingly, the claims data segment is highlighted in recent market reports as one of the fastest growing within the RWE solutions space.
In the global RWE market, the end user segment comprising pharmaceutical and medical device companies is anticipated to record significant growth throughout the forecast period. These companies rely on real world data (RWD) and evidence (RWE) to accelerate drug and device development, support regulatory submissions, enable post market surveillance and demonstrate value to payers.
As regulatory bodies and markets place greater emphasis on real world outcomes and lifecycle management, pharma and device firms are integrating RWE more deeply into approval, reimbursement and market access strategies. For instance, in Febraury 2025, NEC’s Orchestrating Future Fund invested in Aetion, and both began collaborating on RWD/RWE for drug development. This partnership addressed growing global demand for RWE to evaluate drug safety and efficacy and improve development efficiency. Despite challenges in data collection, standardization, and regulatory compliance, the collaboration strengthened the pharmaceutical and medical device sector, advancing adoption of RWE solutions and supporting growth in the global real-world evidence healthcare market. This intensifying requirement for evidence outside conventional trials drives increased investment in RWE platforms, analytics and partnerships, making this end user segment a major growth engine for the RWE solutions market.
The North America region is projected to witness strong growth in the global real world evidence market over the forecast period. Anchored by the United States and Canada, the region boasts advanced healthcare infrastructure, high biopharma R&D expenditure, widespread electronic health record adoption and supportive regulatory frameworks for RWE use.
In February 2025, Heart and Stroke Canada, published a report that stated, in 2019, Heart and Stroke Canada reported 258,550 new CVD cases, 46,153 deaths, and over one million DALYs among adults, highlighting the growing burden of chronic diseases. This rising cardiovascular prevalence increased the demand for real-world evidence in North America, as healthcare providers, payers, and pharmaceutical companies sought data-driven insights to improve outcomes, manage costs, and support value-based care strategies.
With value based care models gaining traction and payers increasingly demanding real world outcomes, the region offers a fertile environment for RWE solutions. Moreover, North America already accounts for a large share of current global RWE market revenue, and that dominance is expected to persist. For instance, in March 2025, Oracle introduced significant enhancements to its Clinical One Data Collection EDC, enabling seamless EHR interoperability, improved site data collection, and integration with safety solutions. These advancements simplified clinical workflows, reduced data friction, and accelerated research and safety reporting. In North America, they strengthened the real-world evidence market by supporting faster, data-driven insights, improving trial efficiency, and enabling healthcare stakeholders to generate actionable evidence for regulatory and market-access decisions. As service providers scale analytics, data integration capabilities and regional partnerships, North America remains a key growth geography in the RWE landscape.
The competitive landscape of the RWE market is marked by both specialized data analytics firms and large healthcare technology companies. Key players such as IQVIA, Evidation Health, Optum, and Oracle Health Sciences are investing in advanced analytics platforms, AI integration, and partnerships with pharmaceutical companies and research institutions. Competition is driven by the ability to offer high-quality, comprehensive, and timely insights, proprietary data access, and robust technological infrastructure. Companies also focus on expanding global presence, regulatory compliance, and innovation to maintain a competitive edge.
The major players for above market are:
Recent Development
Q1. What the main growth driving factors for this market?
The RWE market is primarily driven by the massive and growing volume of real-world data (RWD) collected from sources like Electronic Health Records (EHRs), insurance claims, and wearable devices. This data influx is coupled with rapid advancements in analytical technologies, specifically Artificial Intelligence (AI) and Machine Learning (ML), which make it possible to process and extract meaningful insights efficiently. Additionally, regulatory bodies like the FDA are increasingly accepting RWE to support drug approvals, label expansions, and post-market surveillance, significantly accelerating its adoption by pharmaceutical companies who seek faster, more cost-effective ways to prove product efficacy and safety.
Q2. What are the main restraining factors for this market?
The main restraints for the RWE market revolve around data quality and governance challenges. Issues like data fragmentation across different health systems, lack of standardized collection methods, and incomplete or inconsistent data quality can lead to unreliable conclusions. Furthermore, growing concerns about patient data privacy (such as GDPR and CCPA regulations) and the need for rigorous data security measures impose significant costs and complexities on organizations.
Q3. Which segment is expected to witness high growth?
The application segment involving Pharmaceutical and Medical Device Companies is expected to witness the highest growth. These companies are the primary users, leveraging RWE across the entire product lifecycle, from optimizing clinical trial design to supporting regulatory submissions and market access/reimbursement strategies.
Q4. Who are the top major players for this market?
The Real-World Evidence market is dominated by major technology and Contract Research Organizations (CROs) that possess extensive data infrastructure and advanced analytical capabilities. Key players include IQVIA Inc., which leads the market with vast data sets and technology solutions. Other major competitors are Optum, Inc. (a subsidiary of UnitedHealth Group), Merative (formerly IBM Watson Health), and leading CROs like ICON plc and Parexel International. These companies often engage in mergers and acquisitions to consolidate data and expertise, driving market consolidation.
Q5. Which country is the largest player?
The United States (within North America) is the largest player and dominates the global RWE market. This leadership is attributed to several factors: a highly mature healthcare infrastructure with widespread adoption of electronic health records (EHRs), significant investments in research and development (R&D) by major pharmaceutical companies, and a favorable regulatory environment, particularly the proactive stance of the FDA in integrating RWE into regulatory decision-making.
Data Library Research are conducted by industry experts who offer insight on industry structure, market segmentations technology assessment and competitive landscape (CL), and penetration, as well as on emerging trends. Their analysis is based on primary interviews (~ 80%) and secondary research (~ 20%) as well as years of professional expertise in their respective industries. Adding to this, by analysing historical trends and current market positions, our analysts predict where the market will be headed for the next five years. Furthermore, the varying trends of segment & categories geographically presented are also studied and the estimated based on the primary & secondary research.
In this particular report from the supply side Data Library Research has conducted primary surveys (interviews) with the key level executives (VP, CEO’s, Marketing Director, Business Development Manager and SOFT) of the companies that active & prominent as well as the midsized organization
FIGURE 1: DLR RESEARH PROCESS
Extensive primary research was conducted to gain a deeper insight of the market and industry performance. The analysis is based on both primary and secondary research as well as years of professional expertise in the respective industries.
In addition to analysing current and historical trends, our analysts predict where the market is headed over the next five years.
It varies by segment for these categories geographically presented in the list of market tables. Speaking about this particular report we have conducted primary surveys (interviews) with the key level executives (VP, CEO’s, Marketing Director, Business Development Manager and many more) of the major players active in the market.
Secondary ResearchSecondary research was mainly used to collect and identify information useful for the extensive, technical, market-oriented, and Friend’s study of the Global Extra Neutral Alcohol. It was also used to obtain key information about major players, market classification and segmentation according to the industry trends, geographical markets, and developments related to the market and technology perspectives. For this study, analysts have gathered information from various credible sources, such as annual reports, sec filings, journals, white papers, SOFT presentations, and company web sites.
Market Size EstimationBoth, top-down and bottom-up approaches were used to estimate and validate the size of the Global market and to estimate the size of various other dependent submarkets in the overall Extra Neutral Alcohol. The key players in the market were identified through secondary research and their market contributions in the respective geographies were determined through primary and secondary research.
Forecast Model
