U.S. Real World Evidence Solutions Market - By Component, By Application, By Revenue Model, By Deployment Model, By End Use, Growth Forecast, 2025 - 2034

U.S. Real World Evidence Solutions Market Size

The U.S. real world evidence solutions market size was estimated at USD 909.4 million in 2024. The market is expected to grow from USD 1.1 billion in 2025 to USD 4.1 billion in 2034, growing at a CAGR of 16.3%, according to the latest report published by Global Market Insights Inc.

The market is growing significantly due to the growing focus towards accelerating drug development and cost reduction, growing demand for real-time safety and efficacy monitoring of drugs and medical devices, increasing adoption of RWE solutions for informed reimbursement decision-making and increasing adoption of data analytics services in clinical decision making.
 

Real world evidence solutions include the systems, tools, and methods that gather and analyze data from everyday healthcare settings to yield clinical knowledge. These solutions use real world data for example, electronic health records, insurance claims, patient registries, and wearable devices to examine the effectiveness, safety, and value of medical interventions outside of controlled clinical trials. Major companies in the market include IQVIA Holdings Inc., UnitedHealth Group, IBM Corporation, Flatiron Health Inc., and Syneos Health Inc. They invest heavily in integrating diverse real-world data sources such as electronic health records, claims data, and patient registries into advanced analytics platforms.
 

The market grew from USD 590.1 million in 2021 to USD 786.1 million in 2023.  The increasing use of real world evidence in reimbursement decision-making is helping drive growth in the U.S. real world evidence market. As healthcare shifts towards value-based care, payers and health technology assessment bodies rely on RWE to evaluate treatment effectiveness, safety, and cost-efficiency in real-world settings, beyond traditional clinical trials. RWE supports pricing, coverage, and indication decisions throughout the reimbursement lifecycle.
 

The growing focus on accelerating drug development and reducing associated costs is a major driver of growth in the U.S. real world evidence solutions market. Traditional clinical trials are often time-consuming and expensive, whereas RWE enables pharmaceutical companies to leverage existing healthcare data such as electronic health records, insurance claims, and patient registries to generate insights more efficiently. As the demand for faster, cost-effective innovation increases, RWE solutions are becoming essential tools for optimizing clinical strategies and improving return on investment across the drug development lifecycle.
 

For instance, the U.S. pharmaceutical industry spent USD 83 billion on R&D in 2019. This surge in spending has fueled demand for real world evidence solutions, which offer a cost-effective and data-driven approach to support drug development. As pharmaceutical companies seek to maximize returns on their R&D investments, RWE has become a critical tool for improving productivity and reducing development costs, thereby driving growth in the U.S. real world evidence solutions market.
 

Additionally, the increasing adoption of data analytics services in clinical decision making is boosting the U.S. real world evidence (RWE) market. As healthcare systems become more data-driven, clinicians and researchers are leveraging advanced analytics to extract actionable insights from vast volumes of real-world data. RWE platforms provide rapid access to real time clinical information, enabling real-time analysis of treatment efficacy, safety, and patient outcomes. The rapid acceleration of digital transformation in the health sector has led to a growing need for scalable RWE solutions.
 

Real world evidence solutions encompasses data derived from routine healthcare activities, including electronic health records, insurance claims, patient registries, and other non-experimental sources. It is utilized to evaluate the performance, safety, and effectiveness of medical treatments in real-world settings, thereby informing regulatory decisions, guiding clinical practice, and supporting pharmaceutical research and development.
 

U.S. Real World Evidence Solutions Market Trends

• Rising demand for real-time safety and efficacy monitoring of drugs and medical devices is significantly shaping U.S. real world evidence solutions industry. As chronic diseases like cancer, cardiovascular conditions, and diabetes continue to increase, stakeholders across the healthcare ecosystem are turning to real world data solutions to assess treatment effectiveness, monitor safety, and support regulatory approvals beyond the scope of traditional clinical trials.
   
• The integration of advanced analytics technologies particularly artificial intelligence (AI) and machine learning (ML) is transforming RWE applications. These technologies allow researchers and clinicians to uncover patterns in large, diverse datasets sourced from electronic health records (EHRs), insurance claims, patient registries, and wearable devices.
   
• For instance, IQVIA supports real-time safety and efficacy monitoring by combining large-scale real-world data including over 1.2 billion de-identified patient records with advanced analytics and AI technologies. Through platforms like the Human Data Science Cloud, they enable fast data processing, predictive modeling, and continuous evidence generation, helping life sciences organizations track treatment outcomes, identify safety signals, and respond quickly to regulatory and market needs.
   
• Additionally, strategic collaborations among pharmaceutical companies, contract research organizations (CROs), health tech firms, and academic institutions are driving innovation. These partnerships are helping build scalable, secure, and compliant RWE platforms capable of handling complex datasets and delivering high-impact insights. Together, these trends are positioning RWE as a foundational element of modern healthcare in the U.S.
   

U.S. Real World Evidence Solutions Market Analysis

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The U.S. real world evidence solutions market was valued at USD 590.1 million in 2021. The market size reached USD 909.4 million in 2024, from USD 680.4 million in 2022.
 

Based on components, the U.S. real world evidence solutions market is classified into services and data sets. The data sets segment is further segmented into disparate data sets and integrated data sets. Disparate data sets include patient powered data sets, clinical settings data sets, claims data sets, registry-based data sets, and pharmacy data sets.
 

The services segment dominated the U.S. real world evidence solutions industry by securing a share of 58.4% in 2024. The dominance is propelled by availability of subscription-based advanced analytical tools for analyzing data outputs, increasing adoption of RWE services among pharmaceutical and medical device companies, and increasing adoption of value-based healthcare models.
 

• The services segment is a key part of the real-world evidence (RWE) solutions market, offering essential support for planning, conducting, and gaining regulatory approval for RWE studies.
   
• Data collection and management services facilitate the integration of diverse datasets from electronic health records (EHRs) and claim databases to wearable devices and patient-reported outcomes ensuring data quality, consistency, and compliance. For instance, Syneos Health provides flexible source-agnostic data collection services through its Real World & Late Phase Research (RWLP) division. Their approach integrates data from multiple sources such as clinical sites, registries, claims, and wearables using advanced analytics and AI/ML tools.
   
• Additionally, advanced technologies like cloud platforms and AI-based data harmonization tools are now widely used to automate and scale real-world evidence processes. These tools help integrate both structured and unstructured data smoothly, supporting advanced analytics such as predictive modeling, comparative effectiveness research, and regulatory reporting.
   
• Thus, as the healthcare industry continues to embrace data-driven approaches, the service segment is playing a vital role in scaling the adoption of RWE across the U.S. market.
   

Based on application, the U.S. real world evidence solutions market is classified into drug development and approvals, medical device development and approvals, post-market surveillance, market access and reimbursement/coverage decision-making, and clinical and regulatory decision-making. The drug development and approval segment is further segmented into oncology, cardiovascular disease, neurology, immunology, and other therapeutic areas. Drug development and approvals segment dominated the market in 2024 and is expected to reach USD 1.6 billion by 2034. Increase in clinical trials for novel drug developments, growing approvals, and ample availability of clinical trial data sets is driving the growth in the segment.
 

• The drug development and approval segment covers activities such as protocol design, patient recruitment, trial optimization, safety and efficacy monitoring, and evidence generation for regulatory bodies like the FDA.
   
• This segment is a major growth driver as pharmaceutical and biotech companies increasingly rely on RWE to complement traditional randomized controlled trials (RCTs). RWE helps accelerate drug development timelines by identifying suitable patient populations, optimizing trial designs, and enabling decentralized or hybrid trials.
   
• For instance, Aetion provides regulatory-grade RWE through its Aetion Evidence Platform (AEP), which enables rapid analysis of clinical and claims data. The platform is used by pharmaceutical companies, regulators, and payers to support drug development, regulatory submissions, and clinical trial planning.
• Hence, as the demand for faster, more cost-effective drug development continues to rise, the drug development and approval segment is playing a pivotal role in expanding the U.S. RWE market.
   

Based on the revenue model, the U.S. real world evidence solutions market is classified into pay-per-use (value-based pricing) and subscription. Pay-per-use (value-based pricing) segment dominated the market in 2024, securing a share of about 65.3%.
 

• The pay-per-use segment in the U.S. RWE market refers to flexible, on-demand access to real-world data and analytics services. Instead of long-term contracts or full-platform subscriptions, stakeholders such as pharmaceutical companies, CROs, and healthcare providers can purchase specific datasets, analytical tools, or study support services as needed. This model typically includes access to curated patient data, disease registries, claims databases, and AI-powered analytics platforms for targeted research or regulatory submissions.
   
• It allows companies to scale their research efforts based on project needs, making RWE more accessible for early-stage drug development, post-market surveillance, and health economics studies. This flexibility makes it easier for healthcare organizations to adopt real-world evidence solutions, encourage innovation, and enable quicker decision-making without requiring large upfront investments.
   
• Companies like Aetion and TriNetX are known to support flexible access models, enabling users to purchase targeted RWE services such as protocol feasibility, patient cohort identification, or post-market surveillance data as needed. This approach is especially beneficial for smaller firms or early-stage projects, helping reduce upfront costs and improve scalability.
   
• Its affordability, scalability, and project-specific utility make it a key enabler of growth and innovation in the U.S. RWE market.
   

Based on the deployment model, the U.S. real world evidence solutions market is segmented into cloud-based and on-premise. Cloud-based segments dominated the market valuing at about USD 784.9 million in 2024.
 

• The cloud-based deployment model is rapidly transforming the real world evidence solutions market by offering scalable, flexible, and cost-efficient access to data platforms, analytics tools, and real-world datasets. This approach is particularly attractive to pharmaceutical companies, contract research organizations (CROs), and healthcare providers seeking to accelerate evidence generation while minimizing operational overhead.
   
• For example, Merative’s MarketScan WorkSpace stands out by offering instant, cloud-based access to comprehensive, de-identified healthcare data, paired with analysis-ready datasets and integrated analytics tools. This platform simplifies the real-world evidence research process by providing a secure, scalable, and HIPAA-compliant environment that supports efficient collaboration and quick generation of actionable insights.
   
• Cloud-based real world evidence solutions offer adaptability and cost-effectiveness which is further driving growth in this market.
   

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Based on the end user, the real world evidence solutions market is classified into pharmaceutical and medical device companies, healthcare payers, healthcare providers, other end users. The pharmaceutical and medical device companies segment dominated the market with a share of about 60.4% in 2024.
 

• Pharmaceutical and medical device companies are among the primary end users of RWE solutions. Their use of RWE spans across the entire product lifecycle from early-stage drug discovery and clinical trial design to regulatory submissions, post-market surveillance, and market access strategies.
   
• RWE helps optimize clinical trial design, identify suitable patient populations, and generate regulatory-grade evidence that complements or substitutes traditional randomized controlled trials (RCTs). As regulatory bodies like the FDA increasingly accept RWE in approval processes, pharmaceutical and device companies are investing heavily in RWE platforms and services, fueling market growth.
   
• With their strong focus on innovation, regulatory compliance, and market access, pharmaceutical and medical device companies are playing a pivotal role in expanding the U.S. RWE market.
   

U.S. Real World Evidence Solutions Market Share

• The top five players, IQVIA Holdings Inc., UnitedHealth Group, IBM Corporation, and Flatiron Health Inc., Syneos Health Inc., collectively hold 85% of the market share in the U.S. real world evidence solutions market.
   
• UnitedHealth Group, through its subsidiary Optum, is a major player in the U.S. real world evidence (RWE) solutions market, offering a comprehensive suite of data-driven services that support healthcare innovation, regulatory decision-making, and value-based care.
   
• Through its real world data platform, Optum leverages one of the largest integrated datasets in the U.S., including claims, clinical, pharmacy, and behavioral health data, to generate actionable insights. Its RWE capabilities span drug development, post-market surveillance, health economics, and outcomes research.
   
• Other notable players in the U.S. real world evidence solutions market including Thermo Fisher Scientific Inc., ICON plc, Syneos Health Inc., Merative, TriNetX LLC, Parexel International Corporation, and Fortrea Inc. are actively engaged in advancing healthcare analytics and clinical research technologies.
   
• For example, in February 2021, Parexel and NeoGenomics announced a strategic collaboration to enhance precision medicine in oncology trials. The partnership aimed to integrate real-world genomics data to improve patient matching, optimize trial design, and support translational research.
   
• These companies are strategically increasing their investments in AI integration, decentralized trials, data platforms, and partnerships with biopharma and healthcare institutions to strengthen their presence in U.S. and expand their market reach.
   

U.S. Real World Evidence Solutions Market Companies

Few of the prominent players operating in the U.S. real world evidence solutions industry include:

• Aetion, Inc.
• Cytel Inc
• Flatiron Health Inc
• Fortrea Holdings Inc
• IBM Corporation
• ICON plc
• IQVIA Holdings Inc
• Medidata Solutions, Inc.
• Merative
• Oracle Corporation
• Parexel International Corporation
• Syneos Health Inc
•  Tempus
• TriNetX
• Thermo Fisher Scientific, Inc.
• UnitedHealth Group Incorporated
   
• Aetion, Inc.

Aetion delivers regulatory-grade RWE through its Aetion Evidence Platform, which applies advanced causal inference and epidemiologic methods to transform complex healthcare data into reliable insights. Its platform is widely used by biopharma, payers, and regulators to support clinical development, market access, and regulatory submissions. Aetion’s strategic partnerships, including with the FDA and NEC, further strengthen its position as a trusted provider of scalable, transparent, and scientifically validated RWE solutions.
 

• Flatiron Health Inc.

Flatiron Health specializes in oncology-focused RWE, offering deep clinical datasets and integrated analytics through its Flatiron Horizon platform. With over a decade of experience and collaborations with the FDA, NICE, and top biopharma companies, Flatiron supports evidence generation across the drug lifecycle—from trial design to post-market strategy. Its flexible engagement models and data empathy-driven approach make it a leader in cancer RWE research.
 

• Syneos Health Inc

Syneos Health Inc offers a distinctive blend of traditional clinical research and real-world evidence services. By integrating clinical trial operations with RWE capabilities, Syneos Health helps clients accelerate time-to-market, improve trial design, and generate evidence that meets both US and global regulatory requirements. Their global network and hybrid solutions make them a versatile partner for pharmaceutical and biotech companies navigating the evolving evidence landscape.
 

U.S. Real World Evidence Solutions Industry News:

• In March 2020, Syneos Health partnered with ConcertAI to enhance oncology clinical trials by integrating real-world evidence (RWE), focusing on external control arms and regulatory-grade data to accelerate drug development, especially for rare and complex cancers.
   
• In August 2025, Aetion, part of Datavant, launched Activate, a solution designed to streamline real-world evidence (RWE) generation. Activate combines low-code tools with a hosted coding environment, allowing users to define measures, transform complex datasets, and run advanced analytics in a reproducible, audit-ready workflow. It reduces time spent on data preparation by offering customizable, point-and-click algorithms. The launch of Activate helps Aetion strengthen its position in the real-world evidence (RWE) market by addressing a major bottleneck in data analytics—preparation and transformation of complex datasets.
   

The U.S. real world evidence solutions market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million and from 2021 – 2034 for the following segments:

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Market, By Component

• Services          
  • Data collection and integration       
  • Study design and execution 
    • Prospective observational studies   
    • Retrospective database studies       
    • Site-centric studies   
    • Registry-based studies         
    • Hybrid studies           
  • Regulatory and market access support       
  • Evidence network     
  • Other services
• Data sets        
  • Disparate data sets   
    • Clinical settings data
    • Claims data sets        
    • Pharmacy data sets   
    • Patient powered data sets   
    • Registry-based data sets      
  • Integrated data sets 

Market, By Application

• Drug development and approval     
  • Oncology        
  • Cardiovascular disease         
  • Neurology      
  • Immunology  
  • Other therapeutic areas       
• Medical device development and approvals          
• Post-market surveillance      
• Market access and reimbursement/coverage decision-making    
• Clinical and regulatory decision-making      

Market, By Revenue Model

• Pay-per-use (value-based pricing)   
• Subscription  

Market, By Deployment Model

• On-premise    
• Cloud-based  

Market, By End Use

• Pharmaceutical and medical device companies     
• Healthcare payers     
• Healthcare providers
• Other end use