Real World Evidence Solutions Market

Real World Evidence Solutions Market Size

The global real world evidence solutions market was estimated at USD 2.3 billion in 2024. The market is expected to grow from USD 2.6 billion in 2025 to USD 10.2 billion in 2034, growing at a CAGR of 16.2%, according to the latest report published by Global Market Insights Inc. The growth of the market is largely influenced by 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.

The market increased from USD 1.5 billion in 2021 to USD 2 billion in 2023. This growth was driven by the growing focus towards accelerating drug development and cost reduction, traditional drug development is slow and expensive, relying heavily on multi-phase clinical trials and regulatory reviews. RWE enables faster, data-driven decisions by integrating real-world data (RWD) from sources like EHRs, claims, and patient registries. This helps pharmaceutical companies identify viable candidates, validate efficacy across diverse populations, and monitor safety in real-world settings ultimately reducing trial size and cost.

Additionally, RWE is increasingly used in preclinical research to supplement animal studies with historical clinical data. This helps detect early safety signals and optimize dosing strategies. Regulatory bodies like the FDA and EMA now recognize RWE’s value, encouraging biopharma firms to invest in RWE platforms for faster approvals and reduced trial expenditures.

The increasing adoption of RWE solutions for informed reimbursement decision-making, as healthcare systems increasingly shift toward value-based care, the adoption of Real World Evidence (RWE) solutions is becoming essential for informed reimbursement decisions. Health Technology Assessment (HTA) bodies and payers are leveraging RWE to evaluate how therapies perform in real-world clinical settings, beyond the controlled conditions of randomized clinical trials. This enables more transparent, cost-effective, and patient-centered decision-making.

To fully integrate RWE into reimbursement frameworks, HTA bodies are building strong infrastructures, including analytical capabilities and standardized methodologies. The European Medicines Agency (EMA), for instance, has developed the DARWIN EU network to generate timely, reliable RWE for regulatory and payer decisions. Such initiatives enhance consistency and transparency, fostering trust among stakeholders and accelerating the adoption of RWE platforms across global healthcare systems.

Real world evidence solutions represent a diverse array of methodologies, technologies, and services that are designed to generate valuable insights into various aspects of healthcare. These solutions leverage real-world data, which is collected from sources outside the controlled environment of traditional clinical trials, to provide a more comprehensive understanding of healthcare outcomes, treatment effectiveness, and patient experiences.

Real World Evidence Solutions Market Trends

• The global RWE solutions market is being driven by the growing need for real-time tracking of drug and device performance. Traditional surveillance methods often suffer from delays and limited data, making it harder to catch safety issues early. RWE platforms overcome this by continuously analysing data from sources like EHRs, claims, registries, and wearables.
  
• Pharmaceutical firms, regulators, and providers increasingly rely on RWE to detect adverse events and assess treatment effectiveness in near real-time. Additionally, these platforms discover off-label usage patterns or unexpected side effects, allowing for quicker interventions and more informed decision-making further driving adoption across the healthcare ecosystem.
  
• RWE platforms support dynamic research workflows and faster regulatory reviews, especially critical during public health emergencies or in rapidly evolving therapeutic areas.
  
• Additionally, the ability to access up-to-date clinical data enhances agility in clinical development. As value-based care gains traction, investment in RWE infrastructure and analytics continues to grow robustly.
  

Real World Evidence Solutions Market Analysis

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Based on the component type, the real-world evidence solutions market is segmented into services and data sets The services segment held a significant market share of 58.4% in 2024.

• The RWE solutions market is segmented into services and data sets, with the services segment holding a dominant position. This is primarily due to the increasing complexity of healthcare data and the critical need for expert interpretation and tailored solutions. Services such as data aggregation, advanced analytics, regulatory consulting, and evidence generation are essential for transforming raw real-world data into actionable insights.
  
• Moreover, the growing reliance of pharmaceutical companies, payers, and healthcare providers on RWE to guide clinical and commercial decisions is stimulating demand for specialized service providers. These experts ensure data quality, regulatory compliance, and relevance making their role indispensable. Additionally, the rise in chronic diseases and personalized medicine has expanded the use of RWE services across therapeutic areas like oncology and cardiology.
  
• Advanced technologies like AI and machine learning are being integrated into service offerings, enabling predictive modeling, risk stratification, and early signal detection. Furthermore, regulatory bodies such as the FDA and EMA increasingly accept RWE in submissions, boosting demand for consulting services that help navigate approval pathways. Global outsourcing trends also contribute to this growth, as firms seek cost-effective and scalable RWE solutions.
  

Based on application, the real world evidence solutions market is segmented 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 approvals segment was worth USD 840.7 million in 2024.  

• Drug development and approval segment dominated the market due to increasing complexity, cost, and risk associated with traditional drug development processes. Pharmaceutical companies are turning to RWE to streamline clinical trials, identify target populations, and monitor long-term safety and effectiveness using real-world data from electronic health records, claims, and registries.
  
• Moreover, regulatory agencies like the FDA and EMA are actively promoting the use of RWE in drug approvals. The FDA’s RWE Framework supports its use in label expansions, post-approval studies, and new indications accelerating its integration into clinical pipelines. This regulatory support is encouraging pharma companies to adopt RWE earlier in the development cycle.
  
• RWE is especially valuable in areas like rare diseases and oncology, where randomized controlled trials (RCTs) are often impractical due to small patient populations. In such cases, RWE enables the creation of external control arms and supports accelerated approval pathways. Additionally, AI-driven platforms are enhancing RWE’s utility by enabling predictive modeling, patient stratification, and real-time monitoring.
  

Based on revenue model, the real world evidence solutions market is segmented into pay-per-use (value-based pricing) and subscription model. The pay-per-use segment held a significant market share of 65.3% in 2024.

• Pay-per-use model is a pricing approach where organizations pay only for the specific data, analytics, or services they use, without long-term contracts. It offers flexibility and cost-efficiency, especially for targeted studies or early-stage research.
  
• As RWE applications expand across drug development, regulatory submissions, and post-market surveillance, organizations prefer scalable solutions that align with the scope of individual projects. This model allows users to pay only for the specific data, analytics, or consulting services they need minimizing financial risk and optimizing resource allocation.
  
• Moreover, the rise of cloud-based platforms and AI-powered tools has made modular, on-demand access to RWE services more practical. Startups and emerging biopharma firms especially benefit from this model, gaining access to high-quality insights without large upfront investments. This democratization of access is fostering innovation and accelerating development timelines.
  

Based on deployment model, the real world evidence solutions market is segmented into on-premises and cloud-based model. The cloud-based segment held a significant market share of 86.3% in 2024.

• Cloud-based deployment refers to delivering RWE solutions via remote servers hosted on the internet, allowing users to access data storage, analytics tools, and computing resources on-demand without needing local infrastructure.
  
• The cloud-based segment dominates the RWE market due to its ability to handle the growing volume and complexity of real-world data (RWD) from sources like EHRs, claims, registries, and wearables. Cloud platforms offer scalable computing power and flexible storage, making them ideal for processing diverse datasets efficiently.
  
• Moreover, the rapid adoption of AI and machine learning in RWE analytics requires high-performance environments that cloud platforms are uniquely equipped to provide. These technologies enable predictive modeling, cohort analysis, and real-time insights all supported seamlessly in cloud ecosystems.
  
• Cloud deployment also enhances collaboration among stakeholders such as pharma companies, CROs, and regulators by enabling secure, shared access to data environments. Additionally, modern cloud platforms offer security features like HIPAA and GDPR compliance making them a choice for handling sensitive healthcare data.
  

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Based on end use, the real world evidence solutions market is categorized into pharmaceutical and medical device companies, healthcare payers, healthcare providers and other end users. Among these, the pharmaceutical and medical device companies segment dominated the market in 2024, accounting for 60.4% of the total market share. This dominance is projected to continue, with the segment expected to reach USD 6.3 billion by 2034.

• Real-world evidence (RWE) is increasingly being adopted by pharmaceutical and medical device companies due to their growing reliance on data-driven strategies for clinical development and regulatory compliance. The increasing complexity of clinical trials and the need for faster, cost-effective pathways have made RWE essential for identifying patient cohorts, simulating trial outcomes, and validating therapeutic efficacy.
  
• Regulatory agencies like the FDA and EMA are encouraging the use of RWE in drug applications, label expansions, and safety monitoring, prompting life sciences firms to adopt RWE platforms more widely. Medical device companies also use RWE to demonstrate product performance and safety across diverse patient populations, especially in chronic disease and surgical applications.
  
• Post-market surveillance and pharmacovigilance are key areas where RWE adds value, helping companies detect adverse events and monitor long-term outcomes. Strategic collaborations with RWE solution providers further enhance access to high-quality data, analytics, and regulatory expertise accelerating innovation and improving decision-making.
  

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North America Real World Evidence Solutions Market

The North America market dominated the market with a market share of 43.2% in 2024.

The U.S. real world evidence solutions market was valued at USD 590.1 million and USD 680.4 million in 2021 and 2022, respectively. The market size reached USD 909.4 million in 2024, growing from USD 786.1 million in 2023.

• The U.S. dominates the RWE solutions market due to its high burden of chronic diseases like cardiovascular conditions and cancer, which demand continuous monitoring and data-driven interventions. RWE platforms help identify at-risk populations, guide preventive strategies, and support post-treatment, especially critical given the scale and urgency of these health challenges.
  
• Additionally, the country’s aging population is driving demand for personalized care and long-term disease management, areas where RWE plays a vital role. The widespread adoption of cloud-based technologies and AI-powered analytics further strengthens the infrastructure for real-world data collection and analysis.
  
• Regulatory support from agencies like the FDA, which actively encourages the use of RWE in drug approvals and safety monitoring, has accelerated adoption among pharmaceutical and medical device companies. Combined with robust healthcare data systems and strategic collaborations, these factors position the U.S. as a global leader in RWE innovation and implementation.
  

Europe Real World Evidence Solutions Market

Europe market accounted for USD 623.6 million in 2024 and is anticipated to show lucrative growth over the forecast period.

• Europe is steadily expanding in the RWE market, driven by a high burden of chronic and neurodegenerative diseases, and a robust public healthcare infrastructure. The region’s commitment to data-driven healthcare and evidence-based policymaking makes RWE a vital tool for improving clinical outcomes and guiding regulatory and reimbursement decisions.
  
• For instance, according to the World Health Organization (WHO), Europe reports over 3.7 million new cancer cases and 1.9 million related deaths each year. In 2021, cancer was responsible for 21.6% of all deaths in the EU, highlighting the urgent need for real-world data to support early diagnosis and improve treatment outcomes.
  
• Cancer remains a major public health challenge, with millions of new cases and deaths annually. RWE platforms are increasingly used to support early detection, optimize treatment strategies, and monitor long-term outcomes especially in oncology, where personalized medicine is rapidly evolving. These tools help stakeholders analyze diverse patient data and identify gaps in care delivery.
  

Germany real world evidence solutions market is anticipated to witness considerable growth over the analysis period.

• Germany is emerging market for RWE solutions in Europe, driven by Germany's significant disease burden and advanced healthcare infrastructure.
  
• The growing adoption of RWE in Germany is fueled by its commitment to evidence-based healthcare, rising demand for personalized medicine, and the need to optimize clinical and reimbursement decisions. RWE platforms are increasingly being integrated into national cancer strategies and clinical guidelines to support more efficient and targeted care delivery.
  

Asia Pacific Real World Evidence Solutions Market

The Asia Pacific market is anticipated to grow at the CAGR of 16.6% during the analysis timeframe.

• The Asia Pacific region is experiencing rapid growth in the adoption of RWE solutions, driven by a combination of healthcare challenges, demographic shifts, and the rising demand for data-driven decision-making. With an increasing burden of chronic and age-related diseases such as cancer, cardiovascular conditions, and musculoskeletal disorders there is a growing need for scalable and accurate health data analytics across the region.
  
• For instance, according to global cancer observatory Cancer remains a major concern, with the region recording nearly 9.8 million new cases and 5.46 million deaths annually.
  
• These figures highlight the urgent need for real-world data to support early detection, optimize treatment strategies, and improve survivorship care. RWE platforms are increasingly being adopted to enhance clinical outcomes, align with regulatory standards, and improve healthcare resource planning across diverse systems in the region.
  

Japan real world evidence solutions market is predicted to grow significantly over the forecast period.

• The growing adoption of RWE in Japan is fueled by its advanced healthcare infrastructure, strong regulatory framework, and focus on precision medicine. RWE platforms are increasingly being used to support early diagnosis, optimize treatment pathways, and monitor long-term outcomes—especially in oncology and age-related conditions.
  
• For instance, according to global cancer observatory  in 2022, the country reported over 1 million new cancer cases and 426,000 cancer-related deaths, underscoring the urgent need for data-driven healthcare strategies.
  
• This shift reflects Japan’s commitment to improving clinical decision-making and healthcare resource planning through real-world data.
  

Latin America Real World Evidence Solutions Market

Brazil is experiencing significant growth in the Latin America market due to the high burden of chronic diseases.

• Brazil’s RWE market is expanding rapidly due to its high burden of chronic diseases especially cardiovascular conditions and its strong clinical research infrastructure. With noncommunicable diseases accounting for the majority of deaths, there is an urgent need for data-driven healthcare strategies to improve outcomes and guide public health planning.
  
• The country’s transition from participating in global trials to leading large-scale randomized studies reflects its growing capability in generating regulatory-grade RWE. Additionally, Brazil’s large and diverse population, high patient recruitment rates, and increasing adoption of digital health tools are driving demand for scalable, localized RWE platforms. These factors position Brazil as a regional leader in leveraging real-world data for clinical, regulatory, and policy decision-making.
  

Middle East and Africa Real World Evidence Solutions Market

Saudi Arabia market is poised to witness substantial growth in the Middle East and Africa market during the forecast period.

• Saudi Arabia is emerging as a key market for RWE solutions in the Middle East, driven by its strategic healthcare reforms under Vision 2030 and the urgent need to address chronic diseases particularly cardiovascular conditions. With CVDs accounting for nearly one-third of all deaths, the country faces significant clinical and economic burdens, including high healthcare costs and productivity losses.
  
• The government’s focus on improving population health and reducing disease impact is accelerating the adoption of RWE platforms. These solutions support early detection, treatment optimization, and long-term disease management by enabling access to real-time, high-quality health data. Saudi Arabia’s investment in digital health infrastructure and its growing participation in clinical research further reinforce its role in advancing regulatory-grade RWE across the region.
  

Real World Evidence Solutions Market Share

• Top players like IQVIA Holdings Inc, United Health Group, IBM Corporation, Flatiron Health, and ICON Plc are expanding their global footprint through strategic initiatives. These include mergers, partnerships, and innovation-driven approaches aimed at strengthening long-term competitiveness in the evolving healthcare data landscape. These top players hold a combined market share of ~65% in the global RWE Solutions market.
  
• These companies are actively integrating artificial intelligence and advanced analytics into RWE platforms. By embedding AI into clinical workflows and enabling decentralized trials, they are enhancing the speed, accuracy, and scalability of evidence generation.
  
• Collaborations with regulatory bodies are central to their strategy, helping align RWE solutions with evolving compliance standards. Additionally, efforts to expand access to underserved populations are making RWE more inclusive and impactful across diverse healthcare systems.
  
• Through data-driven innovation, these market leaders are improving healthcare intelligence and patient outcomes. Their focus on real-world data is transforming clinical research, regulatory decision-making, and public health planning on a global scale.
  

Real World Evidence Solutions Market Companies

Some of the eminent market participants operating in the Real world evidence solutions industry include:

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

Flatiron Health Inc. is a leading provider of oncology-focused RWE solutions, offering platforms that integrate electronic health records and clinical data to generate actionable insights. Its technology supports cancer research, treatment optimization, and regulatory submissions. By combining real-world data with advanced analytics, Flatiron enables life sciences companies and healthcare providers to improve patient outcomes and accelerate innovation. Strategic partnerships and a deep focus on oncology position Flatiron as a key player in the evolving RWE landscape.

• ICON plc

ICON plc is a global leader in clinical research and real-world evidence (RWE) solutions, offering end-to-end services across drug development. With deep expertise in oncology and late-phase research, ICON integrates advanced analytics, EHR platforms, and patient-centric technologies to optimize outcomes and accelerate market access. Its proprietary Real World Intelligence™ platform and strategic partnerships empower life sciences companies to generate impactful evidence for regulatory, payer, and provider decisions, positioning ICON as a key innovator in the evolving RWE landscape.

• Oracle Corporation

Oracle Corporation delivers robust RWE solutions through its Life Sciences division, leveraging over 100 million EHRs and global claims data to support clinical research, market access, and regulatory strategies. Its platforms integrate AI, cloud, and analytics to enable observational studies, patient registries, and safety signal detection. Oracle’s expansive datasets and proprietary tools empower life sciences companies to generate actionable insights, optimize treatment value, and accelerate innovation across the healthcare ecosystem.

Neurostimulation Devices Industry News

• In July 2024, OneMedNet and Cytel announced a strategic partnership to enhance real-world data solutions in clinical research. The alliance integrates OneMedNet’s BEAM platform, offering regulatory-grade clinical data, with Cytel’s advanced analytics and trial design expertise. This collaboration aims to accelerate drug development and improve patient outcomes by enabling deeper insights from real-world evidence across a broad healthcare network.
  
• In July 2023, Thermo Fisher Scientific Inc. announced the acquisition of CorEvitas LLC, enhancing its capabilities in regulatory-grade real-world evidence. CorEvitas, known for its multi-therapeutic registries and longitudinal patient data, supports pharmaceutical and biotech companies in evaluating treatment effectiveness and safety. This strategic move aligned with Thermo Fisher’s mission to accelerate innovation and improve clinical outcomes. By integrating CorEvitas’ data intelligence platform, Thermo Fisher strengthened its position in the real-world evidence solutions market, enabling more efficient drug development and deeper insights into post-approval therapy performance.
  

The 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 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-premises 
• Cloud-based  

Market, By End Use

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

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America 
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa 
  • South Africa
  • Saudi Arabia
  • UAE