Real-World Evidence Market Research Report Information By Components [Services, Data sets {Disparate Data Sets (Clinical Setting Data Sets, Claims Data Set, Pharmacy Data Set, Patient-powered Data Set, Registry-Based Data Sets}, Integrated Data sets], By Application (Drug Development and Approvals (Oncology, Cardiovascular Disease, Neurology, Immunology, Other therapeutic areas), Medical Device Development and Approvals, Post-Market Surveillance, Market Access and Reimbursement Coverage Decision Making and Clinical, Clinical and Regulatory

Global Real-World Evidence Market Overview

Real-World Evidence Market Size was valued at USD 2.2 Billion in 2022. The Real-World Evidence market industry is projected to grow from USD 2.6 Billion in 2023 to USD 9.2 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 17.20% during the forecast period (2024 - 2032). Rising healthcare costs and the shift towards value-based care are the key market drivers enhancing the market growth.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Real-World Evidence Market Trends

• Rising healthcare costs and the shift toward value-based care are driving the market growth

Market CAGR for real-world evidence is being driven by the rising healthcare costs and the shift towards value-based care. As healthcare expenditures continue to escalate globally, stakeholders are increasingly seeking cost-effective solutions that demonstrate real-world effectiveness and value. Real-world data (RWD) derived from routine clinical practice and patient outcomes provide valuable insights into the comparative effectiveness, safety, and economic impact of healthcare interventions. Value-based care models prioritize outcomes and patient satisfaction over volume of services, emphasizing the importance of evidence-based decision-making. RWE plays a crucial role in supporting value-based care initiatives by informing treatment decisions, assessing healthcare interventions' real-world impact, and optimizing resource allocation. Consequently, there is a growing demand for RWE solutions and analytics platforms that can harness the power of real-world data to drive informed healthcare decision-making, improve patient outcomes, and contain costs in an increasingly value-driven healthcare landscape.

The demand for evidence-based decision-making is a key driver fueling the growth of the Real-World Evidence (RWE) Market. Healthcare stakeholders, including policymakers, payers, providers, and pharmaceutical companies, are increasingly relying on real-world data (RWD) to inform their decision-making processes. Unlike data from traditional clinical trials, RWD offers insights into treatment effectiveness, safety profiles, and patient outcomes in real-world clinical settings. This shift towards evidence-based decision-making is driven by several factors, including the need to optimize healthcare resource allocation, improve patient outcomes, and contain rising healthcare costs. RWE enables stakeholders to assess the real-world effectiveness and value of healthcare interventions, inform treatment guidelines, and identify opportunities for quality improvement and cost savings. As a result, there is growing demand for RWE solutions, analytics platforms, and services that can generate actionable insights from diverse sources of real-world data, driving the expansion of the RWE Market.

Advancements in data analytics are playing a pivotal role in driving the Real-World Evidence (RWE) Market forward. As the volume and complexity of real-world data (RWD) continue to grow exponentially, sophisticated data analytics techniques are essential for extracting meaningful insights and actionable intelligence from diverse sources. Advanced analytics platforms, including machine learning, artificial intelligence, and natural language processing, enable healthcare stakeholders to analyze large-scale datasets efficiently, identify patterns, and uncover hidden relationships. These analytics tools empower stakeholders to derive real-world evidence (RWE) insights on treatment effectiveness, safety profiles, patient outcomes, and healthcare utilization patterns. Moreover, innovative analytics solutions facilitate the integration of disparate data sources, such as electronic health records (EHRs), claims data, patient registries, and wearable devices, enabling comprehensive analyses and holistic insights into real-world healthcare dynamics. Consequently, the demand for advanced data analytics capabilities is driving investment in RWE solutions and propelling the growth of the RWE market revenue.

For instance, the Real-World Evidence Transparency Initiative introduced the Real-World Evidence Registry to promote transparency in the analysis and reporting of real-world evidence in healthcare and health research. This initiative, established through collaboration between ISPOR, the International Society for Pharmacoepidemiology, the Duke-Margolis Center for Health Policy, and the National Pharmaceutical Council, aims to cultivate a culture of openness and accountability within the field.

• Real-World Evidence Components Insights

The Real-World Evidence Market segmentation, based on components, includes Services, Data sets {Disparate Data Sets (Clinical Setting Data Sets, Claims Data Set, Pharmacy Data Set, Patient-powered Data Set, Registry-Based Data Sets}, Integrated Data sets. In 2023, the Services segment dominated the market due to their integral role in delivering comprehensive and tailored solutions to address diverse customer needs. These components encompass a range of services, including data collection, analysis, interpretation, and consulting, designed to generate actionable insights from real-world data. By offering end-to-end solutions that enable evidence-based decision-making in healthcare, companies in this segment have established themselves as key players driving the adoption and dominance of RWE Solution, Service Components in the market.

Real-World Evidence (RWE) Solution Components are experiencing the highest compound annual growth rate (CAGR) in the Real-World Evidence Market due to their increasing importance in providing comprehensive and customizable solutions. These components include data analytics platforms, software solutions, and integrated systems designed to extract insights from real-world data efficiently. As demand grows for sophisticated analytics tools and platforms that can harness the full potential of real-world data, the market for RWE Solution Components continues to expand at a rapid pace, driving its highest CAGR in the market.           

• Real-World Evidence Application Insights

The Real-World Evidence Market segmentation, based on application, includes Drug Development and Approvals (Oncology, Cardiovascular Disease, Neurology, Immunology, Other therapeutic areas), Medical Device Development and Approvals, Post-Market Surveillance, Market Access and Reimbursement Coverage Decision Making and Clinical, Clinical and Regulatory Decision Making and Others. In 2023, the drug development and approvals category generated the most income due to its critical role in supporting regulatory submissions, clinical trials, and post-market surveillance. Real-world evidence (RWE) plays a crucial role in demonstrating the safety, efficacy, and effectiveness of pharmaceutical products throughout their lifecycle. By providing insights into real-world patient outcomes and treatment patterns, RWE facilitates evidence-based decision-making by regulatory agencies, pharmaceutical companies, and healthcare stakeholders, driving its dominance in the market.

Oncology Application is experiencing the highest compound annual growth rate (CAGR) in the Real-World Evidence Market due to several factors. The rising prevalence of cancer, coupled with advancements in oncology treatments, has led to an increased demand for real-world evidence (RWE) to support clinical decision-making and drug development in oncology. Additionally, initiatives such as precision medicine and value-based care further drive the need for robust RWE in oncology, contributing to its rapid growth in the market.

• Real-World Evidence Mode of Deployment Insights

The Real-World Evidence Market segmentation, based on mode of deployment, includes On-premises and Cloud Based. In 2023, the On-premises category generated the most income due to factors such as data security concerns, regulatory compliance requirements, and the need for full control over data management. Healthcare organizations often prefer on-premises solutions to ensure data privacy, confidentiality, and compliance with industry regulations. Additionally, some organizations may have infrastructure limitations or specific data governance policies that necessitate on-premises deployment, contributing to its dominance in the market.

Cloud-based mode of deployment is experiencing the highest compound annual growth rate (CAGR) in the Real-World Evidence Market due to several factors. The increasing adoption of cloud computing technologies across healthcare organizations, coupled with the benefits of scalability, flexibility, and cost-effectiveness offered by cloud-based solutions, is driving its growth. Additionally, the growing volume and complexity of real-world data require scalable and agile infrastructure, making cloud-based deployment an attractive option for handling large datasets and facilitating collaborative research efforts.

Figure 1: Real-World Evidence Market, by Mode of Deployment, 2023 & 2032 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Real-World Evidence Revenue Model Insights

The Real-World Evidence Market segmentation, based on revenue model, includes Pay Per Usage and Subscription. In 2023, the Pay Per Usage (Value-Based Pricing) category generated the most income due to its alignment with the evolving needs of healthcare organizations and pharmaceutical companies. This model offers flexibility and cost-effectiveness by allowing users to pay based on their usage of real-world evidence (RWE) solutions and services. It provides transparency, scalability, and ensures that customers pay for the value they receive, driving its widespread adoption and dominance in the market.

The Subscription Revenue Model is experiencing the highest compound annual growth rate (CAGR) in the Real-World Evidence Market due to its appeal to healthcare organizations seeking predictable costs and continuous access to real-world evidence (RWE) solutions and services. This model offers flexibility, scalability, and ease of budgeting by providing access to RWE platforms and updates for a fixed recurring fee. Additionally, subscription-based pricing aligns with the ongoing trend towards subscription services in the healthcare industry, driving its rapid growth in the market.

Real-World Evidence End Users Insights

The Real-World Evidence Market segmentation, based on end users, includes Pharmaceutical & Medical Device Companies, Healthcare Payers, Healthcare Providers and Other End Users. In 2023, Pharmaceutical & Medical Device Companies category generated the most income (35%). Pharmaceutical and medical device companies dominate the real-world evidence market due to several factors. First, they have substantial resources to invest in research and development. Second, they possess vast amounts of data collected during clinical trials and post-market surveillance, providing a rich source for real-world evidence generation. Additionally, regulatory agencies increasingly require real-world evidence to complement traditional clinical trial data, further driving demand. Finally, these companies have established networks and collaborations with healthcare providers, facilitating data access and analysis.

Healthcare payers are experiencing rapid growth in the real-world evidence market primarily due to the increasing focus on value-based healthcare models. Payers are under pressure to demonstrate the effectiveness and cost-effectiveness of treatments and interventions. Real-world evidence enables them to assess the real-world outcomes and economic impact of healthcare interventions, aiding in informed decision-making regarding coverage and reimbursement. Additionally, advancements in data analytics technologies allow payers to harness real-world data more effectively, driving the demand for real-world evidence solutions at a high CAGR.

Real-World Evidence Regional Insights

By region, the study provides the market insights into North America, Europe, Asia-Pacific and the Rest of the World. The North American Real-World Evidence market area will dominate this market, with a strong presence of pharmaceutical and biotechnology companies. North America dominates the Real-World Evidence Market due to several factors. The region boasts advanced healthcare infrastructure, a strong presence of pharmaceutical and biotechnology companies, and significant investments in real-world evidence (RWE) initiatives. Moreover, a favorable regulatory environment and government initiatives encourage the adoption of RWE solutions for regulatory submissions, clinical trials, and healthcare decision-making. Additionally, the presence of key market players and research institutions further solidifies North America's leadership position in the Real-World Evidence Market.

Further, the major countries studied in the market report are the US, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2: REAL-WORLD EVIDENCE MARKET SHARE BY REGION 2023 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe Real-World Evidence market accounts for the second-largest market share due to the healthcare policy development. Europe secures the second-largest market share in the Real-World Evidence (RWE) Market due to its advanced healthcare infrastructure, stringent regulatory framework, and strong emphasis on evidence-based medicine. The region's healthcare systems prioritize the use of real-world data (RWD) to inform decision-making, regulatory submissions, and healthcare policy development. Additionally, collaborations between academia, industry, and government entities drive innovation and adoption of RWE solutions. These factors contribute to Europe's significant presence and influence in the global RWE Market. Further, the German Real-World Evidence market held the largest market share, and the UK Real-World Evidence market was the fastest growing market in the European region.

The Asia-Pacific Real-World Evidence Market is expected to grow at the fastest CAGR from 2024 to 2032. The Asia Pacific region is experiencing the highest compound annual growth rate (CAGR) in the Real-World Evidence (RWE) Market due to several factors. Rapid economic development, increasing healthcare investments, and growing adoption of digital health technologies are driving the demand for RWE solutions. Additionally, the region's diverse patient populations and expanding clinical research activities create opportunities for leveraging real-world data (RWD) to inform healthcare decision-making and drug development processes. These factors contribute to the significant growth of the RWE Market in the Asia Pacific region. Moreover, China’s Real-World Evidence market held the largest market share, and the Indian Real-World Evidence market was the fastest growing market in the Asia-Pacific region.

Real-World Evidence Key Market Players & Competitive Insights

Leading players in the Real-World Evidence (RWE) Market are focusing on innovation, strategic partnerships, and expanding their service offerings. Companies like IQVIA, Optum, and IBM Watson Health are investing in advanced analytics platforms to harness the power of real-world data (RWD) for evidence generation and insights. Additionally, strategic collaborations with healthcare providers, pharmaceutical companies, and regulatory agencies strengthen their market position and broaden their customer base. These players are also expanding their geographic presence and investing in research and market developments to drive innovation in the RWE Market.

Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the global Real-World Evidence industry to benefit clients and increase the market sector. In recent years, the Real-World Evidence industry has offered some of the most significant advantages to on-premises. Major players in the Real-World Evidence market, including IQVIA, Optum, IBM Watson Health, Cerner Corporation, SAS Institute Inc., Oracle Corporation, Syneos Health, Flatiron Health, Palantir Technologies and Clinithink are attempting to increase market demand by investing in research and development operations.

IQVIA is a leading global provider of advanced analytics, technology solutions, and contract research services in the Real-World Evidence (RWE) Market. The company offers a comprehensive suite of RWE solutions, including data analytics platforms, consulting services, and evidence generation services, to pharmaceutical companies, healthcare providers, and regulatory agencies worldwide. IQVIA leverages its extensive network of healthcare data sources and proprietary analytics capabilities to generate actionable insights from real-world data (RWD), supporting evidence-based decision-making across the healthcare ecosystem. With a focus on innovation, quality, and customer satisfaction, IQVIA continues to drive advancements in RWE methodologies and technologies, empowering clients to optimize clinical research, improve patient outcomes, and enhance healthcare delivery.

Optum, a subsidiary of UnitedHealth Group, is a leading provider of health services and technology solutions in the Real-World Evidence (RWE) Market. The company offers a wide range of RWE solutions, including data analytics platforms, consulting services, and research collaborations, to pharmaceutical companies, healthcare organizations, and government agencies globally. Leveraging its extensive healthcare data assets and advanced analytics capabilities, Optum delivers actionable insights from real-world data (RWD) to inform clinical research, improve patient outcomes, and drive evidence-based decision-making. With a focus on innovation, collaboration, and customer-centricity, Optum continues to play a pivotal role in advancing RWE methodologies and technologies, empowering clients to navigate complex healthcare challenges and achieve their strategic objectives.

Key Companies in the Real-World Evidence market include

• IQVIA


• Optum


• IBM Watson Health


• Cerner Corporation


• SAS Institute Inc.


• Oracle Corporation


• Syneos Health


• Flatiron Health


• Palantir Technologies


• Clinithink

Real-World Evidence Industry Developments

December 2021: EVERSANA has entered into an agreement with Janssen Research & Development LLC (Janssen) aimed at facilitating evidence-based development of Janssen therapies, treatments, and patient support models.

August 2022: Change Healthcare introduced InterQual 2022, providing the most recent evidence-based criteria and technology to enhance clinical decision support.

Real-World Evidence Market Segmentation

Real-World Evidence Components Outlook

• Services


• Data sets
  
  
  
  • Disparate Data Sets
    
    
    
    • Clinical Setting Data Sets
    
    
    • Claims Data Set
    
    
    • Pharmacy Data Set
    
    
    • Patient-powered Data Set
    
    
    • Registry-Based Data Sets
    
    
    
    
  
  
  • Integrated Data sets
  
  
  
  

Real-World Evidence Application Outlook

• Drug Development and Approvals
  
  
  
  • Oncology
  
  
  • Cardiovascular Disease
  
  
  • Neurology
  
  
  • Immunology
  
  
  • Other therapeutic areas
  
  
  
  


• Medical Device Development and Approvals


• Post-Market Surveillance


• Market Access and Reimbursement Coverage Decision Making and Clinical


• Clinical and Regulatory Decision Making


• Others

Real-World Evidence Mode of Deployment Outlook

• On-premises


• Cloud Based

Real-World Evidence Revenue Model Outlook

• Pay Per Usage


• Subscription

Real-World Evidence End Users Outlook

• Pharmaceutical & Medical Device Companies


• Healthcare Payers


• Healthcare Providers


• Other End Users

Real-World Evidence Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  

• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America