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Global Real-world Evidence Solutions Market on Track for 10% CAGR Driven by Regulatory Backing by 2030

 


The real-world evidence (RWE) solutions market is expected to expand at a CAGR of ~10% during the forecast period. Key factors driving this growth include increasing regulatory support for RWE adoption, the rising incidence of chronic diseases, increased investment from pharmaceutical companies, the growing focus on personalized medicine and targeted therapies, the widespread adoption of electronic health records (EHRs) and digital health data, and the potential of RWE to lower drug development costs and enhance the efficiency of clinical trials.

Real-world evidence (RWE) solutions refer to advanced analytical tools, platforms, and methodologies that leverage real-world data (RWD) to generate clinical insights on the usage, effectiveness, safety, and value of medical products, treatments, and healthcare interventions. These solutions integrate data from various sources including electronic health records (EHRs), claims databases, patient registries, wearable devices, and patient-reported outcomes to support drug development, regulatory decision-making, market access, post-market surveillance, and value-based healthcare initiatives. RWE solutions help pharmaceutical companies, healthcare providers, payers, and regulatory bodies assess treatment outcomes, improve patient care, optimize clinical practices, and inform reimbursement and policy decisions. Real-world evidence (RWE) has been in use for decades, but recent advances in digital technology and advanced analytics allow it to be employed in new ways.

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RWE plays a vital role in helping regulators formulate decisions

RWE could potentially help the FDA while making regulatory decisions about the safety and effectiveness of medical products such as identifying new safety issues post-approval or determining the effectiveness of a drug for a new indication or patient population. Unlike traditional clinical trials, which are conducted in controlled environments with limited patient populations, RWE provides insights from diverse patient groups, routine clinical practice, and post-market surveillance. This enables regulators to evaluate treatment outcomes, monitor adverse events, and refine drug labeling based on real-world usage. Additionally, RWE supports expedited approvals and label expansions by supplementing clinical trial data, especially in areas like rare diseases, personalized medicine, and oncology. Citing the potential, the 21st Century Cures Act (Cures Act, signed in 2016) required the FDA to publish a framework for a program to evaluate the use of RWE in regulatory decision-making; FDA published the framework for this program in December 2018. As part of its RWE Program, the FDA committed to understanding the full potential of RWD and RWE in regulatory decision-making. The agency has been holding workshops, funding demonstration projects, creating mobile and web applications that can collect RWD, and engaging with sponsors on the topic.

Pharma/biopharma companies are focusing on strengthening RWE capabilities

The ability to rapidly convert real-world data sources, such as claims data and electronic medical records (EMRs), into actionable evidence enhances patient health outcomes by enabling pharmaceutical companies to streamline drug development and optimize commercialization strategies. These insights empower biopharmaceutical firms to accelerate the development of effective therapies, generate robust evidence for payers, and strengthen their competitive positioning in the healthcare market. To access high-quality real-world data and refine study designs, many pharma companies are establishing strategic collaborations with healthcare providers, payers, and data analytics firms. Enhancing RWE capabilities also allows them to adapt to the growing focus on value-based care and reimbursement models, ensuring that new treatments align with both regulatory and payer expectations. Consequently, the industry is shifting toward integrated RWE platforms, real-time evidence generation, and adaptive trial designs, reinforcing RWE as a key driver of innovation and improved patient outcomes.

Competitive Landscape Analysis

The global real-world evidence (RWE) solutions market is marked by the presence of established and emerging market players such as IQVIA Holdings; Parexel; Icon; PPD; Syneos Health; Clarivate; Cerner; Medpace Holdings; Flatiron Health; Symphony Innovation; Aetion; Cognizant Technology; IBM; Oracle; Data Matrix; SAS Institute Inc.; Clinigen Group; and UnitedHealth Group; among others. Some of the key strategies adopted by market players include new product development, strategic partnerships and collaborations, and investments.

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Global Real-world Evidence (RWE) Solutions Market Segmentation

This report by Medi-Tech Insights provides the size of the global real-world evidence (RWE) solutions market at the regional- and country-level from 2023 to 2030. The report further segments the market based on component, application, and end user.

Market Size & Forecast (2023-2030), By Component, USD Million

  • Services
  • Data Sets
    • Claims Data
    • Clinical Settings Data
    • Patient-Powered Data
    • Pharmacy Data

Market Size & Forecast (2023-2030), By Application, USD Million

  • Drug development & approvals
  • Medical device development & approvals
  • Post-market safety & adverse events monitoring
  • Reimbursement/coverage and regulatory decision making

Market Size & Forecast (2023-2030), By End User, USD Million

  • Healthcare Companies (Pharmaceutical, Biopharmaceutical, Medical Devices)
  • Healthcare Payers
  • Healthcare Providers
  • Others

Market Size & Forecast (2023-2030), By Region, USD Million

  • North America
    • US
    • Canada
  • Europe
    • UK
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Rest of Asia Pacific
  • Latin America
  • Middle East & Africa

About Medi-Tech Insights

Medi-Tech Insights is a healthcare-focused business research & insights firm. Our clients include Fortune 500 companies, blue-chip investors & hyper-growth start-ups. We have completed 100+ projects in Digital Health, Healthcare IT, Medical Technology, Medical Devices & Pharma Services in the areas of market assessments, due diligence, competitive intelligence, market sizing and forecasting, pricing analysis & go-to-market strategy. Our methodology includes rigorous secondary research combined with deep-dive interviews with industry-leading CXO, VPs, and key demand/supply side decision-makers.

Contact:

Ruta Halde
Associate, Medi-Tech Insights
 +32 498 86 80 79
 info@meditechinsights.com 

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