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United States Real-World Evidence (RWE) Solutions Market Report 2022: Market is Expected to Grow at a CAGR of 13% from 2021 to 2028 to Reach $2.01 Billion by 2028 -

DUBLIN--(BUSINESS WIRE)--The "U.S. Real-World Evidence (RWE) Solutions Market Report 2022" has been added to's offering.

The U.S. RWE solutions market is expected to grow at a CAGR of 13.0% from 2021 to 2028 to reach $2.01 billion by 2028

Growing incidence of chronic & infectious diseases, delays in drug development and the subsequent increase in development costs, rising focus towards personalized healthcare, a shift from volume to value-based care, and rapidly growing big data in healthcare are the key factors driving steady growth in the U.S. RWE solutions market. Further, significant opportunities for existing market players and new entrants are provided by rising focus on end-to-end RWE services, and rising adoption of wearable devices and AI in RWE

Based on component, the datasets segment commanded the largest share in the market in 2021. Real-world data (RWD) are derived from various sources associated with outcomes in a heterogeneous patient population in real-world settings. Datasets are present in a secondary format on which retrospective studies are conducted to generate real-world evidence.

This real-world evidence provides meaningful insights into unmet needs and the clinical and economic impacts on patients and healthcare systems. It also determines the outcomes based on much larger data samples, reduces costs, and improves the efficiency of clinical trials.

Based on application, the drug development & approvals segment is expected to show the fastest growth rate in the forecast period. Factors attributing towards the growth of this segment are increasing demand for real-world data and real-world evidence to accelerate drug discovery and development, and increasing investments by biopharmaceutical companies in R&D.

In the field of drug development, quality-of-life metrics, and Patient-Reported Outcome Measures (PROMs) are now becoming common elements in clinical trials. The evidence generated from real-world data is regularly utilized to inform aspects of drug development. The role of RWE in drug development is expanding as RWE studies are significantly less costly and time-consuming than RCTs, providing easier access to long-term effectiveness data and helping overcome some of the feasibility barriers of running RCTs.

Based on end user, the pharmaceutical & medical device companies segment is expected to show the fastest growth rate in the forecast period. The growth of this segment is primarily attributed to the increasing importance of RWE studies in drug development & approvals and the growing need to avoid costly drug recalls and assess drug performance in real-world settings.

The cost of developing a new drug was more than ~USD 2,600 million in 2020 compared to USD 802 million in 2003. This increase in drug development costs reflects various technical, regulatory, and economic challenges pharmaceutical R&D pipelines face.

Market Overview


  • Growing Burden of Chronic and Infectious Diseases
  • Rising Focus Towards Personalized Healthcare
  • Delays in Drug Development and the Subsequent Increase in Development Costs
  • Shift Towards Value-Based Care
  • Rapidly Growing Big Data in Healthcare


  • Reluctance to Rely on Real-World Studies


  • Rising Focus on End-to-End RWE Services
  • Rising Adoption of Wearable Devices and Artificial Intelligence in RWE


  • Lack of Standardized Methodologies to Develop RWE

Key Market Trends

  • Growing Adoption of RWE in Drug Development and Commercialization
  • Rising Number of Consolidations
  • Improved Patient Outcomes and Value Creation from Real-World Evidence
  • Impact Assessment of COVID-19 on the U.S. RWE Solutions Market

The key companies operating in the U.S. RWE solutions market are

  • ICON plc (Ireland)
  • PPD Inc. (U.S.)
  • Clinigen Group plc (U.K.)
  • Cognizant Technology Solutions Corporation (U.S.)
  • IBM Corporation (U.S.)
  • SAS Institute Inc. (U.S.)
  • UnitedHealth Group Incorporated (U.S.)
  • Oracle Corporation (U.S.)
  • PAREXEL International Corporation (U.S.)
  • PerkinElmer Inc. (U.S.)
  • Flatiron Health (U.S.)
  • Medpace Holdings Inc. (U.S.)
  • Symphony Innovation LLC (U.S.).

Scope of the Report

U.S. RWE Solutions Market, by Component

  • Datasets
  • Disparate Datasets
  • EMR/EHR/Clinical Data
  • Claims & Billing Data
  • Pharmacy Data
  • Product/Disease Registries Data
  • Other Disparate Datasets
  • Integrated Datasets
  • Consulting and Analytics

U.S. RWE Solutions Market, by Application

  • Market Access & Reimbursement/Coverage Decisions
  • Drug Development & Approvals
  • Oncology
  • Neurology
  • Immunology
  • Cardiovascular Diseases
  • Other Therapeutic Areas
  • Post Market Surveillance
  • Medical Device Development & Approvals
  • Other Applications

U.S. RWE Solutions Market, by End User

  • Pharmaceutical, Biotechnology, and Medical Device Companies
  • Healthcare Payers
  • Healthcare Providers
  • Other End Users

For more information about this report visit

Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
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Editor Details

  • Company:
    • Businesswire
Last Updated: 11-Mar-2022