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Getting Real with Healthcare Data: RWD/RWE Enabling New Models of Research and Care Delivery

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  • September 2023
  • Region: Global
  • Chilmark Research
  • ID: 5869262

From HITECH to the COVID-19 PHE: These Real-World Data Technologies are Helping Define Evidence-Based Care

The mass digitization of healthcare records over the past decade has led to an explosion of new, highly-valued clinical data assets. According to the research report, Getting Real with Healthcare Data: Real World Data and Evidence Enabling New Models of Research and Care Delivery, a health data goldrush has been catalyzed by a combination of macro trends across the industry, with three being particularly notable: near-universal adoption of electronic health records (EHRs) following the HITECH Act, public health surveillance during the COVID-19 PHE, and pharma’s urgent need to reduce the costs of new filings.

These trends are leading to a rapidly growing market, which this report forecasts will experience an average 14.6% CAGR through 2030, roughly tripling today’s addressable market from $4.6B to $13.6B USD. This forecast anticipates demand will continue to increase as the success of numerous modernization priorities rests upon the insights contained within these data, including value-based care, clinical decision support, personalized medicine, population health management, post-market outcomes, supplemental new drug applications, and public health research, to name a few.

‘Real-world data’ (RWD) has been used in a variety of research purposes to develop ‘real-world evidence’ (RWE) for decades, but never to the extent that is occurring today. Only in recent years have digital health strategies been adopted broadly enough to start collecting and analyzing RWD at a population scale, leading to novel opportunities for data-driven value creation and advancements in medical science. However, nearly 80% of healthcare data is still in unstructured formats, necessitating specialized solutions that can help process this data so it can be applied effectively.

When combined with the historic lack of interoperable data standards and siloed systems in health IT, the result is the convoluted RWD/RWE market we have today with dozens of solutions aggregating, repackaging, and selling slices of health data. To better understand these nuances, Getting Real with Healthcare Data provides detailed definitions of the major categories of vendors offering solutions, types of data assets being leveraged, and current approaches to data aggregation and normalization.

“This research underscores the significance of fostering collaborations among healthcare organizations, technology providers, and regulators as a fundamental step towards unlocking the full potential of Real-World Evidence,” according to analyst Joshua McHale. “By working together, they can overcome barriers such as data fragmentation, data quality concerns, and regulatory uncertainties. This collaborative approach allows for the establishment of a robust ecosystem that maximizes the potential of RWE to improve healthcare outcomes, accelerate medical research, support drug development, and inform health policy decisions.”

As RWD/RWE offerings quickly become fundamental tools for enabling healthcare informatics, established entities will continue to enter this space by leveraging their unique data (ie Epic, Flatiron, PointClickCare), creating joint ventures with other organizations (Truveta, McKesson/HCA), or acquiring organizations that complement a core strategic initiative (ie Invitae, ThermoFisher). This is also an appealing opportunity for new entrants with novel data acquisition and/or processing models that can expose different insights than legacy solutions.

The research is relevant to any healthcare stakeholder looking to leverage real-world data for evidence-based decision making. Providers and payers will appreciate the comprehensive overview of market solutions and vendor types, with the follow-on Buyers’ Guide providing more specific recommendations. Technology vendors and investors will find valuable the detailed discussion of which trends are impacting buyer behavior and the Buyers’ Guide Preview introducing how solutions will be evaluated in the next phase of this research. Finally, life sciences companies will benefit from the in-depth examinations of what’s changing as new solutions come to market, and which partners are best aligned for their needs in trial recruitment or regulatory filing.

Overall, the report provides valuable insights into the current and future state of the RWD/RWE market. As healthcare enterprises continue to seek out new sources of data to inform decision-making, RWE is likely to play an increasingly vital role in improving patient outcomes and reducing healthcare costs.

Report purchase includes a 45-minute consultation with the author(s).

Table of Contents

  • What are Real-World Data & Real-World Evidence?
  • What is Real World Evidence?
  • Real World Data and Real-World Evidence Market
  • Clinical Data: Digitized Health Records
  • EMR/EHR Data
  • Claims data
  • Patient Generated Data
  • Registries data
  • Clinical Trials
  • Emerging Data sources
  • Structured Data
  • Unstructured Data
  • Analytics Engines Are Not Just for RWE Generation But Also RWD Extraction & Normalization
  • Technology Stack for Aggregating & Normalizing Different
  • Sources of RWD
  • Drug Development/Life Sciences
  • Life Sciences Use Cases Are Relatively More Established and Extend From Discovery Through Commercialization Efforts
  • RWD/RWE in Pharmacovigilance and Regulatory
  • Requirements Post-Approval
  • RWD/RWE in Pharmacovigilance and Regulatory Requirements Post-Approval
  • Payers
  • RWD/RWE in the Payer Market is Similarly Widespread
  • Clinicians
  • RWD/RWE in Care Delivery is Targeting How Physicians Find Answers to Questions for Patients & for Populations
  • Regulators
  • Why Real World Data and Real World Evidence?
  • Operation Warp Speed
  • Stakeholders across the sector are fueling market growth
  • New entrants and incumbents are leveraging RWD/RWE to generate valuable insights
  • Natural Language Processing (NLP)/Optical Character
  • Recognition (OCR) Limitations for Unstructured Data
  • Fitness for Purpose Frameworks Still in Development
  • Incumbent Data Silos and Outdated Data Governance
  • Health Data Complexity without Transparency
  • Public Agencies are Helping to Build Evaluation Frameworks to Accelerate Adoption of RWD/RWE
  • Decentralized Clinical Trials Solutions
  • Impact of COVID-19: Renewed Focus on Public Health Data
  • Infrastructure, and Conducting Research Trials More Efficiently and Quickly
  • Market Context: More Health Data, New Cloud Tools, & Renewed Focus on Cost Effectiveness in Care Delivery & Drug Development
  • Biopharma development is a powerful driver of demand for data science investment
  • Fluidity of Vendor Categories
  • Variability of approaches market
  • The Mayo Clinic Platform
  • Aetion
  • Epic Cosmos
  • Life sciences is the only market segment that drives demand without contributing to supply Market forecast
  • 2023 RWD/RWE Buyers’ Guide Solution Vendors*
  • Capabilities and Features
  • About the Analyst Team



Companies Mentioned

  • Aetion
  • Arcadia.io
  • Carevive
  • Cerner Enviza
  • Clarify Health Solutions
  • Epic Cosmos
  • Eversana
  • Evidation
  • Flatiron Health
  • Inovalon
  • Invitae (Ciitizen)
  • Komodo Health
  • McKesson/HCA
  • Optum
  • Picnic Health
  • Pluto Health
  • PointClickCare
  • Quantiphi
  • Syapse
  • Tempus
  • TriNetX
  • Truveta
  • Veradigm
  • Verana Health
  • Verantos
  • ThermoFisher