Despite growing regulatory acceptance and demonstrated value, real-world data (RWD) remains significantly underutilized across the healthcare and life sciences sector. Research published in health technology assessment literature confirms that real-world evidence (RWE) "remains underutilized" in evaluation processes, while recent 2024 research by managed care organizations revealed "payers' hesitancy in embracing RWE" and identified a critical need for standardized approaches to RWE evaluation. Academic studies point to persistent structural barriers: lack of coordination between organizations, insufficient training on RWE methodologies, and what researchers from the National Academies describe as a "gravitational pull" back to traditional methods despite the availability of more comprehensive data sources.
The scope of this gap is sobering. Healthcare has a well-documented implementation challenge: research on the evidence-practice gap shows it takes an average of 17 years for new clinical evidence to be adopted into routine practice. While RWD itself is relatively new as a regulatory tool, it faces similar implementation barriers documented in this broader research: inadequate training, cultural resistance to new methodologies, and organizational structures that favor familiar approaches.
This underutilization represents a significant missed opportunity across the entire healthcare and life sciences ecosystem. The same data sources that could accelerate pharmaceutical development can provide equal value for medical device companies seeking post-market surveillance insights, health technology firms validating digital interventions, and biotech organizations identifying therapeutic targets, many of which remain unaware of both the existence and practical accessibility of these resources.
Before diving deeper, it's important to distinguish between two related concepts. RWD refers to the data sources themselves: electronic health records, claims databases, registries, and patient-generated information. RWE is the clinical evidence derived from analyzing that data. While this post focuses primarily on the data sources, the regulatory momentum and market growth reflect increasing acceptance of the evidence generated from these sources.
What Real-World Data Actually Comprises
Real-world data refers to information about patient health and healthcare delivery that's routinely collected outside of traditional controlled clinical trials. The FDA defines RWD as data relating to patient health status and healthcare delivery from various sources, and it's generated from multiple streams:
Electronic Health Records (EHRs) contain the clinical details captured during patient care: diagnoses, procedures, lab results, vital signs, medication orders, and increasingly, physician notes and clinical narratives. These records provide the richest clinical context but vary significantly across health systems in their structure and completeness.
Medical Claims Data captures the billing and reimbursement side of healthcare: what services were provided, when, and at what cost. Claims data excels at showing longitudinal patient journeys across different providers and care settings, though it lacks the clinical granularity found in EHRs.
Disease and Product Registries track specific patient populations, conditions, or medical products over time. Because they're purpose-built for research or surveillance, registries often contain more detailed condition-specific information than general clinical databases.
Patient-Generated Health Data increasingly includes information from wearables, home monitoring devices, and patient-reported outcomes. This data type is growing rapidly as digital health technologies proliferate.
Each data source has distinct strengths and limitations. EHR data offers clinical depth but can be fragmented across health systems. Claims data provides continuity across providers but limited clinical detail. The most sophisticated analyses often combine multiple data sources to offset individual limitations. Linking EHR and claims data, for instance, provides both clinical context and comprehensive utilization patterns.
The Trajectory: Rapid Growth and Regulatory Momentum
The real-world data market is experiencing substantial growth. The global RWD market reached $1.88 billion in 2025 and is projected to grow to $6.37 billion by 2034, representing a compound annual growth rate of 14.5%. North America currently leads the market, driven by advanced healthcare infrastructure and strong regulatory frameworks promoting RWE use.
More significant than market size is the regulatory evolution. The FDA established its Real-World Evidence Program following the 21st Century Cures Act, and the pace has accelerated notably. In July 2024, the FDA finalized guidance on using electronic health records and medical claims data to support regulatory decisions. In December 2024, the FDA announced the creation of the Center for Real-World Evidence Innovation within CDER, signaling a long-term commitment to integrating RWD into drug evaluation.
The FDA's Advancing Real-World Evidence Program, expanded under the 2022 reauthorization of the Prescription Drug User Fee Act (PDUFA VII), now enables early discussions between sponsors and the agency about RWE-based study proposals. This represents a fundamental shift: real-world data isn't just supplementary evidence anymore. It's becoming central to how regulators evaluate medical products.
Underutilization persists despite this regulatory momentum. Research points to several structural barriers: lack of coordination between organizations, insufficient training on RWE methodologies, and what researchers describe as organizational inertia favoring familiar approaches over newer methods. These barriers affect organizations of all sizes, from major pharmaceutical companies to emerging biotech firms.
Why This Matters Beyond Pharma
Here's what I've learned from working across different healthcare sectors: the cost and accessibility of real-world data are often better than people expect. Organizations assume that acquiring meaningful datasets requires massive budgets and lengthy procurement processes. In reality, working with established data vendors (with appropriate data use agreements) can be relatively straightforward and cost-effective.
For medical device companies, RWD offers opportunities for post-market surveillance, comparative effectiveness studies, and identifying patient populations for new indications. Health technology firms can use real-world data to understand treatment patterns, validate digital health interventions, and demonstrate value to payers. Biotech organizations can leverage RWD for target identification, trial planning, and understanding current standard-of-care approaches.
The key is knowing which data source fits your specific question. Having worked with most major dataset types and data vendors, I've found that selecting the right data source depends on three factors: the specific variables you need, the patient population you're studying, and the type of evidence you're trying to generate. A feasibility assessment (examining whether your cohort of interest exists in sufficient numbers within a given dataset) is often the critical first step.
Looking Ahead
Real-world data represents a strategic resource that remains underutilized across the healthcare and life sciences sector. As regulatory acceptance expands and data infrastructure improves, organizations that develop expertise in RWD now will have a significant advantage.
In my next post, I'll focus specifically on medical device companies. Device manufacturers face unique evidence challenges that make real-world data particularly valuable, from post-market surveillance requirements to demonstrating long-term device performance. I'll share what I've learned about how device companies can leverage existing registry networks and real-world data infrastructure for both regulatory success and competitive advantage.
Sources
- FDA. (2024). Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. Federal Register, July 25, 2024.
- FDA. (2024). CDER Establishes New Center for Real-World Evidence Innovation. December 12, 2024.
- FDA. (2022). PDUFA VII: Advancing Real-World Evidence Program. Prescription Drug User Fee Amendments, September 30, 2022.
- Precedence Research. (2025). Real-World Data (RWD) Market Size to Hit USD 6.37 Bn by 2034. Market Report, March 2025.
- Coherent Market Insights. (2025). Real-world Data (RWD) Market Size and Forecast, 2025-2032. Market Analysis Report.
- Frontiers in Pharmacy and Pharmaceutical Sciences. (2023). Integration of real-world evidence from different data sources in health technology assessment. June 30, 2023.
- Academy of Managed Care Pharmacy (AMCP). (2024). Real-World Evidence (RWE) Initiative. 2024 Payer Survey Results.
- National Academies of Sciences, Engineering, and Medicine. (2019). Barriers and Disincentives to the Use of Real-World Evidence and Real-World Data. In: Examining the Impact of Real-World Evidence on Medical Product Development. Washington, DC: The National Academies Press.
- Health Research Policy and Systems. (2020). Bridging the research-practice gap in healthcare: a rapid review of research translation centres. BioMed Central, October 9, 2020.
- Nashville Biosciences. (2025). Claims Data vs EHRs: Distinct but United in Real-World Research. January 24, 2025.
- NCBI. Registries for Evaluating Patient Outcomes: A User's Guide - Data Sources for Registries.
