Real-world data refers to data collected from healthcare settings outside of randomized clinical trials, including electronic health records, claims, registries and other real-time data sources gathered during routine care. RWD provides insights into patient outcomes in real-world clinical settings and complements randomized clinical trials. It plays a key role in generating insights around patient treatments, care patterns and clinical outcomes. The global real-world data market is characterized by increasing adoption of RWD solutions by pharmaceutical and biotech companies to expedite drug development and commercialization.

The global Real-world Data (RWD) Market is estimated to be valued at US$ 1.59 Bn in 2023 and is expected to exhibit a CAGR of 14.% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.

Market Dynamics:
One of the key drivers for the real-world data market is the rising demand for clinical insights generated from RWD for drug development, reimbursement and regulatory purposes. Pharmaceutical companies are increasingly collaborating with data vendors and real world evidence providers to leverage RWD for clinical trial design, patient recruitment and postmarketing surveillance. Leveraging RWD helps life sciences companies shorten drug development timelines and bring products to market faster. The rising prevalence of chronic and rare diseases has also boosted demand for RWD insights to develop disease pathways, improve clinical outcomes and reduce healthcare costs.

SWOT Analysis

Strength: The real-world data (RWD) market enables access to large real-world patient datasets, which aids in understanding a drug's effectiveness and safety profiles better than traditional clinical trials. RWD also allows faster and less expensive drug development cycles compared to traditional trials. Additionally, RWD leverages existing data which reduces costs associated with patient recruitment and data collection compared to traditional trials.

Weakness: Data quality and consistency remain a concern in RWD as there is variability in how data is collected and coded across different sources. Missing, inconsistent or incorrect data can undermine research findings. Also, regulatory acceptance of RWD findings still lags traditional evidence from randomized trials.

Opportunity: The COVID-19 pandemic highlighted RWD's potential to speed up clinical research. Regulators are becoming more open to using RWD to supplement traditional trials for faster approval of COVID-19 vaccines and treatments. There is also a need for RWD in evaluating safety and efficacy of vaccines and new variants. Additionally, digitization of healthcare is increasing availability of granular real-world patient data.

Threats: Privacy and security of patient data remain key concerns which can impede widespread sharing and integration of real-world data sources. Regulatory frameworks around data privacy and security still need more clarity. Lack of standards around data collection, integration and analysis methodologies also limit reliability and comparability of RWD findings.

Key Takeaways

The Global Real-World Data (RWD) Market is expected to witness high growth with an increasing need for real-world evidence in clinical research and development. The market size for 2023 is projected to reach US$ 1.59 billion, growing at a CAGR of 14% during the forecast period of 2023 to 2030.

Regional analysis: North America currently dominates the RWD market with the largest share estimated at 45% in 2023. Growth in the US market has been high driven by initiatives like the 21st Century Cures Act that supports use of RWD. Europe is expected to be the fastest growing market aided by investments in national electronic health record networks that improve RWD availability. The Asia Pacific region is emerging as a lucrative market and is expected to grow at over 18% CAGR during the forecast period primarily due to rising R&D investments in China, Japan and India.

Key players: Key players operating in the real-world data market are IQVIA Holdings Inc., Optum, Inc., Cerner Corporation, Flatiron Health, Inc., IBM Corporation, Tempus Labs Inc., Syneos Health Inc., Evidera, Inc., Palantir Technologies Inc., and SAS Institute Inc. IQVIA is the leading RWD provider with extensive datasets and analytics capabilities. Other major players are expanding their RWD platforms and services through collaborations and acquisitions to meet the growing demand for real-world evidence.