Pharmaceutical and Life Sciences Real World Evidence Market to be USD 6.19 Bn by 2032

The Pharmaceutical and Life Sciences Real World Evidence market, projected to be valued at USD 2.30 billion in 2025, is poised for robust growth, with estimates reaching USD 6.19 billion by 2032, reflecting a strong CAGR of 15.2% during the forecast period. This growth is driven by the increasing need to generate insights from real-world data to support regulatory decisions, market access strategies, and clinical development. As the industry shifts toward value-based care and personalized medicine, stakeholders are leveraging RWE to demonstrate treatment effectiveness, enhance drug safety monitoring, and optimize clinical trial design. The expansion of digital health tools, electronic health records, and wearable devices is further fueling the integration of RWE into pharmaceutical and life sciences strategies.

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The Pharmaceutical and Life Sciences Real World Evidence market is experiencing rapid momentum as healthcare stakeholders increasingly seek actionable insights from real-world data to inform drug development, regulatory submissions, and market access strategies. RWE solutions are being adopted to improve clinical trial efficiency, demonstrate value-based outcomes, and support post-market surveillance, particularly in an era of rising healthcare costs and the demand for personalized medicine. The ability to analyze large-scale patient data from sources such as electronic health records (EHRs), claims databases, and wearable devices is proving critical in validating the safety, efficacy, and economic impact of therapies in diverse patient populations.

In March 2024, the EMA’s DARWIN EU network—launched in 2022—announced plans to expand its federated real‑world data infrastructure by adding ten new data partners, forming a network across 13 European countries with ~130 million patient records. This expansion will support more than 140 RWE studies by 2025, empowering regulators with robust evidence drawn from routine healthcare settings.

Additionally, regulatory bodies such as the U.S. FDA and EMA are increasingly endorsing the use of RWE in submissions for drug label expansions and approvals, particularly in rare and orphan diseases where traditional trials are limited. This regulatory support is prompting pharmaceutical companies to invest in advanced analytics platforms, AI-driven data integration, and interoperable health systems to generate credible and regulatory-grade evidence.

With continued advances in AI, machine learning, and federated data platforms, the market is expected to evolve into a foundational pillar for data-driven decision-making across the pharmaceutical value chain—from R&D and commercialization to post-market monitoring—positioning it as a critical enabler of next-generation healthcare innovation.

The pharmaceutical and life sciences real world evidence market is increasingly leveraging artificial intelligence (AI), machine learning (ML), and natural language processing (NLP) to extract actionable insights from large and unstructured real-world data (RWD) sources. These tools enable faster signal detection, predictive modeling, and patient stratification, enhancing the efficiency of clinical research and regulatory submissions. Pharmaceutical companies are adopting advanced analytics platforms to identify unmet needs, optimize trial designs, and track patient outcomes more accurately.

In December 2023, IQVIA introduced a platform combining NLP, machine learning, and generative AI to automate literature-based review updates. This significantly sped up extraction and summarization from RWD sources, achieving 2–3× efficiency gains in vaccine and antiviral research workflows.

To ensure privacy and data security while enhancing the scale of RWE studies, stakeholders are adopting federated data models that allow analysis without direct data sharing. This approach supports cross-border studies, especially in rare diseases and chronic conditions, by accessing distributed EHRs, claims data, and registry information.

In July 2024, Health Data Research UK launched a pilot federated RWE network. Up to seven data partners using OMOP CDM will run studies locally, return aggregated results, and form a sustainable national-level federated research infrastructure.

The market opportunities lie in delivering integrated, full‑lifecycle platforms—from data ingestion, AI analytics, study design, to regulatory submission support. Services that can smoothly integrate EHRs, claims, wearables, registries, and genomic data are increasingly in demand by pharma and healthcare payers embracing value‑based care.

In May 2023, Flatiron Health built upon its oncology-focused real-world data infrastructure by launching Integrated RWE Solutions. This offering combines curation of EHR-derived oncology data with analytics, scientific consulting, and end-to-end support, spanning from early development to commercialization.

There’s a growing push to capture patient-reported outcomes (PROs), social determinants of health (SDOH), and wearable data. These enrich RWE analyses by adding patient experience and adherence variables—crucial for market access and payer negotiations. Over 65% of providers now use RWE, and PRO integration enhances personalized health solutions.

A PubMed-listed qualitative study in September 2023 surveyed regulators, clinicians, and patients, highlighting growing emphasis on integrating PROs into real-world studies, while also documenting operational challenges and the need for standardized collections.