Revolutionizing Drug Development: The Rise of Real-World Evidence and Its Impact on the Life Science Industry

Author: Mike Cao, Market Analyst, Hanson Wade Intelligence


Real-world evidence (RWE) in drug development space typically refers to the collective real-world data (RWD) from various sources including clinic-genomic data derived from electronic health records (EHRs) and genomic data, claims and billing data, patient registries, patient-reported outcomes (PROs) and data from wearable devices or mobile health apps. While the usage of RWE for drug development is lagging behind compared to other sectors, its application in life science industry is becoming increasingly important in recent years, as it provides valuable insights outside the controlled clinical trials to inform various aspects of drug development, regulation and health economics. According to a review published in 2022, over 85% of 136 NDAs and BLAs of interest approved by FDA involved the use of RWE at various capacities between Jan 2019 and June 2021 (Purpura, C.A., et al. 2022). This figure has grown from 75% in 2019 to 96% in 2021.

Current Development

The accelerated adoption of RWE in drug development has been facilitated by the advancements in data collection, storage and analysis, as well as the growing acceptance of RWE by regulatory agencies (Framework for FDA’s RWE Program 2018; EMA network strategy to 2025) and other stakeholders in the healthcare industry. In particular, clinico-genomic data is an area that has seen the fastest development with numerous providers filling the space. From pharma’s perspective, the key consideration for pharma stakeholders is the quality of data, which includes sample size, completeness of dataset (% coverage) and dictionary of the data (endpoints). Other factors such as delivery time and the applicability of the dataset for multiple studies across functions can also play an important role when it comes to vendor selection.

Looking ahead, as pharma companies continue in the search for novel data types that further complement drug development through cost-efficiency improvement as well as increasing the chance of approval. Most notably, multimodal RWE that incorporates imaging data such as digital pathologies and radiographic images presents a significant market gap which drug developers regard as the gold dust. Other data types such as social determinant of health data and DNA methylation profiles are also becoming increasingly applicable in drug development and health economic research.

Market Forecast

Several factors are expected to contribute to the growth of the RWE market including:

•  An increasing focus on personalised medicine and targeted therapies
•  The growing adoption of RWE by regulatory agencies around the world for decision making
•  The rising prevalence of chronic diseases and ageing population in key markets
•  Technological advancements such as AI and machine learning in data collection, storage and analysis
•  The need for cost effective healthcare solutions and comparative effectiveness research

According to Allied market research report, the global RWE solutions market was valued at $1.4 billion in 2021 and is projected to reach $5 billion by 2031 with a CAGR of 13.7% from 2022 to 2031. North America accounted for the majority of the market share in 2021 followed by APAC market. North America is anticipated to remain dominant for the next 10 years with RWE market in APAC anticipating the fastest growth in the same period.


Purpura, C.A., Garry, E.M., Honig, N., Case, A., et al. (2022) The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications. Clinical Pharmacology & Therapeutics, 111 (1), 135–144.

Arlett, P., Kjær, J., Broich, K. & Cooke, E. (2022) Real‐World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value. Clinical Pharmacology & Therapeutics, 111 (1), 21–23.

Real World Evidence Solution Market 2022, Allied Market Research