Global Real-World Evidence (RWE) Solutions Market estimated at close to $1 billion (2020), is growing at a steady growth rate of 15%

 

RWE is the clinical evidence regarding usage and potential benefits/risks of a medical product based on analysis of the real-world data.

RWE to play vital role in helping regulators formulating decisions

RWE could potentially help FDA while making regulatory decisions about the safety and effectiveness of medical products such as identifying new safety issues post-approval or determine the effectiveness of a drug for a new indication or patient population. Citing the potential, the 21st Century Cures Act (Cures Act, signed in 2016) required FDA to publish a framework for a program to evaluate the use of RWE in regulatory decision-making; FDA published the framework for this program in December 2018. As part of its RWE Program, FDA committed to understanding the full potential of RWD and RWE in regulatory decision-making. The agency has been holding workshops, funding demonstration projects, creating mobile and web applications that can collect RWD, and engaging with sponsors on the topic.

Funding from private equity and pharma industries for Real-world evidence (RWE) Solutions market

Private equity firms are backing the RWE solution providers by offering fundings. For instance, Aetion, one of the RWE solution providers, received $110 million funding, led by private equity firm Warburg Pincus, in May 2021. Aetion’s platform compiles and analyses real-world data from a variety of sources to assess the safety and effectiveness of medical products. Aetion would use the capital to advancing the capabilities of its data analytics platform, enhance commercial team and expand its geographic footprint.

Major challenges in adoption of Real-world evidence (RWE) solutions market

Major regulatory authorities across the globe have pointed that the poor data quality and inconsistent data are the major obstacles in executing RWE studies. The data often originates from electronic health records (EHRs), where the data may be unstructured, poor quality and/or in inconsistent formats, such as doctors’ notes that aren’t entered in a standardized way. Further, during the clinical trials (RCTs), a patient’s daily activities are monitored. However, in the real world, patients don’t go to the doctor frequently, and therefore the EHR data is less regular and inconsistent.

“Clinical research networks will be necessary for the successful and long-term application of real-world evidence. It entails developing cross-sector collaborations between providers, payers, patients, and life science companies to pool resources and expertise in clinical research” – President, Leading Pharma Company

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