RWE is the clinical evidence related to the use and potential advantages/risks of a medical product based on examination of real-world data.

Global Real-world evidence (RWE) Solutions market is estimated close to $1 billion (2020), growing at lucrative rate of ~15%. The Real-world evidence (RWE) solutions market growth is driven by rising support for RWE adoption from regulatory authorities, increased funding from pharma, and additional insights generated compared to randomized clinical trials (RCTs).

RWE to play vital role in helping regulators formulating decisions

RWE may be able to help FDA in making regulatory decisions on the safety and effectiveness of medical products, such as discovering new safety issues after approval or analysing a drug's effectiveness 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 conducted workshops, offered funding for demonstration projects, created mobile and web applications that can gather RWD, and engaged in conversations with sponsors about the topic.

Funding from private equity and pharma

By providing funding, private equity firms support the RWE solution providers.

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.

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Poor quality medical data and lack of interoperability present major challenges in adoption of RWE

According to major regulatory authorities across the globe, the poor data quality and inconsistent data are the key 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. Furthermore, a patient's daily activities are observed during clinical trials (RCTs). Patients visit the doctor less frequently in the real world, therefore the EHR data is less reliable 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

Competitive Landscape Analysis of Real-world evidence (RWE) Solutions Market

The key players in global real-world evidence (RWE) solutions market are IQVIA Holdings, Parexel, Icon, PPD, Syneos Health, Clarivate, Cerner, Medpace Holdings, Flatiron Health, Symphony Innovation, Aetion, Cognizant Technology, IBM, Oracle, Data Matrix, SAS Institute Inc., Clinigen Group, and UnitedHealth Group.

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