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Real World Evidence (RWE)…the new competitive advantage

Prediction for 2025 

Here’s my prediction for 2025. Companies will be significantly expanding their Real World Evidence (RWE) capabilities by building dedicated teams comprising RWE leaders, analysts, statisticians, epidemiologists, artificial intelligence (AI) experts, communication specialists and more.



Because we’re seeing an exponential awareness of the commercial value that RWE can deliver.  

The data is now available to an extent that it hasn’t been in the past and advances in computing power, analytics and AI mean that insights can be quickly derived from complex and diverse datasets.

At the same time, companies are adapting their business models from mass engagement to micro-targeting with personalised messaging.

And it’s the RWE that is providing the insights that are incorporated into these messages. All to engage and influence across a range of audiences (from regulators to patients).

Currently, in Australia, we’re seeing companies with a small number of people focusing on RWE and managing exploratory projects (either locally generated or as part of global teams) as they further understand this emerging discipline.

In the near future, these teams will grow both in number and in capability….and here are the reasons why…


1. There’s an increasing recognition by regulatory agencies of the value of RWE in supporting the data from pre-registration clinical trials, and as an important component of post-market safety surveillance.

2. RWE will increasingly be used to support pricing negotiations prior to and post launch, especially when reimbursement levels are tied to the real world performance of a drug or device.

3. Insights from RWE are valuable during life cycle management in identifying new indications for existing drugs and for planning clinical trials.

4. The analysis of real-world outcomes across different patient demographics, disease states and treatment pathways allows marketing to develop segmented and personalised messaging that can then be used by sales teams and Field Medical to enhance engagement and influence.

5. Patients and patient advocacy groups are becoming increasingly knowledgeable about RWE evidence and will be seeking tailored company responses that go beyond the data from tightly controlled clinical trials, especially in our new era of ‘personalised medicine’.


On the basis of these trends my prediction is that pharmaceutical and medical device companies will be investing in their RWE capabilities. We’ll be seeing larger and more specialized teams in the near future as RWE expertise becomes the new competitive advantage.