October 5, 2018

Real World Evidence: Unearthing the Gold Mine

By Arun Gupta Contract Research Organizations, Healthcare 0 Comments

Estimates suggest that each prescription drug requires an average of about 10 years and over USD 2.5 billion in working capital before it gets commercialized. In order to gain regulatory approval and establish standards for the safety and efficacy of these products, randomized clinical trials (RCTs) are conducted; these account for a staggering 40% of the pharmaceutical industry’s budget. In addition to excessive R&D costs, these trials are fraught with various other challenges, such as prolonged delays and risk of failure / termination. Real world evidence has demonstrated the potential to validate the therapeutic value of pharmaceutical products and help customize product development in a more patient centric manner. In December 2016, the 21st Century Cures Act was passed directing the FDA to evaluate the applications of real world evidence in supporting healthcare decision-making. Its numerous applications have further encouraged pharmaceutical companies and health economists to utilize it in the evaluation of product candidates targeting even the rarest of medical conditions.

The gradual shift towards value based healthcare is evident from the growing number of conferences / other events related to the importance and applications of real world evidence

The rising interest in this field is also apparent in the opinions expressed by several industry / academic stakeholders on social media platforms, such as Twitter

Currently, about 200 industry players are actively offering a wide array of data collection and analytics solutions for generating insights based on real world data from a variety of sources

The market landscape is fragmented, featuring several new entrants, small- and mid-sized players, providing real world data related services to the pharma and life science industries

North America, with companies offering novel approaches / real world data insights to diverse problems, is presently a major hub of real word evidence-based research

Such insights are expected to significantly augment healthcare decision-making, given the potential to address a variety of current and future needs of stakeholders

In fact, between January 2016 and June 2018, ~500 scientific articles were published, highlighting relevant data sources and novel application areas

Pharmaceutical / medical device companies are already leveraging real world data insights for end-to-end product development and product lifecycle management

Over 1,000 real world clinical studies have been registered across the globe; cardiovascular, oncological and neurological disorders have emerged as key focus areas

We expect the market to grow at an annualized rate of ~14.1% over the next decade; the opportunity is likely to be well distributed across different application areas and geographies

Estimates of future revenue generation potential indicate that the shares of oncological disorders and clinical setting data are anticipated to be high in the mid-long term