RWE: Unearthing the Gold Mine

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 (RWE) 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 RWE in supporting healthcare decision-making. Its numerous applications have further encouraged biologics contract manufacturing 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 RWE.


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 RWE from a variety of sources

As per Roots Analysis, Over 60% of sources of real world data is from clinical setting followed by 57% patient powered.

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

Around 45% of players are service providers followed by 39% of analytics providers.

North America, with companies offering novel approaches / RWE 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

Over 1,000 clinical trials have been registered for real world evidences across various regions of the globe. Europe being the largest share holder.

We expect the real world evidence solutions 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

The overall real world evidence market is fragmented across different segments including therapeutic areas and sources of data being the prominent one.

To learn more, please click Real World Evidence Solutions Market. For any queries / suggestions, please do not hesitate to contact us at sales@rootsanalysis.com. You can also download the SAMPLE REPORT on RWE by Roots Analysis.

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