Per the report, in support of development and post-approval programs, real-world evidence (RWE) generation and use is predicted to increase 8-12% over the next two to three years, with the strongest growth expected within Phase III and IV programs.
“Pharma understands the value proposition of RWE and benefit as a product development and lifecycle management strategy tool,” said Jon Meyer, MSc, MBA, co-founder and principal, Life Science Strategy Group (LSSG).
Cost and access to real world data (RWD), however, are among the barriers to widespread adoption. Still, more than half of respondents said they are learning and gaining experience with RWE, but are challenged with generating meaningful evidence.
“Pharma selects vendors based on their data access, quality, and expertise with the data ... Vendors need to be more consultative and advisory to pharma," Meyer said.
LSSG survey respondents currently outsource 57% of RWD analytics/RWE services, according to the report, and expect to outsource 62% of services in 2 to 3 years.
Additionally, nearly 40% of respondents said they see shifts in the types of studies used to generate RWE, including those using artificial intelligence (AI) and other technology, such as wearables.
“Wearables can give a different side of the story that’s not always collected in the controlled clinical trial environment or even through routine care. The information collected can tell the story of the patient’s habits and lifestyle beyond what is seen in the controlled setting,” said Karla Feghali, RWE and partnership lead at ConvergeHealth by Deloitte.
As for AI, Meyer said it’s still early and the real payoff is yet to be seen, until it’s more reproduceable.
Market intricacies
The most surprising finding of the report was the perceived market dominance of Iqvia, Meyer said.
“Iqvia is the key market leader, generally unchallenged,” he said, adding that he also was surprised by how poorly contract research organizations (CROs) and vendors have been in generating meaningful RWE to date.
An opportunity to challenge Iqvia in this space is through specialization: “Select a niche of the RWE market and become very expert,” said Meyer. “Due to the highly specialized nature of RWE and difficulty in generating meaningful insights, a high degree of expertise will be needed.”
Today, he explained, this is where vendors fall short. Meyer said, “Consistently in our research we hear that ‘the vendors today just don’t understand my brand/product and the intricacies of the market that it competes in.’”
Ultimately, Meyer believes that the growth in RWE-based strategies may force traditional, large CROs to rethink their business strategies. “RWE is here to stay and is not going away,” he added.
Additionally, in his opinion, “’generalists’ won’t be very successful in the highly specialized area of RWE generation.” To improve their offerings, Meyer suggests choosing targets and markets carefully, and in the near term, his advice is to focus on RWD.