The commercialization gap
FDA approval is not the finish line in drug development. Instead, it signals the start of another critical phase: commercialization.
Increasing specialization of therapies, including precision medicine and rare diseases, makes identifying patients more complex. This can be especially true for patients who have diseases with complex or delayed diagnostic pathways, who often receive fragmented care spread across multiple health systems. When the right patients and providers aren’t identified early in the commercialization phase, therapies can struggle to gain traction.
Pharmaceutical companies are increasingly investing in advanced analytics to address these gaps. Data-driven commercialization strategies, including predictive analytics and real-world data analysis, are becoming essential for improving commercial performance and optimizing launches.
“Commercial success depends on identifying where eligible patients are in the healthcare system and which physicians are treating them,” says More. “Without that near-real-time visibility, even groundbreaking therapies can face slower uptake.”
Lab testing generates longitudinal, real-world clinical insights, providing visibility into disease prevalence, testing patterns, and progression. Compared with retrospective analysis, which identifies known eligible patients, predictive modeling identifies “hidden” or undiagnosed patients who fit target profiles, maps disease progression and high-risk cohorts, and identifies physicians treating eligible populations through deidentified patient data to move beyond simple retrospective analyses and toward proactive identification of potential patients. Besides helping commercial teams understand where patient populations are concentrated and which providers are most likely to encounter them in practice, predictive analytics can also inform market sizing and launch planning.
Using diagnostic data as a strategic asset enables more precise education and outreach and supports sponsored testing initiatives to close diagnostic gaps.
“When we use predictive analytics to determine populations that haven’t been diagnosed yet, commercial teams can reach out to their providers to educate them on the patient journey and the diagnostic tests that can help to make a diagnosis,” More says. “As a result, physicians can ensure that patients receive an accurate and timely diagnosis, easing their uncertainty and helping them get on the right treatment path sooner.”