Liquid Biopsy Deep Dive: MRD in Solid Tumors

THE COWEN INSIGHT

Minimal residual disease (MRD) monitoring is a “marquee” liquid biopsy application that seeks to inform treatment decisions and detect relapse in earlier/intermediate-stage cancer patients and survivors. Our TAM analysis supports a strong multi-year growth runway and room for multiple winners. From a data, reimbursement, and adoption standpoint, we believe 2022-2025 will be catalyst-rich years.

THE EMERGING APPLICATION OF MRD MONITORING

Liquid biopsies are blood-based tests used to diagnose and manage a variety of diseases, including solid tumor cancers. This Ahead Of The Curve Series® report builds upon Cowen’s 2014 and 2020 liquid biopsy reports and dives deeper into an emerging application: minimal residual disease (MRD) monitoring. MRD monitoring tests evaluate a patient’s blood sample for circulating tumor DNA to inform pre- and post-surgical treatment decisions, monitor immunotherapy effectiveness, and monitor cancer survivors for disease relapse.

We believe our proprietary TAM analyses, gross margin ramp analyses, catalyst calendar, and 1×1 KOL checks will prove helpful in evaluating industry- and company-level implications of rising MRD monitoring use in solid tumor cancers. Looking forward to FY’23-24, we believe accelerating MRD monitoring revenues may jumpstart the next wave of top-line beat-and-raises. Accelerating MRD revenues should translate to GM improvements, cash burn reductions, and a faster path to profitability for key MRD monitoring participants.

TAM ANALYSIS OF THE MRD MONITORING LANDSCAPE

This collaborative, multi-analyst report provides a comprehensive analysis of the MRD monitoring landscape for solid tumor cancers. The report highlights the “must-track” catalysts for growth acceleration, high-impact clinical readouts, detailed technology, and company analyses (for public and private companies), as well as the evolving regulatory and reimbursement dynamics. Our research includes a proprietary “detoxed” volume and revenue TAM analysis supported by US disease statistics, KOL interviews with oncologists and reimbursement experts, and 1×1 management check-ins.

Our “detoxed” TAM analysis includes specific cancer types and applications being served by MRD monitoring tests today (or in the near future), in an attempt to right-size the market opportunity. We discuss key factors driving MRD monitoring’s expansion into solid tumor cancers, specific cancer types likely to drive inflecting MRD usage over the coming years, and the mechanics of MRD monitoring gross margins during a patient’s 5+ year testing protocol (linked to cash burn expectations for key participants). Finally, we evaluated the link between MRD monitoring tests and therapeutic usage and provided a list of neoadjuvant and adjuvant trials (for chemo and/ /or immuno-oncology (IO) therapies) that may stand to boost MRD monitoring usage.