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Market Assessment and Valuation: 505(b)(2) Cardiology Drug Therapy

Market Assessment and Valuation for a 505(b)(2) Cardiology Drug Therapy


The  developer of a novel formulation of a standard treatment for congestive heart failure wanted to better understand the commercial potential of the opportunity in order to support its financing efforts for upcoming Phase 1a / 1b trials.

The company retained RNA was asked to provide an independent perspective on valuation and to assess the company’s key assumptions.


Conducted secondary market research to quantify annual patient volumes at each site of care (inpatient, outpatient, ER, etc.).

Developed estimates of health economic savings owing to fewer required visits with healthcare providers.

Interviewed cardiologists, ER physicians and health system administrators to explore unmet needs in this indication in order to assess whether the client’s drug would address key areas of interest.

Developed a forecast model and valuation that reflected the abbreviated development pathway (higher probabilities of success).

Conducted a sensitivity analysis around discount rates, patient shares and pricing ranges.

Explored the value of potential upsides in adjacent indications.


Our market assessment served as a data-supported validation that the client’s product addressed key unmet needs, and articulated how the lower-risk development pathway contributed to higher valuations.

The company used RNA’s findings to engage potential investors in productive discussions, which ultimately helped to secure financing for the company’s development activities from Phase 1 through NDA.

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