Abstract

The financial valuation of a drug that is still under development is required for various purposes. The risk-adjusted net present value (r-NPV) method, which recently emerged in the biotech industry, uses the development attrition rate as a discount factor to reflect risk during each development phase. The r-NPV method was developed to overcome the disadvantages of the prevailing discounted cash flow and real options methods and considers drug type, as well as the stage of development in its approach. Using this method, the current study examines technology values in the biopharmaceutical industry and matches the clinical development periods and success rates of these new drugs by analyzing datasets from ClinicalTrials.gov and MedTrack DB. It thus provides support for an empirical valuation model for experts in the field. Notably, there is limited research on the attrition rate and development period of new substance drugs and the research results are not consistently presented. In addition to new substance drugs, further research is necessary to deepen understanding of the attrition rate and development period of biologically-based drugs because of their inherent physical and developmental differences. Similarly, research on performance specifics within drug class models would enable refinement of the model.

Highlights

  • IntroductionBiopharmaceutical development takes more than 10 years for technological development [1,2]

  • The type of new drugs is classified into likelihood of FDA approval (LOA) and development period of all drugs, LOA and development period of NDA, and LOA and development period of Biologics License Application (BLA)

  • The development period of all new drugs (NDA+BLA) in each phase using the dataset of ClinicalTrials is calculated by drug type (Table 8)

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Summary

Introduction

Biopharmaceutical development takes more than 10 years for technological development [1,2]. The most important revenue model in the biopharmaceutical industry results from the blockbuster-level manufacturing capacity or licensing-out. As stated by the Deal Survey, the economic spread of biotechnology technology is far greater than that of any other industry [3]. For these reasons, an objective valuation within the biopharmaceutical industry remains a challenge. A great deal of effort is required in this industry for generating suitable technology valuations for investment judgments

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