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Economic potential for clinically significant in vitro diagnostics

In recent years, significant advances have been made in the realm of in vitro diagnostics with the development of novel tests which are able to meaningfully impact the course of a patients' disease management. This transformation has strained the traditional in vitro diagnostic business model and raised questions as to whether the economics support the commercial development of these tests. The goal of this study is to evaluate the economics of in vitro diagnostics from development to commercialization, with a focus on a specific a class of novel and complex tests called In Vitro Diagnostic Multivariate Index Assays (IVDMIA). My hypothesis is that the current dynamics of the market can only sustain a small number of such novel tests. To evaluate this hypothesis, I construct an economic model of the development of a hypothetical new in vitro diagnostics which focuses on both the cost of development and commercialization together with market potential and adoption. The analysis reviews specific break-even scenarios to determine the parameters which would allow for an economically viable complex in vitro diagnostic. The conclusion I reach based on this analysis is that only a very small number of medical conditions could economically support the development of a novel in vitro diagnostic. The medical conditions which could support the development of a novel test are governed by complexity, severity and prevalence of the disease. Given the dramatic impact these new tests may have on disease management, incentives may be required to offset the risks associated with expanding novel diagnostics into smaller but medically significant disease areas. Thesis Advisor: Ernst Berndt, Ph.D Title: Louis E. Seley Professor in Applied Economics Thesis Advisor: Mark Trusheim Title: Executive in Residence and Visiting Scientist Acknowledgements Over the past three years I have had the fortune and privilege to be guided by an outstanding group of mentors from across MIT, Harvard and the Biomedical Enterprise Program. Their experiences and insights, which they have generously been willing to share with me, have given me an amazing foundation to address the challenges I face as both a student and a professional. I would like to express my special gratitude and appreciation to Prof. Ernst Berndt and Mark Trusheim for their support and advice in the development of my thesis. Their incredible generosity, knowledge and drive to address the challenges of the complex healthcare industry inspired me to expand my own thinking in the field. Thank you to the faculty, staff and fellow students at MIT, Harvard Medical School and the Biomedical Enterprise Program. My fellow students in the Biomedical Enterprise Program provided an amazing foundation of experiences and interests which continues to motivate me academically, professionally and personally. I would also like to give a special acknowledgement to Teo Dagi and Stan Lapidus, who provided a window into the world of healthcare entrepreneurship along with guidance for how that world might influence both my thesis and professional goals.