Determinants of licensing A study of selected biotech companies and research institutions

Abstract

Licensing and collaborations are very important for the pharmaceutical and biotech institutes to discover, develop, manufacture and commercialize new medicines for treatment of human diseases. With the advancement in science and technology, our understanding of human biology, drug targets and mechanisms of drug resistance have increased manifold. However, it takes several years and billions of dollars in investment to bring a new drug to the marketplace. The period for new product discovery, development and eventual approval for marketing is the longest in the case of pharmaceutical industry leading to loss of effective on-market patent life of a new molecule. This coupled with the high risk of failure in clinical development makes it important for pharmaceutical companies to seek external innovation to fill their portfolio. newlineBiotech s that have achieved non-clinical or clinical proof-of-concept need the access to capital to conduct expensive phases of non-clinical and clinical drug development. The licensing process can be very competitive as there would be several pharmaceutical companies interested in licensing first-in-class or best-in-class molecules at various stages of development. However, it is important for biotech and pharmaceutical companies that are seeking licensing partners for their molecules to choose the partners carefully as it takes several years of commitment to bring a new drug to the market. This study investigated the literature on different aspects of new drug discovery and development and the need for licensing by pharmaceutical companies seeking access to new drugs to fill their product portfolios. The study laid special emphasis on licensing in the global context as well as licensing activities by Indian pharmaceutical and biotech companies. newlineThis study investigated the five determinants including size of the company, pharmaceutical sales, number of employees, age of the company and pharmaceutical research and development expenditure as key determinants that could have an effe