Chapter 10 - Commercial aspects of drug development

Abstract

Drug development is a costly, time-consuming, and high-risk enterprise that takes 10–15 years and has a high attrition rate. Medical need, disease prevalence, and the possibility of success all play a role. Drug candidate selection is an iterative chemistry-biology process that refines molecular attributes until a molecule appropriate for human use is discovered. Typically, only around one out of every thousand synthesized molecules is chosen for clinical trials. The pharmacology and biochemistry of a medicine are determined using a variety of in vitro and in vivo test protocols before it is administered to humans. It is also a legal necessity that the medicine be adsorbable. This chapter shifts away from the technical aspects of drug research and instead focuses on biopharmaceutical companies' commercial operations. The chapter begins with a discussion of the global market for prescription drugs before moving on to the various sorts of organizations that perform pharmaceutical R&D, customer base, pharmacoeconomics, and portfolio management. Finally, the vital topic of intellectual property and generic competition is thoroughly examined.