Product and Process Innovation in the Development Cycle of Biopharmaceuticals

Abstract

The biopharmaceutical market has shown continuous growth under the intensive focus of the pharmaceutical industry. The processes for RD and production of biopharmaceuticals are significantly more complex compared to those associated with small-molecule drugs. The complex structures of protein molecules make achieving successful development while meeting quality requirements challenging. We aimed to elucidate differences in patterns of product and process innovations between the biopharmaceutical and chemical-based pharmaceutical industries. We tracked, categorized, and compared patented pharmaceutical and biopharmaceutical technologies along development cycles using International Patent Classification (IPC) codes. Our analyses illustrate patterns of product and process innovations in the biopharmaceutical industry and show how they differ from those of the chemical pharmaceutical industry. Our study builds on the latest research on innovation theories to provide empirical evidence that demonstrates reshaping of innovation processes through utilization of scientific knowledge.