Open Access

Alexander Schuhmacher, Oliver Gassmann, Markus Hinder

• The efficiency of pharmaceutical research and development (R&D) reflected by increasing costs of R&D, long timelines, and low probabilities of technical and regulatory success decreased continuously in the past years. Today, the costs for discovering and developing a new drug are enormously high with more than USD 2 billion per new molecular entity (NME), while the average overall success of a research project to provide an NME is in the single-digit percentage rate, and the total timelines of R&D easily exceeds 10 years questioning the return on investment (ROI) of pharmaceutical R&D. As a consequence and also caused by numerous patent expirations of blockbuster drugs that increased the pressure to return to an acceptable ROI, the pharmaceutical industry addressed this challenge and the related causes and identified several actions that need to be taken to increase the output/input ratio of R&D. This book chapter will review the pipeline sizes and the R&D investments of multinational pharmaceutical companies, will describe new processes that have been implemented to increase the reach and to reduce costs of pharmaceutical R&D, and it will illustrate new innovation models that were developed to increase the R&D efficiency.