ABSTRACT
This chapter examines the impact of market access and pricing considerations and needs on the drug development process. It considers three key phases of the development and commercialization process: asset shaping, evidence building and implementation and adjustment. The evidence building stage involves a number of pre-launch decisions that have an important impact on our ability to implement a successful commercial strategy. The chapter discusses the impact of patent expiration and generic defense strategies. As global drug markets are increasingly cost sensitive and government and private payers are instituting various market access and price control systems, it has become critical to alter the drug development approach to one which takes better notice of the requirements of payers. In Europe and Japan the awareness of the need to consider payer perspectives in drug development has been more evident than in the United States.
