The pharmaceutical industry has entered a critical period of transition. Business models that have proven remarkably successful over the past twenty years are now encountering major challenges. As companies grapple with the leading symptoms of these challenges — pricing pressures, pipeline productivity concerns, growing public distrust, and greater political scrutiny — it’s becoming increasingly clear that a profound shift is underway in the requirements for success in this environment.

Governments across the world are hitting the wall with respect to healthcare costs. Increasingly, manufacturers must offer a convincing case to decision makers at a country-by-country, payer-by-payer, and patient-by-patient level to pursue treatment or not, or to choose a newer, more expensive treatment vs. an older, less expensive one. That case depends on hard evidence of economic and clinical value.