Design for manufacturing is helping to drive continuous improvement in most industries today. Quality by Design, driven by ICH, FDA and other regulatory agencies, aims to take that approach to drug development, to reduce the time and cost of bringing new drugs to market. The past few years have seen pilot QbD programs, case studies for small molecules and biopharmaceuticals and the sharing of information. How far has the concept come in the pharma industry? What will be needed to drive it forward in the future?