Anna Casse
Alacrita, Zug, Switzerland

Abstract

Europe is a key market for US biopharma companies and to ensure success, early planning to determine the most effective commercialization strategy is key.
In the past it was not extraordinary for US biotech companies to develop drugs in the US and to launch them only in the US market. Any business coming from outside the US was seen as a bonus, but not always strategically planned, and often via partnering rather than direct commercialization. However, with mounting pricing pressures on biopharmaceutical companies, it is becoming increasingly important to launch products globally to maximise value. This article will explore the rising importance for US companies to expand into Europe and the different routes to get there. What considerations need to be made and how can you best prepare yourself for European commercialization?

REASONS WHY US COMPANIES HAVE TURNED THEIR FOCUS TO EUROPE

Commercial Potential

Europe – although fragmented and comprising multiple national systems, represents the most profitable and sizeable market after the US. The European market for pharmaceuticals currently represents approximately 22% of the global pharmaceutical market and is expected to continue growing, driven mainly by the expanding purchasing power in central and eastern Europe. For some indications such as rare or orphan diseases Europe is often as profitable as in the US due to the nature of the state healthcare systems.

Impact on Global Prices

What happens in Europe impacts the rest of the world. Europe is the most advanced region of the world in terms of assessing the cost/benefit impact of pharmaceuticals and asserting corresponding pressure on pricing/reimbursement. European countries cross-reference each other’s prices heavily as can be seen in Figure 2. On ...