LOUIS GARGUILO
Life Science Connect, 34 Swan Place, Slingerlands, NY 12159, USA

Abstract

It feels so “cold war” to talk in terms of geographic blocs, global corners of influence and regional and country power centers. However, this is the global lay of the land in the CRO/CMO industry in 2014. Not quite an axis vs. allied, but very much a Quadrilateral World Order (QWO) competing for pharmaceutical outsourcing supremacy…or at the least sustained relevancy in a dynamic market. The four sides? The U.S. (it’s always the U.S.); China, India, and the main focus of this article, Europe.

THE CRO/CMO INDUSTRY AS A WHOLE

Before dividing (and conquering, to keep our realpolitik metaphor), taken as a whole and despite a diverse set of challenges, it is a good time to be in the contract drug discovery, development and manufacturing industry (CRO/CMO) (1). It is an industry – to move to modern-day parlance – that has gone viral. In 2011, the Center for the Study of Drug Development at Tufts University, Boston, MA (Tufts CSDD) did a (now quite often cited) study that identified 3,244 unique contract R&D service companies actively operating in the U.S. alone. There are well more than 100 USA FDA approved manufacturing sites in India, making it the country outside the U.S. to have the highest number of FDA certified manufacturing facilities. And by the way, India pumps out about 150,000 chemistry graduates each year (2). And then there has been what can only be described as the stampede to China – based on the emergence of opportunities in the healthcare industry there and its increasing integration into world markets, and of course pricing and a preponderance of labor – that shifted the global CRO/CMO landscape. Europe is the traditi ...