MIKE CHACE-ORTIZ

Senior Director, Generics Product Strategy
Clarivate Analytics

Abstract

There are more than 3,000 corporate groups worldwide engaged in manufacturing active pharmaceutical ingredients, participating in an estimated $135 billion market. Manufacturers vary in their experience of producing APIs for use in regulated markets and only 16% of groups have demonstrated consistent, long-term ability to do so. Margins are small and manufacturers are under tremendous pressures from many challenges in the global healthcare environment. Successful companies continue to develop by exploring a number of organic and acquisition-based growth strategies.

Ask anyone with a passing knowledge of drug development and they are sure to recognize the role of clinical trials and regulatory approval as innovative treatments reach the $1.4 trillion global pharmaceutical market. However, the role that manufacturing plays in that same process, and especially development of Active Pharmaceutical Ingredients (APIs), is often far less well understood or even mentioned during such discussions.

As novel drugs proceed through R&D phases, regulatory approval, and into the hands of needy patients, skillful chemists, biologists and engineers in innovator companies and Contract Manufacturing Organizations (CMOs) must continue to devise new manufacturing processes that are capable of transforming lab-scale API production into commercial quantities quickly, safely, cheaply and with predictable high quality. This process, which often takes many years, can require changes in scale from a few grams to hundreds of kilos or several tonnes of commercial product and sometimes even the construction of brand new, dedicated manufacturing facilities.

In 2015, the top global R&D companies spent around $75 billion (1) to bring new drugs to m ...