ROGER LAFORCE
Managing Director Dorra Europe, Magadino, Switzerland

Abstract

This article aims to elucidate the dynamics and intricacies of Contract Development and Manufacturing Organizations (CDMOs), mainly for small molecules in the chemical pharmaceutical industry, contrasting them with traditional outsourcing practices. It explores the critical factors for success, including the balance between hard factors (infrastructure, technology) and soft factors (customer orientation, reliability). The piece discusses the historical context, market trends, and future projections, highlighting the competitive landscape and challenges faced by both established and emerging CDMOs. Recent market data and strategic advice for navigating this complex industry are presented.

What is CDMO in Fine Chemicals?
According to Peter Pollak (1) Contract Manufacturing (CM) is the antonym for Outsourcing. CM constitutes the “Königsdisziplin”, that is, the most prominent activity in the fine chemicals industry.
Peters’ definition of Outsourcing: «The transfer of an industrial activity – production or service – that so far was carried out in-house to a third party through a contractual agreement.
Note: If outsourcing is done with an overseas partner, it is also referred to as “offshoring.” (And today, there is the term “onshoring” or “reshoring”).

Other quotes from Peter:

• “Within CM for pharmaceutical companies, entry gate is number 2, when the new drug is in Phases II and III.”
• “Newcomers must start their business development effort already at Phase I. “
• “Entry gate number 4 is linked to the decline phase of the life cycle, when patent expiration is approaching.”
• “The chance of a particular fine chemical company to build up a rewarding exclusive business depends on a “two-level demand hierarchy”, namely,
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