By Richard Steiner, senior manager, business strategy, Pharmatech Associates
Pharmaceutical continuous manufacturing (PCM) is a technical solution usually explained by outlining what benefits to expect from implementing this technology, with few to no facts. Development and commercialization of a drug product in a highly regulated market is already risky enough. Using advanced manufacturing technologies is an added risk and often a barrier to implementing any new technology. To lower this perceived risk, a strategic approach is necessary.
In this first article of a two-part series, examine a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with specific considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers. We consider the main drivers of competitiveness, specific needs, and a value chain analysis for each segment. In part two, we will introduce a financial equation to calculate amortization for each business case, supported by real-world examples.