The Rise Of HPAPI Molecules

By Maurits Janssen, Senior Director, Strategic Business Development, Small Molecules, Lonza, Basel, Switzerland

A growing proportion of the drug development pipeline is made up of more complex, highly potent APIs (HPAPI). These molecules are commonly associated with innovative cancer treatments, such as antibody-drug conjugates (ADC), but they also have shown effectiveness in treating autoimmune diseases, diabetes and a range of other indications. HPAPI molecules now make up over 30% of the drug development pipeline.

Alongside the growth in HPAPI molecules, smaller companies are increasingly driving the development of innovative molecules and products. These companies are submitting higher numbers of drug products for regulatory approval as specialty medicines, which often requires meeting accelerated timelines to market. Additionally, when these products are designed to treat rare diseases with small patient populations, they face uncertain demand if or when they reach the market. This uncertainty underscores the importance of flexible manufacturing capacity that can help avoid regulatory changes (e. g., due to change of scale) in response to an increase or decrease in demand.

For biopharma leaders, these trends mean it is more critical than ever to secure the capabilities to contain, handle, develop and manufacture increasingly complex molecules, including HPAPI. For many companies, particularly small, emerging and even virtual biopharma companies which lack extensive in-house manufacturing capabilities, the path forward typically includes working with an external partner such as a contract development & manufacturing organization (CDMO). In these cases, it is essential to select a partner with the appropriate experience and capabilities to help advance and develop innovative, life-saving HPAPI products.