ROB CROOK1, JEAN-BAPTISTE VENDEVILLE2
1.Director of Chemical Sciences at CatSci Ltd
2.Senior Scientist at CatSci Ltd

Abstract

The high potency drug market is an exciting place and is likely only going to evolve. In this article, Rob Crook and Jean-Baptiste Vendeville discuss the current considerations needed when developing a synthesis for a HPAPI, as well as the challenges faced by these complex molecules, in particular ADCs. They will first highlight the development and growth of the market before a short review of the innovations being undertaken that can lead to lower costs and more efficient use of time and resources. Overall, they discuss how the requirement for excellent chemistry and innovation, along with exceptional route design, will be critical to the successful development of high potency molecules to secure their future potential as treatments.

INTRODUCTION
During this short article we will highlight some of the challenges brought by the design of routes for high potency molecules. Our experience with these molecules has shown that due to low volume requirements of the APIs, alongside the difficulties and lack of facilities available to carry out the chemistry, the optimisation of routes is often not undertaken. Before getting into some of the more interesting technical discussion we feel it is first important to highlight the development of this market and the increasing need for high quality facilities to carry out route selection and process development.

The high potency drug market is an exciting place right now. There are a growing number of approved drugs, plus an increasing pipeline of drug candidates vying to be future blockbusters.

In 2022, the current market for high potency medicines was $25 billion. What’s more, it is expected that by the end of the decade, this figure will grow at a CAGR (Compound Annual Growth Rate) of between 6 and 8%. This will lead to a market value for high potency drugs of >$40 billion by 2030 (1).

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