Within early development, there are a variety of different challenges that hinder a molecule’s ability to progress to the next phase such as complex formulation.
The complexity of sterile drug development has been on the rise, which is driven by a variety of different factors. Complex formulation trends are being driven by the industries focus on:
- Orphan drugs: This market is projected to grow at 13% CAGR from 2020-2024
- mRNA therapeutics: Prior to the COVID-19 Pandemic, the global mRNA therapeutics market was estimated to reach ~3B by 2026
- Repurposed drugs: Costs of bringing a repurposed drug to market have been estimated to be US$300 million on average, compared with an estimated ~$2–3 billion for a new chemical entity