According to GlobalData’s new Likelihood of Approval (LoA) tool, small molecules are 22% more likely to be approved than biologics when comparing LoA for Phase I, II, and III clinical trials combined. GlobalData’s LoA tool allows clients to determine the probability of a drug with specific characteristics progressing to the next stage of clinical development, as well as the ultimate probability of the drug receiving market authorization based upon its historical data.
Figure 1 below was generated using this tool, and shows that small molecules have a distinct lead over biologics in LOA at each stage of clinical development. In Phase I of clinical trials, small molecules have a 27% greater LoA than biologics, but this decreases to only 20% in Phase II and to 19% in Phase III. However, once past clinical stages and into pre-registration, small molecules display no advantages in LOA over biologics and in fact exhibit nearly the same percentage likelihood of receiving market approval.
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Despite this predominance in LoA for small molecules during Phases I, II, and III, biologics are continually growing; this trend is evident in big pharmaceutical companies such as Bayer, which is aiming to expand its biologic molecules offering to account for one-third of its entire pipeline.
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Bayer AG