A team from Evolution Global analysed historical new drug approval statistics and the current clinical trials pipeline to identify trends that highlight the rise and diversification of biologics. From start-ups to blue chips, they evaluated the pharmaceutical players involved in the ongoing research and development of biologics in order to identify upcoming therapeutic categories with disruptive potential. Get the resulting infographic here
2015 saw 51 New Drug Approvals by the FDA (CDER & CBER), with 32 of these drugs classed as small molecules and 19 classed as biologics. The infographic divides these newly approved biologics into eight categories, with the dominant class being monoclonal antibodies, accounting for 42% of approvals. Recombinant peptides & proteins accounted for 21% of approvals, whilst biobetter recombinant peptides & proteins ranked third with 11% of overall biologics approvals. In 2015 a single biologic was approved for each of the five other classes (antibody fragments, oncolytic viral therapy, recombinant fusion proteins, recombinant glycoproteins and vaccines).
In-depth analysis of the clinical trials pipeline from 2016-2019 has identified 286 ongoing industry-funded Phase-III trials globally, 131 of which are classified as novel treatments. By applying historical attrition rates, Dr. Frank Rinaldi, Director of Market Intelligence & Innovation at Evolution, has forecast that 75 of these novel treatments will be approved. The infographic splits the novel treatments into categories, highlighting the predicted number of approvals for each type of treatment.
As biologics expand to include a wider use of cell therapy treatments, the cell becomes the product. Dr. Jason Beckwith, Managing Director at Evolution Global, anticipates that the industry is likely to experience a talent demand paradigm shift for enhanced expertise specific to complex quality control, cell characterisation, regulatory & logistics skill-sets. “As classical bioproduction shifts to different therapeutic areas, it is key that specialised talent providers are aware of their client strategy and understand their bespoke requirements,” asserts Dr. Beckwith. “A competent technical search provider will be an important industry partner to help provide the required differentiation for strategic success in this evolving dynamic market.”
Read the full analysis on the Evolution Global site