Summary
Large and Innovative Pipeline
Analysis has confirmed the asthma pipeline to be highly active, with 252 products in active development across all stages. The range of mechanisms of action employed by these compounds is also highly diverse, especially in comparison to the existing market landscape. More pertinently, the degree and proportion of breakthrough innovations is significant. GBI Research analysis identified 59 first-in-class programs in the asthma pipeline, acting on 43 first-in-class molecular targets, accounting for 23% of all products with a disclosed molecular target and reflective of the high degree of innovation in this indication. This has far-reaching strategic implications for all market participants, as, despite the high clinical trial attrition rate, it is highly likely that many of the first-in-class technologies will reach the market over the coming decade and may transform the clinical and commercial landscape.
Biologics Growing in Prominence in Asthma Treatment
While the current asthma market is almost exclusively dominated by small molecules, which account for approximately 99% (the exception being Xolair), the current asthma pipeline includes 64 biologics, accounting for 24%. Small molecules amount to 178 compounds, equating to 66%.
This highlights both the commercial and clinical appeal of developing drugs of this class, and follows trends seen in other therapy areas, particularly oncology. Xolair (omalizumab), a recombinant humanized anti-IgE monoclonal Antibody (mAb), was the first humanized therapeutic mAb to be indicated for asthma. It was approved by the FDA in 2003 as an add-on therapy for adults and adolescents aged 12 and over, with moderate-to-severe allergic asthma and symptoms not adequately controlled with Inhaled Corticosteroids (ICS).
Xolair is also the only targeted therapy indicated for the treatment of a specific asthma phenotype. Its launch therefore addressed a significant unmet need for personalized therapy in asthma. Approximately 60% of asthmatics have allergic asthma, and may therefore benefit from Xolair treatment. However, only a minority of these patients has moderate-to-severe disease that is inadequately controlled with standard-of-care therapies, and is therefore eligible for treatment. Despite this, the drug has achieved blockbuster status, and although this can be attributed to a high Annual Cost of Therapy (ACoT), it is also reflective of how innovative drug development that targets unmet clinical needs can result in strong commercial outcomes. Indeed, drug developers are now looking to follow this example by developing highly specific biologics aimed at specific patient sub-types with the hope of benefiting previously underserved patients and generating strong revenues. Notable examples are mepolizumab, reslizumab, lebrikizumab and dupilumab, all of which target Interleukins (IL) heavily implicated in the inflammatory response.
A Deals Landscape with Numerous Investment Opportunities
Analysis has confirmed that 52 of the 59 first-in-class products have not been involved in a licensing or co-development deal. Although a number act on targets that are not yet strongly substantiated in terms of their therapeutic potential in asthma in clinical studies, many are supported by promising in vivo and in vitro preclinical evidence, and as such are highly promising asthma therapies. Indeed, breakthrough innovations are highly desirable as an investment option.
However, many deals involving first-in-class products were in early-stage development, whereas advance-in-class and addition-to-class product deals were typically made in late-stage development, indicating significant differentiation. These findings have significant strategic implications for both biotech companies seeking to out
