Biologics for bowel disease face threat from cheaper small molecules

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The total sales of inflammatory bowel disease (IBD) drugs are estimated to reach approximately $10.2 billion in the US in 2023, according to analysts.

The increase in IBD biologic treatments has been a major driving force in the growth of this market in recent years. In 2007, AbbVie’s Humira received approval from the FDA to treat moderate-severe Crohn’s disease (CD). Since then, the IBD market has seen the entry of seven biologics.

With more biologics anticipated to enter the market in the coming years, GlobalData predicts that external forces could potentially suppress previous growth.

Adeleke Badejo, Senior Analyst of Immunology at GlobalData, commented: “Barriers to US market growth will primarily result from the loss of patent exclusivity of current biologics, and the subsequent entry of biosimilars to these reference therapies. Additionally, pharmaceutical companies must face the growing swell of bipartisan and public support for increased legislation aimed at increasing transparency and reducing the costs of prescription drugs in the US.”

Biologics need to justify cost

Companies in this sector will need to contend with the emergence of novel small molecules, particularly Janus kinase (JAK) and sphingosine 1 phosphate receptor modulators (S1PR).

In another example, Insilico Medicine recently launched Phase I studies into its poly hydroxylase domain (PHD) 1/2 inhibitor for the treatment of IBD.

If these newer small molecule therapies are shown to have comparable therapeutic efficacy, it will be harder to justify the use of the more expensive biologics over these therapies. AbbVie has chosen to develop both a biologic and a small molecule, Skyrizi and Rinvoq respectively, and is expected to be the market leader.

Badejo concludes: “For the IBD market to continue to grow, it is critical for biologics entering the market to continue to show substantial efficacy over current biological and small molecule therapies to justify their higher cost. Fortunately, this will force innovation by companies that seek to enter this space.”

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