In recent years, the increase in inflammatory bowel disease (IBD) biologic treatments has been a major driving force in the growth of this market. 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, this segment of the IBD landscape will experience significant events and external forces that could potentially suppress previously observed growth, according to GlobalData, a leading data and analytics company.

According to GlobalData’s reports on ulcerative colitis and Crohn’s disease, the total sales of IBD drugs are estimated to reach approximately $10.2 billion in the US in 2023.

Adeleke Badejo, Senior Analyst of Immunology at GlobalData, comments: “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.”

It should be noted that in this current environment, the stature of pharmaceutical lobbying groups, such as Pharmaceutical Research and Manufacturers of America (PhRMA) has diminished, as evidenced by the departure of members, AstraZeneca, AbbVie, and Teva. The exodus of these companies could also be viewed as an indication of the overall support for such regulations. Alternatively, the factors facing the US market are not expected to have the same impact in the EU and other major markets, such as Canada and Japan, where regulations to keep drug prices low are well established.

Badejo continues: “In addition to the previously mentioned challenges facing the biologic sector, companies must also contend with the emergence of novel small molecules, particularly Janus kinase (JAK) and sphingosine 1 phosphate receptor modulators (S1PR).  Small molecules can challenge with biologics for significant market share, due to their favorable oral route of administration and relatively lower costs.”

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. Subsequently, the impact of the eventual entry of the respective generics to these small molecules will compound the negative force on the market. Companies, such as AbbVie, have taken the position to hedge their bet by putting forward both a biologic and a small molecule, Skyrizi and Rinvoq respectively, as they are expected to be market leaders and will have a significant influence on the market during and beyond the forecast period.

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.”