The changing of the guard is expected in the Crohn’s disease marketplace

The advent of biologics and the application of these agents to treat patients with moderate to severe Crohn’s disease (CD) has allowed AbbVie to position Humira (adalimumab) as the first-line option, establishing the company in this space. As per GlobalData’s estimates, over the last five years, AbbVie has remained the market leader within CD, with Humira sales of $2.7bn in 2022 in the eight major markets (8MM) (US, Canada, UK, France, Germany, Spain, Italy, and Japan).

The recent launch of adalimumab biosimilars will not only cause an overall reduction in the cost of treatment but also provide the opportunity for another company to knock AbbVie from its standing as the market leader within CD. Although AbbVie has been dominant in the space, the market has been fairly competitive in recent years, with Janssen’s Stelara and Takeda’s Entyvio earning $2.1bn and $1.7bn in sales respectively in the 8MM. However, as with Humira, revenues from these therapies are expected to decline with the release of their corresponding biosimilars, which are anticipated to enter the market in the coming years. However, unlike Humira, Stelara and Entyvio are seen and typically prescribed as a second-line or third-line therapy following failure with adalimumab or other anti-tumor necrosis factor (anti-TNF) biologics. Most companies seeking to displace AbbVie in this biologic-exposed market are using the same strategy as Janssen and Takeda—specifically, with a rush to market to establish a significant market share as opposed to providing the next-generation replacement of adalimumab.

The biologic-exposed CD patient population remains the most underserved group in this space, with limited therapeutic options and high clinical unmet need. The strategy to focus on these patients, as opposed to directly dethroning adalimumab, is evident. Most of the late-stage pipeline products target CD patients who are refractory to anti-TNF, and only a few clinical trials utilise an active comparator, preventing the positioning of these novel therapies as next-generation, enhanced options. While GlobalData believes that this strategy of developing therapies for the TNF-refractory patient group is a viable approach for companies with products that are currently in late-stage development, it is expected that competition within the TNF-refractory population will intensify 5–10 years from now.

The future of CD therapy appears to be highly dynamic and competitive, with the advancement of developing novel mechanisms of action, both in biologics and with the introduction of small molecule agents. Within the landscape, the maturation of the selective anti-interleukin (IL)-23 drug class is particularly notable. The anticipated launches in the US and Europe of Janssen’s Tremfya (guselkumab) and Lilly’s mirikizumab, in Q4 2025 and Q3 2026, respectively, are expected to shape the market. These pipeline agents, with AbbVie’s marketed Skyrizi, could be elevated as second-generation therapies over Janssen’s non-selective anti-IL-12/23 Stelara. Out of these new biologics, mirikizumab has the potential to become the best-in-class when it enters the field mid-forecast, reflecting the confidence Lilly showed by assigning ustekinumab as its active comparators in its pivotal trials. In addition to these new biologics, the oral options of small molecules, especially that of AbbVie’s Janus kinase inhibitor, Rinvoq, which was approved and launched in the US and EU in 2023, will shape the market with the preference for oral administration over the intravenous or subcutaneous administration of biologics. AbbVie may retain its hold as the market leader through the combined promotion of Skyrizi and Rinvoq, although this is not anticipated, as a new therapy will ultimately emerge within the coming years and establish itself as the primary therapeutic option, allowing the company to displace AbbVie as it ascends to the top of the CD market.