Crohn’s disease treatment market sees major shift with biosimilars and next-gen therapies: GlobalData

There is a transformative shift taking place in the Crohn’s disease (CD) treatment market, challenging AbbVie’s Humira’s long-standing dominance. Adalimumab biosimilars are reshaping the landscape, impacting Humira and competitors like Janssen’s Stelara and Takeda’s Entyvio. With a focus on biologic-exposed CD patients, novel therapies for TNF-refractory individuals are gaining prominence. Advancements in biologics and oral small molecules are driving dynamic changes, potentially altering the market hierarchy, says GlobalData.

As per GlobalData’s estimates, over the last five years, AbbVie has remained the market leader within CD, with Humira sales of $2.7 billion in 2022 in the eight major markets ((8MM) (US, Canada, UK, France, Germany, Spain, Italy and Japan)).

Adeleke Badejo, Senior Analyst of Immunology at GlobalData, comments, “The recent launch of adalimumab biosimilars not only will 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 competitive in recent years, with Janssen’s Stelara and Takeda’s Entyvio earning $2.1 billion and $1.7 billion 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- or third-line therapy following failure with adalimumab or other anti-TNF biologics.

Badejo continues, “Interestingly, the biologic-exposed market targeted by Janssen and Takeda is the strategy being implemented by most companies to displace AbbVie; 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 utilising an active comparator, preventing the positioning of these novel therapies as next generation, enhanced options.

Badejo continues, “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 is dynamic and competitive, marked by innovative mechanisms in biologics and small molecules. Notably, the maturation of selective anti-IL-23 drugs is noteworthy.

Anticipated US and Europe launches of Janssen’s Tremfya (guselkumab) and Lilly’s mirikizumab in 2025-2026 are poised to impact the market. These, along with AbbVie’s Skyrizi, could be second-generation therapies surpassing non-selective Stelara. Mirikizumab, particularly, shows potential for best-in-class status, demonstrated by its comparison with ustekinumab in pivotal trials.

Additionally, AbbVie’s Rinvoq, an oral small molecule, approved in 2023, may shape the market by catering to the preference for oral over intravenous or subcutaneous biologics.

Badejo concludes, “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.”