The Crohn’s disease (CD) market is expected to grow from $7.4bn in 2019 to $12.6bn by 2029 across the eight major markets (8MM*) at a compound annual growth rate (CAGR) of 5.5%, according to GlobalData, a leading data and analytics company.

GlobalData’s report, ‘Crohn’s Disease – Global Drug Forecast and Market Analysis to 2029’, states that growth will be driven by the launch of new drugs, most of which are expected to launch between 2023 and 2025, that will target the moderate-to-severe patient population, as well as the often-neglected CD patient with fistulizing disease.

Antoine Grey, Senior Immunology Analyst at GlobalData, comments: “The CD market has historically been reliant on anti-tumor necrosis factor (anti-TNF) therapies that have been available for over a decade, but recent developments have led to research on novel mechanisms of action (MOAs) in order to combat the high numbers of patients experiencing treatment non-response. These are seen as generally satisfactorily in treating CD patients who are not adequately controlled by steroids and aminosalicylates, however, some patients can experience a loss of response to these therapies – particularly anti-TNFs.”

With Stelara being the last biologic approved for CD in 2016, there is demand for therapies with novel MOAs that are less immunogenic than current offerings and many new classes of therapies are looking to enter the CD market over the next ten years. Most notable are the IL-23 inhibitors, which are suspected to offer greater efficacy and safety than Stelara and include AbbVie’s Skyrizi (risankizumab), Janssen’s Tremfya (guselkumab), Eli Lilly’s mirikizumab and AstraZeneca’s brazikumab. Similarly anticipated are the Janus kinase (JAK) inhibitors, which include AbbVie’s Rinvoq (upadacitinib) and Gilead’s Jyseleca (filgotinib). Safety concerns regarding the formation of blood clots from the use of JAK inhibitors in rheumatoid arthritis patients have led to boxed warnings for all JAK inhibitors, potentially limiting their uptake upon approval for CD. This will be compounded by concerns over Jyseleca’s impact on male fertility.

Grey continues: “With a greater focus on fistulizing CD patients, two drugs in late-stage development are also being tested in this patient population. These are Jyseleca and Takeda’s Alofisel (darvadstrocel). Although already approved in Europe, Takeda’s Alofisel is currently in Phase III testing for the US and Japan. Fistulizing patients typically require surgical intervention and the prospect of new pharmacological treatment will be exciting to gastroenterologists.”

Despite the looming prospect of biosimilars launching across the next ten years, the future growth of the CD market is expected to be substantial. While adalimumab biosimilars launched in the EU in 2018 and are expected to launch in the US in 2023, Humira is expected to retain its crown as 2019’s highest selling CD drug by 2029. Certolizumab pegol, vedolizumab, and ustekinumab biosimilars are all expected to launch during the next decade, adversely affecting sales of the originator products, but not to a detrimental extent.

Grey adds: “Physicians were excited at the prospect of new therapies that would offer hope to patients who have been refractory to multiple MOAs currently on the market, as well as the impressive safety profile of some of the drugs in late-stage development. Overall, the looming threat of biosimilars and the expected high cost of new therapies will not be enough to derail significant growth of the CD market in the 8MM over the next decade.”

*8MM: US, France, Germany, Italy, Spain, UK, Japan, and Canada