GlobalData: Sanofi and Regeneron’s additional label expansion for Dupixent reinforces its dominance in atopic dermatitis market; Dupixent expected to reach sales of US$5.3B in US by 2030, showcasing its blockbuster potential in a lucrative market

Sample article from our Tissue & Hygiene

July 5, 2022 (press release) –

The Food and Drug Administration’s (FDA) approval for Sanofi and Regeneron’s interleukin (IL)-4/13 inhibitor, Dupixent (dupilumab), for the treatment of children ages 6 months to 5 years with moderate-to-severe atopic dermatitis (AD) earlier this month, has solidified first-mover advantage for Dupixent and reinforces its market-leading position for the treatment of moderate-to-severe AD, says GlobalData, a leading data and analytics company.

Dupixent was already approved for use in adults (ages 18 years and over) and adolescents (ages 12 years and younger) in March 2017 and March 2019 in the US, respectively, and then approved for the treatment of severe AD in pediatric patients (6 to 11 years of age) in May 2020.

Ramla Salad, Pharma Analyst at GlobalData, comments: “This highlights the broad label for Dupixent across different patient groups, which continues to bolster confidence in the agent as the companies also tout real-world evidence supporting Dupixent’s strong safety and efficacy profile across a range of patient groups. Furthermore, this recent approval provides hope for younger patients who are underserved within this market.”

Sanofi and Regeneron’s Dupixent is anticipated to reach sales of $5.3 billion in the US by 2030, growing at a compound annual growth rate (CAGR) of 6.3%, while the US AD market is expected to grow at a CAGR of 10.5%. It is clear that Dupixent is responsible for a huge proportion of that growth, further showcasing its blockbuster potential in a lucrative market.

Although Dupixent is a widely adopted therapy for the treatment of AD, there are other companies seeking to expand into the pediatric population to garner market share from Dupixent. Notably, these include AbbVie’s Janus kinase (JAK)-1 inhibitor, Rinvoq (upadacitinib), which was approved in the US for adults and adolescents in January 2022; Pfizer’s JAK-1 inhibitor Cibinqo (abrocitinib), which was approved in the US for adults in January 2022; Eli Lilly’s JAK-1/2 inhibitor, Olumiant (baricitinib), which is awaiting FDA approval following filing in April 2021; Leo Pharma’s marketed anti-IL-13 Adtralza/Adbry (tralokinumab), which was approved in the US for adult patients in December 2021; and Galderma’s anti-IL-31 Phase III pipeline candidate, nemolizumab.

Salad continues: “In order to fiercely compete with Dupixent, developers—particularly those with JAK inhibitors—will need to conduct extensive safety studies similar to the open-label Dupixent study, LIBERTY AD PED-OLE (NCT02612454), conducted by Sanofi and Regeneron. GlobalData anticipates Eli Lilly’s Olumiant to launch in the US for pediatric patients (2–11 years) in 2024, with Galderma’s nemolizumab to follow closely behind in 2026. As such, Sanofi and Regeneron will have two to three years to capitalize on the 6 months–11 years moderate-to-severe group, which GlobalData estimates to be 11.9 million diagnosed prevalent cases across the seven major markets (7MM*) in 2022.”

Rinvoq, Olumiant, Adtralza, and Cibinqo are expected to see some growth, with US peak sales of around $1.8 billion, $380.4 million, $1.1 billion, and $476.0 million, respectively. It should be noted that their growth will be overshadowed by Dupixent as more and more age groups are exposed to the IL-4/13 inhibitor, although there are some patients who do not respond well to the biologic, leaving room for second-line therapy with these agents.

Salad concludes: “Dupixent is now the first and only biologic medicine approved to treat moderate-to-severe AD from infancy through adulthood. GlobalData anticipates strong uptake of Dupixent in this patient population due to the pent-up demand for an effective disease-modifying agent.”

*7MM: The US, France, Germany, Italy, Spain, the UK, and Japan

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Dan Rivard
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