The hidradenitis suppurativa (HS) market across the seven major pharmaceutical markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is forecast to grow from $1.84bn in 2024 to $7.83bn in 2034, according to GlobalData. This 15.6% compound annual growth rate (CAGR) is largely attributed to the launch of novel biologics and small molecules targeting multiple inflammatory pathways beyond TNF-alpha inhibition.
Currently, only three biologics are approved for HS: AbbVie’s Humira (adalimumab), Novartis’ Cosentyx (secukinumab), and UCB’s Bimzelx (bimekizumab). While Humira, the first approved biologic, remains the market leader, it is widely viewed by KOLs as having limited efficacy, with response rates near 25%–30% and high rates of treatment fatigue. In contrast, the newer IL-17 inhibitors have demonstrated more robust outcomes. In pivotal trials (BE HEARD I/II), Bimzelx achieved hidradenitis suppurativa clinical response (HiSCR) rates of up to 64%, with a faster onset and more durable effect than Cosentyx, despite being a second-line biologic. However, candidiasis risk and high cost may temper uptake.
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The landscape is now shifting further with a maturing pipeline with varying mechanisms of action. MoonLake Immunotherapeutics’ sonelokimab, a tri-specific nanobody targeting IL-17A/F and albumin, is anticipated to be a best-in-class agent based on its deeper tissue penetration and strong Phase II performance. Similarly, Incyte’s JAK1 inhibitor povorcitinib is advancing through late-stage development, showing promise particularly in pain reduction and quality-of-life improvement metrics. GlobalData forecasts that by 2034, pipeline products, including sonelokimab and povorcitinib will represent 47.3% of the total HS market.
A defining challenge in HS care remains the heterogeneity of disease severity and the high unmet need in both early- and late-stage disease. Diagnostic delays, averaging 7–10 years, often result in irreversible structural damage by the time patients reach speciality care. Furthermore, current treatments target only moderate-to-severe HS, leaving early-stage (Hurley stage I) patients without effective interventions. As highlighted by GlobalData’s analysis, products that can safely intervene earlier in disease progression represent a significant commercial opportunity.
KOLs also emphasised that clinical endpoints such as HiSCR50 do not fully capture the burden of disease, particularly in tunnel-dominant or refractory cases. As a result, next-generation trials are adopting stricter endpoints such as HiSCR75, and increasingly incorporating patient-reported outcomes such as dermatology life quality index (DLQI) and numerical rating scale-30 (NRS-30). This evolution in trial design aligns with payer and physician expectations for more meaningful, real-world benefits.
Market growth will be led by the US, which accounted for over 70% of HS sales in 2024 due to a larger diagnosed population, broader biologic access, and premium pricing. While biosimilar entry may moderate TNF-alpha sales, the expansion of high-cost IL-17 and JAK pathway inhibitors is expected to intensify market competition and drive overall market prices upward due to the premium pricing of these agents.
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By GlobalDataBarriers to market growth include safety monitoring requirements for JAK inhibitors, competition among newer biologics, and access challenges in countries with tighter reimbursement frameworks. However, if emerging therapies show consistent improvements in flare reduction, pain control, and psychosocial burden, as seen with Bimzelx and sonelokimab, they could reshape the treatment algorithm and expand biologic usage to earlier disease stages.
With nearly 33 agents in active clinical development and multiple first-in-class mechanisms poised to enter the market, HS is undergoing a therapeutic transformation. GlobalData expects this evolution to redefine the standard of care for a historically underserved patient population.
