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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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SEARCH JOBSTopical therapies have a long history as cornerstone treatments for immune-mediated skin diseases, such as psoriasis and atopic dermatitis. They are the go-to, often first-line option for many patients, especially those with mild-to-moderate disease affecting only a small area of their body.
The topicals segment represents about 5% of the combined value of the global markets for prescription medicines for psoriasis and atopic dermatitis, which are dominated by systemic, biologic therapies, and is worth $3 billion, at ex-manufacturer prices, based on IQVIA MIDAS MAT Q2/2024. Mainstay topical therapies include emollients and steroid creams, which aim to restore the skin barrier function and microbiome, and reduce inflammation and pruritus.
Since topical calcineurin inhibitors tacrolimus and pimecrolimus entered the market in the early 2000s, innovation in topical therapies stalled for over a decade until the approval of PDE4 inhibitor crisaborole for atopic dermatitis in 2016.
Biopharma innovators have recently shown a growing interest in topical treatments with targeted MoAs that explore new therapeutic pathways, e.g., targeting Janus kinase (JAK) or aryl hydrocarbon receptor (AhR). IQVIA Pipeline Link identifies over 30 clinical-stage topical candidates currently in development for immune-mediated skin conditions, while six novel topicals were approved in the past four years (see Table 1):
Table 1: Approvals of novel topicals since 2020
| Brand (molecule) | MoA | First approval/country | Indications |
|---|---|---|---|
| Corectim (delgocitinib) | JAK | Q1/2020; Japan | Atopic dermatitis |
| Opzelura (ruloxitinib) | JAK | Q3/2021; US | Atopic dermatitis, vitiligo |
| Moizerto (difamilast) | PDE4 | Q3/2021; Japan | Atopic dermatitis |
| Vtama (tapinarof) | AhR | Q2/2022; US | Psoriasis |
| Zoryve (roflumilast) | PDE4 | Q3/2022; US | Psoriasis, seborrheic dermatitis |
| Anzupgo (delgocitinib) | JAK | Q3/2024; EU | Chronic hand eczema |
Well-known limitations of established topical therapies have created an opportunity for novel topicals to address unmet patient need by delivering superior efficacy combined with a clean(er) safety and tolerability profile – for example, avoiding the side effects of the long-term use of steroid creams, such as skin atrophy, acne or potential risks from systemic absorption; or skin irritation, burning and stinging reported for other established topicals, which negatively impact patient adherence and thus clinical outcomes.
Overall headline growth of topicals in the combined global psoriasis and atopic dermatitis markets is weighed down by mature products such as emollients and off-patent steroid creams, however, the entry of novel topicals has injected new growth momentum. Year-over-year (YoY) value growth for total topicals, including established and novel therapies, accelerated from -1.5% in 2021 to 2.4% in 2022 and 2.5% in 2023 to reach 4.8% in 2024 (based on respective MAT Q2 for all years).
Collectively, the segment of novel topicals delivered impressive 45% YoY value growth (MAT Q2/2024 vs. MAT Q2/2023), while the segment of established topicals declined in value by 4% over the same time period. The latest YoY growth momentum of novel topicals also compares favourably to the oral and parenteral segments within the combined global psoriasis and atopic dermatitis markets, which grew at 29% and 20%, respectively (see Figure 1).
Individual novel topical brands are growing at attractive annual rates in the double- or even triple digits, with Vtama (tapinarof) and Opzelura (ruloxitinib), which have been launched in the US market, already generating several $100 million in annual sales in psoriasis and atopic dermatitis alone.
Incyte’s topical JAK inhibitor Opzelura has emerged as the standout performer among novel topicals, and a key growth driver for the company, which generates over $400 million in annual sales across its two approved indications of atopic dermatitis and vitiligo. Building on the broad utility of the JAK MoA, Incyte is exploring indication expansions for Opzelura into other immune-mediated skin conditions, including hidradenitis suppurativa, prurigo nodularis, lichen planus and lichen sclerosus.
Since topicals do not compete with biologics, because they are either used in the pre-biologics setting or as a complementary add-on to biologics therapy, they avoid head-on competition with major, big pharma immunology players, e.g., AbbVie, Sanofi, Novartis, J&J or Lilly. This explains why novel topicals have emerged as an attractive segment for small- and medium-size biopharma companies, for example, Incyte, LEO or Arcutis, which unlike big pharma do not need to pursue multi-billion dollar blockbuster opportunities.
The typically multi-faceted manifestations of dermatological conditions include a wide range of symptoms, e.g., dry, cracked, scaly or discoloured skin; rashes, open sores, nodular or pustular lesions, accompanied by itch (pruritus) and pain, which may cause sleep disturbance and severely impact patients’ overall quality of life and mental health.
Innovators seeking differentiation in the topical treatment landscape must therefore deliver patient-relevant benefits on multiple dimensions. This is illustrated, for example, by a network meta-analysis [1] which compares selected topical therapies for atopic dermatitis spanning a range of different MoAs (see Figure 2).
Specifically, it shows that innovation is not a simplistic race for greater potency on a single, traditional clinical outcomes measure, e.g., improvement in atopic dermatitis severity. Instead, the opportunity for novel topicals in atopic dermatitis lies in translating headline efficacy into patient-relevant quality of life (QoL) benefits and to demonstrate those under real world conditions.
This is an important lesson for innovators aiming to develop successful novel topical therapies, and it is applicable across the spectrum of dermatological conditions.
The arrival of novel topicals, with their targeted MoAs and distinct profiles, has been a welcome addition to dermatologists’ therapeutic armamentarium, introducing valuable new treatment options for patients. However, to maximise the opportunity for novel topicals, innovators must focus on four strategic priorities:
Recent innovation efforts focused on developing novel topical therapies have culminated in the approval of several new treatments for immune-mediated skin conditions in the past few years. As treatment options for patients continue to expand, compelling evidence will play a crucial role in substantiating the benefits, especially under real world conditions, of novel topicals for them to fulfil their promise.
1. Topical treatments for atopic dermatitis: Systematic review and network meta-analysis of randomized trials; Chu, Derek K. et al., Journal of Allergy and Clinical Immunology, Vol.152, Issue 6, 1493 – 1519 (2023)
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