Severe Atopic Dermatitis - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• The market size of moderate-to-severe atopic dermatitis in the 7MM was around USD 10,400 million in 2023 and is expected to increase with a significant CAGR during the forecast period.
• Among the 7MM, the US accounted for the largest market size of moderate-to-severe atopic dermatitis, i.e., approximately USD 7,100 of the overall market in 2023.
• The total prevalent cases of atopic dermatitis in the 7MM were ~ 72,707,300 in 2023.
• Currently, the treatment regimen of atopic dermatitis involves the use of topical treatment options such as emollients, Topical Corticosteroids (TCS), Topical Calcineurin Inhibitors (TCIs), and systemic treatment such as immunosuppressants, corticosteroids, and others (phototherapy). For moderate-to-severe disease, systemic therapies are warranted, particularly in refractory cases or in cases with body surface area involvement that makes topical application impractical.
• The approval of DUPIXENT (dupilumab) in 2017 marked a landmark change in the treatment landscape for atopic dermatitis patients. The drug has been progressively approved by the FDA for moderate-to-severe atopic dermatitis across various age groups: adults (2017), adolescents aged 12-17 (2019), children aged 6-11 (2020), and children aged 6 months-5 years (2022), specifically for patients inadequately controlled by or unsuitable for topical therapies.
• Other FDA-approved therapies for treating adults and adolescents with moderate-to-severe atopic dermatitis include EBGLYSS (lebrikizumab), RINVOQ (upadacitinib), CIBINQO (abrocitinib), ADBRY (tralokinumab), and OLUMIANT (baricitinib). Other than these, therapies such as VTAMA (tapinarof), MITCHGA (nemolizumab), MOIZERTO (difamilast), and CORECTIM ointment (delgocitinib) are only approved in Japan.
• Emerging biological therapies for atopic dermatitis are increasingly focusing on specific immune pathways such as IL-4, IL-13, IL-22, IL-31, TSLP, and OX40-OX40L axis, which are integral to the pathophysiology of the disease. As these biologics advance through clinical trials, they hold the potential to reshape the therapeutic landscape of atopic dermatitis.
• Pharmaceutical companies developing therapies for treating moderate-to-severe atopic dermatitis include Kyowa Kirin and Amgen (Rocatinlimab), Kymab/Sanofi (Amlitelimab), UNION Therapeutics (Orismilast), Biosion (Bosakitug), LEO Pharma (Temtokibart), Connect Biopharma (Rademikibart), Aclaris Therapeutics (ATI-1777), GSK (GSK1070806), Nektar Therapeutics (Rezpegaldesleukin), Apogee Therapeutics (APG777), and others.
• The demand for more convenient dosing regimens in atopic dermatitis is on the rise, with therapies like APG777, which offers the potential for annual dosing, poised to disrupt a market currently dominated by bi-weekly to monthly treatments. Additionally, the development of topical and oral options such as ATI-1777, orismilast, tradipitant, and others is providing needle-averse patients with effective alternatives. These advancements are expected to enhance patient adherence and challenge the dominance of injectable biologics requiring frequent administration.
• The rising incidence of atopic dermatitis in younger populations, combined with the limited availability of approved therapies for pediatric patients, presents a substantial opportunity to develop treatments specifically designed for children and adolescents, particularly long-term safety-focused biologics.
• The evolving landscape of atopic dermatitis therapies, bolstered by global market expansion, holds the potential to redefine outcomes in atopic dermatitis, addressing critical gaps and improving survival rates.

DelveInsight's "Severe Atopic Dermatitis - Market Insight, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of moderate-to-severe atopic dermatitis, historical and forecasted epidemiology as well as the moderate-to-severe atopic dermatitis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The moderate-to-severe atopic dermatitis market report provides current treatment practices, emerging drugs, moderate-to-severe atopic dermatitis market share of individual therapies, and current and forecasted moderate-to-severe atopic dermatitis market size from 2020 to 2034, segmented by seven major markets. The report also covers current moderate-to-severe atopic dermatitis treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Moderate-to-Severe Atopic Dermatitis Disease Understanding and Treatment Algorithm

Moderate-to-severe Atopic Dermatitis Overview

Moderate-to-severe atopic dermatitis is a chronic inflammatory skin condition characterized by intense itching, red and inflamed lesions, and significant dryness, often leading to lichenification from chronic scratching. It primarily affects children but can persist into adulthood, impacting the quality of life through sleep disturbances and social withdrawal. The condition is associated with genetic predispositions, immune dysregulation, and environmental triggers, and it is part of the "atopic march," which can lead to other allergic diseases like asthma and allergic rhinitis. Patients frequently experience a range of symptoms that can vary in severity, and while some may see improvement over time, many continue to deal with the challenges posed by this persistent condition.

Moderate-to-severe Atopic Dermatitis Diagnosis

Currently, no specific test for atopic dermatitis exists, and no single symptom or feature can be used to identify the disease. Each patient has a unique combination of symptoms and rash appearance. Diagnosis of atopic dermatitis is based on the history and physical examination of the patient. In uncertain cases, a skin biopsy may be taken for a histopathological diagnosis of dermatitis.

Atopic Dermatitis Treatment

Currently, the treatment regimen of atopic dermatitis involves the use of topical treatment options such as emollients, TCS, TCIs, and systemic treatment such as immunosuppressant, corticosteroids, and others (phototherapy).

Moderate-to-severe Atopic Dermatitis Epidemiology

The moderate-to-severe atopic dermatitis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total prevalent cases of atopic dermatitis, total prevalent cases of atopic dermatitis by age, total diagnosed cases of atopic dermatitis, total diagnosed cases of atopic dermatitis by severity, total diagnosed cases of atopic dermatitis by gender, and total treated cases of atopic dermatitis in the 7MM covering the US, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan from 2020 to 2034.

• Among the 7MM, the US accounted for approximately 32,759,600 prevalent cases of atopic dermatitis in 2023.
• The US accounted for approximately 9,933,500, cases of moderate to severe atopic dermatitis in 2023.
• In the EU4 and the UK, in 2023, the total prevalent cases of atopic dermatitis by age were 9,202,300 (for patients >18 years) and 21,332,100 (For patients 18 years and above), which is expected to increase by 2034.
• As per the DelveInsight estimates, it has been found that the total diagnosed cases of atopic dermatitis by severity were 30,896,000 for mild, 19,289,700 for moderate, and 3,339,900 for severe atopic dermatitis in 7MM in 2023.

Atopic Dermatitis Drug Chapters

Marketed Drugs

EBGLYSS (lebrikizumab [LY3650150]): Roche/Eli Lilly and Company/Almirall

EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate. EBGLYSS binds to the IL-13 cytokine at an area that overlaps with the binding site of the IL-4Ra subunit of the IL-13Ra1/IL-4Ra heterodimer, preventing the formation of this receptor complex and inhibiting IL-13 signaling. IL-13 is implicated as a primary cytokine tied to the pathophysiology of eczema, driving the type-2 inflammatory loop in the skin, and EBGLYSS selectively targets IL-13

In September 2024, Eli Lilly and Company announced that the US FDA approved EBGLYSS (lebrikizumab-lbkz) for the treatment of adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies. In November 2023, Almirall announced that the EC had approved EBGLYSS (lebrikizumab-lbkz) for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis, who are candidates for systemic therapy. In January 2024, EBGLYSS (lebrikizumab-lbkz) was approved by MHLW for atopic dermatitis not responding adequately to conventional treatments with usual dosage for patients for adults and children aged =12 years weighing =40 kg is 500 mg of lebrikizumab (genetical recombination) at Week 0 and Week 2, followed by 250 mg at 2-week intervals after Week 4, administered by subcutaneous injection.

ADBRY/ADTRALZA (tralokinumab): LEO Pharma

ADBRY (tralokinumab) is marketed outside of the US under the tradename ADTRALZA and is approved for the treatment of adults and pediatric patients (12 years and above) with moderate-to-severe atopic dermatitis in the US, Canada, the European Union, the United Arab Emirates, Great Britain, and South Korea. ADTRALZA is approved for use in adults with moderate-to-severe atopic dermatitis in Saudi Arabia, Switzerland, and Japan. ADBRY is the first biological injection that specifically targets IL-13, one of the proteins in the immune system that contributes to skin inflammation in eczema. ADBRY is an antibody that works with the immune system to neutralize IL-13, helping prevent inflammation in your skin. It is a drug for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

In December 2021, LEO Pharma announced that the US FDA had approved ADBRY for treating moderate-to-severe atopic dermatitis in adults aged 18 or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. In June 2021, LEO Pharma announced that the European Commission (EC) approved ADTRALZA or the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. In December 2022, LEO Pharma announced that the Japan Ministry of Health, Labor and Welfare (MHLW) approved the manufacturing and marketing of ADTRALZA subcutaneous injection for adults with atopic dermatitis, which has inadequately responded to conventional therapies.

Emerging Drugs

Rocatinlimab (KHK4083/AMG451): Kyowa Kirin and Amgen

Rocatinlimab is an anti-OX40 human monoclonal antibody being investigated for the treatment of moderate-to-severe atopic dermatitis. Rocatinlimab has the potential to be the first and only T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting the OX40 receptor. OX40 is a co-stimulatory receptor responsible for driving systemic and local inflammatory responses in atopic dermatitis and other conditions. It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology. It is also being studied for moderate to severe uncontrolled asthma, prurigo nodularis, and potentially other conditions where T-cell imbalance is a root cause of inflammation. The initial antibody was discovered in collaboration between Kyowa Kirin and La Jolla Institute for Immunology. Rocatinlimab is currently under clinical investigation, and the US FDA or any other regulatory authority has not evaluated its safety and efficacy.

As per Amgen's third quarter financial results for 2024, additional key data readouts from the ROCKET Phase III programs are anticipated in 2025, with ROCKET SHUTTLE anticipated in late 2024 to early 2025, ROCKET IGNITE anticipated in late 2024-early 2025, ROCKET ASCEND, data readout is anticipated in H2 2025. ROCKET ASTRO, data readout is anticipated in H2 2025.

Amlitelimab (KY1005): Kymab/Sanofi

Amlitelimab is a fully human non-T-cell depleting monoclonal antibody that blocks OX40-Ligand, a key immune regulator. It has the potential to be a first- or best-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis. In June 2023, the Phase IIb (STREAM-AD) results announced that the drug had its primary endpoint in adults with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach.

As per the Q4 presentation of Sanofi in February 2024, the company anticipates the submission of amlitelimab (KY1005) for atopic dermatitis in adults and adolescents by 2027.

Drug Class Insight

IL-13 inhibitors

IL-13 inhibitors, such as EBGLYSS and ADBRY, play a crucial role in treating moderate to severe atopic dermatitis (AD) by selectively targeting and blocking the IL-13 cytokine, which is central to the inflammatory processes underlying the disease. These biologics have demonstrated significant efficacy in clinical trials, leading to rapid improvements in key symptoms like skin lesions, itching, and overall quality of life. Specifically, they reduce the expression of inflammatory markers and enhance skin barrier function, which is often compromised in AD patients. Both EBGLYSS and ADBRY have shown good safety profiles, with mild adverse effects, making them promising options for patients inadequately controlled by traditional therapies.

JAK inhibitors

JAK inhibitors, including CIBINQO and RINVO function by blocking the JAK enzymes involved in the JAK-STAT signaling pathway, which is crucial for mediating inflammatory responses in atopic dermatitis. By inhibiting JAK1, JAK2, and JAK3, these medications disrupt the signaling of various cytokines that contribute to inflammation and immune cell activation, leading to reduced production of pro-inflammatory cytokines such as IL-4, IL-13, and IL-31. This results in significant improvements in skin lesions, decreased itching, and enhanced skin barrier function. Clinical trials have demonstrated that both oral and topical JAK inhibitors can rapidly alleviate symptoms of moderate-to-severe atopic dermatitis, providing effective relief for patients who have not responded adequately to traditional therapies. Additionally, their favorable safety profiles make them a valuable option in managing this chronic condition.

Moderate-to-severe Market Outlook

The current market uses several off-label therapies apart from pharmacological systemic treatment. Localized atopic itch is frequently treated with topical or intralesional therapeutic agents. Topical corticosteroids have been used for AD for decades. Pimecrolimus and tacrolimus, topical calcineurin inhibitors, are used as steroid-sparing agents for patients with AD. Phosphodiesterase-4 (PDE-4) inhibitors are an alternative option for the topical treatment of pruritis in AD. Oral antihistamines are commonly used for atopic itch. Additionally, phototherapy is efficacious in targeting atopic itch.

The current treatment landscape for atopic dermatitis includes several medications across different regions, with the U.S. market featuring DUPIXENT, OPZELURA, RINVOQ, EUCRISA, CIBINQO, and ADBRY/ADTRALZA. EUCRISA, a phosphodiesterase 4 inhibitor approved in December 2016, is specifically indicated for mild to moderate AD in patients aged three months and older. OPZELURA (ruxolitinib) cream, a topical JAK inhibitor approved in September 2021, is the first JAK inhibitor available in the U.S., joining two other oral JAK inhibitors for AD treatment. In Europe (EU4) and the UK, the market includes DUPIXENT, RINVOQ, CIBINQO, and ADBRY/ADTRALZA, while STAQUIS received marketing authorization in March 2020 but was withdrawn in January 2022 for commercial reasons. Japan's market mirrors that of the U.S. and EU with products like DUPIXENT and CIBINQO approved for moderate to severe AD. The recent approvals of CIBINQO and ADTRALZA in Japan provide hope for improved treatment options in a country with limited therapies for this chronic condition.

Conclusively, while the treatment of atopic itch is challenging, advancements in the last several years have provided multiple options ranging from topical agents to systemic therapies. In addition, newer treatments on the horizon hold great promise. Moreover, improved treatment of atopic itch will improve AD symptoms and the quality of life in many patients across 7MM.

• Among the 7MM, the US accounted for the largest market size of moderate-to-severe atopic dermatitis, i.e., approximately USD 7,100 of the overall market in 2023.
• Among EU4, Germany accounted for the highest market size in 2023 (i.e. USD 560 million), while the Spain occupied the lowest (i.e. USD 360 million).
• In 2034, among all the therapies, the highest revenue was generated by DUPIXENT in the 7MM.

Key Updates

• In November 2024, Aclaris Therapeutics entered into an exclusive license agreement with Biosion for worldwide rights.
• In October 2024, LEO Pharma presented the final results of the five-year extension study ECZTEND of ADBRY in adults and adolescent patients (aged 12 years and over) with moderate-to-severe atopic dermatitis at the Fall Clinical Dermatology Conference.
• In September 2024, Kyowa Kirin announced the top-line data from the Phase III ROCKET HORIZON trial for adults with moderate-to-severe atopic dermatitis.
• In September 2024, the data from the EBGLYSS ADjoin long-term extension study was presented at the EADV Congress.
• In September 2024, Eli Lilly and Company announced that the US FDA approved EBGLYSS (lebrikizumab) for the treatment of adults and children 12 years of age and older who weigh at least 88 pounds with moderate-to-severe atopic dermatitis that is not well controlled despite treatment with topical prescription therapies.
• In March 2024, Chugai Pharmaceutical announced that Maruho obtained regulatory approval from the MHLW for MITCHGA subcutaneous injection of 30 mg vials for the treatment of atopic dermatitis (children aged =6 and <13 years) in Japan.
• In February 2024, Galderma announced that the EMA accepted the MAA of MITCHGA for atopic dermatitis.

Moderate-to-severe Atopic Dermatitis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. The landscape of moderate-to-severe atopic dermatitis treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

Moderate-to-severe Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, Phase I/II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for GBM emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, PhD, Research Project Manager, Director, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or GBM market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Delveinsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the RWTH Aachen University Hospital, University of Valencia, Vall d'Hebron University Hospital, Drexel University, Saint Louis University, University of Birmingham, Juntendo University, Kyoto University, etc., were contacted. Their opinion helps understand and validate GBM epidemiology and market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial's primary and secondary outcome measures are evaluated.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

DUPIXENT (dupilumab)

DUPIXENT MyWay: It is a patient support program that can help access DUPIXENT and offers financial assistance to eligible patients, one-on-one nursing support, and more. DUPIXENT MyWay can assist with:

• Verifying patient's specific health plan coverage for DUPIXENT
• Determining Utilization Management (UM) criteria
• Identifying patient's possible out-of-pocket responsibilities
• Helping navigate any required prior authorization (PA) processes
• Educating patients about the appeals process if coverage is denied

Copay card: Eligible patients covered by commercial health insurance may pay as little as a USD 0* copay per fill of DUPIXENT (maximum of USD 13,000 per patient per calendar year). Patients may be eligible for the DUPIXENT MyWay copay card if they:

• Have commercial insurance
• Have a DUPIXENT prescription for an FDA-approved condition
• Are a resident of the 50 United States, the District of Columbia, Puerto Rico, Guam, or the USVI, and are a patient or caregiver aged 18 years or older.
• Approval is not guaranteed. Not valid for prescriptions paid, in whole or in part, by Medicaid, Medicare, VA, DOD, TRICARE, or other federal or state programs, including any state pharmaceutical assistance programs. This program is not valid where prohibited by law, taxed, or restricted. DUPIXENT MyWay reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use without notice.

Scope of the Report:

• The report covers a descriptive overview of moderate-to-severe atopic dermatitis, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into moderate-to-severe atopic dermatitis epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for moderate-to-severe atopic dermatitis is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the moderate-to-severe atopic dermatitis market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM moderate-to-severe atopic dermatitis market.

Moderate-to-severe Atopic Dermatitis Report Insights

• Patient Population
• Therapeutic Approaches
• Moderate-to-severe Atopic Dermatitis Pipeline Analysis
• Moderate-to-severe atopic dermatitis Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

Moderate-to-severe Atopic Dermatitis Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Moderate-to-severe Atopic Dermatitis Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Moderate-to-severe Atopic Dermatitis Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

• What was the moderate-to-severe atopic dermatitis market share (%) distribution in 2020 and what it would look like in 2034?
• What would be the moderate-to-severe atopic dermatitis total market size as well as market size by therapies across the 7MM during the study period (2020-2034)?
• Which country will have the largest moderate-to-severe atopic dermatitis market size during the study period (2020-2034)?
• What are the disease risks, burdens, and unmet needs of moderate-to-severe atopic dermatitis?
• What is the historical moderate-to-severe atopic dermatitis patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• What will be the growth opportunities across the 7MM concerning the patient population of moderate-to-severe atopic dermatitis?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of moderate-to-severe atopic dermatitis?
• What are the key collaborations (Industry-Industry, Industry), mergers and acquisitions, and licensing activities related to moderate-to-severe atopic dermatitis therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the clinical studies going on for moderate-to-severe atopic dermatitis and their status?
• What are the key designations that have been granted for the emerging therapies for moderate-to-severe atopic dermatitis?

Reasons to buy:

• The report will help in developing business strategies by understanding trends shaping and driving moderate-to-severe atopic dermatitis.
• To understand the future market competition in the moderate-to-severe atopic dermatitis market and an insightful review of the SWOT analysis of moderate-to-severe atopic dermatitis.
• Organize sales and marketing efforts by identifying the best opportunities for moderate-to-severe atopic dermatitis in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the moderate-to-severe atopic dermatitis market.
• To understand the future market competition in the moderate-to-severe atopic dermatitis market.