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시장보고서
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아토피 피부염 : 시장 인사이트, 역학 및 예측(2036년)Atopic Dermatitis - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
G7 국가들의 아토피 피부염 시장 규모 및 전망
본 아토피 피부염 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 또한, 아토피 피부염 환자의 부담 추이, 수익 및 시장 점유율 추이, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가하고, 전 세계 각 지역 시장 규모에 대한 상세한 평가와 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 아토피 피부염 분야의 주요 미충족 수요 사항에 초점을 맞추어, 경쟁 구도와 임상 현황을 분석함으로써 고부가가치 기회를 도출하는 한편, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
아토피 피부염 유병률 증가
특히 여성을 중심으로 아토피 피부염의 전반적인 유병률이 증가하고 있는 것이 아토피 피부염 시장의 확장을 이끄는 주요 요인이 되고 있습니다. 미국에서는 2025년에 약 3,312만 건의 아토피 피부염 확진 사례가 있었으며, 2036년까지는 이 수치가 더욱 증가할 것으로 전망됩니다.
아토피 피부염 치료 기회의 확대
최근 RINVOQ, CIBINQO, OPZELURA와 같은 JAK 억제제가 승인된 것은 이 적응증에 대한 JAK 억제제를 개발 중인 다른 주요 기업들에게 한 줄기 희망이 되고 있습니다. 이러한 약제 중에는 블랙박스 경고가 첨부된 제품도 있어, DUPIXENT와 대등한 경쟁을 펼치며 시장에서 상당한 점유율을 확보할 가능성이 있기 때문입니다.
젊은 층의 진단 건수가 증가함에 따라, 소아 및 사춘기 환자에게 최적화된 치료법, 특히 장기적인 안전성에 중점을 둔 생물학적 제제는 큰 잠재력을 가지고 있습니다. 일반적인 인지도 제고, 의료 서비스 접근성 개선, 보험 적용 및 재정적 지원에 힘입어 아토피 피부염 및 가려움증 시장이 활성화되고, 신약 시장 진입이 촉진될 가능성이 있습니다.
아토피 피부염의 개요와 진단
아토피 피부염(습진이라고도 함)은 만성 질환이며, 가장 흔한 피부 염증 중 하나입니다. 일반적으로 유아기에 발병하지만, 어떤 연령대에서든 발병할 가능성이 있으며, 평생에 걸쳐 재발하거나 지속될 수 있습니다. '피부염(dermatitis)'이라는 단어에서 'derm'은 '피부'를, 'itis'는 '염증'을 의미합니다. 따라서 피부염이란 유전적 요인, 면역계의 과잉 반응, 감염증, 알레르기, 자극 물질에 의해 유발되며, 가려움증, 발적, 발진을 특징으로 하는 피부의 염증입니다. 중등도에서 중증의 습진 환자 중 절반은 천식, 꽃가루 알레르기(알레르기성 비염), 식품 알레르기도 동반하고 있으며, 소아에게서 가장 흔한 만성 피부 질환입니다.
아토피 피부염의 진단
아토피 피부염에는 특이적인 검사가 없기 때문에 임상적으로 진단됩니다. 진단은 특징적인 소견, 특히 가려움증(필수), 만성 또는 재발성 습진성 병변, 전형적인 분포 양상(예 : 영아의 경우 안면 및 신측, 나이가 더 많은 소아나 성인의 경우 굴측), 그리고 환자 본인이나 가족의 아토피 병력을 바탕으로 다른 질환을 배제한 후 이루어집니다.
또한, 환자에게는 피부 건조, 긁힌 자국, 구진, 각질화 등이 나타날 수도 있습니다. 가려움증이 나타나지 않는 경우에는 진단을 재검토해야 합니다. 아토피 피부염은 각질이 동반되는 다른 피부 질환(예 : 영아의 지루성 피부염)과 감별해야 합니다. 치료에 반응이 없는 경우에는 영양 장애, 대사 장애, 면역학적 질환 등 다른 진단 가능성을 검토해야 합니다. IgE 수치의 상승은 흔히 관찰되지만, 진단을 내리는 결정적인 근거가 되지는 않습니다. 피부 생검이나 미생물학적 검사는 다른 질환이나 이차적인 병태를 배제하는 데 도움이 될 수 있지만, 아토피 피부염의 확정 진단이 되지는 않습니다.
아토피 피부염의 치료
아토피 피부염 치료의 주요 목표는 염증과 가려움을 완화하고, 피부 장벽 기능을 회복 및 유지하며, 증상 악화를 예방하고, 감염을 최소화하며, 삶의 질과 수면을 개선하는 것입니다. 치료는 단계적으로 진행되며 여러 전문직 간의 협력을 바탕으로, 약물 요법과 지지 요법을 중심으로 이루어집니다. 기초 치료법에는 피부 보습을 유지하기 위한 에몰리언트제의 정기적인 사용과, 증상이 악화되었을 때 1차 선택이 되는 항염증 치료인 외용 코르티코스테로이드가 포함됩니다. 또한, 민감한 부위나 장기적인 관리에는 외용 칼시뉴린 억제제(예 : 타크로리무스, 피메클로리무스)나 포스포디에스테라제 4(PDE4) 억제제가 사용됩니다.
중등도에서 중증의 경우나, 외용 요법에 대한 반응이 불충분한 경우에는 전신 치료가 시행됩니다. 여기에는 제2형 염증을 표적으로 하는 듀필마브나 트랄로키누맙 등의 생물학적 제제, 그리고 가려움증과 염증을 신속하게 억제하는 경구용 야누스 키나제(JAK) 억제제(예 : 우파다시티닙, 아브로시티닙)이 포함되지만, 안전성 위험에 대한 모니터링이 필요합니다. 보조 요법으로는 가려움증 완화를 위한 항히스타민제(효과는 제한적), 2차 감염에 대한 항균제 치료, 그리고 적응증이 있는 환자에 대한 광선 요법 등이 있습니다.
아토피 피부염의 역학 분석 및 예측에 관한 주요 조사 결과
아토피 피부염 환자의 대부분은 피부 연화제나 처방전을 통한 외용 요법으로 증상을 충분히 조절할 수 있습니다. 한편, 증상이 더 심각하거나 광범위하게 나타나는 아토피 피부염 환자, 삶의 질(QOL)이 현저히 저하된 환자, 그리고 최적화된 외용 요법에 반응하지 않는 환자는 질환을 조절하고 삶의 질을 개선하기 위해 광선 요법이나 전신 요법의 사용을 고려할 수 있습니다.
최근 몇 년간 아토피 피부염 환자를 위한 몇 가지 효과적인 치료법이 이용 가능해졌으며, 더 많은 치료법이 개발 중에 있습니다. 현재 시장에서는 약리학적 전신 요법과는 별도로, 몇 가지 적응증 외 요법이 사용되고 있습니다. 국소성 아토피 피부염으로 인한 가려움증에는 국소 요법이나 병변 내 주사를 통한 치료제가 자주 사용됩니다. 국소 코르티코스테로이드는 수십년동안 아토피 피부염 치료에 사용되어 왔습니다. 국소 칼시뉴린 억제제인 피메클로리무스와 타크로리무스는 아토피 피부염 환자의 스테로이드 사용량을 줄이는 약물로 사용되고 있습니다. 포스포디에스테라제-4(PDE-4) 억제제는 아토피 피부염에 수반되는 가려움증의 국소 치료에 있어 대안 중 하나입니다. 경구용 항히스타민제는 아토피 피부염에 따른 가려움증 치료에 일반적으로 사용됩니다. 또한, 광선 요법도 아토피 피부염에 수반되는 가려움증에 효과적입니다. 국소 치료에 반응하지 않는 환자의 경우, 전신 약물 치료가 유익하다는 것이 입증되었습니다.
FDA가 아토피 피부염에 대해 최초로 승인한 표적 지향적 전신 치료제는 IL-4 및 IL-13 신호 전달을 억제하는 인간 단일클론 항체인 '듀픽센트(듀필마브)'입니다. 듀필루맙은 처방된 외용 요법만으로는 증상을 충분히 조절할 수 없거나, 해당 요법의 사용이 권장되지 않는 중등도 내지 중증의 아토피 피부염을 앓고 있는 성인 및 생후 6개월 이상의 소아 환자의 치료에 적응증이 있습니다. 이 약제는 2017년에 유럽연합(EU)에서 2018년에는 일본에서 승인되었습니다.
2021년 12월, 트랄로키누맙(ADBRY/ADTRALZA)은 미국에서 아토피 피부염 치료제로 승인된 두 번째 생물학적 제제가 되었으며, 특히 IL-13을 표적으로 하는 최초의 치료제가 되었습니다. 트라로키누맙은 처방전이 필요한 외용제 치료만으로는 증상을 충분히 조절할 수 없거나, 해당 치료법의 사용이 권장되지 않는 12세 이상의 환자를 대상으로, 중등도에서 중증의 아토피 피부염 치료에 적응증이 있습니다.
애비(AbbVie)사의 'RINVOQ'는 아토피 피부염 시장에서 강력한 성장세를 보이고 있으며, 이는 DUPIXENT와의 직접 비교 임상시험에서 EASI-90 및 최소 가려움증과 같은 엄격한 평가 지표에서 통계적으로 유의미한 우월성이 입증된 데 기인합니다. 이러한 결과를 바탕으로 'RINVOQ'는 시장에서 2위의 점유율을 차지하는 주요 치료제로서의 입지를 확고히 했습니다.
생물학적 제제와 JAK 억제제는 아토피 피부염 치료의 혁신을 주도하고 있으며, 생물학적 제제는 1차 전신 요법으로서 확고한 입지를 다지고 있습니다. 한편, 경구용 저분자 약제는 그 편의성, 신속한 효과, 그리고 더 폭넓은 환자층에 대한 적용 가능성 덕분에 2022년부터 2036년까지의 예측 기간 동안 향후 시장 성장을 주도할 것으로 전망됩니다.
Atopic Dermatitis Market Size and Forecast in the 7MM
DelveInsight's 'Atopic Dermatitis - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the Atopic Dermatitis, historical and forecasted epidemiology, as well as the atopic dermatitis market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The atopic dermatitis market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates atopic dermatitis patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in atopic dermatitis and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.
Key Factors Driving the Atopic Dermatitis Market
Rising Atopic Dermatitis Prevalence
The overall prevalence of atopic dermatitis increasing, particularly among females, is a primary driver of atopic dermatitis market expansion. In the US, there were ~33,120, 000 diagnosed prevalent cases of atopic dermatitis in 2025, which is projected to increase by 2036.
Rising Opportunities in Atopic Dermatitis
Recent approvals of JAK inhibitors like RINVOQ, CIBINQO, and OPZELURA has given a ray of hope to other key players developing JAKs for this indication, as even though they come with a black box warning, these drugs could give fair competition to DUPIXENT, and take up a good share of the market.
With increasing diagnoses in younger populations, there is significant potential for therapies tailored to children and adolescents, particularly long-term safety-focused biologics. Increased public awareness, improved access to health services, reimbursements, and financial support may boost the atopic dermatitis and pruritus in the market and improve the market accessibility of the emerging drugs.
Emerging Atopic Dermatitis Competitive Landscape
Some of the topic dermatitis drugs in clinical trials include Rocatinlimab, Amlitelimab, Orismilast, Ucenprubart, and others.
Atopic Dermatitis Overview and Diagnosis
Atopic dermatitis, also called eczema, is a chronic condition and the most common type of skin inflammation that usually starts in early childhood but can occur at any age and can be recurrent or persistent throughout life. In 'dermatitis,' 'derm' means 'skin,' and 'itis' means 'inflammation.' Thus, dermatitis is a skin inflammation characterized by itchiness, redness, and a rash caused by genetics, an overactive immune system, infections, allergies, and irritating substances. Half of the patients with moderate-to-severe eczema also have asthma, hay fever (allergic rhinitis), and food allergies; it is the most common chronic skin disease in children.
Atopic Dermatitis Diagnosis
Atopic dermatitis is diagnosed clinically, as there is no specific laboratory test. Diagnosis is based on characteristic features especially pruritus (essential), chronic or relapsing eczematous lesions, typical distribution patterns (e.g., face/extensor areas in infants, flexural areas in older children and adults), and a personal or family history of atopy along with exclusion of other conditions.
Patients may also present with dry skin, excoriations, papules, and lichenification. Absence of itching should prompt reconsideration of the diagnosis. Atopic dermatitis must be differentiated from other scaly skin disorders (e.g., seborrheic dermatitis in infants). If treatment fails, alternative diagnoses, including nutritional, metabolic, or immunologic conditions, should be evaluated. Elevated IgE levels are common but are not diagnostic. Skin biopsy and microbiological tests may help rule out other or secondary conditions but are not definitive for atopic dermatitis.
Atopic Dermatitis Treatment
The primary goals of atopic dermatitis treatment are to reduce inflammation and pruritus, restore and maintain the skin barrier, prevent flares, minimize infections, and improve quality of life and sleep. Management is stepwise and multidisciplinary, centered on pharmacologic and supportive care. Foundational therapy includes regular use of emollients to maintain skin hydration and topical corticosteroids as first-line anti-inflammatory treatment during flares, with topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) or phosphodiesterase-4 inhibitors used for sensitive areas or long-term control.
For moderate-to-severe disease or inadequate response to topical therapy, systemic treatments are used, including biologics such as dupilumab and tralokinumab targeting type 2 inflammation, and oral Janus kinase (JAK) inhibitors (e.g., upadacitinib, abrocitinib) for rapid itch and inflammation control, though they require monitoring for safety risks. Adjunctive measures include antihistamines for itch relief (limited benefit), antimicrobial therapy for secondary infections, and phototherapy in appropriate patients.
Atopic Dermatitis Unmet Needs
The section "unmet needs of Atopic Dermatitis" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.
Comprehensive unmet needs insights in atopic dermatitis and their strategic implications are provided in the full report.
Key Findings from Atopic Dermatitis Epidemiological Analysis and Forecast
Atopic Dermatitis Drug Chapters & Competitive Analysis
The Atopic dermatitis drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the atopic dermatitis treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the atopic dermatitis therapeutics market.
Approved Therapies for Atopic Dermatitis
Upadacitinib (RINVOQ): AbbVie
RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. Recently, the company announced topline results of LEVEL UP studies, in Phase III/IV and plans to present results from the LEVEL UP study at a future medical congress.
In January 2022, AbbVie announced that the US FDA approved RINVOQ (upadacitinib) for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when the use of other pills or injections is not recommended
Atopic Dermatitis Pipeline Analysis
Amlitelimab (KY1005): Sanofi
Amlitelimab (SAR445229, KY1005) is a fully human, non-T cell depleting monoclonal antibody that blocks OX40L, a key immune regulator. With its novel mechanism of action, amlitelimab aims to normalize the overactive immune system, without depleting T cells. It has the potential to be a first- or best-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including the anchor indication of moderate-to-severe atopic dermatitis.
As per the Q4 2026 presentation, the company plans to release the remaining Phase III data in H2 2026 and is also targeting regulatory submission within the same timeframe.
Atopic Dermatitis Key Players, Market Leaders and Emerging Companies
Atopic Dermatitis Drug Updates
Drug Class Insights
For most people with atopic dermatitis, emollients and prescription topical therapies are sufficient to achieve control. In contrast, people with more severe or widespread atopic dermatitis, people with substantially impaired QoL, and individuals whose atopic dermatitis is refractory to optimized topical therapy may consider the use of phototherapy or systemic therapies to improve disease control and QOL.
Several effective treatments have become available in recent years for patients with atopic dermatitis, and more are in development. 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 atopic dermatitis for decades. Pimecrolimus and tacrolimus, topical calcineurin inhibitors, are used as steroid-sparing agents for patients with atopic dermatitis. Phosphodiesterase-4 (PDE-4) inhibitors are an alternative option for the topical treatment of pruritis in atopic dermatitis. Oral antihistamines are commonly used for atopic itch. Additionally, phototherapy is efficacious in targeting atopic itch. Systemic pharmacologic treatments have proven to be beneficial in patients who are unresponsive to topical therapies.
The first FDA-approved targeted systemic treatment for atopic dermatitis was DUPIXENT (dupilumab), a human monoclonal antibody that inhibits IL-4 and IL-13 signaling. Dupilumab is indicated for the treatment of adult and pediatric patients 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when use of those therapies is not advisable. The drug was approved in the European Union in 2017, as well as in Japan in 2018.
In December 2021, tralokinumab (ADBRY/ADTRALZA) became the second biologic indicated for the treatment of atopic dermatitis and the first treatment to target IL-13 in the US specifically. Tralokinumab is indicated for the treatment of moderate-to-severe atopic dermatitis in patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when use of those therapies is not advisable.
AbbVie's RINVOQ has gained strong traction in the atopic dermatitis market, supported by head-to-head trials versus DUPIXENT demonstrating statistically significant superiority on stringent endpoints such as EASI-90 and minimal itch. These results have positioned RINVOQ as a leading therapy, ranking second in the market.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Atopic Dermatitis (2022-2036 Forecast)
The atopic dermatitis market comprises targeted biologics, oral small molecules, topical therapies, and emerging immune-modulating approaches, each addressing distinct inflammatory pathways such as type 2 cytokine signaling, JAK-STAT pathways, and skin barrier dysfunction underlying atopic dermatitis.
Biologics and JAK inhibitors together define the core innovation landscape in atopic dermatitis, with biologics firmly established as first-line systemic therapies and oral small molecules driving future market expansion through convenience, rapid efficacy, and broader patient applicability during the 2022-2036 forecast period.
Atopic Dermatitis Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the atopic dermatitis market's uptake by drugs, patient uptake by therapy, and sales of each drug.
The uptake of therapies in atopic dermatitis is expected to vary across targeted biologics, oral small-molecule inhibitors, and topical agents. Recently approved and emerging targeted therapies such as dupilumab (DUPIXENT), tralokinumab (ADTRALZA), and upadacitinib (RINVOQ) demonstrate strong and sustained uptake, while lebrikizumab is anticipated to show progressive and competitive uptake, supported by their targeted mechanisms, robust efficacy in moderate-to-severe disease, and increasing physician confidence in biologic and JAK inhibitor use. Their adoption is primarily driven by the limitations of conventional topical corticosteroids and systemic immunosuppressant's in achieving long-term disease control, as well as the growing demand for therapies that provide rapid itch relief and durable skin clearance.
In comparison, other next-generation therapies such as Abrocitinib (CIBINQO) and Baricitinib are expected to show gradual but steady uptake as long-term safety data matures and their positioning becomes clearer within treatment algorithms. Additionally, novel agents like Nemolizumab and emerging OX40 pathway inhibitors are projected to gain traction over the forecast period, particularly in patients with persistent pruritus or inadequate response to existing biologics, further diversifying the atopic dermatitis treatment landscape.
Market Access and Reimbursement of Atopic Dermatitis
Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.
Atopic Dermatitis Therapies Price Scenario & Trends
Pricing and analogue assessment of atopic dermatitis therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.
The wholesale acquisition cost (WAC) of DUPIXENT subcutaneous solution 300 mg/2 mL in 2020 was USD 3,171, resulting in an annual cost of USD 42,809.
Further details are provided in the final report....
Industry Experts and Physician Views for Atopic Dermatitis
To keep up with atopic dermatitis market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the atopic dermatitis emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in atopic dermatitis, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University of North Carolina at Chapel Hill, Berlin Institute of Health at Charite, and the University of Nottingham, etc. were contacted. Their opinion helps understand and validate current and emerging atopic dermatitis therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in atopic dermatitis.
Qualitative Analysis: SWOT and Conjoint Analysis
We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.
In the SWOT analysis of Atopic Dermatitis, 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.
Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
The team of analysts analyzes promising 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, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Insights