結節性痒疹 - 市場考察、疫学、市場予測（2034年）

主なハイライト

• 主要7市場の結節性痒疹の市場規模は、2023年に約6億9,000万米ドルであり、予測期間に大幅なCAGRで増加すると予測されます。
• 主要7市場中で結節性痒疹の市場規模がもっとも大きいのは米国であり、2023年の市場全体の約76%を占めています。
• 主要7市場の結節性痒疹と診断された総患者数は2023年に最大60万9,254人であり、そのうちこの疾患の患者数がもっとも多いのは米国でした。
• 結節性痒疹の各性別の症例数は、2023年に男性が最大28万8,607人であったのに対し、女性は最大32万647人でした。
• DUPIXENT（dupilumab）とNEMLUVIO（nemolizumab）は結節性痒疹の新治療法です。DUPIXENTはIL-4およびIL-13サイトカインを標的として炎症とかゆみを軽減し、NEMLUVIOはIL-31を標的として強いかゆみを軽減します。両剤とも、中等度から重度の症例に有効な選択肢を提供し、症状や生活の質を改善します。
• Rocatinlimab（Amgen/Kyowa Kirin）、PovorcitinibとRuxolitinib（Incyte）、Barzolvolimab（Celldex）、Vixarelimab（Kiniksa/Genentech）などの主要企業は、それぞれ異なる臨床開発段階でリード候補を評価しており、予測期間（2024年～2034年）に結節性痒疹市場に大きな影響を与える見込みです。
• 結節性痒疹の市場力学は、診断手法の改善、疾患に対する認知度の向上、世界中での医療費の増加により、今後数年間で変化すると予測されます。

結節性痒疹市場の見通し

結節性痒疹は、持続的な掻破や摩擦によって生じる、硬くて痒みのある隆起（結節）を特徴とする慢性皮膚疾患です。結節は通常、腕、脚、腹部、背中などにできますが、まれに手のひら、足の裏、顔にもできます。痒みと掻破の繰り返しが症状を悪化させ、新たな結節や瘢痕形成につながります。治療は、この痒みと掻破のサイクルを断ち切り、治癒を促進することに重点を置きます。

結節性痒疹の治療情勢は近年進化しており、慢性的で衰弱しやすい疾患であることから製薬産業からの注目も高まっています。疾患を悪化させる持続的な痒みと掻破のサイクルを断ち切る効果的な治療法の必要性が認識されつつあります。

結節性痒疹の治療は、痒みと炎症を和らげることに重点を置いています。皮膚の炎症とかゆみを抑えるために、強力なステロイドクリームを含む局所用コルチコステロイドが一般的に処方されます。ステロイド以外の選択肢であるタクロリムス軟膏も炎症を抑えるのに役立ちます。患部に絆創膏やフィルムを貼ることで、ステロイドの効果を高め、過剰な掻破を防ぐことができます。エモリエント剤は乾燥した皮膚に潤いを与え、その他の治療の効果を高めるために重要です。抗ヒスタミン薬、特にフェキソフェナジンのような鎮静作用のないタイプはかゆみを和らげるのに役立ちます。UVB/UVA治療などの光線療法は、結節やかゆみを軽減します。ストレスや精神的苦痛の管理には心理的サポートが有効で、重症例には経口コルチコステロイド、ciclosporin、methotrexate、azathioprineなどの免疫抑制療法が用いられます。

• 主要7市場で結節性痒疹の市場規模がもっとも大きかったのは米国で、2023年に最大5億2,320万米ドルでした。
• 欧州4ヶ国・英国では、ドイツが2023年にもっとも大きな市場規模を持ち、スペインはもっとも小さいです。
• 結節性痒疹のパイプラインは限られており、ヤヌスキナーゼ阻害薬（JAK）、KIT拮抗薬、オンコスタチンM受容体βサブユニット阻害薬などの治療薬で構成されています。

当レポートでは、結節性痒疹の主要7市場（米国、ドイツ、スペイン、イタリア、フランス、英国、日本）について調査分析し、各地域の市場規模、現在の治療法、アンメットニーズ、新薬などの情報を提供しています。

目次

第1章 重要考察

第2章 レポートのイントロダクション

第3章 エグゼクティブサマリー

第4章 重要な出来事

第5章 疫学と市場予測の調査手法

第6章 結節性痒疹市場の概要

• 結節性痒疹の市場シェアの分布：治療法別（2023年）
• 結節性痒疹の市場シェアの分布：治療法別（2034年）

第7章 疾患の背景と概要

• イントロダクション
• 分類
• 臨床的兆候と症状
• 病態生理学
• 診断
• 鑑別診断
• 病因
• 治療と管理
  • 治療アルゴリズム

第8章 ガイドライン

• 結節性痒疹ガイドライン：米国（2022年）
• 結節性痒疹IFSIガイドライン：欧州（2020年）
• 結節性痒疹ガイドライン：日本（2020年）

第9章 主要7市場の結節性痒疹の疫学と患者人口

• 主な調査結果
• 前提条件と根拠
• 主要7市場の結節性痒疹と診断された総患者数
• 米国
• 欧州4ヶ国・英国
• 日本

第10章 ペイシェントジャーニー

第11章 上市済み薬品

• 主な競合
• NEMLUVIO/MITCHGA（nemolizumab-ilto）：Galderma Laboratories/Maruho
  • 製品の説明
  • 規制のマイルストーン
  • その他の開発活動
  • 臨床開発
  • 安全性と有効性
• DUPIXENT（dupilumab）：Sanofi/Regeneron

第12章 新薬

• 主な競合
• Povorcitinib：Incyte
  • 製品の説明
  • その他の開発活動
  • 臨床開発
  • 安全性と有効性
• Ruxolitinib：Incyte
• Rocatinlimab：Amgen/Kyowa Kirin
• Barzolvolimab（CDX-0159）：Celldex Therapeutics
• Vixarelimab：Kiniksa Pharmaceuticals/Genentech

第13章 結節性痒疹：主要7市場の分析

• 主な調査結果
• 市場見通し
• 主な市場予測の前提条件
  • コストの想定とリベート
  • 価格動向
  • アナログの評価
  • 発売年と治療の普及
• コンジョイント分析
• 主要7市場の結節性痒疹の総市場規模
• 主要7市場の結節性痒疹の市場規模：治療法別
• 米国の市場規模
  • 米国の結節性痒疹の総市場規模
  • 米国の結節性痒疹の市場規模：治療法別
• 欧州4ヶ国・英国の市場規模
  • 欧州4ヶ国・英国の結節性痒疹の総市場規模
  • 欧州4ヶ国・英国の結節性痒疹の市場規模：治療法別
• 日本の市場規模
  • 日本の結節性痒疹の総市場規模

第14章 アンメットニーズ

第15章 SWOT分析

第16章 KOLの見解

第17章 市場参入と償還

• 米国
• 欧州4ヶ国・英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • 英国
• 日本
• 結節性痒疹の市場参入と償還

第18章 付録

第19章 DelveInsightのサービス内容

第20章 免責事項

第21章 DelveInsightについて

List of Tables

• Table 1: Summary of Prurigo Market, and Epidemiology (2020-2034)
• Table 2: Diagnostic Workshop
• Table 3: Recommendations Suggested Regimens for Topical and Systemic Medication for Prurigo Nodularis
• Table 4: Used Wording Regarding the Level of Study Quality, Recommendations, and Strength of Consensus
• Table 5: Diagnostic Approach of CPG
• Table 6: Therapy Approach of CPG
• Table 7: Total Diagnosed Prevalent Cases of Prurigo Nodularis in the 7MM (2020-2034)
• Table 8: Total Diagnosed Prevalent Cases of Prurigo Nodularis in the United States (2020-2034)
• Table 9: Gender-specific Diagnosed Prevalent Cases of Prurigo Nodularis in the United States (2020-2034)
• Table 10: Age-specific Diagnosed Prevalent Cases of Prurigo Nodularis in the United States (2020-2034)
• Table 11: Severity-specific Diagnosed Prevalent Cases of Prurigo Nodularis in the United States (2020-2034)
• Table 12: Total Diagnosed Prevalent Cases of Prurigo Nodularis in EU4 and the UK (2020-2034)
• Table 13: Gender-specific Diagnosed Prevalent Cases of Prurigo Nodularis in EU4 and the UK (2020-2034)
• Table 14: Age-specific Diagnosed Prevalent Cases of Prurigo Nodularis in EU4 and the UK (2020-2034)
• Table 15: Severity-specific Diagnosed Prevalent Cases of Prurigo Nodularis in EU4 and the UK (2020-2034)
• Table 16: Total Diagnosed Prevalent Cases of Prurigo Nodularis in Japan (2020-2034)
• Table 17: Gender-specific Diagnosed Prevalent Cases of Prurigo Nodularis in Japan (2020-2034)
• Table 18: Age-specific Diagnosed Prevalent Cases of Prurigo Nodularis in Japan (2020-2034)
• Table 19: Severity-specific Diagnosed Prevalent Cases of Prurigo Nodularis in Japan (2020-2034)
• Table 20: Key Cross of Marketed Drug
• Table 21: NEMLUVIO/MITCHGA (nemolizumab-ilto), Clinical Trial Description, 2024
• Table 22: DUPIXENT (dupilumab), Clinical Trial Description, 2024
• Table 23: Comparison of Emerging Drugs Under Development
• Table 24: Povorcitinib, Clinical Trial Description, 2024
• Table 25: Ruxolitinib, Clinical Trial Description, 2024
• Table 26: Rocatinlimab, Clinical Trial Description, 2024
• Table 27: Barzolvolimab, Clinical Trial Description, 2024
• Table 28: Vixarelimab, Clinical Trial Description, 2024
• Table 29: Key Market Forecast Assumption of Current Treatment Options in Prurigo Nodularis in the 7MM
• Table 30: Key Market Forecast Assumption of Prurigo Nodularis in the US
• Table 31: Key Market Forecast Assumption of Prurigo Nodularis in EU4 and the UK
• Table 32: Key Market Forecast Assumption of Prurigo Nodularis in Japan
• Table 33: Total Market Size of Prurigo Nodularis in the 7MM, in USD million (2020-2034)
• Table 34: Market Size of Prurigo Nodularis by Therapies in the 7MM, in USD million (2020-2034)
• Table 35: Total Market Size of Prurigo Nodularis in the United States, in USD million (2020-2034)
• Table 36: Market Size of Prurigo Nodularis by Therapies in the United States, in USD million (2020-2034)
• Table 37: Total Market Size of Prurigo Nodularis in EU4 and the UK, in USD million (2020-2034)
• Table 38: Market Size of Prurigo Nodularis by Therapies in EU4 and the UK, in USD million (2020-2034)
• Table 39: Total Market Size of Prurigo Nodularis in Japan, in USD million (2020-2034)
• Table 40: Market Size of Prurigo Nodularis by Therapies in Japan, in USD million (2020-2034)
• Table 41: IQWiG Assessment for Prurigo Nodularis Therapies
• Table 42: Haute Autorite de Sante (HAS) Decisions for Prurigo Nodularis Therapies
• Table 43: AIFA Assessment for Prurgio Nodularis Therapies
• Table 44: BaseCase - Cost-Effectiveness Results with Lifetime Time Horizon
• Table 45: AEMPS Assessment for Therapies in Prurigo Nodularis

List of Figures

• Figure 1: Clinical Diagonsis of Prurigo Nodularis
• Figure 2: Symptoms of Prurigo Nodularis
• Figure 3: Overview of the Mechanism of Prurigo Nodularis
• Figure 4: Laboratory Diagnostic Approach to the Patient Suspected of Having Prurigo Nodularis
• Figure 5: Etiology of Prurigo Nodules
• Figure 6: Immunomodulating Treatments of Current and Promising Therapeutic Targets in Prurigo Nodularis
• Figure 7: Treatment Algorithm of Prurigo Nodularis
• Figure 8: Total Diagnosed Prevalent Cases of Prurigo Nodularis in the 7MM (2020-2034)
• Figure 9: Total Diagnosed Prevalent Cases of Prurigo Nodularis in the United States (2020-2034)
• Figure 10: Gender-specific Diagnosed Prevalent Cases of Prurigo Nodularis in the United States (2020-2034)
• Figure 11: Age-specific Diagnosed Prevalent Cases of Prurigo Nodularis in the United States (2020-2034)
• Figure 12: Severity-specific Diagnosed Prevalent Cases of Prurigo Nodularis in the United States (2020-2034)
• Figure 13: Total Diagnosed Prevalent Cases of Prurigo Nodularis in EU4 and the UK (2020-2034)
• Figure 14: Gender-specific Diagnosed Prevalent Cases of Prurigo Nodularis in EU4 and the UK (2020-2034)
• Figure 15: Age-specific Diagnosed Prevalent Cases of Prurigo Nodularis in EU4 and the UK (2020-2034)
• Figure 16: Severity-specific Diagnosed Prevalent Cases of Prurigo Nodularis in EU4 and the UK (2020-2034)
• Figure 17: Total Diagnosed Prevalent Cases of Prurigo Nodularis in Japan (2020-2034)
• Figure 18: Gender-specific Diagnosed Prevalent Cases of Prurigo Nodularis in Japan (2020-2034)
• Figure 19: Age-specific Diagnosed Prevalent Cases of Prurigo Nodularis in Japan (2020-2034)
• Figure 20: Severity-specific Diagnosed Prevalent Cases of Prurigo Nodularis in Japan (2020-2034)
• Figure 21: Total Market Size of Prurigo Nodularis in the 7MM (2020-2034)
• Figure 22: Market Size of Prurigo Nodularis by Therapies in the 7MM (2020-2034)
• Figure 23: Total Market Size of Prurigo Nodularis in the United States (2020-2034)
• Figure 24: Market Size of Prurigo Nodularis by Therapies in the United States (2020-2034)
• Figure 25: Total Market Size of Prurigo Nodularis in EU4 and the UK (2020-2034)
• Figure 26: Market Size of Prurigo Nodularis by Therapies in EU4 and the UK (2020-2034)
• Figure 27: Total Market Size of Prurigo Nodularis in Japan (2020-2034)
• Figure 28: Market Size of Prurigo Nodularis by Therapies in Japan (2020-2034)
• Figure 29: Health Technology Assessment
• Figure 30: Reimbursement Process in Germany
• Figure 31: Reimbursement Process in France
• Figure 32: Reimbursement Process in Italy
• Figure 33: Reimbursement Process in Spain
• Figure 34: Reimbursement Process in the United Kingdom
• Figure 35: Reimbursement Process in Japan

Key Highlights:

• The market size of prurigo nodularis in the 7MM was around USD 690 million in 2023 and is expected to increase with a significant CAGR during the forecast period.
• Among the 7MM, the United States accounted for the largest market size of prurigo nodularis, i.e., approximately 76% of the overall market in 2023.
• The total diagnosed prevalent cases of prurigo nodularis in the 7MM were ~ 609,254 in 2023, out of which the highest prevalent cases of this disease were in the United States.
• The gender-specific cases of prurigo nodularis in the 7MM were majorly contributed by female with almost ~ 320,647 cases, compared to male with ~ 288,607 cases in 2023.
• DUPIXENT (dupilumab) and NEMLUVIO (nemolizumab) are new treatments for prurigo nodularis. DUPIXENT targets IL-4 and IL-13 cytokines, reducing inflammation and itching, while NEMLUVIO targets IL-31 to alleviate severe itching. Both drugs offer effective options for managing moderate-to-severe cases, improving symptoms and quality of life.
• Key players such as Rocatinlimab (Amgen/Kyowa Kirin), Povorcitinib and Ruxolitinib (Incyte), Barzolvolimab (Celldex), and Vixarelimab (Kiniksa/Genentech), and others are evaluating their lead candidates in different stages of clinical development, respectively and will significantly impact the prurigo nodularis market during the forecast period (2024-2034).
• The dynamics of the prurigo nodularis market are anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, raising awareness of the disease, and incremental healthcare spending across the world.

DelveInsight's "Prurigo Nodularis - Market Insight, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of prurigo nodularis, historical and forecasted epidemiology as well as the prurigo nodularis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The prurigo nodularis market report provides current treatment practices, emerging drugs, prurigo nodularis market share of individual therapies, and current and forecasted prurigo nodularis market size from 2020 to 2034, segmented by seven major markets. The report also covers current prurigo nodularis 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

Prurigo Nodularis Disease Understanding and Treatment Algorithm

Prurigo Nodularis Overview

Prurigo nodularis is a chronic skin disorder characterized by the appearance of multiple, firm, itchy nodules on the skin, which are often the result of repetitive scratching or rubbing. These nodules can range in size and are typically found on areas like the arms, legs, back, and chest. The primary symptom of prurigo nodularis is intense pruritus (itching), which causes individuals to scratch, further aggravating the lesions and leading to thickened, scaly, or hyperpigmented skin. In severe cases, the nodules can ulcerate or become infected due to ongoing friction and trauma.

The exact cause of prurigo nodularis remains unclear, but it is frequently associated with a variety of underlying conditions such as atopic dermatitis, chronic kidney disease, liver disease, and neuropsychiatric disorders like anxiety or depression. The condition often presents as a manifestation of immune system dysregulation, chronic inflammation, and nerve involvement. Prurigo nodularis can significantly impact an individual's quality of life, as the persistent itching and skin lesions can interfere with daily activities, sleep, and emotional well-being.

Prurigo Nodularis Diagnosis

The diagnosis of prurigo nodularis is primarily clinical, based on the characteristic appearance of itchy, raised nodules on the skin. A healthcare provider will typically assess the patient's medical history, including any underlying conditions such as atopic dermatitis, kidney disease, or mental health issues that may contribute to the development of prurigo nodularis. A physical examination is conducted to evaluate the number, size, and location of the nodules, which are typically found on the arms, legs, and torso.

In some cases, a skin biopsy may be performed to rule out other conditions, such as skin infections or malignancies, as the nodules may resemble other dermatologic disorders. Laboratory tests may also be conducted to assess for underlying systemic conditions, particularly in patients with suspected renal or hepatic disease. The diagnosis is often confirmed by the persistence of lesions and a pattern of intense itching, which is key in distinguishing prurigo nodularis from other dermatological conditions.

Prurigo Nodularis Treatment

The treatment of prurigo nodularis focuses on relieving the intense itching and inflammation, while addressing the underlying causes if identified. First-line treatments typically include topical therapies such as potent corticosteroids to reduce inflammation and suppress the immune response. Topical calcineurin inhibitors, like tacrolimus, may also be used as an alternative to steroids, particularly for sensitive areas. Emollients and moisturizing creams are recommended to maintain skin hydration and prevent further irritation.

For more severe cases, systemic treatments may be considered. Oral antihistamines can help reduce itching, while oral corticosteroids may be prescribed for short-term flare-ups. Immunosuppressive drugs like methotrexate, cyclosporine, or azathioprine are sometimes used to control inflammation in refractory cases. Phototherapy, specifically narrowband ultraviolet B (NB-UVB) light therapy, is another effective treatment option that can help improve symptoms by modulating immune function and reducing skin inflammation.

In cases where prurigo nodularis is associated with an underlying condition, such as kidney disease or psychiatric disorders, treating the primary illness may help alleviate the skin symptoms. Psychological support, including cognitive-behavioral therapy or counseling, may also benefit patients experiencing significant stress or anxiety related to the condition. Due to the chronic nature of PN, a combination of therapies is often required to achieve symptom control and improve the patient's quality of life.

Prurigo Nodularis Epidemiology

The prurigo nodularis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the Diagnosed Prevalent Cases of Prurigo Nodularis, Gender-specific Diagnosed Prevalent Cases of Prurigo Nodularis, Age-specific Diagnosed Prevalent Cases of Prurigo Nodularis, and Severity-specific Diagnosed Prevalent Cases of Prurigo Nodularis in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In the US, there were ~258,600 diagnosed prevalent cases of prurigo nodularis in 2020.
• In EU4 and the UK, the diagnosed prevalent cases of prurigo nodularis were ~94,900 in males and ~133,900 in females in 2023.
• In 2023, the diagnosed prevalent cases of prurigo nodularis in the UK were distributed across different age groups as follows: 1% of cases were in individuals under 15 years old, 2% in those aged 15-24, 10% in the 25-44 age group, 36% in individuals aged 45-64, and highest for 51% in those aged 65 and older.
• Moderate cases (~61,500) were most prevalent followed by mild (~42,700) and severe (~17,600) cases for the year 2023, in Japan.
• Patients with prurigo nodularis face many challenges, including delayed diagnosis or misdiagnosis due to lack of awareness by patients and providers; unpredictable disease course.

Marketed Drugs

NEMLUVIO/MITCHGA (nemolizumab-ilto): Galderma Laboratories/Maruho

NEMLUVIO is the first and only treatment that blocks IL-31 signaling, a key driver of itch, inflammation, and the formation of prurigo nodularis nodules, by relieving itch and reducing the urge to scratch, and allowing skin to heal. NEMLUVIO is intended for adults who have been diagnosed with prurigo nodularis. It is the only self-injectable treatment for prurigo nodularis that is administrated approximately once a month.

In August 2024, US FDA approved NEMLUVIO (nemolizumab-ilto) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.

In February 2024, Galderma announced that the EMA had accepted the Marketing Authorization Applications for nemolizumab in prurigo Nodularis.

In March 2024, the company announced that the Japan Ministry of Health, Labor and Welfare (MHLW) approved the manufacturing and marketing of MITCHGA SC injection 30mg Vials for adults and children aged =13 years with prurigo nodularis.

Emerging Drugs

Povorcitinib: Incyte

Povorcitinib is an oral small-molecule JAK1 inhibitor. Janus kinases (JAKs) are intracellular signaling enzymes that act downstream of key proinflammatory cytokines to mediate normal immune function and modulate inflammation. Currently, povorcitinib is in Phase III clinical trials for prurigo nodularis, hidradenitis suppurativa, and vitiligo.

In April 2024, Incyte and China Medical System Holdings announced that the companies entered into a collaboration and license agreement through a wholly-owned dermatology medical aesthetic subsidiary, CMS Skinhealth, for the development and commercialization of povorcitinib, a selective oral JAK1 inhibitor, in Mainland China, Hong Kong, Macau, Taiwan Region and eleven Southeast Asian countries.

In September 2024, Incyte presented long-term extension data at the 2024 EADV Congress from the Phase II randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of povorcitinib in patients with prurigo Nodularis.

The company anticipates the data release of the povorcitinib Phase III trial for prurigo nodularis by 2027

Barzolvolimab (CDX-0159): Celldex Therapeutics

Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival, and activity of mast cells. In certain inflammatory diseases, mast cell activation plays a central role in the onset and progression of the disease

In May 2024, Celldex Therapeutics announced the first patient was administrated with dosed in the Company's Phase II subcutaneous study of barzolvolimab in prurigo Nodularis.

In April 2024, the company initiated a Phase II study in prurigo nodularis, and enrollment is ongoing; positive data from a Phase I study in prurigo nodularis was reported in November 2023.

Drug Class Insight

Corticosteroids

Topical corticosteroids are the first-line treatment for mild to moderate prurigo nodularis , working by reducing inflammation, suppressing immune responses, and constricting blood vessels to alleviate itching and inflammation. Potent corticosteroids, such as betamethasone dipropionate, clobetasol propionate, and fluocinonide, are effective for areas with thicker skin or resistant lesions. They provide rapid relief but are used for short durations to avoid side effects like skin thinning, delayed wound healing, and stretch marks.

Systemic corticosteroids, like oral prednisone, are used for severe or widespread prurigo nodularis that doesn't respond to other treatments. They control inflammation and generalized itching but are typically prescribed for short durations (weeks to months) to avoid side effects such as weight gain, osteoporosis, and increased infection risk. The goal is to provide temporary relief while adjusting other treatments.

Antihistamines and leukotriene inhibitors

Antihistamines are commonly used in prurigo nodularis treatment due to the high presence of mast cells in prurigo nodularis lesions. A case series showed that high-dose nonsedating antihistamines during the day and sedating antihistamines at night improved symptoms in chronic prurigo patients. A combination therapy of fexofenadine and montelukast also improves lesions and pruritus in some prurigo nodularis patients.

Janus kinase (JAK) inhibitors

Janus kinase (JAK) inhibitors are emerging as a promising treatment for prurigo nodularis , particularly for patients with moderate to severe disease. JAK inhibitors work by targeting specific enzymes involved in the inflammatory process, which can help reduce itching and the formation of skin lesions in prurigo nodularis. By inhibiting the JAK-STAT signaling pathway, these drugs block the activity of pro-inflammatory cytokines such as interleukins (IL-4, IL-13, IL-31) and interferons, which play a key role in the pathogenesis of prurigo nodularis. This action can reduce both inflammation and pruritus, providing relief from the symptoms of prurigo nodularis.

Prurigo Nodularis Market Outlook

Prurigo nodularis is a chronic skin condition marked by hard, itchy bumps (nodules) caused by persistent scratching and rubbing. The nodules typically appear on areas like the arms, legs, abdomen, and back, but rarely on the palms, soles, or face. The cycle of itching and scratching worsens the condition, leading to new nodules and potential scarring. Treatment focuses on breaking this itch-scratch cycle to promote healing.

The treatment landscape for prurigo nodularis has been evolving in recent years, with increasing attention from the pharmaceutical industry due to the chronic and debilitating nature of the condition. There is growing recognition of the need for effective treatments that can break the persistent itch-scratch cycle that exacerbates the disease.

Treatments for prurigo nodularis focus on relieving itching and inflammation. Topical corticosteroids, including strong steroid creams, are commonly prescribed to reduce skin inflammation and itching. Tacrolimus ointment, a non-steroid option, also helps reduce inflammation. Applying paste bandages or cling film over the affected areas enhances the effect of steroids and prevents excessive scratching. Emollients are crucial for moisturizing dry skin and improving the effectiveness of other treatments. Antihistamines, particularly non-sedative types like fexofenadine, help relieve itching. Phototherapy, such as UVB or UVA treatments, reduces nodules and itching. Psychological support may aid in managing stress and emotional distress, while immune-suppressing treatments like oral corticosteroids, ciclosporin, methotrexate, or azathioprine are used for severe cases.

• Among the 7MM, the US accounted for the largest market size of prurigo nodularis. i.e., USD ~ 523.2 million in 2023.
• Among EU4 and the UK, Germany accounted for the highest market size in 2023, while Spain occupied the lowest.
• The pipeline for prurigo nodularis is limited and consist of therapies including Janus kinase inhibitors (JAK), KIT antagonist, Oncostatin M receptor beta subunit inhibitors and others.

Key Updates

In September 2024, Incyte presented long-term extension data at the 2024 EADV Congress from the Phase II randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of povorcitinib in patients with prurigo nodularis

In March 2024, Incyte presented new late-breaking data from its Phase II study evaluating povorcitinib (INCB54707), an oral JAK1 inhibitor, in adult patients with prurigo nodularis. The study met its primary and secondary endpoints following 16 weeks of treatment across all dosing groups. The results were shared as a late-breaking oral presentation at the American Academy of Dermatology (AAD) Annual Meeting, marking Incyte's first presentation of data on prurigo Nodularis.

In 2007, Sanofi and Regeneron entered into a global, strategic collaboration agreement to discover, develop, and commercialize fully human therapeutic antibodies utilizing Regeneron's proprietary VelociSuite of technologies where Sanofi-Aventis will take the lead in commercialization activities and will consolidate the sales. Regeneron will have the right to co-promote any collaboration products worldwide.

Prurigo Nodularis 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 prurigo nodularis treatment has experienced an 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 treatment care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

Prurigo Nodularis Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. 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 prurigo nodularis 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, Professor and Vice Chair Department of Critical Care Medicine and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or prurigo nodularis 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 University of Miami, US; University of Lubeck, Germany; Universita Cattolica del Sacro Cuore, Italy; Johns Hopkins University School of Medicine, US; University Hospital Munster, Munster, Germany; Johns Hopkins University School of Medicine, US; Massachusetts General Hospital, US; Nagasaki University, Japan; Department of Dermatology, Nagasaki University School of Medical Sciences, Nagasaki, Japan, etc., were contacted. Their opinion helps understand and validate prurigo nodularis 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: MyWay CoPay program

The eligible patients covered by commercial health insurance may pay as little as a USD 0 co-pay per fill of DUPIXENT (maximum of USD 13,000 per patient per calendar year).

Key eligibility criteria:

• Patients are eligible for the program if they meet all of the following criteria:
• The patient currently has commercial (private) health insurance that covers DUPIXENT
• The patient has a DUPIXENT prescription for an FDA-approved condition
• Patients are residents of the 50 United States, the District of Columbia, Puerto Rico, Guam, or the USVI and are patients or caregivers aged 18 years or older.

Scope of the Report:

• The report covers a descriptive overview of prurigo nodularis, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into prurigo nodularis epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for prurigo nodularis is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the prurigo nodularis 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 prurigo nodularis market.

Prurigo Nodularis Report Insights

• Patient Population
• Therapeutic Approaches
• Prurigo Nodularis Pipeline Analysis
• Prurigo Nodularis Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

Prurigo Nodularis Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Prurigo Nodularis Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Prurigo Nodularis Report Assessment

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

FAQs:

• What was the prurigo nodularis market share (%) distribution in 2020 and what it would look like in 2034?
• What would be the prurigo nodularis 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 prurigo nodularis market size during the study period (2020-2034)?
• What are the disease risks, burdens, and unmet needs of prurigo nodularis?
• What is the historical prurigo nodularis patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan?
• What will be the growth opportunities across the 7MM concerning the patient population of prurigo nodularis?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of prurigo nodularis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to prurigo nodularis 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 prurigo nodularis and their status?
• What are the key designations that have been granted for the emerging therapies for prurigo nodularis?

Reasons to buy:

• The report will help in developing business strategies by understanding trends shaping and driving prurigo nodularis.
• To understand the future market competition in the prurigo nodularis market and Insightful review of the SWOT analysis of prurigo nodularis.
• Organize sales and marketing efforts by identifying the best opportunities for prurigo nodularis 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 prurigo nodularis market.
• To understand the future market competition in the prurigo nodularis market.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

5. Epidemiology and Market Forecast Methodology

6. Prurigo Nodularis Market Overview at a Glance

• 6.1. Market Share (%) Distribution of Prurigo Nodularis by Therapies in 2023
• 6.2. Market Share (%) Distribution of Prurigo Nodularis by Therapies in 2034

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Classification
• 7.3. Clinical Signs and Symptoms
• 7.4. Pathophysiology
• 7.5. Diagnosis
• 7.6. Differential Diagnosis
• 7.7. Etiology
• 7.8. Treatment and Management
  • 7.8.1. Treatment algorithm

8. Guidelines

• 8.1.1. Prurigo Nodularis Guidelines: The United States (2022)
• 8.1.2. Prurigo Nodularis IFSI Guidelines: Europe (2020)
• 8.1.3. Prurigo Nodularis Guidelines: Japan (2020)

9. Epidemiology and Patient Population of Prurigo Nodularis in the 7MM

• 9.1. Key Findings
• 9.2. Assumptions and Rationales
• 9.3. Total Diagnosed Prevalent Cases of Prurigo Nodularis in the 7MM
• 9.4. The United States
  • 9.4.1. Total Diagnosed Prevalent Cases of Prurigo Nodularis in the United States
  • 9.4.2. Gender-specific Diagnosed Prevalent Cases of Prurigo Nodularis in the United States
  • 9.4.3. Age-specific Diagnosed Prevalent Cases of Prurigo Nodularis in the United States
  • 9.4.4. Severity-specific Diagnosed Prevalent Cases of Prurigo Nodularis in the United States
• 9.5. EU4 and the UK
  • 9.5.1. Total Diagnosed Prevalent Cases of Prurigo Nodularis in EU4 and the UK
  • 9.5.2. Gender-specific Diagnosed Prevalent Cases of Prurigo Nodularis in EU4 and the UK
  • 9.5.3. Age-specific Diagnosed Prevalent Cases of Prurigo Nodularis in EU4 and the UK
  • 9.5.4. Severity-specific Diagnosed Prevalent Cases of Prurigo Nodularis in EU4 and the UK
• 9.6. Japan
  • 9.6.1. Total Diagnosed Prevalent Cases of Prurigo Nodularis in Japan
  • 9.6.2. Gender-specific Diagnosed Prevalent Cases of Prurigo Nodularis in Japan
  • 9.6.3. Age-specific Diagnosed Prevalent Cases of Prurigo Nodularis in Japan
  • 9.6.4. Severity-specific Diagnosed Prevalent Cases of Prurigo Nodularis in Japan

10. Patient Journey

11. Marketed Drugs

• 11.1. Key Cross Competition
• 11.2. NEMLUVIO/MITCHGA (nemolizumab-ilto): Galderma Laboratories/Maruho
  • 11.2.1. Product Description
  • 11.2.2. Regulatory Milestones
  • 11.2.3. Other Developmental Activities
  • 11.2.4. Clinical Development
    • 11.2.4.1. Clinical Trial Information
  • 11.2.5. Safety and Efficacy
• 11.3. DUPIXENT (dupilumab): Sanofi/Regeneron
  • 11.3.1. Product Description
  • 11.3.2. Regulatory Milestones
  • 11.3.3. Other Developmental Activities
  • 11.3.4. Clinical Development
    • 11.3.4.1. Clinical Trial Information
  • 11.3.5. Safety and Efficacy

12. Emerging Drugs

• 12.1. Key Cross Competition
• 12.2. Povorcitinib: Incyte
  • 12.2.1. Product Description
  • 12.2.2. Other Developmental Activities
  • 12.2.3. Clinical Development
    • 12.2.3.1. Clinical Trials Information
  • 12.2.4. Safety and Efficacy
• 12.3. Ruxolitinib: Incyte
  • 12.3.1. Product Description
  • 12.3.2. Other Developmental Activities
  • 12.3.3. Clinical Development
    • 12.3.3.1. Clinical Trials Information
• 12.4. Rocatinlimab: Amgen/Kyowa Kirin
  • 12.4.1. Product Description
  • 12.4.2. Other Developmental Activities
  • 12.4.3. Clinical Development
    • 12.4.3.1. Clinical Trials Information
• 12.5. Barzolvolimab (CDX-0159): Celldex Therapeutics
  • 12.5.1. Product Description
  • 12.5.2. Other Developmental Activities
  • 12.5.3. Clinical Development
    • 12.5.3.1. Clinical Trial Information
  • 12.5.4. Safety and Efficacy
• 12.6. Vixarelimab: Kiniksa Pharmaceuticals/Genentech
  • 12.6.1. Product Description
  • 12.6.2. Other Developmental Activities
  • 12.6.3. Clinical Development
    • 12.6.3.1. Clinical Trial Information
  • 12.6.4. Safety and Efficacy

13. Prurigo Nodularis: 7MM Analysis

• 13.1. Key Findings
• 13.2. Market Outlook
• 13.3. Key Market Forecast Assumptions
  • 13.3.1. Cost Assumptions and Rebates
  • 13.3.2. Pricing Trends
  • 13.3.3. Analogue Assessment
  • 13.3.4. Launch Year and Therapy Uptakes
• 13.4. Conjoint Analysis
• 13.5. Total Market Size of Prurigo Nodularis in the 7MM
• 13.6. Market Size of Prurigo Nodularis by Therapies in the 7MM
• 13.7. The United States Market Size
  • 13.7.1. Total Market Size of Prurigo Nodularis in the United States
  • 13.7.2. Market Size of Prurigo Nodularis by Therapies in United States
• 13.8. EU4 and the UK Market Size
  • 13.8.1. Total Market Size of Prurigo Nodularis in EU4 and the UK
  • 13.8.2. Market Size of Prurigo Nodularis by Therapies in EU4 and the UK
• 13.9. Japan Market Size
  • 13.9.1. Total Market Size of Prurigo Nodularis in Japan
  • 13.9.2. Market Size of Prurigo Nodularis by Therapies in Japan

14. Unmet Needs

15. SWOT Analysis

16. KOL Views

17. Market Access and Reimbursement

• 17.1. United States
  • 17.1.1. Centre for Medicare and Medicaid Services (CMS)
• 17.2. EU4 and the UK
  • 17.2.1. Germany
  • 17.2.2. France
  • 17.2.3. Italy
  • 17.2.4. Spain
  • 17.2.5. United Kingdom
• 17.3. Japan
  • 17.3.1. MHLW
• 17.4. Market Access and Reimbursement of Prurigo Nodularis

18. Appendix

• 18.1. Bibliography
• 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight