The prurigo nodularis treatment landscape 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. Additionally, the launch of emerging therapies such as Povorcitinib, OPZELURA, Rocatinlimab, Barzolvolimab, and others will further fuel the market growth.
LAS VEGAS, Sept. 22, 2025 /PRNewswire/ -- DelveInsight's Prurigo Nodularis Market Insights report includes a comprehensive understanding of current treatment practices, prurigo nodularis emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Key Takeaways from the Prurigo Nodularis Market Report
- According to DelveInsight's analysis, the market size for prurigo nodularis was found to be nearly USD 1 billion in the leading markets in 2024, which is anticipated to grow tremendously owing to the uptake of approved therapies and the emerging pipeline moving towards patients inadequately controlled on topical therapies.
- In 2024, among all the current therapies for prurigo nodularis, the highest estimated revenue was generated by DUPIXENT, i.e., nearly USD 630 million in the United States.
- The total diagnosed prevalent cases of prurigo nodularis in the 7MM were ~614,000 in 2024, out of which the highest prevalent cases of this disease were in the United States, with major contribution by patients aged 65 years and old.
- The US, EU4, and the UK show a higher prevalence of prurigo nodularis in females, which could be attributed to hormonal or genetic factors influencing the development of the condition. Japan, on the other hand, has a significant male predominance, which may indicate regional genetic or lifestyle factors that predispose men to a higher risk of developing the condition.
- DUPIXENT (dupilumab) became the first FDA-approved treatment for prurigo nodularis in September 2022, with its EU approval expanded in December 2022 for adults with moderate-to-severe cases. Japan's MHLW also approved DUPIXENT in June 2023 for patients unresponsive to conventional treatments. Based on its existing performance and physician acceptance, we anticipate it to generate more than USD 1.2 billion by 2030 in the 7MM.
- In recent developments for prurigo nodularis treatment, NEMLUVIO (nemolizumab) received US FDA approval in August 2024 for adult patients, with approximately 1,100 healthcare professionals prescribing it since its launch. Prior to this, NEMLUVIO was approved in Japan as the brand name MITCHGA (nemolizumab) in March 2024 for prurigo nodularis in adults and children aged 13 and older, and was launched by Maruho in June 2024.
- In February 2025, Galderma received marketing authorization for NEMLUVIO from both the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Commission (EC) for the SC treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
- Leading companies developing emerging therapies for prurigo nodularis include Incyte, Amgen, Kyowa Kirin, and Celldex Therapeutics, which are advancing promising candidates that are expected to enter the prurigo nodularis market in the coming years.
- The promising prurigo nodularis therapies in the pipeline include Povorcitinib, OPZELURA (ruxolitinib), Rocatinlimab, Barzolvolimab (CDX-0159), and others.
Discover which therapies are expected to grab the major prurigo nodularis treatment market share @ Prurigo Nodularis Market Report
Key Factors Driving the Prurigo Nodularis Market
Rising Prurigo Nodularis Disease Prevalence and Awareness
The increasing prevalence of prurigo nodularis, particularly among individuals with underlying skin conditions like atopic dermatitis and eczema, has heightened the demand for effective treatments. The US accounted for approximately 261K diagnosed prevalent cases of prurigo nodularis in 2024. These cases are expected to increase during the forecast period (2025−2034) owing to growing populations, improved diagnostic methods, changes in lifestyle and environmental factors, and advancements in medical technology, allowing for better treatment. Moreover, there is a growing awareness among healthcare professionals and patients about the condition, leading to earlier diagnosis and intervention.
Drug Approvals in Prurigo Nodularis Market
The approval of DUPIXENT (dupilumab) in 2022 and NEMLUVIO (nemolizumab) in 2024 provides a significant breakthrough for patients with moderate-to-severe prurigo nodularis. These prurigo nodularis therapies offer targeted therapies with proven efficacy. As more treatments are developed and approved, expanding access to biologic therapies like DUPIXENT and NEMLUVIO through improved insurance coverage and cost reduction programs could make these therapies more accessible to a broader range of patients.
Emerging Therapies in Prurigo Nodularis Market
The emerging prurigo nodularis clinical trial landscape offers a diverse range of therapeutic alternatives, including rocatinlimab (Amgen/Kyowa Kirin), povorcitinib and ruxolitinib (Incyte), barzolvolimab (Celldex), and others across various treatment lines. The expected launch of these therapies shall further create a positive impact on the prurigo nodularis market.
Prurigo Nodularis Market Analysis
The treatment landscape for prurigo nodularis has seen significant advancements in recent years, driven by growing interest from the pharmaceutical sector due to the condition's chronic and distressing nature. Current therapies aim primarily to alleviate itching and inflammation. Potent topical corticosteroids are frequently used to calm inflamed skin and ease itching, while tacrolimus ointment offers a non-steroidal alternative with anti-inflammatory benefits. Moisturizers, or emollients, play a vital role in hydrating dry skin and enhancing the effectiveness of other treatments.
Non-drowsy antihistamines like fexofenadine can also help control the itch. Phototherapy, including UVA or UVB light therapy, is effective in reducing nodules and itching. Psychological support may help patients cope with stress-related flare-ups. In more severe cases, systemic immunosuppressants such as oral corticosteroids, ciclosporin, methotrexate, or azathioprine are prescribed.
A major milestone in treatment was the FDA approval of DUPIXENT, the first medication specifically authorized for prurigo nodularis. DUPIXENT, a monoclonal antibody that blocks IL-4 and IL-13 signaling, helps reduce inflammation and severe itching. Another breakthrough came in August 2024 with the FDA approval of NEMLUVIO, a monoclonal antibody targeting IL-31, offering a new therapeutic option for managing this condition.
To know more about prurigo nodularis treatment guidelines, visit @ Prurigo Nodularis Treatment Options
Prurigo Nodularis Competitive Landscape
Although there are very few approved medications for prurigo nodularis, several drugs are currently under research and development. These include rocatinlimab (Amgen/Kyowa Kirin), povorcitinib and ruxolitinib (Incyte), and barzolvolimab (Celldex), which are being investigated as potential treatments for prurigo nodularis.
Povorcitinib is an oral JAK1 inhibitor currently in Phase III clinical trials for prurigo nodularis, with data expected by 2026 and a launch anticipated between 2027–2028. In March 2024, Incyte presented positive late-breaking Phase II data showing that povorcitinib met its primary and secondary endpoints in treating prurigo nodularis. Ruxolitinib, a topical JAK1/2 inhibitor, is also being investigated for prurigo nodularis, with Phase III trial data was presented in March 2025, and a launch is anticipated between 2026–2027. Currently, no oral or topical therapies are approved for prurigo nodularis. While the first study, TRuE-PN1, met its primary endpoint and all key secondary endpoints, the second trial, TRuE-PN2, did not reach statistical significance on its primary endpoint despite the numbers favoring OPZELURA.
Rocatinlimab (formerly AMG 451 / KHK4083) is a monoclonal antibody that targets the OX40 receptor to inhibit and reduce pathogenic T-cells, with potential for treating prurigo nodularis. The company launched a Phase III trial for rocatinlimab in July 2024 to assess its efficacy in treating prurigo nodularis.
The anticipated launch of these emerging therapies is poised to transform the prurigo nodularis market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the prurigo nodularis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about prurigo nodularis marketed and pipeline drugs @ Prurigo Nodularis Clinical Trials
Recent Developments in the Prurigo Nodularis Market
- In July 2025, Incyte's Q2 2025 report noted that the launch of povorcitinib for the treatment of prurigo nodularis is expected by 2027–2028.
- In March 2025, Incyte announced the results of Phase III clinical trials (TRuE-PN1 and TRuE-PN2 studies) evaluating ruxolitinib cream 1.5% (OPZELURA) in patients with prurigo nodularis at the 2025 American Academy of Dermatology (AAD) Annual Meeting.
- According to the Q2 2025 Kyowa Kirin corporate presentation, Phase III completion for rocatinlimab in prurigo nodularis is expected by 2027.
What is Prurigo Nodularis?
Prurigo nodularis is a long-term skin condition marked by the presence of numerous firm, itchy bumps or nodules that often result from persistent scratching or rubbing. These nodules can vary in size and commonly appear on the arms, legs, back, and chest. The main symptom is severe itching, which leads to repeated scratching, worsening the skin lesions, and causing them to become thickened, scaly, or darkened. In more advanced cases, the nodules may break open or become infected due to continuous irritation and trauma.
While the precise cause of prurigo nodularis is not fully understood, it is frequently linked to underlying health issues such as atopic dermatitis, chronic kidney or liver disease, and psychological conditions like anxiety or depression. Diagnosis is mainly clinical, based on the distinct appearance of itchy, raised nodules. Healthcare professionals typically review the patient's medical history, particularly any related conditions, and perform a physical examination to assess the size, number, and distribution of the nodules, which are usually found on the limbs and trunk.
Prurigo Nodularis Epidemiology Segmentation
The prurigo nodularis epidemiology section provides insights into the historical and current prurigo nodularis patient pool and forecasted trends for the leading markets. The total diagnosed prevalent cases of prurigo nodularis in the US were around 261,900 cases in 2024. According to DelveInsight estimates, in 2024, among the age-specific diagnosed prevalent cases of prurigo nodularis in the US, the highest number of cases were found in the =65 years age group, followed by the 25–44 years age group, while the lowest number of cases was observed in the <15 years age group.
The prurigo nodularis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
- Diagnosed Prurigo Nodularis Prevalence
- Gender-specific Diagnosed Prurigo Nodularis Prevalence
- Age-specific Diagnosed Prurigo Nodularis Prevalence
- Severity-specific Diagnosed Prurigo Nodularis Prevalence
Prurigo Nodularis Market Report Metrics | Details |
Study Period | 2020–2034 |
Coverage | 7MM [The United States, the EU4 (Germany, France, Italy, and Spain) and The United Kingdom, and Japan]. |
Prurigo Nodularis Market CAGR | 23.2 % |
Prurigo Nodularis Market Size in 2024 | USD 1 Billion |
Key Prurigo Nodularis Companies | Incyte, Amgen, Kyowa Kirin, Celldex Therapeutics, Sanofi, Regeneron, Galderma, Maruho, and others |
Key Approved and Pipeline Prurigo Nodularis Therapies | Povorcitinib, OPZELURA (ruxolitinib), Rocatinlimab, Barzolvolimab (CDX-0159), DUPIXENT (dupilumab), NEMLUVIO/ MITCHGA (nemolizumab), and others |
Scope of the Prurigo Nodularis Market Report
- Therapeutic Assessment: Prurigo Nodularis current marketed and emerging therapies
- Prurigo Nodularis Market Dynamics: Key Market Forecast Assumptions of Emerging Prurigo Nodularis Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Prurigo Nodularis Market Access and Reimbursement
Download the report to understand which factors are driving prurigo nodularis market trends @ Prurigo Nodularis Drug Treatment
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 2024 |
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 |
8.1.2 | Prurigo Nodularis IFSI Guidelines: Europe |
8.1.3 | Prurigo Nodularis Guidelines: Japan |
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 |
11.2.6 | Analyst Views |
11.3 | DUPIXENT (dupilumab): Sanofi/Regeneron |
12 | Emerging Therapies |
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 |
12.2.5 | Analyst Views |
12.3 | OPZELURA (ruxolitinib): Incyte |
12.4 | Rocatinlimab: Amgen/Kyowa Kirin |
12.5 | Barzolvolimab (CDX-0159): Celldex Therapeutics |
13 | Prurigo Nodularis: 7MM Analysis |
13.1 | Key Findings |
13.2 | Market Outlook |
13.3 | Key Market Forecast Assumptions |
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 | The United States |
17.2 | EU4 and the UK |
17.3 | Japan |
17.4 | Market Access and Reimbursement of Prurigo Nodularis |
18 | Bibliography |
19 | Prurigo Nodularis Market Report Methodology |
Related Reports
JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the market trends, market drivers, market barriers, and key JAK inhibitors companies, including Incyte Corporation, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Arcutis Biotherapeutics, Reistone Biopharma, among others.
Prurigo Nodularis Clinical Trial Analysis
Prurigo Nodularis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key prurigo nodularis companies, including Menlo Therapeutics, Galderma R&D, Kiniksa Pharmaceuticals, Sanofi, Maruho, among others.
Epidermolysis Bullosa Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key epidermolysis bullosa companies, including Abeona Therapeutics, Castle Creek Biosciences, RHEACELL, Ishin Pharma, Holostem Terapie Avanzate, BridgeBio (Phoenix Tissue Repair), InMed Pharmaceuticals, Shionogi, Anterogen, among others.
Bullous Pemphigoid Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bullous pemphigoid companies, including AstraZeneca, Kyowa Kirin, Regeneron, Sanofi, Argenx, Innate Pharma, ARTham Therapeutics, Kaken Pharmaceutical, among others.
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.
Contact Us
Shruti Thakur
info@delveinsight.com
+14699457679
www.delveinsight.com
Logo: https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg
View original content:
Voltar noticias em Inglês