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Prurigo Nodularis Drugs Market 2034

Prurigo Nodularis Drugs Market 2034: Trials, EMA/PMDA/FDA Approvals, Therapies, Epidemiology, Companies - DelveInsight

(Albany, USA) DelveInsight's "Prurigo Nodularis Market Insights, Epidemiology, and Market Forecast-2034" report provides a comprehensive analysis of Prurigo Nodularis, including historical and forecasted epidemiology, market trends, and drug developments in the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.

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Key Facts from the Prurigo Nodularis Market Report:

  • The market is projected to grow significantly with a notable CAGR from 2020-2034.
  • Recent developments include Incyte's May 2025 study on povorcitinib for prurigo nodularis itch and lesions, Amgen's Phase 3 trial of rocatinlimab in May 2025, Incyte's March 2025 Phase 3 TRuE-PN results for ruxolitinib cream (Opzelura®), positive topline data from the STOP-HS trial for povorcitinib in hidradenitis suppurativa, and Galderma's February 2025 EU approval of Nemluvio for atopic dermatitis and prurigo nodularis.
  • Prevalence is estimated at 3.27 cases per 10,000 patients (Morgan et al., 2022), with the US having the largest diagnosed population in 2023 among the 7MM. Europe shows the highest age-specific prevalence (40-59 years, over 30% in 2023). Females are more affected than males.
  • Dupilumab (Dupixent) is the only FDA-approved therapy; numerous others are in development.
  • Key Companies: Trevi Therapeutics, Galderma, Genentech, Incyte Corporation, Vyne Therapeutics Inc., Celgene Corporation, Novartis, Pfizer, Regeneron Pharma, and others.
  • Key Therapies: Nalbuphine ER, Nemolizumab, Vixarelimab (KPL-716), Povorcitinib (INCB-54707), Ruxolitinib Cream, INCB054707, Serlopitant, CC-10004, Pimecrolimus, Abrocitinib, Dupilumab (SAR231893), and others.
  • Market growth is driven by rising prevalence, awareness, and upcoming pipeline launches.
  • Japanese companies are primary drivers of the PN pipeline, with Chugai Pharmaceutical Co., Ltd. as a foundational innovator in PN biologics through neuro-immune cytokine blockade. Their drug candidate, Nemolizumab (Mitchga® / Nemluvio®), is a humanized monoclonal antibody against IL-31 receptor A, blocking itch-neuron signaling and neuro-immune inflammation. It progressed from Phase 2 to Phase 3 (global pivotal) and is approved in Japan, with trials sponsored by Chugai early-phase and later by licensees, including key registries NCT03181503 and NCT03181581 (OLYMPIA-1 and OLYMPIA-2). Licensed globally (except Japan/Taiwan) to Galderma, it demonstrated sustained symptom improvement up to 2 years, obtained FDA approval via the partner, and has multiple ongoing regulatory reviews. Nemolizumab is the first drug designed specifically for itch neurobiology, validating IL-31 as the central PN pathway and creating the modern PN market. Maruho Co., Ltd., a dermatology specialist, sponsors Japanese development and commercialization of Nemolizumab (Mitchga®), an IL-31 receptor monoclonal antibody in Phase 3 Japan and post-marketing, with Japanese trials in JAPIC/UMIN registries and global PN trials inherited from Chugai. They received Japanese approval for PN and launched the injection formulation, running Japan-specific clinical development required by PMDA. Otsuka Pharmaceutical Co., Ltd. has early-stage PN neuro-immune pipeline with OPN-305 and related opioid-pathway neuromodulation programs, focusing on kappa-opioid receptor modulation for anti-pruritic effects in Phase 1–2 exploratory pruritus trials, including PN as a subgroup under chronic pruritus (various NCT IDs). Kyowa Kirin Co., Ltd. is an emerging participant with KHK4083 and rocatinlimab-related T-cell modulation programs targeting OX40-pathway immune modulation in Phase 1–2 dermatologic immune diseases, including chronic pruritic dermatoses, with potential PN label expansion after atopic dermatitis success. Korean companies, such as LG Chem Life Sciences, Yuhan, Daewoong, and HK inno.N, have atopic dermatitis biologics, JAK inhibitors, and topical immunomodulators but no sponsored PN-specific trials; they only serve as trial sites in global biologic trials. Taiwanese companies, like TaiMed and PharmaEssentia, focused on hematology/immunology, have no PN therapeutic clinical programs, though Taiwan is in nemolizumab's commercialization territory via Chugai licensing. Clinically, PN is now understood as a neuro-immune disease with IL-31 as the dominant pathway, explaining Japan's dominance in innovation, particularly through Chugai's antibody engineering, which spurred global competitors like Sanofi/Regeneron dupilumab, Trevi nalbuphine, and Kiniksa vixarelimab. Recent 2024-2025 news includes Japanese-origin nemolizumab's global approvals, long-term safety/efficacy data, and commercial launches.

Prurigo Nodularis Overview Prurigo Nodularis is a chronic skin disorder featuring intensely itchy nodules, often on arms, legs, or trunk. It results from scratching, potentially worsening irritation. Causes may involve skin conditions, nerve issues, and immune factors.

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Prurigo Nodularis Epidemiology The report covers epidemiology trends in the 7MM (2020-2034), analyzing causes, patient pools, and forecasts. Segmentation includes total prevalence, severity-based cases, gender-specific prevalence, and diagnosed episodic/chronic cases.

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Prurigo Nodularis Drugs Uptake and Pipeline Development Activities This section examines uptake rates of launched and emerging drugs, patient adoption, sales, and comparisons. It highlights rapid-uptake therapies and covers pipeline activities, including collaborations, acquisitions, and key companies.

Prurigo Nodularis Therapies and Key Companies

  • Nalbuphine ER: Trevi Therapeutics
  • Nemolizumab: Galderma
  • Vixarelimab (KPL-716): Genentech
  • Povorcitinib (INCB-54707): Incyte Corporation
  • Ruxolitinib Cream: Incyte Corporation
  • INCB054707: Incyte Corporation
  • Serlopitant: Vyne Therapeutics Inc.
  • CC-10004: Celgene Corporation
  • Pimecrolimus: Novartis
  • Abrocitinib: Pfizer
  • Dupilumab (SAR231893): Regeneron Pharma

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Prurigo Nodularis Market Strengths and Opportunities

  • Novel formulations improve quality of life for patients with limited options, with Vixarelimab offering dual relief for pruritus and nodules.
  • Growing population drives awareness and innovation; the single approved drug creates opportunities for new therapies.

Scope of the Prurigo Nodularis Market Report

  • Study Period: 2020-2034
  • Coverage: 7MM (US, EU5, Japan)
  • Key Companies and Therapies: As listed above.
  • Therapeutic Assessment: Current marketed and emerging therapies.
  • Market Dynamics: Drivers, barriers, SWOT, PESTLE, Porter's Five Forces, BCG Matrix, entry strategies.
  • Unmet Needs, KOL/Analyst Views, Market Access, Reimbursement.

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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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach. 

Media Contact 

Company Name: DelveInsight Business Research LLP

Contact Person: Abhishek kumar

Email: abhishek@delveinsight.com

City: Albany

State: New York

Country: United States

Website: https://www.delveinsight.com

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