Prurigo Nodularis - Market Insight, Epidemiology, and Market Forecast - 2034

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.