Granulomatosis with Polyangiitis Market

Market Overview:

The 7 major granulomatosis with polyangiitis markets reached a value of USD 67.6 Million in 2024. Looking forward, IMARC Group expects the 7MM to reach USD 86.3 Million by ​2035​, exhibiting a growth rate (CAGR) of 2.25% during ​2025-2035​.

The granulomatosis with polyangiitis market has been comprehensively analyzed in IMARC's new report titled "Granulomatosis with Polyangiitis Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast ​2025-2035​". Granulomatosis with polyangiitis (GPA), formerly known as Wegener's granulomatosis, is one of the extremely rare autoimmune vasculitides mainly involving small and medium-sized blood vessels in the respiratory tract, kidneys, skin, and nervous system. Because the initial symptoms usually resemble an everyday infection, it causes diagnostic delays. Some persistent nasal crusting, sinusitis, recurrent ear infections, nose bleeding, chronic cough, arthralgia, dermal ulcers, hemoptysis, dyspnea, ocular manifestations, pyrexia, malaise, night sweats, and unintended weight loss can be seen. Rapidly progressive renal failure may result from severe glomerulonephritis. Serology, c-ANCA/PR3-ANCA positivity in approximately 80-90 percent of the cases, imaging CT/MRI for involvement of the lung and sinuses, and tissue biopsy, which confirms the necrotizing granulomatous inflammation, are the diagnostic measures. Urinalysis aids in the detection of renal involvement. Early treatment with immunosuppressive therapy using corticosteroids and biologic agents like rituximab can prevent organ damage and enhance survival rates, making diagnosis and treatment as early as possible imperative.

The granulomatosis with polyangiitis (GPA) market is driven by growing prevalence of autoimmune diseases, advanced diagnostic capabilities, and developments in targeted therapies. Biologic therapy adoption, especially rituximab, has revolutionized disease management by providing better efficacy and lower toxicity than conventional immunosuppressants such as cyclophosphamide. Therapeutic options are further being broadened by research on complement inhibitors and JAK inhibitors. Early rates of diagnosis are also on the rise as a result of improved ANCA testing, imaging methods (CT/MRI), and biomarker studies. The establishment of tailored medicine and AI-based diagnosis equipment is also advancing market growth. Moreover, spreading awareness among physicians and improved reimbursement schemes for biologics are pushing treatment adoption at a faster rate. Increasing geriatric population and increased clinical trials assessing new immunomodulators will also propel market growth. Overall, ongoing drug development, early intervention strategies, and global research initiatives are expected to characterize the GPA treatment landscape over the next decade.

IMARC Group's new report provides an exhaustive analysis of the granulomatosis with polyangiitis market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for granulomatosis with polyangiitis and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the granulomatosis with polyangiitis market in any manner.

Recent Developments:

• In September 2024, AstraZeneca’s Fasenra (benralizumab) received U.S. FDA approval for eosinophilic granulomatosis with polyangiitis (EGPA). The decision was based on the MANDARA trial, where nearly 60% achieved remission, and 41% discontinued oral corticosteroids. The approval provides a vital alternative treatment for approximately 15,000 U.S. patients with EGPA.
• In February 2024, MANDARA Phase III trial results for FASENRA (benralizumab) in eosinophilic granulomatosis with polyangiitis (EGPA) were published in NEJM, showing 59% remission at weeks 36 and 48. The trial demonstrated non-inferiority to mepolizumab, with more patients tapering off corticosteroids.
• In January 2024, NS Pharma received orphan drug designation from the European Commission for NS-229, a treatment for eosinophilic granulomatosis with polyangiitis (EGPA). The company also plans to initiate a global Phase II clinical trial for NS-229 to assess its efficacy in managing this rare autoimmune disease.

Key Highlights:

• GPA is a rare autoimmune disorder causing inflammation of small- and medium-sized blood vessels, primarily affecting the respiratory tract and kidneys.
• Initial manifestations often include fatigue, joint pain, and upper respiratory issues like persistent nasal congestion and sinusitis, which can lead to diagnostic delays.
• Definitive diagnosis typically requires a biopsy of affected tissues, supported by blood tests and imaging studies.
• The combination of cyclophosphamide and prednisone has significantly improved patient outcomes, achieving remission in approximately 75% of cases.
• Despite successful treatment, GPA has a high relapse rate, with about half of patients experiencing disease recurrence, necessitating ongoing monitoring and management.

Drugs:

Fasenra (benralizumab) is a humanized IgG1k monoclonal antibody targeting IL-5Rα on eosinophils and basophils. It blocks IL-5 binding, inhibiting eosinophilic inflammation in granulomatosis with polyangiitis. Developed by MedImmune, AstraZeneca, it was FDA-approved on November 14, 2017, and enhances immune cell-mediated eosinophil depletion via FcγRIIIα binding.

Rituxan (rituximab) is an anti-CD20 monoclonal antibody approved for granulomatosis with polyangiitis (GPA). It targets B lymphocytes to reduce inflammation and disease progression. Initially approved for non-Hodgkin’s lymphoma in 1997, Rituxan has expanded indications, demonstrating efficacy in autoimmune conditions like GPA by depleting CD20-positive B cells.

Nucala (mepolizumab) is a fully humanized IgG1 kappa monoclonal antibody targeting IL-5, reducing eosinophilic inflammation in granulomatosis with polyangiitis (GPA). By inhibiting eosinophil differentiation and activation, it mitigates tissue damage and fibrosis. FDA-approved, it is used adjunctively to control GPA symptoms and prevent relapses effectively.

Time Period of the Study

• Base Year: 2024
• Historical Period: 2019-2024
• Market Forecast: ​2025-2035​

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the granulomatosis with polyangiitis market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the granulomatosis with polyangiitis market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current granulomatosis with polyangiitis marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:

Market Insights

• How has the granulomatosis with polyangiitis market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2024 and how are they expected to perform till 2035?
• What was the country-wise size of the granulomatosis with polyangiitis market across the seven major markets in 2024 and what will it look like in 2035?
• What is the growth rate of the granulomatosis with polyangiitis market across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?

Epidemiology Insights

• What is the number of prevalent cases (​​2019-2035​​) of granulomatosis with polyangiitis across the seven major markets?
• What is the number of prevalent cases (​​2019-2035​​) of granulomatosis with polyangiitis by age across the seven major markets?
• What is the number of prevalent cases (​​2019-2035​​) of granulomatosis with polyangiitis by gender across the seven major markets?
• How many patients are diagnosed (​​2019-2035​​) with granulomatosis with polyangiitis across the seven major markets?
• What is the size of the granulomatosis with polyangiitis patient pool (2019-2024) across the seven major markets?
• What would be the forecasted patient pool (​2025-2035​) across the seven major markets?
• What are the key factors driving the epidemiological trend of granulomatosis with polyangiitis?
• What will be the growth rate of patients across the seven major markets?

Granulomatosis with Polyangiitis: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for granulomatosis with polyangiitis drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the granulomatosis with polyangiitis market?
• What are the key regulatory events related to the granulomatosis with polyangiitis market?
• What is the structure of clinical trial landscape by status related to the granulomatosis with polyangiitis market?
• What is the structure of clinical trial landscape by phase related to the granulomatosis with polyangiitis market?
• What is the structure of clinical trial landscape by route of administration related to the granulomatosis with polyangiitis market?