Granulomatosis with Polyangiitis (GPA) - 7MM Market Insights, Epidemiology, and Forecast - 2036 | Targeted, Steroid-Sparing Therapies Drive Growth and Investment
Dublin, Oct. 01, 2026 (GLOBE NEWSWIRE) -- "Granulomatosis With Polyangiitis - Market Insight, Epidemiology, and Market Forecast - 2036" has been added to ResearchAndMarkets.com's offering.
The Granulomatosis with Polyangiitis (GPA) - Market Insights, Epidemiology and Market Forecast - 2036 report provides a comprehensive assessment of the GPA treatment landscape, patient population, epidemiology, market dynamics and commercial opportunities across the United States, EU4 countries of Germany, Spain, Italy and France, the United Kingdom and Japan.
Granulomatosis with polyangiitis is a rare ANCA-associated vasculitis characterized by necrotizing inflammation of small- to medium-sized blood vessels. The disease frequently involves the upper respiratory tract, lungs and kidneys and is commonly associated with proteinase 3 anti-neutrophil cytoplasmic antibodies. Clinical manifestations may include chronic sinusitis, nasal ulcers, pulmonary nodules, hemoptysis and rapidly progressive glomerulonephritis. Early diagnosis and treatment are critical because uncontrolled inflammation can result in irreversible organ damage.
GPA is considered the most prevalent form of ANCA-associated vasculitis. Its estimated annual incidence is approximately 10-20 cases per million people worldwide, although geographic variation is substantial. Upper respiratory tract involvement occurs in approximately 92% of patients, followed by lower respiratory tract involvement in about 85% and renal involvement in approximately 80%. Musculoskeletal, ocular, skin and peripheral nervous system manifestations may also develop during the disease course. PR3-ANCA-positive disease represents approximately three-quarters of diagnosed GPA cases.
GPA Diagnosis and Treatment Landscape
Diagnosis is based on clinical presentation, ANCA serology, imaging, laboratory findings and histopathological confirmation when tissue biopsy is feasible. Routine laboratory results may show impaired renal function, abnormal urinalysis, elevated erythrocyte sedimentation rate and increased C-reactive protein. Improved access to ANCA testing, updated classification criteria and more advanced disease monitoring are supporting earlier diagnosis, patient stratification and relapse detection.
GPA treatment is divided into induction and maintenance phases. For severe disease, induction commonly includes RITUXAN or cyclophosphamide with glucocorticoids. Methotrexate may be considered for selected patients with less severe disease. Maintenance options include rituximab, azathioprine and methotrexate. Treatment objectives include rapid remission, prevention of relapse, preservation of organ function and reduction of cumulative therapy-related toxicity.
TAVNEOS is an oral C5a receptor antagonist approved for severe active GPA and microscopic polyangiitis in combination with standard therapy. By inhibiting C5a-mediated neutrophil activation, TAVNEOS supports disease control while reducing reliance on high-dose glucocorticoids. Amgen completed its approximately USD 3.7 billion acquisition of ChemoCentryx in October 2022, adding TAVNEOS to its inflammation and nephrology portfolio.
Granulomatosis with Polyangiitis Market Drivers
The United States represented the largest GPA market among the 7MM in 2025 and is expected to retain its leading position during the forecast period. Market growth through 2036 is anticipated to be supported by increasing biologic use, earlier diagnosis, improved access to specialist care and adoption of steroid-sparing therapies. High treatment costs, reimbursement restrictions and long-term safety concerns may moderate uptake.
Competitive and Pipeline Analysis
The report evaluates approved therapies and clinical-stage assets across Phase I-III development, including mechanisms of action, clinical data, patents, collaborations, regulatory milestones and strategic partnerships. It also examines emerging treatments within the broader ANCA-associated vasculitis landscape.
Depemokimab, developed by GSK, is an ultra-long-acting anti-interleukin-5 monoclonal antibody in Phase III development for eosinophilic granulomatosis with polyangiitis and other eosinophil-driven inflammatory disorders. NS-229, an investigational selective JAK1 inhibitor from NS Pharma, is being evaluated in a global Phase II trial for eosinophilic granulomatosis with polyangiitis. These programs are relevant to the broader competitive environment but are not positioned as GPA-specific therapies in the current development landscape.
In June 2026, Amgen presented real-world evidence at EULAR 2026 indicating that avacopan maintained its established efficacy and safety profile while supporting reduced steroid use in ANCA-associated vasculitis. GSK has also outlined planned regulatory milestones for depemokimab in eosinophilic granulomatosis with polyangiitis during the second half of 2026.
GPA Drug Uptake, Pricing and Market Access
RITUXAN is expected to maintain substantial use because of its established efficacy, guideline-supported role and clinical experience in induction and maintenance therapy. TAVNEOS is projected to gain adoption based on its steroid-sparing profile, although cost, reimbursement requirements and the availability of long-term real-world evidence may influence uptake.
The report assesses therapy adoption, peak patient share, anticipated sales, pricing trends and reimbursement considerations. It also reviews how treatment cost, clinical benefit, route of administration, dosing frequency, safety and efficacy may affect market access and long-term utilization.
Key Unmet Needs in GPA
Report Coverage and Strategic Value
The GPA market report includes historical and forecasted epidemiology and market analysis for 2022-2036, current treatment practices, patient journey insights, therapy-specific market share, clinical development activity and competitive positioning. Bottom-up forecasting connects the eligible patient population with therapy uptake and revenue projections across the 7MM.
Primary research incorporates perspectives from physicians, researchers and other Key Opinion Leaders across institutions in the United States and Europe. These insights support analysis of prescribing behavior, treatment switching, patient adherence, access barriers, unmet needs and the anticipated adoption of emerging therapies.
SWOT and conjoint analyses evaluate the competitive environment and rank therapies using attributes including efficacy, safety, administration frequency, route of administration, market entry timing, probability of success and addressable patient population. The findings are designed to support pharmaceutical companies, investors, healthcare providers and other stakeholders with pipeline prioritization, market access planning, product positioning and launch strategy development.
Key Topics Covered:
1. Key Insights
2. Report Introduction
3. Executive Summary of Granulomatosis with Polyangiitis (GPA)
4. Key Events
4.1. Upcoming Key Catalyst
4.2. Key Conferences and Meetings
4.3. Key Transactions and Collaborations
4.4. News Flow
5. Epidemiology and Market Forecast Methodology of Granulomatosis with Polyangiitis (GPA)
6. Granulomatosis with Polyangiitis (GPA) Market Overview at a Glance
6.1. Clinical Landscape Analysis (by Phase, MoA, and RoA)
6.2. Market Share (%) Distribution of Granulomatosis with Polyangiitis (GPA) by Therapies in the 7MM in 2025
6.3. Market Share (%) Distribution of Granulomatosis with Polyangiitis (GPA) by Therapies in the 7MM in 2036
7. Disease Background and Overview of Granulomatosis with Polyangiitis (GPA)
7.1. Introduction
7.2. Cause and Inheritance
7.3. Signs and Symptoms
7.4. Complications
7.5. Pathophysiology
7.6. Diagnosis
7.6.1. Differential Diagnosis
7.6.2. Diagnosis Algorithm
7.6.3. Diagnosis Guidelines
8. Treatment
8.1. Treatment Algorithm
8.2. Treatment Guidelines
8.2.1. Practical Guidelines for Managing Adults with Granulomatosis with Polyangiitis (GPA)
8.2.2. Towards a Safety Net For Management of Granulomatosis with Polyangiitis (GPA): Guidelines
9. Epidemiology and Patient Population of Granulomatosis with Polyangiitis (GPA)
9.1. Key Findings
9.2. Assumptions and Rationale
9.3. Total Prevalent Cases of Granulomatosis with Polyangiitis (GPA) in the 7MM
9.4. The United States
9.4.1. Total Diagnosed Prevalent of Granulomatosis with Polyangiitis (GPA) in the US
9.4.2. Diagnosed Prevalent Cases of Granulomatosis with Polyangiitis (GPA) by Organ Involvement in the US
9.4.3. Diagnosed Prevalent Cases of Granulomatosis with Polyangiitis (GPA) by Antibody Type in the US
9.4.4. Diagnosed Prevalent Cases of Granulomatosis with Polyangiitis (GPA) by Severity in the US
9.4.5. Total Treated Cases of Granulomatosis with Polyangiitis (GPA) in the US
9.5. EU4 and the UK
9.5.1. Total Diagnosed Prevalent of Granulomatosis with Polyangiitis (GPA) in EU4 and the UK
9.5.2. Diagnosed Prevalent Cases of Granulomatosis with Polyangiitis (GPA) by Organ Involvement in EU4 and the UK
9.5.3. Diagnosed Prevalent Cases of Granulomatosis with Polyangiitis (GPA) by Antibody Type in EU4 and the UK
9.5.4. Diagnosed Prevalent Cases of Granulomatosis with Polyangiitis (GPA) by Severity in EU4 and the UK
9.5.5. Total Treated Cases of Granulomatosis with Polyangiitis (GPA) in EU4 and the UK
9.6. Japan
9.6.1. Total Diagnosed Prevalent of Granulomatosis with Polyangiitis (GPA) in Japan
9.6.2. Diagnosed Prevalent Cases of Granulomatosis with Polyangiitis (GPA) by Organ Involvement in Japan
9.6.3. Diagnosed Prevalent Cases of Granulomatosis with Polyangiitis (GPA) by Antibody Type in Japan
9.6.4. Diagnosed Prevalent Cases of Granulomatosis with Polyangiitis (GPA) by Severity in Japan
9.6.5. Total Treated Cases of Granulomatosis with Polyangiitis (GPA) in Japan
10. Patient Journey of Granulomatosis with Polyangiitis (GPA)
11. Marketed Therapies
11.1. Marketed Competitive Landscape of Granulomatosis with Polyangiitis (GPA)
11.2. Avacopan (TAVNEOS): Amgen
11.2.1. Product Description
11.2.2. Regulatory Milestones
11.2.3. Other Developmental Activities
11.2.4. Summary of Pivotal Trials
11.2.5. Clinical Development
11.2.5.1. Clinical Trial Information
11.2.6. Analyst Views
11.2.7. Safety and Efficacy
12. Emerging Therapies
12.1. Emerging Competitive Landscape of Granulomatosis with Polyangiitis (GPA)
12.2. Depemokimab: GSK
12.2.1. Product Description
12.2.2. Other Developmental Activities
12.2.3. Clinical Development
12.2.3.1. Clinical Trial Information
12.2.4. Safety and Efficacy
12.2.5. Analyst Views
12.3. NS-229: NS Pharma
12.3.1. Product Description
12.3.2. Other Developmental Activities
12.3.3. Clinical Development
12.3.3.1. Clinical Trial Information
12.3.4. Safety and Efficacy
12.3.5. Analyst Views
13. Granulomatosis with Polyangiitis (GPA): 7MM Analysis
13.1. Key Findings
13.2. Market Outlook
13.3. Conjoint Analysis
13.4. Key Market Forecast Assumptions
13.4.1. Cost Assumptions and Rebates
13.4.2. Pricing Trends
13.4.3. Analogue Assessment
13.4.4. Launch Year and Therapy Uptakes
13.5. Total Market Size of Granulomatosis with Polyangiitis (GPA) in the 7MM
13.6. The United States
13.6.1. Total Market Size of Granulomatosis with Polyangiitis (GPA) in the US
13.6.2. Market Size of Granulomatosis with Polyangiitis (GPA) by Therapies in the US
13.7. EU4 and the UK
13.7.1. Total Market Size of Granulomatosis with Polyangiitis (GPA) in EU4 and the UK
13.7.2. Market Size of Granulomatosis with Polyangiitis (GPA) by Therapies in EU4 and the UK
13.8. Japan
13.8.1. Total Market Size of Granulomatosis with Polyangiitis (GPA) in Japan
13.8.2. Market Size of Granulomatosis with Polyangiitis (GPA) by Therapies in Japan
14. Unmet Needs of Granulomatosis with Polyangiitis (GPA)
15. SWOT Analysis of Granulomatosis with Polyangiitis (GPA)
16. KOL Views of Granulomatosis with Polyangiitis (GPA)
17. Market Access and Reimbursement of Granulomatosis with Polyangiitis (GPA)
17.1. The US
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
17.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
17.5. Market Access and Reimbursement of Granulomatosis with Polyangiitis (GPA) Therapies
18. Appendix
18.1. Bibliography
18.2. Report Methodology
19. Analyst's Capabilities
20. Disclaimer
21. About the Publisher
List of Tables [54]
List of Figures [45]
A selection of companies mentioned in this report includes, but is not limited to:
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