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(Albany, US) On November 02, 2026, DelveInsight’s “Granulomatosis with Polyangiitis Market Insights, Epidemiology and Market Forecast – 2036” report provides comprehensive insights into the Granulomatosis with Polyangiitis (GPA) market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type, and examines the market drivers and barriers shaping the space.

Discover the latest drugs and treatment options in the Granulomatosis With Polyangiitis Pipeline @ https://www.delveinsight.com/report-store/granulomatosis-with-polyangiitis-market

Key Takeaways from the Granulomatosis With Polyangiitis Report

• In June 2026, the EMA’s CHMP recommended revoking the EU marketing authorization for TAVNEOS (avacopan). The review concluded the pivotal ADVOCATE trial breached good clinical practice, rendering the efficacy data unreliable, and cited safety risks including drug-induced liver injury and vanishing bile duct syndrome.

• In June 2026, Amgen announced new data presentations at EULAR 2026, including real-world evidence on avacopan’s efficacy and safety with reduced steroid use in ANCA-associated vasculitis.

• In October 2025, GSK outlined planned regulatory milestones for depemokimab in eosinophilic granulomatosis with polyangiitis (EGPA) for H2 2026.

• GPA is the most prevalent form of ANCA-associated vasculitis (AAV), with an estimated annual incidence of about 10 to 20 cases per million, and PR3-ANCA-positive disease represents about three-quarters of diagnosed cases.

• DelveInsight’s report depicts a space shifting from broad immunosuppression toward targeted, steroid-sparing therapies, with the US the largest market among the 7MM in 2025.

• Leading Granulomatosis With Polyangiitis companies include GSK, Amgen, NS Pharma, and others.

• Promising therapies include depemokimab, SHR-1703, avacopan (TAVNEOS), NS-229, rituximab (RITUXAN), and others.

Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Granulomatosis With Polyangiitis market

Granulomatosis With Polyangiitis Overview

GPA, formerly known as Wegener’s granulomatosis, is a rare systemic autoimmune disorder characterized by necrotizing inflammation of small- to medium-sized blood vessels and granuloma formation, primarily affecting the upper respiratory tract, lungs, and kidneys. It belongs to the group of ANCA-associated vasculitides, with most patients testing positive for PR3-ANCA. Diagnosis combines clinical presentation, ANCA serology, imaging, and tissue biopsy when feasible. Treatment is divided into induction and maintenance. Severe disease is typically induced with rituximab or cyclophosphamide plus glucocorticoids, and maintenance uses rituximab, azathioprine, or methotrexate. Relapse, cumulative organ damage, and long-term corticosteroid toxicity remain key challenges.

Common manifestations include:

• Chronic sinusitis, nasal crusting, or ulcers

• Cough, hemoptysis, and pulmonary nodules

• Rapidly progressive glomerulonephritis

• Musculoskeletal, ocular, and skin involvement

• Peripheral nervous system involvement

Granulomatosis With Polyangiitis Emerging Drugs Profile

Depemokimab: GSK Depemokimab is an ultra-long-acting anti-IL-5 monoclonal antibody for eosinophil-driven inflammatory diseases, including EGPA. By inhibiting IL-5, a cytokine central to eosinophil growth and survival, it aims to provide sustained suppression of eosinophilic inflammation with less frequent dosing, reduce relapses, and lower corticosteroid dependence. It is given subcutaneously. Currently, the drug is in Phase III.

NS-229: NS Pharma NS-229 is an investigational oral, selective JAK1 inhibitor for EGPA. By modulating cytokine signaling involved in eosinophilic inflammation and immune activation, it aims to reduce vascular inflammation, control disease activity, and decrease corticosteroid dependence. Currently, the drug is in a global Phase II trial.

Explore groundbreaking therapies and clinical trials in the Granulomatosis With Polyangiitis Pipeline @ Granulomatosis With Polyangiitis market research

Granulomatosis With Polyangiitis Market Drivers

• Shift to targeted, steroid-sparing therapy: Rituximab and avacopan have moved care away from broad immunosuppression, and the aim is to improve remission, cut relapses, and limit glucocorticoid exposure.

• Better recognition and diagnosis: Growing awareness of AAV, wider ANCA testing, and improved imaging support earlier diagnosis and a larger identified patient population.

• Precision diagnostics and monitoring: ANCA serology, refined classification criteria, and better disease monitoring improve patient stratification and early relapse detection.

• Active pipeline: Depemokimab and NS-229 target eosinophilic and cytokine-driven pathways, and SHR-1703 is also in development.

• Large unmet need: Persistent relapse, cumulative organ damage, and long-term steroid toxicity sustain demand for safer, more durable options.

• Increasing biologic adoption: Rituximab is guideline-supported for induction and maintenance in moderate-to-severe disease.

Learn about new drugs, pipeline developments, and key players with DelveInsight’s expert analysis @ Granulomatosis With Polyangiitis market insight

Granulomatosis With Polyangiitis Market Barriers

• Safety and regulatory uncertainty for avacopan: The proposed EU revocation, citing data reliability and safety concerns, could weaken the leading steroid-sparing option.

• High treatment costs and reimbursement constraints: These may moderate uptake of newer agents.

• Entrenched rituximab: Broad physician familiarity and a well-established profile set a high bar for new entrants.

• Rarity of the disease: A small patient population limits trial recruitment and commercial scale.

• Limited biomarkers: There are few reliable markers of disease activity and relapse prediction.

• Long-term immunosuppression risks: Infection burden and cumulative toxicity limit the benefit of current regimens.

• Pipeline focus on EGPA: Both profiled late- and mid-stage candidates target EGPA, so GPA-specific evidence is still limited.

Scope of the Granulomatosis With Polyangiitis Report

• Coverage: 7MM (US, EU4, UK, Japan)

• Companies: As listed above

• Therapies: Depemokimab, SHR-1703, avacopan (TAVNEOS), NS-229, rituximab (RITUXAN), and others

• Assessment by Product Type: Mono, Combination, Mono/Combination

• Assessment by Clinical Stage: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Download DelveInsight’s in-depth Granulomatosis With Polyangiitis report today! @ Granulomatosis With Polyangiitis market trends

Table of Contents

1. Introduction

2. Executive Summary

3. Granulomatosis With Polyangiitis: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. DelveInsight’s Analytical Perspective

7. Late Stage Products (Phase III): Depemokimab (GSK)

8. Mid Stage Products (Phase II): NS-229 (NS Pharma)

9. Early Stage Products (Phase I): None currently

10. Preclinical and Discovery Stage Products

11. Inactive Products

12. Key Companies

13. Key Products

14. Unmet Needs

15. Market Drivers and Barriers

16. Future Perspectives and Conclusion

17. Analyst Views

18. Appendix

19. About Us

About DelveInsight DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.

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