ANCA Vasculitis Market to Reach USD 3.8 Billion by 2036 at 6.5% CAGR Across the 7MM
(Albany, New York) – October 19, 2026: DelveInsight’s “ANCA Vasculitis Market Insights, Epidemiology and Market Forecast – 2036” report delivers an in-depth understanding of ANCA Vasculitis, historical and forecasted epidemiology, and the ANCA Vasculitis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
Key Takeaways from ANCA Vasculitis Market Report
• The ANCA Vasculitis market in the 7MM is projected to grow from approximately USD 1.8 billion in 2025 to nearly USD 3.8 billion by 2036, registering a CAGR of around 6.5% during the forecast period from 2026 to 2036.
• According to DelveInsight’s estimates, there were approximately 226,000 diagnosed prevalent cases of ANCA vasculitis across the 7MM in 2025, with the United States accounting for the highest share.
• Among EU4, Germany accounted for the largest number of diagnosed prevalent cases of ANCA Vasculitis, followed by Italy, whereas Spain accounted for the lowest cases in 2025.
• Granulomatosis with polyangiitis (GPA) was found to be more prevalent than any other type of ANCA Vasculitis in the United States (~35,000).
• In 2025, pANCAs/MPO-ANCAs represented the most commonly diagnosed antibody-specific subtype of AAV in MPA, accounting for approximately 28,000 cases in the US.
• In March 2026, Amgen announced continued commercial expansion of avacopan (TAVNEOS) for ANCA-associated vasculitis following increasing global uptake as a steroid-sparing complement 5a receptor inhibitor.
• The leading ANCA Vasculitis companies developing therapies in the treatment market include GSK, CSL, Amgen, NS Pharma, Novartis, NovelMed, and others.
• Promising ANCA Vasculitis therapies include depemokimab (GSK3511294), NS-229, FABHALTA (iptacopan), ruxoprubart, and others.
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What is ANCA Vasculitis?
ANCA vasculitis is a rare, life-threatening autoimmune disease characterized by inflammation and destruction of small blood vessels, which can lead to significant organ damage. The disease primarily affects the kidneys, lungs, upper respiratory tract, skin, nerves, and other organs. It is broadly classified into three major subtypes: granulomatosis with polyangiitis (GPA, formerly Wegener granulomatosis), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA, previously Churg-Strauss syndrome), each differing in clinical presentation and organ involvement. The disease occurs when the immune system mistakenly attacks healthy blood vessels, leading to inflammation, reduced blood flow, and tissue damage. If left untreated, ANCA vasculitis can result in severe complications such as kidney failure, pulmonary hemorrhage, and permanent organ dysfunction. Diagnosis involves clinical evaluation, laboratory testing (including PR3-ANCA and MPO-ANCA), imaging studies, and tissue biopsy to confirm disease subtype and assess organ involvement.
ANCA Vasculitis Epidemiology Segmentation in the 7MM
• Total Diagnosed Prevalent Cases of ANCA Vasculitis
• Type-specific Diagnosed Prevalent Cases of ANCA Vasculitis
• Severity-specific Diagnosed Prevalence of ANCA Vasculitis
• Diagnosed Prevalent Cases of ANCA Vasculitis by Organ Involvement
• Diagnosed Prevalent Cases of ANCA Vasculitis by Antibody Type
• Total Treated Cases of ANCA Vasculitis
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ANCA Vasculitis Approved Therapies
• Mepolizumab (NUCALA): GlaxoSmithKline
NUCALA is a first-in-class monoclonal antibody targeting IL-5, blocking its interaction with receptors on eosinophils. In November 2021, the European Commission approved additional indications for NUCALA in eosinophil-driven diseases, including HES, EGPA, and chronic rhinosinusitis with nasal polyps, as an add-on therapy.
• Avacopan (TAVNEOS): CSL/Amgen
TAVNEOS, developed by Amgen and CSL (outside the US), is a first-in-class, orally administered small molecule approved by the FDA as an adjunctive treatment for adults with severe active AAV, offering a highly targeted mechanism in complement-driven inflammation. In August 2022, NICE recommended TAVNEOS in combination with rituximab or cyclophosphamide for adult patients with severe GPA or MPA following MHRA approval in May 2022. In March 2023, it was also included in the updated EULAR AAV management recommendations.
ANCA Vasculitis Pipeline Analysis
• Depemokimab (GSK3511294): GlaxoSmithKline
Depemokimab is a humanized anti-IL-5 monoclonal antibody (IgG1, kappa) designed with an extended half-life and higher IL-5 affinity than approved anti-IL-5 therapies. It binds the same epitope as mepolizumab, with modifications intended to prolong duration of action without altering efficacy or safety, and has shown ~29-fold greater IL-5 potency in vitro. It is currently in Phase III development, including the OCEAN study for EGPA, with top-line results expected in H2 2026 and potential European regulatory submissions in 2026.
• NS-229: NS Pharma
NS-229 is a potent, selective JAK1 inhibitor developed in-house, designed to suppress the overactivation of T cells, B cells, and other white blood cells, thereby potentially reducing tissue damage and symptoms in EGPA. It is currently being evaluated in a Phase II randomized, double-blind, placebo-controlled global study by Nippon Shinyaku and NS Pharma. NS-229 received Orphan Drug Designation from the EC in January 2024 and the US FDA in April 2025, followed by FDA Fast Track Designation in September 2025.
ANCA Vasculitis Companies
GSK, CSL/Amgen, NS Pharma, Novartis, NovelMed, and others
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ANCA Vasculitis Market Outlook
ANCA vasculitis treatment has historically relied on broad immunosuppressive regimens such as cyclophosphamide, glucocorticoids, azathioprine, methotrexate, and mycophenolate mofetil, which are effective in inducing remission but are associated with significant long-term toxicities, infection risks, and high relapse rates. The introduction of rituximab (RITUXAN/MabThera) significantly transformed the treatment landscape by offering a targeted B-cell depletion approach for both remission induction and maintenance therapy. A major shift occurred with the approval of avacopan (TAVNEOS), a first-in-class oral C5a receptor inhibitor that reduces dependence on chronic steroid use. The emerging pipeline is increasingly focused on complement inhibition, precision immunology, and safer long-term disease control, with key emerging therapies including iptacopan (Novartis), ruxoprubart (NovelMed Therapeutics), tarperprumig (Alexion/AstraZeneca), and cell-based immunotherapies such as NKX019 (Nkarta). Despite these advances, the market continues to face challenges, including delayed diagnosis, small patient populations, high biologic costs, relapse risk, and long-term monitoring requirements. However, increasing physician awareness, improved ANCA diagnostic testing, favorable reimbursement for rare diseases, and the expected launch of novel targeted therapies are anticipated to drive gradual market growth over the forecast period.
Scope of the ANCA Vasculitis Market Report
• Study Period: 2022-2036
• Forecast Period: 2026-2036
• Coverage: 7MM
• ANCA Vasculitis Companies: GSK, CSL/Amgen, NS Pharma, Novartis, NovelMed, and others
• ANCA Vasculitis Therapies: Mepolizumab (NUCALA), Avacopan (TAVNEOS), Depemokimab (GSK3511294), NS-229, Iptacopan (FABHALTA), and others
• ANCA Vasculitis Therapeutic Assessment: ANCA Vasculitis current marketed and emerging therapies
• ANCA Vasculitis Market Dynamics: ANCA Vasculitis market drivers and market barriers
• Competitive Intelligence Analysis: SWOT analysis, Conjoint Analysis, KOL Views, Unmet Needs, Reimbursement
Table of Contents
1. Key Insights
2. Report Introduction
3. Executive Summary
4. Key Events
5. Epidemiology and Market Forecast Methodology of ANCA Vasculitis
6. ANCA Vasculitis Market Overview at a Glance
7. Disease Background and Overview of ANCA Vasculitis
8. Epidemiology and Patient Population of ANCA Vasculitis
9. Patient Journey of ANCA Vasculitis
10. ANCA Vasculitis Marketed Therapies
11. Emerging Drugs
12. ANCA Vasculitis: 7MM Analysis
13. Unmet Needs of ANCA Vasculitis
14. SWOT Analysis of ANCA Vasculitis
15. KOL Views of ANCA Vasculitis
16. Market Access and Reimbursement of ANCA Vasculitis
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight
About Us
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