ANCA-Associated Vasculitis (U.S.), January 2023
The MarketVue®: ANCA-associated vasculitis market landscape report combines primary (KOL interviews and survey data) and secondary market research to empower strategic decision-making and provide a complete view of the market.
Every MarketVue® includes a disease overview, epidemiology (US and EU5), current treatment, unmet needs, pipeline and access and reimbursement chapter.
Topics covered in this report:
- Disease overview: Review the disease pathophysiology and potential druggable targets
- Epidemiology: Understand prevalence, diagnosed and drug-treated prevalence of the population and key market segments
- Current treatment: Understand the treatment decision tree and strengths and weaknesses of current on-label and off-label treatment
- Unmet needs: Identify opportunities to address treatment or disease management gaps
- Pipeline analysis: Compare current and emerging therapy clinical development strategy; their performance on efficacy, safety, and delivery metrics; and their potential to address unmet needs
- Value and access: Gain insights into the drug pricing landscape and payer controls within the disease market or analogous markets
Methodology:
Research for the MarketVue®: ANCA-associated vasculitis report is supported by 5 qualitative interviews with key opinion leaders, a quantitative survey with 26 U.S. physicians and secondary research. Qualitative interview participants included 3 Rheumatologists, 1 Nephrologist, and 1 Pulmonologist (all U.S.).
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
Key companies mentioned:
- Amgen
- GlaxoSmithKline
- ChemoCentryx / Amgen
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- AstraZeneca
Key drugs mentioned:
- Avacopan (Tavneos)
- Mepolizumab (Nucala)
- Rituximab
- Cyclophosphamide (Cytoxan)
- Azathioprine
- Mycophenolate mofetil
- Methotrexate
- Glucocorticoids
- Prednisone
- Benralizumab (Fasenra)
- Dupilumab (Dupixent)
- BDB-001
- Depemokimab
Key takeaways from the report:
AAV is a chronic organ-threatening autoimmune condition marked by inflammation of small-to-medium blood vessels.
Previously a life-threatening disease, there has been improvement in prognosis for AAV since introduction of immunosuppressive treatments to manage the condition – non-steroidal immunosuppressants with corticosteroids is the current standard of care.
While corticosteroids effectively induce and sustain remission, findings from REACH’s MarketVue® assessment show that >60% of surveyed physicians report high need for steroid-sparing induction and maintenance treatments, due to concerns over safety associated with long-term steroid use. As one rheumatologist comments: “To not require steroids would be very good, and that was the purpose of the avacopan trial.”
Physicians are eager for steroid-sparing treatments, which explains the positive feedback about avacopan’s ability to get patients off steroids in as quickly as a month.
Meghana Pandit, REACH Analyst: “To supplant current therapies, newer agents must be able to induce long-term remission, reduce corticosteroid burden, and prevent relapses.”
Few companies are developing therapies for AAV to induce remission on minimal steroids; the main primary outcome across AAV trials, including:
- AstraZeneca’s benralizumab for eosinophilic GPA (EGPA)
- GlaxoSmithKline’s depemokimab for EGPA
Presently, there are no late-stage trials for MPA and GPA, which affirms Tavneos’ strong position in the AAV market.
1. DISEASE OVERVIEW
A heterogenous group of chronic, life-threatening, autoimmune disorders marked by inflammation of small-to-medium blood vessels
Figure 1.1. ANCA-associated vasculitis autoantibodies
Blocking neutrophil priming has a therapeutic role in AAV management
Figure 1.2. Pathogenesis of AAV and associated drug targets
2. EPIDEMIOLOGY & PATIENT POPULATIONS
Disease definition
Figure 2.1. Diagnosed prevalent cases of ANCA-associated vasculitis by region
Table 2.1. Diagnosed prevalent and drug-treated patients in the US and EU5
3. DIAGNOSIS & CURRENT TREATMENT
Overview
Figure 3.1. Referral and diagnostic pathway for AAV patients
Steroid-free long-term disease remission is a difficult-to-achieve goal in AAV
Table 3.1. Treatment goals for AAV patients
Figure 3.2. Physician-reported percentage of ANCA-vasculitis patients receiving some form of drug therapy
Treatment flow for ANCA-associated vasculitis (AAV)
Immune suppression is the mainstay of care in both induction and maintenance phases
Figure 3.3. Physician-reported current treatment share for AAV patients
Figure 3.4. Physician-reported % of patients with refractory disease
Upsides and downsides of current AAV treatments
Relapse rates are high in AAV; over 15% of AAV patients do not achieve remission with current txs
Figure 3.5. Physician-reported proportion of AAV pts achieving different levels of disease responses
Table 3.2. Physician-reported remission and relapse patterns in AAV patients
Avacopan is viewed favorably by physicians for its oral dosing an quick steroid-tapering ability
Figure 3.6. Physician-reported experience with/impression of new AAV therapies
Physician perspectives on avacopan product attributes
Key treatment dynamics that will shape disease management and drug use in AAV
Table 3.3. Must-know AAV treatment dynamics
Improvements over steroid-sparing ability and/or steroid-free remission is the future of AAV therapy
Figure 3.7. Improvement dynamics of AAV market evolution
4. UNMET NEED
Overview
Figure 4.1. Top unmet needs in ANCA-associated vasculitis
Figure 4.2. Physician-reported unmet needs in ANCA-associated vasculitis
Physician perspectives on unmet needs in AAV
5. PIPELINE ANALYSIS
Overview
Figure 5.1. Physician-reported perspectives on promising targets/mechanisms of action for AAV
Table 5.1. Comparison of targets within the terminal complement pathway
The pipeline for AAV is sparse with three therapies targeting the immune system
Table 5.2. Comparison of ongoing trials of therapies for ANCA-associated vasculitis
Physician perspectives on drug development in AAV
6. VALUE & ACCESS
Overview
Table 6.1. Current AAV therapy pricing, U.S.
Table 6.2. Typical U.S. commercial payer coverage of approved AAV therapies
The recenty acquired Chemocentryx and GSK have laid a pathway to increase access
Table 6.3. The 3 P’s of measuring access for new therapies entering the AAV market based on Tavneos
7. METHODOLOGY
Primary market research approach
Epidemiology methodology
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