MarketVue®: Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
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: Review the evidence needed to assess and communicate value to key stakeholders (e.g., providers, payers, regulators) and learn what competitors have done or are doing
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.
Please note: the online download version of this report is for a global site license.
- 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
Research Assistance
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