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ANCA-Associated Vasculitis Market Assessment: Epidemiology, Treatment Landscape, Unmet Needs, Emerging Therapies, and Value & Access

  • Report

  • 25 Pages
  • January 2023
  • Region: Global
  • REACH Market Research
  • ID: 5996424
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 this 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.

An analyst from the research firm, stated: '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.

Table of Contents

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

Samples

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Companies Mentioned

  • Amgen
  • GlaxoSmithKline
  • ChemoCentryx / Amgen
  • Staidson (Beijing) Biopharmaceuticals Co., Ltd
  • AstraZeneca