MarketVue®: Immunoglobulin A (IgA) Nephropathy
The MarketVue®: IgA Nephropathy 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®: IgA Nephropathy report is supported by 3 qualitative interviews with key opinion leaders, a quantitative survey with 25 U.S. physicians and secondary research.
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
Key companies mentioned:
• Calliditas Therapeutics
• Travere Therapeutics
• Novartis
• Chinook Therapeutics/Novartis
• Ionis/Roche
• Vera Therapeutics
• Otsuka
• Omeros
• ChemoCentryx/Amgen
• Alnylam
• Alexion/AstraZeneca
• MorphoSys / Biogen
• Apellis Pharmaceuticals
• KeyMed Bio/Rona Therapeutics
• Eledon Pharmaceuticals
• Alpine Immune Sciences
• Takeda Pharmaceuticals
Key drugs mentioned:
• Sparsentan (Filspari)
• Budesonide (Tarpeyo)
• Dapagliflozin (Farxiga)
• Canagliflozin (Invokana)
• Spironolactone (Aldactone)
• Atrasentan
• Iptacopan / LNP023 (Fabhalta)
• IONIS-FB-LRx / RO7434656
• Zigakibart / BION-1301
• Atacicept
• Sibeprenlimab
• Narsoplimab
• Avacopan (Tavneos)
• Cemdisiran
• Ravulizumab (Ultomiris)
• Felzartamab
• Pegcetacoplan (Empaveli)
• Vemircopan
• CM338
• Tegoprubart
• Povetacicept / ALPN-303
• Mezagitamab / TAK-079
Key takeaways from the report:
IgA nephropathy (IgAN) is an autoimmune glomerular disease and leading cause of chronic kidney disease. Published studies on IgAN outcomes indicate that up to 50% of patients progress to end stage renal disease suggesting significant room for improvement to reduce risk of disease progression.
Until the FDA accelerated approvals of Calliditas’ Tarpeyo (delayed-release budesonide) in 2022 and Travere’s Filspari (sparsentan) in 2023, treatment consisted of:
• Angiotensin converting-enzyme inhibitors
• Angiotensin receptor blockers
• Diuretics
• Anticoagulants
• Sodium-glucose cotransporter-2 inhibitors
• Glucocorticoids
Surveyed nephrologists by REACH Market Research report they are already prescribing Filspari or Tarpeyo in up to 20% of their IgAN patients in the hope these new options can improve outcomes for patients unresponsive to existing treatments.
Nephrologist, U.S. — ""If the patient is not responding, it is Tarpeyo versus Filspari. We have used both for patients who still have significant urine protein despite maximizing medical therapy, especially if they could not tolerate steroids.""
Reflecting high unmet need in this patient population, the IgAN pipeline is dense with multiple novel classes of products in late-stage development, including:
o BLyS/APRIL targeted therapies (Novartis’ zigakibart, Vera’s atacicept, Otsuka’s sibeprenlimab)
o MASP-2 targeted therapies (Omeros’ narsoplimab)
o Factor B targeted therapies (Novartis’ iptacopan, Roche’s RO7434656)
Melissa Curran, Senior Director at REACH: “It is an exciting time for the IgAN patient community with so many novel therapeutics likely to be approved in the coming years. We anticipate emerging IgAN therapies will position themselves as either induction treatments to gain rapid disease control or as maintenance treatments for long-term use.”
Please note: the online download version of this report is for a global site license.
- 1. DISEASE OVERVIEW
- An autoimmune nephropathy characterized by pathogenic immunoglobulin A (IgA) deposits in the glomerular mesangium
- Figure 1.1. Targets for IgAN treatments
- 2. EPIDEMIOLOGY & PATIENT POPULATIONS
- Disease definition
- Figure 2.1. Prevalent cases of primary IgAN by region
- Table 2.1 Diagnosed prevalent populations of primary IgAN in the U.S. and EU5
- Proteinuria and eGFR are important to consider in assessing risk of progression and treatment response
- Table 2.2. KDIGO 2021 clinical criteria for assessing risk of progression in IgAN
- Figure 2.2. Percentage of IgAN patients by proteinuria (g/d) according to surveyed nephrologists (n=25)
- Figure 2.3. eGFR of patients with ≥0.5 g/d proteinuria according to surveyed nephrologists (n=25)1
- 3. DIAGNOSIS & CURRENT TREATMENT
- Diagnosis overview
- Figure 3.1. Diagnostic pathway for IgAN patients
- Timing of kidney biopsy for IgAN patients varies
- Figure 3.2. Percentage of IgAN patients with delayed or misdiagnosis according to surveyed nephrologists (n=25)
- Delaying end-stage renal disease as long as possible is the ultimate goal of treatment
- Figure 3.3. Phases of IgAN disease progression
- Table 3.1. Treatment goals for IgaN
- Treatment flow for primary IgAN
- Almost half of patients receive therapies second-line to supportive therapy (ACEi/ARB and SGLT2)
- Figure 3.4. Current treatment share
- Upsides and downsides of current IgAN treatments
- Comparison of FDA approved treatments for IgAN
- Table 3.2. Comparison of FDA approved IgAN treatments
- Figure 3.5. Phase 3 results for Calliditas’ Tarpeyo vs Travere’s Filspari
- Surveyed nephrologists are impressed with both FDA recently approved products for IgAN
- Figure 3.6. Physician-reported experience/impression of IgAN FDA-approved products
- After an IgAN patient fails ACEis/ARBs and SGLT2, limited treatment options exist
- Figure 3.7. Level of response achieved with current IgAN treatments
- Physician perspectives on FDA approved IgAN treatments
- Key treatment dynamics that will shape disease management and drug use in IgAN
- Table 3.3. Must-know IgAN treatment dynamics
- Figure 3.8. Important dynamics of IgAN market evolution
- 4. UNMET NEED
- Overview
- Figure 4.1. Nephrologist-reported unmet needs in IgAN
- The need for new IgAN treatments is moderate-high compared to other glomerular diseases
- Figure 4.2. U.S. nephrologists rating of the need for new treatments in nephrological conditions
- Physician insights on the most urgent unmet needs for IgAN
- 5. PIPELINE ANALYSIS
- Overview
- Figure 5.1. Nephrologist-reported most promising therapeutic targets in IgAN
- The IgAN pipeline is very active with various mechanisms being studied
- Table 5.1. Comparison of ongoing phase 3 trials of therapies for IgAN1
- Table 5.2. Comparison of ongoing phase 1 and 2 trials of therapies for IgAN
- Basket trials measuring reduction in proteinuria are becoming a common way to study renal diseases
- Figure 5.2. Phase 2 trial design for IgAN
- Table 5.3. Design of pivotal trials in IgAN1
- Physician insights on emerging therapies
- 6. VALUE & ACCESS
- Overview
- Table 6.1. IgAN therapy pricing, U.S.
- Table 6.2. ESRD treatment option costs, U.S.
- Commercial insurers will be the most relevant US payer for novel therapeutics in IgAN
- Table 6.3. Typical U.S. commercial payer coverage of Tarpeyo and Filspari for IgAN patients (United Healthcare, Aetna, BlueCross BlueShield, Cigna)
- Figure 6.1. IgAN patients by insurance type
- 7. METHODOLOGY
- Primary market research approach
- Epidemiology methodology
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