Immunoglobulin A (IgA) Nephropathy Market Assessment: Epidemiology, Treatment Landscape, Unmet Needs, Emerging Therapies, and Value & Access

Table of Contents

• An autoimmune nephropathy characterized by pathogenic immunoglobulin A (IgA) deposits in the glomerular mesangium
• Figure 1.1. Targets for IgAN treatments

• 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

• 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

• 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

• 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

• 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

• Primary market research approach
• Epidemiology methodology

Samples

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