Immunoglobulin A (IgA) Nephropathy (U.S.), July 2023
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: Gain insights into the drug pricing landscape and payer controls within the disease market or analogous markets
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:
- BLyS/APRIL targeted therapies (Novartis’ zigakibart, Vera’s atacicept, Otsuka’s sibeprenlimab)
- MASP-2 targeted therapies (Omeros’ narsoplimab)
- 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.”
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
What is the difference between purchasing a published report and requesting a new report?
Published reports have been pre-produced on the specified date and can be delivered immediately. If you prefer to refresh an existing report or request an entirely new disease, REACH can create and deliver any new report within 15 business days.
How does REACH produce new primary market research reports in 15 business days?
By deploying our senior team to each of our reports, we can begin insight generation on day 1. The REACH team also recruits Key Opinion Leaders from our internal panel rather than outsourcing recruitment which enables us to quickly begin primary market research interviews.
Who writes REACH reports?
Each REACH report is produced by one of our senior US-based team members with 10+ years of experience in life sciences market research. We are deeply committed to ensuring REACH reports are high quality and strategic to enable informed decision-making for our clients.
Does REACH cover both rare and non-rare diseases?
REACH specializes in covering diseases and subpopulations that are not addressed by traditional market research reports. As such, we focus on rare diseases and niche subpopulations of more common conditions (e.g., Dupixent-refractory atopic dermatitis). Our flexible model enables in-depth assessments across all disease types, allowing us to support research for non-rare conditions as well.
Can I meet with the team to discuss the report?
Contact us to set up a call directly with the analyst who has written the report to answer any questions and discuss the key takeaways.
Published Report
New Report
Undecided about purchasing this report?
Reach out to learn more about report bundle discounts