150,000 US patients carry an IgA nephropathy diagnosis, but the biopsy-confirmed pool and the novel-therapy-eligible cohort inside it are far smaller and are what this model has to size precisely.
The funnel narrows sharply at each step. Adult primary IgA nephropathy incidence runs 1.29-2.2 new cases per 100,000 per year in a diverse US population, with the highest rates in patients of Asian ancestry and the lowest in Black patients. Because a confirmed diagnosis requires a kidney biopsy, an estimated 150,000 US patients carry the disease overall, but only 70,000-90,000 have a biopsy-confirmed diagnosis on record. Milder disease managed as chronic kidney disease without biopsy sits outside that confirmed pool entirely, understating the true prevalence a forecast has to account for.
Diagnosis is only the first gate. Of the biopsy-confirmed pool, just 5,000-8,000 patients are on a novel disease-modifying therapy today, a low penetration rate shaped by payer caution around the accelerated-approval status most of these agents still carry. The near-term addressable market is narrower still: an estimated 15,000-25,000 patients with UPCR above 1g/g and declining eGFR, already optimized on ACEi/ARB and increasingly SGLT2i, are the high-risk cohort nephrology KOLs and payers actually treat as eligible for a novel agent. Every conversion step in this funnel carries its source, live in the model.
US IgA nephropathy funnel — from total patient pool to the treatment-eligible high-risk cohort
| Funnel Stage | Population | Source |
|---|---|---|
| Total estimated US IgAN patient pool | 150,000 | AXLRx IgA Nephropathy Launch Readiness Brief (US) |
| Biopsy-confirmed diagnosis | 70,000–90,000 | AXLRx IgA Nephropathy Launch Readiness Brief (US); Am J Nephrol incidence analysis (PMID 39496243) |
| High-risk cohort (UPCR >1g/g, declining eGFR) | 15,000–25,000 | AXLRx IgA Nephropathy Launch Readiness Brief (US) |
| Currently on a novel disease-modifying therapy | 5,000–8,000 | AXLRx IgA Nephropathy Launch Readiness Brief (US) |
Sources: AXLRx IgA Nephropathy Launch Readiness Brief (US); Am J Nephrol adult IgAN incidence analysis (PMID 39496243); Nat Rev Dis Primers IgAN progression review (PMID 27189177); CJASN RaDaR registry kidney survival analysis (PMID 37055195).
What this model answers
Every section answers a named commercial question your team is asking, scoped to your asset.
Delivers
- The 70,000-90,000 biopsy-confirmed pool
- the 5,000-8,000 patients currently on a novel agent
- why the undiagnosed gap matters for forecasting
Delivers
- The 15,000-25,000 UPCR >1g/g high-risk cohort
- the ACEi/ARB and SGLT2i optimization gate patients must clear first
- why UPCR alone no longer defines eligibility
Delivers
- 8-sheet structure (Strategic Context, Inputs, Model, Projections, Sensitivity, References, Market Context, QC)
- source citation per conversion step from published nephrology literature and FDA labeling
Custom model delivered in 72 hours.
Commission This ModelWhat's inside
- Why the biopsy-confirmation gap, not incidence alone, sets the true diagnosed pool
- Pressure-tested against payer caution on accelerated-approval status before the rest of the model is built out
- 1.29-2.2 new adult IgAN cases per 100,000/yr, varying by ancestry
- Estimated 150,000 total US patient pool
- 70,000-90,000 biopsy-confirmed patients within the total pool
- Why undiagnosed CKD-managed disease sits outside the confirmed count
- 15,000-25,000 patients with UPCR >1g/g and declining eGFR
- ACEi/ARB and SGLT2i optimization as the eligibility gate
- 5,000-8,000 patients currently on a novel agent
- How accelerated-approval status and payer prior-authorization criteria shape uptake
- Which assumptions move the eligible pool most
- Scenario ranges across incidence, biopsy rate, and UPCR threshold
- Patient volume by horizon under conservative, base, and aggressive scenarios
- Revenue translation inputs
- The open questions your forecasting team must close before the model is finalised
- Structured for an internal forecast-review session
Included with every brief
How AXLRx builds this model
Prepared by MoatRx analysts.
Every AXLRx patient flow model is built on a five-layer funnel, Population, disease burden (E1), diagnosis and specialist capture (E2), treatment and biomarker eligibility (E3), market access (E4), then Year 1-3-5 projections across three scenarios. Delivered as a live Excel workbook, not a static table: 126 formulas across 8 sheets, zero hardcoded cells.
US IgA nephropathy sources: Am J Nephrol adult incidence analysis, Nat Rev Dis Primers progression review, CJASN RaDaR registry kidney-survival data, and AXLRx's own launch-readiness research on current novel-therapy uptake and payer prior-authorization criteria.
- Adult IgAN incidence range (1.29-2.2 per 100,000/yr) verified against Am J Nephrol population-based analysis (PMID 39496243)
- Total US patient pool, biopsy-confirmation rate, and current novel-therapy uptake verified against AXLRx IgA Nephropathy Launch Readiness Brief (US)
- High-risk UPCR >1g/g eligibility criteria verified against AXLRx IgA Nephropathy Launch Readiness Brief (US)
- Progression-to-ESKD and RaDaR kidney-survival figures verified against Nat Rev Dis Primers (PMID 27189177) and CJASN (PMID 37055195)
Frequently asked questions
Commission this model
AXLRx delivers nephrology patient flow models built for forecasting and launch teams sizing the US IgA nephropathy opportunity. Custom model in 72 hours.
Specify your indication, market, and cohort definition.
AXLRx analyst confirms funnel scope and comparator set before building.
Research-verified patient flow model in 72 hours with optional analyst readout.