Every AXLRx Hereditary Angioedema report, across 9 report types and 3 markets. Each is scoped to your asset and verified to a live source.
The prophylaxis class is fracturing along route: oral berotralstat and the first oral on-demand agent against a still-injectable antibody field.
HAE pathophysiology, the Type I/II split, attack burden and the diagnostic-delay problem that defines the US in-market landscape.
Specialty-tier prior authorization, prophylaxis above $300K/patient/yr, ICER 2018/2021 value-based benchmarks and no-concurrent-acute-agent rules.
GCC HAE management is acute-only — prophylaxis penetration is near zero, more than 85% of patients are undiagnosed, and NPHC coverage for lanadelumab would be the access trigger for the region's largest market.
Three NICE technology appraisals (TA606, TA738, TA1101) each carry a confidential Patient Access Scheme, so garadacimab's published £20,625 per-pen price is the only fully transparent figure in the class, and two MHRA-licensed agents still have no NICE-confirmed net price.
Lanadelumab tenders at SAR 300,000-400,000 a year, but NPHC has no routine formulary price at all; access runs through an individual-case bar only 30-40% of submissions clear, while private VHI approves at a materially lower documentation threshold.
An estimated 8,000-9,000 Americans have HAE; only 35-40% receive any prophylaxis, leaving 2,500-4,000 attack-eligible patients never treated, a pool nearly as large as the entire treated population.
A 37-centre national survey confirms 1,152 UK HAE type I/II patients, a top-down 1:32,000 prevalence rate implies roughly 2,000, and the UK HAE Alliance's broader planning estimate runs to 5,000-6,000, of which only 1,500-2,000 are on prophylaxis today.
Epidemiology implies 1,200-1,500 true GCC HAE patients; the KFSH&RC registry confirms fewer than 200; and a separate planning estimate used for launch work lands at 400-600 — three numbers, one diagnostic-capacity story.
An estimated 8,000-9,000 Americans live with hereditary angioedema. Just 35-40% receive any prophylaxis, leaving 2,500-4,000 patients who meet treatment criteria untreated, the funnel this model sizes precisely.
England's NICE has issued three positive technology appraisals funding HAE prophylaxis since 2019 (TA606, TA738, TA1101), but the two newest MHRA-licensed agents, donidalorsen and sebetralstat, remain in NICE appraisal with no confirmed final NHS funding decision.
The UK HAE Alliance counts 5,000-6,000 total patients, of whom 1,500-2,000 are on NICE-commissioned prophylaxis. A further 1,500-2,500 are attack-active but never treated, and Longhurst et al.'s 37-centre registry confirms 1,152 patients from the bottom up.
Epidemiology projects 1,200-1,500 GCC HAE patients; the GCC allergy society's own case registry counts only 400-600. The gap is not a contradiction, it is the diagnostic-capacity constraint of just 6-10 specialist physicians across all six states.
Five NHS specialist centres, Sheffield, Cambridge, Birmingham, Guy's and St Thomas', and Manchester, manage more than 90% of UK HAE patients. That concentration is what this workbook sizes before any physician enters the K1-K6 gate structure.
KFSH&RC, AUH, and Hamad Medical Corporation anchor a GCC HAE specialist community that SACIA sizes at just 6-10 physicians regionwide. That concentration is exactly what this workbook sizes before any individual name enters it.
HAE family cascade screening opportunity, laryngeal attack burden, and the prophylactic therapy access gap across GCC specialist centres.
UK HAE Alliance genetic testing, an 87% attack-rate reduction on lanadelumab, and the NICE TA606 prophylaxis standard defining NHS management.
Binding constraint: grow the never-prophylaxed cohort before donidalorsen resets the oral efficacy bar — not switch stable lanadelumab patients.
NICE TA606 commissioned lanadelumab with PAS and 87.5% real-world attack reduction — berotralstat's NICE TA738 recommendation is now tested against that same benchmark.
Three completed NICE standard technology appraisals already fund HAE prophylaxis in England (TA606, TA738, TA1101), every one cleared at the ordinary £20,000 to £30,000 per QALY bar and held behind a confidential Patient Access Scheme, so a new entrant inherits a comparator-dense field in which garadacimab's £20,625 list pen is the only transparent price.
GCC HAE access is structurally two-tier — broad acute coverage, but an NPHC individual-case prophylaxis bar only 30-40% of applicants clear, and private insurance beats the NPHC pathway on speed.
HAE prophylaxis barely exists as a category in GCC — under 15% of patients are on any prophylaxis versus 35-40% in the US, making this category creation, not competitive share capture.
The never-prophylaxed growth market lanadelumab leaves open, the PAS discount needed to clear NICE's standard TA bar, and the donidalorsen clock a fast-moving competitor is running against you.
Lanadelumab lists near $450,000 a year against berotralstat's roughly $95,000, and ICER's 2021 fair-value benchmark for berotralstat lands almost exactly on that list price. The three 2025 entrants carry no ICER anchor of their own.
AXLRx publishes Competitive Intelligence, Disease Landscape, Payer & HTA, Pricing Strategy Model, Market Sizing Model, Patient Flow Model, KOL Mapping, Launch Readiness, and HTA Strategy Model for Hereditary Angioedema. Each report is scoped to your asset, verified to a live source, and delivered in 72 hours.
Current Hereditary Angioedema coverage spans United States, GCC (Gulf), and United Kingdom. Additional markets can be commissioned against the same evidence standard.
Every figure is cited to a live source at the point of writing and re-checked in an independent audit pass. The latest Hereditary Angioedema reports were updated July 2026.