Hereditary Angioedema Market Size, Share, Growth, Trends, and Global Industry Analysis: By Product (Kalbitor, Ruconest, Icatibant, Firazyre, Berinert, Orladeyo, Cinryze, Haegarda and Takhzyro), By Drug Class (C1-esterase inhibitor, Bradykinin B2 receptor antagonist, Kallikrein inhibitor and Others) By Route of Administration (Intravenous, Subcutaneous and Oral) and Region Forecast 2020-2031

Hereditary Angioedema Market size was valued at US$ 3,761.1 million in 2024 and is expected to reach US$ 34,770.9 million by 2031, growing at a significant CAGR of 37.4% from 2025-2031. Hereditary Angioedema (HAE) is a hereditary disease. There is a 50% probability that a parent with HAE will pass it on to their offspring. As a result of a spontaneous gene mutation, HAE can also develop in people with no family history. HAE is managed by acute attack management, short-term prophylaxis, and long-term prophylaxis. The Kalbitor, Ruconest, Icatibant, Firazyr and Berinert are using for acute attack management. The Orladeyo, Cinryze, Haegarda, and Takhzyro drugs are using for short-term and long term prophylaxis treatment. The diversity of HAE's phenotype makes diagnosis challenging. Initial misdiagnoses happen frequently.

For instance, HAE-related edoema can be mistaken for an allergic reaction. It is possible to misinterpret gastrointestinal symptoms for the gastrointestinal disease alone. Due to its rarity and significant symptom overlap with other conditions, HAE is rarely detected early, usually disregarded, and misdiagnosed. The right diagnosis typically takes a patient more than 10 years after the onset of symptoms. Even though the illness is uncommon, it is dangerous.

STAR 0125 for Hereditary Angioedema Therapeutics and Market Value (US$ Million), 2027 -2030 in USA

Key Developments

• In February 2023, BioCryst Pharmaceuticals, Inc. unveiled major statistics from the APeX-S and APeX-2 clinical trials which assessed oral, once-daily ORLADEYO® (berotralstat) for the preventative treatment of hereditary angioedema (HAE) exhibiting sustained declines in attack rates and a boost in quality of life (QoL) among patients living with HAE, showcasing its profile as a well-tolerated, effective and convenient prophylactic HAE therapeutic option.
• In September 2022, CSL Behring has received manufacturing and marketing approval from MHLW (Japan) for Berinert® S.C. Injection 2000, for the prevention of acute HAE attacks. Berinert® S.C. Injection 2000 is administered twice-weekly as subcutaneously and it can be self-administered at home.
• In August 2022, CSL Behring’s Garadacimab (CSL312), the company's experimental first-in-class monoclonal antibody blocking Factor XIIa that is being developed as a long-term preventative therapy for individuals with hereditary angioedema, has received good top-line Phase 3 findings (HAE). The trial accomplished its primary and secondary effectiveness goals while also demonstrating good safety and acceptability. CSL intends to begin submitting with global health authorities for complete clearance by the conclusion of the current fiscal year.
• In June 2019, Channel Medsystems received CE Mark for its Cerene Cryotherapy Device (Cerene device) to market in Europe

KalVista (Sebetralstat – On Demand & KVD-824 - Prophylaxis) for Hereditary Angioedema Therapeutics and Market Value (US$ Million), 2024 -2029 in USA