DelveInsight, a leading market research firm, announces the release of its latest report, “DelveInsight’s Hereditary Angioedema (HAE) Market Insights, Epidemiology, and Market Forecast 2036.” This comprehensive report provides an in-depth understanding of HAE, including historical and forecasted epidemiology, market trends, and treatment scenarios across the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
Key Takeaways from the Hereditary Angioedema (HAE) Market
The market size for Hereditary Angioedema (HAE) in the leading markets is expected to grow significantly by 2036.
The United States accounted for the highest HAE treatment market size in 7MM in 2025, in comparison to the other major markets, i.e., EU4 countries, the United Kingdom, and Japan.
As per DelveInsight’s assessment, the total diagnosed prevalent cases of HAE in the 7MM in 2025 were ~14,500, which are expected to increase by 2036 at a considerable CAGR.
Among the 7MM, the US accounted for the highest prevalent cases of HAE in 2025, while Japan accounted for the least number of prevalent cases.
The type-specific diagnosed prevalent cases of HAE are categorized into Type I, Type II, and HAE with normal C1-INH (Type III). Among these, Type I HAE accounted for the highest cases in the 7MM in 2025.
According to Hide et al. (2021), the estimated number of patients with Type I HAE and Type II HAE in Japan is 2,000–3,000, though only 450 patients have received a formal diagnosis to date.
Approximately 40% of HAE attacks go untreated, even among patients on prophylaxis. More attacks could be addressed effectively for both prophylaxis and on-demand patients.
Leading HAE companies, such as ADARx Pharmaceuticals, Intellia Therapeutics, Astria Therapeutics, CSL Behring, Takeda, BioCryst Pharmaceuticals, Pharvaris, and others, are developing new HAE treatment drugs that can be available in the HAE market in the coming years.
The promising HAE therapies in clinical trials include ADX-324, NTLA-2002, Navenibart (STAR-0215), deucrictibant, and others.
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Key Factors Driving the Hereditary Angioedema (HAE) Market
Increasing Awareness and Diagnosis Rates: Growing awareness regarding rare genetic diseases and improved diagnostic testing are leading to earlier and more accurate diagnosis of HAE. Enhanced physician education and patient advocacy initiatives are also contributing to market growth.
Rising Demand for Long-term Prophylactic Therapies: The increasing adoption of prophylactic therapies such as TAKHZYRO, HAEGARDA, ANDEMBRY, and ORLADEYO is significantly reducing disease burden and improving quality of life for HAE patients.
Advancements in Novel Therapeutic Approaches: Emerging therapies, including RNA-targeted therapies, monoclonal antibodies, oral kallikrein inhibitors, and gene-editing approaches, are expected to revolutionize HAE treatment by providing long-lasting disease control and potentially curative outcomes.
Hereditary Angioedema (HAE) Competitive Landscape
Several HAE drugs in development include ADX-324 (ADARx Pharmaceuticals), Lonvoguran ziclumeran/NTLA-2002 (Intellia Therapeutics), Navenibart (STAR-0215) (Astria Therapeutics), deucrictibant (Pharvaris), and others.
These candidates target diverse mechanisms such as plasma kallikrein inhibition, factor XIIa inhibition, RNA-targeted therapies, and CRISPR-based gene editing aimed at reducing HAE attack frequency and improving patient convenience with less frequent dosing and self-administration options.
Discover more about therapies set to grab major Hereditary Angioedema (HAE) market share @ Hereditary Angioedema (HAE) Treatment Landscape
Recent Developments in the Hereditary Angioedema (HAE) Market
In October 2025, ADARx Pharmaceuticals announced that the first patient has been dosed in its Phase III STOP-HAE clinical trial evaluating ADX-324 in patients with HAE.
In November 2025, Intellia Therapeutics announced interim Phase I/II clinical data showing dramatic reductions in attack rate, as well as consistent, deep, and durable reductions in kallikrein levels with NTLA-2002.
In January 2026, Intellia Therapeutics announced that Phase III results of the HAELO trial for NTLA-2002 are expected by mid-2026, with BLA submission planned for H2 2026 and a potential market launch expected in 2027.
In February 2025, Astria Therapeutics initiated the ALPHA-ORBIT Phase III pivotal trial of Navenibart in HAE.
In July 2025, the US FDA approved sebetralstat (EKTERLY), the first and only oral on-demand treatment for HAE in adult and pediatric patients aged 12 years and older.
In August 2025, the US FDA approved donidalorsen (DAWNZERA), the first RNA-targeted treatment for HAE.
What is Hereditary Angioedema (HAE)?
Hereditary Angioedema (HAE) is a rare genetic disorder characterized by recurrent episodes of severe swelling affecting various parts of the body, including the extremities, gastrointestinal tract, face, and airway. The disease is primarily caused by mutations affecting C1 esterase inhibitor (C1-INH), leading to excessive bradykinin production and increased vascular permeability. HAE attacks can be painful, debilitating, and potentially life-threatening when airway swelling occurs.
Hereditary Angioedema (HAE) Epidemiology Segmentation
The HAE epidemiology section provides insights into the historical and current HAE patient pool and forecasted trends for the leading markets. The HAE market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into:
Total Diagnosed Prevalent Cases of HAE
Type-specific Diagnosed Prevalent Cases of HAE
Gender-specific Diagnosed Prevalent Cases of HAE
Age-specific Diagnosed Prevalent Cases of HAE
Scope of the Hereditary Angioedema (HAE) Market Report
Therapeutic Assessment: HAE current marketed and emerging therapies
HAE Market Dynamics: Key Market Forecast Assumptions of Emerging HAE Drugs and Market Outlook
Key Companies: ADARx Pharmaceuticals, Intellia Therapeutics, Astria Therapeutics, CSL Behring, Takeda, BioCryst Pharmaceuticals, Pharvaris, and others
Key Therapies: ADX-324, NTLA-2002, Navenibart (STAR-0215), deucrictibant, TAKHZYRO, HAEGARDA, ORLADEYO, ANDEMBRY, and others
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
Unmet Needs, KOL’s views, Analyst’s views, HAE Market Access and Reimbursement
To know more about Hereditary Angioedema (HAE) companies working in the treatment market, visit @ Hereditary Angioedema (HAE) Clinical Trials and Therapeutic Assessment
Table of Contents
Hereditary Angioedema (HAE) Market Report Introduction
Executive Summary for HAE
SWOT Analysis of HAE
HAE Patient Share (%) Overview at a Glance
HAE Market Overview at a Glance
HAE Background and Overview
HAE Epidemiology and Patient Population
Country-Specific Patient Population of HAE
HAE Current Treatment and Medical Practices
HAE Unmet Needs
HAE Emerging Therapies
HAE Market Outlook
Country-Wise HAE Market Analysis (2022–2036)
HAE Market Access and Reimbursement of Therapies
HAE Market Drivers
HAE Market Barriers
HAE Appendix
HAE Report Methodology
DelveInsight Capabilities
Disclaimer
About DelveInsight
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