Hereditary Angioedema Market Overview
Valued at nearly USD 3 billion in 2023, the Hereditary Angioedema market is projected to witness substantial growth, primarily fueled by the launch of innovative therapies. HAE is a rare inherited disorder marked by repeated episodes of severe swelling affecting areas such as the face, extremities, gastrointestinal tract, and airway.
Existing treatment options include C1 esterase inhibitor (C1-INH) therapies like BERINERT and RUCONEST, kallikrein inhibitors such as Ecallantide, bradykinin receptor antagonists like FIRAZYR, and prophylactic agents including CINRYZE, HAEGARDA, and LANADELUMAB. The United States dominates the global market, contributing nearly 90% of total revenue. Approximately 65% of patients diagnosed with HAE are women.
The pipeline remains highly promising, featuring candidates such as Navenibart (STAR-0215), Donidalorsen, NTLA-2002, and Sebetralstat. Major 2024 developments include FDA acceptance of Ionis’s NDA for Donidalorsen, KalVista’s NDA filing for Sebetralstat, and Astria’s partnership with Ypsomed for STAR-0215. Positive Phase III OASIS-HAE data for Donidalorsen demonstrated more than a 90% reduction in attack rates, reinforcing strong future market growth potential.
DelveInsight’s report, “Hereditary Angioedema Market Insights, Epidemiology, and Market Forecast – 2034,” delivers an extensive assessment of HAE, covering both historical and forecasted epidemiology as well as market dynamics across the United States, EU4 (Germany, Spain, Italy, France), the UK, and Japan. The report evaluates current therapies, pipeline assets, drug-wise market share, and overall market size from 2020 to 2034. It further examines treatment pathways, growth drivers, barriers, and unmet needs to identify key opportunities and future expansion trends.
To Know in detail about the Hereditary Angioedema market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Hereditary Angioedema Market Forecast
Key Highlights from the Hereditary Angioedema Market Report
- The HAE market was valued at approximately USD 3 billion in 2023 and is forecasted to expand at a strong CAGR between 2020 and 2034.
- In September 2025, following FDA approval of Dawnzera (donidalorsen), Piper Sandler maintained an Overweight rating on Ionis Pharmaceuticals and increased its price target to $65, citing competitive positioning in the HAE segment.
- In August 2025, the FDA approved Dawnzera (donidalorsen) for preventing HAE attacks in patients aged 12 and older, marking the first RNA-targeted therapy for HAE by inhibiting plasma prekallikrein.
- In July 2025, KalVista received FDA approval for EKTERLY® (sebetralstat), the first oral on-demand therapy for acute HAE attacks in patients aged 12+, offering rapid relief and representing the first new on-demand option in over ten years.
- In June 2025, BioCryst reported favorable long-term efficacy and safety results for ORLADEYO® (berotralstat), a prophylactic therapy for HAE across age groups.
- In March 2025, KalVista completed enrollment for the KONFIDENT-KID study evaluating sebetralstat in children aged 2–11 years.
- In February 2025, Astria initiated the Phase III ALPHA-ORBIT study assessing navenibart in up to 145 patients globally.
- In January 2025, Intellia dosed the first patient in its Phase III HAELO trial investigating NTLA-2002, a CRISPR-based therapy for HAE.
- In December 2024, Astria released strong Phase Ib/II ALPHA-STAR data for navenibart, showing 90–95% reduction in monthly attacks and supporting infrequent dosing schedules.
- In November 2024, the FDA accepted Ionis’s NDA for donidalorsen.
- In August 2024, Astria partnered with Ypsomed to develop an autoinjector device for STAR-0215.
- In June 2024, KalVista submitted its NDA for sebetralstat.
- In May 2024, Ionis announced positive Phase III OASIS-HAE results showing sustained >90% reduction in attack rates.
- The U.S. represents the largest HAE market, valued at around USD 2 billion in 2023 and expected to grow further.
- Among EU4 and the UK, France accounts for the largest market, estimated at roughly USD 100 million in 2023.
- Women constitute approximately 65% of diagnosed HAE cases.
- Long-term prevention strategies include C1-INHs, 17 alpha-alkylated androgens, and antifibrinolytics.
- In 2023, the U.S. diagnosed HAE population was about 7,000 patients, with Type I HAE comprising roughly 5,500 cases.
- Around 1,000 U.S. cases were reported in individuals aged 17–65 years.
- Key companies advancing HAE therapies include Ionis, Astria, KalVista, Intellia, BioMarin, CSL Behring, Pharvaris, Takeda, and Shire.
- Notable pipeline therapies include Donidalorsen, Navenibart, KVD900, NTLA-2002, BMN 331, Garadacimab, TAK-743, CSL312, Lanadelumab, and others.
- Epidemiological data across the 7MM show higher prevalence in females compared to males.
- Market growth is anticipated to accelerate with increased awareness, earlier diagnosis, and the introduction of innovative late-stage therapies.
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Hereditary Angioedema Overview
HAE is a rare inherited disorder characterized by episodic, potentially life-threatening swelling of the skin and mucosal tissues, particularly affecting the face, limbs, gastrointestinal tract, and airway. The condition arises due to C1-INH deficiency or dysfunction, resulting in excessive bradykinin production and increased vascular permeability. HAE is categorized into Type I, Type II, and normal C1-INH variants.
Women are disproportionately affected, and triggers such as stress, trauma, or hormonal fluctuations may precipitate attacks. Available treatments include acute therapies (C1-INH products, kallikrein inhibitors, bradykinin antagonists) and preventive options such as lanadelumab and HAEGARDA. Emerging innovations, including RNA-based, monoclonal antibody, and gene-editing therapies, aim to deliver longer-lasting and more convenient disease control. However, challenges remain in ensuring global access and achieving curative outcomes.
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Hereditary Angioedema Epidemiology Insights
In 2023, the U.S. recorded nearly 7,000 diagnosed HAE cases, with Type I representing the majority (~5,500 cases). Approximately 1,000 cases were observed among individuals aged 17–65 years.
The epidemiological analysis (2020–2034) segments the disease by total prevalence, severity, gender distribution, and episodic versus chronic cases across the 7MM.
Hereditary Angioedema Epidemiology Segmentation:
The Hereditary Angioedema market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
- Total Prevalence of Hereditary Angioedema
- Prevalent Cases of Hereditary Angioedema by severity
- Gender-specific Prevalence of Hereditary Angioedema
- Diagnosed Cases of Episodic and Chronic Hereditary Angioedema
Hereditary Angioedema Pipeline and Drug Uptake
Navenibart (Astria Therapeutics):
Navenibart (STAR-0215) by Astria Therapeutics is a long-acting monoclonal antibody targeting plasma kallikrein, developed to provide sustained prevention of HAE attacks with dosing every three or six months. Results from the ALPHA-STAR Phase Ib/II trial showed a 90–96% reduction in attack frequency and strong safety and tolerability. Following these promising results, Astria plans to begin Phase III trials in Q1 2025, with top-line data expected by late 2026.
Donidalorsen (Ionis Pharmaceuticals):
Donidalorsen (IONIS-PKK-LRx) by Ionis Pharmaceuticals is an investigational ligand-conjugated antisense (LICA) therapy designed to inhibit the production of prekallikrein (PKK), a key mediator in Hereditary Angioedema (HAE) attacks. By lowering PKK levels, it aims to prevent acute episodes effectively. In the Phase III OASIS-HAE trial, subcutaneous donidalorsen administered every 4 weeks reduced the mean monthly attack rate by 81% versus placebo, while dosing every 8 weeks achieved a 55% reduction.
Hereditary Angioedema Therapies and Key Companies
- Donidalorsen (IONIS-PKK-LRx): Ionis Pharmaceuticals
- Navenibart (STAR-0215): Astria Therapeutics
- KVD900: KalVista Pharmaceuticals
- NTLA-2002: Intellia Therapeutics
- BMN 331: BioMarin Pharmaceutical
- Garadacimab: CSL Behring
- Donidalorse: Ionis Pharmaceuticals
- STAR-0215: Astria Therapeutics
- PHA121: Pharvaris Netherlands B.V
- NTLA-2002: Intellia Therapeutics
- TAK-743: Takeda
- KVD900: KalVista Pharmaceuticals
- CSL312: CSL Behring
- Lanadelumab: Shire
Discover more about therapies set to grab major Hereditary Angioedema market share @ Hereditary Angioedema Medication and Companies
Hereditary Angioedema Market Dynamics
Hereditary Angioedema Market Drivers
- Improved awareness and diagnostic rates
- Expanding therapeutic options
- Innovative pipeline assets
- Significant disease burden
- Regulatory incentives and orphan drug benefits
- Strong U.S. healthcare infrastructure
Hereditary Angioedema Market Barriers
- High treatment costs
- Misdiagnosis and delayed identification
- Limited patient pool
- Injection-related compliance challenges
- Uneven access across regions
Scope of the Hereditary Angioedema Market Report
- Study Period: 2020-2034
- Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
- Key Hereditary Angioedema Companies: Ionis Pharmaceuticals, Astria Therapeutics, KalVista Pharmaceuticals, Intellia Therapeutics, BioMarin Pharmaceutical, CSL Behring, Ionis Pharmaceuticals, Astria Therapeutics, Pharvaris Netherlands B.V, Intellia Therapeutics, Takeda, CSL Behring, Shire, and others
- Key Hereditary Angioedema Therapies: Donidalorsen (IONIS-PKK-LRx), Navenibart (STAR-0215), KVD900, NTLA-2002, BMN 331, Garadacimab, Donidalorse, STAR-0215, PHA121, NTLA-2002, TAK-743, KVD900, CSL312, Lanadelumab, and others
- Hereditary Angioedema Therapeutic Assessment: Hereditary Angioedema current marketed and Hereditary Angioedema emerging therapies
- Hereditary Angioedema Market Dynamics: Hereditary Angioedema market drivers and Hereditary Angioedema market barriers
- Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
- Hereditary Angioedema Unmet Needs, KOL's views, Analyst's views, Hereditary Angioedema Market Access and Reimbursement
To know more about Hereditary Angioedema companies working in the treatment market, visit @ Hereditary Angioedema Clinical Trials and Therapeutic Assessment
Table of Contents
1. Hereditary Angioedema Market Report Introduction
2. Executive Summary for Hereditary Angioedema
3. SWOT analysis of Hereditary Angioedema
4. Hereditary Angioedema Patient Share (%) Overview at a Glance
5. Hereditary Angioedema Market Overview at a Glance
6. Hereditary Angioedema Disease Background and Overview
7. Hereditary Angioedema Epidemiology and Patient Population
8. Country-Specific Patient Population of Hereditary Angioedema
9. Hereditary Angioedema Current Treatment and Medical Practices
10. Hereditary Angioedema Unmet Needs
11. Hereditary Angioedema Emerging Therapies
12. Hereditary Angioedema Market Outlook
13. Country-Wise Hereditary Angioedema Market Analysis (2020-2034)
14. Hereditary Angioedema Market Access and Reimbursement of Therapies
15. Hereditary Angioedema Market Drivers
16. Hereditary Angioedema Market Barriers
17. Hereditary Angioedema Appendix
18. Hereditary Angioedema Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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