DelveInsight’s “Hereditary Angioedema Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding, historical and forecasted epidemiology, as well as the Hereditary Angioedema market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The Hereditary Angioedema Market is an evolving segment of the global healthcare landscape, driven by the increasing Hereditary Angioedema prevalence of the disorder and the continuous development of innovative treatment options. The Hereditary Angioedema market encompasses various therapeutic categories, including antipsychotics, adjunctive therapies, and emerging treatment modalities.
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Key Takeaways from the Hereditary Angioedema Market Report
- In November 2024:- Octapharma- Prospective, Multicenter, Randomized, Double-blind, Parallel Group, Placebo- Controlled, Efficacy and Safety Phase 3 Study of an Intravenous Human Plasma- Derived C1 Esterase Inhibitor (C1-INH) Concentrate in Participants With Congenital C1-INH Deficiency for the Treatment and Pre-procedure Prevention of Acute Hereditary Angioedema Attacks
- In November 2024:- CSL Behring- A Phase 3 Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema in Pediatric Subjects 2 to 11 Years of Age. The purpose of this study is to investigate the safety, PK / PD, and efficacy of SC CSL312 for prophylactic treatment of pediatric subjects with HAE.
- In November 2024:- Pharvaris Netherlands B.V.- This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to prevent angioedema attacks in participants aged ≥ 12 years with hereditary angioedema.
- In 2023, the diagnosed prevalent population of HAE was found to be ~7,000 cases in the US.
- With type I Hereditary Angioedema (HAE) occupying the maximum diagnosed patient pool in the US, this condition had ~5,500 diagnosed cases in 2023.
- DelveInsight’s analysts have estimated that there were ~1,000 cases diagnosed for the age group 17 to below 65 years in 2023.
- The leading Hereditary Angioedema Companies such as KalVista Pharmaceuticals, Intellia Therapeutics, BioMarin Pharmaceutical, CSL Behring, Ionis Pharmaceuticals, Astria Therapeutics, Pharvaris Netherlands B.V, Intellia Therapeutics, Takeda, KalVista Pharmaceuticals, CSL Behring, Shire, and others
- Promising Hereditary Angioedema Therapies such as KVD900, NTLA-2002, BMN 331, Garadacimab, Donidalorse, STAR-0215, PHA121, NTLA-2002, TAK-743, KVD900, CSL312, Lanadelumab, and others
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Hereditary Angioedema Epidemiology Segmentation in the 7MM
- total Hereditary Angioedema diagnosed prevalent population
- Hereditary Angioedema type-specific
- Hereditary Angioedema gender-specific
- Hereditary Angioedema age-specific
- Hereditary Angioedema site-specific cases
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Hereditary Angioedema Marketed Drugs
- Takhzyro: Takeda
Takhzyro (Lanadelumab; DX-2930) is the first of its kind, a fully human monoclonal antibody (mAb) that binds and inhibits the activity of plasma kallikrein, an enzyme that is uncontrolled in people with HAE. Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin. This potent vasodilator increases vascular permeability resulting in swelling and pain associated with HAE. In patients with HAE due to C1-inhibitor (C1-INH) deficiency or dysfunction, it led to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks. Lanadelumab decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE. Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and available as subcutaneous formulation.
- Firazyr: Shire/Takeda
Firazyr (Icatibant) is a selective, competitive bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. The dysfunctional C1-esterase-inhibition leads to bradykinin production. Bradykinin is a vasodilator which is thought to be responsible for the characteristic HAE symptoms of localized swelling, inflammation, and pain. Icatibant inhibits bradykinin from binding the B2 receptor, with an affinity similar to bradykinin, and thereby treats the clinical symptoms of an acute, episodic attack of HAE. Firazyr is currently approved in 37 countries worldwide, including the countries of the European Union.
Hereditary Angioedema Emerging Drugs
- Donidalorsen (IONIS-PKK-LRx): Ionis Pharmaceuticals
Donidalorsen, formerly known as IONIS-PKK-LRx, is an investigational LIgand-Conjugated Antisense (LICA) medicine designed to target the production of prekallikrein (PKK), which plays an important role in the activation of inflammatory mediators associated with acute attacks of hereditary angioedema (HAE). By reducing the production of PKK, donidalorsen could be an effective prophylactic approach to preventing HAE attacks.
In the phase III OASIS-HAE study, donidalorsen administered subcutaneously every 4 weeks (Q4W) showed an 81% lower mean monthly attack rate compared to placebo over weeks 1 to 25 (p<0.001). The Q8W dosing showed a 55% reduction (p=0.004).
- Navenibart (STAR-0215): Astria Therapeutics
navenibart (STAR-0215), is a potential best-in-class monoclonal antibody inhibitor of plasma kallikrein designed to provide long-acting, safe, and effective attack prevention for HAE, with potential for dosing once every 3 and 6 months.
Positive initial proof-of-concept results from the ALPHA-STAR Phase Ib/II clinical trial evaluating navenibart in HAE patients demonstrate a favorable safety and tolerability profile, mean monthly attack rate reduction of 90-96% for up to 6 months of follow up, and support both three- (Q3M) and six- month (Q6M) dosing regimens. Based on the positive results, company plan to advance navenibart to Phase III development with trial initiation expected in Q1 2025 and top-line results expected by year-end 2026.
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Scope of the Hereditary Angioedema Market Report
- Coverage- 7MM
- Hereditary Angioedema Companies- KalVista Pharmaceuticals, Intellia Therapeutics, BioMarin Pharmaceutical, CSL Behring, Ionis Pharmaceuticals, Astria Therapeutics, Pharvaris Netherlands B.V, Intellia Therapeutics, Takeda, KalVista Pharmaceuticals, CSL Behring, Shire, and others
- Hereditary Angioedema Therapies- KVD900, NTLA-2002, BMN 331, Garadacimab, Donidalorse, STAR-0215, PHA121, NTLA-2002, TAK-743, KVD900, CSL312, Lanadelumab, and others
- Hereditary Angioedema Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Hereditary Angioedema Unmet Needs, KOL’s views, Analyst’s views, Hereditary Angioedema Market Access and Reimbursement
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Table of Content
1. Key Insights
2. Hereditary Angioedema (HAE): Market Overview at a Glance
3. Executive summary
4. Organizations
5. Epidemiology and Market Methodology
6. Treatment of Hereditary Angioedema
7. Epidemiology and Patient Population
8. Marketed Therapies
9. Emerging Therapies
10. Hereditary Angioedema: 7 Major Market Analysis
11. KOL Views
12. SWOT Analysis
13. Unmet Needs
14. Market Access and Reimbursement
15. Appendix
16. DelveInsight Capabilities
17. Disclaimer
18. About DelveInsight
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