Hereditary Angioedema Market Outlook 2034 - Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

Hereditary Angioedema Companies are 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
Hereditary Angioedema Market Summary

The global Hereditary Angioedema (HAE) market was valued at around USD 3 billion in 2023 and is projected to grow significantly with the approval of new therapies. HAE is a rare genetic disorder marked by recurrent, severe swelling episodes affecting the face, limbs, gastrointestinal tract, and airway. Current treatments include C1-INH concentrates (BERINERT, RUCONEST), kallikrein inhibitors (Ecallantide), bradykinin receptor antagonists (FIRAZYR), and prophylactic options such as CINRYZE, HAEGARDA, and LANADELUMAB, mainly approved in the U.S., which holds ~90% of the market share. Women represent about 65% of cases. The pipeline is robust, with promising candidates like Navenibart (STAR-0215), Donidalorsen, NTLA-2002, and Sebetralstat. Key 2024 updates include FDA acceptance of Donidalorsen's NDA by Ionis, KalVista's NDA submission for Sebetralstat, and Astria's partnership with Ypsomed for STAR-0215. Positive Phase III OASIS-HAE results for Donidalorsen showed over 90% reduction in attacks, indicating strong future growth potential.

DelveInsight's report, "Hereditary Angioedema Market Insights, Epidemiology, and Market Forecast-2034", provides a comprehensive analysis of Hereditary Angioedema, including historical and projected epidemiology, along with market trends across the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan. The study highlights current treatment approaches, emerging therapies, individual drug market shares, and the market size from 2020 to 2034 across these seven major markets. Additionally, it outlines existing treatment algorithms, key market drivers and barriers, and unmet medical needs, helping identify potential opportunities and evaluate the future growth prospects of the Hereditary Angioedema market.

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Some of the key facts of the Hereditary Angioedema Market Report:

* The Hereditary Angioedema market size was valued ~USD 3000 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034)
* In March 2025, KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that it has completed enrollment for the open-label KONFIDENT-KID clinical trial, which is evaluating sebetralstat, a novel oral plasma kallikrein inhibitor, in pediatric patients aged 2 to 11 with hereditary angioedema (HAE).
* In February 2025, Astria Therapeutics initiated the randomized, placebo-controlled ALPHA-ORBIT Phase III trial to evaluate navenibart for treating patients with hereditary angioedema (HAE). This global, double-blind study aims to assess the safety and effectiveness of the treatment over a six-month period. The trial will involve up to 135 adults and ten adolescents with HAE type 1 or type 2. Adult participants will receive one of three dosing regimens of the therapy or a placebo across different treatment groups.
* In January 2025, Intellia Therapeutics administered the first dose to a participant in a randomized, placebo-controlled global Phase III trial of its experimental CRISPR-based treatment, NTLA-2002, for hereditary angioedema (HAE). The HAELO study is a double-blind trial designed to evaluate the safety and effectiveness of the therapy in 60 adult patients with Type I or Type II HAE.
* In December 2024, Astria Therapeutics, Inc. (NASDAQ: ATXS), a biopharmaceutical company dedicated to developing transformative treatments for allergic and immunologic conditions, today reported positive final outcomes from the target enrollment group of 16 patients in the ALPHA-STAR Phase 1b/2 clinical trial assessing navenibart (STAR-0215), a monoclonal antibody plasma kallikrein inhibitor, in hereditary angioedema (HAE) patients. The final data showed a 90-95% reduction in the average monthly attack rate at 6 months, a favorable safety and tolerability profile, and supported dosing every three months (Q3M) and every six months (Q6M). These findings highlight navenibart's potential to become a leading therapy for HAE. Astria plans to advance navenibart into Phase 3 development, with trial initiation anticipated in Q1 2025.
* In November 2024, Ionis Pharmaceuticals, Inc. announced that the U.S. FDA has accepted the New Drug Application (NDA) for donidalorsen, an experimental RNA-targeted therapy designed to prevent hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 and older.
* In August 2024, Astria Therapeutics announced that it has chosen Ypsomed as its partner to collaborate on the development of an autoinjector for STAR-0215.
* In June 2024, KalVista has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the review of sebetralstat, an innovative oral plasma kallikrein inhibitor for treating HAE attacks in adults and pediatric patients aged 12 and older.
* In May 2024, Ionis Pharmaceuticals announced favorable outcomes from the Phase III OASIS-HAE and OASISplus studies of donidalorsen for hereditary angioedema (HAE). The studies demonstrated substantial and lasting reductions in monthly HAE attack rates, with more than 90% improvement after one year of treatment, regardless of whether the drug was administered monthly or bi-monthly. The results will be shared at the 2024 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress in Valencia and published in The New England Journal of Medicine.
* The United States holds the largest market size for Hereditary Angioedema, estimated at around USD 2,000 million in 2023, with expectations for growth during the forecast period.
* Among the EU4 and the UK, France has the largest Hereditary Angioedema market size, approximately USD 100 million in 2023.
* Hereditary angioedema (HAE) is commonly believed to affect women more than men, with around 65% of cases occurring in females.
* Currently, three categories of Hereditary Angioedema medications-C1-INHs, 17 alpha-alkylated androgens, and antifibrinolytics-are utilized for the long-term prevention of HAE type 1 and 2.
* The diagnosed prevalent population of HAE in the United States was estimated to be approximately 7,000 cases in 2023.
* Type I Hereditary Angioedema (HAE) represented the largest share of diagnosed cases in the US, with approximately 5,500 cases in 2023.
* Analysts estimated that approximately 1,000 cases were diagnosed in the age group of 17 to under 65 years in 2023.
* 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
* The Hereditary Angioedema epidemiology based on gender analyzed that the diagnosed prevalent cases of Hereditary Angioedema in the 7MM varied according to gender, with prevalent cases higher in females than males
* The Hereditary Angioedema market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Hereditary Angioedema pipeline products will significantly revolutionize the Hereditary Angioedema market dynamics.

Hereditary Angioedema Overview

Hereditary Angioedema (HAE) is a rare genetic disorder that causes recurrent, potentially life-threatening swelling in the face, limbs, airway, and digestive tract. Symptoms often begin in childhood or adolescence and may worsen over time. The condition is usually linked to low or dysfunctional C1-inhibitor protein, leading to abnormal immune system activation and increased vascular permeability. Diagnosis relies on blood tests but is frequently delayed due to misdiagnosis as allergies or gastrointestinal issues. HAE types include Type I (low C1-inhibitor), Type II (non-functional C1-inhibitor), and HAE with normal C1-inhibitor. Treatment involves on-demand drugs for acute attacks and prophylactic therapies to prevent recurrences, alongside patient education and trigger management. Growing awareness, advancing research, and support from healthcare providers and patient groups are improving diagnosis, treatment, and quality of life for people living with HAE.

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Hereditary Angioedema Epidemiology

In 2023, the United States had about 7,000 diagnosed cases of Hereditary Angioedema (HAE), with Type I accounting for the majority (~5,500 cases). Among these, roughly 1,000 cases were reported in individuals aged 17 to under 65 years.

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

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Hereditary Angioedema Drugs Uptake and Pipeline Development Activities

Donidalorsen (Ionis Pharmaceuticals): Donidalorsen is an investigational LICA antisense therapy targeting prekallikrein (PKK) to prevent HAE attacks. In the Phase III OASIS-HAE trial, subcutaneous dosing every 4 weeks reduced mean monthly attacks by 81% versus placebo, while every 8 weeks achieved a 55% reduction.

Navenibart (Astria Therapeutics): Navenibart (STAR-0215) is a long-acting monoclonal antibody inhibiting plasma kallikrein, with potential dosing every 3-6 months. Phase Ib/II ALPHA-STAR results showed a 90-96% reduction in attacks with strong safety and tolerability. Phase III trials are planned for 2025, with results expected by late 2026.

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

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Hereditary Angioedema Market Drivers

* Rising disease awareness: Improved education among patients and healthcare providers is reducing misdiagnosis and delays in treatment.
* Growing availability of effective therapies: Approved options like C1-INH concentrates, bradykinin receptor antagonists, and prophylactic drugs (e.g., lanadelumab) support wider adoption.
* Pipeline innovation: Emerging therapies such as donidalorsen, navenibart (STAR-0215), and sebetralstat promise long-acting, convenient, and more effective solutions.
* High disease burden: Life-threatening attacks, especially involving the airway, drive strong demand for effective management.
* Regulatory support & orphan drug designations: Incentives accelerate R&D and market entry of novel therapies.
* Dominance of U.S. market (~90%): Strong healthcare infrastructure and reimbursement policies boost growth.

Hereditary Angioedema Market Barriers

* High treatment costs: Advanced therapies are expensive, limiting accessibility, particularly outside the U.S.
* Delayed or incorrect diagnosis: HAE is often mistaken for allergies or gastrointestinal issues, leading to underdiagnosis.
* Small patient population: Being a rare disorder restricts overall market size and investment attractiveness.
* Injection/administration burden: Some therapies require frequent or intravenous/subcutaneous dosing, reducing patient compliance.
* Regional disparities: Limited availability and lower awareness in developing regions hinder global market penetration.

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

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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

About DelveInsight

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