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Hereditary Angioedema Market

Hereditary Angioedema Market Summary

The Hereditary Angioedema market, valued at approximately USD 3 billion in 2023, is expected to experience strong growth driven by the approval of new treatment options. Hereditary Angioedema is a rare genetic condition characterized by recurrent episodes of severe swelling in the face, limbs, gastrointestinal tract, and airway. Current therapies include C1-INH concentrates (BERINERT, RUCONEST), kallikrein inhibitors (Ecallantide), bradykinin receptor antagonists (FIRAZYR), and preventive treatments such as CINRYZE, HAEGARDA, and LANADELUMAB — with the U.S. accounting for nearly 90% of the global market. Women make up around 65% of affected patients.

The development pipeline remains strong, featuring promising candidates like Navenibart (STAR-0215), Donidalorsen, NTLA-2002, and Sebetralstat. Key milestones in 2024 include FDA acceptance of Ionis’s NDA for Donidalorsen, KalVista’s NDA submission for Sebetralstat, and Astria’s collaboration with Ypsomed for STAR-0215. Encouraging Phase III OASIS-HAE results for Donidalorsen demonstrated over a 90% reduction in attack frequency, signaling significant potential for future Hereditary Angioedema market expansion.

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.

To Know in detail about the Hereditary Angioedema market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Hereditary Angioedema Market Forecast

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

• The Hereditary Angioedema market was valued at roughly USD 3 billion in 2023 and is projected to grow at a strong CAGR throughout the forecast period (2020–2034).
• In September 2025, following FDA approval of Dawnzera (donidalorsen) for hereditary angioedema (HAE), Piper Sandler reaffirmed an Overweight rating on Ionis Pharmaceuticals and raised its price target to $65, highlighting the company’s strong sales team and potential in the competitive HAE market.
• In August 2025, Ionis Pharmaceuticals (NASDAQ: IONS) announced FDA approval of Dawnzera (donidalorsen) for preventing hereditary angioedema (HAE) attacks in patients aged 12 and older. Dawnzera is the first RNA-targeted therapy for HAE, designed to inhibit plasma prekallikrein (PKK), a key trigger of inflammatory attacks.
• In July 2025, KalVista Pharmaceuticals announced FDA approval of EKTERLY® (sebetralstat), the first oral on-demand treatment for acute hereditary angioedema (HAE) attacks in patients aged 12 and older. EKTERLY offers rapid symptom relief and could transform HAE management as the first new on-demand therapy in over a decade.
• In June 2025, BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced new long-term efficacy and safety data for ORLADEYO® (berotralstat), used as prophylactic treatment for hereditary angioedema (HAE) in patients of all ages.
• In March 2025, KalVista Pharmaceuticals (Nasdaq: KALV) announced the completion of enrollment for its KONFIDENT-KID open-label trial, assessing sebetralstat, an oral plasma kallikrein inhibitor, in children aged 2–11 years with HAE.
• In February 2025, Astria Therapeutics launched the Phase III ALPHA-ORBIT trial, a randomized, placebo-controlled study to evaluate navenibart for HAE treatment. The six-month global study will include up to 135 adults and 10 adolescents with Type 1 or Type 2 HAE, testing multiple dosing regimens versus placebo.
• In January 2025, Intellia Therapeutics dosed the first participant in its global Phase III HAELO trial, a placebo-controlled, double-blind study evaluating NTLA-2002, a CRISPR-based therapy, in 60 adults with Type I or II HAE.
• In December 2024, Astria Therapeutics (NASDAQ: ATXS) announced positive final data from its Phase 1b/2 ALPHA-STAR trial of navenibart (STAR-0215) in 16 HAE patients, showing a 90–95% reduction in monthly attack rates after six months, along with strong safety and tolerability. The results support quarterly or biannual dosing, positioning navenibart as a potential best-in-class therapy. Astria plans to start Phase III trials in Q1 2025.
• In November 2024, Ionis Pharmaceuticals reported that the U.S. FDA accepted its New Drug Application (NDA) for donidalorsen, an RNA-targeted therapy aimed at preventing HAE attacks in adults and adolescents aged 12 and above.
• In August 2024, Astria Therapeutics partnered with Ypsomed to co-develop an autoinjector device for STAR-0215, enhancing patient convenience and self-administration.
• In June 2024, KalVista Pharmaceuticals submitted an NDA to the FDA seeking approval for sebetralstat, its oral kallikrein inhibitor, for treating HAE attacks in adults and adolescents (≥12 years).
• In May 2024, Ionis Pharmaceuticals shared positive Phase III OASIS-HAE and OASISplus trial results for donidalorsen, demonstrating a >90% sustained reduction in monthly HAE attacks after one year, regardless of dosing frequency. The findings will be presented at the EAACI 2024 Congress in Valencia and published in the New England Journal of Medicine.
• The United States represents the largest HAE market, valued at approximately USD 2 billion in 2023, and is expected to expand over the forecast period.
• Within EU4 and the UK, France holds the largest HAE market, valued at about USD 100 million in 2023.
• HAE predominantly affects women, accounting for roughly 65% of diagnosed cases.
• Three main drug classes—C1-INHs, 17 alpha-alkylated androgens, and antifibrinolytics—are currently used for the long-term prevention of HAE types 1 and 2.
• In 2023, the diagnosed prevalent population of HAE in the U.S. was estimated at around 7,000 patients.
• Type I HAE accounted for the majority of U.S. cases, with about 5,500 diagnoses in 2023.
• Roughly 1,000 cases were reported in the 17–65 age group in 2023.
• Leading HAE companies include Ionis Pharmaceuticals, Astria Therapeutics, KalVista Pharmaceuticals, Intellia Therapeutics, BioMarin Pharmaceutical, CSL Behring, Pharvaris Netherlands B.V., Takeda, and Shire, among others.
• Key therapies in the HAE pipeline include Donidalorsen (IONIS-PKK-LRx), Navenibart (STAR-0215), KVD900, NTLA-2002, BMN 331, Garadacimab, TAK-743, CSL312, Lanadelumab, and others in development.
• Gender-based epidemiology across the 7MM indicates higher prevalence in females compared to males.
• The HAE market is expected to expand rapidly due to rising disease awareness, improved diagnosis, and new multi-stage pipeline drugs, which are anticipated to transform the treatment landscape over the coming years.

Hereditary Angioedema Overview

Hereditary Angioedema (HAE) is a rare genetic disorder characterized by recurrent episodes of severe swelling (angioedema) affecting the face, extremities, gastrointestinal tract, and airway, which can become life-threatening if left untreated. It results from a deficiency or dysfunction of the C1 esterase inhibitor (C1-INH), leading to excessive bradykinin production that increases vascular permeability. The condition is classified into Type I, Type II, and normal C1-INH HAE. Women represent the majority of affected individuals, and triggers such as stress, trauma, or hormonal changes can provoke attacks. Current treatment options include on-demand therapies like C1-INH concentrates, kallikrein inhibitors, and bradykinin receptor antagonists, as well as prophylactic agents such as lanadelumab and HAEGARDA. Emerging therapies, including RNA-targeted, monoclonal antibody, and gene-editing approaches, promise more convenient and durable control. Despite therapeutic advances, unmet needs persist for broader global access and long-term, curative solutions for HAE patients.

Get a Free sample for the Hereditary Angioedema Market Report: Hereditary Angioedema Treatment Market

Hereditary Angioedema Epidemiology

In 2023, approximately 7,000 diagnosed cases of Hereditary Angioedema (HAE) were reported in the United States, with Type I HAE accounting for about 5,500 of these cases. Around 1,000 diagnosed cases were observed 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

Download the report to understand which factors are driving Hereditary Angioedema epidemiology trends @ Hereditary Angioedema Epidemiology Forecast

Hereditary Angioedema Drugs Uptake and Pipeline Development Activities

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.

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.

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: Drivers and Barriers

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

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

About DelveInsight

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