Hereditary Angioedema Market Dynamics Indicate Upward Trajectory Through 2034, Reports DelveInsight

DelveInsight's "Hereditary Angioedema Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Hereditary Angioedema, historical and forecasted epidemiology as well as the Hereditary Angioedema market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

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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 August 2025, The U.S. Food and Drug Administration (FDA) approved donidalorsen (DAWNZERA), an RNA-targeted therapy, to prevent hereditary angioedema (HAE) attacks in adults and children aged 12 and older. Ionis Pharmaceuticals announced the approval on August 21, 2025. "Donidalorsen is designed to address patient needs by providing a significant and sustained reduction in HAE attacks, ongoing improvements over time, and a lower treatment burden," said Marc Riedl, MD, MS, clinical director at the US HAEA Angioedema Center and investigator of the OASIS-HAE and OASISplus trials.
• In August 2025, On Thursday, the Food and Drug Administration approved Ionis Pharmaceuticals' drug for the rare genetic disorder hereditary angioedema, making donidalorsen the third new therapy for this condition to reach the market this year. Ionis will market donidalorsen under the brand name Dawnzera, which is approved to prevent swelling attacks in adults and children aged 12 and older. Company executives stated in a conference call that Dawnzera carries a list price of $57,462 per dose.
• 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 characterized by recurrent episodes of swelling (angioedema) in various parts of the body, including the face, limbs, abdomen, and airways. The condition is caused by a deficiency or dysfunction of a protein called C1 inhibitor, which helps regulate inflammation. HAE attacks can be triggered by stress, trauma, or infections, and may result in painful swelling and potential life-threatening complications if the airway becomes involved. Treatment options include medications to prevent or treat attacks, such as C1 inhibitor replacement therapies, bradykinin receptor antagonists, and other targeted therapies.

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Hereditary Angioedema Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

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
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Hereditary Angioedema market or expected to get launched during the study period. The analysis covers Hereditary Angioedema market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Hereditary Angioedema Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

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 Strengths
• Increasing identification of a novel genetic mutation in various regions warranting further focus on the types and associated pathophysiology, including recognition of hormonal changes

Hereditary Angioedema Market Opportunities
• Proliferating demand for therapies with improved patient compliance, fewer side effects, improved resistance profile, and long-acting therapies

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

Media Contact
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Contact Person: Gaurav Bora
Email: info@delveinsight.com
City: Albany
State: New York
Country: United States
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About DelveInsight
DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

This release was published on openPR.