Hereditary Angioedema Drugs Market 2034: EMA, PDMA, FDA Approvals, Clinical Trials, Prevalence, Medication, Statistics, NICE Approval.Revenue and 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
(Albany, USA) 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.

The Hereditary Angioedema market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Hereditary Angioedema market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Hereditary Angioedema treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential 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, potentially life-threatening genetic disorder characterized by recurrent episodes of severe swelling in various parts of the body, including the limbs, face, intestinal tract, and airway. Hereditary Angioedema symptoms usually appear in childhood or adolescence and can worsen over time. Hereditary Angioedema is often caused by a deficiency or dysfunction of the C1-inhibitor protein, leading to uncontrolled activation of the complement system and increased vascular permeability.

Hereditary Angioedema diagnosis is typically confirmed through blood tests that measure C1-inhibitor levels and function. Hereditary Angioedema can often be misdiagnosed as allergic reactions or gastrointestinal conditions, leading to delayed treatment. Hereditary Angioedema treatment options include on-demand therapies for acute attacks and long-term prophylactic therapies to prevent future episodes. Hereditary Angioedema management also involves patient education and avoidance of known triggers such as stress, trauma, or certain medications.

Hereditary Angioedema types include Type I (low C1-inhibitor levels), Type II (non-functional C1-inhibitor), and HAE with normal C1-inhibitor levels. Hereditary Angioedema awareness is critical to improving diagnosis rates and treatment outcomes. Hereditary Angioedema research is advancing rapidly, offering hope for better therapies and improved quality of life for patients. Hereditary Angioedema support from healthcare providers and patient communities is essential for effective disease management.

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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

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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

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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