(Albany, New York) – October 27, 2026: DelveInsight’s “Hereditary Angioedema Market Insights, Epidemiology, and Market Forecast-2036″ 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.
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 size was valued ~USD 3000 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2022-2036).
In September 2026, Navenibart and donidalorsen continue to advance through Phase III clinical development for hereditary angioedema (HAE), with ongoing studies assessing their long-term efficacy in preventing HAE attacks and evaluating their safety profiles.
In August 2026, ADARx Pharmaceuticals announced on August 24, 2026, that the FDA had granted Fast Track designation to onvuzosiran, an investigational siRNA-based therapy designed to prevent hereditary angioedema (HAE) attacks. The therapy is currently being assessed in the Phase III STOP-HAE clinical trial. This designation is intended to accelerate the development and review process but does not constitute FDA approval.
In July 2026, Pharvaris announced that the FDA had accepted its New Drug Application (NDA) for deucrictibant immediate-release capsules for the on-demand treatment of acute hereditary angioedema (HAE) attacks. The FDA established April 23, 2027, as the target action date. However, NDA acceptance does not mean the treatment has received regulatory approval.
In June 2026, Intellia Therapeutics announced further positive findings from its Phase III HAELO trial on June 13, 2026, demonstrating reductions in hereditary angioedema (HAE) attack rates across the evaluated patient subgroups. The company also confirmed that it had initiated a rolling submission of the biologics license application (BLA) to the US FDA in April 2026.
In June 2026, Pharvaris presented data supporting differentiated profile of deucrictibant in HAE at European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2026.
In June 2026, Intellia Therapeutics presented additional positive results from the global Phase III HAELO clinical trial of lonvo-z for HAE in a late-breaking oral presentation at the EAACI Annual Congress 2026. Results from the trial were simultaneously published in the New England Journal of Medicine.
In June 2026, ADARx Pharmaceuticals announced that Phase I/II clinical data for onvuzosiran, was presented at the 2026 Annual Meeting of the EAACI. The presentation included the design of the ongoing Phase III STOP-HAE clinical trial.
In May 2026, Pharvaris announced topline data from CHAPTER-3, a pivotal Phase III study of deucrictibant extended-release (XR) for the prophylaxis of HAE attacks, expected in 3Q of 2026.
In May 2026, BioCryst Pharmaceuticals announced that it entered into a license agreement granting an Irish affiliate of Neopharmed Gentili exclusive rights to commercialize navenibart for HAE in Europe. In exchange, BioCryst will receive USD 70 million upfront and will be eligible to receive up to USD 275 million in future regulatory and sales milestone payments. BioCryst will also receive tiered royalties on net sales ranging from 18% to 30%.
In May 2026, BioCryst Pharmaceuticals announced that the company presented seven abstracts from its HAE portfolio at the Annual Meeting of the EAACI. One of the absrtracts was featuring clinical trial outcomes with navenibart.
Intellia Therapeutics in its May 2026 corporate presentation, anticipated efforts for planned US commercial launch in H1 of 2027.
Astria Therapeutics, in its Q1 2026 presentation, anticipated IP through 2042.
In April 2026, Pharvaris presented data evaluating safety margins of administration of deucrictibant immediate-release (IR) capsule(s) in combination with deucrictibant XR tablet at the Consortium of Independent Immunology Clinics (CIIC) Spring 2026 Conference.
In April 2026, Intellia Therapeutics announced that it has initiated a rolling submission of a biologics license application (BLA) to the US FDA seeking approval of lonvo-z for HAE.
In March 2026, KalVista Pharmaceuticals announced new interim results from its KONFIDENT-KID clinical trial evaluating sebetralstat for the on-demand treatment of HAE attacks in children ages 2-11 presented at the 2026 Global Angioedema Leadership Conference.
In February 2026, ADARx Pharmaceuticals announced that it will present Phase I/II clinical data and Phase III design for its onvuzosiran program for the treatment of HAE. The poster presentation was given at the 2026 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI).
In Janurary 2026, BioCryst Pharmaceuticals announced that it has completed its acquisition of Astria Therapeutics. The transaction strengthens BioCryst’s position as a leader in HAE and enhances the company’s long-term growth trajectory.
In Janurary 2026, Ionis Pharmaceuticals and Otsuka Pharmaceutical announced that the EC has approved donidalorsen in the EU for the routine prevention of recurrent attacks of HAE in adults and adolescents aged 12 years and older. The approval follows the positive opinion of the Committee for Medicinal Products for Human Use.
As per DelveInsight’s assessment, the total Hereditary Angioedema Diagnosed Prevalent Cases in the 7MM in 2025 was ~14,000, which is expected to increase by 2036.
Among the 7MM, the US accounted for the highest prevalent cases of HAE in 2025 while Japan accounted for the least number of prevalent cases.
A higher percentage of diagnosed prevalent cases were observed in the age group 17–65 years in the US, i.e., ~5,500 in 2025.
Based on type-specific diagnosed prevalent cases of HAE, Type I (~80) had the highest number of type-specific cases followed by Type II (~10) cases.
Key Hereditary Angioedema Companies: KalVista Pharma, CSL Behring, Intellia Therapeutics, ADARx Pharma, Attune Pharma, Ionis Pharmaceuticals, Astria Therapeutics, BioMarin Pharmaceutical, CSL Behring, Pharvaris Netherlands B.V, Takeda, CSL Behring, Shire, and others
Key Hereditary Angioedema Therapies: Sebetralstat (EKTERLY), Garadacimab (ANDEMBRY), Lonvoguran ziclumeran (lonvo-z; formerly NTLA-2002), ADX-324 (Onvuzosiran), ATN-249 ,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 2022 to 2036. 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 2022–2036 in the 7MM segmented into:
Total Hereditary Angioedema Diagnosed Prevalent Cases
Hereditary Angioedema Type-specific Diagnosed Prevalent Cases
Hereditary Angioedema Gender-specific Diagnosed Prevalent Cases
Hereditary Angioedema Age-specific Diagnosed Prevalent Cases
Total Hereditary Angioedema Treated Cases
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
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
Sebetralstat (EKTERLY): KalVista Pharmaceuticals
Garadacimab (ANDEMBRY): CSL Behring
Lonvoguran ziclumeran (lonvo-z; formerly NTLA-2002): Intellia Therapeutics
ADX-324 (Onvuzosiran): ADARx Pharmaceuticals
ATN-249: Attune Pharmaceuticals
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
TAK-743: Takeda
CSL312: CSL Behring
Lanadelumab: Shire
Discover more about therapies set to grab major Hereditary Angioedema market share @ Hereditary Angioedema Treatment Market
Hereditary Angioedema Market Drivers
Increasing Disease Awareness and Diagnosis: Growing awareness of hereditary angioedema (HAE), improved diagnostic capabilities, and greater recognition of disease symptoms are supporting early diagnosis and increasing demand for effective treatments.
Advancements in Novel Therapies: The development of innovative treatments targeting the kallikrein-kinin pathway and bradykinin-mediated mechanisms is expanding therapeutic options for acute attacks and long-term prophylaxis.
Growing Demand for Preventive Treatments: The need to reduce the frequency and severity of recurrent HAE attacks is driving demand for long-term preventive therapies that improve disease control and patients’ quality of life.
Increasing Research and Development Activities: Pharmaceutical companies are investing in clinical trials, next-generation biologics, oral therapies, and gene-based approaches to improve treatment efficacy, safety, and convenience.
Improved Access to Targeted Therapies: The availability of newer treatments with more convenient dosing schedules and alternative administration routes is supporting treatment adoption and expanding market opportunities.
Hereditary Angioedema Market Barriers
High Treatment Costs: The high cost of HAE therapies, particularly biologics and long-term prophylactic treatments, can create financial challenges for patients, insurers, and healthcare systems.
Limited Access and Reimbursement Challenges: Variations in insurance coverage, reimbursement policies, and access to specialized healthcare providers may restrict the availability of advanced HAE treatments across regions.
Challenges in Early and Accurate Diagnosis: The rarity of HAE, symptom overlap with other forms of angioedema, and limited disease awareness can lead to misdiagnosis and delays in initiating appropriate treatment.
Safety and Tolerability Concerns: Potential adverse effects, administration-related challenges, and the need for ongoing monitoring may influence treatment selection, adherence, and patient preferences.
Clinical Development and Regulatory Challenges: The rarity of HAE can make patient recruitment difficult, while the need to demonstrate meaningful reductions in attack frequency and establish long-term safety may increase clinical development timelines and costs.
Scope of the Hereditary Angioedema Market Report
Study Period: 2022–2036
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Hereditary Angioedema Therapies: Sebetralstat (EKTERLY), Garadacimab (ANDEMBRY), Lonvoguran ziclumeran (lonvo-z; formerly NTLA-2002), ADX-324 (Onvuzosiran), ATN-249, 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 (2022–2036)
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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