Hereditary Angioedema Market to Surpass USD 3 Billion by 2034 Across 7MM | 10+ Companies Advancing Novel Therapies and FDA-Approved Treatments, analyses DelveInsight

DelveInsight's "Hereditary Angioedema Market Insights, Epidemiology, and Market Forecast 2034" report delivers an in-depth understanding of the Hereditary Angioedema, historical and forecasted epidemiology as well as the Hereditary Angioedema market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Hereditary Angioedema market report also covers emerging drugs, current treatment practices, Hereditary Angioedema market share of the individual therapies, current and forecasted Hereditary Angioedema Market Size from 2020 to 2034 segmented by seven major markets.

To know more about the Hereditary Angioedema report offerings, click here: https://www.delveinsight.com/report-store/hereditary-angioedema-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Some facts of Hereditary Angioedema Market Report
• According to DelveInsight, Hereditary Angioedema market size is expected to grow at a decent CAGR by 2034
• The Hereditary angioedema market size was found to be ~USD 3,000 million in 2023, which with the approval of many new therapies in the Hereditary angioedema market is further expected to increase in the forecasted period.
• On December 12, 2025, the FDA approved BioCryst's berotralstat (Orladeyo) prophylactic oral pellets for pediatric patients aged 2 to 11 years with hereditary angioedema (HAE), according to an announcement from the pharmaceutical company. The approval makes berotralstat the first targeted oral prophylactic therapy available to children younger than 12 years with HAE
• In August 2025, Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved DAWNZERATM (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. DAWNZERA is the first and only RNA-targeted medicine approved for HAE, designed to target plasma prekallikrein (PKK), a key protein that activates inflammatory mediators associated with acute attacks of HAE. DAWNZERA 80mg is self-administered via subcutaneous autoinjector once every four (Q4W) or eight weeks (Q8W).
• In July 2025, KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. EKTERLY is the first and only oral on-demand treatment for HAE.
• In June 2025, Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the U.S. Food and Drug Administration (FDA) approved ANDEMBRY® (garadacimab-gxii), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. By targeting factor XIIa, a plasma protein that plays a key role in attacks of swelling in people with HAE, ANDEMBRY inhibits the top of the HAE cascade to prevent HAE attacks. ANDEMBRY, the only treatment to offer once-monthly dosing from the start for all patients, is a subcutaneous self-injection delivered in 15 seconds or less via an autoinjector with a citrate-free formula.
• In May 2025, BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for the use of oral, once-daily ORLADEYO® (berotralstat) in pediatric patients with hereditary angioedema (HAE) aged 2 to 11 years. The FDA also granted Priority Review of the application, with a Prescription Drug User Fee Act (PDUFA) target action date of September 12, 2025.
• Leading Hereditary Angioedema companies working in the treatment market are BioCryst Pharmaceuticals, Ionis Pharmaceuticals, KalVista Pharmaceuticals, CSL Behring, Shire, Pharming Group, Takeda Pharmaceuticals, BIOCRYST PHARMACEUTICALS, INC., Attune Pharmaceuticals, Arrowhead Pharmaceuticals, Inc., Adverum Biotechnologies, Inc., CENTOGENE N.V., and Sanofi, and many others.
• Increasing prevalence and rising awareness of hereditary angioedema and increasing support from non-profit organizations towards intensive research are dome of the factors that are driving the Hereditary Angioedema market growth.

Hereditary Angioedema Overview
Hereditary Angioedema (HAE) is a rare, genetic disorder characterized by recurrent episodes of severe swelling (angioedema) in various parts of the body, including the limbs, face, intestinal tract, and airway. Unlike allergic reactions, HAE is not mediated by histamine but by a deficiency or dysfunction of the C1 inhibitor protein, which regulates pathways in the immune system that control inflammation.

Symptoms of HAE typically begin in childhood or adolescence and include non-itchy, painful swelling that can last for several days. Swelling in the gastrointestinal tract can cause severe abdominal pain, nausea, and vomiting, while airway swelling can be life-threatening due to the risk of asphyxiation.

Diagnosis is based on clinical history, family history, and specific blood tests that measure C1 inhibitor levels and function. Genetic testing can confirm the diagnosis.
Management of HAE involves both acute treatment of attacks and long-term prophylaxis. Acute attacks are treated with C1 inhibitor concentrates, bradykinin receptor antagonists, or kallikrein inhibitors to reduce swelling. Long-term prophylaxis may include regular infusions of C1 inhibitor concentrate, attenuated androgens, or newer medications like lanadelumab, which target pathways involved in the disease.

Despite its chronic nature, ongoing research and advancements in treatment options are improving the quality of life for individuals with HAE, allowing for better management of symptoms and reduction in the frequency and severity of attacks.

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Key Benefits of Hereditary Angioedema Market Report
• Hereditary Angioedema market report provides an in-depth analysis of Hereditary Angioedema Market Size, Share, Trend, Epidemiology and Market Forecast till 2030, in 7 major market i.e. EU5 (Germany, Italy, Spain, France and the UK), Japan, and the United States.
• The Hereditary Angioedema market report will help in developing business strategies by understanding the Hereditary Angioedema Market trends & developments, key players and future market competition that will shape and drive the Hereditary Angioedema market in the upcoming years.
• The Hereditary Angioedema market report covers Hereditary Angioedema current treatment practices, emerging drugs, market share of the individual therapies in 7 MM.
• The report provides a detailed assessment of the Hereditary Angioedema market in terms of market drivers & barriers, Unmet Needs, market opportunities, patient population, comparative analysis of pipeline products with detailed clinical profiles, and other factors.

Hereditary Angioedema Market
The landscape of therapeutic options for patients with HAE has changed dramatically in the last two decades. Ongoing research promises even greater change in the foreseeable future. Given the economic and psychosocial burdens for patients living with angioedema, effective therapies with novel mechanisms will offer more choices for patients and physicians, as well as provide greater flexibility in routes of administration. Owing to the launch of upcoming therapies, market size shall increase during forecast period (2020-2034).
The Hereditary Angioedema market outlook section of the report helps to build the detailed comprehension of the historic, current and forecasted Hereditary Angioedema market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers and demand for better technology.
The report gives a thorough detail of Hereditary Angioedema market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, and view of the key opinion leaders.

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Hereditary Angioedema Epidemiology
In 2023, the United States recorded approximately 7,000 diagnosed HAE cases, with around 5,500 attributed to Type I disease. Nearly 1,000 diagnosed patients were identified within the 17 to under-65 age bracket.

Epidemiology Segmentation Covered in the Report:
Overall prevalence of Hereditary Angioedema
Severity-based prevalence of HAE
Gender-specific prevalence patterns
Diagnosed episodic and chronic HAE cases

Hereditary Angioedema Drugs Uptake and Key Market Players
Donidalorsen (Ionis Pharmaceuticals):

Donidalorsen (IONIS-PKK-LRx) is an investigational ligand-conjugated antisense therapy developed by Ionis Pharmaceuticals to suppress plasma prekallikrein production, a key driver of HAE attacks. By reducing PKK levels, the therapy aims to effectively prevent acute episodes. In the Phase III OASIS-HAE study, subcutaneous administration every four weeks reduced monthly attack rates by 81% compared with placebo, while eight-week dosing achieved a 55% reduction.



Navenibart (Astria Therapeutics):

Navenibart (STAR-0215) is a long-acting monoclonal antibody targeting plasma kallikrein, designed for sustained HAE prevention with dosing every three or six months. Data from the ALPHA-STAR Phase Ib/II trial demonstrated a 90-96% reduction in attack frequency, along with favorable safety and tolerability. Based on these outcomes, Astria plans to initiate Phase III trials in early 2025, with top-line results anticipated by late 2026.

Key Hereditary Angioedema Therapies and 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
PHA121 - Pharvaris Netherlands B.V.
TAK-743 - Takeda
CSL312 - CSL Behring
Lanadelumab - Shire

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Hereditary Angioedema Companies:
Some of the Hereditary Angioedema companies working in the Hereditary Angioedema Market are BioCryst Pharmaceuticals, Ionis Pharmaceuticals, KalVista Pharmaceuticals, CSL Behring, Shire, Pharming Group, Takeda Pharmaceuticals, BIOCRYST PHARMACEUTICALS, INC., Attune Pharmaceuticals, Arrowhead Pharmaceuticals, Inc., Adverum Biotechnologies, Inc., CENTOGENE N.V., and Sanofi, and many others.

Hereditary Angioedema Therapies:
Hereditary Angioedema Drugs Covered are BCX7353, IONIS-PKK-LRx, KVD900, CSL312, and many others.

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Table of Content
1. Key Insights
2. Executive Summary
3. Hereditary Angioedema Competitive Intelligence Analysis
4. Hereditary Angioedema Market Overview at a Glance
5. Hereditary Angioedema Disease Background and Overview
6. Hereditary Angioedema Patient Journey
7. Hereditary Angioedema Epidemiology and Patient Population
8. Hereditary Angioedema Treatment Algorithm, Current Treatment, and Medical Practices
9. Hereditary Angioedema Unmet Needs
10. Key Endpoints of Hereditary Angioedema Treatment
11. Hereditary Angioedema Marketed Products
12. Hereditary Angioedema Emerging Therapies
13. Hereditary Angioedema Seven Major Market Analysis
14. Attribute Analysis
15. Hereditary Angioedema Market Outlook (7 major markets)
16. Hereditary Angioedema Access and Reimbursement Overview
17. KOL Views on the Hereditary Angioedema Market.
18. Hereditary Angioedema Market Drivers
19. Hereditary Angioedema Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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