United States Hereditary Angioedema (HAE) Market 2025 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

the global hereditary angioedema (HAE) market was valued at US$ 3.10 Billion. The global Hereditary Angioedema (HAE) market size reached US$ 3.31 Billion in 2024 and is expected to reach US$ 6.40 Billion by 2033, growing at a CAGR of 7.7% during the forecast period 2025-2033

Key Development:

United States: Recent HAE Developments

✅ In August 2025, Ionis Pharmaceuticals' Dawnzera (donidalorsen) received FDA approval as a prophylactic, self-injectable therapy for Hereditary Angioedema (HAE). Administered every 4 or 8 weeks, it achieved around 81% reduction in monthly attacks compared to placebo.

✅ In July 2025, the U.S. FDA approved Ekterly (sebetralstat), marking it as the first and only oral on-demand treatment for acute HAE attacks in patients aged 12 years and older. This breakthrough provides convenient, fast-acting symptom control.

Japan: Recent HAE Developments

✅ In April 2025, CSL Behring launched ANDEMBRY® (garadacimab) in Japan following MHLW approval. It is a first-in-class monoclonal antibody targeting activated Factor XII (FXIIa), administered once monthly for preventing acute HAE attacks.

✅ In January 2025, KalVista Pharmaceuticals received Orphan Drug Designation and submitted a New Drug Application (NDA) for sebetralstat in Japan. The therapy aims to introduce the first oral on-demand treatment option for HAE attacks in the region.

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Hereditary Angioedema (HAE) is a rare inherited disorder caused by a deficiency or dysfunction of the C1 esterase inhibitor (C1-INH), leading to recurrent swelling in the skin, gastrointestinal tract, and airways. It follows an autosomal dominant pattern and is triggered by factors like stress or trauma. Early diagnosis and targeted treatments, including C1-INH replacement and bradykinin inhibitors, are crucial to prevent life-threatening attacks and improve patient quality of life.

Recent Merger and acquisition:

United States: Recent M&A and Partnership Developments

✅ In September 2025, Ionis Pharmaceuticals entered a strategic manufacturing and supply partnership with Catalent to scale up global production of Dawnzera (donidalorsen) following its FDA approval. The collaboration focuses on meeting U.S. and international demand for HAE prophylaxis therapies.

✅ In June 2025, CSL Behring expanded its partnership with Thermo Fisher Scientific to enhance biologics production capacity in Pennsylvania, supporting next-generation HAE treatments including Garadacimab. The move aims to strengthen CSL's U.S. biologics network.

✅ In April 2025, KalVista Pharmaceuticals secured a commercial supply and distribution agreement with a U.S. specialty pharma firm to prepare for the U.S. rollout of Sebetralstat, its oral on-demand HAE therapy, post-FDA approval.

Japan: Recent M&A and Licensing Developments

✅ In August 2025, Kaken Pharmaceutical signed a US$32 million licensing deal with Astria Therapeutics for the Japanese rights to Navenibart, a plasma kallikrein inhibitor in late-stage clinical trials. The agreement includes upfront and milestone payments tied to commercialization.

✅ In April 2025, KalVista Pharmaceuticals divested the Japanese rights for Sebetralstat to Kaken Pharmaceutical for US$22 million. The deal includes upfront payment, regulatory milestones, and tiered royalties on future sales.

✅ In February 2025, CSL Behring Japan collaborated with Nipro Corporation for local production and supply chain optimization of ANDEMBRY® (Garadacimab), ensuring wider patient access and cost-efficient distribution in the Japanese HAE market.

Key Players:

=> Pharming Intellectual Property, B.V., CSL Behring GmbH, Takeda Pharmaceutical Company Limited, BioCryst Pharmaceuticals, Inc., among others.

Growth Forecast Projected:

The Global Hereditary Angioedema (HAE) Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2033. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Hereditary Angioedema (HAE) Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

By Type:
Type I HAE, Type II HAE, HAE with Normal C1-INH

By Treatment:
C1-esterase Inhibitor, Bradykinin B2 Receptor Antagonist, Kallikrein Inhibitor, Others

By Route of Administration:
Intravenous, Subcutaneous, Oral

Regional Analysis for Hereditary Angioedema (HAE) Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Hereditary Angioedema (HAE) producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Hereditary Angioedema (HAE) revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FAQ

What is the current size of the Hereditary Angioedema (HAE) Market?

A: In 2024, the Hereditary Angioedema (HAE) Market was valued at US$ 3.31 Billion, reflecting its strong industry presence.

Q2: How large is the Hereditary Angioedema (HAE) Market expected to be by 2033?

A: By 2033, industry forecasts suggest the Hereditary Angioedema (HAE) Market will grow to around US$ 6.40 Billion , demonstrating significant expansion.

Q3: What is the growth rate of the Hereditary Angioedema (HAE) Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 7.7% during the forecast period from 2025 to 2033.

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