Hereditary Angioedema Treatment Market Size & Share, by Treatment Type (C1-esterase inhibitor, Bradykinin B2 receptor antagonist, Kallikrein inhibitor); Route of Administration; Age Group; Distribution Channel - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2025-2037

  • Report ID: 6520
  • Published Date: Oct 07, 2024
  • Report Format: PDF, PPT

Global Market Size, Forecast, and Trend Highlights Over 2025-2037

Hereditary Angioedema Treatment Market size is estimated at USD 5.3 billion in 2024 and is set to reach USD 15.7 billion by the end of 2037, witnessing around 9.5% CAGR during the forecast period i.e., between 2025-2037. In 2025, the industry size of hereditary angioedema treatment is assessed at USD 5.8 billion.

The hereditary angioedema treatment market is expanding rapidly, fueled by the advancements in treatment options, improved diagnosis, and rising awareness of the disease. Furthermore, growing accessibility to novel biologics, gene therapies, and preventive treatments aimed at reducing the frequency and severity of HAE attacks is also boosting market growth. As per the Rare Disease Advisor, hereditary angioedema affects 1 in every 50,000 people globally.

The rise of patient advocacy groups, orphan drug designations, and the promotion of drug development for rare diseases are driving the hereditary angioedema treatment market expansion. On-going clinical trials focused on long-term curative solutions, and addressing the rising therapy demands are two factors majorly explored by the market players. For instance, in February 2024, KalVista Pharmaceuticals, Inc. announced positive results from the phase 3 KONFIDENT clinical trial. KONFIDENT demonstrated statistically and clinically significant efficacy of sebetralstat as an oral on-demand therapy for HAE. Personalized medicine approaches and advancements in genomic research are expected to further shape the market’s future.


Hereditary Angioedema Treatment Market Overview
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Hereditary Angioedema Treatment Sector: Growth Drivers and Challenges

Growth Drivers

  • Rising case of HAE: An article published by the Rare Disease Advisor in June 2022, states that HAE episodes lead to 15,000 to 30,000 annual emergency department admissions, in the U.S. As awareness of the condition increases, more individuals are being diagnosed, leading to a greater demand for effective treatments. The rising cases are also attributed to an improved understanding of the genetic factors of the disease. This leads to early detection, and intervention, which boosts the market for therapies aimed at managing symptoms and preventing attacks. The rising patient pool is projected to boost the demand for both acute symptom management and preventive measures to reduce the attack frequency.
  • Technological advances in diagnostics and new drug developments: Innovations in biotechnology, including gene editing, monoclonal antibodies, and biologics have led to the creation of more targeted therapies for managing HAE. These advances allow for treatments that not only provide symptom relief but also prevent attacks. Additionally, improved drugs formulations are making therapy more accessible for patients. In January 2024, Pharvaris announced that the U.S. FDA has lifted the clinical hold on the Investigational New Drug (IND) application for deucrictibant for the prophylactic treatment of HAE attacks. As new drugs continue to emerge, alongside technological advancements, the HAE market is poised for significant growth, with better-targeted treatments.

Challenges

  • Stringent regulations on new HAE therapies: This poses a significant challenge for the market as the approval process for novel treatments is often lengthy and complex owing to the extensive need for clinical trials to ensure safety and efficacy. Regulatory authorities impose rigorous standards, which can delay the introduction of new therapies, limiting the availability of treatment options for HAE patients.
  • High cost of treatment: A major challenge faced by the hereditary angioedema treatment market is the rising cost of advanced treatment for HAE. Owing to the specialized nature of the medications and the small patient population target, many current therapies are severely expensive. This creates financial barriers for patients and healthcare systems, restricting access to effective treatments, mainly in regions with limited healthcare resources.

Hereditary Angioedema Treatment Market: Key Insights

Base Year

2024

Forecast Year

2025-2037

CAGR

9.5%

Base Year Market Size (2024)

USD 5.3 billion

Forecast Year Market Size (2037)

USD 15.7 billion

Regional Scope

  • North America (U.S., and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, Malaysia, Australia, South Korea, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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Hereditary Angioedema Treatment Segmentation

 Distribution Channel (Hospital Pharmacies, Drug Store & Retail Pharmacies, Online Pharmacies)

By distribution channel, hospital pharmacies in hereditary angioedema treatment market are anticipated to grow at a considerable CAGR during the forecast period. The need for specialized care in managing severe and acute HAE attacks often require immediate medical intervention and the administration of advanced therapies including C1 inhibitors. Hospitals are equipped with the necessary resources to handle these emergencies, including diagnostic tools and skilled healthcare professionals trained in rare disease management. The rising prevalence of HAE has increased the number of hospital visits for both emergency treatment and regular monitoring.

Increasing number of clinical trials and development of novel therapies conducted in hospital settings is also boosting the segment’s growth. Hospitals are centers for innovatie treatments such as gene therapies, which are initially introduced through clinical trial programs. Furthermore, adoption of more advanced therapeutic protocols in hospitals, such as precision therapies, and personalized medicine, is projected to boost enhances patient outcomes. Development of specialized HAE treatment centers within hospitals is also likely to drive the segment’s growth during the forecast period.

Age Group (Pediatric, Adult, Geriatric)

Adult segment is projected to account for more than 51% hereditary angioedema treatment market share by the end of 2037. The segment is majorly driven by factors including late onset or delayed diagnosis of HAE where symptoms are more accurately identified during adulthood. Additionally, adults tend to experience more frequent and severe attacks, increasing the demand for preventive and acute treatments. Lifestyle factors such as stress, hormonal changes, and work-related pressures also trigger HAE attacks, further contributing to the segment’s growth.

Tailored treatment plans owing to personalized medicines advancements based on genetic and symptomatic profiles, ensure better disease management for adult patients. Furthermore, development of long-term prophylactic treatments and greater use of self-administration therapies are anticipated in the market.  This will empower adult patients to manage their conditions more independently is projected to further fuel the market growth during the forecast period.

Our in-depth analysis of the market includes the following segments:

Treatment Type

  • C1-esterase inhibitor
  • Bradykinin B2 receptor antagonist
  • Kallikrein inhibitor
  • Other treatment types

Route of Administration

  • Oral
  • Parenteral

Age Group

  • Pediatric
  • Adult
  • Geriatric

Distribution Channel

  • Hospital pharmacies
  • Drug store & retail pharmacies
  • Online pharmacies 

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Hereditary Angioedema Treatment Industry - Regional Synopsis

North America Market Analysis

The North America in hereditary angioedema treatment market is driven by advancements in genetic research and increased awareness of rare genetic disorders. The market encompasses therapies designed to treat conditions inherited through genetic mutations. This includes gene therapies, enzyme replacement therapies, and gene editing technologies. The rise in precision medicine and personalized healthcare has further fueled the demand for these treatments in the region. Moreover, the presence of prominent players and their R&D and product developments are also significantly boosting the region’s market growth. For instance, in March 2024, Astria Therapeutics announced positive initial proof-of-concept outcomes from the ALPHA-STAR Phase 1b/2 clinical trial evaluating STAR-0215. It is a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients. 

The National Library of Medicine conducted an internet-based survey among the US physicians. The survey concluded that about 1,230 to 1,331 people in the U.S. suffered from HAE-nl-C1INH between May 2019 and April 2020.  Owing to the rising number of HAE cases since 2020, the U.S. market is witnessing significant growth, which is further driven by improved diagnosis of the rare genetic disorder. Prominent players in the market are focusing on developing novel biologics to provide long-term solutions. The market is also supported by favorable reimbursement policies and ongoing clinical research.

With better diagnostic practices and improved access to advanced treatments in Canada the HAE market is showcasing steady growth in the country. A robust healthcare system and ongoing government support for rare disease treatment are also boosting the market. Companies in the country are increasingly investing in developing advanced devices. In November 2021, BioCryst Pharmaceutical, Inc., Royalty Pharma plc, and OMERS Capital Markets announced the addition of USD 350 million in new funding for BioCryst. The added funds are aimed to enable further advancement of BCX9930 and also support the global launch of ORLADEYO.

Europe Market Statistics

Increased awareness of the condition, and improved diagnostic rates, in addition to the development of novel therapies by the prominent players in the region, are driving the Europe market steadily. Well-established healthcare facilities and regulatory frameworks encourage the development and adoption of orphan drugs for rare diseases including HAE. Germany, Italy, and France are leading contributors to the region’s market growth. Prominent players are also presenting a great number of developments in the region. For instance, in December 2023, Otsuka Pharmaceuticals Co., Inc., entered a license agreement where Otsuka acquired exclusive marketing rights to Ionis HAE drug candidate donidalorsen in Europe. Organizations including European Medicines Agency, and rare diseases advocacy groups are playing a vital role in facilitating the approval and reimbursement of HAE therapies.

Germany healthcare system facilitates early diagnosis and treatment of rare diseases, including HAE. As per the National Library of Medicine, in January 2024, there were approximately 1,700 patients suffering from HAE in Germany. The country’s regulatory bodies and health insurance systems also play a significant role in ensuring patient access to these advanced treatments. The presence of prominent players in the hereditary angioedema treatment market is also boosting the growth significantly.

France focuses on patient-centric care and the availability of novel treatments, in addition to its comprehensive coverage and public support for rare diseases. These factors are driving the country’s market successfully. Organizations such as the French National Rare Disease Plan support research, diagnosis, and patient care for conditions including HEA. Furthermore, the country’s extensive network of specialist centers for rare diseases ensures that the patients receive appropriate care and management. Hence, the country’s market is projected to witness considerable growth in the upcoming years.

Research Nester
Hereditary Angioedema (HAE) Therapeutics Market Share
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Companies Dominating the Hereditary Angioedema Treatment Landscape

    The hereditary angioedema treatment market is dominated is dominated by several key companies, significantly shaping the landscape of innovative treatments. These companies focus on both acute and prophylactic treatments. In September 2021, Cycle Pharmaceuticals announced the launch of SAJAZIR Injection, a new treatment option for patients affected by Hereditary Angioedema. The treatment has been approved by the US Food and Drug Administration (FDA). Competitive dynamics in the hereditary angioedema treatment market have intensified in the last few years. Companies are seeking to differentiate their products through improved efficacy, safety, and ease of use. Some of these prominent companies are:

    • Attune Pharmaceuticals
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • BioCryst Pharmaceuticals, Inc.
    • Biomarin
    • CSL Behring LLC
    • Intellia Therapeutics
    • Ionis Pharmaceuticals
    • KalVista Pharmaceuticals, Inc.
    • Pharming Healthcare, Inc.
    • Pharvaris

In the News

  • In January 2024, Ionis Pharmaceuticals, Inc. announced positive results for the Phase 3 OASIS-HAE study of donidalorsen in people with hereditary angioedema
  • In March 2023, Intellia Therapeutics received FDA clearance for an Investigational New Drug (IND) application for NTLA-2002. It is an in vivo genome editing candidate designed to inactivate the target gene and prevent HAE attacks after a single-dose treatment.
  • In November 2022, BioCryst Pharmaceuticals, Inc. received marketing authorization from the Israeli Ministry of Health for oral, once-daily ORLADEYO to prevent HAE attacks.
  • In July 2021, Orchard Therapeutics and Pharming Group N.V. announced a strategic collaboration to research, develop, manufacture, and commercialize OTL-105, for the treatment of hereditary angioedema.

Author Credits:  Radhika Pawar


  • Report ID: 6520
  • Published Date: Oct 07, 2024
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

In the year 2024, the industry size of the hereditary angioedema treatment market was over USD 5.3 billion.

The market size for the hereditary angioedema treatment market is projected to reach USD 15.7 billion by the end of 2037 expanding at a CAGR of 9.5% during the forecast period i.e., between 2025-2037.

The major players in the market are BioCryst Pharmaceuticals, Inc., Biomarin, CSL Behring LLC, and others.

In terms of age group segment, the adults segment is anticipated to garner the largest market share by 2037 and display lucrative growth opportunities during 2025-2037.

The market in North America is projected to hold the largest market share of 50.5% by the end of 2037 and provide more business opportunities in the future.
Hereditary Angioedema (HAE) Therapeutics Market Report Scope
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