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Hereditary Angioedema Market Report and Forecast 2025-2034

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    Report

  • 400 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6052546
The hereditary angioedema market was valued at USD 3.76 Billion in 2024, driven by the rising cases of hereditary angioedema (HAE) across 8 major markets. The market is anticipated to grow at a CAGR of 7.40% during the forecast period of 2025-2034, with the values likely to reach USD 7.68 Billion by 2034.

Hereditary Angioedema Market Overview

Hereditary angioedema is a disorder in which the patient experiences recurrent episodes of severe swelling in various body parts such as limbs, face, intestinal tract, and airway. Episodes that affect the intestinal tract may cause severe abdominal pain, nausea, and vomiting. Further, a swollen airway can restrict breathing and lead to life-threatening obstruction of the airway. It is also common for the patient with this condition to develop a non-itchy rash called erythema marginatum during an attack.

Hereditary Angioedema Market Growth Drivers

FDA Approvals Contributing to Increased Treatment Options and Cost Efficiency

The market growth can be attributed to the rising research and development activities by the researchers backed by key market players and governments. The rise in these clinical studies is significantly contributing to the increase in regulatory applications and approvals, leading to market development. For instance, in June 2024, Alembic Pharmaceuticals Ltd announced that they received the final approval from the United States health regulator for their generic Icatibant injection indicated for the treatment of acute attacks of hereditary angioedema in adults. The FDA approval is poised to bring a new and effective treatment option into the market, potentially solidifying the presence of Alembic Pharmaceuticals Ltd in the market while contributing to market growth.

Rising Collaborations to Expand Accessibility for Medications in Underserved Areas

The market players are increasing efforts to expand their market presence by attempting to serve more regions other than their primary hubs. Market expansion plays a crucial role in increasing the availability of the treatment in other regions and bridging the gaps of unmet need for appropriate treatments. For instance, in June 2024, Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced the expansion of the licensing agreement for hereditary angioedema (HAE) drug candidate donidalorsen (genetic name) with Ionis Pharmaceuticals, Inc. (Ionis) to widen its development and commercialisation area to the Asia-Pacific region, including Japan. Otsuka has further planned to submit applications for regulatory approval of donidalorsen in Europe and the Asia-Pacific region. The company plans to apply for regulatory approval and exclusively commercialise the product in Asian-Pacific markets. The collaboration between companies is projected to stimulate market growth by delivering donidalorsen to patients across Asia Pacific and Europe to address the unmet medical needs of patients with HAE.

Hereditary Angioedema Market Trends

The market is witnessing several trends and developments to improve the current scenario. Some of the notable trends are as follows:

Introduction of Novel Therapies

There is a growing focus on advanced treatments such as monoclonal antibodies and gene therapies aimed at reducing attack frequency and improving long-term outcomes, bolstering market growth.

Rising Awareness

The increasing awareness of the disorder is leading to an increase in the early detection of HAE by healthcare providers, creating a larger patient pool and demand for appropriate treatments.

Expansion into Emerging Markets

The underserved regions with unmet needs are becoming the new focus of pharmaceutical companies. The market players are increasing efforts to expand their global presence, strengthening market development.

Rising Collaborations to Offer Effective Therapeutic Solutions

Companies are increasingly entering into partnerships with other market players to boost their research and development activities by sharing their powerful expertise and resources, contributing to the introduction of innovative HAE therapies in the market.

Hereditary Angioedema Market Segmentation

The market report offers a detailed analysis of the market based on the following segments:

Market Breakup by Drug Class

  • C1 Esterase Inhibitor
  • Selective Bradykinin B2 Receptor Antagonist
  • Kallikrein Inhibitor
  • Others

Market Breakup by Route of Administration

  • Intravenous
  • Subcutaneous
  • Others

Market Breakup by End User

  • Hospitals
  • Clinics
  • Others

Market Breakup by Region

  • United States
  • EU-4 and the United Kingdom
  • Germany
  • France
  • Italy
  • Spain
  • United Kingdom
  • Japan
  • India

Hereditary Angioedema Market Share

Segmentation Based on Drug Class to Witness Substantial Growth

The market report offers insights into several drug classes, namely, C1 esterase inhibitors, selective bradykinin B2 receptor antagonists, Kallikrein inhibitors and others. Out of these, the C1 Esterase inhibitor drug class dominates the market share due to its established efficacy in both acute and prophylactic treatment. It reduces the frequency and severity of HAE attacks by targeting the root cause which is C1 inhibitor deficiency. It is also available in various formulations (plasma-derived and recombinant), C1 esterase inhibitors are backed by several research, and a long track record of safety and effectiveness.

Subcutaneous Administration Leads Segmentation by Route of Administration

The subcutaneous route of administration leads the market share due to its convenience, improved patient compliance, and effectiveness in delivering therapies. Unlike intravenous administration, subcutaneous treatments can often be self-administered at home, reducing healthcare costs and enhancing patient comfort. This has contributed to the rise in preference for this administration method for long-term prophylactic treatments.

Hereditary Angioedema Market Analysis by Region

Based on region, the market is segmented into the United States, EU-4 (Germany, France, Italy, Spain), the United Kingdom Japan and India. The regional market is dominated by the United States due to the presence of a well-established healthcare infrastructure and high awareness of the condition. The market dominance can also be attributed to the availability of advanced therapies, strong investment in research and development, and the presence of major pharmaceutical companies, bolstering the region’s leadership. The presence of a large patient pool and favourable reimbursement policies that enable individuals to access expensive treatments, resulting in increased diagnoses, propels market growth.

Leading Players in the Hereditary Angioedema Market

The key features of the market report comprise patent analysis, clinical trial analysis, grants analysis, funding and investment analysis and strategic initiatives by the leading players. The major companies in the market are as follows:

Takeda Pharmaceutical Company

Takeda Pharmaceutical is a global leader based in Japan. The company has a significant presence in the HAE market, primarily through its Firazyr, which is commonly used for the treatment of acute HAE attacks in adults. Takeda also offers Takhzyro, a preventive treatment for HAE, enhancing its portfolio in hereditary angioedema management.

CSL Behring

CSL Behring is a global biotechnology leader that provides a range of therapies for rare and serious diseases, including hereditary angioedema. Their HAE portfolio includes Haegarda, a C1 esterase inhibitor (human) for routine prevention of HAE attacks in adolescent and adult patients, and Berinert, for the treatment of acute abdominal, facial, or laryngeal HAE attacks in any patient group.

Pharvaris N.V.

Pharvaris is a clinical-stage biopharmaceutical company focused on bringing oral therapy to patients suffering from HAE. They are pioneering the development of new oral bradykinin B2 receptor antagonists, offering an innovative approach to the treatment and prevention of HAE attacks. The company aims to replace injectable treatments with easy-to-administer pills.

BioCryst Pharmaceuticals Inc.

BioCryst Pharmaceuticals specialises in the development and marketing of novel, oral, small-molecule medicines for rare diseases like HAE. Their key product, Orladeyo (berotralstat), is an oral, once-daily therapy designed to prevent attacks in HAE patients, representing a shift toward more patient-friendly, oral therapeutic options in the market.

Other key players in the market include Ionis Pharmaceuticals Inc., KalVista Pharmaceuticals Inc., Sanofi S.A., BioMarin Pharmaceutical Inc., Adverum Biotechnologies Inc., and Novartis AG., among others.

Key Questions Answered in the Hereditary Angioedema Market

  • What was the hereditary angioedema market value in 2023?
  • What is the hereditary angioedema market forecast outlook for 2025-2034?
  • What are the regional markets covered in the report?
  • What is market segmentation based on drug class?
  • How does segmentation by route of administration influence market dynamics?
  • Who are the end-users in the market?
  • What are the major factors aiding the hereditary angioedema market demand?
  • How has the market performed so far and how is it anticipated to perform in the coming years?
  • What are the market's major drivers, opportunities, and restraints?
  • Which regional market is expected to lead the market share in the forecast period?
  • Which country is expected to experience expedited growth during the forecast period?
  • What are the major hereditary angioedema market trends?
  • Which drug class is expected to dominate the market?
  • Which route of administration will lead the market segment?
  • Which end-user will lead the market?
  • Who are the key players involved in the hereditary angioedema market?
  • What is the patent landscape of the market?
  • What are the current unmet needs and challenges in the market?
  • How are partnerships, collaborations, mergers, and acquisitions among the key market players shaping the market dynamics?

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Table of Contents

1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage - Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Hereditary Angioedema Market Overview - 8 Major Markets
3.1 Hereditary Angioedema Market Historical Value 2018-2024
3.2 Hereditary Angioedema Market Forecast Value 2025-2034
4 Vendor Positioning Analysis
4.1 Key Vendors
4.2 Prospective Leaders
4.3 Niche Leaders
4.4 Disruptors
5 Hereditary Angioedema Overview
5.1 Guidelines and Stages
5.2 Pathophysiology
5.3 Screening and Diagnosis
5.4 Treatment Pathway
6 Patient Profile
6.1 Patient Profile Overview
6.2 Patient Psychology and Emotional Impact Factors
6.3 Risk Assessment and Treatment Success Rate
7 Hereditary Angioedema Market - Epidemiology Scenario and Forecast - 8 Major Markets
7.1 8MM Epidemiology Scenario Overview 2018-2034
7.2 Prevalence, by Country
7.2.1 United States
7.2.2 United Kingdom
7.2.3 EU4
7.2.4 India
7.2.5 Japan
7.3 Diagnosed Cases, by Country
7.3.1 United States
7.3.2 United Kingdom
7.3.3 EU4
7.3.4 India
7.3.5 Japan
7.4 Treatment Seeking Rate, by Country
7.4.1 United States
7.4.2 United Kingdom
7.4.3 EU4
7.4.4 India
7.4.5 Japan
8 Hereditary Angioedema Market Landscape - 8 Major Markets
8.1 Hereditary Angioedema Market: Developers Landscape
8.1.1 Analysis by Year of Establishment
8.1.2 Analysis by Company Size
8.1.3 Analysis by Region
9 Hereditary Angioedema Market Challenges and Unmet Needs
9.1 Treatment Pathway Challenges
9.2 Compliance and Drop-Out Analysis
9.3 Awareness and Prevention Gaps
10 Cost of Treatment
11 Hereditary Angioedema Market Dynamics
11.1 Market Drivers and Constraints
11.2 SWOT Analysis
11.2.1 Strengths
11.2.2 Weaknesses
11.2.3 Opportunities
11.2.4 Threats
11.3 PESTEL Analysis
11.3.1 Political
11.3.2 Economic
11.3.3 Social
11.3.4 Technological
11.3.5 Legal
11.3.6 Environment
11.4 Porter’s Five Forces Model
11.4.1 Bargaining Power of Suppliers
11.4.2 Bargaining Power of Buyers
11.4.3 Threat of New Entrants
11.4.4 Threat of Substitutes
11.4.5 Degree of Rivalry
11.5 Key Demand Indicators
11.6 Key Price Indicators
11.7 Industry Events, Initiatives, and Trends
11.8 Value Chain Analysis
12 Hereditary Angioedema Market Segmentation 218-2034 - 8 Major Markets
12.1 Hereditary Angioedema Market 2018-2034 by Drug Class
12.1.1 Market Overview
12.1.2 C1 Esterase Inhibitor
12.1.3 Selective Bradykinin B2 Receptor Antagonist
12.1.4 Kallikrein Inhibitor
12.1.5 Others
12.2 Hereditary Angioedema Market 2018-2034 by Route of Administration
12.2.1 Market Overview
12.2.2 Intravenous
12.2.3 Subcutaneous
12.2.4 Others
12.3 Hereditary Angioedema Market 2018-2034 by End User
12.3.1 Market Overview
12.3.2 Hospitals
12.3.3 Clinics
12.3.4 Others
12.4 Hereditary Angioedema Market 2018-2034 by Region
12.4.1 Market Overview
12.4.2 United States
12.4.3 EU-4 and the United Kingdom
12.4.3.1 Germany
12.4.3.2 France
12.4.3.3 Italy
12.4.3.4 Spain
12.4.3.5 United Kingdom
12.4.4 Japan
12.4.5 India
13 United States Hereditary Angioedema Market 218-2034
13.1 United States Hereditary Angioedema Market 2018-2034 by Drug Class
13.1.1 Market Overview
13.1.2 C1 Esterase Inhibitor
13.1.3 Selective Bradykinin B2 Receptor Antagonist
13.1.4 Kallikrein Inhibitor
13.1.5 Others
13.2 United States Hereditary Angioedema Market 2018-2034 by Route of Administration
13.2.1 Market Overview
13.2.2 Intravenous
13.2.3 Subcutaneous
13.2.4 Others
13.3 United States Hereditary Angioedema Market 2018-2034 by End User
13.3.1 Market Overview
13.3.2 Hospitals
13.3.3 Clinics
13.3.4 Others
14 EU-4 and United Kingdom Hereditary Angioedema Market 218-2034
14.1 EU-4 and United Kingdom Hereditary Angioedema Market 2018-2034 by Drug Class
14.1.1 Market Overview
14.1.2 C1 Esterase Inhibitor
14.1.3 Selective Bradykinin B2 Receptor Antagonist
14.1.4 Kallikrein Inhibitor
14.1.5 Others
14.2 EU-4 and United Kingdom Hereditary Angioedema Market 2018-2034 by Route of Administration
14.2.1 Market Overview
14.2.2 Intravenous
14.2.3 Subcutaneous
14.2.4 Others
14.3 EU-4 and United Kingdom Hereditary Angioedema Market 2018-2034 by End User
14.3.1 Market Overview
14.3.2 Hospitals
14.3.3 Clinics
14.3.4 Others
15 Japan Hereditary Angioedema Market 218-2034
15.1 Japan Hereditary Angioedema Market 2018-2034 by Drug Class
15.1.1 Market Overview
15.1.2 C1 Esterase Inhibitor
15.1.3 Selective Bradykinin B2 Receptor Antagonist
15.1.4 Kallikrein Inhibitor
15.1.5 Others
15.2 Japan Hereditary Angioedema Market 2018-2034 by Route of Administration
15.2.1 Market Overview
15.2.2 Intravenous
15.2.3 Subcutaneous
15.2.4 Others
15.3 Japan Hereditary Angioedema Market 2018-2034 by End User
15.3.1 Market Overview
15.3.2 Hospitals
15.3.3 Clinics
15.3.4 Others
16 India Hereditary Angioedema Market 218-2034
16.1 India Hereditary Angioedema Market 2018-2034 by Drug Class
16.1.1 Market Overview
16.1.2 C1 Esterase Inhibitor
16.1.3 Selective Bradykinin B2 Receptor Antagonist
16.1.4 Kallikrein Inhibitor
16.1.5 Others
16.2 India Hereditary Angioedema Market 2018-2034 by Route of Administration
16.2.1 Market Overview
16.2.2 Intravenous
16.2.3 Subcutaneous
16.2.4 Others
16.3 India Hereditary Angioedema Market 2018-2034 by End User
16.3.1 Market Overview
16.3.2 Hospitals
16.3.3 Clinics
16.3.4 Others
17 Regulatory Framework
17.1 Regulatory Overview
17.2 US FDA
17.3 EU EMA
17.4 Japan PMDA
17.5 India CDSCO
17.6 Others
18 Patent Analysis
18.1 Analysis by Type of Patent
18.2 Analysis by Publication Year
18.3 Analysis by Issuing Authority
18.4 Analysis by Patent Age
18.5 Analysis by CPC Analysis
18.6 Analysis by Patent Valuation
19 Clinical Trials Analysis
19.1 Analysis by Trial Registration Year
19.2 Analysis by Trial Status
19.3 Analysis by Trial Phase
19.4 Analysis by Therapeutic Area
19.5 Analysis by Geography
20 Grants Analysis
20.1 Analysis by Year
20.2 Analysis by Amount Awarded
20.3 Analysis by Issuing Authority
20.4 Analysis by Grant Application
20.5 Analysis by Funding Institute
20.6 Analysis by NIH Departments
20.7 Analysis by Recipient Organization
21 Funding and Investment Analysis
21.1 Analysis by Funding Instances
21.2 Analysis by Drug Class of Funding
21.3 Analysis by Funding Amount
21.4 Analysis by Leading Players
21.5 Analysis by Leading Investors
21.6 Analysis by Geography
22 Strategic Initiatives
22.1 Analysis by Partnership Instances
22.2 Analysis by Drug Class of Partnership
22.3 Analysis by Leading Players
22.4 Analysis by Geography
23 Supplier Landscape
23.1 Market Share Analysis, By Region (Top 5 Companies)
23.2 Takeda Pharmaceutical Company
23.2.1 Financial Analysis
23.2.2 Product Portfolio
23.2.3 Demographic Reach and Achievements
23.2.4 Company News and Developments
23.2.5 Certifications
23.3 CSL Behring
23.3.1 Financial Analysis
23.3.2 Product Portfolio
23.3.3 Demographic Reach and Achievements
23.3.4 Company News and Developments
23.3.5 Certifications
23.4 Pharvaris N.V.
23.4.1 Financial Analysis
23.4.2 Product Portfolio
23.4.3 Demographic Reach and Achievements
23.4.4 Company News and Developments
23.4.5 Certifications
23.5 BioCryst Pharmaceutical Inc.
23.5.1 Financial Analysis
23.5.2 Product Portfolio
23.5.3 Demographic Reach and Achievements
23.5.4 Company News and Developments
23.5.5 Certifications
23.6 Ionis Pharmaceuticals Inc.
23.6.1 Financial Analysis
23.6.2 Product Portfolio
23.6.3 Demographic Reach and Achievements
23.6.4 Company News and Developments
23.6.5 Certifications
23.7 KalVista Pharmaceuticals Inc.
23.7.1 Financial Analysis
23.7.2 Product Portfolio
23.7.3 Demographic Reach and Achievements
23.7.4 Company News and Developments
23.7.5 Certifications
23.8 Sanofi S.A.
23.8.1 Financial Analysis
23.8.2 Product Portfolio
23.8.3 Demographic Reach and Achievements
23.8.4 Company News and Developments
23.8.5 Certifications
23.9 BioMarin Pharmaceutical Inc.
23.9.1 Financial Analysis
23.9.2 Product Portfolio
23.9.3 Demographic Reach and Achievements
23.9.4 Company News and Developments
23.9.5 Certifications
23.10 Adverum Biotechnologies Inc.
23.10.1 Financial Analysis
23.10.2 Product Portfolio
23.10.3 Demographic Reach and Achievements
23.10.4 Company News and Developments
23.10.5 Certifications
23.11 Novartis AG
23.11.1 Financial Analysis
23.11.2 Product Portfolio
23.11.3 Demographic Reach and Achievements
23.11.4 Company News and Developments
23.11.5 Certifications
24 Hereditary Angioedema Market - Distribution Model (Additional Insight)
24.1 Overview
24.2 Potential Distributors
24.3 Key Parameters for Distribution Partner Assessment
25 Key Opinion Leaders (KOL) Insights (Additional Insight)
26 Payment Methods (Additional Insight)
26.1 Government Funded
26.2 Private Insurance
26.3 Out-of-Pocket

Companies Mentioned

  • Takeda Pharmaceutical Company
  • CSL Behring
  • Pharvaris N.V.
  • BioCryst Pharmaceuticals Inc.

Table Information