Global Hereditary Angioedema (HAE) Market Outlook
Thelansis's "Global Hereditary Angioedema (HAE) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report (Top 32 Markets) - 2025 To 2035" covers disease overview, epidemiology, kidney biopsy cases, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Hereditary Angioedema treatment modalities options for the 32 markets (North America, Europe, Middle East, Asia Pacific, Africa, South / Latin America).
Hereditary Angioedema (HAE) Overview
Hereditary angioedema (HAE) is a rare autosomal dominant disorder characterized by recurrent, self-limiting episodes of non-pruritic subcutaneous and submucosal edema primarily affecting the skin, gastrointestinal tract, and upper airway. Driven by mutations in the SERPING1 gene, type I HAE causes deficient C1-inhibitor (C1-INH) levels while type II results in dysfunctional C1-INH protein, both leading to unregulated bradykinin production and vascular permeability. Normal C1-INH variants also exist. Attacks present as localized swelling or debilitating abdominal pain, with laryngeal edema causing fatal asphyxiation risk. Diagnosis relies on low C4 levels and specific C1-INH quantitative or functional assays. Treatment in 2026 utilizes plasma-derived or recombinant C1-INH concentrates and the bradykinin B2 receptor antagonist icatibant for acute attacks, while modern long-term prophylaxis favors the plasma kallikrein inhibitor berotralstat or the monoclonal antibody lanadelumab.
Key Highlights
- In South Korea, diagnosed prevalent HAE cases are projected to increase from 186 in 2025 to 230 by 2035.
- HAE is a rare genetic disorder characterized by recurrent, potentially life-threatening swelling attacks.
- Improved awareness and genetic testing are increasing diagnosis rates globally.
- Long-term prophylactic therapies are transforming disease management and reducing attack frequency.
Market Overview
- The Spain HAE market is projected to grow from $126M in 2025 to $315M by 2035.
- Market growth is driven by:
- Strong uptake of prophylactic biologics and targeted therapies
- Improved diagnosis and patient identification
- Future expansion will depend on convenient long-acting and gene-based treatment approaches.
Market Definition:
- North America (United States, Canada)
- Europe (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom)
- Middle East (Saudi Arabia, UAE, Kuwait, Turkey)
- Asia Pacific (Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam)
- Africa (Egypt, Nigeria, South Africa, Morocco)
- South / Latin America (Argentina, Brazil, Chile, Colombia, Mexico, Peru)
Insights driven by robust research, including:
- In-depth interviews with leading KOLs and payers
- Physician surveys
- RWE analysis for claims and EHR datasets
- Secondary research (e.g., peer-reviewed journal articles, third-party research databases)
Deliverables format and updates*:
- Detailed Report (PDF)
- Market Forecast Model (MS Excel-based automated dashboard)
- Epidemiology (MS Excel; interactive tool)
- Executive Insights (PowerPoint presentation)
- Others: regular updates, customizations, consultant support
- As per Thelansis's policy, we ensure that we include all the recent updates before releasing the report content and market model.
Salient features of Market Forecast model:
- 10-year market forecast (2025-2035)
- Bottom-up patient-based market forecasts validated through the top-down sales methodology
- Covers clinically and commercially-relevant patient populations/ line of therapies
- Annualized drug-level sales and patient share projections
- Utilizes our proprietary Epilansis and Analog tool (e.g., drug uptake and erosion) datasets and conjoint analysis approach
- Detailed methodology/sources & assumptions
- Graphical and tabular outputs
- Users can customize the model based on requirements
Key business questions answered:
- How can drug development and lifecycle management strategies be optimized across the 32 markets (North America, Europe, Middle East, Asia Pacific, Africa, South / Latin America)?
- How large is the patient population in terms of incidence, prevalence, segments, and those receiving drug treatments?
- What is the 10-year market outlook for sales and patient share?
- Which events will have the greatest impact on the market's trajectory?
- What insights do interviewed experts provide on current and emerging treatments?
- Which pipeline products show the most promise, and what is their potential for launch and future positioning?
- What are the key unmet needs and KOL expectations for target profiles?
- What key regulatory and payer requirements must be met to secure drug approval and favorable market access?
Countries Covered
- North America (United States, Canada)
- Europe (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom)
- Middle East (Saudi Arabia, UAE, Kuwait, Turkey)
- Asia Pacific (Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam)
- Africa (Egypt, Nigeria, South Africa, Morocco)
- South / Latin America (Argentina, Brazil, Chile, Colombia, Mexico, Peru)
Companies Mentioned
- Intellia Therapeutics
- Astria Therapeutics, Inc.
- Ionis Pharmaceuticals, Inc.
- CSL Behring
- ADARx Pharmaceuticals, Inc.
- KalVista Pharmaceuticals, Ltd.
- BioCryst Pharmaceuticals
- Shanghai Argo Biopharmaceutical Co., Ltd.
- Pharvaris Netherlands B.V.
- Nang Kuang Pharmaceutical Co., Ltd.
Table of Contents
1. Key Findings and Analyst Commentary
- Key trends: market snapshots, SWOT analysis, commercial benefits and risks, etc.
2. Disease Context
- Disease definition, classification, etiology and pathophysiology, drug targets, etc.
3. Epidemiology
- Key takeaways
- Incidence / Prevalence
- Diagnosed and Drug-Treated populations
- Comorbidities
- Other relevant patient segments
4. Market Size and Forecast
- Key takeaways
- Market drivers and constraints
- Drug-class specific trends
- Country-specific trends
5. Competitive Landscape
- Current therapies
- Key takeaways
- Dx and Tx journey/algorithm
- Key current therapies - profiles and KOL insights
- Emerging therapies
- Key takeaways
- Notable late-phase emerging therapies - profiles, launch expectations, KOL insights
- Notable early-phase pipeline
6. Unmet Need and TPP Analysis
- Top unmet needs and future attainment by emerging therapies
- TPP analysis and KOL expectations
7. Regulatory and Reimbursement Environments (by country and payer insights)
8. Appendix (e.g., bibliography, methodology)