유전성 혈관부종(HAE) : 신규 요법, 미충족 수요 및 TPP 인사이트 보고서(2026년)

Hereditary Angioedema (HAE) Emerging Therapy and TPP Insights

Thelansis's "Hereditary Angioedema (HAE) Emerging Therapy, with Unmet Needs and TPP Insights Report - 2026" provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

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.

Insights driven by surveys with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs
• Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
• Pipeline analysis
• Target patients for emerging therapies
• Key companies
• Key mechanism of actions
• Launch date estimates, etc.
• Clinical trial landscape analysis
• Target patient segments
• Trial endpoints
• Trial design
• Recruitment criteria, etc.
• Unmet Needs and Opportunities
• Performance of key current therapies
• Top areas of unmet needs
• Opportunity sizing for key unmet needs
• Target Product Profiles
• Attributes and levels
• Physician likelihood of prescribing
• Expected patient shares
• KOL insights on key emerging therapies
• Level of awareness
• Expected use / line of therapy
• Extent to fulfil key unmet needs
• KOL quotes

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard will cost USD 1,750 per country

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 risk, etc.

2. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key emerging therapies - profiles and KOL insights

3. Product Attribute Analysis

• Key takeaways
• Scientific attributes
• Commercial attributes
• Product positioning

4. Primary Market Research

• Current treatment landscape
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Current challenges
• Unmet needs
• Emerging therapies
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Unmet needs and KOL expectations

5. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

6. Regulatory and Reimbursement Environments (by country and payer insights)

7. Appendix (e.g., bibliography, methodology)