유전성 혈관부종 치료제 : 시장 점유율 분석, 산업 동향 및 통계 데이터, 성장 예측(2026-2031년)

According to Mordor Intelligence, the hereditary angioedema therapeutics market size in 2026 is estimated at USD 6.83 billion, growing from 2025 value of USD 5.86 billion with 2031 projections showing USD 14.69 billion, growing at 16.56% CAGR over 2026-2031.

This report is Segmented by Drug Class (C1 Esterase Inhibitor, and More), Route of Administration (Intravenous, and More), Patient Type (Type I, and More), Treatment Type (Acute/On-Demand and Long-Term Prophylaxis), Distribution Channel (Hospital Pharmacies, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Hereditary Angioedema Therapeutics Market Trends and Insights

Commercial Roll-Out of First-In-Class Oral Kallikrein Inhibitors

BioCryst's berotralstat (Orladeyo) has normalized once-daily oral prophylaxis, driving USD 437 million in 2024 sales and a further 51% year-over-year uplift in Q1 2025. Young, working-age patients favor the pill format, accelerating switches from injectables; 70% of U.S. hereditary angioedema patients now choose oral prophylaxis. A pending FDA decision on KalVista's sebetralstat could inaugurate the first oral on-demand option, with Phase 3 data showing symptom relief within 1.61 hours versus 6.72 hours for placebo. These dynamics are enlarging the hereditary angioedema therapeutics market by capturing previously undertreated segments and broadening geographic reach.

Escalating Use of Subcutaneous C1-INH Self-Administration

CSL Behring's Haegarda cut attack frequency by 95% in pivotal trials and underpinned a global migration from intravenous replacement to patient-controlled subcutaneous dosing. Home programs reduce annual per-patient costs by 11.3% and maintain technical failure rates below 2%. Specialty pharmacies supply 24-hour helplines and nurse coaching, reinforcing adherence and freeing infusion-center capacity. Pediatric cohorts as young as eight years now achieve durable prophylaxis outside hospital settings, reinforcing quality-of-life gains.

High Annual Therapy Cost Pressures Healthcare Budgets

Despite strong clinical value, incremental cost-effectiveness ratios can breach USD 150,000 per QALY, challenging conventional thresholds. Real-world evidence places direct medical costs near USD 364,000 and indirect losses at USD 52,500 per patient yearly, straining public payers and limiting coverage in low-income markets. Biosimilar potential is restricted by plasma supply constraints and complex biologics manufacturing.

Other drivers and restraints analyzed in the detailed report include:

1. Momentum Behind Gene-Silencing & CRISPR One-Shot Cures
2. Rising Orphan-Drug Pricing Power & Payer Acceptance
3. Limited HAE Expertise Outside Tier-1 Academic Centers

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

C1 esterase inhibitors generated 60.92% of 2025 revenue, anchoring the hereditary angioedema therapeutics market size at USD 3.57 billion. CSL Behring's Berinert and Haegarda safeguard this position through reliable efficacy and extensive real-world data. Yet kallikrein inhibitors are scaling faster at a 19.12% CAGR, led by BioCryst's oral berotralstat, which delivered USD 437 million in 2024 sales. With modular oral, subcutaneous, and long-acting monoclonal formats in late-stage pipelines, kallikrein agents are positioned to capture incremental hereditary angioedema therapeutics market share over the forecast window.

Patient preference is steering capital allocation toward oral compounds and long-interval injectables, pressuring conventional plasma-derived segments. Nonetheless, plasma-free recombinant C1-INH (Ruconest) and supply-diversification strategies protect incumbents against sourcing constraints and infectious-disease risk, sustaining a two-pillar class dynamic through 2030.

Subcutaneous products contributed 51.48% of hereditary angioedema therapeutics market share in 2025, equal to USD 3.02 billion, and underscore a decade-long shift toward home dosing. Training completion rates above 98% validate the model, while health-economic studies confirm 11.30% annual savings versus hospital-based intravenous care. Concurrently, oral delivery is expanding at 19.7% CAGR, on track to exceed USD 4.72 billion by 2031, driven by berotralstat and the anticipated approval of sebetralstat.

Intravenous treatments, though declining, remain critical for emergency departments and for patients requiring immediate high-dose intervention. Future pipeline assets targeting granule formulations for children aged 2-11 years will further broaden oral reach, reinforcing patient-centric care trajectories.

Complete Report Scope:

• By Drug Class
  • C1 Esterase Inhibitor
  • Selective Bradykinin B2 Receptor Antagonist
  • Kallikrein Inhibitor
  • Other Drug Classes
• By Route of Administration
  • Intravenous
  • Sub-cutaneous Injection
  • Oral
• By Treatment Type
  • Acute / On-Demand
  • Long-term Prophylaxis
• By Patient Type
  • Type I (C1-INH deficiency)
  • Type II (C1-INH dysfunction)
  • nC1-INH (Type III & others)
• By Distribution Channel
  • Hospital Pharmacies
  • Specialty & Home-infusion Pharmacies
  • Online Pharmacies
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 79.55% of 2025 revenue, reflecting robust reimbursement, fast-track regulatory designations, and dense specialty-pharmacy infrastructure. More than 1,200 U.S. physicians have adopted berotralstat, and payer alignment on outcomes contracts sustains high adherence. Canada leverages provincial formularies for coverage, while Mexico's medical-tourism corridors attract regional HAE patients seeking advanced regimens.

Europe displays mature penetration, yet continued product cycling sustains value growth. EMA's positive opinion on garadacimab and MHRA's lanadelumab pediatric nod highlight regulatory momentum. France's early-access program reported 65% clinically meaningful quality-of-life gains at six months, reinforcing payer confidence.

Asia-Pacific is the fastest-growing region at 17.44% CAGR, propelled by Japan's regulatory clarity, China's expanding rare-disease catalog, and advocacy-driven awareness. The 2024 Manila HAEi summit showcased collaborative efforts across 25 nations, though diagnostic and reimbursement heterogeneity remain hurdles. Investments in regional plasma fractionation and tele-education platforms are expected to mitigate supply and expertise gaps over time.

1. CSL Behring
2. Takeda Pharmaceutical Co Ltd
3. Sanofi
4. Pharming Healthcare
5. BioCryst Pharmaceuticals
6. Attune Pharmaceuticals
7. Ionis Pharmaceuticals
8. KalVista Pharmaceuticals
9. Adverum Biotechnologies
10. Cipla
11. Arrowhead Pharmaceuticals
12. Astria Therapeutics Inc.
13. Grifols
14. Swedish Orphan Biovitrum (SOBI)
15. Regeneron Pharmaceuticals
16. CSL Vifor
17. Bayer
18. Novartis
19. Merck
20. Roche

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Escalating Use of Sub-Cutaneous C1-INH Self-Administration
  • 4.2.2 Commercial Roll-Out of First-In-Class Oral Kallikrein Inhibitors
  • 4.2.3 Rising Orphan-Drug Pricing Power & Payer Acceptance
  • 4.2.4 Precision-Medicine Push for Nc1-INH HAE Genotyping
  • 4.2.5 Home-Infusion & Tele-Pharmacy Infrastructure Expansion
  • 4.2.6 Momentum Behind Gene-Silencing & CRISPR One-Shot Cures
• 4.3 Market Restraints
  • 4.3.1 High Annual Therapy Cost (> US $500k/Patient) Pressures Budgets
  • 4.3.2 Limited HAE Expertise Outside Tier-1 Academic Centers
  • 4.3.3 Cold-Chain & Plasma-Supply Bottlenecks for C1-INH
  • 4.3.4 Regulatory Uncertainty for Long-Acting Monoclonal in Pediatrics
• 4.4 Regulatory Landscape
• 4.5 Porter's Five Forces Analysis
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Intensity of Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Drug Class
  • 5.1.1 C1 Esterase Inhibitor
  • 5.1.2 Selective Bradykinin B2 Receptor Antagonist
  • 5.1.3 Kallikrein Inhibitor
  • 5.1.4 Other Drug Classes
• 5.2 By Route of Administration
  • 5.2.1 Intravenous
  • 5.2.2 Sub-cutaneous Injection
  • 5.2.3 Oral
• 5.3 By Treatment Type
  • 5.3.1 Acute / On-Demand
  • 5.3.2 Long-term Prophylaxis
• 5.4 By Patient Type
  • 5.4.1 Type I (C1-INH deficiency)
  • 5.4.2 Type II (C1-INH dysfunction)
  • 5.4.3 nC1-INH (Type III & others)
• 5.5 By Distribution Channel
  • 5.5.1 Hospital Pharmacies
  • 5.5.2 Specialty & Home-infusion Pharmacies
  • 5.5.3 Online Pharmacies
• 5.6 Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global-level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 CSL Behring
  • 6.3.2 Takeda Pharmaceutical Co Ltd
  • 6.3.3 Sanofi
  • 6.3.4 Pharming Healthcare Inc.
  • 6.3.5 BioCryst Pharmaceuticals Inc.
  • 6.3.6 Attune Pharmaceuticals Inc.
  • 6.3.7 Ionis Pharmaceuticals
  • 6.3.8 KalVista Pharmaceuticals Inc.
  • 6.3.9 Adverum Biotechnologies Inc.
  • 6.3.10 Cipla Inc.
  • 6.3.11 Arrowhead Pharmaceuticals Inc.
  • 6.3.12 Astria Therapeutics Inc.
  • 6.3.13 Grifols S.A.
  • 6.3.14 Swedish Orphan Biovitrum (SOBI)
  • 6.3.15 Regeneron Pharmaceuticals Inc.
  • 6.3.16 CSL Vifor
  • 6.3.17 Bayer AG
  • 6.3.18 Novartis AG
  • 6.3.19 Merck & Co. Inc.
  • 6.3.20 F. Hoffmann-La Roche Ltd

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment