Global Hereditary Angioedema Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

The Global Hereditary Angioedema (HAE) Market is segmented by Drug Class, Distribution Channel, Route of Administration and Geography, Drug Class, which includes C1 Inhibitor Concentrates, Bradykinin B2 Receptor Antagonists, Plasma kallikrein Inhibitors, and Others. C1 Inhibitor Concentrates are considered the gold standard treatment for HAE, as they help control the swelling episodes by inhibiting the activation of complement pathways involved in the disease. Bradykinin B2 Receptor Antagonists, such as Icatibant, block bradykinin, a peptide that causes blood vessels to dilate and leads to swelling. Plasma kallikrein inhibitors (e.g., Ecallantide) target an enzyme that contributes to the inflammatory process in HAE. The use of biologic therapies, including monoclonal antibodies, is also gaining traction in the treatment of HAE, offering patients new, effective treatment options to manage the condition.

In terms of Distribution Channel, the HAE market is segmented into Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, and Others. Hospital pharmacies hold a significant share due to the high reliance on acute treatment and monitoring of HAE patients, particularly in emergency settings during severe swelling episodes. Retail pharmacies are a key distribution channel for patients who are on long-term prophylactic treatment or require regular medications to manage their condition. The growth of online pharmacies is also impacting the market as more patients gain access to treatments through convenient online platforms, especially in regions where healthcare access may be limited. Additionally, the expansion of specialty pharmacies that focus on rare diseases like HAE is further boosting distribution.

Geographically, the Global Hereditary Angioedema Market is segmented into North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa. North America dominates the market due to a high prevalence of HAE, availability of advanced healthcare systems, and significant investments in research and development of innovative treatments. The European market is also substantial, with widespread access to advanced therapeutics and a growing number of treatment options approved by regulatory agencies. Asia-Pacific is witnessing rapid growth in the HAE market as healthcare access improves, and the region experiences a rising number of diagnosed cases, particularly in countries like China and Japan. While Latin America and Middle East & Africa have lower market shares, these regions are expected to experience growth driven by improving healthcare infrastructure and increasing awareness of hereditary angioedema.

Global Hereditary Angioedema Segment Analysis

In this report, the Global Hereditary Angioedema Market has been segmented by Drug Class, Distribution Channel, Route of Administration and Geography.

Global Hereditary Angioedema Market, Segmentation by Drug Class

The Global Hereditary Angioedema Market has been segmented by Drug Class into C1 Esterase Inhibitor, Kallikrein Inhibitor, Bradykinin Receptor, Attenuated Androgens and Others.

C1 esterase inhibitors form a cornerstone of HAE treatment, particularly for acute attacks and prophylactic use. These drugs work by replenishing the deficient or dysfunctional C1 inhibitor protein in patients, thereby regulating the complement and contact system pathways that are often disrupted in HAE. Available in both intravenous and subcutaneous formulations, C1 esterase inhibitors offer flexibility in administration and have been shown to be highly effective in controlling acute symptoms and preventing recurrent attacks. This class includes both plasma-derived and recombinant products, reflecting ongoing innovations and advancements in treatment options.

Kallikrein inhibitors and bradykinin receptor antagonists represent newer therapeutic classes that specifically target the molecular mechanisms underlying HAE attacks. Kallikrein inhibitors block the activity of plasma kallikrein, an enzyme that plays a critical role in the generation of bradykinin, a peptide responsible for increased vascular permeability and edema in HAE. Similarly, bradykinin receptor antagonists prevent bradykinin from binding to its receptors, thereby mitigating the swelling associated with HAE attacks. These targeted therapies provide effective options for both acute management and long-term prophylaxis, contributing to improved patient outcomes and quality of life. The development of these drugs highlights the shift towards precision medicine in the HAE market.

Attenuated androgens, such as danazol, have been used historically for long-term prophylaxis in HAE patients by increasing the production of C1 inhibitor protein. However, their use has declined due to significant side effects and the availability of more targeted and safer alternatives. The "others" category includes various adjunct therapies and experimental treatments under investigation, reflecting ongoing research efforts to find novel and more effective treatments for HAE. As the understanding of HAE pathophysiology advances, the market continues to evolve, with new drug classes and innovative therapies emerging to better meet the needs of patients worldwide.

Global Hereditary Angioedema Market, Segmentation by Distribution Channel

The Global Hereditary Angioedema Market has been segmented by Distribution Channel into Hospital Pharmacies, Retail Pharmacies and E-Commerce.

The hospital pharmacies are a crucial distribution channel, especially for patients requiring immediate and specialized care. These pharmacies are integrated within hospital settings and provide a comprehensive range of medications, including those for acute HAE attacks and long-term prophylaxis. The advantage of hospital pharmacies lies in their ability to offer specialized pharmaceutical care and immediate access to medications, which is vital during severe HAE episodes that may require emergency intervention.

Retail pharmacies also play a significant role in the HAE market by providing easier access to maintenance medications for patients. These pharmacies are more widely distributed across urban and rural areas, making it convenient for patients to obtain their prescriptions. Retail pharmacies offer personalized services, such as patient counseling, medication management, and the facilitation of prescription refills. For chronic conditions like HAE, where patients need ongoing access to their medications to prevent attacks, retail pharmacies ensure continuity of care and improve adherence to treatment plans. Their accessibility and the ability to offer in-person consultations make them a valuable component of the distribution network.

E-commerce is rapidly becoming an important distribution channel in the HAE market, driven by the increasing adoption of digital health solutions and the convenience of online shopping. E-commerce platforms provide patients with the ability to order their medications from the comfort of their homes, which is particularly beneficial for those living in remote areas or with limited mobility. These platforms often offer a wider range of products and competitive pricing, along with the convenience of home delivery. E-commerce can facilitate automatic prescription refills and provide digital tools for medication management, enhancing adherence and patient engagement. As digital health continues to evolve, e-commerce is likely to play an increasingly prominent role in the HAE market, offering new ways to support patient care and improve access to essential medications.

Global Hereditary Angioedema Market, Segmentation by Route of Administration

The Global Hereditary Angioedema Market has been segmented by Route of Administration into Subcutaneous, Intravenous and Oral.

The subcutaneous administration has gained significant traction due to its convenience and ease of use, allowing patients to self-administer treatments in the comfort of their homes. This method is particularly beneficial for prophylactic therapies, which require regular dosing to prevent HAE attacks. The ability to administer medication subcutaneously has greatly improved patient compliance and quality of life, reducing the frequency of hospital visits and enhancing overall disease management.

Intravenous (IV) administration has been the traditional route for many HAE treatments, particularly for acute management during severe attacks. IV treatments, such as C1 esterase inhibitors, provide rapid relief by directly delivering the medication into the bloodstream, ensuring immediate action. Despite its efficacy, IV administration often requires healthcare professional supervision, making it less convenient for patients. The need for hospital or clinic visits can be burdensome, especially for those experiencing frequent attacks. However, IV treatments remain a critical option for acute intervention, particularly in emergency situations where swift action is necessary to prevent serious complications.

Emerging oral treatments represent the next frontier in HAE management, offering the potential for even greater convenience and patient adherence. Oral medications are particularly appealing as they eliminate the need for injections, making treatment more accessible and less intimidating for patients. While oral therapies are still in various stages of clinical development and market introduction, they hold promise for transforming HAE management by providing an easy-to-use option that can be seamlessly integrated into daily routines. The development of effective oral treatments is expected to significantly enhance patient compliance, broaden treatment accessibility, and further improve the quality of life for individuals living with hereditary angioedema.

Global Hereditary Angioedema Market, Segmentation by Geography

In this report, the Global Hereditary Angioedema Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Hereditary Angioedema Market Share (%), by Geographical Region, 2024

North America holds a significant share of the market due to the high prevalence of HAE, advanced healthcare infrastructure, and substantial investments in research and development. The presence of leading pharmaceutical companies and the availability of innovative therapies contribute to the region's market dominance. Supportive government policies, extensive awareness programs, and patient advocacy groups enhance diagnosis rates and access to effective treatments, driving market growth in North America.

Europe is another major player in the hereditary angioedema market, characterized by well-established healthcare systems and strong regulatory frameworks that facilitate the approval and distribution of HAE therapies. Countries such as Germany, France, and the United Kingdom lead the region in terms of market share due to their proactive healthcare policies and robust clinical research activities. European Union initiatives aimed at rare diseases also support the development and availability of HAE treatments. Collaborative efforts among healthcare providers, researchers, and patient organizations play a crucial role in improving patient outcomes and expanding the market in Europe.

The Asia Pacific region represents a rapidly growing segment of the hereditary angioedema market, driven by increasing awareness of the disease, improving healthcare infrastructure, and rising healthcare expenditures in countries like China, India, and Japan. Although the prevalence of HAE may be lower compared to Western countries, the large population base and increasing access to healthcare services present significant growth opportunities. Governments and healthcare organizations in the Asia Pacific are focusing on enhancing diagnostic capabilities and expanding access to advanced treatments. Additionally, local pharmaceutical companies are actively participating in the market, developing and distributing affordable HAE therapies to meet the region's growing demand.

This report provides an in depth analysis of various factors that impact the dynamics of Global Hereditary Angioedema Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Increased Awareness
• Orphan Designations
• Targeted Therapies

• Diagnostic Advancements : Diagnostic advancements in the global hereditary angioedema (HAE) market have significantly enhanced the ability to accurately identify and manage this rare genetic disorder. Early and precise diagnosis is critical for effective treatment and improving patient outcomes. Recent developments in genetic testing and biomarker identification have played a pivotal role in diagnosing HAE. Genetic tests that detect mutations in the SERPING1 gene, which encodes the C1 inhibitor protein, allow for definitive diagnosis, differentiating HAE from other forms of angioedema. These advancements have facilitated early diagnosis, even in asymptomatic family members, enabling timely intervention and management.

  Advancements in laboratory diagnostics have improved the accuracy and reliability of HAE diagnosis. Functional assays measuring C1 inhibitor activity, C4 levels, and other complement system components have become standard in the diagnostic process. These assays help confirm the diagnosis and subtype classification of HAE, whether it is Type I, Type II, or normal C1 inhibitor (Type III). Enhanced diagnostic techniques have reduced the rate of misdiagnosis and inappropriate treatment, ensuring that patients receive the most effective therapies tailored to their specific HAE type. This precision in diagnosis is crucial for managing the condition and preventing severe attacks.

  The integration of next-generation sequencing (NGS) and other high-throughput genomic technologies into clinical practice represents a major leap forward in the diagnostic landscape of HAE. These technologies enable comprehensive genetic profiling, uncovering novel mutations and variants associated with HAE. This not only aids in diagnosis but also enhances our understanding of the genetic underpinnings of the disease, guiding the development of new targeted therapies. Additionally, the use of advanced diagnostic tools in research settings has accelerated the identification of potential biomarkers, which could further refine diagnostic criteria and prognostic assessments. These diagnostic advancements are transforming the HAE market by enabling more accurate, efficient, and personalized approaches to patient care.

Restraints

• Limited Awareness
• Diagnosis Challenges
• Side Effects

• Regulatory Hurdles : Regulatory hurdles pose significant challenges to the Global Hereditary Angioedema (HAE) Market, impacting the development, approval, and commercialization of therapies. One key obstacle is the rarity of HAE, which often leads to limited clinical trial data and challenges in conducting large-scale studies to demonstrate safety and efficacy. Regulatory agencies require robust evidence of a treatment's benefit-risk profile before granting approval, necessitating innovative trial designs, patient registries, and collaboration among stakeholders to overcome these hurdles. The variability in disease presentation and patient response further complicates the regulatory process, as treatments may need to be tailored to individual patient needs.

  Another regulatory challenge in the HAE market is the classification of therapies as orphan drugs. Orphan drug designation provides incentives to pharmaceutical companies, such as market exclusivity and tax credits, to encourage the development of treatments for rare diseases like HAE. Obtaining orphan drug status requires meeting specific criteria set forth by regulatory agencies, including prevalence thresholds and the absence of satisfactory treatment options. The classification process can be time-consuming and resource-intensive, with no guarantee of success. Furthermore, orphan drug pricing and reimbursement policies vary across regions, posing additional challenges for market access and commercial viability.

  Regulatory agencies often set high standards for manufacturing, quality control, and product labeling to ensure the safety and efficacy of HAE therapies. Compliance with Good Manufacturing Practice (GMP) regulations is essential for pharmaceutical companies seeking approval for their products. Manufacturing processes must be meticulously documented, and quality control measures must be implemented to minimize the risk of contamination or product defects. Product labeling must accurately reflect the indications, dosing, and potential risks associated with HAE treatments to inform healthcare providers and patients adequately. Meeting these regulatory requirements demands substantial investment in infrastructure, expertise, and resources, further complicating market entry and commercialization efforts in the global HAE market.

Opportunities

• Targeted Therapies
• Prophylactic Treatments
• Market Expansion

• Novel Therapeutics : Innovations in novel therapeutics are reshaping the landscape of the global hereditary angioedema (HAE) market, offering promising treatment options for patients with this rare genetic disorder. These novel therapies represent a significant advancement over traditional treatments, addressing unmet needs and improving outcomes for individuals affected by HAE. One notable development in recent years is the emergence of targeted therapies that specifically inhibit key components of the bradykinin pathway, which plays a central role in the pathogenesis of HAE. These therapies include bradykinin receptor antagonists and kallikrein inhibitors, which offer alternative mechanisms of action compared to conventional treatments like C1 esterase inhibitors.

  Bradykinin receptor antagonists, also known as B2 receptor antagonists, block the action of bradykinin on its receptor, thereby preventing the vasodilation and increased vascular permeability that characterize HAE attacks. These agents provide rapid relief from symptoms and are particularly useful for acute management of attacks. Similarly, kallikrein inhibitors target the enzymatic activity of plasma kallikrein, which catalyzes the production of bradykinin from high-molecular-weight kininogen. By inhibiting kallikrein, these agents effectively reduce bradykinin levels in the bloodstream, mitigating the severity and duration of HAE attacks. Both bradykinin receptor antagonists and kallikrein inhibitors offer promising alternatives for patients who may not respond adequately to or tolerate conventional treatments.

  Advancements in gene therapy and RNA-based therapeutics hold great potential for transforming the treatment landscape of hereditary angioedema. Gene therapy approaches aim to restore functional C1 inhibitor protein levels in patients with HAE caused by C1 inhibitor deficiency. By delivering functional copies of the C1 inhibitor gene to target cells, gene therapy holds promise for providing long-term relief from HAE attacks and potentially even curing the disease. Similarly, RNA-based therapeutics such as antisense oligonucleotides offer a targeted approach to modulating gene expression and protein production, providing a novel avenue for HAE treatment. As these innovative therapies continue to undergo clinical development and regulatory evaluation, they represent exciting opportunities for further improving patient care and outcomes in the global hereditary angioedema market.

Key players in Global Hereditary Angioedema Market include:

• CSL Behring
• Takeda Pharmaceutical Company Limited.
• Pharming
• BIOCRYST PHARMACEUTICALS INC
• Ionis Pharmaceuticals Inc
• Attune Pharmaceuticals
• Arrowhead Pharmaceuticals Inc
• Adverum Biotechnologies Inc
• KalVista Pharmaceuticals

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis