• In February 2021, BioCryst Pharmaceuticals Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of ORLADEYO (Berotralstat) for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.

• In February 2021, KalVista reported positive results in its Phase 2 clinical trial for KVD900 as an oral on-demand treatment for HAE attacks.

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

Global Hereditary Angioedema Therapeutics Market, Segmentation by Type

The Global Hereditary Angioedema Therapeutics Market has been segmented by Type into Type I, and Type II.

Type I

Type I hereditary angioedema is the most prevalent form of HAE, accounting for approximately 85–90% of diagnosed cases worldwide. This type is marked by a deficiency in the C1 esterase inhibitor (C1-INH) protein, which leads to unpredictable and recurring swelling attacks. Due to its high occurrence, Type I drives the majority of therapeutic demand and continues to be the primary focus of drug development in the HAE treatment landscape.

Type II

Type II hereditary angioedema makes up around 10–15% of HAE cases and is distinguished by the presence of normal or elevated levels of C1-INH that are functionally inactive. Though less common than Type I, this subtype requires equally effective management due to the similar severity of symptoms. Advances in diagnostic precision and targeted therapies are helping improve outcomes for Type II patients.

Global Hereditary Angioedema Therapeutics Market, Segmentation by Drug Class

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

C1 Esterase Inhibitor

C1 esterase inhibitors lead the HAE therapeutics market with a commanding share of over 45%. Their dual application in both acute and preventive treatments makes them a preferred choice among clinicians. The rising adoption of subcutaneous and intravenous formulations is further strengthening their market position across global healthcare systems.

Kallikrein Inhibitor

Kallikrein inhibitors contribute to nearly 25% of the overall market share, driven by their fast-acting relief in acute HAE episodes. These drugs are gaining momentum, particularly in regions with high awareness and accessibility to advanced therapies, as they offer a better safety profile compared to older treatment options.

Bradykinin Receptor Antagonist

Holding close to 15% of the market, bradykinin receptor antagonists are used primarily for acute symptom control by blocking the B2 receptor pathway. Although effective, their growth is moderated due to limited drug options in this category and strong competition from newer biologics with broader indications.

Attenuated Androgens

Attenuated androgens now account for less than 10% of the market as their use has significantly declined in favor of safer alternatives. Concerns over long-term side effects, especially in female and pediatric patients, have contributed to the steady shift away from this class of HAE therapies.

Others

The “Others” segment, representing under 5% of the market, includes a mix of emerging biologics and experimental therapies. Although currently small, this category holds potential for growth as innovative treatments are developed to meet unmet clinical needs in hereditary angioedema management.

Global Hereditary Angioedema Therapeutics Market, Segmentation by Route of Administration

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

Subcutaneous

The subcutaneous route leads the HAE therapeutics market, accounting for approximately 50% of the overall share. It is preferred for its ease of self-administration, patient convenience, and reduced need for clinical supervision. The growing availability of long-acting formulations further supports the dominance of this route.

Intravenous

Intravenous administration holds around 35% of the market share, primarily used for acute intervention during severe HAE attacks. While effective, this method often requires medical supervision and is associated with higher treatment burden, making it less convenient for long-term management.

Oral

The oral route comprises about 15% of the market and is gaining traction due to its non-invasive nature and improved patient compliance. Although currently limited by fewer approved therapies, the segment is expected to expand with ongoing drug development targeting oral formulations for both prophylactic and on-demand treatment.

Global Hereditary Angioedema Therapeutics Market, Segmentation by Distribution Channel

The Global Hereditary Angioedema Therapeutics Market has been segmented by Distribution Channel into Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies.

Hospital Pharmacies

Hospital pharmacies dominate the HAE therapeutics market, accounting for nearly 55% of the total distribution share. These settings are preferred for the availability of specialized medications and the ability to manage acute episodes under medical supervision. The presence of trained staff ensures safe drug administration and monitoring.

Retail Pharmacies

Retail pharmacies hold approximately 30% of the market, offering easy access to prescription medications for HAE patients. Their widespread presence and growing focus on chronic disease management contribute to their popularity. However, they are typically used for maintenance therapies rather than acute interventions.

Online Pharmacies

Online pharmacies represent around 15% of the market and are gaining momentum due to the rising trend of e-commerce in healthcare. They offer benefits such as home delivery, price transparency, and convenience, especially for patients on long-term prophylactic therapies. Regulatory enhancements are expected to further boost this segment.

Global Hereditary Angioedema Therapeutics Market, Segmentation by Geography

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

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

North America

North America leads the HAE therapeutics market with a share exceeding 40%, driven by the presence of advanced healthcare infrastructure and high awareness levels among patients. The region also benefits from strong regulatory support and a high concentration of leading pharmaceutical companies.

Europe

Europe holds approximately 25% of the global market share, supported by increasing government healthcare spending and growing access to innovative therapies. Several countries in the region have established reimbursement frameworks that enhance the adoption of HAE treatments.

Asia Pacific

The Asia Pacific region accounts for nearly 20% of the market, with rising demand fueled by improving healthcare infrastructure and increased diagnosis rates. Growth in countries like China, India, and Japan is being accelerated by greater pharmaceutical investment and expanding awareness programs.

Middle East & Africa

Middle East & Africa contributes to around 8% of the HAE therapeutics market. While access to advanced treatments is limited in some areas, increasing government initiatives and international healthcare partnerships are gradually improving the regional landscape.

Latin America

Latin America represents close to 7% of the global market. Countries like Brazil and Mexico are witnessing growth due to better diagnostic capabilities and increasing availability of branded and generic drugs. However, challenges remain in terms of affordability and accessibility.

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

Drivers, Restraints and Opportunity Analysis

Drivers

• Increasing prevalence of hereditary angioedema globally
• Growing awareness and early disease diagnosis
• Rising use of targeted biologic therapies

• Advancements in subcutaneous and oral treatments - Revolutionizing treatment for hereditary angioedema (HAE), significantly enhancing patient comfort and adherence. Earlier methods primarily involved intravenous administration, which was invasive and often required clinical supervision. Now, subcutaneous and oral delivery formats offer simpler, self-administered options that reduce treatment time and increase patient independence.

  Ongoing pharmaceutical innovation continues to refine these therapies by improving drug absorption, minimizing adverse reactions, and increasing patient safety. This reflects a broader trend in healthcare toward personalized, patient-centered care, enabling individuals to manage their conditions more effectively from home and outside traditional healthcare settings.

  As global regulatory bodies approve more accessible delivery methods, the adoption of subcutaneous and oral HAE treatments is set to grow. These delivery advances will boost treatment uptake, reduce healthcare burden, and propel overall market expansion in the coming years.

Restraints

• High treatment costs and affordability issues
• Limited access in low-income regions
• Diagnostic delays due to rare disease nature

• Adverse effects linked to long-term use - Despite clinical advancements, long-term use of HAE therapies presents safety concerns. Many treatments, especially those using biologics or plasma-derived substances, carry risks such as hypersensitivity, immune responses, or liver complications. As a result, some patients hesitate to continue with chronic treatment regimens.

  Extended use of specific drug classes, including androgen-based options, may also cause metabolic changes or cardiovascular issues. This increases the burden of routine monitoring and can limit widespread, long-term adoption. Such risks make healthcare providers cautious in prescribing preventive therapies for infrequent HAE episodes.

  These challenges slow down the uptake of long-term therapies, affecting the market's potential growth. To mitigate these concerns, the industry must focus on developing safer, well-tolerated therapies that maintain clinical efficacy without imposing health risks.

Opportunities

• Expansion of home-based treatment options
• Development of gene-based HAE therapies
• Strategic collaborations in rare disease research

• Regulatory support for orphan drug approvals - One of the most promising growth levers in the HAE therapeutics market is the global regulatory support for orphan drug approvals. As a rare disease, HAE qualifies for special designations that offer attractive incentives to pharmaceutical companies. These include tax benefits, reduced regulatory costs, market exclusivity, and faster approval processes.

  In recent years, these favorable policies have led to a notable increase in new product launches. Several companies have successfully used orphan designation pathways to introduce more effective, patient-centric, and accessible HAE therapies. This trend has already begun reshaping the treatment landscape with more advanced and targeted options.

  As global awareness and pharmaceutical participation in rare disease markets increase, this regulatory environment will continue to foster innovation and market growth. The combination of scientific advancement and policy backing makes the orphan drug pathway a major opportunity for stakeholders in the HAE therapeutic segment.

Key players in Global Hereditary Angioedema Therapeutics Market include:

• CSL Behring
• Shire Plc.
• Pharming Healthcare, Inc.
• BioCryst Pharmaceuticals, Inc.
• Attune Pharmaceuticals, Inc.
• Arrowhead Pharmaceuticals
• Adverum Biotechnologies

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

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