PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 2128963
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 2128963
Hereditary Angioedema Therapeutics Market size was valued at US$ 3,490.6 Million in 2025, expanding at a CAGR of 10.6% from 2026 to 2033.
The Hereditary Angioedema (HAE) Therapeutics Market comprises drugs that prevent or cure recurring swellings from hereditary angioedema (HAE), which is a rare inherited condition marked by the dysregulation of the kallikrein-kinin system. There are different kinds of treatment that can be used including C1-esterase inhibitors, bradykinin B2 receptor antagonists, and kallikrein inhibitors as well as other newer, more specific biological treatments. The drugs may be categorized as on-demand treatment, which is applied during an attack of the disease, or prophylactic, which decreases the frequency of attacks. The market is increasingly focusing on targeted treatment and convenient administration of the drug including subcutaneous and oral therapy.
Hereditary Angioedema Therapeutics Market- Market Dynamics
Rising Need for Effective Long-Term Prevention and Rapid Treatment of HAE Attacks
The increasing clinical need for preventing attacks that might become life-threatening and for treating HAE in acute conditions is the important reason for Hereditary Angioedema Therapeutics Market growth. The swelling of the skin, gastrointestinal tract, and upper respiratory passage may happen repeatedly in HAE. The complication that might become life-threatening is laryngeal attacks. The disease is chronic and recurrent, so patients might need chronic treatment and prevention as well as on-demand treatment. HAE is thought to affect about 1 in every 50,000 people, clearly a rare disease that needs additional care.
Pathway-specific medicines are also becoming the focus of the treatment environment. C1-esterase inhibitors are used to replace or replace a defective C1-INH, kallikrein inhibitors and bradykinin receptor antagonists are used to target downstream components that cause swelling. Increasingly frequent preference for home dosing and oral administration further drives development of oral and subcutaneous and prefilled-device formulations.
The Global Hereditary Angioedema Therapeutics Market is segmented on the basis of Drug Class, Treatment Type, Route of Administration, End User, and Region.
Drug Class shows that Kallikrein Inhibitors are expected to be a major contributor since plasma kallikrein is considered a major part of the bradykinin pathway associated with HAE inflammation. The category includes oral and injectable treatment for HAE attacks and prophylaxis. FDA has approved EKTERLY (sebetralstat), which is an oral plasma kallikrein inhibitor for acute HAE attacks in July 2025. The drug received its approval based on the results of the KONFIDENT study involving 110 participants across 66 sites in 20 countries. The treatment comes as a tablet to take orally when an attack is first noticed, thus highlighting the importance of oral kallikrein inhibition in on-demand treatment.
Prophylaxis Treatment is becoming more relevant because patients and physicians are increasingly looking for a permanent decrease in attack frequency, not just emergency treatment. In June 2025, for instance, FDA approved ANDEMBRY (garadacimab) specifically for the prevention of HAE attacks, a treatment that is administered subcutaneously once a month after a loading dose.
Hereditary Angioedema Therapeutics Market- Geographical Insights
The Hereditary Angioedema therapeutics market in North America is one of the most advanced regions as it has witnessed specialized services for rare diseases, robust reimbursement and treatment care, clinical trials, and quick regulatory acceptance of novel therapies. In 2025, several key HAE drugs were approved by the U.S. FDA, such as ANDEMBRY (June), EKTERLY (July), and DAWNZERA (August). These approvals brought additional treatment options to the market for monoclonal-antibody prophylaxis, oral on-demand therapy and RNA-targeted prophylaxis.
The European region is also a key market due to its well-developed treatment infrastructure for rare diseases and access to rare disease immunology and allergy specialists. For instance, CSL said it had secured regulatory approvals in Australia and UK, with the European Commission approving ANDEMBRY on February 11, 2025. European authorization was granted for use of a Factor XIIa-targeting once-monthly therapy for HAE prophylaxis.
The Hereditary Angioedema Therapeutics Market features intense competition from plasma derived product manufacturers and biotech firms developing drugs for targeted kallikrein, bradykinin, Factor XIIa, and RNA therapeutics. Some of the major market players include CSL Behring, Takeda Pharmaceutical Company, BioCryst Pharmaceuticals, KalVista Pharmaceuticals, Ionis Pharmaceuticals, Pharming Group, Intellia Therapeutics, and CENTOGENE. The focus of the competition has been shifting to the number of attacks reduced, how quickly to respond, how long the interval between doses and how easy it is to administer at home.
In July 2026, Pharvaris announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for deucrictibant immediate-release capsules to treat a hereditary angioedema attack when needed. The application included favorable clinical results showing fast onset, long duration of response and a favourable safety profile. April 23, 2027 was the FDA's PDUFA action date.
In December 2025, GENESIS Pharma signed an exclusive partnership agreement with Otsuka Pharmaceutical Europe Ltd. for the commercialization of donidalorsen for hereditary angioedema (HAE) in Central and Eastern Europe. GENESIS Pharma has agreed to be the exclusive distributor and commercialiser of donidalorsen in fourteen markets: Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Poland, Romania, Slovakia and Slovenia.