The Hereditary Angioedema Market, estimated at USD 3.13 Bn in 2025, is expected to exhibit a CAGR of 9.6% and reach USD 5.96 Bn by 2032.
The market growth is driven by increasing demand for innovative and effective drugs across diverse therapeutic areas. Advances in drug discovery, biopharmaceuticals, and digital technologies are improving treatment outcomes and operational efficiency. Supportive regulations, rising R&D investments, and a strong focus on patient-centric care are creating new opportunities for pharmaceutical companies.
Market Dynamics
Hereditary angioedema market growth is primarily driven by increasing prevalence of HAE and launch of novel therapies. HAE is a rare and potentially life-threatening genetic disease characterized by episodes of swelling. According to data provided by MedlinePlus in March 2025, hereditary angioedema is estimated to affect 1 in 50,000 people worldwide. Rising awareness about the disease diagnosis and management leads to increase in cases being reported.
Pharmaceutical companies are focusing on developing novel therapies for HAE due to high unmet needs. In recent years, the U.S. Food and Drug Administrationapproved several drugs such as Takhzyro, Haegarda and Orladeyo for preventive treatment of HAE attacks. The approval and launch of these drugs have provided improved treatment options to patients and stimulated market growth.
Increasing government support for rare diseases can drive the hereditary angioedema market growth
Government bodies around the world have recognized hereditary angioedema as a rare disease, and are providing support to boost awareness, diagnosis and treatment. For example, the U.S. Rare Disease Act of 2002 designated HAE as a rare disease and provided funding for research. This has helped increase awareness among physicians and patients. Several countries in Europe such as Germany and the U.K. have also included HAE in their national plans and strategies for rare diseases. Increased focus on rare diseases encourages more research into developing new treatments for HAE. As a result of growing awareness and treatment options, more patients are being correctly diagnosed and seeking long-term prophylaxis or on-demand therapies.
Introduction of novel drug classes boosts innovation
Hereditary angioedema market has witnessed approval and launch of novel drug classes like C1 esterase inhibitors, bradykinin B2 receptor antagonists and plasma kallikrein inhibitors in recent years. Pharma companies continue advancing new pipeline candidates like recombinant human C1INH and gene therapies which can deliver transformative outcomes. The availability of novel drug classes drives both physicians and patients to opt for the latest treatment innovations for better management of HAE.
High cost of treatment acts as a key restraint
HAE therapies available in the market are quite expensive, ranging from US$ 100,000 to over US$ 300,000 per patient annually in the U.S. The specialized drugs require frequent administration or patient self-administration and come with a hefty price tag. This high cost of treatment poses affordability challenges. Many private and public health plans have strict coverage policies or require prior authorization for these specialty drugs due to the costs involved. Patients may be denied access or forced to try cheaper but less effective options. High drug costs also overburden country healthcare budgets. Addressing the issue of pricing and making therapies more affordable can help expand patient access and market potential.
Lack of diagnosis in developing regions restrains early treatment
HAE awareness and diagnosis rates are very low in developing and underdeveloped regions of the world where access to specialized healthcare is limited. In these areas, the condition often goes undiagnosed for many years. Patients suffer recurrent attacks without proper preventive treatment. Physicians in rural primary care centers may not be equipped to recognize HAE symptoms. Lack of diagnosis restricts patient identification and delays appropriate management. This poses significant challenges, worsening disease outcomes and quality of life. Improving basic diagnosis capabilities can address this restraint.
Opportunities in emerging markets with growing patient populations
Many developing countries in Asia Pacific, Latin America, Middle East and Africa are expected to witness increase in hereditary angioedema patients, owing to factors like larger population size, increasing life expectancy and better disease recognition. While current diagnosis and treatment rates are low, these emerging regions have significant unmet needs and headroom for growth. As standards of living improve and healthcare infrastructures expand accessibility, the market potential in emerging markets will rise considerably. Pharma companies can capitalize on this opportunity by expanding access programs, establishing in-country capabilities and filing regulatory approvals for these populations.
Link: https://www.coherentmarketinsights.com/market-insight/hereditary-angioedema-market-1292
Key Developments
- On September 3, 2025, KalVista Pharmaceuticals, Inc., a pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) had accepted its New Drug Application (NDA) for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older
- On June 18, 2025, Ionis Pharmaceuticals, Inc., a pharmaceutical company, announced a license agreement with Otsuka Pharmaceutical Co., Ltd., a biopharmaceutical company. As per agreement, Otsuka obtains exclusive rights across the Asia Pacific region for donidalorsen, an investigational RNA-targeted prophylactic medicine for hereditary angioedema (HAE).
- On June 18, 2025, KalVista Pharmaceuticals, Inc., a pharmaceutical company, announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the review of sebetralstat, a novel investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older
- In June 2025, BioCryst Pharmaceuticals, Inc., a company that designs and develops small molecule medicines for rare diseases such as hereditary angioedema (HAE) and fibrodysplasia ossificans progressive (FOP), announced that Swissmedic, the Swiss surveillance authority for medicines and medical devices, had granted marketing authorization for oral, once-daily ORLADEYO (berotralstat) for the routine prevention of recurrent hereditary angioedema (HAE) attacks in patients 12 years and older in Switzerland
- In March 2025, Ionis Pharmaceuticals, Inc., a biotechnology company, announced the publication of positive Phase 2 data for donidalorsen in the New England Journal of Medicine (NEJM). Donidalorsen is an investigational antisense medicine that Ionis Pharmaceuticals, Inc. is evaluating for treating patients with hereditary angioedema (HAE). In the Phase 2 study, donidalorsen demonstrated a 90% reduction in angioedema attacks as compared with placebo at the 80 mg monthly dose. There was significant improvement in quality of life as assessed by the Angioedema Quality of Life Questionnaire (AE-QoL) in the patients treated with donidalorsen.
Key Players
CSL Behring, Sanofi, Takeda Pharmaceutical Company Limited, Orchard Therapeutics plc., Pharming Group N.V., BioCryst Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc., Attune Pharmaceuticals, Arrowhead Pharmaceuticals, Inc., Adverum Biotechnologies, Inc., KalVista Pharmaceuticals, and CENTOGENE N.V.
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