Global Hereditary Angioedema Market

MARKET SCOPE:

The global hereditary angioedema market is projected to grow significantly, registering a CAGR of 6.2% during the forecast period (2026 – 2034).

The global hereditary angioedema (HAE) market is growing solidly, driven primarily by rising disease awareness, improved diagnostics, and expanding patient groups. Growing awareness of rare genetic disorders and improved diagnostic capability—such as higher-quality genetic testing and clinician education—have driven more frequent earlier and more precise diagnosis of HAE cases, stimulating demand for specialist services. Favorable regulatory conditions, including orphan designations and fast-track approvals, have also attracted pharma investment. This has resulted in an active pipeline of novel therapies, including lanadelumab (Takhzyro), berotralstat, and garadacimab (Andembry), as well as emerging prophylactic treatments and gene therapies.

Yet another key driver of growth is therapeutic innovation in convenience of administration and routes to the patient. On-demand injectable therapy has been the traditional norm. Yet recent approvals and clinical evidence for oral kallikrein inhibitors such as berotralstat and sebetralstat have unlocked the market for less invasive, convenient-to-use drug forms. Oral treatment lowers compliance barriers, enhances quality of life, and enhances treatment initiation. In addition, the advent of subcutaneous formulations and gene editing solutions that address root causes (e.g., CRISPR or AAV-based) has the potential to revolutionize the marketplace from reactive treatments to long-term prevention or even cures.

MARKET OVERVIEW:

Driver: Rising Adoption of Preventive Therapies Transforming HAE Management

The increasing momentum towards prophylactic treatment is the major driver in the hereditary angioedema (HAE) market. HAE patients were relying on on-demand therapies for treating severe swelling attacks previously. Patient care has shifted with the introduction of long-term preventive therapies like lanadelumab (Takhzyro) and berotralstat (Orladeyo). These drugs have a crucial role in reducing the frequency and severity of attacks, giving the patient improved stability and quality of life.

Additionally, the ease of newer drug delivery mechanisms—such as subcutaneous injection and once-daily oral tablets—has also provided increased compliance and increased adoption. Physicians now increasingly prescribe preventive therapy to reduce hospitalization, emergency room utilization, and absenteeism. This rising practice not only improves patient outcomes but also creates recurring revenues in the market, driving overall growth.

Restraint: High Treatment Costs Limiting Accessibility in Emerging Markets

Despite significant therapeutic advancements, the high cost of treatment remains a critical barrier in the HAE market. Leading drugs like Takhzyro cost more than $500,000 per year, which is unaffordable to most patients, especially in developing countries. The excessive cost limits access even in developed economies, where insurance reimbursement is not likely to cover the cost of treatment in full or subject patients to tough reimbursement conditions.

Thus, delays in treatment and diagnosis are common among patients, especially in countries with poor healthcare infrastructure. This not only hinders business growth in growing markets but also puts undue pressure on payers and healthcare systems to cut costs, which slows down the uptake of innovative medicines.

Opportunities: Gene Therapy as a Breakthrough for Long-Term or Curative Treatment

The emergence of gene therapy presents a transformative opportunity in the HAE market. In contrast to existing treatments where patients are lifelong on therapy, gene-editing methods like CRISPR-Cas9 or AAV-based vectors may be able to fix the underlying genetic defect for HAE—mutations in the SERPING1 gene. This may be a single one-time curative therapy, a shift from symptom suppression to disease elimination.

In addition, biotech companies are investing heavily in early-stage trials, and early-stage preclinical success is fueling optimism. If successful, gene therapy would sharply reduce treatment burden and long-term cost to payers and patients. It would also establish new revenue streams for pharma companies and place them at the forefront of rare disease innovation. As regulatory frameworks for genetic medicine keep on changing, this field is likely to be one of the key drivers of the HAE market in the near future.

SEGMENTATION ANALYSIS:

The C1-Esterase Inhibitor Segment is anticipated to grow significantly during the forecast period

The hereditary angioedema (HAE) market is segmented based on treatment type into C1-esterase inhibitors, bradykinin B2 receptor antagonists, kallikrein inhibitors, and other treatment types. Each treatment category addresses specific needs in managing or preventing HAE attacks, offering a range of options in terms of efficacy, mode of administration, patient convenience, and cost.

The C1-esterase inhibitor segment currently dominates the HAE market. This is due to its longstanding role in both on-demand and prophylactic treatment. These therapies, such as Cinryze, Berinert, and Haegarda, are very widely prescribed to prophylactically prevent and treat attacks of HAE by replacing deficient or defective C1-INH protein in the patient. Their proven efficacy, strong safety profiles, and approvals in key geographies have granted them the gold standard status in the treatment of HAE. Additionally, increased awareness and improved diagnostic rates have led to an increased prescription rate among these inhibitors, further establishing their market dominance.

REGIONAL ANALYSIS:

The North America region is set to witness significant growth during the forecast period

The North America HAE market is expected to maintain leadership during the forecast period with the help of a well-established healthcare infrastructure, high rate of disease prevalence, and early adoption of next-generation therapies. The United States and Canada are a large market share due to the wide availability of approved medication such as Takhzyro, Cinryze, and Orladeyo, and robust reimbursement policies and specialist networks. Increasing focus on rare disease management and support from organizations such as the U.S. Hereditary Angioedema Association (HAEA) has also increased the levels of diagnosis and treatment adoption.

Along with this, the presence of big pharmaceutical companies and a strong pipeline of new treatments continue to propel regional growth. North American patients also have better access to genetic screening and preventive treatment, which has enabled the market emphasis to move from reactive treatment to disease management in the long term. Along with this, favorable regulatory environments for orphan drugs and active patient advocacy allow treatment innovation to reach the market earlier, which keeps the region ahead in the treatment of HAE.

Although the Asia-Pacific HAE market is the most rapidly growing market on the strength of increasing awareness in healthcare, increasing genetic diagnostics, and increased access to rare disease therapy, China, India, and Japan are all experiencing an ever-increasing number of diagnosed cases of HAE as backed by increasing investments in healthcare and increasing awareness of rare diseases. Although underdiagnosis continues to be a challenge, regional governments and global health organizations are initiating programs for increased early detection and access.

COMPETITIVE ANALYSIS:

The global hereditary angioedema market is reasonably competitive with mergers, acquisitions, and product launches. See some of the major key players in the market.

KalVista Pharmaceuticals, Inc

Pharming Healthcare, Inc

Attune Pharmaceuticals

BioCryst Pharmaceuticals, Inc

Intellia Therapeutics

Ionis Pharmaceuticals

Biomarin

CSL Behring LLC

Pharvaris

Takeda Pharmaceutical Company Ltd

Recent Development:

In March 2025, Pharming Healthcare, Inc. received European approval to extend the use of RUCONEST®, its recombinant C1 esterase inhibitor, for treating acute HAE attacks in pediatric patients.

In January 2025, Intellia Therapeutics dosed the first patient in its global Phase III HAELO trial for NTLA‑2002, a CRISPR-based gene-editing therapy designed as a single-dose treatment for HAE.

In December 2023, Ionis Pharmaceuticals, Inc. announced that it has entered into a license agreement with Otsuka Pharmaceutical Co., Ltd.

SCOPE OF THE REPORT:

By Age Group

• Pediatric
• Adult
• Geriatric

By Treatment Type

• Bradykinin B2 receptor antagonist
• Kallikrein inhibitor
• C1-esterase inhibitor
• Other treatment types

By Route of Administration

• Parenteral
• Oral

By Distribution Channel

• Hospital pharmacies
• Online pharmacies
• Drug store & retail pharmacies

By Region

• North America (United States & Canada)
• Europe (Germany, UK, France, Spain, Italy and Rest of Europe)
• Asia-Pacific (China, Japan, India, South Korea, Australia and Rest of Asia-Pacific)
• Latin America (Brazil, Mexico, Argentina and Rest of Latin America)
• Middle East & Africa (Saudi Arabia, UAE, Israel, South Africa and Rest of Middle East and Africa)

KEY REASONS TO PURCHASE THIS REPORT:

It provides a technological development map over time to understand the industry’s growth rate and indicates how the hereditary angioedema market is evolving.

The report offers a dynamic method to various factors that drive or restrain the growth of the market and specifies which hereditary angioedema submarket will be the main driver of the overall market from 2026 to 2034.

It renders a definite analysis of changing competitive dynamics and stipulates the leading players and what are their prospects over the forecast period.

It builds a nine-year estimate based on how the market is predicted to grow and shows what will market shares of the global region change by 2034 and which country will lead the market in 2034. Show more