Hereditary Angioedema (HAE) Treatment Market (By Drug Class: C1-esterase Inhibitor, Bradykinin B2 Receptor Antagonist, Kallikrein Inhibitor, Others; By Treatment Type: Prophylaxis, On-demand; By Route Of Administration: Intravenous, Subcutaneous, Oral) - Global Industry Analysis, Market Size, Opportunities And Forecast 2020 - 2027

The global hereditary angioedema (HAE) treatment market is expected to grow at a CAGR of around 8.8% from 2020 to 2027 and projected to reach the market value of around US$ 4.9 Bn by 2027.

Hereditary Angioedema (HAE) is a rare genetic disorder known to be inherited in the autosomal dominant pattern. The condition is usually associated with recurrent attacks of severe swelling (angioedema) that involves any part of the body attacking frequently mucosal surfaces such as the lining of the gastrointestinal tract, the mouth, the tongue, the throat, the larynx, the genitourinary system, and others. As per the estimates released by the Food and Drug Administration (FDA), Hereditary Angioedema affects approx. 1 in 50,000 people. Also, there are about 6500 individuals suffering from this condition in the US. Additionally, HAE resulted in >5000 emergency department visits with 41% resulting in hospitalization over a one year period in the US. Furthermore, according to the statistics released by the National Organization for Rare Disorder (NORD), HAE affects male and female in equal numbers. Symptoms typically start from the early childhood. An estimated one in 50,000 to 150,000 individuals is affected by this disorder globally.

Market Drivers

Approval of novel drugs for the treatment coupled with pipeline drugs boosts the Hereditary Angioedema (HAE) market globally

The US Food and Drug Administration (USFDA) approved Orladeyo (berotralstat) as an oral treatment for the prevention against swelling attacks in people suffering from HAE aged 12 years and older. These approval marks Orladeyo, the first and only oral treatment available for the patients where preventive treatment was only available previously through injection or infusions. Additionally, in August 2018, the USFDA approved Takhzyro (lanadelumab), the first monoclonal antibody approved in the US for treating patients 12 years and older with types 1 and 2 HAE. Apart from that, drug name, "Lanadelumab" is currently under pipeline analysis/clinical trials of phase 3. The clinical study is sponsored by the Takeda Pharmaceutical Company Limited for evaluating the safety, pharmacokinetics, and pharmacodynamics of "Lanadelumab" in children with the age of 2 years to <12 years for people suffering from Hereditary Angioedema (HAE).

Fast product approvals stimulate the growth of Hereditary Angioedema (HAE) market globally

With the help of the US Hereditary Angioedema Association, it has been witnessed that there are fast product approvals to treat HAE. The US Hereditary Angioedema Association encourages pharmaceutical companies to continue to develop new and improve current HAE therapies. The HAEA takes a pivotal role in patient recruitment for clinical trials. In December 2020, BioCryst Pharmaceuticals, Inc. announced that the US Food and Drug Administration (USFDA) has approved oral, once-daily ORLADEYO™ (berotralstat). The new product helps in preventing attacks of HAE in adults and pediatric patients 12 years and older.

Rising prevalence of global hereditary angioedema market upsurge the demand for innovative therapies

Hereditary angioedema (HAE) is a rare but potentially life threatening disease that affects approx.1 in 67,000 individuals with no identified differences in prevalence due to associated sex or ethnicity. There is a genetic component of autosomal dominant inheritance in approx. 75% of patients, while 25% of patients present with a spontaneous mutation. Therefore, it is found that there is no evidence of family history of disease. Symptoms of HAE often begin during childhood or adolescence that worsen around puberty and persists through a patient’s lifetime. The onset of symptoms of 11.2 years, with approx. 50% of patients experiences their first attack before the age of 10 years. The US HAEA Angioedema Center at UC San Diego provides comprehensive care for patients suffering from angioedema. The several range of innovative therapies involve state-of-the-art diagnostic test and techniques. Currently, the new study has been announced that evaluates the safety and efficacy of repeated subcutaneous (SC) administration of "Lanadelumab". It plays a vital role in preventing angioedema attacks in adolescents and adults with non-histaminergic angioedema with normal C1-INH.

Segmental Outlook

Hereditary Angioedema (HAE) treatment market is segmented as drug class, treatment type, and route of administration. By drug class, the market is segmented as C1-esterase inhibitor, bradykinin B2 receptor antagonist, kallikrein inhibitor, and among others. By treatment type, the market is segmented as prophylaxis and on-demand. By route of administration, the market is segmented as intravenous, subcutaneous, and oral.

Based on drug class, C1-esterase inhibitor dominates the overall hereditary angioedema (HAE) treatment market. C1-esterase inhibitor dominated the segment since the past and will continue its trend in the forthcoming years. Majority of the people suffering from HAE either don’t have enough of protein called C1 esterase inhibitor (C1-INH), or the protein does not function properly. Such deficiency or dysfunction leads to episodes of swelling. By utility of CINRYZE (C1 esterase inhibitor [human]) was the first preventive therapy indicated to assist and prevent HAE attacks in children (6 to 12 years old). Additionally, C1-esterase inhibitor is recommended as the first line treatment for long-term prophylaxis and short-term prophylaxis. Moreover, it is prescribed for the management of HAE involving C1-esterase inhibitor as an option for acute treatment of HAE.

By treatment type, on-demand treatment accounted largest market share in the past and will continue to dominate till the forecast period. Consistent utility of on-demand products for management of acute hereditary angioedema attacks has a strong impact in driving the hereditary angioedema treatment market. As HAE is a complement disorder on-demand treatment with newly approved and emerging therapies offer relief for HAE attacks according to the American Academy of Allergy, Asthma & Immunology. As per the estimates released by Prime Therapeutics, four different ranges of products are approved for on-demand treatment of HAE acute episodes. These involve subcutaneous (SC) ecallantide (Kalbitor®), a plasma kallikrein inhibitor; SC icatibant (Firazyr®), a bradykinin receptor antagonist; and two intravenous (IV), C1-INH drugs, and Berinert® and Ruconest.

Further, by route of administration, intravenous therapies segment is the dominating segment from the past and will continue to mark significant revenue share till the forecast period. Existing therapies for management of HAE is mostly administered intravenously. This is one of the prominent factors that act as a key contributor for the overall hereditary angioedema market globally.

North America dominates the hereditary angioedema (HAE) treatment market

North America is a leading region in the global hereditary angioedema (HAE) treatment market. This is attributed to rising prevalence of hereditary angioedema, increasing focus on treatment options for hereditary angioedema, and well established healthcare system. As per the American Osteopathic Association, hereditary angioedema (HAE) is estimated to affect approx. 1 in 50,000 persons, with no ethnic group differences. In the US, HAE attacks are associated with 15,000 to 30,000 emergency room visits annually. To overcome such condition, management of HAE attacks is well supported by innovative therapies and treatment. Fast product approvals have gained significant prominence in the regional market. Human plasma–derived C1 INH concentrate (Berinert) received approval from the FDA in 2009 for the management of angioedema attacks of the face and abdomen in adults and adolescent patients. Moreover,

Berinert received FDA approval to expand its label to include self-administration and acute laryngeal attacks of HAE. On the other hand, Asia-Pacific is expected to gain significant pace in the forthcoming years in the forecast period. Surge in patient awareness levels and coupled with launch of novel therapies for hereditary angioedema management is expected to offer lucrative opportunities for the Asia-Pacific regional growth.

Competitive Landscape

Key companies profiled in this report involve BIOCRYST PHARMACEUTICALS, INC., Ionis Pharmaceuticals, Pharming Group NV, CSL Limited, Takeda Pharmaceutical Company Limited., Attune Pharmaceuticals., Adverum Biotechnologies, Inc., and KalVista Pharmaceuticals, and among others.

Market Segmentation

Market By Drug Class

C1-esterase inhibitor
Bradykinin B2 receptor antagonist
Kallikrein inhibitor
Others

Market By Treatment Type

Prophylaxis
On-demand

Market By Route of Administration

Intravenous
Subcutaneous
Oral

Market By Geography

North America

• U.S.
• Canada

Europe

• U.K.
• Germany
• France
• Spain
• Rest of Europe

Asia-Pacific

• China
• Japan
• India
• Australia
• South Korea
• Rest of Asia-Pacific

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC
• South Africa
• Rest of Middle East & Africa