Angioedema - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Angioedema market is projected to maintain a stable Compound Annual Growth Rate (CAGR) from 2025 to 2034, driven by the launch of innovative therapies, continual improvements in diagnostic methods, increasing disease awareness, and a rising prevalence of reported cases globally.
• Based on our secondary analysis, in the US, the diagnosed prevalence of angioedema is estimated at approximately 2.43 per 100,000 population.
• In Japan, the prevalence of angioedema also reflects a distinct gender trend: about 78.6% of cases occur in females, compared to 21.4% in males. This indicates a notably higher burden among women, highlighting the importance of recognizing gender-specific factors and ensuring appropriate management strategies.
• The growing recognition of angioedema can be linked to improved diagnosis, rising awareness, and evolving treatment landscapes. Growing use of genetic testing and biomarker assays is improving diagnosis of hereditary angioedema and distinguishing it from other types, potentially influencing prevalence estimates and epidemiological understanding.
• ANDEMBRY (garadacimab-gxii), approved in June 2025, is the first and only once-monthly prophylactic treatment targeting Factor XIIa to prevent hereditary angioedema attacks in adults and adolescents aged 12 and older.
• Takeda's CINRYZE is one of the key FDA-approved therapies for angioedema, addressing a critical need for reliable prophylaxis in hereditary cases. Its established role highlights the importance of effective C1-INH replacement and supports ongoing innovation in next-generation targeted treatments.
• Despite progress in acute and preventive therapies, there remains a clear unmet need for emerging drugs in angioedema treatment that can deliver faster relief, provide more reliable long-term control, and reduce the risk of life-threatening attacks. Innovative therapies that go beyond current options are needed to close these gaps, enhance patient outcomes, and strengthen the overall management landscape in the years ahead.
• In May 2025, Intellia Therapeutics confirmed it remains on track to complete enrollment in the global Phase III HAELO trial for hereditary angioedema by third quarter of 2025. Extended durability data from the Phase I/II study were presented at the June European Academy of Allergy and Clinical Immunology (EAACI) Congress, with additional long-term Phase II results expected in second half of 2025. A Biologics License Application (BLA) submission is planned for the second half of 2026.
• Another key unmet need in angioedema treatment is the lack of highly targeted therapies that can safely manage complex or severe cases, especially in patients who do not respond adequately to standard options or who experience frequent, unpredictable attacks. Addressing this gap could greatly reduce life-threatening complications and improve long-term quality of life for these high-risk patients.

DelveInsight's comprehensive report titled "Angioedema - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of angioedema. The report presents historical and projected epidemiological data covering Total Prevalent Cases of Angioedema, Total Diagnosed Prevalent Cases of Angioedema, Gender-specific Diagnosed Prevalent Cases of Angioedema, Age-specific Diagnosed Prevalent Cases of Angioedema, and Treated Cases of Angioedema. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in angioedema. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Angioedema Overview

Angioedema is defined as circumscribed, non-pitting swelling of the subcutaneous and/or submucosal tissues, most commonly affecting the lips, face, neck, extremities, oral cavity, larynx, and gastrointestinal tract. The condition poses a serious risk when the larynx is involved, potentially leading to airway obstruction. Intestinal angioedema, meanwhile, can cause significant pain and often mimics an acute abdomen, making timely recognition and accurate diagnosis essential to avoid unnecessary interventions and ensure appropriate care.

The primary symptoms of angioedema include persistent sneezing, nasal itching, a clear watery nasal discharge, and nasal congestion that often worsens after exposure to allergens like pollen or dust. These symptoms may appear suddenly, especially during certain seasons or in specific environments, and tend to be more troublesome in the morning. Individuals may also experience red, itchy, and watery eyes, along with swelling of the eyelids and a gritty or burning sensation. Other signs can include postnasal drip, frequent throat clearing, and disturbed sleep due to nasal blockage and discomfort.

Angioedema Diagnosis and Treatment Algorithm

The diagnosis of angioedema is fundamentally clinical, relying on the recognition of sudden, well-defined, non-pitting swelling involving the subcutaneous or submucosal tissues. A thorough patient history is essential to uncover possible triggers, such as recent exposure to allergens, the use of medications like ACE inhibitors, or a family history suggestive of a hereditary form. Careful assessment helps distinguish between histamine-mediated, bradykinin-mediated, or idiopathic causes, each of which requires a different management approach. Prompt and accurate identification of the underlying mechanism is vital for effective treatment and for preventing potentially life-threatening complications, particularly when airway structures are involved.

Treatment for angioedema depends on its cause. Histaminergic angioedema responds well to antihistamines, corticosteroids, and epinephrine. In contrast, bradykinin-mediated forms, such as hereditary angioedema, require targeted treatments like C1 inhibitor concentrate, ecallantide, or icatibant, with early intervention being crucial. Airway protection may require intubation or surgery, while prevention involves short-term prophylaxis before high-risk procedures and long-term prophylaxis with C1 inhibitors or androgens when appropriate.

For acquired angioedema, treatment focuses on eliminating triggers, such as certain medications, and using targeted therapies to manage acute episodes. In cases caused by underlying deficiencies, preventive strategies may include specialized immune therapies or surgical options. Extra care is needed for vulnerable groups like pregnant women and children, with safe, well-established treatments available for both acute attacks and prevention. Individualized approaches remain vital, especially for rare or resistant cases.

Angioedema Epidemiology

The epidemiology section of the Angioedema market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of Angioedema. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

• In the US, angioedema most commonly begins in childhood, with approximately 51.2% of cases starting between ages 0-10, 37.8% between ages 11-20, and only about 11% presenting at age 21 or older. This pattern underscores the significant impact of early-life factors and the need for prompt recognition and management to prevent ongoing complications into adulthood.
• In Germany, the prevalence of angioedema is estimated at approximately 1 in 50,000 population.
• In Germany, angioedema most often begins in adulthood, with around 76.8% of cases occurring between ages 18-59, 14.1% in individuals aged 60 and above, and only about 9.1% starting before age 18. This highlights that, unlike in the US, angioedema in Germany is more commonly diagnosed later in life, emphasizing the importance of recognizing adult-onset cases and addressing potential underlying causes promptly.
• In the UK, the prevalence of angioedema also shows a clear gender pattern: approximately 60.3% of cases occur in females, while about 39.7% affect males. This highlights a higher burden among women, emphasizing the need for awareness of gender-related risk factors and tailored management approaches.
• In Japan, the estimated prevalence of angioedema is around 1 in 50,000 people nationwide.

The epidemiology of angioedema is expected to change during the forecast period (2025-2034).

Angioedema Market Outlook

The angioedema therapeutics market is further expected to increase by the major drivers, such as the rising prevalent population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

When standard therapies prove insufficient, especially in hereditary or treatment-resistant angioedema, carefully selected off-label options may offer additional benefit. In hereditary angioedema, agents such as long-term antihistamines or corticosteroids, though not ideal for bradykinin-mediated swelling, are sometimes used when other options are limited. Androgens like DANAZOL and antifibrinolytics such as TRANEXAMIC ACID are also employed off-label to help prevent attacks by boosting C1 inhibitor levels or reducing its breakdown. These strategies highlight the need for tailored, specialist-guided management when conventional treatments alone are not enough.

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the Angioedema market in the 7MM is expected to change significantly during the study period 2020-2034.

Angioedema Drug Chapters

Angioedema Marketed Drugs

CINRYZE: Takeda Pharmaceuticals

CINRYZE, is an approved therapy for routine prevention of angioedema attacks in adolescents and adults with hereditary angioedema. Its active ingredient, C1-Esterase Inhibitor (C1-INH), works by increasing plasma C1-INH levels in patients who lack sufficient amounts of this critical protein, which otherwise leaves them vulnerable to uncontrolled bradykinin production and recurrent swelling. By directly replacing the deficient protein, CINRYZE addresses the root cause of hereditary angioedema and helps stabilize the body's inflammatory pathways during an attack. Notably, CINRYZE was the first C1-INH therapy shown to effectively prevent swelling episodes in people living with this challenging condition, setting an important standard for long-term disease control.

HAEGARDA: CSL Behring Medical Affairs

HAEGARDA is a self-administered, plasma-derived C1-esterase inhibitor concentrate and remains the only subcutaneous therapy approved in the United States for routine prevention of hereditary angioedema attacks in patients aged six and older. By directly replacing deficient or malfunctioning C1-INH, HAEGARDA tackles the underlying cause of hereditary angioedema, restoring functional C1-INH levels to above 40% of normal-levels believed to significantly lower the risk of attacks. Its weight-based dosing allows treatment to be tailored to each patient's needs, helping individuals maintain protective C1-INH levels and achieve more consistent disease control with the convenience of at-home administration.

BERINERT: CSL Behring Medical Affairs

BERINERT is a plasma-derived C1 Esterase Inhibitor (Human) specifically indicated for the treatment of acute attacks of hereditary angioedema involving the abdomen, face, or larynx in both adults and children. By replacing the deficient or malfunctioning C1-INH protein in patients with hereditary angioedema, BERINERT helps control the excessive bradykinin production that causes sudden, severe swelling episodes. Sourced from carefully screened human plasma, BERINERT provides rapid, targeted relief during acute attacks, aiming to reduce the severity and duration of swelling and prevent potentially life-threatening complications such as airway obstruction.

EKTERLY (sebetralstat): KalVista Pharmaceuticals

Sebetralstat is a novel investigational oral inhibitor of plasma kallikrein being developed to treat hereditary angioedema. KalVista Pharmaceuticals received FDA approval for EKTERLY (sebetralstat) on July 7, 2025, for the treatment of acute hereditary angioedema attacks in individuals aged 12 years and older, marking the first oral on-demand therapy for hereditary angioedema.

Emerging Angioedema Drugs

The angioedema market is expected to see gradual advancements as new therapies move through development to address persistent gaps in care. Emerging treatments such as NTLA-2002, STAR-0215, and others highlight the growing focus of key developers on providing targeted options for patients living with hereditary and other forms of angioedema. These innovative candidates hold the potential to improve disease management and expand future treatment choices for this challenging condition.

NTLA-2002: Intellia Therapeutics

NTLA-2002 has the potential to become the first one-time treatment for hereditary angioedema a major step forward for patients who currently rely on lifelong therapy. This innovative gene-editing therapy active in Phase III is designed to prevent attacks by permanently inactivating the KLKB1 gene which encodes prekallikrein, the precursor to plasma kallikrein that drives excessive bradykinin production.

NTLA-2002 has already earned multiple notable regulatory designations including Orphan Drug and RMAT status from the US FDA, the Innovation Passport from the UK MHRA, Priority Medicines (PRIME) designation from the EMA, and Orphan Drug status from the European Commission.

Navenibart (STAR-0215): Astria Therapeutics

Navenibart is an investigational monoclonal antibody that targets plasma kallikrein a key driver of swelling episodes in hereditary angioedema. Designed to deliver rapid and long-lasting prevention of hereditary angioedema attacks, navenibart aims to combine a proven mechanism with the convenience of dosing every three to six months. This extended dosing schedule could significantly reduce treatment burden for patients while maintaining reliable protection against attacks. Reflecting its potential impact, the FDA has granted navenibart both Orphan Drug and Fast Track designations underscoring the need for more convenient, durable options for people living with hereditary angioedema.

The drug is currently being evaluated in a Phase III trial for hereditary angioedema, with results of Phase II trial ALPHA-SOLAR expected by mid-2025.

Angioedema Market Segmentation

DelveInsight's angioedema - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future angioedema market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Angioedema Market Size by Countries

The angioedema market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) angioedema market, primarily attributed to the country's higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Angioedema Drugs Uptake

This section focuses on the sales uptake of potential angioedema drugs that have recently been launched or are anticipated to be launched in the angioedema market between 2020 and 2034. It estimates the market penetration of angioedema drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the angioedema market.

The emerging angioedema therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the angioedema market.

Angioedema Market Access and Reimbursement

DelveInsight's 'Angioedema - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of angioedema.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current angioedema market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the angioedema domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or Angioedema market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the angioedema unmet needs.

Angioedema: KOL Insights

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as University of California, US; Fraunhofer Institute for Translational Medicine and Pharmacology, Germany; Grenoble Alpes University Hospital, France; Seville Institute of Biomedicine, Spain; University Hospital of Wales, UK; and Chiba University Hospital, Japan; among others.

"Diagnosing angioedema remains a significant clinical challenge, experts emphasize, as there is no single definitive test to confirm the condition in all patients. This gap highlights a clear unmet need for more reliable and standardized diagnostic tools to support timely and accurate identification of angioedema across its different forms."

"Effective management of angioedema requires rapid control of swelling and airway protection based on the underlying cause, yet there remains a clear unmet need for faster, more reliable treatments to prevent severe or recurrent attacks and reduce life-threatening risks."

"Significant unmet needs persist in Japan for better awareness, diagnosis, and timely access to angioedema treatments, highlighting the importance of continued education and new prevention options to improve patient care."

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the angioedema Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Angioedema Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for angioedema. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging angioedema therapies.

Angioedema Report Insights

• Angioedema Patient Population
• Therapeutic Approaches
• Angioedema Pipeline Analysis
• Angioedema Market Size and Trends
• Angioedema Market Opportunities
• Impact of Upcoming Therapies

Angioedema Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Angioedema Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Angioedema Market
• Angioedema Drugs Uptake

Angioedema Report Assessment

• Angioedema Current Treatment Practices
• Unmet Needs
• Angioedema Pipeline Product Profiles
• Angioedema Market Attractiveness

Key Questions:

• How common is Angioedema?
• What are the key findings of angioedema epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for angioedema?
• What are the disease risk, burden, and unmet needs of angioedema?
• At what CAGR is the angioedema market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the angioedema market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of angioedema in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of angioedema?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the angioedema market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What are the treatment goals for angioedema?

The main treatment goals for angioedema are to rapidly reduce swelling, secure and maintain a clear airway if needed, and prevent life-threatening complications such as airway obstruction. Management also aims to identify and address the underlying cause to guide targeted therapy and minimize the risk of future attacks. Long-term goals include preventing recurrence through appropriate on-demand or prophylactic treatment and ensuring patients have access to timely emergency care and education to manage potential triggers and complications.

2. What are the challenges in managing angioedema?

The main challenges in managing angioedema include the difficulty of accurately diagnosing the underlying cause, which can delay appropriate treatment, and the unpredictable nature of attacks, which may escalate rapidly and threaten the airway. Management is further complicated by limited treatment options for certain forms, such as bradykinin-mediated angioedema, which do not respond to standard allergy medications.

3. What are the key factors driving the growth of the angioedema market?

The main factors driving the growth of the angioedema market include increasing awareness and improved recognition of hereditary and acquired forms, which are leading to earlier diagnosis and greater demand for targeted therapies. Advances in innovative treatments including next-generation prophylactic and on-demand options - are expanding choices for patients who previously had limited options. Supportive regulatory designations and ongoing clinical research are accelerating the development of novel therapies.

4. How will the angioedema market and epidemiology forecast report benefit the clients?

The angioedema market and epidemiology forecast report will benefit clients by providing comprehensive insights into market trends, treatment options, patient populations, and future growth opportunities, helping them make informed strategic decisions and identify potential areas for investment or expansion.