Chronic Spontaneous Urticaria Epidemiology Forecast 2026-2035

Parameter

Insight

Largest Patient Pool

United States

Fastest Growing Country

India

High-Risk Population

Individuals at higher risk of chronic spontaneous urticaria (CSU) include women, adults aged 20-50 years, people with a personal or family history of autoimmune disease, and patients with other allergic or inflammatory conditions.

Key Diagnostic Method

The key diagnostic method for chronic spontaneous urticaria (CSU) is clinical diagnosis based on the patient's history and physical examination, particularly the presence of recurrent wheals, angioedema, or both for more than 6 weeks without a consistent identifiable trigger.

Major Risk Factor

The major risk factor for chronic spontaneous urticaria (CSU) is an underlying autoimmune predisposition, particularly the presence of autoimmune thyroid disease and other systemic autoimmune disorders.

Major gap in the market

The major gap in the chronic spontaneous urticaria (CSU) market is the limited availability of rapidly acting, durable, and well-tolerated therapies that achieve complete disease control in patients who remain inadequately controlled with standard-dose or up-dosed H1-antihistamines and existing biologic treatment.

Epidemiology Segment

Key Insights

Diagnosed Prevalent Cases of the Disease

Chronic spontaneous urticaria (CSU) affects approximately 1% of the general population worldwide, although estimates of diagnosed prevalence vary substantially according to the case definition and data source. In the United States, a 2025 National Health and Wellness Survey analysis estimated the physician-diagnosed prevalence of CSU at 0.78%, while a separate 2025 analysis of U.S. electronic health-record and claims databases reported diagnosed prevalence estimates ranging from 0.244% to 0.283% depending on the database.

Gender-Specific Cases of the Disease

Chronic spontaneous urticaria (CSU) shows a consistent female predominance, with women generally accounting for approximately two-thirds of affected patients. A 2024 systematic review of 26 studies found higher CSU incidence and prevalence among females across the available epidemiological studies; in a U.S. population-based study, standardized prevalence was 309.3 cases per 100,000 women versus 145.5 per 100,000 men, corresponding to approximately a 2.1-fold higher prevalence in women.

Age-Specific Cases of the Disease

Chronic spontaneous urticaria (CSU) can occur across the lifespan but is predominantly an adult disease, with onset and prevalence generally concentrated in young and middle-aged adults. Epidemiological literature places the typical age of CSU onset at approximately 30-50 years, with the disease particularly common during the third to fifth decades of life. In a large U.S. population-based analysis of chronic urticaria, prevalence was highest among adults aged 40-49 years (256 cases per 100,000), followed by those aged 50-59 years (246 per 100,000).

Ethnicity-Wise Cases of the Disease

Chronic spontaneous urticaria (CSU) occurs across all ethnic groups, but available U.S. epidemiological evidence suggests higher prevalence among Black/African American populations than among White populations. A large population-based analysis of more than 55 million U.S. patients reported adjusted chronic urticaria prevalence of 292 cases per 100,000 among Black patients, compared with 262 per 100,000 among White patients; patients categorized as “other” had 331 per 100,000.

Mortality and Survival Analysis of the Disease

Chronic spontaneous urticaria (CSU) has historically been regarded as a non-life-limiting disease, and most patients do not die from the urticaria itself. A large 2025 U.S. population-based cohort study involving 264,680 propensity-score-matched adults with CSU found significantly higher all-cause mortality at 3 months, 1 year, and 5 years compared with controls, with a 5-year mortality hazard ratio of 1.69 (95% CI, 1.65-1.73).

Country

Key Insights

United States

Chronic spontaneous urticaria (CSU) has a diagnosed prevalence of approximately 0.78% in the United States, according to a 2025 analysis of the U.S. National Health and Wellness Survey. Among 74,994 respondents, 635 had physician-diagnosed CSU, producing a weighted 12-month prevalence of 0.78%. The mean age at diagnosis was 37.0 years, and 51.7% of diagnosed patients were female.

Germany

Among 15,020 German respondents, 112 had physician-diagnosed CSU, corresponding to an age- and sex-adjusted prevalence of 0.79% (95% CI: 0.78%–0.79%). This was comparable to the United Kingdom (0.79%) and higher than France (0.76%). A German statutory health-insurance analysis provides a more conservative real-world estimate. In 2017, 0.5% of the insured population had diagnosed chronic urticaria (CU), of whom 71.2% had CSU, 19.7% had chronic inducible urticaria, and 9.1% had both. The corresponding diagnosed prevalence specifically for CSU was 0.35% overall, rising to 0.44% among women and 0.26% among men.

France

Chronic spontaneous urticaria (CSU) has a diagnosed prevalence of 0.76% in France, according to the 2020 EU5 National Health and Wellness Survey (NHWS). Among 15,152 French respondents, 109 reported physician-diagnosed CSU, corresponding to an age- and sex-adjusted prevalence of 0.76%. This was lower than the estimates for Germany (0.79%), the United Kingdom (0.79%), Spain (1.0%), and Italy (1.3%).

Italy

Chronic spontaneous urticaria (CSU) has a diagnosed prevalence of 1.3% in Italy, according to the 2020 EU5 National Health and Wellness Survey (NHWS). Among 10,026 Italian respondents, 134 reported physician-diagnosed CSU, corresponding to an age- and sex-adjusted prevalence of 1.3%. This was the highest diagnosed CSU prevalence among the five European countries evaluated: Italy (1.3%), Spain (1.0%), Germany (0.79%), the United Kingdom (0.79%), and France (0.76%).

Spain

The most recent robust country-specific estimate for chronic spontaneous urticaria (CSU) in Spain comes from the 2020 EU5 National Health and Wellness Survey. The age- and sex-adjusted prevalence of physician-diagnosed CSU was 1.0% among Spanish adults. The estimate was based on 75 diagnosed CSU respondents among 7,074 Spanish survey participants. This was higher than France (0.76%), Germany (0.79%) and the United Kingdom (0.79%), but lower than Italy (1.3%).

United Kingdom

The most recent robust country-specific estimate for chronic spontaneous urticaria (CSU) in the United Kingdom is 0.79% of the adult population. This comes from the 2020 EU5 National Health and Wellness Survey, with results published in the Journal of the European Academy of Dermatology and Venereology in 2025. The estimate was age- and sex-adjusted and was based on 109 physician-diagnosed CSU cases among 15,047 UK respondents.

Japan

The most recent evidence indicates that chronic spontaneous urticaria (CSU) prevalence in Japan is approximately 1.1%. A 2025 cross-sectional analysis of the Japanese National Health and Wellness Survey included 30,006 adults, of whom 334 reported physician-diagnosed CSU. After weighting to the Japanese population, the estimated 12-month prevalence was 1.1% (95% CI: 1.1–1.1%). Using the JMDC claims database, investigators estimated CSU prevalence increased from 1.2% in 2016 to 1.6% in 2021, with a standardized prevalence also reaching 1.6% in 2021. The prevalence was highest among children younger than 10 years, at 2.2%, while prevalence among people in their twenties was approximately 1.1%.

India

A national population-based prevalence estimate for chronic spontaneous urticaria (CSU) in India has not yet been established. The 2024 North Indian CSU cohort specifically notes that comprehensive population-level data from the Indian subcontinent remain limited. The study analyzed 1,104 CSU patients attending the urticaria clinic at PGIMER, Chandigarh, but because this was a tertiary-care retrospective cohort, its patient count cannot be converted into a national prevalence estimate. Indian guidelines similarly state that the exact prevalence of CSU in India is unknown.