Amyloidosis Epidemiology Forecast 2026-2035

Parameter

Insight

Largest Patient Pool

United States

Fastest Growing Country

Japan

High-Risk Population

Older adults and individuals with plasma-cell disorders, hereditary TTR variants, or age-associated ATTR amyloidosis

Key Diagnostic Method

Amyloid tissue confirmation with Congo-red staining and definitive protein typing by mass spectrometry

Major Risk Factor

Underlying disease-specific amyloid precursor abnormality

Major gap in the market

Delayed diagnosis and incomplete access to specialized amyloid typing and disease-modifying treatment

Epidemiology Segment

Key Insights

Diagnosed Prevalent Cases of the Disease

According to Laires et al., 2025, the estimated incidence of immunoglobulin light-chain (AL) amyloidosis in the United States was 16.7 cases per million adults, while prevalence was 69.0 cases per million adults in 2021, demonstrating a substantial diagnosed disease burden.

Gender-Specific Cases of the Disease

According to Laires et al., 2025, AL amyloidosis occurs in both sexes, with epidemiological analyses indicating a higher incidence among males. The sex distribution varies according to amyloidosis subtype, particularly between AL and transthyretin amyloidosis.

Age-Specific Cases of the Disease

As per Laires et al., 2025, AL amyloidosis predominantly affects older adults, with incidence increasing with advancing age. ATTR amyloidosis is also strongly age-associated, particularly wild-type ATTR, which is predominantly diagnosed in elderly individuals.

Ethnicity-Wise Cases of the Disease

According to available epidemiological evidence, amyloidosis occurs across multiple ethnic populations, although the distribution of specific subtypes and hereditary variants differs geographically and ethnically. ATTRv amyloidosis, for example, exhibits marked geographic and genetic heterogeneity because pathogenic TTR variants are unevenly distributed among populations.

Mortality and Survival Analysis of the Disease

Amyloidosis is associated with substantial mortality, particularly when cardiac involvement is present. Prognosis varies considerably by amyloid subtype, disease stage, and extent of organ involvement. In AL amyloidosis, cardiac biomarkers and hematologic response are major determinants of survival, while effective plasma-cell-directed therapy has substantially improved outcomes compared with historical treatment approaches.

Disease Type

Prevalence

Immunoglobulin Light-Chain (AL) Amyloidosis

According to recent epidemiological evidence, AL amyloidosis is the most common systemic amyloidosis subtype and has an estimated incidence of approximately 8–15.2 cases per million persons per year. A 2025 U.S. real-world analysis estimated an incidence of 16.7 cases per million adults and prevalence of 69.0 cases per million adults in 2021.

Transthyretin (ATTR) Amyloidosis

ATTR amyloidosis comprises wild-type ATTR (ATTRwt) and variant/hereditary ATTR (ATTRv) and represents an increasingly recognized component of the amyloidosis burden. A 2025 systematic review reported ATTR prevalence ranging from 6.1 per million in the United States to 232 per million in Portugal, with higher prevalence observed among older adults, men, and patients with cardiac disease.

AA (Serum Amyloid A) Amyloidosis

AA amyloidosis develops secondary to chronic inflammatory or infectious disorders and predominantly causes renal involvement. Recent reviews indicate that its incidence has declined in many settings because of improved treatment of underlying inflammatory diseases, although it remains clinically important in populations with persistent chronic inflammation and infection.

Others

Other forms include hereditary and localized amyloidosis, as well as rarer types associated with proteins such as apolipoprotein A-I, fibrinogen Aα, lysozyme, β2-microglobulin, and gelsolin. Current classification recognizes 42 amyloidogenic proteins, demonstrating substantial biological and clinical heterogeneity beyond AL, ATTR, and AA amyloidosis.

Country

Key Insights

United States

According to Laires et al., 2025, the estimated incidence of AL amyloidosis was 16.7 cases per million person-years, while prevalence reached 69.0 cases per million adults in 2021, representing a substantial diagnosed disease burden. A separate 2025 analysis estimated the prevalence of ATTR amyloidosis at 59.8 cases per million people in 2022 using a narrow case definition.

Germany

Germany has established specialist diagnostic and treatment networks for systemic amyloidosis, particularly AL and ATTR amyloidosis. Published European evidence indicates that the recognized burden is increasing with improved disease awareness and detection of cardiac ATTR, although a directly comparable contemporary national prevalence estimate is not firmly established.

France

France has reported substantial clinical experience with systemic amyloidosis, particularly AL and ATTR. Contemporary European evidence indicates increasing recognition of transthyretin-related cardiac disease, but country-level estimates vary according to case definition and diagnostic ascertainment, making direct comparison with U.S. registry estimates inappropriate.

Italy

Italy represents an important European amyloidosis population, particularly for ATTR amyloidosis, reflecting the presence of hereditary transthyretin variants and specialized amyloidosis referral centres. Epidemiological estimates remain heterogeneous because registry, hospital, and genetic-screening studies capture different segments of the disease population.

Spain

Spain has a significant recognized burden of both AL and ATTR amyloidosis, with hereditary transthyretin amyloidosis contributing to regional clustering of disease. Available evidence indicates substantial geographic variation in ATTRv prevalence because of founder TTR variants, while broader national estimates remain dependent on diagnostic ascertainment.

United Kingdom

The United Kingdom has extensive specialist amyloidosis services and national diagnostic pathways, with increasing recognition of both AL and ATTR disease. The expanding identification of ATTR cardiac amyloidosis has increased the recognized patient population, although a single contemporary national prevalence figure covering all amyloidosis subtypes is not reliably available.

Japan

Japan has one of the strongest contemporary national datasets for systemic amyloidosis. According to Kubota, 2026, registered systemic amyloidosis cases increased from 2,304 in 2015 to 8,168 in 2024, a 3.5-fold increase, while the population-adjusted rate rose from 0.18 to 0.65 per 10,000 population. ATTR was the predominant subtype in a Japanese pathological-autopsy analysis, accounting for 44.4% of classified systemic amyloidosis cases, compared with 38.8% for AL.

India

India has a clinically important but incompletely quantified amyloidosis burden. Published evidence is particularly limited by underdiagnosis, heterogeneous access to amyloid typing, and the absence of a comprehensive nationwide registry covering all amyloidosis subtypes. Consequently, a reliable contemporary national prevalence or incidence estimate cannot presently be stated without substantial uncertainty.