Critical limb ischemia (CLI) Insights and Trends

• Critical limb ischemia (CLI/CLTI) represents the most severe form of peripheral arterial disease (PAD) and accounts for a small but clinically significant subset (~1–2%) of the overall PAD population, with higher prevalence observed in elderly patients and those with diabetes or end-stage atherosclerosis. 

• The annual incidence of CLI is estimated at ~500–1000 cases per million population in developed countries, with incidence expected to rise due to increasing aging populations, diabetes prevalence, smoking burden, and cardiovascular risk factors, which drive progressive peripheral atherosclerotic disease. 

• CLI is associated with a high risk of major adverse limb events, with major amputation rates historically reported in the range of ~10–40% within 1 year if untreated or in patients not eligible for revascularization, and it also carries a high 1-year mortality rate (~20–25%), reflecting its systemic cardiovascular disease burden.

CLI Epidemiology Forecast in the 7MM

• 2025 Prevalent Cases of CLI : ~XX

• CLI Growth Rate (2026–2036): XX% CAGR

DelveInsight's ‘CLI Epidemiology Forecast – 2036’ report delivers an in-depth understanding of the CLI, historical and forecasted epidemiology, in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

CLI Understanding 

CLI Overview and Diagnosis

CLI, also referred to as chronic limb-threatening ischemia (CLTI), is the most severe form of peripheral arterial disease (PAD), caused by advanced arterial obstruction leading to critically reduced blood flow to the lower limbs. It is characterized by ischemic rest pain, non-healing ulcers, tissue loss, and gangrene, and is strongly associated with diabetes, smoking, hypertension, hyperlipidemia, aging, and sedentary lifestyle. Diagnosis is based on clinical evaluation and vascular assessment using ankle-brachial index (ABI), toe pressures (TBI), duplex ultrasound (DUS), and imaging modalities such as CTA/MRA to define arterial disease severity and guide treatment decisions.

Diagnosis of CLI is based on clinical assessment of ischemic symptoms such as rest pain, non-healing ulcers, tissue loss, and gangrene, along with reduced or absent peripheral pulses. It is confirmed using vascular tests including ankle-brachial index (ABI), toe-brachial index (TBI), and pressure measurements, supported by duplex ultrasound (DUS). CT angiography (CTA) and MR angiography (MRA) are used to define arterial anatomy and guide treatment planning. Early diagnosis is essential for risk stratification, limb salvage decisions, and selection of revascularization strategies.

Further details are provided in the report.

CLI Epidemiology

Key Findings from CLI Epidemiological Analysis and Forecast 

• CLI is associated with a high rate of cardiovascular comorbidities, and patients frequently present with co-existing coronary artery disease, cerebrovascular disease, or chronic kidney disease, reinforcing that CLI is a manifestation of systemic atherosclerotic disease rather than an isolated limb disorder.

• According to data from the US Medicare population, CLI prevalence increases with advancing age. In Medicare based analyses, the overall prevalence has been reported at approximately 0.23%, rising from 0.13% in individuals aged 65–69 years to 0.31% in those aged ≥85 years, reflecting a strong age-dependent increase in disease burden. In addition, other population-based studies suggest that nearly 20% of adults aged ≥70 years have a diagnosis consistent with CLI/CLT.

• There is a markedly higher burden of CLI in patients with diabetes mellitus, with studies showing that diabetic patients account for a disproportionate share (often >50%) of CLI-related limb events and amputations, due to accelerated peripheral arterial disease and associated microvascular dysfunction.

• Studies from the United Kingdom reported that CLI prevalence increases with age, with the highest burden in individuals aged ≥75 years. The condition is associated with high mortality, poor functional outcomes, and a frequent need for urgent vascular intervention to prevent limb loss or death.

• Japanese PAD patients treated with endovascular therapy, around 28% had CLI at presentation, and approximately 5% progressed from intermittent claudication to CLI.

Scope of the Report

• The report covers a segment of a descriptive overview of hand eczema, explaining their causes, signs and symptoms, and pathogenesis.

• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression. 

Report Insights

• CLI Patient Population Forecast

Report Key Strengths

• Epidemiology‑based (Epi‑based) Bottom‑up Forecasting

• 11-year Forecast 

• Patient Burden Trends (by geography)

FAQs

• What are the disease risks, burdens, and unmet needs of hand eczema? What will be the growth opportunities across the 7MM concerning the patient population with hand eczema?

• What is the historical and forecasted hand eczema patient pool in the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?

Reasons to Buy

• 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 key opinion leaders’ perspectives around the diagnostic challenges to overcome barriers in the future.

• Detailed insights on various factors hampering disease diagnosis and other existing diagnostic challenges.