Critical Limb Ischemia Market Size in the 7MM is Estimated to Exceed USD 2.7 Billion by 2035

The critical limb ischemia market reached a value of USD 1.4 Billion across the top 7 markets (US, EU4, UK, and Japan) in 2024. Looking forward, IMARC Group expects the top 7 major markets to reach USD 2.7 Billion by 2035, exhibiting a growth rate (CAGR) of 6.37% during 2025-2035.

Critical limb ischemia (CLI) is a severe peripheral arterial disease (PAD) that results from a substantial narrowing or blockage of the arteries supplying blood to the legs and feet. It is a chronic condition that can lead to tissue damage, chronic pain, and non-healing ulcers, as well as amputation of the affected limb. The most common manifestations of this disorder are severe foot or leg pain, shiny, smooth, hairless, dry, or very dry feet, discoloration of skin, discharge from gangrene, thick toenails, slow-healing wounds, poor pulse in the feet or legs, etc.

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Rising Incidence and Market Expansion

The prevalence of CLI is on the rise due to the growing rate of diabetes mellitus, hypertensive conditions, and peripheral artery diseases. IDF Diabetes Atlas suggests that the global prevalence of diabetes in adults will significantly grow by the year 2045 which will severely contribute to the prevalence of CLI Subsequently, peripheral artery disease which is already affecting over 200 million people across the globe will, on the other expectation, surge by almost 50% by 2045. This will further increase the CLI risk.

The increase in the existing population of patients is bound to expand the market for CLI treatment which includes pharmacological treatment, surgical treatment, and innovative regenerative therapeutic approaches. Growth is also observed in the awareness and early diagnosis of diseases which encourages timely intervention, subsequently improving patient outcomes.

Technology Changes in Diagnosis and Treatment

Innovations in technology are changing the diagnosis and treatment of CLI. New imaging techniques, such as duplex ultrasound, CTA, and MRA, have improved visualization of arterial blockages. More accurate and effective assessments and treatment plans can now be made.

The use of AI and machine-learning models is also becoming more common in diagnostic workflows. They enable early detection and create personalized plans for each patient. Patient-monitoring wearable biosensors and AI-powered diagnostic tools help in real-time monitoring for disease progression and the effectiveness of therapies.

Patients recovering from endovascular procedures like angioplasty and stenting are experiencing quicker, safer, and easier recovery. New bioresorbable stents such as Abbott's Esprit BTK System, which recently gained FDA approval, represent significant advancements. The stents temporary support affacted arteries but dissolve while the vessel heals.

Conventional therapies produce unsatisfactory results for some patients. Advaced regenarative approaches, such as stem cell and gene-based therapies, emerge as options. The therapies aim to restore blood supply to the limbs prone to amputation and improve the patients' quality of life.

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Countries Covered

United States
Germany
France
United Kingdom
Italy
Spain
Japan

This report also provides a detailed analysis of the current critical limb ischemia marketed drugs and late-stage pipeline drugs.

In-Market Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

Competitive Landscape With Key Players:

The competitive landscape of the critical limb ischemia market has been studied in the report with the detailed profiles of the key players operating in the market.

BioGenCell
Helixmith Co., Ltd.

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