Global Critical Limb Ischemia (CLI) Treatment Market - 2025 - 2032

Global Critical Limb Ischemia (CLI) Treatment Market - 2025 - 2032

The global critical limb ischemia (CLI) treatment market reached US$ 6.02 billion in 2024 and is expected to reach US$ 13.13 billion by 2032, growing at a CAGR of 7.9 % during the forecast period 2025-2032.

Critical Limb Ischemia (CLI) is a severe condition characterized by significant obstruction of the arteries, leading to markedly reduced blood flow to the extremities, particularly the legs and feet. Critical Limb Ischemia (CLI) represents the advanced stage of Peripheral Artery Disease (PAD), which is primarily caused by atherosclerosis the gradual hardening and narrowing of the arteries due to the accumulation of fatty deposits known as plaque.

Critical limb ischemia (CLI) is a chronic condition that manifests as intense pain in the feet or toes, even when at rest. This pain, often referred to as ischemic rest pain, can severely impact daily life. Complications associated with critical limb ischemia (CLI) include non-healing ulcers and wounds on the extremities, which arise from insufficient blood circulation necessary for healing. If left untreated, these complications can lead to serious outcomes, including amputation of the affected limb. Critical limb ischemia (CLI) poses significant health risks and requires prompt diagnosis and intervention to prevent further deterioration and preserve limb function. These factors have driven the global critical limb ischemia (CLI) treatment market expansion.

Market Dynamics: Drivers & Restraints

Increasing Prevalence of Critical Limb Ischemia (CLI)

The increasing prevalence of critical limb ischemia (CLI) is significantly driving the growth of the global critical limb ischemia (CLI) treatment market and is expected to drive throughout the market forecast period.

Critical limb ischemia (CLI) is recognized as the most severe form of peripheral arterial disease (PAD), characterized by significant arterial blockages in the lower extremities. This condition leads to markedly reduced blood flow, resulting in severe complications such as ulceration, gangrene, and an increased risk of lower-limb amputation.

Peripheral artery disease (PAD) is a common chronic circulatory condition that causes the narrowing of blood vessels, leading to reduced blood flow to the limbs, particularly the legs. It often remains undiagnosed and undertreated, with an estimated 20 million Americans living with PAD, yet only 8.5 million have received a formal diagnosis. While PAD typically begins asymptomatically, it can progress to severe symptoms that may necessitate revascularization procedures to prevent amputation. PAD is the leading cause of amputations in the United States and is associated with high rates of both fatal and non-fatal cardiovascular events.

Critical limb ischemia (CLI) is defined as a state of severe ischemia in the limbs, often accompanied by ischemic rest pain, non-healing ulcers, or gangrene lasting more than two weeks. It represents the end stage of PAD, where blood flow is critically compromised, leading to significant morbidity. Approximately 25 million people worldwide are affected by CLI. Despite its prevalence, effective therapies remain limited, highlighting a significant gap in treatment options for these patients.

CLI is associated with extremely high mortality rates. The five-year mortality rate can be as high as 67%, with about 20% of patients dying within six months of diagnosis. This high mortality is often linked to underlying systemic cardiovascular diseases, including coronary artery disease (CAD) and cerebrovascular disease (CVD). The prognosis for patients with CLI is dire; approximately 40% to 50% will lose their leg within 6 to 12 months after diagnosis. Furthermore, about 15% will require contralateral amputation (amputation of the other leg) within two years. These statistics underscore the urgent need for effective management strategies.

Furthermore, key players in the industry more focus on clinical trials and product launches & approvals that would propel this critical limb ischemia (CLI) treatment market growth. For instance, in March 2022, LimFlow completed patient enrollment for the PROMISE II pivotal trial, which focuses on a novel device aimed at preventing amputations in patients suffering from chronic limb-threatening ischemia (CLTI). This trial is particularly significant as it targets patients who have exhausted all other treatment options and are at high risk of major limb amputation.

Also, in June 2022, Koninklijke Philips N.V. announced that the U.S. Food and Drug Administration (FDA) approved its innovative device, the Philips Endovascular System–Tack (4F). This device is specifically designed to address chronic limb ischemia (CLI), a severe form of peripheral artery disease that can lead to significant morbidity, including limb amputation. All these factors demand the global critical limb ischemia (CLI) treatment market.

Moreover, the rising demand for the growth of advancements in treatment options contributes to the global critical limb ischemia (CLI) treatment market expansion.

High Treatment Costs

The high treatment costs will hinder the growth of the global critical limb ischemia (CLI) treatment market. The costs associated with therapies for critical limb ischemia (CLI), including advanced surgical procedures and medications, are notably high, leading to substantial financial burdens for both patients and healthcare systems. This financial strain can significantly limit access to necessary treatments, especially in developing regions where healthcare budgets are constrained.

CLI treatment often involves complex interventions such as revascularization procedures (angioplasty, stenting, or bypass surgery) and ongoing medical management (antiplatelet therapy, lipid-lowering agents). These procedures can be expensive due to the need for specialized equipment, skilled healthcare professionals, and extended hospital stays.

During the 12 months leading up to the diagnosis of critical limb ischemia (CLI), the average costs incurred were $27,500 for patients who ultimately underwent endovascular revascularization, $26,100 for those treated with surgical revascularization, and $38,300 for patients who required major amputation. Thus, the above factors could be limiting the global critical limb ischemia (CLI) treatment market's potential growth.

Segment Analysis

The global critical limb ischemia (CLI) treatment market is segmented based on Treatment Type, end-user, and region.

Treatment Type:

The vascular stents segment is expected to dominate the global critical limb ischemia (CLI) treatment market share

The vascular stents segment holds a major portion of the global critical limb ischemia (CLI) treatment market share and is expected to continue to hold a significant portion of the global critical limb ischemia (CLI) treatment market share during the forecast period.

Vascular stents are a cornerstone in the treatment of critical limb ischemia, enhancing patient outcomes through effective revascularization strategies. Their development continues to evolve, focusing on improving safety and efficacy in managing this serious condition.

Vascular stents are essential in managing critical limb ischemia (CLI), a severe condition resulting from inadequate blood flow to the limbs, which can lead to pain and tissue loss. The CLI treatment landscape increasingly emphasizes advanced endovascular techniques, particularly the use of stents and balloon angioplasty, which are vital for effective revascularization.

Types of stents include drug-eluting stents (DES) and balloon-expandable stents. Drug-eluting stents (DES): These stents are coated with medication that helps prevent restenosis (the re-narrowing of arteries) by inhibiting cell proliferation. They have demonstrated low rates of repeat revascularization, making them particularly advantageous in CLI management.

Balloon-expandable stents designed to be expanded within the artery using a balloon catheter, these stents allow for precise placement and effective dilation of narrowed vessels. They are commonly used in treating lesions in the infragenicular region, where they have shown safety and efficacy.

The use of vascular stents in CLI has been associated with improved clinical outcomes. For instance, studies indicate that limb salvage rates can reach up to 89.3%, and primary patency rates (the percentage of treated vessels that remain open) can be around 62.8% at one-year post-treatment. The combination of stenting with angioplasty is often superior to angioplasty alone, particularly in cases involving complex lesions.

Furthermore, key players in the industry product launches that would drive this global critical limb ischemia (CLI) treatment market growth. For instance, in November 2023, the LimFlow System (P220025) was a significant medical device recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of Chronic Limb-Threatening Ischemia (CLTI).

This condition is a severe form of peripheral arterial disease (PAD) that leads to critical reductions in blood flow to the lower extremities, often resulting in severe complications such as non-healing wounds and the risk of amputation. These factors have solidified the segment's position in the global critical limb ischemia (CLI) treatment market.

Geographical Analysis

North America is expected to hold a significant position in the global critical limb ischemia (CLI) treatment market share

The incidence of CLI is on the rise, with estimates indicating that between 2 million and 3 million individuals in the U.S. are affected. This growing patient population underscores the necessity for more effective treatment options to manage the condition effectively. CLI often leads to serious health complications, necessitating frequent hospitalizations; in fact, up to 60% of patients may be readmitted within six months of their initial treatment.

Chronic limb-threatening ischemia (CLTI) affects up to four million Americans, with a disproportionate impact on minority and underserved populations. This condition leads to severe arterial blockages in the lower extremities, resulting in inadequate blood flow, which can cause significant complications, including non-healing ulcers and gangrene. Each year, more than 150,000 major amputations are performed in the U.S. due to CLI.

The prevalence of diabetes, a major risk factor for CLI, is expected to continue increasing. Current projections suggest that the number of Americans with diabetes could rise from 32 million to 36 million by 2050, further fueling market growth as more individuals develop conditions leading to CLI. The availability of innovative medical devices, such as drug-eluting stents and minimally invasive surgical options, significantly enhances treatment efficacy and patient outcomes. These advancements are driving demand within the CLI treatment market.

Furthermore, a major number of key players' presence, innovative product launches, and approvals would propel this global critical limb ischemia (CLI) treatment market growth. For instance, in September 2023, LimFlow SA, a pioneer in minimally invasive technology for treating Chronic Limb-Threatening Ischemia (CLTI), announced that the U.S. Food and Drug Administration (FDA) has approved its LimFlow System. This approval is significant as it provides a new treatment option for patients suffering from CLTI who have no other suitable endovascular or surgical interventions available and are at risk of major amputation.

Also, in August 2021, the U.S. Food and Drug Administration (FDA) approved an expanded indication for XARELTO (rivaroxaban) in combination with aspirin, specifically for patients suffering from Peripheral Artery Disease (PAD) who have recently undergone lower-extremity revascularization (LER) due to symptomatic PAD. This approval marks a significant advancement in the management of PAD, particularly for patients at high risk for serious thrombotic events.

Thus, the above factors are consolidating the region's position as a dominant force in the global critical limb ischemia (CLI) treatment market.

Asia Pacific is growing at the fastest pace in the global critical limb ischemia (CLI) treatment market share

Asia Pacific holds the fastest pace in the global critical limb ischemia (CLI) treatment market and is expected to hold most of the market share.

The incidence of CLI is rising notably in countries like India and China, where lifestyle changes and an aging population contribute to higher rates of peripheral artery disease. This expanding patient population necessitates more effective treatment options. The growth of the elderly population across Asia-Pacific countries is a critical driver, as older adults are more susceptible to CLI and related cardiovascular conditions. This demographic shift increases the demand for specialized treatments.

There has been a significant increase in healthcare expenditure in the region, which facilitates better access to advanced medical technologies and treatments for CLI. This financial support enables healthcare systems to adopt innovative therapies and devices. Governments are actively implementing initiatives aimed at raising awareness about CLI and its risk factors, promoting early diagnosis and treatment. Such efforts are crucial for improving patient outcomes and effectively managing the disease.

Furthermore, key players in the industry have innovative launches and approvals that would propel this critical limb ischemia (CLI) treatment market growth. HONEDRA is an innovative experimental regenerative medicine developed as a treatment for Chronic Limb Ischemia (CLI) and Buerger’s disease in Japan. It has been designated as a SAKIGAKE product candidate, which is a special designation by the Japanese regulatory authority aimed at expediting the development and review of innovative medical products.

Also, Stempeucel is an innovative stem cell-based biological product that has received approval from the Drug Controller General of India (DCGI), marking it as the first of its kind to be approved for manufacturing and marketing for the treatment of Critical Limb Ischemia (CLI). This approval represents a significant advancement in the therapeutic options available for patients suffering from this severe condition.

Thus, the above factors are consolidating the region's position as the fastest-growing force in the global critical limb ischemia (CLI) treatment market.

Competitive Landscape

The major global players in the critical limb ischemia (CLI) treatment market include Medtronic plc, Boston Scientific Corporation, Abbott. (Cardiovascular Systems, Inc.), Inari Medical, Koninklijke Philips N.V., Lisata Therapeutics, Cook, Baxter, B. Braun Melsungen AG, and Biotronik SE & Co. KG among others.

Key Developments
• In April 2024, the FDA's recent approval of Abbott's Espirit BTK Everolimus Eluting Resorbable Scaffold System marks a significant advancement in the treatment of Chronic Limb-Threatening Ischemia (CLTI), particularly in arteries below the knee. This innovative treatment represents the first dissolving stent approved in the United States specifically for this condition.

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• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global critical limb ischemia (CLI) treatment market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

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