Critical Limb Ischemia Treatment Market Size, Share, and Trends

The global critical limb ischemia treatment market size was estimated at USD 4.43 billion in 2022 and is projected to hit around USD 9.18 billion by 2032, growing at a CAGR of 7.56% during the forecast period 2023 to 2032.

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Key Takeaways

• On the basis of geography, North America will likely lead the market from 2023 to 2032.
• On the basis of geography, the Asia Pacific is projected to expand at a rapid CAGR from 2023 to 2032.
• On the basis of treatment, the devices segment is anticipated to hold a significant share.
• On the basis of treatment, the peripheral dilatation system is expected to make up a sizable portion of the devices segment from 2023 to 2032.

Critical Limb Ischemia Treatment Marke Overview

Some significant market developments for treating critical limb ischemia are improved endovascular procedures and the best revascularization approaches. Players in the market have the potential to profit from the need to enhance revascularization results with a focus on lowering ischemia-related cardiovascular risk factors. 

In terms of treatment, dilation devices and stents dominate the critical limb ischemia market. As a result, businesses are focused on developing stents and dilation devices for revascularization. When these are used, clinical outcomes improve, ultimately improving patient quality of life. Since the FDA approved technologically improved peripheral dilatation systems a few years ago, this market segment has seen lucrative opportunities, enhancing the value chain of the manufacturers in the market for acute limb ischemia treatment.

The product pipeline will be enriched, and the need for critical limb ischemia therapies will increase as more clinical trials are conducted to address the drawbacks of current peripheral dilatation devices and endovascular treatments. The critical limb ischemia treatment market will grow due to the demand for cutting-edge tools and balloon dilators for critical limb ischemia (CLI) vascular surgery.

Critical Limb Ischemia Treatment Market Scope

Critical Limb Ischemia Treatment Market Dynamics

The market for critical limb ischemia will rise due to the rising prevalence of diabetes brought on by an aging global population and improved critical limb ischemia treatment options. In addition, despite the disease's complexity and low visibility, businesses are actively working to produce critical limb ischemia medications to meet the unmet needs of the condition.

Except for Japan, there are no approved pharmacological options for treating critical limb ischemia, which offers enormous potential for investment and development into new medications while reducing competition. The market for critical limb ischemia currently has an unmet demand for drugs that can cure the condition as effectively and safely as possible. The expansion of the critical limb ischemia market is, nevertheless, constrained by various issues.

The condition is not properly identified or treated, increasing morbidity, mortality, and expenses. A lack of knowledge and other diseases with a similar presentation hampers the expansion of the critical limb ischemia market. Along with the failure of medications in clinical development, the evolution of the critical limb ischemia market is also constrained by rigorous pricing and reimbursement regulations. Furthermore, the accessibility of surgical techniques can make it challenging for novel treatments to gain traction.

Covid-19 Impact

The COVID-19 epidemic has negatively impacted the market for treatments for critical limb ischemia around the world. This is true, although a sizable portion of the population in some areas has received every recommended shot. During the pandemic's breakout year, the governments of the affected countries postponed non-essential procedures and patient visits. As a result, hospitals and clinics saw a decrease in the overall number of critical limb ischemia diagnoses and treatments.

The lack of comprehensive knowledge regarding the epidemiology and etiology of the disease has declined the development of successful therapy options. Leading market participants for the treatment of critical limb ischemia consequently reported a reduction in revenue due to the pandemic. The market has been bouncing back from COVID-19, nevertheless, due to the relaxation of regulations by governments worldwide.

During the forecast period, the devices segment is anticipated to hold a significant share of the worldwide critical limb ischemia therapy market. Stents and dilation devices successfully dilate the artery while safeguarding the arterial wall. These are the tools that are frequently used to treat critical limb ischemia. Patients experience a higher quality of life thanks to the low complication rates and the tremendous technical success of dilation devices and stents. During the forecast period, the devices segment is expected to be driven by these benefits. The growing number of FDA approvals and patient preference for revascularization as the first line of treatment can also be attributed to the segment's dominance.

Treatment Insights

Based on treatment, during the forecast period, the devices segment is anticipated to hold a significant share of the worldwide critical limb ischemia therapy market. Stents and dilation devices successfully dilate the artery while safeguarding the arterial wall. These are the tools that are frequently used to treat critical limb ischemia. Patients experience a higher quality of life thanks to the low complication rates and the tremendous technical success of dilation devices and stents.

During the forecast period, the devices segment is likely to be driven by these benefits. Another reason for the segment's dominance is the rise in FDA approvals and patient preference for revascularization as the initial course of treatment. The Tack Endovascular System in Below the Knee Arteries (TOBA II BTK) optimized balloon angioplasty study has recently produced promising outcomes in clinical trials.

Devices Insights

The devices segment has been divided into peripheral dilatation systems and embolic protection devices. The peripheral dilatation system is expected to make up a sizable portion of the devices segment during the forecast period, which is explained by the rise in balloon dilatation procedures and CLI vascular surgery. Leading companies in the critical limb ischemia market are concentrating on creating and introducing cutting-edge peripheral dilatation devices.

The Peripheral System by Radianz Radial will be used by people, according to a June 2022 announcement from Cordis, a world authority on cardiovascular technologies. The Peripheral System solution Radianz Radial consists of the PTA Catheter by SABER X RADIANZTM to facilitate treatment, the Guiding Sheath by BRITE TIP RADIANZTM to maximize lesion access of the lower extremity and the Vascular Stent System, SMART RADIANZTM, to help sustain patency for long-lasting positive outcomes.

Regional Insights

In the upcoming years, North America will likely lead the global market for critical limb ischemia treatments. During the forecast period, the market in the area is anticipated to expand at a moderate CAGR. The growth can be attributed to the rise in government activities and awareness about CLI and other risk-associated conditions, as well as to increases in healthcare spending, disposable income, and the accessibility to cutting-edge technology in the area. A new study estimates 2 million and 3 million Americans have significant limb ischemia.

From 2022 to 2031, the market in Asia Pacific is projected to expand at a rapid CAGR. The growth in the prevalence of CLI in nations like China and India, the expansion in the senior population, and the explosion in government initiatives and healthcare spending are driving the market for critical limb ischemia treatment in the area. The region's market is expected to grow due to the area's large population, unmet medical requirements, and rising patient awareness. Because of the rise in disposable income brought on by economic growth in emerging economies like China and India, consumers' purchasing power is improving. In the foreseeable future, this is anticipated to increase the market in these nations.

Recent Developments

• In June 2022, the Radianz Radial Peripheral System was made available for human use by Cordis, a leader in cardiovascular technologies. The PTA Catheter by SABERX RADIANZTM makes the treatment process more accessible, the Vascular Stent System by SMART RADIANZTM assists in preserving patency for long-lasting favorable outcomes, and the BRITE TIP RADIANZTM Guiding Sheath are all components of the System solution called Radianz Radial Peripheral.
• In June 2019, the drug-coated SurVeilballoon from Surmodics, which is now undergoing clinical trials to cure the superficial femoral artery, will have Abbott's exclusive worldwide commercialization rights under the terms of an agreement that the two companies disclosed.

Critical Limb Ischemia Treatment Market Companies

• Boston Scientific Corporation
• Pluristem Therapeutics Inc.
• Micro Medical Solutions
• Cesca Therapeutics Inc.
• Cardiovascular Systems, Inc.
• Abbott Laboratories
• LimFlow SA
• Rexgenero Ltd.

Segment Covered in the Report

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By Treatment

• Medication
  • Antihypertensive Agents
  • Antiplatelet Drugs
  • Antithrombotic Agents
  • Lipid-lowering Agents
  • Others

By Devices

• Embolic Protection Devices
• Peripheral Dilatation System
  • Balloon Dilators
  • Vascular Stents

By Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)