Critical Limb Ischemia Treatment Market to Reach USD 10.02 Billion by 2032, Owing to Rising Demand for Minimally Invasive Vascular Therapies | Coherent Market Insights

/EIN News/ -- Burlingame, CA, June 18, 2025 (GLOBE NEWSWIRE) -- The Coherent Market Insights reveals that the Critical Limb Ischemia Treatment Market is estimated to be valued at USD 5.55 Bn in 2025 and is expected to reach USD 10.02 Bn by 2032, exhibiting a compound annual growth rate (CAGR) of 8.8% from 2025 to 2032. The critical limb ischemia treatment market is projected to experience significant growth during the forecast period. Key factors driving this expansion include the increasing global geriatric population and the rising prevalence of peripheral artery disease, both of which are contributing to a growing demand for effective treatment options.

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Global Critical Limb Ischemia Treatment Market Key Takeaways

According to Coherent Market Insights (CMI), the global critical limb ischemia market size is projected to expand at a CAGR of 8.8%, growing from USD 5.55 Bn in 2025 to USD 10.02 Bn by 2032.

Based on drugs, antihypertensive agents category is expected to dominate the market, generating a revenue of around USD 1.69 Bn in 2025.

By route of administration, parental segment is anticipated to account for more than three-fifths of the global critical limb ischemia treatment market share in 2025.

By end user, hospitals segment will likely hold a prominent market share of over 2/5 by 2025.

As per Coherent Market Insights’ new critical limb ischemia treatment market analysis, North America is set to account for a market share of more than two-fifths in 2025.

Asia Pacific critical limb ischemia treatment market is expected to experience fastest growth throughout the assessment period.

Rising Prevalence of Diabetes and Peripheral Artery Disease Fueling Market Growth

Coherent Market Insights’ latest critical limb ischemia treatment market report highlights key factors driving the industry’s growth. One such prominent growth factor is the increasing incidence of diabetes and peripheral artery disease (PAD).

According to the CLI Global Society, more than 202 million adults worldwide are affected by PAD—a number expected to rise due to the growing global burden of diabetes. Since diabetes is a major risk factor for PAD and CLI, this trend is anticipated to significantly boost demand for critical limb ischemia treatments.

Patients with critical limb ischemia, a severe form of PAD, are commonly treated with medications like antihypertensive agents and antithrombotic agents. As the number of PAD cases increases, so will demand for effective CLI treatments.

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High Treatment Costs Restraining Market Growth

The future critical limb ischemia treatment market outlook looks promising, considering the rising prevalence of peripheral artery disease (PAD). However, high treatment costs are expected to limit market growth to some extent.

Advanced critical limb ischemia therapies are often expensive and may not be readily accessible to patients in low- and middle-income countries. This cost barrier can hinder widespread adoption and negatively impact the overall critical limb ischemia treatment market demand.

Improved Diagnostic Rates to Create Lucrative Growth Opportunities

Rise in early detection of critical limb ischemia is expected to open new revenue-generation opportunities for industry players. Advanced diagnostic technologies like duplex ultrasound, MRA, and OCT are significantly improving the accuracy and rate of CLI diagnoses. This improved diagnostic capability is likely to drive higher demand for CLI treatments during the forecast period.

Impact of AI Trend on the Critical Limb Ischemia Treatment Market

Artificial intelligence (AI) is having a profound impact on the critical limb ischemia treatment market. This is due to its ability to enhance diagnostic speed, improve treatment precision, and enable personalized care.

AI-powered image analysis, particularly for CT angiography, enables automated detection of arterial stenosis and rapid lesion segmentation. By doing so, it significantly accelerates diagnosis and preoperative planning.

Emerging Critical Limb Ischemia Treatment Market Trends

Shift toward non-invasive and pharmacological therapies is acting as a catalyst triggering critical limb ischemia treatment market growth. Many patients with CLI prefer drug-based approaches like antihypertensive agents, statins, and antiplatelet agents, over surgical interventions due to the associated risks, costs, and recovery time of invasive procedures.

Advancements in CLI treatment options are expected to significantly influence the target industry. Leading industry players are striving to develop innovative therapies like stem cell therapy, gene therapy, and drug-eluting stents to improve clinical outcomes in patients with critical limb ischemia.

Some manufacturers of critical limb ischemia drugs are focusing on developing targeted therapies for CLI patients. This shift towards personalized medicine is expected to play a key role in boosting the critical limb ischemia treatment market value.

There is a growing trend toward using multiple drug classes—such as antiplatelet agents, anticoagulants, and antihypertensive medications—to manage the multifactorial nature of CLI. This increasing preference for combination therapies is expected to drive sales growth.

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Analyst’s View

“The global critical limb ischemia treatment market is experiencing robust growth, owing to rising prevalence of peripheral artery disease (PAD), improved early diagnosis, and technological advancements in revascularization therapies and regenerative medicine,” said senior analyst Vipul Patil

Current Events and Their Impact on the Critical Limb Ischemia Treatment Market

Event	Description and Impact
FDA Fast-Tracking of Novel CLI Therapies	Description: The U.S. FDA has recently granted Fast Track status to several innovative CLI drugs, including cell-based regenerative therapies and gene-based interventions. Impact: Continuous approval for novel CLI therapies will likely boost growth of the critical limb ischemia treatment market.
Breakthrough Clinical Trial Results for Gene Therapy	Description: Positive Phase 2b results from companies like Helixmith and others for gene therapies targeting CLI show improved limb salvage rates. Impact: Adoption of gene therapy as a viable drug-based CLI treatment alternative is expected to create new growth opportunities for the target market.
AI Integration in CLI Diagnosis and Prognosis	Description: Health systems are increasingly using AI and machine learning to detect CLI earlier and stratify patients. Impact: This will likely improve diagnostic rate of CLI as well as help companies meet increasing demand for tailored CLI treatment options.

Competitor Insights

Key companies in critical limb ischemia treatment market research report

• AstraZeneca plc
• B. Braun Melsungen AG
• Boston Scientific Corporation
• Medtronic plc
• Abbott Laboratories
• Cook Medical Inc.
• Smith & Nephew plc
• Cordis Corporation
• Cardiovascular Systems, Inc.
• Philips Healthcare
• Sanofi S.A.
• Biotronik SE & Co. KG
• Stryker Corporation
• Bristol-Myers Squibb Company
• AngioDynamics, Inc.
• GE Healthcare
• Terumo Corporation
  

Key Developments

In May 2025, Penumbra launched STRIDE II clinical study to further evaluate its CAVT technology for lower extremity acute limb ischemia.

In April 2024, Abbott received U.S. FDA approval for its breakthrough dissolving stent, the Esprit BTK Everolimus Eluting Resorbable Scaffold System, designed to treat people with chronic limb‑threatening ischemia (CLTI) below the knee.

Market Segmentation

By Drugs

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

By Route of administration

• Oral
• Parentral
• Others
  

By End User

• Hospitals
• Specialty Clinics
• Ambulatory Surgery Centers
• Nursing Homes
• Others (Rehabilitation Centers, etc.)
  

By Region:

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East
• Africa

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