Critical Limb Ischemia Treatment Market to Reach Up to US$ 10.02 Billion by 2032 at 7.2%-9.17% CAGR, Led by North America's 38% Share and Key Players Medtronic, Boston Scientific & Abbott

The Global Critical Limb Ischemia (CLI) Treatment Market is witnessing steady expansion, projected to grow from US$ 4.09 billion to US$ 5.55 billion in 2025, and further reach US$ 8.49 billion to US$ 10.02 billion by 2032, reflecting a CAGR between 7.2% and 9.17% over the forecast period. Market growth is being driven by the rising burden of chronic diseases such as diabetes and peripheral artery disease, along with the increasing proportion of elderly patients who are more susceptible to advanced vascular complications.

The CLI treatment landscape includes devices, drugs, and surgical interventions, with medical devices-especially peripheral dilatation systems-capturing a substantial share of the market due to their effectiveness in restoring blood flow and reducing the need for amputation. The shift toward minimally invasive endovascular procedures, growing clinical adoption of advanced revascularization technologies, and improved access to vascular care are further supporting market expansion. As healthcare systems prioritize limb-saving treatments and early intervention strategies, the market is positioned for sustained long-term growth.

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Critical Limb Ischemia (CLI) Treatment refers to the medical therapies and procedures used to restore blood flow, manage pain, and prevent limb loss in patients with severe arterial blockage in the legs.

Key Developments

United States
✅ September 2023: The LimFlow percutaneous deep vein arterialization system received U.S. FDA approval for patients with chronic limb-threatening ischemia (CLTI) who have no suitable endovascular or surgical revascularization options.

Japan
✅ June 2025: A national study reported regional disparities in incidence, treatment approaches, and in-hospital outcomes for chronic limb ischemia across Japanese prefectures, highlighting gaps in access and variability in care.

✅ October 2025: MEDINET Japan signed an option/license agreement with Stempeutics (India) for Stempeucel, an autologous/allogeneic stem-cell therapy for CLTI; the pact covers development and potential commercialization in Japan, pending regulatory clearance.

Mergers & Acquisitions

United States
✅ November 2023: LimFlow announced an agreement to be acquired by an interventional/commercial partner.

Japan
✅ October 2025: MEDINET Japan and Stempeutics signed the option licence agreement for Stempeucel in Japan.

Key Players:
Medtronic plc | Boston Scientific Corporation | Abbott (Cardiovascular Systems, Inc.) | Inari Medical | Koninklijke Philips N.V. | Lisata Therapeutics | Cook Medical | Baxter | B. Braun Melsungen AG | Biotronik SE & Co. KG

Key Highlights :
• Medtronic plc - Holds 18.7% market share, driven by its strong portfolio of endovascular devices, drug-coated balloons, and stent systems for peripheral artery disease and CLI management.

• Boston Scientific Corporation - Accounts for 16.4% share, supported by innovative atherectomy devices, angioplasty solutions, and expanding minimally invasive vascular treatment technologies.

• Abbott (Cardiovascular Systems, Inc.) - Maintains 14.9% share, propelled by leading atherectomy systems, vascular imaging technologies, and comprehensive peripheral intervention solutions.

• Inari Medical - Holds 11.3% share, backed by rapid adoption of its mechanical thrombectomy and clot management systems used in severe CLI and related vascular conditions.

• Koninklijke Philips N.V. - Contributes 9.6% share, driven by advanced intravascular imaging (IVUS), hemodynamic monitoring systems, and image-guided therapy platforms.

• Baxter - Holds 7.8% share, supported by its wound care solutions, advanced therapeutic devices, and regenerative treatment technologies relevant to CLI management.

• Cook Medical - Accounts for 6.4% share, fueled by its angioplasty catheters, stents, guidewires, and peripheral intervention devices.

• B. Braun Melsungen AG - Maintains 5.2% share, backed by vascular access devices, infusion systems, and specialized surgical solutions used in CLI care.

• Biotronik SE & Co. KG - Holds 4.1% share, driven by its vascular stents, drug-eluting technologies, and advanced endovascular solutions.

• Lisata Therapeutics - Contributes 2.6% share, supported by ongoing clinical development of regenerative and cell-based therapies targeted at no-option CLI patients.

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Market Drivers
• Rising prevalence of peripheral arterial disease (PAD), driven by diabetes, hypertension, and obesity, is significantly increasing demand for CLI treatment solutions.

• Growing aging population worldwide is boosting the need for minimally invasive revascularization procedures and advanced wound care technologies.

• Increasing adoption of drug-coated balloons, stents, and atherectomy devices is improving treatment outcomes and supporting market expansion.

• Advancements in cell therapy, regenerative medicine, and angiogenesis-based therapies are creating new growth opportunities for CLI treatment.

• Higher rates of ulcers, tissue necrosis, and chronic non-healing wounds are accelerating the use of advanced wound dressings, biologics, and hyperbaric oxygen therapy.

• Rising preference for outpatient and catheter-based interventions is reducing hospitalization time and boosting procedural volumes.

Industry Developments
• September 2025 (US): Medical device manufacturers introduced next-generation drug-eluting peripheral stents designed to reduce restenosis and improve long-term limb salvage rates.

• July 2025 (Germany): Clinical research centers initiated multicenter trials evaluating the effectiveness of stem cell-based vascular regeneration therapies for advanced CLI cases.

• May 2025 (Japan): Hospitals adopted advanced imaging systems integrating real-time perfusion mapping to optimize treatment planning for critical limb ischemia.

• March 2025 (UK): Healthcare providers expanded the use of hybrid peripheral procedures combining atherectomy and drug-coated balloon angioplasty for improved revascularization outcomes.

Regional Insights
• North America: US$ 1.9 billion with 38 percent share
Growth is driven by "high prevalence of diabetes and PAD, strong adoption of minimally invasive vascular procedures, and advanced hospital infrastructure supporting complex CLI interventions."

• Europe: US$ 1.5 billion with 30 percent share
Expansion is supported by "strong clinical adoption of revascularization technologies, rising geriatric population, and widespread reimbursement for advanced wound care and peripheral interventions."

• Asia Pacific: US$ 1.2 billion with 24 percent share
Growth is fueled by "rapid rise in diabetes-linked ischemic conditions, improving access to vascular specialists, and growing investment in modern catheterization labs across emerging economies."

• Latin America: US$ 0.3 billion with 6 percent share
Demand is increasing due to "increasing burden of chronic wounds, growing availability of endovascular treatment options, and expanding public healthcare programs addressing PAD."

• Middle East and Africa: US$ 0.1 billion with 2 percent share
Growth is supported by "rising incidence of diabetes-related foot complications, increasing focus on limb preservation clinics, and gradual improvement in vascular care infrastructure."

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Key Segments

➥ By Treatment Type
Drug class treatments dominate the market as they remain the primary therapeutic approach for managing symptoms, controlling disease progression, and improving patient outcomes across various conditions. Devices are increasingly adopted for targeted, minimally invasive, and long-term management solutions, offering enhanced precision and patient compliance. Other treatment types include emerging therapeutic modalities and supportive care methods that complement conventional treatment strategies.

➥ By End-User
Hospitals & specialty clinics lead due to advanced infrastructure, availability of skilled specialists, and higher patient inflow for diagnosis and comprehensive treatment. Ambulatory surgical centers (ASCs) are growing steadily as they offer cost-effective, efficient, and minimally invasive procedures with shorter recovery times. Other end-users include outpatient facilities and homecare settings that support ongoing monitoring and less intensive treatment needs.

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