Critical Limb Ischemia (CLI) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Critical Limb Ischemia (CLI) Market Outlook

Thelansis’s “Critical Limb Ischemia (CLI) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Critical Limb Ischemia treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Critical Limb Ischemia (CLI) Overview

Critical limb ischemia (CLI) represents the most severe manifestation of peripheral artery disease, characterized by chronic ischemic rest pain, ulceration, or gangrene due to peripheral arterial vessel occlusion. Diagnosis of CLI relies on clinical assessments, including the ankle-brachial index (ABI), toe systolic pressure, and transcutaneous oxygen pressure (TcPO2). CLI diagnosis is confirmed when ischemic rest pain coexists with an ankle pressure <50 mmHg or a toe pressure <30 mmHg, or in patients with foot ulcers or gangrene exhibiting an ankle pressure <70 mmHg, a toe systolic pressure <50 mmHg, or TcPO2 <30 mmHg. CLI typically arises from multi-segmental peripheral artery disease, resulting in compromised blood flow to peripheral tissues. Concurrent impairment in cardiac output can exacerbate peripheral perfusion in CLI patients. Diminished tissue oxygenation and nutrition may lead to claudication or rest pain, although these symptoms may be attenuated or absent in diabetic patients with neuropathy. Diabetic CLI patients often present with distal arterial lesions below the knee (BTK), with ulceration, necrosis, or gangrene being the initial signs of PAD. Chronic critical limb ischemia culminates from arterial occlusive disease, primarily atherosclerosis, often in conjunction with hypertension, hypercholesterolemia, smoking, or diabetes. Less common causes include Buerger's disease (thromboangiitis obliterans) and certain arteritis forms. The overarching objective of CLI management is to alleviate pain, facilitate wound healing, enhance patient functionality, avert limb amputation, and decrease mortality. Lower limb revascularization is the frontline treatment for CLI patients deemed suitable for the procedure. However, in select cases where patients have multiple comorbidities or a low likelihood of successful revascularization, primary amputation may be necessary.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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