Critical Limb Ischemia Market

• According to DelveInsight’s estimates, the total diagnosed prevalent cases of Critical Limb Ischemia in the 7MM were estimated to be ~2,439 thousand cases in 2023, the number of these cases are expected to increase by 2034.
• In 2023, the Critical Limb Ischemia Market Size was highest in the US among the 7MM, accounting for approximately USD 1,367 million which is further expected to increase by 2034.
• Various Critical Limb Ischemia Drugs are employed to treat Critical Limb Ischemia, currently used therapies includes standard of care, Ranger Drug-coated Balloon, SeQuent Please OTW, and Others. Among these, Standard of care had the highest market share in 2023, accounting for approximately USD 1,845 million in the 7MM, according to our analysis.
• Other than standard of care, Collategene was distributed by Mitsubishi Tanabe Pharma Corporation since September 2019, was marketed based on the conditional and time-limited marketing approval by AnGes in Japan.
• As of June 2024, AnGes has drawn the manufacturing and marketing approval application that was to be refiled after the conditional and time-limited marketing approval. The expiration date of the current conditional and time-limited marketing approval is expired, and the distribution of Collategene is also discontinued.
• The emerging drug ACP-01 is expected to launch in the US by 2026, in EU4 and the UK by 2027, and in Japan by 2028, which has the potential to reduce the disease burden of Critical Limb Ischemia in the forecasted years.

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DelveInsight’s “Critical Limb Ischemia Market Insights, Epidemiology, and Market Forecast – 2034” report deliver an in-depth understanding of the Critical Limb Ischemia, historical and forecasted epidemiology as well as the Critical Limb Ischemia market trends in the United States, EU4 and the UK (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

The Critical Limb Ischemia Treatment Market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Critical Limb Ischemia market size from 2020 to 2034. The Report also covers current Critical Limb Ischemia treatment market practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and Critical Limb Ischemia unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Study Period	2020 to 2034
Forecast Period	2024-2034
Geographies Covered	The US EU4 (Germany, France, Italy, and Spain) UK Japan
Critical Limb Ischemia Market	Total Critical Limb Ischemia Market Size Critical Limb Ischemia Market Size by Therapies Critical Limb Ischemia Market Size by Class
Critical Limb Ischemia Market Size	USD 51 Million in 2023 (Japan)
Critical Limb Ischemia Companies	Boston Scientific Corporation, Cesca Therapeutics Inc,. Abbott Laboratories, Pluristem Therapeutics Inc., Rexgenero Ltd, LimFlow SA, Micro Medical Solutions, Cardiovascular Systems, Inc., and others.

Critical Limb Ischemia Treatment Market

Critical Limb Ischemia is a severe obstruction of the arteries that markedly reduces blood flow to the extremities (hands, feet, and legs) and has progressed to the point of severe pain and even skin ulcers or sores. Critical Limb Ischemia is the advanced stage of peripheral arterial disease (PAD), which results from a progressive thickening of an artery’s lining (caused by a buildup of plaque). This buildup of plaque, also known as atherosclerosis, narrows or blocks blood flow, reducing blood circulation to the legs, feet, or hands.

The risk factors for Critical Limb Ischemia include age (men over 60 and women after menopause), smoking, diabetes, overweight or obesity, sedentary lifestyle, high cholesterol, high blood pressure, and family history of vascular disease. Warning signs of Critical Limb Ischemia can be severe pain or numbness in the legs and feet while resting, toe or foot sores, infections, or ulcers that will not heal or heal very slowly, a noticeable decrease in the temperature of lower leg or foot, gangrene, thickening of the toenails, absent or diminished pulse in the legs or feet, and shiny, smooth, dry skin in the legs or feet.

The Rutherford categorization has classically defined CLI as rest pain (class 4), tissue loss (class 5), and/or gangrene (class 6). Alternatively, the Fontaine classification labels rest pain as class 3 and tissue loss or gangrene as class 4.

Critical Limb Ischemia Diagnosis

The condition can be diagnosed by Ankle-brachial index (ABI), Auscultation, Doppler Ultrasound, CT angiography, magnetic resonance angiography, angiogram, and others. Ischemic rest pain usually affects the forefoot, is frequently worse at night, and often requires opiate analgesia for management. If present for >2 weeks and combined with hemodynamic evidence of severely impaired perfusion (e.g., absolute AP <50 mm Hg, absolute TP <30 mm Hg), it is diagnostic of Critical Limb Ischemia.

Critical Limb Ischemia Treatment

CLI treatment can be complicated and individualized, but the primary goal is to ease pain and restore blood flow in order to save the leg. The current treatment strategies include endovascular revascularization, surgical revascularization, and primary amputation, and endovascular revascularization is a fundamental strategy to limb preservation. Common endovascular techniques include Angioplasty (plain balloon, drug-eluting), Stenting (bare metal, drug-eluting), and Atherectomy. Other than to surgical approaches, therapeutic angiogenesis can be achieved by gene and cell therapy. It has raised hope for patients who cannot undergo standard revascularization treatment.

Critical Limb Ischemia Epidemiology

As the market is derived using a patient-based model, the Critical Limb Ischemia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, Diagnosed Prevalent Cases of Critical Limb Ischemia, Gender-specific Diagnosed Prevalent Cases of Critical Limb Ischemia, Age-specific Diagnosed Prevalent Cases of Critical Limb Ischemia, and Severity-specific Diagnosed Prevalent Cases of Critical Limb Ischemia, in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

• The highest total diagnosed prevalent cases of Critical Limb Ischemia were accounted by US in 2023 (~1,341 thousand), which are expected to show a rise in the future.
• Among the European countries, Germany had the highest diagnosed prevalent cases of Critical Limb Ischemia with ~311 thousand cases, followed by Italy, which had diagnosed prevalent population of ~202 thousand in 2023. On the other hand, Spain had the lowest prevalent population (~131 thousand cases).
• Japan had ~122 thousand total diagnosed prevalent cases of Critical Limb Ischemia in 2023, accounting for approximately 5% in 7MM.
• In 2023, in the US, the age-specific diagnosed prevalent cases of Critical Limb Ischemia were highest for age group 80–84 (~321 thousand), followed by 60–69 (~310 thousand), 50–59 (~263 thousand), =84 (~169 thousand), 70–79 (~159 thousand), and 50–59 (~119 thousand).
• In 2023, in Japan, the severity-specific diagnosed prevalent cases of Critical Limb Ischemia were highest for Rutherford 5 (~79 thousand), followed by Rutherford 4 (~26 thousand), and Rutherford 6 (~17 thousand).

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Critical Limb Ischemia Drug Chapters

The drug chapter segment of the Critical Limb Ischemia drugs market report encloses a detailed analysis of Critical Limb Ischemia off-label drug and late-stage (Phase-III and Phase-II) Critical Limb Ischemia pipeline drugs. It also helps to understand the Critical Limb Ischemia clinical trials details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest Critical Limb Ischemia news and press releases.

Critical Limb Ischemia Marketed Products

• Ranger Drug-coated Balloon: Boston Scientific Corporation

The Ranger Paclitaxel-coated PTA Balloon Catheter (Ranger DCB) uses a drug-coated balloon to reopen blocked or narrowed arteries in the thigh and knee due to peripheral artery disease (PAD), specifically in Rutherford classification 2, 3, or 4. The balloon is coated on its outer surface with paclitaxel, a drug that may help stop the arteries from narrowing again (restenosis).

The Ranger DCB is used when arteries in the thigh and knee are narrowed or blocked due to PAD. PAD occurs when fatty material (plaque) builds up in these arteries, which can cause hardening and/or narrowing of the arteries (atherosclerosis), limiting the flow of oxygen-rich blood to the body. People with PAD may experience lifestyle-limiting symptoms, such as leg pain or serious complications, including skin ulcers or gangrene.

Critical Limb Ischemia Emerging Drugs

• ACP-01: Hemostemix Inc.

ACP-01, Hemostemix’s lead clinical candidate, is an autologous cell therapy to treat Critical Limb Ischemia in patients facing amputation.

ACP-01 consists of cells that are derived from the patient’s blood and are modified with Hemostemix’s technology that primes them to form new blood vessels. These cells, known as angiogenic cell precursors, or ACPs, secrete growth factors and cytokines that support the formation of blood vessels through vasculogenesis and angiogenesis. Factors secreted by ACPs also facilitate the recruitment of additional progenitor cells to promote the healing of damaged tissues. When these cells are injected into the dying leg muscle of the same patient with critical limb ischemia, they support the regeneration of new small blood vessels and may prevent amputations.

The Phase II trial for ACP-01 was completed by 2020, while the drug is still in company’s pipeline for the treatment of CLI. In February 2024, Hemostemix Inc. announced the publication of their Phase II trial results for ACP-01 in the Journal of Biomedical Research and Environmental Sciences. The study on no-option Critical Limb Ischemia patients showed significant ulcer reduction and lower amputation and mortality rates in the treatment group compared to the placebo group.

• HONEDRA (LSTA12) (Japan): Lisata Therapeutics

HONEDRA®, an experimental regenerative medicine, is the Lisata’s SAKIGAKE-designated product candidate for the treatment of Chronic Limb Ischemia and Buerger’s disease in Japan. Its goal is to prevent the serious adverse consequences of CLI and Buerger’s disease by improving blood flow in the affected limb. Lisata’s randomized and open-label, registration-eligible study of HONEDRA in Japan for the treatment of CLI and Buerger’s disease, diseases with limited therapeutic options, has shown promising results to date. The initial clinical responses are consistent with a positive therapeutic effect and safety profile and are consistent with previously published clinical trials of CD34+ cell therapy in Japan and elsewhere. The Company is conducting ongoing discussions with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) as to what needs to be considered in preparation for the formal consultation meetings which precede the Japanese new drug application. Simultaneously, the Company is focusing its efforts on securing a Japanese partner to complete the remaining steps to produce registration in Japan. Currently it is in Phase II of clinical development.

Further detail in the report...

Critical Limb Ischemia Market Outlook

Critical Limb Ischemia is a clinical syndrome of ischemic pain at rest or tissue loss, such as non-healing ulcers or gangrene, related to peripheral artery disease (PAD). CLI has a high short-term risk of limb loss and cardiovascular events. The clinical presentation of CLI depends on the degree of ischemia, the presence of infection, and coexisting neuropathy. The primary goal is to preserve limb function. Revascularization is a fundamental strategy to limb preservation, but this does not improve limb function and mobility in some patients.

Critical Limb Ischemia treatment can be complicated and individualized, but the primary goal is to ease pain and restore blood flow in order to save the leg. The current Critical Limb Ischemia treatment strategies include endovascular revascularization, surgical revascularization, and primary amputation, and endovascular revascularization is a fundamental strategy to limb preservation. Other than to surgical approaches, the therapeutic angiogenesis can be achieved by gene and cell therapy. It has raised hope for patients who cannot undergo standard revascularization treatment. Some cell therapies are under development.

• According to DelveInsight, the Critical Limb Ischemia Therapeutics Market in 7MM is expected to change in the study period 2020–2034.
• The United States accounted for the highest Critical Limb Ischemia Market Size approximately 74% of the total market size in 7MM in 2023, in comparison to the other major markets i.e., EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
• Among the European countries, Germany had the highest Critical Limb Ischemia market size with nearly USD 136 million in 2023, while Spain had the lowest market size of Critical Limb Ischemia with USD 58 million in 2023.
• The Critical Limb Ischemia Market Size in Japan was estimated to be USD 51 million in 2023, which accounts for 3% of the total 7MM market.
• With the expected launch of upcoming therapies, such as ACP-01 the total Critical Limb Ischemia Market Size is expected to show change in the upcoming years.

Critical Limb Ischemia Drugs Uptake

This section focuses on the uptake rate of potential Critical Limb Ischemia drugs expected to launch in the market during 2020–2034. For example, ACP-01 in the US is expected to be launched by 2026 with a peak shared of 3%. ACP-01 is anticipated to take 7 years to peak with a medium uptake.

Critical Limb Ischemia Pipeline Development Activities

The Critical Limb Ischemia therapeutics market report provides insights into different Critical Limb Ischemia clinical trials within Phase III, Phase II, and Phase I stage. It also analyzes key Critical Limb Ischemia Companies involved in developing targeted therapeutics.

Pipeline Development Activities

The Critical Limb Ischemia therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Critical Limb Ischemia emerging therapies.

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KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Critical Limb Ischemia evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from Fireman Vascular Center, Massachusetts General Hospital, Boston, US; Massachusetts General Hospital, Boston, Massachusetts, US; Yale University School of Medicine, New Haven, CT, US; University of Miami Miller School of Medicine, Miami, FL, US; Gefässzentrum, Asklepios Westklinikum Hamburg, Germany; University Hospital Muenster, A1, 48149 Muenster, Germany; University of Palermo, Palermo, Italy; University of Catanzaro, Catanzaro, Italy; Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan; Department of Surgery, the University of Tokyo, Tokyo, Japan, and others.

Delveinsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Critical Limb Ischemia market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Critical Limb Ischemia Drugs Market: Qualitative Analysis

We perform Qualitative and Critical Limb Ischemia Drugs Market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Critical Limb Ischemia Treatment Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment. The Critical Limb Ischemia treatment market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Critical Limb Ischemia Treatment Market Report Scope

• The Critical Limb Ischemia therapeutics market report covers a segment of key events, an executive summary, descriptive overview, explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the Critical Limb Ischemia epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Critical Limb Ischemia drugs market, historical and forecasted Critical Limb Ischemia treatment market size, Critical Limb Ischemia market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
• The Critical Limb Ischemia treatment market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Critical Limb Ischemia drugs market.

Critical Limb Ischemia Treatment Market Report Insights

• Critical Limb Ischemia Patient Population
• Critical Limb Ischemia Therapeutic Approaches
• Critical Limb Ischemia Pipeline Analysis
• Critical Limb Ischemia Market Size and Trends
• Existing and Future Critical Limb Ischemia Drugs Market Opportunity

Critical Limb Ischemia Treatment Market Report Key Strengths

• 11 years Critical Limb Ischemia Market Forecast
• The 7MM Coverage
• Critical Limb Ischemia Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Critical Limb Ischemia Drugs Uptake
• Key Critical Limb Ischemia Market Forecast Assumptions

Critical Limb Ischemia Treatment Market Report Assessment

• Current Critical Limb Ischemia Treatment Market Practices
• Critical Limb Ischemia Unmet Needs
• Critical Limb Ischemia Pipeline Product Profiles
• Critical Limb Ischemia Drugs Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Critical Limb Ischemia Market Drivers
• Critical Limb Ischemia Market Barriers

Key Questions

Critical Limb Ischemia Treatment Market Insights

• What was the Critical Limb Ischemia drugs market share (%) distribution in 2020 and how it would look like in 2034?
• What would be the Critical Limb Ischemia market size as well as market size by therapies across the 7MM during the forecast period (2024–2034)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Critical Limb Ischemia market size during the forecast period (2024–2034)?
• At what CAGR, the Critical Limb Ischemia drugs market is expected to grow at the 7MM level during the forecast period (2024–2034)?
• What would be the Critical Limb Ischemia market outlook across the 7MM during the forecast period (2024–2034)?
• What would be the Critical Limb Ischemia market growth till 2034 and what will be the resultant market size in the year 2034?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Critical Limb Ischemia Epidemiology Insights

• What is the disease risk, burden, and Critical Limb Ischemia Unmet Needs?
• What is the historical Critical Limb Ischemia patient population in the United States, EU4 (Germany, France, Italy, Spain) and the UK, and Japan?
• What would be the forecasted patient population of Critical Limb Ischemia at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Critical Limb Ischemia?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Critical Limb Ischemia during the forecast period (2024–2034)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2024–2034)?

Current Critical Limb Ischemia Treatment Market Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Critical Limb Ischemia along with the approved therapy?
• What are the current treatment guidelines for the treatment of Critical Limb Ischemia in the US, EU4 and the UK, And Japan?
• What are the Critical Limb Ischemia marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Critical Limb Ischemia?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Critical Limb Ischemia?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Critical Limb Ischemia therapies?
• What are the recent therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Critical Limb Ischemia and their status?
• What are the key designations that have been granted for the emerging therapies for Critical Limb Ischemia?
• What are the 7MM historical and forecasted market of Critical Limb Ischemia?

Reasons to Buy

• The Critical Limb Ischemia treatment market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Critical Limb Ischemia Drugs Market.
• Insights on patient burden/disease Critical Limb Ischemia Incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing Critical Limb Ischemia Drugs Market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the Critical Limb Ischemia Drugs Market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and potential of current and emerging therapies under the conjoint analysis section to provide visibility around leading emerging drugs.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in future.
• Detailed insights on the unmet need of the existing Critical Limb Ischemia Drugs Market so that the upcoming players can strengthen their development and launch strategy.

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