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critical limb ischemia market insight

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Critical Limb Ischemia Market Insight, Epidemiology and Market Forecast -2030

Published Date : 2021

Pages : 200

Region : United States, Japan, EU4 & UK

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critical limb ischemia market insight

DelveInsight’s ‘Critical Limb Ischemia (CLI)-Market Insights, Epidemiology, and Market Forecast–2030’ report deliver an in-depth understanding of the CLI, historical and forecasted epidemiology as well as the CLI market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The CLI market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM CLI market size from 2018 to 2030. The Report also covers current CLI treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

The United States
EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Japan

Study Period: 2018–2030

Critical Limb Ischemia (CLI) Disease Understanding and Treatment Algorithm

Critical limb ischemia (CLI) is a clinical syndrome of ischemic pain at rest and ischemic tissue loss such as nonhealing ulcers or gangrene, related to Peripheral artery disease (PAD) of the lower limbs. CLI is the end stage of PAD, and the macrovascular lesions induce a reduction of distal perfusion. Nutrient blood flow to the tissues and microcirculation exchange is severely altered in this condition.

The term “Critical limb ischemia” (CLI) is outdated and fails to encompass the full spectrum of patients who are evaluated and treated for limb-threatening ischemia in modern practice. Instead, the new term “Chronic limb-threatening ischemia” (CLTI) is proposed to include a broader and more heterogeneous group of patients with varying degrees of ischemia that can often delay wound healing and increase amputation risk.

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 (CLI) Diagnosis

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 (CLI).

Continued in the report…..

Critical Limb Ischemia (CLI) Treatment

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 (CLI) Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of CLI, Age-specific Diagnosed prevalent Cases of CLI, Severity-specific Diagnosed Prevalent Cases of CLI, and Diagnosed Prevalent Cases of No-option CLI in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2018 to 2030.

Key Findings

The total diagnosed prevalent population of CLI in seven major markets (7MM) was 2,053,158 cases in 2020.
The total diagnosed prevalent cases of CLI in the US, in 2020 was 1,073,553.
In 2020, there were 869,822 diagnosed prevalent cases of CLI in EU-5.
In the Epidemiology model of DelveInsight, we have considered six age groups for the estimation of total critical limb ischemia patient’s population i.e. 40-49 years, 50-59 years, 60-69 years, 70-79 years, 80-84 years, and ≥85 years
In 2020, the highest cases of critical limb ischemia were estimated among the population of age group 80-84 years (256,959) followed by 60-69 years (247,975) in the US.
As per the DelveInsight analysis, the total diagnosed prevalent cases of CLI in Japan were 109,783 in 2020.

Country-Wise Critical Limb Ischemia (CLI) Epidemiology

The epidemiology segment also provides the Critical Limb Ischemia (CLI) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

Critical Limb Ischemia (CLI) Drug Chapters

The drug chapter segment of the Critical Limb Ischemia (CLI) report encloses the detailed analysis of Critical Limb Ischemia (CLI) marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Critical Limb Ischemia (CLI) clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug and the latest news and press releases.

Critical Limb Ischemia (CLI) Marketed Drugs

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.

Products detail in the report…

Collategene: AnGes, Inc/Mitsubishi Tanabe Pharma

Collategene (HGF plasmid) is a regenerative medical product, and its main component is a plasmid DNA encoding the HGF gene of 5181 base pairs, containing the cDNA for HGF (Beperminogene Perplasmid). It is intended to treat CLI of arteriosclerosis obliterans (ASO) or Buerger’s disease. It was developed with an expectation of its pharmacological therapeutic effects, as with pharmaceuticals. Collategene administered by injection into muscles near the ischemic focus is expected to induce angiogenesis through HGF production/release and improve the ischemic state of the limb by increasing the number of blood vessels and blood flow. It is considered to exert its therapeutic effects in treating critical limb ischemia in patients with ASO or Buerger’s disease.

Products detail in the report…

Critical Limb Ischemia (CLI) Emerging Drugs

REX-001: Ixaka Ltd (formerly Rexgenero)

REX-001 is a composite multi-cell product that builds on the established biology of using cells from a patient’s bone marrow to treat CLTI. The product is an autologous bone-marrow-derived cell suspension enriched for white blood cells. It consists of a combination of progenitor cells and immune cells (lymphocytes, monocytes, granulocytes).

It is designed to address the complex disease processes (plaque deposition, inflammation, ischemia, vessel degeneration, ulcer formation) that lead to the clinical progression of CLTI.

Products detail in the report…

ACP-01: Hemostemix Inc

ACP-01, Hemostemix’s lead clinical candidate, is an autologous cell therapy to treat critical limb ischemia (CLI) 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.

Products detail in the report…

List to be continued in the report…

Critical Limb Ischemia (CLI) Market Outlook

Critical limb ischemia (CLI) 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.

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. 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. Collategene (HGF plasmid) is the only gene therapy received approval in Japan. Company is also targeting to enter in the US market. Apart from this many cell therapies are under development.

According to DelveInsight, the market of CLI in 7MM is expected to change in the study period 2018–2030.

Key Findings

The therapeutic market of CLI in the 7MM was USD 1,519 million in 2020.
The United States accounts for the highest market size of CLI approximately 72% of the total market size in 7MM with net revenue of USD 1,092 million in 2020, in comparison to the other major markets i.e., EU5 countries (the United Kingdom, Germany, Italy, France, and Spain), and Japan.
Among the EU5 countries, Germany had the highest market size with USD 119 million in 2020, while Spain had the lowest market size of CLI with USD 52 million in 2020.
The market size for CLI in Japan was estimated to be USD 45 Million in 2020, which accounts for 3% of the total 7MM market.
With the expected launch of upcoming therapies, such as REX-001, AMG0001 (beperminogene perplasmid), ACP-01, and Honedra (CLBS12) the total market of CLI is expected to show a decent change in upcoming years.

The United States Market Outlook

This section provides the total Critical Limb Ischemia (CLI) market size and; market size by therapies in the United States.

EU-5 Market Outlook

The total Critical Limb Ischemia (CLI) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Critical Limb Ischemia (CLI) market size and market size by therapies in Japan are provided.

Critical Limb Ischemia (CLI) Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the CLI market or expected to get launched in the market during the study period 2018–2030. The analysis covers CLI market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Critical Limb Ischemia (CLI) Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Critical Limb Ischemia (CLI) emerging therapies.

Reimbursement Scenario in Critical Limb Ischemia (CLI)

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the Critical Limb Ischemia (CLI) market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

The report covers the descriptive overview of CLI, explaining its signs and symptoms, causes, classification ,and currently available therapies.
Comprehensive insight has been provided into the CLI epidemiology and treatment.
Additionally, an all-inclusive account of both the current and emerging therapies for CLI is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
A detailed review of the CLI market; historical and forecasted is included in the report, covering the 7MM drug outreach.
The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM CLI market.

Report Highlights

The robust pipeline with novel MOA and oral ROA and increasing prevalence will positively drive the CLI market.
The companies and academics are working to assess challenges and seek opportunities that could influence CLI R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition and underlying cause.
Major players are involved in developing therapies for CLI. The launch of emerging therapies will significantly impact the CLI market.
Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Critical Limb Ischemia (CLI) Report Insights

Patient Population
Therapeutic Approaches
CLI Pipeline Analysis
CLI Market Size and Trends
Market Opportunities
Impact of upcoming Therapies

Critical Limb Ischemia (CLI) Report Key Strengths

10-Years Forecast
7MM Coverage
CLI Epidemiology Segmentation
Key Cross Competition
Highly Analyzed Market
Drugs Uptake

Critical Limb Ischemia (CLI) Report Assessment

Current Treatment Practices
Unmet Needs
Pipeline Product Profiles
Market Attractiveness
Market Drivers and Barriers
SWOT analysis

Key Questions

Market Insights:

What was the CLI’s market share (%) distribution in 2018 and how it would look like in 2030?
What would be the CLI’s total market size as well as market size by therapies across the 7MM during the forecast period (2021–2030)?
What are the key findings pertaining to the market across the 7MM and which country will have the largest CLI market size during the forecast period (2021–2030)?
At what CAGR, the CLI market is expected to grow at the 7MM level during the forecast period (2021–2030)?
What would be the CLI market outlook across the 7MM during the forecast period (2021–2030)?
What would be the CLI market growth till 2030 and what will be the resultant market size in the year 2030?
How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

What is the disease risk, burden, and unmet needs of CLI?
What is the historical CLI patient population in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
What would be the forecasted patient population of CLI at the 7MM level?
What will be the growth opportunities across the 7MM with respect to the patient population pertaining to CLI?
Out of the above-mentioned countries, which country would have the highest prevalent population of CLI during the forecast period (2021–2030)?
At what CAGR the population is expected to grow across the 7MM during the forecast period (2021–2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

What are the current options for the treatment of CLI along with the approved therapy?
What are the current treatment guidelines for the treatment of CLI in the US and Europe?
What are the CLI 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 CLI?
How many emerging therapies are in the mid-stage and late stages of development for the treatment of CLI?
What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the CLI 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 CLI and their status?
What are the key designations that have been granted for the emerging therapies for CLI?
What are the 7MM historical and forecasted market of CLI?

Reasons to buy

The report will help in developing business strategies by understanding trends shaping and driving the CLI.
To understand the future market competition in the CLI market and an Insightful review of the key market drivers and barriers.
Organize sales and marketing efforts by identifying the best opportunities for CLI in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
Organize sales and marketing efforts by identifying the best opportunities for the CLI market.
To understand the future market competition in the CLI market.

1. Key Insights

2. Report Introduction

3. Critical Limb Ischemia Market Overview at a Glance

3.1. Market Share (%) Distribution of Critical Limb Ischemia by Therapies in 2018

3.2. Market Share (%) Distribution of Critical Limb Ischemia by Therapies in 2030

4. Critical Limb Ischemia Market: Future Perspective

5. Executive Summary of Critical Limb Ischemia

6. Key Events

7. Critical Limb Ischemia: Disease Background and Overview

7.1. Introduction

7.2. Classification of Critical Limb Ischemia

7.3. Symptoms of Critical Limb Ischemia

7.4. Pathophysiology of Critical Limb Ischemia

7.5. Risk factors of Critical Limb Ischemia

7.6. Diagnosis of Critical Limb Ischemia

7.6.1. Diagnosis Algorithm of Critical Limb Ischemia

7.6.2. Diagnosis Recommendations of Critical Limb Ischemia

7.7. Treatment and Management of Critical Limb Ischemia

7.7.1. Treatment Algorithm of Critical Limb Ischemia

7.7.2. Treatment Guidelines of Critical Limb Ischemia

7.7.2.1. Global Vascular Guidelines

7.7.2.2. AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease

8. Epidemiology and Patient Population

8.1. Key Findings

8.2. Epidemiology Methodology

8.3. Assumptions and Rationale: 7MM

8.3.1. United States

8.3.2. Five Major European Countries (Germany, France, Italy, Spain, and the United Kingdom)

8.3.3. Japan

8.3.4. Impact of COVID-19 on Revascularization and Amputation

8.4. Total Diagnosed Prevalent Population of Critical Limb Ischemia in the 7MM

8.5. The United States

8.5.1. Diagnosed Prevalent Cases of Critical Limb Ischemia in the United States

8.5.2. Age-specific Diagnosed Prevalent cases of Critical Limb Ischemia in the United States

8.5.3. Severity-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in the United States

8.5.4. Diagnosed Prevalent Cases of No-option Critical Limb Ischemia in the United States

8.6. The Five European Countries (Germany, France, Italy, Spain, and the United Kingdom)

8.6.1. Diagnosed Prevalent Cases of Critical Limb Ischemia in EU-5

8.6.2. Age-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in EU-5

8.6.3. Severity-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in EU-5

8.6.4. Diagnosed Prevalent Cases of No-option Critical Limb Ischemia in EU-5

8.7. Japan

8.7.1. Diagnosed Prevalent Cases of Critical Limb Ischemia in Japan

8.7.2. Age-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in Japan

8.7.3. Severity-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in Japan

8.7.4. Diagnosed Prevalent Cases of No-option Critical Limb Ischemia in Japan

9. Patient Journey

10. Marketed drugs

10.1. Key Competitors

10.2. Ranger Drug-coated Balloon: Boston Scientific Corporation

10.2.1. Drug Description

10.2.2. Regulatory Milestones

10.2.3. Clinical Development

10.2.4. Clinical Trials Information

10.2.5. Safety and Efficacy

10.2.6. Product Profile

10.3. Collategene: AnGes, Inc/Mitsubishi Tanabe Pharma

10.3.1. Drug Description

10.3.2. Regulatory Milestones

10.3.3. Other Development activities

10.3.4. Clinical Development

10.3.5. Clinical Trials Information

10.3.6. Safety and Efficacy

10.3.7. Product Profile

10.3.8. Analysts’ Views

10.4. SeQuent Please OTW: B. Braun Melsungen AG

10.4.1. Drug Description

10.4.2. Regulatory Milestones

10.4.3. Other Development activities

10.4.4. Clinical Development

10.4.5. Clinical Trials Information

10.4.6. Safety and Efficacy

10.4.7. Product Profile

10.5. IN.PACT Admiral Drug-Coated Balloon: Medtronic Endovascular

10.5.1. Drug Description

10.5.2. Regulatory Milestones

10.5.3. Clinical Development

10.5.4. Clinical Trials Information

10.5.5. Safety and Efficacy

10.5.6. Product Profile

11. Emerging Drugs

11.1. Key Cross Competition

11.2. REX-001: Ixaka Ltd (formerly Rexgenero)

11.2.1. Product Description

11.2.2. Development activities

11.2.3. Clinical Development

11.2.4. Clinical Trials Information

11.2.5. Safety and Efficacy

11.2.6. Product Profile

11.2.7. Analysts’ Views

11.3. Temsirolimus Adventitial Delivery: Mercator MedSystems, Inc.

11.3.1. Product Description

11.3.2. Clinical Development

11.3.3. Clinical Trials Information

11.3.4. Safety and Efficacy

11.3.5. Product Profile

11.3.6. Analysts’ Views

11.4. ACP-01: Hemostemix Inc.

11.4.1. Product Description

11.4.2. Development activities

11.4.3. Clinical Development

11.4.4. Clinical Trials Information

11.4.5. Safety and Efficacy

11.4.6. Product Profile

11.4.7. Analysts’ Views

11.5. Honedra (CLBS12): Caladrius Biosciences

11.5.1. Product Description

11.5.2. Development activities

11.5.3. Clinical Development

11.5.4. Clinical Trials Information

11.5.5. Safety and Efficacy

11.5.6. Product Profile

11.5.7. Analysts’ Views

11.6. RJX (Rejuveinix): Reven Pharmaceuticals, Inc.

11.6.1. Product Description

11.6.2. Clinical Development

11.6.3. Clinical Trials Information

11.6.4. Safety and Efficacy

11.6.5. Product Profile

11.7. YQ23: New Beta Innovation Limited

11.7.1. Product Description

11.7.2. Clinical Development

11.7.3. Clinical Trials Information

11.7.4. Product Profile

11.8. BGC101: BioGenCell Ltd.

11.8.1. Product Description

11.8.2. Clinical Development

11.8.3. Clinical Trials Information

11.8.4. Safety and Efficacy

11.8.5. Product Profile

11.9. Esprit BTK Device: Abbott Medical Devices

11.9.1. Product Description

11.9.2. Development activities

11.9.3. Clinical Development

11.9.4. Clinical Trials Information

11.9.5. Product Profile

11.9.6. Analysts’ Views

12. Critical Limb Ischemia: Seven Major Market Analysis

12.1. Key Findings

12.2. Market Methodology

12.3. Market Size of Critical Limb Ischemia in the 7MM

12.4. Market Size of Critical Limb Ischemia by Therapies in the 7MM

12.5. Potential of Emerging Therapies

12.6. Key Market Forecast Assumptions

12.7. Attribute Analysis

12.8. Market Outlook

12.9. Market Size of Critical Limb Ischemia in the United States

12.9.1. Total Market Size of Critical Limb Ischemia

12.9.2. Market Size of Critical Limb Ischemia by Therapies

12.10. Market Size of Critical Limb Ischemia in the EU-5

12.10.1. Total Market Size of Critical Limb Ischemia

12.10.2. Market Size of Critical Limb Ischemia by Therapies

12.11. Market Size of Critical Limb Ischemia in Japan

12.11.1. Total Market Size of Critical Limb Ischemia

12.11.2. Market Size of Critical Limb Ischemia by Therapies

13. Key Opinion Leaders’ Views

14. Market Drivers

15. Market Barriers

16. SWOT Analysis

17. Unmet Needs

18. Reimbursement and Market Access

19. Appendix

19.1. Bibliography

19.2. Report Methodology

20. DelveInsight Capabilities

21. Disclaimer

22. About DelveInsight

List of Tables:

List of Table

Table 1: Summary of Critical Limb Ischemia Market and Epidemiology (2018–2030)

Table 2: Key Events

Table 3: Rutherford and Fontaine Classifications of Chronic Peripheral Arterial Disease Severity

Table 4: Wound grading in Wound, Ischemia, and Foot Infection (WIfI) Classification

Table 5: Foot infection grading in Wound, Ischemia, and foot Infection (WIfI) classification

Table 6: Ischemia grading in Wound, Ischemia, and foot Infection (WIfI) classification

Table 7: Comparison of methods of noninvasive testing in patients with Critical Limb Ischemia (CLI)

Table 8: Comparison of different imaging modalities for patients with chronic limb-threatening ischemia

Table 9: Recommendations for Diagnosis and limb staging in CLTI as per Global Vascular Guidelines

Table 10: Comparison of advantages and limitations of different types of stem cells

Table 11: Recommendations for Medical management of CLTI as per Global Vascular Guidelines

Table 12: ACC/AHA Recommendation System: Applying Class of Recommendation and Level of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care*

Table 13: Recommendation for Revascularizations for CLI

Table 14: Total Diagnosed Prevalent Cases of Critical Limb Ischemia in the 7MM (2018–2030)

Table 15: Diagnosed Prevalent Cases of Critical Limb Ischemia in the US (2018–2030)

Table 16: Age-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in the US (2018–2030)

Table 17: Severity-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in the US (2018–2030)

Table 18: Diagnosed Prevalent Cases of No-option Critical Limb Ischemia in the US (2018–2030)

Table 19: Diagnosed Prevalent Cases of Critical Limb Ischemia in EU-5 (2018–2030)

Table 20: Age-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in EU-5 (2018–2030)

Table 21: Severity-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in EU-5 (2018–2030)

Table 22: Diagnosed Prevalent Cases of No-option Critical Limb Ischemia in EU-5 (2018–2030)

Table 23: Diagnosed Prevalent Cases of Critical Limb Ischemia in Japan (2018–2030)

Table 24: Age-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in Japan (2018–2030)

Table 25: Severity-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in Japan (2018–2030)

Table 26: Diagnosed Prevalent Cases of No-option Critical Limb Ischemia in Japan (2018–2030)

Table 27: Comparison of Marketed Drugs Under Development

Table 28: Ranger Drug-Coated Balloon, Clinical Trial Description, 2021

Table 29: Collategene, Clinical Trial Description, 2021

Table 30: SeQuent Please OTW, Clinical Trial Description, 2021

Table 31: IN.PACT Admiral Drug Eluting Balloon, Clinical Trial Description, 2021

Table 32: Comparison of Emerging Drugs Under Development

Table 33: REX-001, Clinical Trial Description, 2021

Table 34: Temsirolimus adventitial delivery, Clinical Trial Description, 2021

Table 35: ACP-01, Clinical Trial Description, 2021

Table 36: Honedra (CLBS12), Clinical Trial Description, 2021

Table 37: RJX, Clinical Trial Description, 2021

Table 38: YQ23, Clinical Trial Description, 2021

Table 39: BGC101, Clinical Trial Description, 2021

Table 40: Esprit BTK Device, Clinical Trial Description, 2021

Table 41: Market Size of Critical Limb Ischemia in the 7MM, in USD Million (2018–2030)

Table 42: Market Size of Critical Limb Ischemia by Therapies in the 7MM, in USD Million (2018–2030)

Table 43: Key Market Forecast Assumptions for REX-001

Table 44: Key Market Forecast Assumptions for AMG0001 (beperminogene perplasmid)

Table 45: Key Market Forecast Assumptions for ACP-01

Table 46: Key Market Forecast Assumptions for CLBS12 (Honedra in Japan)

Table 47: United States Market Size of Critical Limb Ischemia in USD Million (2018–2030)

Table 48: Market Size of Critical Limb Ischemia by Therapies in the US, in USD Million (2018–2030)

Table 49: EU-5 Market Size of Critical Limb Ischemia in USD Million (2018–2030)

Table 50: Market Size of Critical Limb Ischemia by Therapies in Germany, in USD Million (2018–2030)

Table 51: Market Size of Critical Limb Ischemia by Therapies in France, in USD Million (2018–2030)

Table 52: Market Size of Critical Limb Ischemia by Therapies in Italy, in USD Million (2018–2030)

Table 53: Market Size of Critical Limb Ischemia by Therapies in Spain, in USD Million (2018–2030)

Table 54: Market Size of Critical Limb Ischemia by Therapies in the UK, in USD Million (2018–2030)

Table 55: Market Size of Critical Limb Ischemia by Therapies in the EU-5, in USD Million (2018–2030)

Table 56: Market Size of Critical Limb Ischemia in Japan, in USD Million (2018–2030)

Table 57: Market Size of Critical Limb Ischemia by Therapies in Japan, in USD Million (2018–2030)

Table 58: Coding and reimbursement guide for hospital outpatient

Table 59: Coding and reimbursement guide for hospital inpatient

Table 60: ICD-10 PCS CODES

List of Figures:

List of Figures

Figure 1: Pictorial representation of Critical Limb Ischemia

Figure 2: Stages of peripheral arterial disease as per Rutherford Classification

Figure 3: Symptoms of Critical Limb Ischemia

Figure 4: Pathophysiology of CLI

Figure 5: Risk factors of Critical Limb Ischemia (CLI)

Figure 6: Flow diagram for the investigation of patients presenting with suspected chronic limb-threatening ischemia (CLTI)

Figure 7: Algorithm for anatomic imaging in patients with CLTI who are candidates for revascularization

Figure 8: Overall goal of CLI treatment

Figure 9: Suggested algorithm for revascularization in patients with critical limb ischemia.

Figure 10: PLAN framework of clinical decision-making in chronic limb-threatening ischemia (CLTI)

Figure 11: Total Diagnosed Prevalent Cases of Critical Limb Ischemia in the 7MM (2018–2030)

Figure 12: Diagnosed Prevalent Cases of Critical Limb Ischemia in the US (2018–2030)

Figure 13: Age-specific Diagnosed prevalent Cases of Critical Limb Ischemia in the US (2018–2030)

Figure 14: Severity-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in the US (2018–2030)

Figure 15: Diagnosed Prevalent Cases of No-option Critical Limb Ischemia in the US (2018–2030)

Figure 16: Diagnosed Prevalent Cases of Critical Limb Ischemia in EU-5 (2018–2030)

Figure 17: Age-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in EU-5 (2018–2030)

Figure 18: Severity-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in EU-5 (2018–2030)

Figure 19: Diagnosed Prevalent Cases of No-option Critical Limb Ischemia in EU-5 (2018–2030)

Figure 20: Diagnosed Prevalent Cases of Critical Limb Ischemia in Japan (2018–2030)

Figure 21: Age-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in Japan (2018–2030)

Figure 22: Severity-specific Diagnosed Prevalent Cases of Critical Limb Ischemia in Japan (2018–2030)

Figure 23: Diagnosed Prevalent Cases of No-option Critical Limb Ischemia in Japan (2018–2030)

Figure 24: Market Size of Critical Limb Ischemia in the 7MM, in USD Million (2018–2030)

Figure 25: Market Size of Critical Limb Ischemia by Therapies in the 7MM in USD Million (2018–2030)

Figure 26: Market Size of Critical Limb Ischemia in the United States, USD Millions (2018–2030)

Figure 27: Market Size of Critical Limb Ischemia by Therapies in the United States, in USD Million (2018–2030)

Figure 28: Market Size of Critical Limb Ischemia in the EU-5, USD Millions (2018–2030)

Figure 29: Market Size of Critical Limb Ischemia by Therapies, in the EU5, in USD Million (2018–2030)

Figure 30: Market Size of Critical Limb Ischemia in Japan, USD Millions (2018–2030)

Figure 31: Market Size of Critical Limb Ischemia by Therapies in Japan, in USD Million (2018–2030)

Figure 32: Market Drivers

Figure 33: Market Barriers

Figure 34: SWOT Analysis

Figure 35: Unmet Needs

Figure 36: ICD codes by the type of vessel

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