How are companies such as Ixaka Ltd, Hemostemix, Caladrius Biosciences, and others influencing the Critical Limb Ischemia market?

LAS VEGAS, CALIFORNIA, UNITED STATES OF AMERICA, March 22, 2024 /EINPresswire.com/ -- The total market size of Critical Limb Ischemia in the 7MM was USD 1.7 billion in 2022 and is projected to grow during the forecast period (2023–2032) due to an increase in the diagnosed prevalent population of Critical Limb Ischemia along with the expected launch of emerging therapies such as REX-001 (Ixaka Ltd), ACP-01 (Hemostemix Inc.), Honedra (Caladrius Biosciences), and others.

DelveInsight’s Critical Limb Ischemia epidemiology-based market forecast report includes a comprehensive understanding of these market drivers and how they will impact the overall Critical Limb Ischemia market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].

Key Takeaways from the Critical Limb Ischemia Market Report

As per the DelveInsight assessment, the diagnosed prevalent cases of Critical Limb Ischemia in the 7MM were approximately 2 million in 2020.

Assessments as per DelveInsight’s analysts show that among EU-5 countries, the highest diagnosed prevalent cases of CLI were reported in Germany followed by Italy and France, in 2020.

In 2020, there were 34% of diagnosed prevalent cases of CLI were of Rutherford class 4, and 45% cases were of Rutherford class 5.

Critical Limb Ischemia companies including Ixaka Ltd (REX-001), Hemostemix Inc. (ACP-01), Caladrius Biosciences (Honedra), and others are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for the treatment of Critical Limb Ischemia.

Critical Limb Ischemia Market Dynamics

Critical Limb Ischemia (CLI) represents a significant challenge in healthcare due to its potential for severe complications such as amputation and mortality. The market dynamics surrounding CLI have been evolving as a result of various factors. One key driver is the increasing prevalence of diabetes and vascular diseases, which are major risk factors for CLI. The aging population in many parts of the world also contributes to the rising incidence of CLI, creating a larger patient pool in need of treatment.

Additionally, advancements in medical technology have spurred market growth, with the development of innovative therapies such as drug-eluting stents, bioresorbable stents, and minimally invasive procedures. These technologies offer more effective and less invasive treatment options for CLI patients, driving demand in the market. Moreover, there has been a growing focus on early diagnosis and intervention, leading to increased awareness among healthcare professionals and patients alike. This shift towards proactive CLI management is expected to further fuel market expansion as it reduces the overall healthcare burden associated with advanced stages of the disease, improving patient outcomes and quality of life.

Download the report to understand which factors are driving Critical Limb Ischemia market trends @ Critical Limb Ischemia Market Insights

Critical Limb Ischemia Treatment Market

Management of CLI often involves a multifaceted approach, with the primary goal of restoring blood flow to the affected limb. This typically begins with lifestyle modifications such as smoking cessation and maintaining a healthy diet. Medications, such as antiplatelet agents and anticoagulants, are commonly prescribed to reduce blood clotting and improve circulation. Additionally, minimally invasive procedures like angioplasty and stenting can be utilized to open blocked arteries and enhance blood flow. In more advanced cases, surgical options such as bypass grafting may be necessary to reroute blood around the blockage, thereby salvaging the limb.

Close monitoring and follow-up care are integral aspects of CLI treatment, as the condition requires ongoing management to prevent recurrence and monitor for potential complications. Patients often undergo rehabilitation programs to improve mobility and reduce the risk of further vascular issues. In severe instances where limb preservation is not feasible, amputation may be considered as a last resort. Through a combination of medical therapies, interventions, and lifestyle adjustments, clinicians strive to improve quality of life, enhance limb function, and mitigate the serious consequences associated with Critical Limb Ischemia.

Emerging Critical Limb Ischemia Therapies and Key Companies

Some of the drugs in the Critical Limb Ischemia pipeline include REX-001 (Ixaka Ltd), ACP-01 (Hemostemix Inc.), Honedra (Caladrius Biosciences), and others.

REX-001 represents an innovative composite product comprising various cells, leveraging the known therapeutic potential of utilizing a patient's own bone marrow cells to manage CLTI. This product consists of a bone marrow-derived cell suspension rich in white blood cells, including progenitor cells and immune cells such as lymphocytes, monocytes, and granulocytes. Its purpose is to target the intricate disease mechanisms—such as plaque buildup, inflammation, ischemia, vessel deterioration, and ulcer formation—that drive the advancement of CLTI clinically.
The development of REX-001 aims to create a personalized cellular immunotherapy, delivering a mix of immune and progenitor cells directly to the affected blood vessels in the lower leg. Currently undergoing a Phase III clinical trial across multiple sites, REX-001 shows promise for the treatment of CLTI.

Hemostemix's primary clinical candidate, ACP-01, represents an autologous cell therapy, which is ready for use within 7 days of collection. This treatment is aimed at addressing Critical Limb Ischemia (CLI) in individuals at risk of amputation. ACP-01 serves the pressing need for novel, minimally invasive, and cost-effective alternatives to surgery for CLI patients, offering a ray of hope for those facing limb loss. The company acknowledges the widespread industry recognition of CLI as a condition with significant unmet needs, while holding the belief that innovative cellular therapies have the potential to revolutionize the treatment landscape for severe illnesses, reshaping medical practices for the better. Moreover, Hemostemix sees robust government and public backing for regenerative medicine as a potential driver for increased investment in biotechnology. Currently, ACP-01 is undergoing Phase II clinical trials.

SAKIGAKE has labeled Honedra (previously named CLBS12) by Caladrius Biosciences as yet another regenerative treatment in its mid-stage of development. This therapy involves CD34+ cells and is designed for intramuscular delivery, with 20 injections in the designated limb during a single session. The discovery of CD34+ cells was a result of a deliberate quest for a type of stem cell capable of encouraging the growth and repair of blood vessels. Early clinical responses indicate a favorable therapeutic impact and safety profile, aligning with findings from prior clinical trials of CD34+ cell therapy both in Japan and other locations. Honedra is currently progressing through its Phase II development phase.

The anticipated launch of these emerging therapies for Critical Limb Ischemia are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Critical Limb Ischemia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Discover more about drugs for Critical Limb Ischemia in development @ Critical Limb Ischemia Clinical Trials

Critical Limb Ischemia: Overview

Critical Limb Ischemia (CLI) is a severe condition characterized by a significant decrease in blood flow to the extremities, most commonly the legs and feet. This reduction in blood flow is often due to atherosclerosis, a condition where arteries become narrowed or blocked by the buildup of fatty deposits called plaques. CLI typically affects individuals with advanced peripheral artery disease (PAD), a condition where the blood vessels supplying the limbs become narrowed or blocked.

The causes of CLI are primarily related to poor circulation, which can be the result of various factors such as smoking, diabetes, high blood pressure, high cholesterol, obesity, and a sedentary lifestyle. These factors contribute to the development of atherosclerosis, which can eventually lead to severe blockages in the arteries supplying the legs and feet.

Symptoms of CLI can vary in severity but often include pain or discomfort in the legs or feet, especially during physical activity or while at rest. Patients may also experience numbness, tingling, weakness, or a feeling of coldness in the affected limb. As the condition progresses, ulcers or sores may develop on the toes or feet, and in severe cases, tissue death (gangrene) can occur.

Diagnosing CLI typically involves a combination of medical history review, physical examination, and specialized tests. Doctors may perform a physical examination to check for signs such as weak or absent pulses, cool skin, or wounds that are slow to heal. Imaging tests such as Doppler ultrasound, magnetic resonance angiography (MRA), or computed tomography angiography (CTA) may be used to visualize the blood vessels and assess blood flow. Ankle-brachial index (ABI) testing, which compares blood pressure measurements in the arms and ankles, can also provide valuable information about the extent of blood flow restriction.

Critical Limb Ischemia Epidemiology Segmentation

The Critical Limb Ischemia epidemiology section provides insights into the historical and current Critical Limb Ischemia patient pool and forecasted trends for individual seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders.

The Critical Limb Ischemia market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:

Total Diagnosed Prevalent Cases of CLI
Age-specific Diagnosed Prevalent Cases of CLI
Severity-specific Diagnosed Prevalent Cases of CLI
Diagnosed Prevalent Cases of No-option CLI

Scope of the Critical Limb Ischemia Market Report

Critical Limb Ischemia Therapeutic Assessment: Critical Limb Ischemia current marketed and emerging therapies
Critical Limb Ischemia Key Companies: Ixaka Ltd, Hemostemix, Caladrius Biosciences, and others
Critical Limb Ischemia Pipeline Therapies: REX-001, ACP-01, Honedra, and others
Critical Limb Ischemia Market Dynamics: Attribute Analysis of Emerging Critical Limb Ischemia Drugs
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
Unmet Needs, KOL’s views, Analyst’s views, Critical Limb Ischemia Market Access and Reimbursement

Table of Contents

1. Critical Limb Ischemia Market Report Introduction
2. Executive Summary for Critical Limb Ischemia
3. SWOT analysis of Critical Limb Ischemia
4. Critical Limb Ischemia Patient Share (%) Overview at a Glance
5. Critical Limb Ischemia Market Overview at a Glance
6. Critical Limb Ischemia Disease Background and Overview
7. Critical Limb Ischemia Epidemiology and Patient Population
8. Country-Specific Patient Population of Critical Limb Ischemia
9. Critical Limb Ischemia Current Treatment and Medical Practices
10. Critical Limb Ischemia Unmet Needs
11. Critical Limb Ischemia Emerging Therapies
12. Critical Limb Ischemia Market Outlook
13. Country-Wise Critical Limb Ischemia Market Analysis (2019–2032)
14. Critical Limb Ischemia Market Access and Reimbursement of Therapies
15. Critical Limb Ischemia Market Drivers
16. Critical Limb Ischemia Market Barriers
17. Critical Limb Ischemia Appendix
18. Critical Limb Ischemia Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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Critical Limb Ischemia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key Critical Limb Ischemia companies, including Pluristem Therapeutics, Reven Pharmaceuticals, Inc., New Beta Innovation Limited, among others.

About DelveInsight

DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

DelveInsight’s healthcare consulting services leverage our extensive industry expertise, market research capabilities, and data analytics to provide clients with practical, data-driven solutions. The consultants work closely with clients to understand their unique needs and challenges and to develop tailored solutions that meet their specific requirements. DelveInsight’s consulting services cover a range of areas, including market access, commercial strategy, product development, and regulatory affairs in the healthcare domain.

Shruti Thakur
DelveInsight Business Research LLP
+ 14699457679
www.delveinsight.com

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