Diabetic Foot Ulcers Market to Witness Upsurge Growth by 2032, Estimates DelveInsight | Leading Companies - Anterogen Co., Lavior Pharma, Vitruvian Medical Devices, Oneness Biotech Co., Energenesis Biomedical Co.

The diabetic foot ulcers market is expected to grow significantly owing to an increase in diabetes cases mainly due to the aging population and sedentary lifestyle, expected entry of emerging therapies containing cell therapy and gene therapy, and readily adoption of these novel therapies.


New York, USA, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Diabetic Foot Ulcers Market to Witness Upsurge Growth by 2032, Estimates DelveInsight | Leading Companies - Anterogen Co., Lavior Pharma, Vitruvian Medical Devices, Oneness Biotech Co., Energenesis Biomedical Co.

The diabetic foot ulcers market is expected to grow significantly owing to an increase in diabetes cases mainly due to the aging population and sedentary lifestyle, expected entry of emerging therapies containing cell therapy and gene therapy, and readily adoption of these novel therapies.

DelveInsight’s Diabetic Foot Ulcers Market Insights report includes a comprehensive understanding of current treatment practices, diabetic foot ulcers emerging drugs, market share of individual therapies, and current and forecasted diabetic foot ulcers 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 Diabetic Foot Ulcers Market Report

  • According to DelveInsight's analysis, the market size for diabetic foot ulcers across the 7MM is expected to grow with a significant CAGR by 2032.
  • DelveInsight's analysis reveals that the overall prevalent population of diabetic foot ulcers in the 7MM was reported as 6.2 million in 2022. 
  • Prominent companies working in the domain of diabetic foot ulcers, including Anterogen Co., Ltd., Lavior Pharma Inc., Vitruvian Medical Devices, Inc., Oneness Biotech Co., Ltd., Energenesis Biomedical Co., Ltd., Tissue Tech Inc., PolarityTE, Technophage, SA, and others, are actively working on innovative drugs for diabetic foot ulcers. These novel diabetic foot ulcer therapies are anticipated to enter the diabetic foot ulcers market in the forecast period and are expected to change the market.
  • Some of the key therapies for diabetic foot ulcers treatment include ALLO-ASC-DFU, Lavior Diabetic Wound Gel, DERMASEAL, ON101 Cream, ENERGI-F703 GEL, TTAX01, SkinTE, TP-102, and others. 

Discover which therapies are expected to grab the diabetic foot ulcers market share @ Diabetic Foot Ulcers Market Report

Diabetic Foot Ulcers Overview

Diabetic foot ulcer (DFU) stands out as a significant and severe complication arising from diabetes mellitus, serving as a primary component of the diabetic foot. As per the American Podiatric Medical Association (APMA), diabetes stands as the primary cause of non-traumatic lower extremity amputations in the United States. Approximately 14-24% of diabetic patients with foot ulcers may necessitate amputation, with 85% of diabetes-related amputations being preceded by foot ulceration. Key risk factors for foot ulceration encompass diabetic neuropathy, peripheral arterial disease, and resultant foot traumas. Additional factors include tobacco use, alcohol consumption, ill-fitting or low-quality shoes, inadequate hygiene, improper toenail trimming, suboptimal glycemic control, and a history of prior foot ulcers. The diagnosis of DFU involves reviewing the patient's medical history for indications of previous complications or medical conditions. Furthermore, DFU diagnosis entails a physical examination to assess the current condition, blood tests to screen for infections, and a metabolic profile to measure glucose levels.


Diabetic Foot Ulcers Epidemiology Segmentation

The diabetic foot ulcer epidemiology section provides insights into the historical and current diabetic foot ulcer patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.

The diabetic foot ulcers market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:

  • Total Prevalent Cases of DFU
  • Total Diagnosed Cases of DFU 
  • Gender-specific Cases of DFU
  • Age-Specific Cases of DFU 
  • DFU Cases by Severity/Chronicity of Wound
  • Treated Cases of DFU 

Download the report to understand which factors are driving diabetic foot ulcers epidemiology trends @ Diabetic Foot Ulcers Epidemiological Insights

Diabetic Foot Ulcers Treatment Market 

Presently, approaches to address DFU predominantly involve non-surgical methods for mild and moderate ulcers, and surgical interventions for those categorized as severe. Non-surgical approaches primarily encompass routine wound care, the application of growth factors and skin substitutes to facilitate wound healing, administration of antibiotics for deep infections, drainage procedures, and management of cellulitis. On the other hand, surgical options involve the removal of unhealthy tissue and vascular surgeries to enhance blood circulation. The advancement of growth factor therapy signifies significant progress in the treatment of diabetic neuropathic foot ulcers, particularly in cases where there is sufficient blood supply.

Platelet-derived growth factor (PDGF) plays a crucial role in the healing process and holds the distinction of being the sole growth factor sanctioned by the FDA. Standard approaches to managing DFUs in the United States encompass surgical debridement, the application of dressings to foster a moist wound environment and control exudate, wound off-loading, vascular evaluation, and the regulation of infection and glycemic levels. In Europe, treatment options for infected diabetic feet involve antibiotic therapy, wound off-loading, and surgical interventions. Regranex (Becaplermin) is the only FDA-approved drug utilizing PDGF, while other growth factors either demonstrated limited efficacy or remain largely unexplored.

Regranex, also known as Becaplermin, is a topical gel indicated for the supportive treatment of stage III and IV diabetic neuropathic ulcers on the lower extremities. Becaplermin, a synthetic form of human platelet-derived growth factor, facilitates the healing of wounds by promoting the development of granulation tissue. This engineered growth factor is administered through a topical gel containing aqueous-based sodium carboxymethylcellulose (NaCMC). The application involves a daily, thin layer of Regranex across the entire ulcer area, covered with a dressing moistened with saline, and left in place for 12 hours until the ulcer achieves complete healing.

Learn more about the FDA-approved drugs for diabetic foot ulcers @ Drugs for Diabetic Foot Ulcers Treatment 

Diabetic Foot Ulcers Emerging Drugs and Key Companies

Key players, such as Oneness Biotech Co., Ltd. (ON101), Energenesis Biomedical Co., Ltd. (ENERGI-F703), PolarityTE (SkinTE), and others are involved in developing drugs for diabetic foot ulcers. ON101 (fespixon) represents an innovative pharmaceutical breakthrough from Oneness Biotech. This novel drug stimulates targeted chemokines within wound sites, fostering the infiltration of immune cells, particularly M2 macrophages. These macrophages play a pivotal role in dampening wound inflammation, spurring vascular growth, and ultimately aiding in ulcer healing. This unique mode of action holds promise for transforming the intricate healing processes of diabetic chronic inflammatory wounds, expediting their recovery. Comprised of extracts from traditional Chinese medicinal herbs, namely Plectranthus amboinicus and Centella asiatica urban, ON101 is formulated as an ointment. Presently, ON101 is undergoing Phase III clinical trials in the US, with the drug having earned Fast Track designation from the US FDA. This designation streamlines its path toward NDA approval, facilitating its development and potential availability in the US DFU market.

ENERGI-F703 is a gel for external use accelerating the healing of diabetes-caused wounds, mainly by activating AMPK inside cells to boost the density of ATP, energy molecules, in tissues near the wounds. Cellular and animal tests show that the application of ENERGI-F703 can produce the following effects: Reducing inflammation of endothelial cells of blood vessels, accelerating the fibrosis of fibroblasts in the skin of wounds, and increasing the deposition of collagen and the formation of granulation tissues, speeding up the healing of wounds by promoting the migration of epithelial cells in the skin of wounds. Via the utilization of diabetic model mice, it's proven that the application of ENERGI-F703 gel on wounds can accelerate the healing of wounds. Currently, ENERGI-F703 is being evaluated in the Phase III clinical development stage for the treatment of Wagner Grade 1 to Grade 2 diabetic foot ulcers.

The other therapies for DFU treatment in the pipeline include

  • ALLO-ASC-DFU: Anterogen Co., Ltd.
  • Lavior Diabetic Wound Gel: Lavior Pharma Inc.
  • DERMASEAL: Vitruvian Medical Devices, Inc.
  • ENERGI-F703 GEL: 
  • TTAX01: Tissue Tech Inc.
  • TP-102: Technophage, SA

The anticipated launch of these emerging therapies for DFU are poised to transform the food allergy market landscape in the coming years. These therapies not only address the underlying pathophysiology of diabetic foot ulcers but also offer more targeted and personalized approaches to care. As research and development continue to drive advancements in this field, we can anticipate a shift towards more comprehensive and holistic treatment strategies, ultimately leading to improved quality of life for individuals living with diabetes and diabetic foot ulcers. This transformation will not only reshape the market dynamics but also bring hope to millions of patients worldwide who suffer from this debilitating complication of diabetes.

To know more about diabetic foot ulcers clinical trials, visit @ Diabetic Foot Ulcers Treatment Drugs 

Diabetic Foot Ulcers Market Dynamics

The diabetic foot ulcers market dynamics are anticipated to change in the coming years. Globally, the number of patients with diabetes surged from 177 million cases in 2000 to 285 million in 2010, and projections indicate that it is poised to exceed 360 million cases by 2030. Given the escalating prevalence of diabetes in all markets, the corresponding increase in patients experiencing diabetic foot ulcers is anticipated, thereby propelling the market forward. Notably, Regranex stands as the sole approved drug in the United States; consequently, new therapies equipped with an early mover advantage are poised to seize greater opportunities with reduced market competition.

Furthermore, many potential therapies are being investigated for the treatment of diabetic foot ulcers, and it is safe to predict that the treatment space will significantly impact the diabetic foot ulcers market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the diabetic foot ulcers market in the 7MM.

However, several factors may impede the growth of the diabetic foot ulcers market. Even after the resolution of a foot ulcer, recurrence is common, with approximately 40% of patients experiencing a recurrence within 1 year after ulcer healing, nearly 60% within 3 years, and a notable 65% within 5 years. Unfortunately, at present, there are limited options for refractory cases, compounded by the high cost of available advanced wound care treatments and the restricted reimbursement available for these products, potentially impeding the growth of the DFU market.

Moreover, diabetic foot ulcer treatment poses a significant economic burden and disrupts patients’ overall well-being and QOL. Furthermore, the diabetic foot ulcers market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the diabetic foot ulcers market growth.

Diabetic Foot Ulcers Report MetricsDetails
Study Period2019–2032
Diabetic Foot Ulcers Report Coverage7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
Key Diabetic Foot Ulcers CompaniesAnterogen Co., Ltd., Lavior Pharma Inc., Vitruvian Medical Devices, Inc., Oneness Biotech Co., Ltd., Energenesis Biomedical Co., Ltd., Tissue Tech Inc., PolarityTE, Technophage, SA, and others
Key Diabetic Foot Ulcers TherapiesALLO-ASC-DFU, Lavior Diabetic Wound Gel, DERMASEAL, ON101 Cream, ENERGI-F703 GEL, TTAX01, SkinTE, TP-102, and others

Scope of the Diabetic Foot Ulcers Market Report

  • Diabetic Foot Ulcers Therapeutic Assessment: Diabetic Foot Ulcers current marketed and emerging therapies
  • Diabetic Foot Ulcers Market Dynamics: Attribute Analysis of Emerging Diabetic Foot Ulcers Drugs
  • Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
  • Unmet Needs, KOL’s views, Analyst’s views, Diabetic Foot Ulcers Market Access and Reimbursement

Discover more about diabetic foot ulcers drugs in development @ Diabetic Foot Ulcers Clinical Trials

Table of Contents

1.Diabetic Foot Ulcers Market Key Insights
2.Diabetic Foot Ulcers Market Report Introduction
3.Diabetic Foot Ulcers Market Overview at a Glance
4.Diabetic Foot Ulcers Market Executive Summary
5.Disease Background and Overview
6.Diabetic Foot Ulcers Treatment and Management
7.Diabetic Foot Ulcers Epidemiology and Patient Population
8.Patient Journey
9.Diabetic Foot Ulcers Marketed Drugs
10.Diabetic Foot Ulcers Emerging Drugs
11.Seven Major Diabetic Foot Ulcers Market Analysis
12.Diabetic Foot Ulcers Market Outlook
13.Potential of Current and Emerging Therapies
14.KOL Views
15.Unmet Needs
16.SWOT Analysis
17.Appendix
18.DelveInsight Capabilities
19.Disclaimer
20.About DelveInsight

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