Diabetic Foot Ulcer Biologics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Indication (Neuro-ischemic Ulcers, Neuropathic Diabetic Foot Ulcer, Ischemic Diabetic Foot Ulcer), By End User (Hospitals, Clinics, Ambulatory Surgical Centers, Long-Term Care Settings, Others), By Region and Competition, 2020-2030F

Market Overview

Global Diabetic Foot Ulcer Biologics Market was valued at USD 0.65 Billion in 2024 and is expected to reach USD 0.88 Billion by 2030 with a CAGR of 5.41% during the forecast period. Diabetic foot ulcers represent a major burden on healthcare systems globally due to their high incidence rate and the complications they cause. These ulcers, often caused by poor circulation, neuropathy, and compromised immune function, can be difficult to treat with conventional therapies. Biologic treatments, such as growth factors, cellular therapies, and gene therapies, are increasingly being used to promote wound healing, reduce the risk of infection, and prevent complications.

The global diabetic foot ulcer biologics market is characterized by a diverse array of biologic therapies, including products such as platelet-rich plasma (PRP), skin substitutes, stem cell therapies, and recombinant human growth factors. These treatments aim to stimulate tissue regeneration, enhance healing rates, and reduce the need for more invasive procedures like amputation. As healthcare professionals continue to recognize the efficacy of biologic treatments in managing DFUs, the demand for these products is expected to grow steadily.

One of the major barriers to widespread adoption of biologic therapies is their high cost. Many biologic treatments require specialized manufacturing processes and complex delivery systems, which contribute to their expense. For patients and healthcare systems with limited budgets, this can pose a significant challenge.

Key Market Drivers

Growth in Healthcare Industry

​ The global incidence of diabetes is on the rise, leading to a higher occurrence of related complications such as diabetic foot ulcers. Approximately 15% of diabetic patients develop foot ulcers, necessitating effective treatment options. The global prevalence of diabetic foot ulcers (DFU) among adults with diabetes is estimated at 6.3%, with the annual incidence ranging from 9.1 to 26.1 million cases. DFU is linked to several risk factors, including prolonged diabetes duration, poorly managed blood sugar levels, diabetic neuropathy, and foot deformities such as calluses and flat feet. This trend drives the demand for specialized treatments, including biologics, to manage and heal DFUs. ​

Continuous investments in healthcare research and technological advancements contribute to the development of innovative biologic therapies. These innovations enhance treatment efficacy and patient outcomes, fostering market growth. For example, AI-based software and applications have been developed to assist healthcare professionals in the screening, detection, and treatment of diabetic foot ulcers, improving accuracy and efficiency. ​

Surge in Technological Advancements

One of the primary technological drivers in the DFU biologics market is the rapid progress in regenerative medicine, including the development of stem cell therapies, tissue-engineered products, and growth factors. Recent attention has focused on stem cell therapy as an emerging approach for treating diabetic lower limb ischemic disease, particularly diabetic foot ulcers. This therapy seeks to enhance wound healing by stimulating the development of new blood vessels, thereby improving blood circulation and alleviating limb ischemia. These biologic treatments are designed to stimulate the body’s natural healing processes, promoting wound healing in diabetic foot ulcers and reducing the risk of infection. For instance, GMP-manufactured skin-derived ABCB5+ mesenchymal stem cells (MSCs) offer a novel adjunctive treatment for diabetic foot ulcers (DFUs). Their exceptional ability to home to skin wounds and integrate effectively, along with their capacity to respond to inflammatory signals and promote wound healing, has been demonstrated in mouse wound models and human chronic venous ulcers.

Technological advancements have led to the development of novel growth factors that accelerate the healing process in diabetic foot ulcers. Biologics such as platelet-derived growth factors (PDGFs) and vascular endothelial growth factors (VEGFs) are now used to promote angiogenesis (formation of new blood vessels), collagen synthesis, and tissue regeneration at the ulcer site. The growing research and clinical adoption of such biologics are enabling more precise and targeted therapies, reducing the likelihood of infection and improving overall treatment outcomes for diabetic patients.

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Key Market Challenges

High Treatment Costs

Biologic treatments are derived from living organisms, and their production involves complex and highly controlled manufacturing processes. This includes the cultivation of cells, purification of growth factors, and the development of bioengineered tissues or skin substitutes. The intricacy of these processes often requires specialized facilities, advanced technologies, and strict quality control measures, all of which increase the overall production cost. These high manufacturing expenses are reflected in the final price of biologic products.

The development of new biologic treatments involves significant investment in research and development (R&D). Companies must conduct extensive preclinical and clinical trials to ensure the safety and efficacy of their products. These R&D activities can be lengthy and costly, particularly for new or innovative therapies. The costs associated with developing, testing, and obtaining regulatory approvals for biologics often translate into higher prices for the final products, which are then passed on to healthcare providers and patients.

Key Market Trends

Growing Prevalence of Diabetes

The global incidence of diabetes has surged markedly over the past decades. This surge is particularly pronounced in low- and middle-income countries, where treatment access remains limited. The global population living with diabetes increased from 200 million in 1990 to 830 million in 2022. The prevalence of diabetes has been rising more swiftly in low- and middle-income countries compared to high-income nations. In 2021, diabetes and its complications, including kidney disease, contributed to over 2 million deaths. Furthermore, approximately 11% of cardiovascular-related deaths were attributed to elevated blood glucose levels. Consequently, the incidence of DFUs, a common and severe complication of diabetes, is on the rise, thereby increasing the demand for effective treatments, including biologics.​

The diabetic foot ulcer treatment market is experiencing substantial growth, propelled by the increasing incidence of DFUs and the availability of advanced therapeutic options. Biologics, including growth factors and cellular therapies, are gaining prominence due to their efficacy in promoting wound healing and reducing infection rates. This trend underscores the critical role of biologic treatments in managing DFUs amidst the growing diabetes epidemic.​

Segmental Insights

Indication Insights

Based on Indication, Neuro-ischemic Ulcers have emerged as the fastest growing segment in the Global Diabetic Foot Ulcer Biologics Market in 2024. The global rise in the prevalence of diabetes, especially type 2 diabetes, has led to an increased number of diabetic foot ulcers, particularly neuro-ischemic ulcers. According to recent studies, nearly 20-30% of individuals with diabetes will develop some form of foot ulcer during their lifetime, with neuro-ischemic ulcers making up a significant proportion. The concurrent presence of neuropathy and ischemia exacerbates the severity and complexity of these ulcers, making their management and treatment more difficult. As a result, there is an escalating need for advanced biologics capable of addressing the multifaceted nature of neuro-ischemic ulcers, contributing to their rapid growth as a segment.

End User Insights

Based on End User, Hospitals have emerged as the fastest growing segment in the Global Diabetic Foot Ulcer Biologics Market during the forecast period. Diabetic foot ulcers are a common complication of diabetes, often requiring advanced wound care and, in many cases, biologic treatments. Hospitals, particularly those with specialized departments in wound care and diabetic management, have seen a significant increase in the number of patients with DFUs. As hospitals serve as the primary care settings for severe cases or patients with comorbid conditions, they are witnessing a higher volume of complex DFU cases, which directly contributes to the rising demand for biologic therapies.

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Regional Insights

Based on Region, North America have emerged as the dominating region in the Global Diabetic Foot Ulcer Biologics Market in 2024. The United States and Canada have some of the highest rates of diabetes prevalence globally, with an increasing number of patients developing diabetic foot ulcers as a complication of poorly controlled diabetes. According to the Centers for Disease Control and Prevention (CDC), more than 34 million Americans are living with diabetes, and a significant portion of them experience diabetic foot complications. This high patient volume drives demand for innovative biologic therapies aimed at improving wound healing and preventing amputations, thus contributing to the market's growth in North America.

Recent Development

• In January 2025, BioStem Technologies announced the initiation of the BR-AM-DFU (BioREtain Amniotic Membrane - Diabetic Foot Ulcers) clinical trial, aimed at evaluating the use of Vendaje for treating patients with non-healing diabetic foot ulcers. This innovative study will compare standard care treatment with and without Vendaje, with the goal of demonstrating its superiority in advanced wound care. The minimally invasive BioREtain technology utilizes placental allografts that preserve the inherent biological properties of the tissue, ensuring the retention of the structure and matrix found in fresh perinatal tissue. While Vendaje is already commercially available, the trial seeks to further validate its clinical efficacy in maintaining amniotic tissue integrity, thereby boosting market adoption.
• In January 2025, RION, a clinical-stage regenerative medicine company specializing in exosome-based therapeutics, announced the completion of patient enrollment in its Phase 2 clinical trial for the Purified Exosome Product (PEP) in the treatment of Diabetic Foot Ulcers (DFUs). This milestone represents a significant advancement in the company’s efforts to develop innovative therapies for chronic wound care. The multi-center, prospective, open-label study enrolled 59 patients across the United States. The trial aims to assess the safety and efficacy of PEP when used topically alongside standard wound care, compared to standard care alone.
• In February 2025, FibroBiologics, Inc. and Charles River Laboratories, a leading global provider of drug discovery, development, and manufacturing solutions, announced the successful completion of FibroBiologics’ proprietary master cell bank, which will support upcoming clinical trials. Produced in compliance with FDA Good Manufacturing Practices (cGMP), the cell bank has passed all required safety testing. FibroBiologics, a clinical-stage biotechnology company with over 160 patents issued and pending, is exploring the potential use of fibroblasts and fibroblast-derived materials for the development of therapeutics and potential cures for chronic diseases, leveraging their immunomodulatory and regenerative properties.
• In February 2024, Technophage, a biopharmaceutical company focused on developing and manufacturing biologics, particularly bacteriophage-based products, announced the successful dosing of the first patient in a critical phase of its trial. The study aims to evaluate the efficacy of TP-102 in treating diabetic foot ulcers infected by Staphylococcus aureus, Pseudomonas aeruginosa, and Acinetobacter baumannii (ID NCT05948592). This Phase 2b trial is a double-blinded, randomized, placebo-controlled, multicenter study designed to assess the safety and effectiveness of TP-102 in patients with diabetic foot infections.

Key Market Players

• Organogenesis Inc.
• Tissue Regenix Group Plc
• BioTissue Holdings, Inc.
• Integra LifeSciences Holdings Corporation
• MIMEDX Group, Inc.
• Convatec Inc.
• Smith & Nephew PLC
• Stedical Scientific, Inc.
• Zimmer Biomet Holdings, Inc.
• GUNZE LIMITED

Report Scope

In this report, the Global Diabetic Foot Ulcer Biologics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Diabetic Foot Ulcer Biologics Market, By Indication:

o   Neuro-ischemic Ulcers

o   Neuropathic Diabetic Foot Ulcer

o   Ischemic Diabetic Foot Ulcer

• Diabetic Foot Ulcer Biologics Market, By End User:

o   Hospitals

o   Clinics

o   Ambulatory Surgical Centers

o   Long-Term Care Settings

o   Others

• Diabetic Foot Ulcer Biologics Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Diabetic Foot Ulcer Biologics Market.

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Company Information

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