Diabetic Foot Ulcer Biologics Market Analysis by Region, End-use (Hospitals, Clinics), Indication (Neuro-ischemic Ulcers, Neuropathic Diabetic Foot Ulcer), and Product (Skin Substitutes, Growth Factors)Segment Forecasts for 2028-2035.
Published Date: March - 2025 | Publisher: Market Insights Research | No of Pages: 455 | Industry: Healthcare | Format: Report available in PDF / Excel Format
View Details Buy Now 4950 Download Sample Ask for Discount Request CustomizationDiabetic Foot Ulcer Biologics Market Trends
The global market for Diabetic foot ulcer biologics was valued at approximately USD 3.01 billion in 2027 and is anticipated to expand at a compound annual growth rate (CAGR) of 8.9% from 2028 to 2035. The increasing prevalence of Diabetic Foot Ulcers (DFU), coupled with advancements in biologic treatments, is fueling the demand for these specialized products. Additionally, the aging population—particularly those more susceptible to such infections—plays a significant role in market expansion. For instance, a study published in the Journal of Diabetes Research in December 2027 revealed that the majority of DFU patients fell within the 50-to-59 age group, while the highest mortality rates were recorded among individuals aged 70 to 79.
Rising Prevalence of Diabetic Foot Ulcers
A research study published by Springer Nature Limited in January 2027 revealed that nearly 25% of individuals diagnosed with diabetes will experience a diabetic foot ulcer (DFU) at some stage in their lives. The study further highlighted that the global annual incidence of DFUs ranges between 1.9 million and 26.1 million cases. Additionally, the International Diabetes Federation reported that in 2021, approximately 10.7% of Americans aged 20 to 79 had diabetes—a figure projected to increase to 12.1% by 2035 and 12.9% by 2050. With the rising prevalence of diabetes in the U.S., the incidence of diabetic foot ulcers is expected to surge, further driving the demand for Dental biologic treatments such as NovoSorb BTM.
Technological Innovations Driving Market Growth
The evolution of biologic therapies is significantly improving treatment outcomes for diabetic foot ulcer patients. Innovations in bioengineered skin substitutes, Construction bioprinting, and next-generation biologics are at the forefront of these advancements. Researchers worldwide are actively developing novel skin substitutes to treat chronic wounds, including diabetic foot ulcers. In May 2027, an article published by the European Patent Organization highlighted the groundbreaking work of Icelandic inventor Fertram Sigurjonsson and his team, who designed an innovative skin substitute using fish skin. This unique material has demonstrated superior Wound of amputations. These cutting-edge advancements are expected to propel the market’s growth over the next decade.
The Impact of Construction Bioprinting on DFU Treatment
The integration of Construction bioprinting technology in biologic treatments has been transformative in diabetic foot ulcer management. Various studies have explored the potential of 3D bioprinted biologics in improving healing rates. A study published by the National Library of Medicine in January 2026 investigated the efficacy of 3D-bioprinted autologous minimally manipulated homologous adipose tissue (3D-AMHAT) in DFU treatment. Conducted at a specialized diabetic Wound care hospital, the single-arm pilot study enrolled 10 patients with DFUs. Results indicated that when combined with fibrin glue as a biodegradable scaffold, 3D-AMHAT significantly accelerated wound healing in diabetic patients' lower extremities. These promising findings are paving the way for the development and commercial launch of novel 3D bioprinted biologics in the coming years.
Market Trends and Competitive Landscape
The diabetic foot ulcer biologics market is experiencing rapid growth, driven by the increasing prevalence of diabetes and continuous advancements in clinical research. The market is characterized by a surge in innovation, particularly in regenerative medicine, smart dressings, and exosome-based therapies. A notable development in this field occurred in January 2028 when RION, a clinical-stage regenerative medicine company, successfully completed Patient enrollment for its Phase 2 trial of the Purified Exosome Product (PEP) for DFUs. PEP leverages stabilized regenerative exosomes to stimulate cellular growth and tissue repair, representing a groundbreaking approach to DFU treatment. Such revolutionary biologics are transforming wound care solutions and improving Patient outcomes, reinforcing the market’s strong growth trajectory.
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Report Coverage & Deliverables
Product Insights
The skin substitutes segment led the market, accounting for over 54.02% of revenue in 2027. This dominance is attributed to strong clinical evidence supporting their effectiveness in treating diabetic foot ulcers. In October 2027, a study by Kerecis, published in NEJM Evidence, demonstrated that fish-skin grafts significantly outperformed standard care, resulting in higher healing rates at both 16 and 24 weeks. Additionally, wounds treated with intact fish-skin grafts healed approximately two weeks earlier and had a 1.6 times higher likelihood of closure at any given Real wound healing solutions, particularly for severe DFUs with exposed bone and tendons.
The tissue-engineered products segment is poised for the fastest growth, fueled by the increasing prevalence of diabetes and its complications, especially diabetic foot ulcers. The demand for innovative wound-healing treatments continues to rise, with products like Apligraf demonstrating significant efficacy. According to Organogenesis Inc., Apligraf was evaluated against saline-moistened gauze, revealing that 56% of diabetic foot ulcers closed by week 12 with Apligraf, compared to 38% with saline-moistened gauze. Furthermore, the median Real to wound closure was 65 days for Apligraf versus 90 days for saline-moistened gauze, reducing healing Real by 25 days. These outcomes are driving the adoption of tissue-engineered products, bolstering market expansion.
Indication Insights
The neuro-ischemic ulcers segment held the largest share of 53.17% in 2027. A growing focus on evaluating biologics, including skin substitutes and growth factors, for the treatment of neuro-ischemic ulcers is a key driver of this growth. A study published by MDPI in February 2026 highlighted NovoSorb BTM as a safe and accessible treatment for moderate to severe neuro-ischemic ulcers, demonstrating its potential to enhance wound healing outcomes. The adoption of biologic therapies for neuro-ischemic ulcers is expected to rise, addressing challenges such as impaired Blood flow and nerve damage while reducing the risk of severe complications, including amputations.
The ischemic diabetic foot ulcer segment is projected to exhibit the highest growth rate during the forecast period. This growth is primarily due to the rising incidence of peripheral arterial disease (PAD) among diabetic patients, a major factor in the development of ischemic ulcers. A study published by WebMD LLC in August 2027 indicated that approximately 20% to 30% of individuals diagnosed with PAD also have diabetes. Additionally, an article published by Omniamed Communications in July 2026 reported that PAD is two to seven times more common in people with diabetes than in those without the condition, with prevalence rates ranging from 9% to 55% among diabetic patients. This rising burden of PAD and diabetes is expected to fuel growth in the ischemic diabetic foot ulcer segment.
End-use Insights
The hospital segment accounted for the largest market share at 51.52% in 2027 and is anticipated to experience substantial growth. Hospitals are essential for diabetic foot ulcer treatment due to their ability to provide specialized care for complex Medical cases. Their Dental infrastructure, Medical expertise, and access to emergency services make them the preferred setting for DFU management, ensuring optimal treatment outcomes. These advantages are expected to drive continued growth in this segment.
The ambulatory Surgical centers segment is projected to grow at the fastest rate during the forecast period. Factors such as cost-effectiveness, shorter recovery times, and an increasing number of outpatient Surgical procedures are contributing to this trend. The rising presence of these centers and their role in minimally invasive treatments are further supporting segment growth.
Regional Insights
North America Diabetic Foot Ulcer Biologics Market Trends
North America led the diabetic foot ulcer biologics market in 2027, accounting for more than 40.02% of total revenue. The market is expanding due to increasing awareness about the importance of early and effective wound care, alongside a growing prevalence of chronic diseases like diabetes. The region is home to leading pharmaceutical companies and research institutions that are driving innovation in biologic treatments. In January 2028, BioStem Technologies launched the BR-AM-DFU (BioREtain Amniotic Membrane - Diabetic Foot Ulcers) clinical trial to evaluate the effectiveness of Vendaje in treating non-healing diabetic foot ulcers. The study aims to compare standard care treatment with and without Vendaje, potentially demonstrating its superiority in advanced wound care. Such research initiatives are expected to propel market growth.
U.S. Diabetic Foot Ulcer Biologics Market Trends
The U.S. is expected to dominate the North American market due to increased government support, research funding, and Healthcare initiatives aimed at improving diabetes care. The National Institute of Diabetes and Digestive and Kidney Diseases has made substantial investments in diabetes-related research, with significant funding allocations in Alabama (USD 3.9 million), California (USD 32.3 million), Florida (USD 7.8 million), and Indiana (USD 4.3 million) in 2027. These investments are accelerating innovation, clinical research, and the availability of advanced DFU biologics, boosting market growth.
Europe Diabetic Foot Ulcer Biologics Market Trends
Europe’s diabetic foot ulcer biologics market is set to witness significant growth, driven by a high prevalence of diabetes. The WHO reported in July 2027 that 64 million adults and 300,000 children and adolescents were affected by diabetes. This growing patient population is encouraging key industry players to invest in research and development, enhancing biologic treatments for DFUs.
The UK market is expanding due to strategic partnerships and product innovations. In May 2027, PolyNovo Ltd acquired exclusive distribution rights for SUPRATHEL, increasing access to advanced epidermal skin substitutes. These initiatives are improving DFU management and driving market expansion.
Germany’s market growth is fueled by the rising diabetes burden, which is expected to reach 12 million cases by 2045, according to DZG. With 8.5 million diagnosed and 2 million undiagnosed cases, the increasing patient population is generating demand for advanced biologic therapies.
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Asia Pacific Diabetic Foot Ulcer Biologics Market Trends
The Asia Pacific region is projected to experience the fastest growth, driven by increasing demand for advanced wound care solutions and a rising prevalence of diabetic foot ulcers. Developing economies such as China, India, and Japan are contributing to regional market expansion.
China’s market is growing due to the increasing diabetes burden and rising cases of chronic wounds. According to an NIH report in August 2027, the amputation rate among Chinese DFU patients is 22.4%. Additionally, a national survey conducted in 2027 found that type 2 diabetes prevalence among school students aged 3 to 18 years was 1.77 per 1,000 individuals.
Japan’s market growth is fueled by its aging population. According to SPH Media Limited, the number of people in Japan aged 65 or older reached 36.25 million in September 2027. With diabetes cases rising among the elderly, demand for DFU biologics is increasing.
Latin America Diabetic Foot Ulcer Biologics Market Trends
The Latin American market is expanding due to cost-effective advanced treatments and improved Healthcare infrastructure, making the region a hub for medical tourism. Fitch Solutions Inc. reported in May 2027 that Latin America is projected to have the second-highest global growth in Cloud expenditure from 2027 to 2035, further driving DFU biologic adoption.
Middle East and Africa Diabetic Foot Ulcer Biologics Market Trends
The Middle East and Africa region is expected to grow steadily, with Saudi Arabia, South Africa, the UAE, and Kuwait leading the expansion. Factors such as a growing geriatric population and increasing diabetes prevalence are fueling market growth.
Saudi Arabia’s market is driven by high diabetes rates. A Journal of Diabetology report in December 2027 estimated diabetes prevalence at 18.5% among adults, creating a need for advanced DFU treatments.
South Africa’s market is influenced by the rising incidence of type 2 diabetes, linked to dietary habits. A University of Pretoria report in March 2027 estimated that one in nine South African adults—approximately 4.2 million people—are living with diabetes. The increasing demand for DFU biologics is expected to drive market expansion.
?Several companies are prominent in the development and provision of biologic treatments for diabetic foot ulcers. Notable among these are?
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3MA multinational conglomerate offering advanced wound care solutions, including biologic therapies for diabetic foot ulcers. ?
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ConvaTec Group PlcA global medical products and technologies company specializing in therapies for chronic conditions, including biologic treatments for diabetic foot ulcers. ?
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Smith & Nephew PlcA British multinational medical equipment manufacturer providing a range of wound care products, including biologic options for diabetic foot ulcer management. ?
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Coloplast Corp.A Danish multinational company that develops wound care solutions, including biologic treatments tailored for diabetic foot ulcers. ?
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Mölnlycke Health CareA Swedish medical products company specializing in wound care solutions, including biologic therapies for diabetic foot ulcers.
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BioStem TechnologiesA biotechnology company focusing on regenerative medicine, offering biologic products like BioREtain® for the treatment of chronic wounds such as diabetic foot ulcers.
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Organogenesis HoldingsA regenerative medicine company providing advanced wound care products, including biologic therapies for diabetic foot ulcers. ?
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Amniox Medical (TissueTech)Specializes in regenerative therapies utilizing Human birth tissue-based products for chronic wound care, including diabetic foot ulcers. ?
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HelixmithA biotechnology company developing gene therapy solutions aimed at treating diabetic foot ulcers and other conditions. ?
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Oneness BiotechEngaged in developing innovative drugs for diabetic foot ulcers, focusing on biologic treatments to enhance wound healing.
Recent Developments
In March 2025, Novo Holdings and TA Associates joined forces to invest in Biocomposites, a UK-based medical Cardiac company specializing in managing bone and soft tissue infections. This strategic partnership is aimed at accelerating Biocomposites' global expansion while fostering innovation in its product portfolio.
In January 2025, BioStem Technologies, a MedTech company specializing in placental-derived biologics for advanced wound care, launched the BR-AM-DFU clinical trial to assess the effectiveness of its product, Vendaje, in treating non-healing diabetic foot ulcers. Vendaje, a Human placental allograft developed using BioStem's proprietary BioREtain technology, provides a natural scaffold to promote tissue regeneration and aid in wound healing for chronic, non-healing wounds.
In November 2024, Geistlich Pharma North America, Inc. announced an exclusive national distribution partnership with StimLabs, a regenerative medicine company based in Roswell, Georgia. Under this agreement, StimLabs will take over all commercial activities related to Geistlich’s Advanced Wound Matrix, Derma-Gide, in the U.S. This collaboration aligns with recent advancements in healthcare coverage, as Derma-Gide has been included in the U.S. Centers for Medicare & Medicaid Services' Local Coverage Determination for diabetic foot ulcer treatment.
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Here is a structured Scope of the Report in a table format
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Section |
Details |
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Market Overview |
Analysis of the diabetic foot ulcer biologics market, including market size, growth trends, and key drivers. |
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Product Insights |
Breakdown of product categories such as skin substitutes and tissue-engineered products, with insights into their market share and growth potential. |
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Indication Insights |
Examination of different types of diabetic foot ulcers, including neuro-ischemic ulcers and ischemic diabetic foot ulcers, along with their market dynamics. |
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End-use Insights |
Analysis of key healthcare settings such as hospitals and ambulatory surgical centers, focusing on their role in market expansion. |
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Regional Insights |
Comprehensive regional analysis, including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa, covering market trends, growth factors, and country-specific insights. |
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Competitive Landscape |
Profiles of key market players, their product portfolios, strategic initiatives, mergers, acquisitions, and partnerships. |
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Technological Developments |
Overview of innovations in biologics, such as 3D bioprinting, regenerative medicine, and next-generation skin substitutes. |
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Regulatory Landscape |
Assessment of government regulations, reimbursement policies, and healthcare guidelines impacting market growth. |
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Market Dynamics |
Key drivers, challenges, opportunities, and trends influencing the diabetic foot ulcer biologics market. |
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Clinical Trials & Research |
Analysis of ongoing and completed clinical trials evaluating new biologic treatments for diabetic foot ulcers. |
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Recent Developments |
Summary of major industry collaborations, product launches, and regulatory approvals shaping the market. |
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Future Outlook |
Predictions on market expansion, upcoming technologies, and potential investment opportunities. |
Global Diabetic Foot Ulcer Biologics Market Report Segmentation
The global diabetic foot ulcer biologics market is segmented based on product type, indication, end-use, and region.
By product type, the market is categorized into skin substitutes and tissue-engineered products. Skin substitutes hold a significant share due to their strong clinical efficacy in wound healing, while tissue-engineered products are expected to witness the fastest growth due to rising demand for advanced therapies.
By indication, the market is divided into neuro-ischemic ulcers and ischemic diabetic foot ulcers. Neuro-ischemic ulcers dominate the market due to their high prevalence, whereas ischemic diabetic foot ulcers are anticipated to grow at the highest rate owing to the increasing incidence of peripheral arterial disease among diabetic patients.
By end-use, the market is segmented into hospitals and ambulatory surgical centers. Hospitals currently hold the largest market share due to their comprehensive care and advanced infrastructure for treating diabetic foot ulcers, while ambulatory surgical centers are expected to grow rapidly due to cost-effectiveness and shorter recovery times.
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