Diabetic Foot Ulcer Biologics Market

Diabetic Foot Ulcer Biologics Market Size

The global diabetic foot ulcer biologics market was valued at USD 1.9 billion in 2024. The market is expected to reach from USD 2.1 billion in 2025 to USD 3.5 billion in 2034, growing at a CAGR of 6.1% during the forecast period. Diabetic foot ulcer (DFU) biologics are special treatments made from natural living source such as human or animal tissues, cells, or proteins that help in the healing process of serious foot wounds in people with diabetes.

The advancement of the DFU biologics market is largely stimulated by the growing number of diabetes globally and its associated complications such as diabetic foot ulcers (DFUs). More individuals are getting diagnosed with diabetes each year, leading to a corresponding increase in patients suffering from chronic, non-healing wounds such as diabetic foot ulcers. For instance, in 2022 the International Diabetes Federation (IDF) reported that around 537 million adults between the ages of 20 and 79 were living with diabetes in 2021.

This number is anticipated to rise to 643 million by 2030. Among these individuals, 15% to 25% are likely to develop a diabetic foot ulcer at some point in their lives. Therefore, as the prevalences of diabetic foot ulcer increases so does the demand for the advance treatment options such as biologics will increase, fostering the market growth.

Moreover, the growing number of geriatric populations is significantly contributing to the growing demand for advanced treatments such as diabetic foot ulcer biologics for age-related health conditions, including DFUs. Older adults are more likely to develop chronic conditions such as diabetes, and with age, the body's ability to heal wounds decreases, making them more susceptible to chronic, non-healing ulcers. For instance, according to the World Health Organization (WHO) in 2025, the global population of individuals aged 60 and above is expected to rise from 1.1 billion in 2023 to 1.4 billion by 2030. This trend is especially noticeable in developing countries, where the aging population is growing at a faster rate.

Additionally, the need for better and more accurate treatment options is continuously growing. Both patients and healthcare providers are now looking beyond traditional methods and turning to advanced biologic therapies for diabetic foot ulcers. These biologics work by targeting the actual cause of the wound, making the treatment more effective. Thus, options such as growth factors, skin substitutes, and platelet-derived therapies are becoming more common. They not only speed up healing but also lower the chances of serious complications, giving patients a better chance at recovery, thereby propelling the market growth.

Diabetic Foot Ulcer Biologics Market Trends

• The growing worldwide dominance of diabetes is stimulating the demand for innovative treatment alternatives, especially as millions of people are affected by diabetic foot ulcers (DFUs) each year. With healthcare systems looking for effective arrangements to improve patient results, biologics have become a critical tool in addressing these challenges.
  
• The rising burden of diabetes-related complications, including DFUs, is not only straining healthcare resources but also driving up long term costs. This emphasizes the critical need for advanced biologic treatments that can help reduce complications, improve healing results.
  
• Moreover, advancements in wound healing biologics have significantly improved treatment outcomes for diabetic foot ulcers (DFUs). New-generation therapies, such as skin substitutes and growth factors, are specifically designed to target the wound environment at a cellular level, encouraging tissue regeneration and promoting faster recovery.
  
• These biologics work by stimulating the body's natural healing processes, improving the formation of healthy tissue and the closure of chronic wounds.
  
• Clinical studies have shown that biologic treatments lead to increased closure rates and decreased healing time in patients with chronic DFUs. For example, a study published by PubMed in 2023 examined the efficacy of 3D-bioprinted autologous adipose tissue for DFUs.
  
• The results indicated that 3D-bioprinted tissues, combined with biodegradable scaffolds, altogether improved healing rates, thus giving a promising solution for chronic diabetic ulcers treatment, which is estimated to reach USD 15.8 billion by 2032.
  
• Therefore, as the number of individuals requiring these treatments continues to rise, the demand for advanced treatment, such as DFU biologics, will simultaneously increase, thereby accelerating the market growth.
  

Trump Administration Tariffs

• Tariffs imposed on essential imports such as collagen scaffolds, growth factors, and skin substitutes from countries such as China are expected to raise the cost of raw materials used in the production of diabetic foot ulcer (DFU) biologics.
  
• Manufacturers of DFU biologics are highly reliant on cost-effective components sourced from Asian markets.
  
• These trade restrictions pose challenges in maintaining a consistent supply of critical materials, potentially leading to production delays, disruptions in product development, and restocking issues for DFU biologic therapies.
  
• Additionally, regulatory hurdles, supplier shifts, and the need for changes in manufacturing processes could further contribute to delays in the distribution and availability of high-demand DFU biologic products.
  

Diabetic Foot Ulcer Biologics Market Analysis

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Based on product, the market is segmented into skin substitutes, growth factors, tissue-engineered products, and platelet-derived therapies. The global market was estimated at USD 1.8 billion in 2023. The skin substitutes segment held revenue of USD 1 billion in 2024, and the segment is poised for significant growth at a CAGR of 6.1% during the forecast period.

• The skin substitutes are advanced bioengineered materials created to imitate both the structure and function of natural human skin. These biologics are essential in diabetic foot ulcer (DFU) management, as they aid in wound healing by supporting cell regeneration, controlling infections, and maintaining a moist wound environment critical factors for effective recovery.
  
• Moreover, the growth of the segment is highly attributed to their demonstrated ability to speed up the healing process and lower the likelihood of severe complications, such as infections or amputations.
  
• Additionally, a significant innovation in this space was the fish-skin-based skin substitute developed by Icelandic inventor Fertram Sigurjonsson and his team. This remarkable innovation closely replicates the structure of human skin while offering additional advantages such as anti-inflammatory and antimicrobial effects, which enhance its effectiveness in the treatment of diabetic foot ulcers (DFUs).
  
• It was acknowledged by the European Patent Office in 2024, this innovation is expected to play a key role in stimulating the growing adoption of biologic therapies in diabetic wound management.
  

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Based on the ulcer type, diabetic foot ulcer biologics market is segmented into neuropathic ulcers, neuro-ischemic ulcers, and ischemic ulcers. The neuro-ischemic ulcers segment dominated the market with a market share of 48.4% in 2024.

• Neuro-ischemic ulcers, characterized by both nerve damage and impaired blood flow, are among the foremost difficult diabetic foot ulcers (DFUs) to treat. These wounds typically heal slowly and pose a higher chance of serious complications, including infection and limb amputation. This creates a significant demand for advanced, targeted treatment solutions.
  
• Thus, viable treatments are essential, and biologic wound care solutions, such as bilayer synthetic matrices, have emerged as promising interventions to address the unique challenges related with these ulcers.
  
• One such innovation is NovoSorb BTM, NovoSorb BTM stands out as a noteworthy advancement in diabetic wound care. This biodegradable synthetic scaffold is specifically designed to aid tissue regeneration in chronic wounds.
  
• A study featured in Biomedicines (MDPI) in February 2023 validated its safety and efficacy in treating moderate to severe neuro-ischemic ulcers. Results illustrated outstanding enhancements in wound closure and a decreased chance of amputation, especially in high-risk Wound, Ischemia, and Foot Infection (WIfI) stage 4 patients, regularly face a greater chance of limb loss.
  
• With growing clinical evidence and increasing acceptance among healthcare providers, such biologics innovations are expected to reshape the treatment landscape for neuro-ischemic diabetic foot ulcers, thereby propelling the segmental in the forward direction.
  

Based on the end use, diabetic foot ulcer biologics market is segmented into hospitals, specialty clinics, ambulatory surgical centers, long term care settings, and other end users. The hospitals segment held revenue of USD 897.2 million in 2024, and the segment is poised for significant growth at a CAGR of 6% during the forecast period.

• Hospitals serve as key centers for administering biologic therapies in the treatment of diabetic foot ulcers (DFUs), for patients with complex medical needs that require expertise. The infrastructure, access to advanced wound care solutions, and presence of highly trained healthcare professionals make them the most suitable environment for managing severe DFUs.
  
• These institutions are often early adopters of cutting-edge biologic treatments, such as skin substitutes, growth factors, and bioengineered tissue products. By integrating these innovations into care protocols, hospitals contribute to better healing outcomes while also helping to lower the long term costs associated with complications such as infections and amputations.
  
• Additionally, their capability to provide immediate care in emergency situations and treat high-risk individuals reinforces their pivotal position in the growing DFU biologics market. With rising demand for effective wound care solutions, hospitals are anticipated to continue playing a leadership role in the implementation and advancement of biologic therapies for diabetic wounds.
  

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The U.S. diabetic foot ulcers biologics market is forecasted to reach USD 1.3 billion by 2034.

• This growth is driven by the increasing prevalence of diabetes and the rising demand for advanced wound care solutions.
  
• In the U.S., approximately 1.6 million individuals with diabetes develop a foot ulcer each year, reported by National Institute of Health (NIH) in 2023, highlighting the significant burden of DFUs. These ulcers are a leading cause of non-traumatic lower extremity amputations and are associated with substantial healthcare costs. Therefore, as the prevalence of DFUs increases so does the demand for diabetic foot ulcers biologics in the country.
  
• Additionally, backing from regulatory authorities and the increasing investments in healthcare technology contributing to the growth and development of the market in the country.

Europe: The diabetic foot ulcer biologics market in the UK is projected to grow significantly from 2025 to 2034.

• The UK has a strong biopharmaceutical industry which invests broadly in research and development of innovative targeted therapies, including diabetic foot ulcers.
• For instance, according to data from Statista, pharmaceutical R&D expenditure of the country reached around EUR 9 billion in 2022.
• Thus, this significant investment strengthens the UK's position in developing advanced treatment and advanced therapies for DFUs, thereby accelerating the market growth of the country.
  

Asia Pacific: The diabetic foot ulcers biologics market in the Japan is projected to grow significantly from 2025 to 2034.

• Japan has a significant elderly population, resulting in an increased need for age-related treatment, including chronic diseases such as diabetes, impelling the adoption of the diabetic foot ulcers biologics.
  
• For instance, in 2023 projections from the World Economic Forum revealed that 1 in 10 people in Japan are aged 80 years and above which was about one-third of the population. The population of this demography is at a higher risk for DFUs, further highlighting the need for effective and targeted biologic treatments in the country.
  
• Furthermore, Japan’s commitment to advancing healthcare standards and integrating innovative technologies will boost the adoption of biologic therapies for DFUs. With the growing demand for advanced wound care solutions, the DFU biologics market in Japan is poised for substantial expansion in the coming years.
  

Middle East and Africa: The Saudi Arabia diabetic foot ulcers biologics market is projected to grow significantly from 2025 to 2034.

• The growth of the market is highly influenced by the increasing investment in healthcare infrastructure, including advanced therapies for DFU, is propelling the growth of the market in the country.
  
• For instance, Saudi Arabia's Vision 2030 includes significant investments in healthcare infrastructure, which are aimed at enhancing the quality and accessibility of medical services including biologic treatments for complex conditions such as DFUs across the country.
  

• Moreover, by 2026, approximately 24.3 percent of the adult population in Saudi Arabia is projected to have diabetes, according to Statista. With the growing incidence of diabetes, there will be an increasing demand for advanced biologic treatments to address DFU complications, such as infections and amputations, driving further market expansion.
  

Diabetic Foot Ulcer Biologics Market Share

The market for diabetic foot ulcers biologics is highly competitive, with both established players and new entrants consistently innovating and developing advanced products. In terms of revenue, the market is primarily dominated by top 5 companies, which includes Organogenesis Holdings, Smith & Nephew, MIMEDX Group, Integra LifeSciences, and Aroa Biosurgery which together account for approximately 40% of the total market share. These companies are focusing on the development of advance technologies enabling market players to strengthen their position in this growing sector.

Diabetic Foot Ulcer Biologics Market Companies

Some of the eminent market participants operating in the diabetic foot ulcers biologics industry include:

• Aroa Biosurgery
• BioStem Technologies
• BioTissue
• Coloplast Group
• GUNZE
• Heber Biotech
• Integra LifeSciences
• LifeNet Health
• MIMEDX Group
• Organogenesis Holdings
• Smith & Nephew
• Stedical Scientific
• Tissue Regenix
• Zimmer Biomet
  
• Smith & Nephew is a well-established players known for its medical technology focused on the repair, regeneration and replacement of soft and hard tissue. The company is heavily investing in research and development to facilitate advancement in technologies. For instance, in 2024 the company has invested 289 million in research and development as per the company’s annual report.
  
• Aroa Biosurgery is a soft-tissue regeneration company that develops, manufactures and distributes medical and surgical products to improve healing in complex wounds. In 2024, Aroa Biosurgery reported an annual revenue of NZ USD 69,066, reflecting its growing impact in the biologic wound care sector.
  

Diabetic Foot Ulcer Biologics Market Industry News:

• In January 2025, BioStem Technologies launched a clinical trial to evaluate the therapeutic benefits of its BioREtain technology in treating diabetic foot ulcers (DFUs) using Vendaje. The trial aims to compare the efficacy of standard care with and without Vendaje, an amniotic membrane product, in patients with non-healing DFUs. The study will monitor the impact of Vendaje on wound closure rates, with the goal of demonstrating its superiority in advanced wound care and boosting its market adoption. A successful trial outcome is expected to provide robust clinical evidence of Vendaje’s enhanced efficacy over standard care alone, thereby offering BioStem Technologies a significant competitive advantage in the DFU biologics market.
  

The diabetic foot ulcers biologics market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

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Market, By Product

• Skin substitutes
  • Biological
  • Synthetic
  • Bio-synthetic
• Growth factors
• Tissue-engineered products
• Platelet-derived therapies

Market, By Ulcer Type

• Neuropathic ulcers
• Neuro-ischemic ulcers
• Ischemic ulcers

Market, By End Use

• Hospitals
• Specialty clinics
• Ambulatory surgical centers
• Long term care settings
• Other end users

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada 
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific 
  • China
  • India
  • Japan
  • Australia
  • South Korea
• Latin America 
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa 
  • Saudi Arabia
  • South Africa
  • UAE