Diabetic Foot Ulcers Market

• Diabetic Foot Ulcer is an open sore (also referred to as wounds) on the skin that does not heal the way it should.
• Owing to the higher prevalent cases and high treatment costs, the highest market size of DFU is expected to be from the United States, i.e., around 90% of the total market size in the 7MM, followed by Italy and Germany.
• Diabetic Foot Ulcers commonly occurs in type 1 and type 2 diabetes mellitus patients, as they are a common complication of poorly controlled diabetes.
• Diabetic Foot Ulcers are complex, chronic wounds, which have a major long-term impact on the morbidity, mortality, and quality of patients’ lives.
• The most significant risk factors for foot ulceration are diabetic neuropathy, peripheral arterial disease, and consequent traumas of the foot.
• Other risk factors include tobacco use, alcohol consumption, poorly fitted or poor quality shoes, poor hygiene, improper trimming of toenails, poor glycemic control, and previous foot ulcerations.
• 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.
• Currently, the only approved therapy for DFU is REGRANEX (becaplermin) gel.
• The Diabetic Foot Ulcers Pipeline is very robust containing cell therapy, gene therapy, and also small molecules as well. A few of these companies are in the final stage of their developments (i.e. in phase III) and are expected to have a significant impact on the DFU market.
• Among the 7MM, the highest number of cases of Diabetic Foot Ulcers were found to be in the US, accounting for ~75% in 2023.

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DelveInsight's “Diabetic Foot Ulcer Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Diabetic Foot Ulcer , historical and forecasted epidemiology as well as the Diabetic Foot Ulcer market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Diabetic Foot Ulcer market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Diabetic Foot Ulcer  market size from 2020 to 2034. The report also covers current Diabetic Foot Ulcer treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Diabetic Foot Ulcer Treatment Market: Understanding and Algorithm

Diabetic Foot Ulcer is an open sore or wound in patients with diabetes; they occur in type 1 and type 2 diabetes mellitus. The average duration of diabetes before ulceration is >10 years. The wound is commonly located on the bottom of the foot. A DFU is caused by neuropathic (nerve) and vascular (blood vessel) complications of diabetes. Nerve damage due to diabetes causes altered or complete loss of feeling in the foot and/or leg, known as peripheral neuropathy.

The diagnosis should encompass a full patient history, including medication, comorbidities, and diabetes status. It should also consider the history of the wound, previous DFUs or amputations, and any symptoms suggestive of neuropathy. After diagnosing a patient with DFU, medical practitioners generally identify the seriousness of an ulcer on a scale of 0 to 3 using the following criteria:

1. Grade 0: no ulcer but foot at risk

2. Grade 1: ulcer present but no infection

3. Grade 2: ulcer deep, exposing joints and tendons

4. Grade 3: extensive ulcers or abscesses from infection

Further details related to country-based variations in diagnosis are provided in the report...

Diabetic Foot Ulcer Treatment

The main goal in the management of diabetic ulcers is the closure of the wound. Treatment of DFU wound in DM patients is carried out regularly with the type of action depending on the severity of the ulcer and the presence or absence of ischemia. The basis of DFU therapy is: necrotomy/debridement, reducing the load/pressure on the area of the injury (off-loading), manage the infection by diagnosing the type of bacteria, providing adequate antibiotics and ulcer treatment using wound dressing clean and moist.

Diabetic Foot Ulcer Epidemiology

The Diabetic Foot Ulcer epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The Diabetic Foot Ulcer epidemiology is segmented with detailed insights into total prevalent cases, total diagnosed cases, gender-specific cases, age-specific diagnosed cases, severity/chronicity of wound-specific diagnosed cases, treated cases of DFU.

• In 2023, the total prevalent cases of DFU in the 7MM were highest in US.
• Among EU4 countries and the UK, the highest number of cases of DFU were found to be in Italy in 2023.
• In 2023, gender-specific cases of diabetic foot ulcers (DFU) in the 7MM comprised of 60% males and 40% females.
• In the United States, the severity/chronicity of wound-specific diagnosed cases of DFU were 35% and 65% cases for acute/healed wound and chronic/unhealed wound, respectively, in 2023.

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Diabetic Foot Ulcer Recent Developments

• In March 2025, Orthofix Medical Inc. announced that it received FDA 510(k) clearance and the European CE Mark for the TrueLok™ Elevate Transverse Bone Transport (TBT) System. TrueLok Elevate offers a limb preservation treatment for bony or soft tissue deformities and defects, such as diabetic foot ulcers and nonhealing or deep tissue wounds.
• In February 2025, PolarityBio announced that its regenerative tissue product, SkinTE, received Breakthrough Therapy Designation (BTD) from the U.S. FDA for treating Wagner Grade 1 Diabetic Foot Ulcers (DFU).

Diabetic Foot Ulcer Drug Chapters

The drug chapter segment of the Diabetic Foot Ulcer treatment market report encloses a detailed analysis of Diabetic Foot Ulcer marketed drugs and late-stage (Phase III and Phase II) Diabetic Foot Ulcers pipeline drugs. It also deep dives into the Diabetic Foot Ulcer pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Diabetic Foot Ulcers Marketed Drugs

• Regranex Gel (Becaplermin): Smith & Nephew

Regranex Gel is the first and only FDA-approved recombinant platelet-derived growth factor (PDGF) therapy for diabetic neuropathic ulcers. Regranex Gel, 0.01% contains becaplermin, a human platelet-derived growth factor that is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. Regranex Gel is indicated as an adjunct to, and not a substitute for, good ulcer care practices. Becaplermin containing Regranex is used as a topical administration.

Note: Detailed current therapies assessment will be provided in the full report of Diabetic Foot Ulcer...

Diabetic Foot Ulcers Emerging Drugs

• TTAX01 (Neox Cord 1K): Amniox (TissueTech)

Neox Cord 1K combines cryopreserved umbilical cord and amniotic membrane, mirroring the embryo's inner cell mass with superior processing. TTAX01, utilizing TissueTech's CryoTek technology, preserves the umbilical cord. Amniotic tissue, unique for its regenerative properties, fosters healing with minimal scarring, driven by innate biological factors promoting tissue growth and repair. TTAX01 aims to harness and transplant these properties for therapeutic use beyond the womb. Currently, TTAX01 is in the Phase III.

• Engensis (VM202; Donaperminogene Seltoplasmid): Helixmith

Engensis (VM202) is HelixMith’s leading product and is being developed as a plasmid DNA treatment. It produces high levels of HGF protein when administered to muscle. HGF is a protein known to induce various biological responses, such as inducing the formation of new blood vessels, inhibiting fibrosis and inflammation, and promoting nerve regeneration. VM202 is currently in the pivotal Phase III (NCT02563522) stage of development in the US.

In November 2020, Helixmith announced that the formulation development team led by Dr. Bae Bae-dong (Process Development/Production Technology Division) of Helixmith developed a special formulation capable of stably maintaining the bio-activity of Engensys (VM202) even in refrigerated (4℃) conditions. This formulation is the world’s first pre-filled disposable syringe formulation for Engensys (VM202)

Note: Detailed emerging therapies assessment will be provided in the final report...

Diabetic Foot Ulcer Market Outlook

Key Diabetic Foot Ulcers Companies, such as Amniox (TissueTech), Helixmith, Oneness Biotech and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Diabetic Foot Ulcer. The high cost of treatment and lack of access to specialists are some of the major factors which might hamper the growth of the market. The launch of TTAX01, Engensis, ON101, ABCB5-positive mesenchymal stem cells, and Bisphosphocin Nu-3, is anticipated during the forecast period. The market is anticipated to witness a substantial positive shift owing to better uptake of existing drugs, gene therapy and raised awareness. 

Diabetic Foot Ulcer Drugs Uptake

This section focuses on the uptake rate of potential Diabetic Foot Ulcers drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Further detailed analysis of emerging therapies drug uptake in the report...

Diabetic Foot Ulcer Pipeline Development Activities

The Diabetic Foot Ulcers therapeutics market report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key Diabetic Foot Ulcers Companies involved in developing targeted therapeutics.

Pipeline Development Activities

The Diabetic Foot Ulcers therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Diabetic Foot Ulcer emerging therapies.

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KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility. DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of Diabetic Foot Ulcer. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the Diabetic Foot Ulcers drugs market and the unmet needs.

Diabetic Foot Ulcers Drugs Market: Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Diabetic Foot Ulcers Therapeutics Market Access and Reimbursement

The Diabetic Foot Ulcers therapeutics market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Diabetic Foot Ulcers Treatment Market Report Scope

• The Diabetic Foot Ulcers treatment market report covers a segment of key events, an executive summary, descriptive overview explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the Diabetic Foot Ulcer therapeutics market, historical and forecasted Diabetic Foot Ulcers treatment market size, Diabetic Foot Ulcers market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The Diabetic Foot Ulcers treatment market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Diabetic Foot Ulcer drugs market.

Diabetic Foot Ulcer Treatment Market Report Insights

• Patient-based Diabetic Foot Ulcers Market Forecasting
• Therapeutic Approaches
• Diabetic Foot Ulcer Pipeline Analysis
• Diabetic Foot Ulcer Market Size and Trends
• Existing and future Diabetic Foot Ulcers Therapeutics Market Opportunity

Diabetic Foot Ulcer Treatment Market Report Key Strengths

• 11 Years Diabetic Foot Ulcers Market Forecast
• 7MM Coverage
• Diabetic Foot Ulcer  Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on approved and emerging therapies
• Key Cross Competition
• Conjoint analysis
• Diabetic Foot Ulcers Drugs Uptake
• Key Diabetic Foot Ulcers Market Forecast Assumptions

Diabetic Foot Ulcer Treatment Market Report Assessment

• Current Diabetic Foot Ulcers Treatment Market Practices
• Diabetic Foot Ulcers Unmet Needs
• Diabetic Foot Ulcers Pipeline Product Profiles
• Diabetic Foot Ulcers Drugs Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What is the growth rate of the 7MM Diabetic Foot Ulcer treatment market?
• What was the Diabetic Foot Ulcer market size, the Diabetic Foot Ulcers treatment market size by therapies, Diabetic Foot Ulcers market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for the treatment of Diabetic Foot Ulcer?
• How many Diabetic Foot Ulcers Companies are developing therapies for the Diabetic Foot Ulcer treatment?
• What are the recent novel therapies, targets, Diabetic Foot Ulcers Mechanisms of Action, and technologies developed to overcome the limitations of existing therapies?
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to Buy

• The Diabetic Foot Ulcers treatment market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Diabetic Foot Ulcer Market.
• Insights on patient burden/disease Diabetic Foot Ulcers prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the Diabetic Foot Ulcers treatment market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing Diabetic Foot Ulcers treatment market so that the upcoming players can strengthen their development and launch strategy.

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