Diabetic Foot Ulcer - Market Insights, Epidemiology, and Market Forecast—2030

Diabetic Foot Ulcer - Market Insights, Epidemiology, and Market Forecast—2030

  • January 2021 •
  • 200 pages •
  • Report ID: 6025268 •
  • Format: PDF
‘Diabetic Foot Ulcer (DFU) - Market Insights, Epidemiology, and Market Forecast—2030’ report delivers an in-depth understanding of the DFU, historical and forecasted epidemiology as well as the DFU market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan.
The DFU market report provides current treatment practices, emerging drugs, DFU market share of the individual therapies, current and forecasted DFU market size from 2018 to 2030 segmented by seven major markets. The Report also covers current DFU treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Geography Covered
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018–2030
Diabetic Foot Ulcer (DFU): Disease Understanding and Treatment Algorithm

Diabetic Foot Ulcer Overview
Diabetic foot ulcer (DFU) 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.
DFU may result in an infection or other ulcer-related complications that can lead to hospitalization. Foot ulcers are a common complication of poorly controlled diabetes. Diabetic foot ulcers form when the lower layers are exposed after the skin tissues break down. When blood sugar levels are high or regularly fluctuate, skin that would usually heal may not properly repair itself because of nerve damage. These ulcers are most common under the big toes and the balls of feet and can affect the feet down to the bones.
DFUs are complex, chronic wounds, which have a major long-term impact on the morbidity, mortality, and quality of patients’ lives. Individuals who develop a DFU are at greater risk of premature death, myocardial infarction, and fatal stroke than those without a history of DFU. Unlike other chronic wounds, the development and progression of a DFU are often complicated by wide-ranging diabetic changes, such as neuropathy and vascular disease. In most DFU patients, peripheral neuropathy and peripheral arterial disease (PAD) (or both) play a central role. Therefore, DFU can be commonly classified into three types i.e. Neuropathic, Ischemic, and Neuro-ischemic.

Diabetic Foot Ulcer (DFU) Diagnosis
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. Diagnosis of DFU includes the doctor investigating the patient’s medical history for signs of any previous complication or medical condition. Other than this diagnosis of DFU requires a physical examination for checking the current condition, a few blood tests for screening any infection, and a metabolic profile to measure glucose levels. Radiological imaging tests, such as CT scan, MRI, Arteriography, etc. may also be used to gather detailed information about the DFU.

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.
Currently, treatment strategies for DFU mainly include non-surgical treatment for mild and moderate ulcers and surgical treatment for ulcers classified as severe. Non-surgical treatment options mainly include simple daily wound care, using growth factors and skin substitutes for wound repair, antibiotics for the deep infection, drainage, and cellulitis. Whereas, surgical treatment options mainly include debridement, or removal of unhealthy tissue, and vascular surgeries, to induce better blood flow. The development of growth factor for treatment represents an important therapeutic advance for diabetic neuropathic foot ulcers with adequate blood supply.

DFU Epidemiology
The DFU epidemiology division provides insights about historical and current DFU patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings
In the year 2020, the total prevalent case of DFU was 5,994,978 cases in the 7MM which are expected to grow during the study period, i.e., 2018–2030.
The disease epidemiology covered in the report provides historical as well as forecasted DFU epidemiology [segmented as 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, and Treated cases of DFU] in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2018 to 2030.

Country Wise- DFU Epidemiology
Estimates show that the highest cases of DFU in the 7MM were in the United States, followed by Italy, Germany, France, the United Kingdom, Spain, and Japan in 2020.
• In the United States, the total number of prevalent cases of DFU was 4,551,498 cases in the year 2020 which are expected to grow during the study period, i.e., 2018–2030.
• In the year 2020, the total prevalent cases of DFU were 1,274,933 cases in EU-5 which are expected to grow during the study period, i.e., 2018–2030.
• In Japan, the total number of prevalent cases of DFU was 168,547 cases in the year 2020 which are expected to grow during the study period, i.e., 2018–2030.

DFU Drug Chapters
The drug chapter segment of the DFU report encloses the detailed analysis of DFU marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the DFU clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
DFU Approved 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 DFU

DFU Emerging Drugs
TTAX01 (Amniox/TissueTech)
TTAX01, developed by Amniox Medical, a TissueTech company, is an investigational biologic form of the company’s proprietary NEOX CORD 1K. TTAX01 is the company’s first biologics license application (BLA) candidate to enter Investigational New Drug (IND) Phase III trials for DFU as the first biologic product to seek FDA approval to treat complex Wagner Grade 3–4 DFUs. TTAX01 is a cGMP experimental trial biologic drug, prepared under stringent 351 chemical manufacturing controls and release criteria. The currently marketed Neox Cord 1K is a homologous HCT/P utilizing the same umbilical cord graft tissue as TTAX01 but is only subject to current GTP 361 chemical manufacturing controls and release criteria requirements.
Engensis/VM202 (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. These functions are mediated by a receptor called c-Met. There are four types of HGF isoforms in their natural state. Helixmith maximized the biological activity of HGF by developing a cDNA-genomic hybrid sequence designed to induce the simultaneous expression of HGF728 and HGF723, the primary forms that activate c-Met receptors.
ON101 (Oneness Biotech)
ON101 is a first-in-class new drug being developed by Oneness Biotech. ON101 induces specific chemokines in wound tissues and promote infiltration of immune cells, especially the aggregation of M2 macrophage, which can inhibit wound inflammation, stimulate vascular proliferation, and ultimately heal ulcers. This special pharmacological mechanism of action allows complex diabetic chronic inflammatory wounds to be converted into normal wound healing procedures, accelerating chronic wound healing. ON101 is an ointment containing extracts commonly used traditional Chinese medicinal herbs, Plectranthus amboinicus and Centella asiatica urban.
Note: Detailed emerging therapies assessment will be provided in the final report.

DFU Market Outlook
DFU is one of the most significant and devastating complications of poorly controlled diabetes (type 1 and type 2), and probably the major component of the diabetic foot. In most DFU patients, peripheral neuropathy and peripheral arterial disease (PAD) (or both) play a central role and people who develop foot ulcers lose the ability to feel pain in the affected area. DFUs are thus complex, chronic wounds, which have a major long-term impact on the morbidity, mortality, and quality of patients’ lives. The goals of therapy for patients with DFU are wound closure, eradication of clinical evidence of infection, and the avoidance of soft tissue loss and amputations.
Currently, treatment strategies for DFU mainly include non-surgical treatment for mild and moderate ulcers and surgical treatment for ulcers classified as severe. Non-surgical treatment options mainly include simple daily wound care, using growth factors and skin substitutes for wound repair, antibiotics for the deep infection, drainage, and cellulitis. Whereas, surgical treatment options mainly include debridement, or removal of unhealthy tissue, and vascular surgeries, to induce better blood flow. The development of growth factor for treatment represents an important therapeutic advance for diabetic neuropathic foot ulcers with adequate blood supply.
Platelet-derived growth factor (PDGF) is one of the main growth factors involved in healing. It is also the only growth factor that has been approved by the US FDA. In the US, the standard practices in DFU management include surgical debridement, dressings to facilitate a moist wound environment and exudate control, wound off-loading, vascular assessment, and infection and glycemic control. Antibiotic therapy, off-loading of the wound, and surgical management of the infected diabetic foot are the treatment options in Europe.
There is only one drug, Regranex (Becaplermin), which uses PDGF and has been approved by the FDA. Other growth factors either did not show much efficacy or have not been researched.
At present, some companies have indulged themselves to initiate clinical trials that investigate new treatment options or studying how to use existing treatment options better. Current ongoing trials are evaluating stem cell therapies, growth factors, tissue grafts, etc., and investigating optimal treatment doses and durations. Key players such as TissueTech (TTAX01), Aurealis Therapeutics (AUP1602-C), Rheacell (a subsidiary of Ticeba) (ABCB5 positive Mesenchymal cells), Oneness Biotech (ON101), Biotherapy Services (RAPID Biodynamic PRP Haematogel), HelixMith (VM202), Lakewood-Amedex (Bisphosphocin Nu-3), Mallinckrodt (ExpressGraft (C9T1 Skin Tissue) and several others are investigating their candidates for the management of DFU in the 7MM.

Key Findings
The DFU market size in the 7MM is expected to change during the study period 2018–2030. The therapeutic market of DFU in the seven major markets is expected to increase during the study period (2018–2030) with a CAGR of 17.0%. According to the estimates, the highest market size of DFU is found in the United States followed by Italy.

The United States Market Outlook
The total market size of DFU therapies in the United States is expected to increase with a CAGR of 17.3% in the study period (2018–2030).

EU-5 Countries: Market Outlook
The total market size of DFU therapies in EU-5 countries is expected to increase with a CAGR of 14.1% in the study period (2018–2030).

Japan Market Outlook
The total market size of DFU therapies in Japan is expected to increase with a CAGR of 13.2% in the study period (2018–2030).

DFU Pipeline Development Activities
The drugs which are in pipeline include:
1. TTAX01 (Amniox/TissueTech)
2. Engensis/VM202 (Helixmith)
3. ON101 (Oneness Biotech)
4. Allo-APZ2-DFU/ABCB5 positive MSCs (Rheacell/Ticeba)
5. Bisphosphocin Nu-3 (Lakewood-Amedex)
6. AUP1602-C (Aurealis Therapeutics)
7. RAPID Biodynamic Platelet Rich Plasma Haematogel (Biotherapy Services)
8. MBN-101 (Microbion Corporation)
9. ExpressGraft/C9T1 Skin Tissue (Mallinckrodt)
Note: Detailed emerging therapies assessment will be provided in the final report.
Analyst Commentary
• The gold standard for DFU treatment includes debridement of the wound, management of any infection, revascularization procedures when indicated, and off-loading of the ulcer. Currently, the market is mainly dominated by off-label generic drugs such as analgesics and anti-infectives, around 78% of the current market is captured by these two classes of drugs.
• The pipeline of DFU is very robust containing cell therapy, gene therapy, and also small molecules as well. Around three 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 emerging therapies, cryopreserved umbilical cord TTAX01 allograft from Amniox Medical (a TissueTech) is expected to garner the highest patient share owing to promising efficacy signals shown in phase II trial, and the company is well on track with two-phase III multicenter randomized controlled clinical trials.
• A strong pipeline containing small molecule, gene, and cell therapy, and the ongoing research in the development of novel products and therapies for the management of DFU is another key factor contributing to the growth of the DFU market.
Access and Reimbursement Scenario in DFU Therapies
DFU complications are challenging and costly. In 2001, diabetes-related foot ulcers and amputations were estimated to cost US health care payers USD 11 billion. In parallel with this, the United Kingdom (UK) estimated expenditure at GBP 3 billion. Moreover, the total annual cost of DFUs was estimated to be GBP 252 million. Lower limb amputations are preceded by foot ulcers in around 75–85% of cases, commonly in association with chronic infection and severe gangrene. In 2007, the treatment of diabetes and its complications in the United States generated at least USD 116 billion in direct costs; at least 33% of these costs were linked to the treatment of foot ulcers.
Data on Medicare beneficiaries reported under the auspices of the Agency for Healthcare Research and Quality indicates that medical expenditures are thought to be 2.3 times higher in people with diabetes than those without the disease. Many of these costs are likely to be related to the complications associated with diabetes, like DFUs and lower extremity amputations (LEAs). The report also states that among the Medicare Fee-For-Service (FFS) population with a DFU, the average number of office visits per year is around 14, and they are hospitalized on average 1.5 times/year. The average Medicare reimbursement (2008) for all their services was USD 35,000. Among the same population, those with an LEA had an average of 12 office visits per year and were hospitalized twice. The average Medicare reimbursement for all their services was approximately USD 51,000.
Among Medicare FFS beneficiaries who had a prevalent DFU, the mean reimbursement for all Medicare services was USD 31,600 in 2006, USD 33,100 in 2007, and USD 35,100 in 2008. Concerning drug costs, the mean total cost of all medications used by Medicare FFS beneficiaries with Part D coverage with a prevalent DFU was USD 5000 in 2006, USD 4,800 in 2007, and USD 5,100 in 2008. The mean reimbursement for selected services for a beneficiary with a DFU (e.g., services likely specific to diabetic foot/lower extremity care) was USD 1,900 in 2006, USD 1,800 in 2007, and USD 1,900 in 2008.
Note: Detailed HTA assessment will be provided in the final report.
KOL-Views
To keep up with current market trends, we take KOLs and SME’s opinion working in the DFU domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or DFU market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the DFU Market by using various Competitive Intelligence tools that includes – SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report
• The report covers the descriptive overview of DFU, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies.
• Comprehensive insight has been provided into the DFU epidemiology and treatment in the 7MM.
• Additionally, an all-inclusive account of both the current and emerging therapies for DFU is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the DFU market; historical and forecasted is included in the report, covering drug outreach in the 7MM.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global DFU market.

Report Highlights
• In the coming years, the DFU market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence DFU R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for DFU. The launch of emerging therapies will significantly impact the DFU market.
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for DFU.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

DFU Report Insights
• Patient Population
• Therapeutic Approaches
• DFU Pipeline Analysis
• DFU Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

DFU Report Key Strengths
• 10 Years Forecast
• 7MM Coverage
• DFU Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market

• Drugs Uptake

DFU Report Assessment
• SWOT Analysis
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Conjoint Analysis
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:
• What was the DFU Market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the DFU total market size as well as market size by therapies across the 7MM during the study period (2018–2030)?
• What are the key findings of the market across the 7MM and which country will have the largest DFU market size during the study period (2018–2030)?
• At what CAGR, the DFU market is expected to grow in the 7MM during the study period (2018–2030)?
• What would be the DFU market outlook across the 7MM during the study period (2018–2030)?
• What would be the DFU market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• DFU patient types/pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
• How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration, and frequencies based on their clinical trial results?
• Among the emerging therapies, what are the potential therapies which are expected to disrupt the DFU market?

Epidemiology Insights:
• What are the disease risks, burdens, and unmet needs of the DFU?
• What is the historical DFU patient pool in the seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What would be the forecasted patient pool of DFU in the 7 major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What will be the growth opportunities in the 7MM concerning the patient population about DFU?
• Out of all the 7MM countries, which country would have the highest prevalent population of DFU during the study period (2018–2030)?
• At what CAGR the population is expected to grow in the 7MM during the study period (2018–2030)?
• What are the various recent and upcoming events which are expected to improve the diagnosis of DFU?

Current Treatment Scenario and Emerging Therapies:
• What are the current options for the treatment of DFU?
• What are the current treatment guidelines for the treatment of DFU in the US, Europe, and Japan?
• How many companies are developing therapies for the treatment of DFU?
• How many therapies are developed by each company for the treatment of DFU?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of DFU?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the DFU therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for DFU and their status?
• What are the key designations that have been granted for the emerging therapies for DFU?
• What is the global historical and forecasted market of DFU?

Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving the DFU market.
• To understand the future market competition in the DFU market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for DFU in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the DFU market.
• To understand the future market competition in the DFU market.