Opportunity Analyzer: Diabetic Foot Ulcers – Opportunity Analysis and Forecast to 2025

GlobalData estimates sales of diabetic foot ulcer (DFU) and diabetic foot infection (DFI) drugs to be approximately $292.1M across the 7MM in 2015, encompassing the US, 5EU, and Japan. DFU sales alone accounting for $118.7M across the 7MM. The DFU, DFI market will grow at a CAGR of 11.6% over the forecast period, reaching sales of $873.4M by 2025. The US is the largest market for DFU, DFI therapies, contributing approximately 62% of total sales in the base year. GlobalData expects the uptake a novel wound healing therapy (FirstString's Granexin) to be the strongest driver of growth in the DFU market in the 7MM, reaching sales of $570.3M in 2025. Despite the anticipated launch of Granexin, there is ample opportunity for pipeline drugs targeting the subset of DFUs that are ischemic. Difficulty of successfully developing a DFU or DFI candidate is expected to be the strongest barrier. There have been multiple Phase III DFU and DFI clinical trial terminations in the past five years alone (mainly due to trials failing to meet primary endpoints), leaving the market void of any new DFU drugs for almost two decades.

Scope

Overview of DFUs and DFIs, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized DFU therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the DFU and DFI therapeutics market.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.

Analysis of the current and future market competition in the global DFU and DFI therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

In addition to standard of care (SOC), Regranex and Fiblast have been the only wound healing pharmacological drugs used to treat DFUs in the US and Japan respectively. The efficacy of these agents is disputed among KOLs, with the majority of experts expressing dissatisfaction with these limited options. Therefore, there is a considerable need for additional therapies within the indication. What are the other main unmet needs in this market?

The current late-stage DFU pipeline encompasses one novel synthetic bioactive peptide, FirstString’s Granexin, which binds the ZO1 protein, and stabilizes connexin 43 gap junctions to reduce excessive inflammation and promote normal tissue regeneration. Will Granexin make a significant impact on the DFU market?

There continues to be an increase in DFU diagnosed prevalence across the 7MM over the past 10 years. How will epidemiological changes impact the growth of the future market? Overall, which of the major markets is the most lucrative within the DFU space?

Companies mentioned

Advanced BioHealing

Advanced Tissue Sciences

CoDa Therapeutics

FirstString Research

Genentech

GlaxoSmithKline (GSK)

Johnson & Johnson (J&J)

Healthpoint Biotherapeutics Kaken Pharmaceutical

Lakewood-Amedex

MiMedx

Relief Therapeutics

Scios

Shire

Shire Regenerative Medicine

Smith & Nephew

Stryker Biotech

Olympus

Olympus Biotech

Organogenesis

Osiris Therapeutics

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Assessment of DFUs

3.2.1Patient Symptoms, History, and Visual Examination

3.2.2Testing for Neuropathy

3.2.3Testing Vascular Status

3.2.4Identifying Infection

3.3Classification of Diabetic Foot Ulcers

3.4Prognosis and Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1Diagnosed Incidence and Total Prevalence

4.4Forecast Methodology

4.4.1Sources Used Tables

4.4.2Forecast Assumptions and Methods

4.4.3Sources Not Used

4.5Epidemiological Forecast of DFU (2015–2025)

4.5.1Diagnosed Incident Cases of DFU Among the Diagnosed Diabetic Population

4.5.2Total Prevalent Cases of DFU Among the Diagnosed Diabetic Population

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Current Treatment Options

5.1Overview

5.2Treatment

5.2.1Treatment Guidelines and Leading Prescribed Drugs

5.2.2Clinical Practice

5.3Product Profiles – Wound-Healing Agents

5.3.1Regranex (Becaplermin) Gel

5.3.2Fiblast (Trafermin) Spray

5.4Product Profiles – Cell-Based Skin Substitutes, Membrane Allografts

5.4.1Dermagraft (Human Fibroblast-Derived Dermal Substitute)

5.4.2Apligraf (Bi-layered Skin Substitute)

5.4.3Grafix (Human Cellular Repair Matrix)

5.4.4Epifix (Dehydrated Human Amnion/Chorion Membrane Allograft)

5.5Additional Therapies for DFUs and DFIs

5.5.1Vasodilators

5.5.2Antibiotics

6Unmet Needs Assessment and Opportunity Analysis

6.1Overview

6.2Unmet Needs Analysis

6.2.1Improved Physician and Patient Education

6.2.2More Effective Treatments: Agents Promoting Quicker Wound Closure and Targeting Neuroischemic DFUs

6.2.3More Effective Antibacterial Treatments for DFIs

6.2.4Affordable Products and Improved Reimbursement

6.2.5Better Understanding of Wound Healing Processes

7Research and Development Strategies

7.1Overview

7.1.1Growth Factors and Bioactive Peptides

7.1.2Cellular Therapies: Platelets and Stem Cells

7.1.3Wound Care Company Acquisitions and Licensing Agreements

7.2Clinical Trial Design

7.2.1Current Clinical Trial Design

7.2.2Future Clinical Trial Design Considerations

8Pipeline Assessment

8.1Overview

8.2Promising Wound-Healing Agent in Clinical Development

8.2.1Granexin (Synthetic Peptide)

8.3Innovative Early-Stage Approaches, Drugs in Development

9Pipeline Valuation Analysis

9.1Clinical Benchmark of Key Pipeline Drugs

9.2Commercial Benchmark of Key Pipeline Drugs

9.3Competitive Assessment

9.4Top-Line Ten-Year Forecast

9.4.1US

9.4.25EU

9.4.3Japan

10Appendix

10.1Bibliography

10.2Abbreviations

10.3Methodology

10.4Forecast Methodology

10.4.1Percent Diagnosed Patients

10.4.2Percent Drug-Treated Patients

10.4.3Drugs Included in Each Therapeutic Class

10.4.4Launch and Patent Expiry Dates

10.4.5General Pricing Assumptions

10.4.6Individual Drug Assumptions

10.5Physicians and Specialists Included in This Study

10.6About the Authors

10.6.1Senior Analyst, Cardiovascular and Metabolic Disorders

10.6.2Director, Cardiovascular and Metabolic Disorders

10.6.3Epidemiologists

10.6.4Global Therapy of Therapy Analysis and Epidemiology

10.7About GlobalData

10.8Disclaimer

List of Tables

Table 1: Typical Features and Characterization of DFUs According to Etiology

Table 2: DFU Risk Factors

Table 3: Wagner Classification System for DFUs

Table 4: University of Texas Classification System for DFUs

Table 5: Risk Factors and Comorbidities of DFUs

Table 6: 7MM, Diagnosed Incidence of DFU Among the Diabetic Population from 1993–2008

Table 7: 7MM, Total Prevalence of DFU Among the Diabetic Population from 1990–2008

Table 8: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of DFU Among the Diagnosed Diabetic Population

Table 9: 7MM, Sources Used for the Classification of DFUs Among the DFU-Diagnosed Incident Population

Table 10: 7MM, Sources Used to Forecast DFI and PAD Cases Among the DFU-Diagnosed Incident Population

Table 11: 7MM, Sources Used to Forecast the Total Prevalent Cases of DFU Among the Diagnosed Diabetic Population

Table 12: 7MM, Sources Not Used in Epidemiological Analysis of DFU

Table 13: 7MM, Diagnosed Incident Cases of DFU, Ages =20 Years, Both Sexes, N, Selected Years 2015–2025

Table 14. 7MM, Diagnosed Incident Cases of DFU, by Age, Both Sexes, N (Row %), 2015

Table 15: 7MM, Diagnosed Incident Cases of DFU, by Sex, Ages =20 Years, N (Row %), 2015

Table 16: 7MM, Total Prevalent Cases of DFU, Ages =20 Years, Both Sexes, N, Selected Years 2015–2025

Table 17. 7MM, Total Prevalent Cases of DFU, by Age, Both Sexes, N (Row %), 2015

Table 18: 7MM, Total Prevalent Cases of DFU, by Sex, Ages =20 Years, N (Row %), 2015

Table 19: Treatment Guidelines for DFUs

Table 20: Leading Advanced Wound Care Treatments Used to Treat DFUs

Table 21: Product Profile – Regranex Gel

Table 22: Regranex Gel SWOT Analysis, 2016

Table 23: Product Profile – Fiblast

Table 24: Fiblast SWOT Analysis, 2016

Table 25: Product Profile – Dermagraft

Table 26: Product Profile – Apligraf

Table 27: Product Profile – Grafix

Table 28: Product Profile – EpiFix

Table 29: Leading Antibiotics Prescribed for DFIs Across 7MM

Table 30: Overall Unmet Needs – Current Level of Attainment

Table 31: DFUs – Late Stage Pipeline, 2016

Table 32: Product Profile – Granexin

Table 33: Granexin SWOT Analysis, 2016

Table 34: Early-Stage Pipeline Products for DFUs and DFIs

Table 35: Clinical Benchmark of Key Pipeline Drugs – Wound-Healing Agents

Table 36: Commercial Benchmark of Key Pipeline Drugs – Wound-Healing Agents

Table 37: Top-Line Sales Forecasts ($M) for the DFU and DFI Market 2015–2025

Table 38: Key Events Impacting Sales in the DFU, 2015–2025

Table 39: DFU Market – Drivers and Barriers, 2015–2025

Table 40: Sales Forecasts ($M) for DFUs and DFIs in the US, 2015–2025

Table 41: Sales Forecasts ($M) for DFUs and DFIs in the 5EU, 2015–2025

Table 42: Sales Forecasts ($M) for DFUs and DFIs in Japan, 2015–2025

Table 43: Key Events Impacting Sales in the DFU Market, 2015–2025

Table 44: Number of High-Prescribing Physicians Surveyed

List of Figures

Figure 1: DFI Characteristics

Figure 2: 7MM, Diagnosed Incident Cases of DFU, Ages =20 Years, Both Sexes, N, Selected Years 2015–2025

Figure 3: 7MM, Diagnosed Incident Cases of DFU, by Age, Both Sexes, N, 2015

Figure 4: 7MM, Diagnosed Incident Cases of DFU, Ages =20 Years, by Sex, N , 2015

Figure 5: 7MM, Age-Standardized Diagnosed Incidence of DFU, Ages =20 Years, by Sex, Cases per 100,000 Diabetic Population, 2015

Figure 6: 7MM, Diagnosed Incident Cases of DFU by Classification, Both Sexes, Ages =20 Years, 2015

Figure 7: 7MM, DFI Cases Among the DFU-Diagnosed Incident Population, Both Sexes, Ages =20 Years, 2015

Figure 8: 7MM, PAD Cases Among the DFU-Diagnosed Incident Population, Both Sexes, Ages =20 Years, 2015

Figure 9: 7MM, Total Prevalent Cases of DFU, Ages =20 Years, Both Sexes, N, Selected Years 2015–2025

Figure 10: 7MM, Total Prevalent Cases of DFU, by Age, Both Sexes, N, 2015

Figure 11: 7MM, Total Prevalent Cases of DFU, Ages =20 Years, by Sex, N , 2015

Figure 12: 7MM, Age-Standardized Total Prevalence of DFU, Ages =20 Years, by Sex, %, 2015

Figure 13: DFU Management

Figure 14: Competitive Assessment of the Late-Stage Pipeline Wound-Healing Agents for DFUs, 2015–2025

Figure 15: DFU and DFI Sales by Region, 2015-2025

Figure 16: Sales for DFUs and DFIs by Drug in the US, 2015 and 2025

Figure 17: Sales for DFUs and DFIs by Drug in the 5EU, 2015 and 2025

Figure 18: Sales for DFUs and DFIs by Drug in Japan, 2015 and 2025

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