당뇨병성 족부궤양(DFU)용 생물제제 시장 : 산업 규모, 점유율, 동향, 기회, 예측, 적응증별, 최종사용자별, 지역별, 경쟁별(2020-2030년)

Global Diabetic foot ulcer (DFU) biologics market was valued at USD 0.65 billion in 2024 and is projected to reach USD 0.88 billion by 2030, growing at a compound annual growth rate (CAGR) of 5.41% during the forecast period. DFUs pose a significant burden on healthcare systems worldwide, driven by their high prevalence and the complications they often entail. These ulcers typically result from impaired circulation, neuropathy, and weakened immune response, making them particularly challenging to treat through conventional methods.

Biologic therapies-such as growth factors, gene therapies, and cellular treatments-are increasingly being adopted for their ability to enhance wound healing, minimize infection risks, and mitigate further complications. The market features a diverse portfolio of biologic products, including platelet-rich plasma (PRP), skin substitutes, stem cell therapies, and recombinant human growth factors. These treatments aim to stimulate tissue regeneration, accelerate healing, and reduce the reliance on invasive interventions, such as amputation.

As medical professionals continue to recognize the clinical benefits of biologics in DFU management, the demand for these therapies is anticipated to grow consistently. However, one of the primary obstacles to broader adoption is the high cost associated with biologic treatments. These therapies often require sophisticated manufacturing processes and complex delivery systems, contributing to their elevated pricing. This presents a significant challenge for healthcare providers and patients operating within constrained budgets.

Key Market Drivers

Expansion of the Healthcare Sector

The rising global incidence of diabetes is a major driver of DFU prevalence, with approximately 15% of diabetic patients developing foot ulcers. Currently, the global prevalence of DFUs among adults with diabetes is estimated at 6.3%, with annual incidence rates ranging from 9.1 to 26.1 million cases. Risk factors include long-standing diabetes, poor glycemic control, peripheral neuropathy, and foot abnormalities such as calluses or deformities.

This growing patient population necessitates more effective treatment modalities, including biologics. Ongoing investment in healthcare research and technological innovation is accelerating the development of novel biologic therapies, improving clinical outcomes and enhancing market growth. Notably, AI-powered diagnostic tools and applications are increasingly used to support the detection and management of DFUs, further improving efficiency and treatment precision.

Key Market Challenges

High Cost of Treatment

Biologic therapies are derived from living organisms and involve highly regulated, intricate manufacturing processes, including cell cultivation, purification of biologically active substances, and development of engineered tissues. These processes often require specialized infrastructure, advanced equipment, and stringent quality assurance protocols, all of which contribute to increased production costs.

Additionally, the research and development (R&D) required to bring biologic products to market is both time-intensive and capital-intensive. Companies must conduct comprehensive preclinical studies and clinical trials to validate product safety and efficacy, as well as navigate complex regulatory pathways. These high development costs are ultimately reflected in the pricing of biologic treatments, posing financial challenges for both healthcare systems and patients.

Key Market Trends

Rising Global Diabetes Prevalence

The incidence of diabetes has increased dramatically over recent decades, particularly in low- and middle-income countries where healthcare access remains limited. The global diabetic population surged from 200 million in 1990 to 830 million by 2022. In 2021 alone, diabetes and its related complications-including kidney disease-accounted for over 2 million deaths. Elevated blood glucose levels were also responsible for approximately 11% of all cardiovascular-related fatalities.

This rising prevalence has directly contributed to an increase in DFU cases, creating greater demand for effective, advanced treatment solutions such as biologics. The DFU biologics market is witnessing robust growth, driven by increasing disease incidence and the expanding availability of innovative therapies. Biologic treatments, particularly those utilizing growth factors and cell-based therapies, are gaining widespread adoption due to their superior efficacy in wound healing and infection control.

Key Market Players

• Organogenesis Inc.
• Tissue Regenix Group Plc
• BioTissue Holdings, Inc.
• Integra LifeSciences Holdings Corporation
• MIMEDX Group, Inc.
• Convatec Inc.
• Smith & Nephew PLC
• Stedical Scientific, Inc.
• Zimmer Biomet Holdings, Inc.
• GUNZE LIMITED

Report Scope

In this report, the Global Diabetic Foot Ulcer Biologics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Diabetic Foot Ulcer Biologics Market, By Indication:

• Neuro-ischemic Ulcers
• Neuropathic Diabetic Foot Ulcer
• Ischemic Diabetic Foot Ulcer

Diabetic Foot Ulcer Biologics Market, By End User:

• Hospitals
• Clinics
• Ambulatory Surgical Centers
• Long-Term Care Settings
• Others

Diabetic Foot Ulcer Biologics Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Diabetic Foot Ulcer Biologics Market.

Available Customizations:

Global Diabetic Foot Ulcer Biologics Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, and Trends

4. Impact of COVID-19 on Global Diabetic Foot Ulcer Biologics Market

5. Global Diabetic Foot Ulcer Biologics Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Indication (Neuro-ischemic Ulcers, Neuropathic Diabetic Foot Ulcer, Ischemic Diabetic Foot Ulcer)
  • 5.2.2. By End User (Hospitals, Clinics, Ambulatory Surgical Centers, Long-Term Care Settings, Others)
  • 5.2.3. By Region
  • 5.2.4. By Company (2024)
• 5.3. Market Map

6. North America Diabetic Foot Ulcer Biologics Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Indication
  • 6.2.2. By End User
  • 6.2.3. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Diabetic Foot Ulcer Biologics Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Indication
      • 6.3.1.2.2. By End User
  • 6.3.2. Mexico Diabetic Foot Ulcer Biologics Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Indication
      • 6.3.2.2.2. By End User
  • 6.3.3. Canada Diabetic Foot Ulcer Biologics Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Indication
      • 6.3.3.2.2. By End User

7. Europe Diabetic Foot Ulcer Biologics Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Indication
  • 7.2.2. By End User
  • 7.2.3. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Diabetic Foot Ulcer Biologics Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Indication
      • 7.3.1.2.2. By End User
  • 7.3.2. Germany Diabetic Foot Ulcer Biologics Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Indication
      • 7.3.2.2.2. By End User
  • 7.3.3. United Kingdom Diabetic Foot Ulcer Biologics Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Indication
      • 7.3.3.2.2. By End User
  • 7.3.4. Italy Diabetic Foot Ulcer Biologics Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Indication
      • 7.3.4.2.2. By End User
  • 7.3.5. Spain Diabetic Foot Ulcer Biologics Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Indication
      • 7.3.5.2.2. By End User

8. Asia Pacific Diabetic Foot Ulcer Biologics Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Indication
  • 8.2.2. By End User
  • 8.2.3. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Diabetic Foot Ulcer Biologics Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Indication
      • 8.3.1.2.2. By End User
  • 8.3.2. India Diabetic Foot Ulcer Biologics Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Indication
      • 8.3.2.2.2. By End User
  • 8.3.3. South Korea Diabetic Foot Ulcer Biologics Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Indication
      • 8.3.3.2.2. By End User
  • 8.3.4. Japan Diabetic Foot Ulcer Biologics Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Indication
      • 8.3.4.2.2. By End User
  • 8.3.5. Australia Diabetic Foot Ulcer Biologics Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Indication
      • 8.3.5.2.2. By End User

9. South America Diabetic Foot Ulcer Biologics Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Indication
  • 9.2.2. By End User
  • 9.2.3. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Diabetic Foot Ulcer Biologics Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Indication
      • 9.3.1.2.2. By End User
  • 9.3.2. Argentina Diabetic Foot Ulcer Biologics Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Indication
      • 9.3.2.2.2. By End User
  • 9.3.3. Colombia Diabetic Foot Ulcer Biologics Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Indication
      • 9.3.3.2.2. By End User

10. Middle East and Africa Diabetic Foot Ulcer Biologics Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Indication
  • 10.2.2. By End User
  • 10.2.3. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Diabetic Foot Ulcer Biologics Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Indication
      • 10.3.1.2.2. By End User
  • 10.3.2. Saudi Arabia Diabetic Foot Ulcer Biologics Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Indication
      • 10.3.2.2.2. By End User
  • 10.3.3. UAE Diabetic Foot Ulcer Biologics Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Indication
      • 10.3.3.2.2. By End User

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global Diabetic Foot Ulcer Biologics Market: SWOT Analysis

14. Porters Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. Organogenesis Inc.
  • 15.1.1. Business Overview
  • 15.1.2. Company Snapshot
  • 15.1.3. Products & Services
  • 15.1.4. Financials (As Reported)
  • 15.1.5. Recent Developments
  • 15.1.6. Key Personnel Details
  • 15.1.7. SWOT Analysis
• 15.2. Tissue Regenix Group Plc
• 15.3. BioTissue Holdings, Inc.
• 15.4. Integra LifeSciences Holdings Corporation
• 15.5. MIMEDX Group, Inc.
• 15.6. Convatec Inc.
• 15.7. Smith & Nephew PLC
• 15.8. Stedical Scientific, Inc.
• 15.9. Zimmer Biomet Holdings, Inc.
• 15.10. GUNZE LIMITED

16. Strategic Recommendations

17. About Us & Disclaimer