생물학적 피부 대체물 시장 기회, 성장 촉진요인, 산업 동향 분석 및 예측(2025-2034년)

The Global Biological Skin Substitutes Market was valued at USD 335.1 million in 2024 and is projected to expand at a CAGR of 8.5% from 2025 to 2034. The increasing prevalence of chronic wounds and burn injuries is driving demand for advanced wound care solutions, particularly biological skin substitutes. These products mimic natural skin, ensuring effective tissue integration and faster healing, making them a preferred choice for healthcare providers worldwide. As the burden of diabetes, obesity, and aging-related conditions continues to rise, so does the incidence of chronic wounds, creating significant growth opportunities for the market.

The increasing awareness regarding advanced wound care treatments and the limitations of conventional methods such as skin grafting have led to a surge in the adoption of biological skin substitutes. Minimally invasive procedures and regenerative medicine advancements have further enhanced the efficacy of these products, making them indispensable in modern healthcare. With biotechnology companies heavily investing in research and development, the industry is witnessing a wave of innovative solutions designed to improve patient outcomes. Government initiatives promoting better wound care management and a strong pipeline of new product approvals are expected to sustain market momentum over the forecast period.

The market is categorized based on product type, including human donor acellular animal-derived products, tissue-derived products, tissue-engineered skin, and biosynthetic skin substitutes. In 2024, human donor tissue-derived products accounted for 65.8% of the market share. These products are widely preferred due to their superior ability to replicate human skin and support natural tissue regeneration. Clinical trials and real-world applications have demonstrated their effectiveness in treating severe and chronic wounds, leading to their widespread adoption among healthcare professionals. The continuous refinement of these products, coupled with advancements in tissue engineering, is further reinforcing their market dominance.

Segmentation by application highlights that biological skin substitutes are used for acute wounds, chronic wounds, and other medical needs. The acute wounds segment held a 59.4% market share in 2024, primarily driven by the demand for rapid and effective treatment options in cases of surgical wounds and trauma-related injuries. The growing preference for advanced biological skin substitutes over traditional skin grafting methods is further fueling this segment's expansion. These products provide quick, reliable healing solutions, especially in emergency situations where immediate care is crucial for preventing complications and infections.

The U.S. Biological Skin Substitutes Market generated USD 126.2 million in 2024, with substantial growth prospects ahead. The rising incidence of diabetic foot ulcers, pressure ulcers, and burn injuries is propelling demand for these advanced wound care solutions. Additionally, the presence of leading biotechnology firms, coupled with increasing FDA approvals for innovative skin substitutes, is accelerating market expansion. The introduction of next-generation biological skin substitutes, including cell-based and tissue-engineered products, is reshaping the industry landscape. With continuous technological advancements and growing investments in regenerative medicine, the U.S. market is poised for sustained growth, offering promising opportunities for manufacturers and healthcare providers alike.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Increasing prevalence of chronic wounds
    • 3.2.1.2 Rising number of burn & trauma cases
    • 3.2.1.3 Growing adoption of wound care facilities
    • 3.2.1.4 Technological advancements in regenerative medicine
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Adverse side effects associated with biological skin substitutes
    • 3.2.2.2 Lack of reimbursement policies
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Future market trends
• 3.6 Gap analysis
• 3.7 Technology landscape
• 3.8 Porter's analysis
• 3.9 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Company market share analysis
• 4.4 Competitive positioning matrix
• 4.5 Vendor matrix analysis
• 4.6 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Type, 2021 – 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Human donor tissue-derived products
• 5.3 Acellular animal-derived products
• 5.4 Tissue-engineered skin products
• 5.5 Biosynthetic skin products

Chapter 6 Market Estimates and Forecast, By Application, 2021 – 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Acute wounds
• 6.3 Chronic wounds
• 6.4 Other applications

Chapter 7 Market Estimates and Forecast, By End Use, 2021 – 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Hospitals
• 7.3 Ambulatory surgical centers
• 7.4 Specialty clinics
• 7.5 Other end use

Chapter 8 Market Estimates and Forecast, By Region, 2021 – 2034 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 France
  • 8.3.3 UK
  • 8.3.4 Italy
  • 8.3.5 Spain
• 8.4 Asia Pacific
  • 8.4.1 Japan
  • 8.4.2 China
  • 8.4.3 India
  • 8.4.4 South Korea
  • 8.4.5 Australia
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Argentina
  • 8.5.3 Mexico
• 8.6 Middle East and Africa
  • 8.6.1 South Africa
  • 8.6.2 Saudi Arabia
  • 8.6.3 UAE

Chapter 9 Company Profiles

• 9.1 Aroa Biosurgery
• 9.2 Avita Medical
• 9.3 BioTissue
• 9.4 Integra LifeSciences
• 9.5 MiMedx Group
• 9.6 Misonix (Bioventus)
• 9.7 Organogenesis
• 9.8 ProgenaCare
• 9.9 Smith & Nephew
• 9.10 Stratatech Corporation (Mallinckrodt Pharmaceuticals)
• 9.11 Stryker
• 9.12 Tissue Regenix
• 9.13 Vericel Corporation