生物皮膚替代品市場機會、成長動力、產業趨勢分析及 2025-2034 年預測

2024 年全球生物皮膚替代品市場價值為 3.351 億美元，預計 2025 年至 2034 年期間的複合年成長率為 8.5%。慢性傷口和燒傷的日益普遍推動了對先進傷口護理解決方案的需求，尤其是生物皮膚替代品。這些產品模仿天然皮膚，確保有效的組織整合和更快的癒合，使其成為全球醫療保健提供者的首選。隨著糖尿病、肥胖症和老化相關疾病的負擔不斷增加，慢性傷口的發生率也在上升，為市場創造了巨大的成長機會。

人們對先進傷口護理治療的認知不斷提高，以及皮膚移植等傳統方法的局限性，導致生物皮膚替代品的採用激增。微創手術和再生醫學的進步進一步提高了這些產品的功效，使其成為現代醫療保健中不可或缺的一部分。隨著生技公司大力投資研發，該產業正經歷一波旨在改善患者治療效果的創新解決方案浪潮。預計政府推動的改善傷口護理管理的舉措和大量新產品的批准將在預測期內維持市場發展勢頭。

市場根據產品類型分類，包括人類捐贈的無細胞動物衍生產品、組織衍生產品、組織工程皮膚和生物合成皮膚替代品。 2024年，人類捐贈組織衍生產品佔65.8%的市佔率。這些產品因其出色的複製人體皮膚和支持自然組織再生的能力而受到廣泛青睞。臨床試驗和實際應用已證明其在治療嚴重和慢性傷口方面的有效性，從而得到醫療保健專業人員的廣泛採用。這些產品的不斷改進，加上組織工程的進步，進一步鞏固了它們的市場主導地位。

按應用細分，生物皮膚替代品用於急性傷口、慢性傷口和其他醫療需求。 2024 年，急性傷口領域佔了 59.4% 的市場佔有率，這主要得益於對手術傷口和創傷相關損傷的快速有效治療方案的需求。與傳統的皮膚移植方法相比，人們對先進的生物皮膚替代品的偏好日益成長，這進一步推動了這一領域的擴張。這些產品提供快速、可靠的治療解決方案，特別是在緊急情況下，立即護理對於預防併發症和感染至關重要。

2024 年美國生物皮膚替代品市場規模達 1.262 億美元，未來成長前景廣闊。糖尿病足潰瘍、壓瘡和燒傷發病率的上升推動了對這些先進傷口護理解決方案的需求。此外，領先的生物技術公司的存在，加上 FDA 對創新皮膚替代品的批准不斷增加，正在加速市場擴張。包括基於細胞和組織工程的產品在內的下一代生物皮膚替代品的推出正在重塑行業格局。隨著技術的不斷進步和再生醫學投資的不斷增加，美國市場有望持續成長，為製造商和醫療保健提供者提供光明的前景。

目錄

第1章：方法論與範圍

第2章：執行摘要

第3章：行業洞察

• 產業生態系統分析
• 產業衝擊力
  • 成長動力
    • 慢性傷口的盛行率不斷上升
    • 燒傷和創傷病例數不斷增加
    • 傷口照護設施的普及率不斷提高
    • 再生醫學的技術進步
  • 產業陷阱與挑戰
    • 與生物皮膚替代品相關的不良副作用
    • 缺乏報銷政策
• 成長潛力分析
• 監管格局
• 未來市場趨勢
• 差距分析
• 技術格局
• 波特的分析
• PESTEL分析

第4章：競爭格局

• 介紹
• 公司矩陣分析
• 公司市佔率分析
• 競爭定位矩陣
• 供應商矩陣分析
• 策略儀表板

第5章：市場估計與預測：按類型，2021 年至 2034 年

• 主要趨勢
• 人類捐贈組織衍生產品
• 無細胞動物源性產品
• 組織工程皮膚產品
• 生物合成皮膚產品

第6章：市場估計與預測：按應用，2021 年至 2034 年

• 主要趨勢
• 急性傷口
• 慢性傷口
• 其他應用

第7章：市場估計與預測：依最終用途，2021 年至 2034 年

• 主要趨勢
• 醫院
• 門診手術中心
• 專科診所
• 其他最終用途

第8章：市場估計與預測：按地區，2021 年至 2034 年

• 主要趨勢
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 法國
  • 英國
  • 義大利
  • 西班牙
• 亞太地區
  • 日本
  • 中國
  • 印度
  • 韓國
  • 澳洲
• 拉丁美洲
  • 巴西
  • 阿根廷
  • 墨西哥
• 中東和非洲
  • 南非
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國

第9章：公司簡介

• Aroa Biosurgery
• Avita Medical
• BioTissue
• Integra LifeSciences
• MiMedx Group
• Misonix (Bioventus)
• Organogenesis
• ProgenaCare
• Smith & Nephew
• Stratatech Corporation (Mallinckrodt Pharmaceuticals)
• Stryker
• Tissue Regenix
• Vericel Corporation

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