According to Nova One Advisor, the global Biological Skin Substitutes market size was exhibited at USD 347.75 million in 2024 and is projected to hit around USD 810.50 million by 2034, growing at a CAGR of 8.83% during the forecast period 2024 to 2034.
The market growth is attributed to the increasing prevalence of chronic wounds, such as burn injuries and ulcers. The biological skin substitutes market is driven by the increasing burden of trauma across the globe and the increase in the demand for wound care products such as skin substitutes.
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Biological Skin Substitute Market Key Takeaways:
• Human donor tissue-derived products held the largest revenue share of around 67.42% in 2024 and is anticipated to be the fastest-growing segment over the forecast period.
• The acellular animal-derived products segment is anticipated to grow from 2024 to 2034.
• The acute wounds segment dominated the market in 2024.
• The chronic wounds segment is anticipated to witness fastest growth at a CAGR of 9.13% over the forecast period.
• Hospitals held the largest revenue share of around 52.0% in 2024.
• The outpatient facilities segment is expected to grow at the highest CAGR from 2024 to 2034.
• North America biological skin substitute market dominated the global marker with a revenue share of 42.0% in 2024.
Market: An Overview and Industry Potential
The prevalence of innovative dermal substitutes such as bioengineered skin grafts is expected to drive the biological skin substitutes market’s growth. In addition, various companies are undertaking studies to offer novel skin substitutes for wound management are further enhances the market growth. On the other hand, the increasing focus on minimally invasive treatments, growing adoption in wound care, and increasing shift to 3D printed and bioengineered skin are the major opportunities driving the growth of the biological skin substitutes market.
By using the patient’s skin cells, 3D bioprinting technology was developed as a convenient method to fabricate skin substitutes utilizing primary cells. This approach offers an advantage, especially in treating chronic wounds, and aims at the generation of preformed microvascular networks inside skin substitutes before their transplantation are further enhance the market growth.
• For instance, in November 2023, an indigenous state-of-the-art bio 3D printer, ‘Mito Plus’ was launched by Indian tech start-up Avay Biosciences that can print human tissues. This advanced prototype was launched at the Indian Institute of Science, Bangalore.
Rising FDA Approvals: Key Development Factor for the Market
In 2024, several new biological skin substitutes received FDA approval, which expanded treatment options for patients with complex skin wounds. One of the most notable approvals was for a stem-cell-based skin substitute, which demonstrated promising results in clinical trials for accelerating wound healing in diabetic foot ulcers. This approval marked a significant milestone in regenerative medicine, with clinical evidence supporting the effectiveness of biological skin substitutes over traditional methods, reducing healing time and improving patient outcomes.
Biological Skin Substitutes Market Trends
• Regulatory support and funding: The increasing funding and supportive regulatory frameworks along with public-private partnerships, private investments, and government grants are expected to drive the market growth.
• Increasing accessibility and awareness in emerging markets: The awareness about the advantages of the market is growing rapidly, particularly in developing markets. These markets are experiencing rapid growth in the healthcare industry, fueled by increasing healthcare spending and GDP.
• Advancements in tissue engineering technology: The growing investment in research and development has led to the creation of cost-effective, biocompatible, and effective products that are anticipated to drive the growth of the biological skin substitutes market.
Advancement and Expansion of Products: North America to Sustain Dominance
North America biological skin substitute market dominated the global marker with a revenue share of 42.0% in 2024. The market growth in the region is attributed to the rising incidence of chronic wounds and burn injuries and the increasing demand for Advanced Wound Care (AWC) products. The market is dominated by various major players, such as 3M, Stryker, Smith+Nephew, and Integra LifeSciences Corporation. Companies are investing significantly in research and development to improve the efficacy and quality of their products. These major factors support the market growth and expand the allograft technology in North America.
U.S. Biological Skin Substitutes Market Trends
• The U.S. market held the largest market share in 2023. The market growth is attributed to the increasing prevalence of chronic diseases in the U.S. The growth in the region is also fueled by product launches and consistent research that drive market growth and increase the product portfolio in the sector.
• The market is seeing a trend towards ready-to-use, off-the-shelf biological skin substitutes, offering better convenience and faster treatment for patients. This trend is being driven by the need for more accessible solutions in emergency and outpatient care settings.
• Cutting-edge research in tissue engineering is enhancing the development of more effective, natural, and durable biological skin substitutes. Innovations in 3D bioprinting and stem cell technologies are improving the functionality and customization of skin substitutes for patients with different needs.
Improving Technologies: Asian Countries to Witness Boom
Asia Pacific is expected to grow fastest during the forecast period. The market growth in the region is attributed to the increasing prevalence of trauma patients, chronic diseases, and skin-related diseases. The rising economic growth is anticipated to attempt to create products and treatments, improved technologies, and innovative technologies suitable for managing wounds in the region. China, India, Japan, and South Korea are the major countries that are attracting stakeholders to expand their portfolios and improve the healthcare infrastructure.
How China and India are Expanding in Biological Skin Substitutes Market?
• Both China and India are witnessing an increase in chronic wound cases, such as diabetic ulcers, venous ulcers, and burns, driven by growing rates of diabetes and an aging population. In China, the prevalence of diabetes is one of the highest globally, and India is witnessing a surge in cases of non-healing wounds. This drives the demand for advanced biological skin substitutes as a crucial treatment option.
• Both countries are witnessing growing government initiatives to improve healthcare infrastructure and promote advanced medical treatments. China’s “Healthy China 2030” plan and India’s National Health Policy 2017 emphasize the need for better healthcare access, which indirectly drives the adoption of advanced wound care products, including biological skin substitutes.
Biological Skin Substitute Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 378.46 Million |
|
Revenue forecast in 2034 |
USD 810.50 Million |
|
Growth rate |
CAGR of 8.83% from 2024 to 2034 |
|
Actual data |
2019 - 2023 |
|
Forecast period |
2024 - 2034 |
|
Quantitative units |
Revenue in USD million, and CAGR from 2024 to 2034 |
|
Report Coverage |
Revenue, competitive landscape, growth factors, and trends |
|
Segments Covered |
Type, Application, End use, Region |
|
Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
|
Country scope |
U.S.; Canada; UK; Germany; France; Italy; Spain; Denmark; Sweden; Norway; Japan; China; India; Australia; South Korea; Thailand; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE; Kuwait |
|
Key companies profiled |
Organogenesis Inc.; Integra LifeSciences Corporation; Smith+Nephew; Tissue Regenix; MIMEDX Group, Inc.; Essity Aktiebolag (publ))( Essity Health & Medical); Stryker; Vericel Corporation; 3M; BioTissue |
|
Customization scope |
Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope |
Biological Skin Substitutes Segmental Insights:
By Type Insights
Human donor tissue-derived products held the largest revenue share of around 67.42% in 2024 and is anticipated to be the fastest-growing segment over the forecast period. These tissues are widely used as they are derived from human tissues such as tendons, bone, and skin. Patients' bodies are readily minimized and accept the chance of rejection by the immune system, as humans are a common source. Human donor tissues provide optimum tensile strength for easy sutures and are designed to be robust, thus expected to drive segment growth.
• For instance, in October 2024, a triple-layered human tissue allograft, “Tri-Membrane Wrap,” was launched by BioLab Sciences which is constructed from the amniotic membrane which perfectly protects poorly located areas and deep wounds.
The acellular animal-derived products segment is expected to grow fastest during the forecast period. These biomaterials are produced from animal tissues including bovine or porcine sources. They support tissue regeneration without triggering an immune response, due to the absence of cellular components. Compared to other alternatives, various studies have concentrated on the effectiveness of acellular animal-derived skin substitutes.
• For instance, in April 2024, acellular fish skin grafts were adopted as more convenient for treating diabetes wounds of different depths, according to the review published. These positive results using acellular animal-generated products for wound management drive the segment growth.
By Application Types Insights
The acute wounds segment dominated the biological skin substitutes market in 2024. The segment growth is attributed to the increasing prevalence of surgical wounds, burns, and traumatic injuries which require effective and rapid healing solutions. Furthermore, the increasing demand for efficient and effective wound-healing solutions is expected to drive the segment growth during the forecast period.
• For example, AlloSkin RT is a human tissue-created meshed[AP3] [SP4] allograft for epidermal and dermal acute wound healing. In addition, the availability of both xenografts and allografts for treating acute wounds is driving the segment growth.
The chronic wounds segment is anticipated to witness fastest growth at a CAGR of 9.13% over the forecast period. The segment growth is driven by the rising prevalence of chronic wounds such as pressure ulcers, venous leg ulcers, and diabetic foot ulcers. By using biological skin substitutes, these chronic wounds attract the focus of physicians to offer better living to patients. In addition, the rising technological advancements in the development of xenografts and allografts, such as biomaterials, growth factors, and stem cells have led to the production of more accurate wound-healing treatments for chronic wounds.
By End Use Insights
Hospitals held the largest revenue share of around 55.0% in 2024. The segment growth is fueled by an increasing patient pool suffering from severe injuries including surgical cases, burns, and others. Various complicated burnt patients are children under 5 years. In addition, hospitals are providing comprehensive care to patients with complex medical needs, as they preferred over other healthcare settings. Moreover, the segment is expected to contribute more revenue to the biological skin substitute market in the coming years, as the number of hospitals is increasing rapidly.
The outpatient facilities segment is anticipated to grow fastest during the forecast period. These involve specialty facilities and ambulatory surgery centers outside the hospitals. The benefits related to outpatient facilities, such as same-day discharge, comparatively low cost, and shorter procedure time compared to hospitals, are expected to support the growth of the segment. In addition, the increasing number of outpatient facilities is further enhancing the segment growth.
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Biological Skin Substitutes Market Top Companies
• Integra LifeSciences Corporation
• Tissue Regenix
• MIMEDX Group, Inc.
• Essity Aktiebolag (publ)) (Essity Health & Medical)
• Stryker
• Vericel Corporation
• 3M
Biological Skin Substitutes Market Recent Developments
• In June 2024, the opening of a state-of-the-art skin bank facility was announced by the Army Hospital in New Delhi. This hospital is the first of its kind to be established within the Armed Forces Medical Services. The aim behind this launch was to revolutionize the treatment of severe burn injuries and other skin-related conditions among service members and their families.
• In May 2023, the state-of-the-art Wound Care and Hyperbaric Center was launched by HCA Florida Woodmont Hospital with a mission to become a leading destination for specialized wound care in South Florida.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the biological skin substitute market
By Type
• Human Donor Tissue-derived Products
• Acellular Animal-derived Products
By Application
• Acute Wounds
• Chronic Wounds
By End Use
• Hospitals
• Outpatient Facilities
• Research & Manufacturing
By Regional
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)
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