Biological Skin Substitutes Market Size, Share & Trends Analysis Report By Type (Human Donor Tissue-derived Products, Acellular Animal-derived Products), By Application (Acute Wounds, Chronic Wounds), By End-use, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global biological skin substitutes market size was valued at USD 297.0 million in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 8.8% from 2023 to 2030. The Increasing prevalence of chronic wounds and the rising number of burn & trauma cases are expected to drive the market growth. Additionally, increasing demand for affordable skin-replacement solutions and the growing adoption of wound care facilities globally is expected further to propel the development of the market. Biological skin substitutes are tissue-engineered products specially designed to provide either permanent or temporary coverage to exposed skin wounds and help restore the affected part's skin functions. These products are widely used to treat chronic, non-healing ulcers (such as diabetic neuropathic ulcers, pressure ulcers, and vascular insufficiency ulcers). The skin substitutes can be differentiated into three main categories: epidermal replacement, dermal replacement, and dermal/epidermal replacement. They are also used as either temporary or permanent wound coverings.

Chronic wounds put a considerable and often neglected burden on patients, healthcare facilities, and society. It represents a silent epidemic that affects a significant portion of the global population. Furthermore, it is anticipated that around 2% of the population may suffer from a chronic wound during their lifetime in developed nations.

Several factors contribute to the upsurge in chronic wounds, including the aging population, the steep rise in the prevalence of obesity that is heavily correlated to diabetes, late effects of radiation therapies. According to a research article published by Mary Ann Liebert, Inc., in March 2021, around 2% of the U.S. population was affected by chronic wounds. In addition, 3% of the population over 65 years suffer from open wounds. Moreover, the U.S. government estimates that, by 2060, the elderly population will continue to rise above 77 Million, indicating that chronic wounds such as pressure ulcers, diabetic foot ulcers, etc., will continue to be an increasingly common problem among the elderly population by then.

The increase in number of reported burns, infections, skin diseases, trauma, etc., has increased the global demand for biological skin substitute products. These products aid in speedy healing and quick recovery of wounds. In addition, several campaigns have been launched by national governments across the globe to educate people about the advantages and importance of biologics for wound care has further propelled the biological skin substitutes market growth. The key players in the industry are providing advanced and better quality affordable biologics to increase their accessibility.

Furthermore, various medical institutions and research facilities are collaborating to develop modern approaches to wound management and trying to modernize wound care practices. For instance, In May 2022, MiMedx Group, Inc., a company that provides transformational placental biologics, announced that it had received a USD 4.6 Million award to evaluate a processed Dehydrated Human Amnion Chorion Membrane (DHACM) named PURION as an advanced solution for burn and wound care.

The WHO has been developing measures to reduce burn injuries and enhance burn care treatment globally in collaboration with The International Society for Burn Injuries (ISBI) and other related institutions. Tissue-engineered biological skin substitutes are classified under Class III medical devices.  To assure the quality and safety of every medical product, the U.S. Food and Drug Administration (FDA) maintains the pre-market clearance process for scientific review of all Class III devices.

The COVID-19 pandemic had a negative impact on the biological skin substitutes market due to the decreased demand for these products and the disruption of supply chains and manufacturing processes. The market went down during the COVID-19 outbreak primarily due to the postponement or cancellation of elective surgeries, including those involving skin grafts and biological skin substitutes. This was done to preserve healthcare resources for the treatment of COVID-19 patients and to minimize the risk of infection among patients and healthcare workers.

Elective surgeries that involve biological skin substitutes, such as skin grafts or skin substitutes made from human or animal cells, are often non-urgent and can be delayed without significant harm to the patient. In 2021, approximately 10 Million of the population in the UK were waiting for surgical treatments, up from 4 Million before the pandemic. Furthermore, per the article published by the JAMA Network, in the U.S., over 13 Million surgical procedures from the 1st of January 2019 to the 30th of January 2021, there was a 48.0% decline in an overall surgical procedure following March 2020 recommendation to postpone elective surgeries.

Type Insights

The human donor, tissue-derived products segment dominated the biological skin substitutes market and held the largest revenue share of 66.9% in 2022. It is expected to continue its dominance with the fastest growth rate of 8.9% over the forecast period. Human donor tissue-derived skin products are more popular than other types of biological skin substitutes as they are made from human tissue, which allows better integration and acceptance by the patient's body. This can lead to improved healing and reduced rejection or allergic reaction risk.

The human donor tissue-derived skin substitutes are more effective in promoting healthy healing than synthetic, biosynthetic, or animal-derived substitutes as they provide a natural scaffold that supports the growth of new tissue and blood vessels. This can help to speed up the healing process and reduce scarring and other complications. In addition, these substitutes are readily available in the market and do not require complex manufacturing processes, making them more cost-effective than synthetic or animal-derived substitutes.

Application Insights

The acute wound segment dominated the biological skin substitutes market and held the largest revenue share of 57.9% in 2022. Their growth is driven owing to the high demand for effective and efficient wound-healing solutions. Acute wounds, such as burns and surgical wounds, are often large, deep, and difficult to heal, making them more susceptible to infection, scarring, and other complications. Biological skin substitutes can help to minimize these risks and improve the healing process. In addition, acute wounds are often associated with high healthcare costs, and the use of biological skin substitutes can help to reduce the overall cost of care by minimizing the need for hospitalization and additional treatments. Moreover, growing awareness among healthcare providers and patients about the advantages and benefits of advanced wound care products, such as human donor tissue-derived skin substitutes in the management of chronic wounds, has resulted in increased adoption of these products, and it is further boosting the market growth.

The chronic wound segment is anticipated to witness the fastest growth rate of 9.0% over the forecast period. This is due to the increasing prevalence of chronic wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, etc., rising due to the growing incidence of chronic conditions and unhealthy lifestyles such as diabetes, obesity, and cardiovascular diseases. The biological skin substitutes offer an effective solution to promote the healing of these wounds, which has resulted in an increased demand for these products. Furthermore, the technological advancements in the development of biological skin substitutes, such as stem cells, growth factors, and other biomaterials, have led to the production of more effective wound-healing solutions for chronic wounds.

End-use Insights

The hospital segment dominated the market and held the largest revenue share of 54.8% in 2022. Hospitals can access advanced equipment and resources that may not be available in other settings, such as specialized burn dressings, wound care products, and surgical interventions. Patients may prefer hospitals for burn treatment because hospitals typically have specialized burn units and staff with expertise in treating burn injuries. Burn injuries can be complex and require specialized care, such as wound debridement, pain management, and infection prevention, which may be difficult to provide outside of a hospital setting. Hospitals are also equipped to provide ongoing monitoring and follow-up care for burn patients, which is essential to ensure proper healing and recovery.

The outpatient facilities segment is expected to witness the fastest CAGR of 8.9% over the forecast period. Outpatient facilities such as wound care centers are gaining attraction among patients as these facilities are often more convenient for patients, have shorter wait times, and have more flexible options than hospitals. This can be particularly beneficial for patients with chronic wounds as they require frequent visits for ongoing treatment. In addition, outpatient wound care centers often have specialized staff that is well-trained in wound care and can provide more personalized and focused care than a general hospital setting.

Regional Insights

North America dominated the market and accounted for the largest revenue share of around 42.0% in 2022. The major factors driving the market growth in the region are highly developed healthcare infrastructure, increasing awareness about wound management among the population, and a noticeable increase in healthcare expenditure in the U.S. and Canada.

The presence of the major companies, mergers among the key players, new product launches, and FDA approvals are expected to fuel the global biological skin substitutes market. For instance, in January 2021, Integra LifeSciences Holdings Corporation, a global medical technology provider, acquired ACell, Inc. The acquisition will support Integra in offering complete management solutions for the complex wound to address its customer’s urgent clinical concerns. Additionally, rising cases of burn injuries are further expected to fuel the market over the forecast period. For instance, as per the global burden of disease study in 2019, around 8.3 Million new burn cases were reported globally, and around one lakh fatalities were accounted for in 2019.

Asia Pacific’s market is anticipated to grow with the fastest CAGR of 9.1% over the forecast period. The rapid economic growth in the region is expected to drive the demand for innovative, tailored technologies and attempts to create solutions and products fit for the purpose to manage wounds.

In addition, improving healthcare infrastructure in the highly populous countries in APAC, such as China, India, and Japan, is providing potential market opportunities and attracting stakeholders to expand their portfolios in the Asia Pacific wound management and biological skin substitutes market. For instance, in March 2019, AVITA Medical collaborated with COSMOTEC, a division of M3 Group Company, to market and distribute RECELL in Japan. RECELL is a drug used to treat wounds caused mainly due to burns and other injuries. The collaboration is expected to offer AVITA Medical significant potential considering the recent surge in the number of patients in Japan suffering from decubitus ulcers and chronic wounds. RECELL System fits around 90% of plastic surgeons in Japan and dermatologists through the portal site 'm3.com. With this opportunity, the company is trying to contribute to advancing injuries and wound management in Japan.

Key Companies & Market Share Insights

The key companies operating in the biological skin substitutes market are trying to enhance their product portfolio by updating their products and seeking government authorizations and acquisitions to increase their client base and obtain a larger market share. Furthermore, the key companies in the market are executing strategies such as mergers, partnerships, new product and service launches, joint ventures, agreements, expansion, and collaboration to improve their position in the industry. For instance, In May 2022, MiMedx Group, Inc., a transforming placental biologics company, announced that it had received a USD 4.6 Million award to evaluate PURION, a processed Dehydrated Human Amnion Chorion Membrane (DHACM), a modern treatment option for burn and wound care. Some of the prominent key players in the global biological skin substitutes market include:

• Organogenesis, Inc.

• 3M

• Integra LifeSciences

• Smith and Nephew

• Tissue Regenix,

• Mimedx,

• BSN medical,

• Stryker

• Vericel Corporation.,

• Mallinckrodt (Stratatech Corporation)

Biological Skin Substitutes Market Report scope

Global Biological Skin Substitutes Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and analyzes the latest industry trends in each sub-segment from 2018 to 2030. For this study, Grand View Research has segmented the global biological skin substitutes market report based on type, application, end-use, and region:

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Human Donor Tissue-Derived Products

  • Acellular Animal-derived Products

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Acute Wounds

  • Chronic Wounds

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals

  • Outpatient Facilities

  • Research and Manufacturing

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  •  Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  •  Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  •  Middle East and Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait