Reconstructed Skin Models Market Size, Share & COVID-19 Impact Analysis, By Type (Reconstructed Human Epidermis (RHE) and Reconstructed Human Skin (RHS)), By Application (Skin Corrosion Test, Skin Irritation Test, Skin Sensitization Test, Skin Biopsy, Radioallergosorbent Assay, Skin Pigmentation Test, and Others), By End User (Cosmetics & Cosmeceutical Companies, Chemical Companies, and Others), and Regional Forecast, 2023-2030

The global reconstructed skin models market size was valued at USD 32.6 million in 2022. The market size is projected to grow from USD 35.7 million in 2023 to USD 84.1 million by 2030 at a CAGR of 13.0% during the forecast period.

Reconstructed skin tissue models are used for the safety and efficacy testing of various cosmetic products and cosmeceuticals in healthcare settings such as cosmeceutical, pharmaceutical companies, and others. The increasing prevalence of certain skin disorders such as psoriasis, acne, atopic dermatitis (AD), and others and the growing patient population demanding effective and novel therapies for these disorders are some of the major factors contributing to the growing demand for these products worldwide.

• For instance, according to a 2022 report published by Global Atopic Dermatitis Atlas, approximately 20% of children and 10% of adults are suffering from atopic dermatitis.

In addition, the rising research and development activities by the players for the development and introduction of novel therapies for various chronic skin conditions, along with strategic initiatives by governmental organizations to promote the use of alternative methods other than animal models, are some of the major contributing factors for the growing demand of these products in the market.

However, the limited focus on the regulatory acceptance for these models and limited clinical data on efficiency and uniformity in formulation are some of the factors anticipated to hamper the reconstructed skin models market growth.

COVID-19 IMPACT

Shifted Focus toward the R&D Activities for COVID-19 Vaccines during the Pandemic Hampered the Market Growth

The COVID-19 pandemic negatively impacted the market due to the decreased demand for these models among healthcare researchers and the disruptions in the supply chain in the market.

The lockdown restrictions resulted in issues pertaining to supply chain disruptions among the manufacturers, which hampered research and development activities for these skin models. Further, the major focus of pharmaceutical companies, contract research organizations, among others, was shifted towards COVID-19 vaccines, which resulted in a decline in the demand for these models among the key players.

• For instance, according to 2021 data published by Reliefweb, Pfizer, BioNTech, and Moderna made combined profit of USD 65,000 every minute through COVID-19 vaccines.

However, in 2021, with the ease of lockdown restrictions, the supply chains recovered, which enabled the R&D activities among the cosmeceutical and chemical companies. The research and development activity further supported the demand for these products in the market.

Thus, the rising focus of pharmaceutical and biotechnological companies and research institutes to develop and introduce novel products for testing the safety and efficacy of cosmetic and cosmeceutical products is expected to fuel the reconstructed skin models market expansion during the forecast period.

Reconstructed Skin Models Market Trends

Rising Innovations and Technological Advancements

The rising demand for skin models with technological advancements and other features to overcome the limitations associated with the traditional models is resulting in robust efforts of the players operating in the market to develop novel technology and solutions. The growing focus of the players to increase R&D spending is a key trend emerging in the market.

The increasing number of launches, government approvals, and R&D activities, along with acquisitions and collaborations among the major players, is resulting in a preferential shift toward advanced in-vitro models among pharmaceutical and cosmeceutical companies.

• According to KOL interviews, several small-scale research laboratories and contract manufacturing organizations in the U.S. are shifting their focus toward the use of non-animal models for the purpose of testing cosmetics and cosmeceutical products.  

Along with this, there is a growing technological advancement in the field leading to the development of organ-on-a-chip models that can offer a microfluidic environment to cells for them to grow, which is another key trend shaping the future of the market.

Thus, a shift toward technologically advanced products including organ-on-a-chip and others and the clinical benefits of these models over traditional skin models is considered to be an emerging trend in the market.

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Reconstructed Skin Models Market Growth Factors

Changing Regulatory Scenario Toward Non-Animal Testing to Boost the Demand for In-vitro Skin Models

The increasing focus toward the ban on animal testing to test the safety and efficacy of cosmeceutical and pharmaceutical products among cosmetic companies, chemical companies, and others is driving the demand for alternatives to animal models. Further, the governmental and non-governmental organizations supporting the ban on animal testing due to ethical considerations is a major factor impelling the growing demand for skin tissue models.

Along with this, certain limitations of animal models, including inefficient mimicking, high costs associated with these models, and others, support the penetration of other skin tissue models among researchers. The growing demand for these dermis and epidermis models is resulting in the focus of the key players to develop advanced reconstructed skin tissue models, thus fostering the growth of the market.

• For instance, according to a KOL interview, the U.S. FDA is increasing their focus on non-animal testing models for the in-vitro testing of cosmeceutical and pharmaceutical products.

Thus, the demand for these models among pharmaceutical companies, cosmeceutical companies, and CROs, among others globally, is anticipated to fuel the industry growth during the forecast period.

RESTRAINING FACTORS

Lack of Regulatory Acceptance for Reconstructed Skin Models to Limit the Adoption

The growing demand for these models among various research institutes is leading to the increasing focus of the market players on developing technologically advanced products to cater to the rising demand. However, there are only a few approved and commercially available reconstructed human epidermis models. The limited regulatory acceptance of these models, especially full-thickness skin models, is an important factor expected to hinder the market growth.

In addition, there are no reconstructed human skin models that are FDA-approved and available in the U.S. market, which limits the adoption of these models among researchers. Furthermore, the limited regulatory acceptance of these models is leading to increasing hesitance toward the use of these models in research activities.

Moreover, there are recent updates on the ban on using animal testing models. However, the U.S. FDA has not completely banned the use of animal models for testing the safety and efficacy of various products, which is further limiting the growing penetration of alternative testing models among researchers in the U.S.

• For instance, according to several KOL interviews, there is a limited push for the use of non-animal models to test the safety and efficacy of pharmaceutical products, which is hampering the adoption of these models in the market.

Therefore, the limited regulatory acceptance resulting in hampered adoption of these models is a major factor anticipated to restrain the market growth during the forecast period.

Reconstructed Skin Models Market Segmentation Analysis

By Type Analysis

Reconstructed Human Epidermis (RHE) Dominated Owing to Increased Penetration Among Research Facilities

On the basis of type, the market for reconstructed skin models is segmented into reconstructed human epidermis (RHE) and reconstructed human skin (RHS).

Of these, the reconstructed human epidermis (RHE) segment dominated the market in 2022 owing to certain benefits such as less complexity in developing these products. All of these factors are further resulting in growing adoption, supporting the increasing demand for these products in the market. Along with this, regulatory bodies, intergovernmental organizations, and others are also focusing on the approvals of these skin tissue models, aiding their wide use and acceptance among researchers in the market.

• For instance, in June 2021, MatTek Corporation’s EpiDerm skin model received approval from the OECD as a standalone method for in-vitro testing for phototoxicity. 

On the other hand, the reconstructed human skin (RHS) segment is anticipated to grow at a significant CAGR during the forecast period. The segmental growth can be attributed to the growing awareness, along with the availability of all three layers of skin to test the safety and efficacy of products, which aids in accurate results among cosmeceutical and other companies. The growing awareness and other factors leading the focus of key players toward collaborations and acquisitions among the major players to support the R&D activities for these products is expected to fuel the growth of the segment.

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By Application Analysis

Skin Irritation Test Dominated the Market Owing to Rising Number of Product Approvals & Launches

On the basis of application, the market for reconstructed skin models is segmented into skin corrosion test, skin irritation test, skin sensitization test, skin biopsy, radioallergosorbent test, skin pigmentation test, and others.

The skin irritation test segment dominated the market in 2022. The dominance is owing to their capability to predict the potential of chemicals to cause skin damage, such as corrosion and irritation among patients. In addition, the growing penetration of cosmeceutical and pharmaceutical products for these applications is leading to the increasing demand for these models, enabling the growth of the segment in the market.

On the other hand, skin corrosion, skin sensitization tests, and skin biopsy segments are growing and are expected to grow at a significant growth rate. The growth of the segments can be attributed to the rising prevalence of skin cancer, among other skin disorders resulting into a rising patient population. The increasing inpatient and outpatient admissions is driving the focus of key players to launch innovative skin models for these disorders, resulting in the growth of the market.

• For instance, according to 2022 statistics published by American Academy of Dermatology, it was reported that approximately 9,500 people are diagnosed with skin cancer every day in the U.S.

In addition, radioallergosorbent test and skin pigmentation test segments are anticipated to grow due to the rising demand of assessing the novel active ingredients in the cosmeceutical products to understand the reaction of several formulations used in the product. This, along with the increasing number of allergic reactions post-application of a product, is also driving the demand for these skin tissue models, supporting the growth of the segment.

• For instance, according to a 2023 study published by DermNet, it was reported that approximately 10% of patients suffer from cosmetic allergies undergoing patch testing in the U.S.

By End User Analysis

Rising Adoption of Skin Models by Cosmetics & Cosmeceutical Companies Led to the Dominance of the Segment

On the basis of end user, the market for reconstructed skin models is segmented into cosmetics & cosmeceutical companies, chemical companies, and others.

The cosmetics & cosmeceutical companies segment dominated the market in 2022. The increasing prevalence of certain skin disorders such as psoriasis, acne, and others, is resulting in the growing adoption and demand of cosmeceutical products among patients. Increasing demand is leading key players to focus on launching innovative skin tissue models, thereby supporting the growth of the market. In addition, strict regulatory guidelines against the use of animal models for testing purposes in the U.S. and the ability of these skin tissue models to mimic efficiently are some of the additional factors contributing to the growth of the segment.

On the other hand, the chemical companies segment is also growing due to the rising number of chemical companies, resulting in increasing R&D investments to discover new chemicals and formulations with an aim to innovate efficient cosmeceutical products in the market. In addition, the government initiatives to support the ban on using animal testing models for testing the safety and efficacy of products is also driving the growing adoption of skin tissue models in these companies.

Moreover, others segment, including medical device companies, CROs, clinical laboratories, and research institutes, is also anticipated to grow during the forecast period. The growth can be attributed to an increasing number of clinical laboratories, subsequently contributing to the R&D activities in these healthcare settings. Furthermore, rising R&D activities is supporting the increasing demand for reconstructed skin models to test pipeline products, thus fueling the growth of the market.

• For instance, according to 2023 data published by American Clinical Laboratory Association, there are approximately 322,488 clinical laboratories in the U.S.

REGIONAL INSIGHTS

By geography, the market for reconstructed skin models is segmented into Europe, U.S., Asia Pacific, and the rest of the world.

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The market size in Europe was valued at USD 15.7 million in 2022 and dominated the market. The regional dominance is owing to the rising adoption of non-animal testing models for the safety and efficacy testing of cosmetic and cosmeceutical products. The rising demand for these models among various healthcare facilities and research centers is leading to increasing penetration of the products in the region.

The U.S. market is expected to grow at a high CAGR during the forecast period owing to rising awareness regarding skin models as an alternative to animal testing models in research facilities. The increasing number of studies showing the efficacy and safety of these models in the testing of cosmetic products is another major factor contributing to the growing adoption of these models in the country. The rising regulations toward promoting non-animal testing models in the country is another reason that is expected to fuel the market growth in the country.

• For instance, in 2022, the U.S. FDA shared constructive plans to reform the drug approval process and drive the use of non-animal testing methods.


• Further, in 2021, the U.S. Environmental Protection Agency (US EPA) pledged to eliminate animal testing by 2035.

The Asia Pacific market is anticipated to grow at a significant growth rate. The growth can be attributed to various factors, such as the rising number of research activities among cosmeceutical, biotechnology, and pharmaceutical companies in countries including Japan and China, among others. The growing collaboration among government bodies, institutions, and others to promote non-animal testing in the region is another factor supporting the growth of the market.

• For instance, according to a 2023 article published by Lhasa Limited, one of the non-profit organizations in the U.K. collaborated with the National Institute of Health Sciences (NIHS) of Japan with an aim to increase the testing on non-animal testing predictive-based models.

The rest of the world is expected to grow at a considerable rate owing to increasing initiatives by several government bodies, as well as other national bodies, to prohibit animal testing and promote testing on non-animal models. The shifting regulations are expected to increase the adoption of these models in the region.

• For instance, according to a 2023 article published by Sage Journal, CONCEA (National Council for the Control of Animal Experimentation), the Brazilian government, prohibited the use of animals for testing cosmetics, hygiene products, and perfumes in the country.

List of Key Companies in  Reconstructed Skin Models Market

MatTek Corporation Dominated the Reconstructed Skin Models Market Owing to Increasing Product Launches

This market is a consolidated market with two major players dominating the market in 2022. MatTek Corporation and SkinEthic (EPISKIN SA) together accounted for around 70% of the entire market.

The rising focus of these companies on research and development activities with an aim to expand their product offerings are a few of the major factors contributing to the growth of the reconstructed skin models market share in the global market.

Henkel AG & Co. KGaA and Japan Tissue Engineering Co., Ltd., are other players operating in the market with a robust product portfolio in reconstructed skin tissue models. The growing focus of these companies on collaborating with the other major players operating in the market is expected to expand their geographical presence, thus strengthening their presence in this market.

In addition, a few emerging players, such as LabSkin, GenoSkin, and Alcyomics Ltd., are focused on the development of reconstructed skin models with efforts to increase brand presence in the market.

• For instance, in March 2022, Alcyomics Ltd., partnered with 7^th 3D Tissue Models Summit with an aim to increase brand awareness and revolutionize the drug discovery and development process with the use of 3D tissue models.

Thus, the rising efforts of key players to increase their penetration and market share in the global market are expected to boost the growth of this market.

LIST OF KEY COMPANIES PROFILED:

• EPISKIN (France)


• Henkel AG & Co. KGaA (Germany)


• Japan Tissue Engineering Co., Ltd. (Japan)


• CELLnTEC (Switzerland)


• BICO - THE BIO CONVERGENCE COMPANY (Sweden)


• Mallinckrodt plc (Ireland)


• STRATICELL (Belgium)


• ZenBio, Inc. (U.S.)    

KEY INDUSTRY DEVELOPMENTS:

• March 2023 - EPISKIN launched new SkinEthic HO2E, a reconstructed human esophageal epithelium with an aim to widen its product portfolio.


• March 2022 - L´Oréal Brazil, UFRJ and EPISKIN collaborated with D'Or Institute for Research and Education to study the accuracy of reconstructed human skin models to understand the changes of skin physiology over the years and the consequent loss of skin sensoriality.


• June 2021 - The European Commission registered the European Citizen’s Initiative (ECI) – ‘Save Cruelty-free Cosmetics - Commit to a Europe without Animal Testing‘, with an aim to reduce animal testing for the chemical products as well.


• December 2020 - Unilever collaborated with animal protection organizations, with an aim to support the animal testing ban for the European Cosmetics.


• November 2020 - Henkel AG & Co. KGaA acquired epiCS skin model technology from SkinINVITRO GmbH, with an aim to strengthen its reconstructed skin models business portfolio under the Phenion brand.

REPORT COVERAGE

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The global reconstructed skin models market report provides a detailed industry analysis. It focuses on key aspects, such as market overview, market segmentation and analysis of type, application, and end user, competitive landscape of the key players in the market. Besides this, it offers insights into market trends and highlights key industry developments. The report further includes a COVID-19 impact analysis on the market.

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