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Tissue Engineering in Orthopedics: Innovations and Market Outlook

The global tissue engineering market is projected to grow from USD 4 billion in 2022 to USD 12.7 billion by 2035, exhibiting a CAGR of 9% during forecast period<br>Research indicates that about 6% of the individuals are expected to get affected from chronic wounds, globally. Specifically, in the US, 6.5 million individuals are estimated to be affected by chronic wounds. Financially, treatment of wound-related complications levies a burden of over USD 25 billion, annually, on the US healthcare system.<br>

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Tissue Engineering in Orthopedics: Innovations and Market Outlook

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  1. Tracking the healthcare innovation Free Insights Tissue Engineering-based Regeneration Products Market, 2022-2035 Distribution by Type of Graft (Allografts, Autografts and Xenografts), Area of Application (Bone Healing, Burn Healing, Surgical Healing, Wound Healing, and Others) Type of Material of Scaffold (Bone Tissue, Collagen-based Tissue, Human Placental Tissue, Other Animal Based Tissue, Other Human Tissue, Stem Cell and Others Tissues), Type of End User (Ambulatory Surgical Centers / Hospitals / Specialty Clinics) And Key Geographies (North America, Europe, Asia, Latin America, Middle East and North Africa and Rest of the World) C O N F I D E N T I A L | www.rootsanalysis.com

  2. Context The present treatment landscape of chronic wound and bone healing is characterized by a variety of unmet needs; tissue engineering-based regeneration products have emerged as a viable therapeutic option, capable of catering to the growing demand Given the ever-increasing demand for tissue transplantation, primarily for wound and bone healing, there is an urgent need for safe and efficient products that enable efficient healing and regeneration >6% 1,300+ 450+ Million Need for Regenerative Medicines Ongoing clinical trials for regenerative medicine and advanced therapy Of the population is anticipated to be affected from chronic wounds, globally Annual cases of acute / long-term symptoms of fractures, globally Prevents Tissue Loss Enables Self-Healing Permits Fast Treatment Tissue-regeneration products offer various benefits, such as faster healing, better growth and close to no scaring, thereby, providing them an edge over the normal healing process Benefits of Tissue Engineering-based Regeneration Products The healing process is carried out without the need for using human tissues Of parts where evolution prohibits natural regeneration of tissues Of diseased small lesions arising from sports injuries and spinal disk ailment Driven by anticipated approval of new tissue engineering-based regeneration products and rising financial support by prominent investors, the market is likely to witness steady growth over the years 150+ ~2 8% CAGR USD Billion Products Current Market Landscape and Upcoming Trends Invested by industry and non-industry stakeholders in the last five years Currently offered by nearly 60 players engaged in this market Estimated rate at which the market is likely to evolve till 2035

  3. Example Highlights • At present, more than 150 tissue engineering-based regeneration products, intended for use across various applications, are being offered by players located across different regions worldwide List of Companies Offering Tissue Engineering-based Regeneration Products Content Illustrative (details available upon request) Distribution by Area of Application1 Burn Healing Surgical Healing Wound Healing 18% 34% Soft Tissue Regeneration Unspecified Bone Healing 3% 25% 5% Information on 150+ tissue engineering-based regeneration products is available in the detailed report Note 1: Tissue engineering-based regeneration products used for more than one area of application has been counted multiple times in this representation

  4. Example Highlights • Majority of the products employ human tissues as a material of scaffold for skin regeneration; additionally, bone regeneration grafts are available in different formulations, majority of which are allografts Tissue Engineering-based Regeneration Products Distribution by Application and Type of Graft2 Tissue Engineering-based Skin Regeneration Products Distribution by Material of Scaffold Tissue Engineering-based Bone Regeneration Products Distribution by Product Formulation Collagen Tissues Human Tissues 65% 15% Soft Tissue Regeneration Other Tissues1 Other Animal Tissues 9% 11% Allograft Xenograft Autograft Wound healing has emerged as the most prominent area of application (more than 50% grafts); it is worth noting that over 80% of such products are allografts Over 65% of regeneration grafts for bone healing are in the form of sheet, bone matrix and putty; majority of such products are developed by well established players More than 50% of human tissue-based products are being offered by companies internationally; prominent examples include BioTissue, VIVEX Biologics and MiMedx Note 1:Other Tissues category includes type of scaffold material that could not be classified in the listed categories Note 2: The area under the curve is representative of the likely competitive advantage witnessed by the company under the chosen parameter

  5. Example Highlights • The growing interest of stakeholders in this market is evident from the rise in partnership activity; a major proportion of the deals were signed by companies based in the US • Partnerships and Collaborations • Distribution by Type of Partnership1 • Partnerships and Collaborations • Distribution by Geography1 • Partnerships and Collaborations • Distribution by Year of Partnership1 Intercontinental Partnerships & Collaborations 3% 6% 42% 12% • Distribution Agreements • Mergers and Acquisitions North America Europe Asia-Pacific and RoW 15% • Product Development and • Commercialization Agreements • Product Utilization Agreements • Others • R&D Agreements 3% 12% 22% Intracontinental Partnerships & Collaborations North America Europe 6% 73% 6% • Merger and acquisitions have emerged as the most prominent type of partnership in this market; such deals are forged to expand technology and product portfolios • Examples of North America based players entering into international deaks include Integra LifeSciences, Vericel, Allergan Aesthetics, MTF Biologics and AlloSource • Both established players and new entrants have forged several partnerships in the recent past; 45% of the partnerships have been inked post 2021 Note 1: Detailed analysis of partnerships and collaborations based on several parameters is available in the report titled “Tissue Engineering- based Regeneration Products Market, 2022–2035”

  6. Example Highlights • Several investors, foreseeing the lucrative potential associated with tissue engineering-based regeneration products, have made significant investments over the past few years • Recent Initiatives Popular Keywords on Google News2 • Recent Initiatives Distribution of Instances by Type of Initiative3 • Recent Initiatives • Distribution of Instances by Type of Funding1 9 24% 57% 10% 9% Scaffold, skin healing, bone grafts, stem cell, wound, implants and biomaterial emerged as some of the frequently occurring keywords in google news • Most of the industry players have raised funds via other equity, followed by the debt and venture series. Debt is another popular funding mechanism for firms • The heightened pace of activity in this field is focused primarily on expanding the existing intellectual capital related to tissue engineered products Note 1: Others category includes those funding instances for which information on type of funding was not available in the public domain Note 2: The word cloud was generated from more than 500 recent news articles related to tissue engineering-based regeneration products on Google news Note 3: Others Category includes initiatives focused on progressing products towards approval and certification

  7. Example Highlights • Around 300 patents have been filed / granted for tissue engineering-based regeneration products; both industry and non-industry players are actively involved in such efforts • Patent Analysis • Distribution by Type of Player1, 2 • Patent Analysis • Distribution by Relative Valuation3 • Patent Analysis • Distribution by Type of Patent 2 1% Patent Value 6% 10% 37% 46% Note: Area under the rectangle represents number of patents Around 40% of patents were filed / granted in the US, indicating high R&D activity in the region; this is followed by WIPO and Asia-Pacific About 240 patent applications have been filed; of these, majority were filed by Momentive, Marine Essence Biosciences and Tepha Over 30% of the most valuable patents have been granted since 2017, highlighting the rising innovation in research in this emerging field of regenerative medicines Note 1: The representation presented here is a cumulative distribution of patents by application year and player, filed / granted till the month when the research / analysis was conducted. Note 2: Otherscategory includes search applications and provisional applications Note 3: Relative valuation of patents was calculated based on several parameters, such as type of patent, patent life, number of citations and geography

  8. Example Highlights • The estimated market opportunity is expected to be well distributed across different areas of application, end users and key geographical regions Tissue Engineering-based Regeneration Products Market Distribution by Area of Application1, 2 Tissue Engineering-based Regeneration Products Market Distribution by Type of End User1, 3 Tissue Engineering-based Regeneration Products Market Distribution by Region1, 4 Percentage Share USD Million USD Million Region 1 -X% End User 1 +X% Market Share 2035 Market Share 2035 Market Share 2035 Market Share 2022 Market Share 2022 Market Share 2022 Change (2022-2035) Change (2022-2035) Change (2022-2035) Region 2 Application 1 Application 2 Application 3 Application 4 Application 5 End User 2 Region 3 +X% Region 4 Region 5 Future Market Share (2035) Region 6 End User 3 Current Market Share (2022) Note 1: Illustrations are not as per actual scale Note 2: The Tissue Engineering-based Regeneration products, 2022-2035 takes into consideration the following Areas of Application: Bone Healing, Burn Healing, Surgical Healing, Wound Healing and others Note 3:The Tissue Engineering-based Regeneration products, 2022-2035 takes into consideration the following end users: Ambulatory Surgical Centre,/Hospitals/Super Specialty Clinics Note 4: The Tissue Engineering-based Regeneration products, 2022-2035 takes into consideration the following geographical regions: North America, Europe, Asia, Latin America, Middle East and North Africa (MENA), and Rest of the World Note: The size of the bubble represents the CAGR

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