TISSUE ENGINEERING MARKET ANALYSIS

Market Size and Trends

The global tissue engineering market is estimated to be valued at USD 11.61 Bn in 2024 and is expected to reach USD 25.50 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 11.9% from 2024 to 2031.

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The global tissue engineering market is also witnessing significant growth due to the ongoing research and development activities in regenerative medicine. The clinical translation of various tissue-engineered products and the commercialization of these products are expected to provide new opportunities for market growth over the coming years. Many companies are investing extensively in developing advanced tissue-engineered products for applications across various therapeutic areas.

Market Driver – Increasing Prevalence of Kidney Related Disorders

Tissue engineering is gaining traction in various areas such as wound care, burn treatment, orthopedics, neurology, urological products, and others. Tissue engineering can play an important role in the management of pediatric patients. Tissue or organs absent at the time of birth, in congenital anomalies such as bladder exstrophy, esophageal atresia, and congenital diaphragmatic hernia pose a serious challenge in surgical repair. Moreover, tissue engineering approaches have become a significant area of interest in burn wound management. Tissue engineered skin substitutes have great potential for widespread applications in wound healing, particularly to address the limited availability of autologous skin increasing burn and trauma related injuries are expected to drive the global tissue engineering market growth. For instance, in February 2022, according to the American Chemical Society, the prevalence of chronic kidney disease (CKD) in the general population is estimated to be as high as 14% across the globe.

Market Concentration and Competitive Landscape

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With an ageing population and chronic diseases on the rise, there is a need for more effective medical treatments and therefore a need for trained tissue engineering researchers to deliver these technologies. Tissue engineering offers alternatives to surgical reconstruction, transplantation, and directing mechanical devices to repair damaged tissues. For instance, in March 2020, according to the National Library of Medicine, spinal cord injury (SCI) affects an estimated three million persons worldwide, with ∼180,000 new cases reported each year leading to severe motor and sensory functional impairments that affect personal and social behaviors. As tissue engineering technology is being developed for use in a variety of different fields, particularly in the biomedical field, a clear understanding of the mechanisms of tissue engineering is important.

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Currently available tissue engineering methods face several problems, including ineffective cell growth, insufficient and unstable production of growth factors to stimulate cell communication and proper response, and lack of appropriate biomaterials and techniques to capture appropriate physiological architectures.

Market Opportunity – Increasing Product Approval by Regulatory Authorities

For instance, in June 2023, the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), named Cholederm, received an approval from the Central Drugs Standard Control Organisation (CDSCO) as a Class D medical device. Cholederm is a wound healing material derived from the extracellular matrix of de-cellularised gall bladder of pig and tissue engineered as membrane forms of scaffold, by the researchers at the Division of Experimental Pathology in the Biomedical Technology wing of SCTIMST.

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The graft type segment includes, autografts, and xenografts. The allografts sub-segment is estimated to hold 43.1% of the market share in 2024 owing to their natural compatibility advantages. Allografts involve transplanting tissue from one individual to genetically non-identical individuals of the same species. Compared to autografts which involve harvesting tissue from one site in the body and transplanting it to another site in the patient, allografts provide a more abundant source of graft material that does not require additional surgery or damage to healthy tissues in the patient’s own body. Allografts are also more compatible options than xenografts which involve tissues from other species. While xenografts from sources like pigs offer more abundant availability, they carry greater immunological rejection risks as the tissues come from non-human donors. Allograft tissues on the other hand are derived from human donors and thus closely match the biological properties of the recipient’s tissues. This greater similarity minimizes immune responses and increases biocompatibility.

Insights, By Material Type: Superior Mechanical Properties Drive the Synthetic Material Demand

The material type segment includes synthetic, biological, and others. The synthetic sub-segment is estimated to hold 52.7% of the market share in 2024 owing to their ability to mimic native tissue attributes better than biological or other options. Tissue engineering applications demand scaffolding or matrices that can support cell growth and tissue generation over time. Compared to biological matrices, synthetics allow for higher control over physical and mechanical characteristics through meticulous engineering approaches. Specifically, synthetic polymers can be designed with precise pore sizes, shapes and interconnectivity to maximize nutrient diffusion, waste removal and new tissue infiltration. Their mechanical properties like stiffness, strength and viscoelasticity can also be tuned to closely match those of target natural tissues. This level of engineered biomimicry proves more difficult with bio-sourced materials. Moreover, synthetics demonstrate excellent flexibility for modification with cell-adhesive ligands, growth factors and other bioactive molecules to promote cell proliferation and differentiation.

Insights, By Application: Strong Clinical Needs Fuel Orthopedic Application Demand

The application segment includes dermal, orthopedic, dental, neurology, and others. The orthopedic sub-segment is estimated to hold 39.4% of the market share in 2024 due to sizeable clinical demands and limited alternative treatment options. Age-related degeneration and injuries are leading to rapidly rising incidences of musculoskeletal diseases worldwide. Traditional options like joint replacements have limitations in longevity, biocompatibility, and natural biomechanical functioning. Tissue engineering presents an attractive regenerative approach but orthopedic reconstruction poses bigger material challenges than other areas due to the structural rigor required. Scaffolds and matrices aimed at bone, cartilage, and tendon repair must replicate the complex compositional heterogeneities and mechanical properties of load-bearing connective tissues. Significant research progress is being made to develop osteochondral grafts, injectable hydrogels, nanofibrous meshes and three-dimensional printed biomaterials that can facilitate cellular recellularization and tissue regeneration for orthopedic injuries like spinal fusion, osteoarthritis, fracture non-unions and ligament tears. Additionally, cell-based therapies utilizing mesenchymal stem cells, platelets and growth factors are demonstrating potential in cartilage and osteochondral repair.

Regional Insights

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North America remains the dominant region in the global tissue engineering market and is estimated to hold 37.4% of the market share in 2024. Strong industry presence of leading tissue engineering companies such as Organogenesis and Smith & Nephew has established the region as the innovation hub. These companies have invested heavily in R&D to develop advanced tissue engineering products and technologies. In addition, favorable government policies supporting regenerative medicine research through increased funding have boosted tissue engineering activities. The presence of advanced healthcare infrastructure and high healthcare spending have also created a conducive environment for new tissue engineering therapies. A large patient pool suffering from chronic wounds, musculoskeletal disorders, and other degenerative diseases demand innovative treatment options, are driving the adoption of tissue engineering products. Other factors such as wide medical insurance coverage and availability of skilled workforce have further aided the regional market growth.

Asia Pacific market is witnessing fastest expansion and is expected to grow at a high rate during the forecast period. Rising healthcare expenditure, increasing healthcare access, and growing incidences of target diseases are some major macroeconomic factors driving the Asia Pacific tissue engineering industry. Countries like China, India, and South Korea are emerging as lucrative markets with the presence of strong bioscience industries and constantly improving medical infrastructure. China and India also have large talent pool of skilled researchers supporting domestic tissue engineering research. Additionally, governments of various APAC countries are promoting regenerative medicine through funding initiatives to develop indigenous product development capabilities. This has attracted global tissue engineering companies to establish manufacturing and R&D bases in the region. With increasing regional exports, Asia Pacific is gradually stepping up as a global production hub for tissue engineering products.

Market Report Scope

Key Developments

• In December 2022, CELLINK, and the Indian Institute of Science (IISc), announced that they had opened Center of Excellence (CoE) for 3D bioprinting for tissue engineering, regenerative medicine. The CoE will provide access to 3D bioprinting systems, enabling researchers to accelerate their work across critical applications with the ultimate goal of improving health outcomes.
• In April 2022, Organogenesis Inc., a global leader in regenerative medicine, announced that the latest advanced wound care research on its PuraPly AM, Affinity, Apligraf, NuShield, Novachor, and Organogenesis Physician Solutions product lines would be showcased at the 2022 Symposium on Advanced Wound Care (SAWC) Spring Conference, held between April 6 and April 10, 2022, in, Arizona, U.S.
• In May 2021, 3D Systems, Inc., a leading provider of 3D printing announced the acquisition of Allevi, Inc., is a technology company making 3 dimensional bioprinters and bioinks to expand regenerative medicine initiative by accelerating growth in medical and pharmaceutical research laboratories
• In May 2021, 3D Systems, Inc., a leading provider of 3D printing, announced the acquisition of a Germany-based software firm, Additive Works GmbH, to expand simulation capabilities for rapid optimization of industrial-scale 3D printing processes

*Definition: Tissue engineering is an interdisciplinary field addressed to develop functional three-dimensional tissues combining cells, scaffolds, and bioactive molecules. This field involves scientific areas such as cell biology, chemistry, material science, molecular biology, medicine, and engineering. It can be used to develop functional constructs that can be used to reestablish, maintain or improve the condition of injured body parts or tissues. Tissue engineering also assist in regeneration of damaged tissues by combining cells from the body with highly porous scaffold biomaterials. Scaffold biomaterials act as templates for tissue regeneration and guide the growth of new tissue.

Market Segmentation

• Graft Type Insights (Revenue, USD Bn, 2019 - 2031)
  • Allografts
  • Autografts 
  • Xenografts
•  Material Type Insights (Revenue, USD Bn, 2019 - 2031)
  • Synthetic
  • Biological
  • Others
•  Application Insights (Revenue, USD Bn, 2019 - 2031)
  • Dermal
  • Orthopedic
  • Dental
  • Neurology
  • Others
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Acelity L.P. Inc.
  • AbbVie Inc.
  • B. Braun SE
  • BioMimetic Therapeutics
  • Bio Tissue Technologies
  • C. R. Bard
  • International Stem Cell
  • Integra Lifesciences
  • Organogenesis Inc.
  • Osiris Therapeutics
  • RTI surgical, Inc.
  • Tissue Regenix Group Plc.
  • Zimmer Biomet
  • 3D Systems, Inc.