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The global tissue engineering and regeneration market size is estimated to grow by USD 21.27 billion at a CAGR of 14.93% between 2022 and 2027. The market is poised for significant growth, driven by the increasing prevalence of chronic diseases. Diseases such as diabetes, cancer, and cardiovascular diseases are on the rise, necessitating innovative treatment options, including cell-based therapies. As healthcare systems worldwide grapple with the challenges posed by chronic diseases, there is a growing emphasis on developing novel treatment methods. With an estimated 6 million people in the US suffering from chronic wounds annually, there's a pressing need for advanced solutions that can reduce hospitalization and offer long-term treatment. Consequently, extensive research and development activities are underway, focusing on biologically derived scaffold materials and technological advancements to address a wide range of medical conditions, including orthopedics, ophthalmology, and gastrointestinal disorders. This concerted effort towards tissue engineering and regeneration is poised to revolutionize healthcare and positively impact market growth in the forecast period.
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Technavio has segmented the market into Material, Application, and Geography.
Synthetic
The market share growth by the synthetic segment will be significant during the forecast period. Synthetic elements and materials used include scaffolds, polymers, hydrogels, and nanomaterials. They have numerous benefits that include controlled properties, customizable structures, and a lower risk of immune rejection. Scaffolds, for instance, are three-dimensional structures that help provide a framework for cells to adhere, grow, and differentiate. The benefits they offer include scaffold architecture, porosity, and mechanical properties.
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The synthetic segment was valued at USD 8.48 billion in 2017. Within this segment, polymers like PLGA and PCL and nanomaterials like nanofibers and nanoparticles have further become extremely useful. Nanofibers help to improve cellular adhesion, enhance mechanical stability, and deliver bioactive molecules. Demand for precise architecture and porosity in customizable constructs and scaffolds boosts the adoption of synthetic materials. Moreover, other factors such as the increasing shift towards personalized healthcare will boost the growth of the market during the forecast period.
Orthopedic
They are significantly applied in the orthopedics segment, aiming to repair and regenerate damaged or degenerated musculoskeletal tissues. For instance, scaffolds and cell-based therapies can be used in the regeneration of bone tissue with bone graft substitutes offering support to the growth of new bone tissue. Techniques like autologous chondrocyte implantation (ACI) and matrix-induced autologous chondrocyte implantation can also be used for cartilage regeneration. Furthermore, the development of artificial intervertebral discs has helped address major spinal disorders and injuries by providing support and cushioning for the spine. Additionally, factors like the massive R&D investment into expanding the scope of tissue scaffolds are also predicted to boost the growth of the market during the forecast period.
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North America is estimated to contribute 47% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that will shape the market during the forecast period. In North America, US and Canada are the largest revenue-generating markets because of the presence of various vendors like Smith and Nephew and RTI Surgical. These vendors are also spending massive amounts on R&D and launching new products which upon approval can be used commercially. Additionally, the increased healthcare expenditure and increased awareness about tissue engineering and regenerative products among end-users are contributing to the further growth of the regional market. Moreover, the Regenerative Medicine Promotion Act of 2014 supports further development of regenerative medicine through increased funding for R&D and quick approval of safe and effective products. Hence the relative ease of regulatory compliance in the region will drive further market growth during the forecast period.
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Vendors are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market players, including:
3M Co. - The company offers tissue engineering and regeneration products such as the 3M Veraflo Cleanse Choice Complete Dressing Kit and 3M Smart Instil for Veraflo Therapy.
Qualitative and quantitative analysis of vendors has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize vendors as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize vendors as dominant, leading, strong, tentative, and weak.
The market is experiencing significant growth, driven by advancements in technology and increasing awareness of its potential benefits. This innovative field focuses on developing biological replacements for damaged or diseased tissues and organs using a combination of cells, biomolecules, and scaffolds. With a prospective pipeline of products targeting chronic diseases and trauma crises, tissue engineering offers promising solutions for various medical needs. Orthopedics and musculoskeletal applications, such as bone and cartilage regeneration, are particularly prominent. The market is characterized by intensive R&D activities aimed at enhancing tissue function and developing biologically derived scaffold materials. From addressing tooth decay to craniofacial reconstruction and ocular tissue engineering for conditions like glaucoma and corneal disease, tissue engineering holds immense potential in revolutionizing medical treatments across multiple disciplines. There are multiple factors influencing market growth. Our researchers analyzed the data with 2022 as the base year, along with the key drivers, trends, and challenges.
Emerging technological advances is a key trend in the market. A trend of technological advancement is emerging in the global market. Recent advances include regenerated trachea for transplantation and 3D bioprinting. 3D bioprinting helps manufacturers gain information on the size, shape, pore size, geometry, and mechanical properties of regenerative products. Despite it being limited to research currently, there is a further development of scaffolds that contain nanomaterials that help the cellular component of the constructed tissue to operate similarly to biological cells.
Additionally, greater engineering such as aligning nanofibers within the scaffold or producing the nanofiber mats with programmed fiber directions are helping to address nanofiber limitations. In Europe, after the launch of STRIMVELIS and Zalmoxis, two gene therapy products, there was observed to be further interest in this market. Moreover, technologies like the CRISPR-Ca9 system can help in slicing the genome present in human cells, allowing for alteration and modifications in the human genome. Hence the above factors will propel the market growth during the forecast period.
Uncertain regulatory approval in the products is challenging market growth. Cell therapy, gene therapy, and tissue engineering and their adoption are still in their nascent stage, and clinical application is still minimal in developed as well as developing countries. Vendors must also adhere to stringent regulations before receiving approval. In the US, medical products which contain human tissues or cells are termed 361 HCT/P as they come under the purview of section 361 of the Public Health Service Act (PHSA). However, HCT/Ps that do not meet all criteria of section 361 must require explicit FDA approval and adhere to 21 CFR 820 and 21 CFR 1271, increasing costs of compliance and waiting times.
Additionally, the regulatory requirements and compliances vary from region to region in both implementation as well as interpretation. For instance, in Europe, advanced therapy medicinal products (ATMP) regulations regarding the definition, classification, packaging, and processing of HCT/Ps vary from country to country. Other factors like high development costs, heterogeneity of reimbursement, and volatile market conditions make gene therapy difficult to commercialize further limiting market growth during the forecast period.
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The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.
Global Market Customer Landscape
The market report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2017 to 2027.
The market is witnessing significant growth driven by advancements in technology and increasing R&D activities. This field focuses on creating biological replacements for damaged tissues or organs, utilizing biomolecules and synthetic biomaterials to engineer tissues with specific functions. Orthopedics, musculoskeletal procedures, and cardiovascular illnesses are major segments benefiting from tissue engineering innovations. Additionally, applications extend to dermatology, ophthalmology, and gastrointestinal disorders. Stem cells play a crucial role in tissue regeneration, alongside engineered scaffolds and tissue grafts. With interdisciplinary collaborations between biomedical engineering, material technologies, physics, chemistry, and biology, the market aims to address various medical needs, from trauma injuries and burns to dental deformities and ocular diseases like glaucoma and age-related macular degeneration.
Moreover, the market is witnessing significant growth driven by technological advancements and a prospective pipeline of innovative products. This market encompasses various segments such as orthopedics, musculoskeletal procedures, cardiology, cosmetic surgery, and more. Key components include biologically derived scaffold materials, synthetic polymers, and engineered heart tissue (EHT). With applications ranging from treating trauma crises and tissue function restoration to addressing conditions like skin abrasions, thermal damage, and tooth decay, tissue engineering plays a vital role in healthcare. Additionally, it addresses critical needs in areas like burn therapy, wound care, and pediatric patients. With the advent of 3D printers and advancements in biologics and small chemicals, the potential for tissue engineering and regeneration continues to expand, offering promising solutions for various medical challenges.
Knowledge of prospective pipeline products is vital for understanding the dynamics of the tissue engineering market, particularly within the orthopedics and musculoskeletal segment. Technology advancements in medical equipment have revolutionized the field, allowing for the development of innovative compositions and microstructures tailored to the needs of the musculoskeletal system. These advancements hold great promise for improving patient outcomes and addressing complex orthopedic challenges.
Tissue Engineering and Regeneration Market Scope |
|
Report Coverage |
Details |
Page number |
164 |
Base year |
2022 |
Historic period |
2017-2021 |
Forecast period |
2023-2027 |
Growth momentum & CAGR |
Accelerate at a CAGR of 14.93% |
Market growth 2023-2027 |
USD 21.27 billion |
Market structure |
Fragmented |
YoY growth 2022-2023(%) |
13.38 |
Regional analysis |
North America, Europe, Asia, and the Rest of the World (ROW) |
Performing market contribution |
North America at 47% |
Key countries |
US, Canada, Germany, UK, and China |
Competitive landscape |
Leading Vendors, Market Positioning of Vendors, Competitive Strategies, and Industry Risks |
Key companies profiled |
3M Co., AbbVie Inc., Astellas Pharma Inc., B.Braun SE, Baxter International Inc., Becton Dickinson and Co., CO.DON GmbH, Cook Group Inc., Integra Lifesciences Corp., Johnson and Johnson Services Inc., Medtronic Plc, Organogenesis Holdings Inc., PLUS THERAPEUTICS Inc., REPROCELL Inc., RTI Surgical Inc., Smith and Nephew plc, Stryker Corp., Tissue Regenix Group Plc, Vericel Corp., and Zimmer Biomet Holdings Inc. |
Market dynamics |
Parent market analysis, Market forecasting, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, and Market condition analysis for the forecast period. |
Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Material
7 Market Segmentation by Application
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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