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The global tissue engineering and regeneration market size is estimated to grow by USD 28.3 billion at a CAGR of 16.86 % between 2023 and 2028. The tissue engineering and regeneration market are experiencing significant growth due to several key factors. The increasing prevalence of chronic diseases, such as diabetes and cardiovascular diseases, necessitates the development of advanced therapeutic solutions. One such solution is tissue engineering, which utilizes scaffolds to promote cell growth and tissue regeneration. The adoption of tissue scaffolds is on the rise as they offer numerous benefits, including reduced surgical invasiveness and faster recovery times. Furthermore, public and private healthcare organizations are increasingly investing in cell-based tissue engineering research, providing substantial initiatives and support to drive innovation in this field. These factors collectively contribute to the expanding market for tissue engineering and regeneration solutions.
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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 9.60 billion in 2018. 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.
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 43% 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, the 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.
In the realm of life science, significant strides are being made in regenerative medicines to address degenerative diseases resulting from various causes such as road accidents and traumatic brain injury (TBI). These advancements leverage living cells and cutting-edge technologies like Quantum Magnetic Resonance Therapy to foster new approaches in organ transplantation techniques and treatments for orthopedic disorders. Tissue engineering solutions and stem cell research are pivotal in exploring therapeutic avenues for conditions such as spinal cord injury and traumatic spinal cord injury, where gene editing techniques hold promise for targeted interventions. The integration of these innovations in hospitals is transforming the landscape of medical care, offering hope for improved patient outcomes and enhanced quality of life.
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.
Moreover, 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.
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 research report provides comprehensive data (region wise segment analysis), with forecasts and estimates in "USD Billion" for the period 2024 to 2028, as well as historical data from 2018 to 2022 for the following segments.
1. Regenerative Medicine Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Germany, UK, Japan, China - Size and Forecast
2. 3D Bioprinting Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, China, Germany, Canada, Japan - Size and Forecast
3. High Performance Biomaterials Market Analysis North America, Europe, APAC, South America, Middle East and Africa - US, China, Japan, Germany, UK - Size and Forecast
In the expansive field of life science, the pursuit of advancements in organ transplants and tissue signaling has led to breakthroughs in vascularization and the creation of complex tissues. Researchers are pioneering human liver prototypes and enhancing surgical tools within sterile environments through medical automation technology. Despite challenges in a monopolistic environment, innovations are targeting organ failures stemming from accidents, burn injuries, and traumatic brain injury (TBI), thereby shaping the trauma injury products market. Materials such as synthetic scaffold and biologically derived scaffold materials like collagen, alginate, and chitosan are crucial for tissue engineering solutions. Emerging technologies like Quantum Magnetic Resonance Therapy and organ transplantation techniques are transforming hospitals, specialty clinics, and ambulatory surgical centers. Regulatory authorities oversee advancements in tissue regeneration technology, stem cell therapies, and gene editing techniques, targeting conditions from spinal cord injury to age-related macular degeneration and ocular cancer. The evolution of 3D bioprinters and organ on a chip technology is paving the way for personalized treatments and expanding the scope of clinical studies in medical tourism.
Market Scope |
|
Report Coverage |
Details |
Page number |
175 |
Base year |
2023 |
Historic period |
2018 - 2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 16.86% |
Market growth 2024-2028 |
USD 28.3 billion |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
14.17 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 43% |
Key countries |
US, Germany, UK, Canada, and China |
Competitive landscape |
Leading Companies, Market Positioning of Companies, 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 growth inducers and obstacles, Fast-growing and slow-growing segment analysis, Market growth and Forecasting, COVID 19 impact and recovery analysis and future consumer dynamics, Market condition analysis for forecast period |
Customization purview |
If our market 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 Opportunity/Restraints
11 Competitive Landscape
12 Competitive Analysis
13 Appendix
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