Tendons, muscles, ligaments, skin, nerve tissue, cartilage, and synovial membrane make up the soft tissue of the human body. Tissue injury changes the structure and biochemical composition of the tissue. Soft tissue repair is divided into two categories: repair and regeneration. Repair refers to the replacement of destroyed body tissue with healthy tissue.
Statistics:
The global soft tissue repair market is estimated to account for US$ 8,702.5 Mn in terms of value by the end of 2027.
Global Soft Tissue Repair Market: Drivers
The worldwide soft tissue repair market is expected to rise due to the high prevalence of obesity. For example, the report titled “Rising Obesity in Saudi Residents.” Obesity was observed in 42 percent of the research group, with low physical activity levels and harmful dietary habits, according to a study published in the International Journal of Health Sciences in January 2018.
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Furthermore, the global soft tissue repair market is likely to benefit from the growing geriatric population. According to the United States Census Bureau, the elderly population in the United States is predicted to reach 77 million by 2034.
Statistics:
In terms of value, North America dominated the global soft tissue repair market in 2019, accounting for 47.5 percent of the market, followed by Europe and Asia Pacific.
Global Soft Tissue Repair Market: Restraints
The worldwide soft tissue repair market is projected to be hampered by a lack of acceptance for biological products and a lack of suitable product knowledge among physicians and surgeons. Physicians and surgeons who lack proper product expertise may misuse and ineffectively employ products, resulting in unsatisfactory patient outcomes or patient damage. Furthermore, the worldwide soft tissue repair market is projected to be hampered by a lack of R&D and regulatory limits for biological mesh. Because biological meshes (Allografts, Xenografts, and Alloplasts) are derived from cutaneous tissue, stringent regulations for biological meshes (Allografts, Xenografts, and Alloplasts) are observed due to regulatory impediments on human tissue banks in a few locations.
Global Soft Tissue Repair Market: Opportunities
Players in the worldwide soft tissue repair market can expect lucrative growth possibilities as the frequency of emergency operations rises. For example, according to Australian Institute of Health and Welfare’s Hospitals at a glance 2017–18 report updated in August 2019, admissions for emergency surgery increased between 2016-2017 and 2017-2018 by 2.9% in public hospitals and by 5.1% in private hospitals in Australia.
Furthermore, growing investment in soft tissue healing is projected to help the market develop. For example, Biorez, a developer of tendon and ligament repair technology, raised US$ 3.5 million in a seed financing round in September 2020.
Statistics:
The global soft tissue repair market was valued at US$ 5,618.7 in 2019 and is forecast to reach a value of US$ 8,702.5 Mn by 2027 at a CAGR of 5.6% between 2020 and 2027.
Market Trends/Key Takeaways
The worldwide soft tissue repair market is expected to rise due to the high prevalence of diabetes. For instance, according to the study, “Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition”, published in the journal Diabetes Research and Clinical Practice, in September 2019, 463 million people are expected to suffer from diabetes in 2019 worldwide and the number is expected to reach 578 million by 2030 and 700 million by 2045.
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Furthermore, the availability of medicines for allograft rejection is projected to boost the global soft tissue repair market’s growth. For example, TFF Pharmaceuticals, Inc. got orphan drug designation for Tacrolimus Inhalation Powder for the prevention of lung allograft rejection from the US Food and Drug Administration in June 2020.
Regulations
U.S.
U.S. FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
Tissue (“361 HCT/P”)
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Human cells, tissues, and cellular and tissue-based products (HCT/P’s) are regulated by the Center for Devices and Radiological Health (CDRH)
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Products are included under Section 361 of PHS Act
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Premarket review and approval not required; Product regulated solely under Tissue Regulations to control spread of communicable disease (21 CRF 1271)
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Establishment registration and product listing required (21 CRF 1271 -Subpart B)
These HCT/P’s are regulated solely as “361 products” when they meet all of the criteria in 21 CFR 1271.10(a):
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BONE (including DEMINERALIZED BONE
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LIGAMENTS
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TENDONS
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FASCIA
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CARTILAGE
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OCULAR TISSUES (CORNEAS & SCLERA)
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SKIN
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VASCULAR GRAFTS (VEINS & ARTERIES), except preserved umbilical cord veins
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PERICARDIUM
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AMNIOTIC MEMBRANE (when used alone (-without added cells-) for ocular repair)
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DURA MATER
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HEART VALVE ALLOGRAFTS
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HEMATOPOIETIC STEM CELLS DERIVED FROM PERIPHERAL OR UMBILICAL CORD BLOOD
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SEMEN
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OOCYTES
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EMBRYOS
Global Soft Tissue Repair Market: Competitive Landscape
- B. Braun Melsungen AG, Baxter, BD, Johnson & Johnson Private Limited, Stryker Corp., Integra LifeSciences Corporation, Medtronic plc, Acera Surgical, Inc., Anthrex, Inc., Acelity L.P. Inc., Biorez, Aroa Biosurgery Limited, Misonix, Inc., and Ortho Regenerative Technologies Inc. are some of the major players in the global soft tissue repair market.
Global Soft Tissue Repair Market: Key Developments
- To extend their product portfolio, major companies in the global soft tissue repair market are focusing on R&D of new products. For example, in December 2019, Misonix, Inc., a manufacturer of minimally invasive ultrasonic medical devices used for precise bone sculpting, removal of soft and hard tumors and tissue debridement, announced publication of two new large real-world studies proving the clinical effectiveness of its all human split thickness skin allograft TheraSkin for the treatment of complex wounds.
- Major market participants are also focusing on new product R&D in order to extend their product line. For instance, in August 2020, Aroa Biosurgery Limited, a soft tissue regeneration company, announced that a study published in respected international peer-reviewed journal PLOS ONE described the ability of components found within the Endoform ECM platform technology, its flagship extracellular matrix (ECM), to signal stem cells in laboratory models.
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