Bone Grafts And Substitutes Market by geography into – North America, South America, Europe, Asia-Pacific (APAC), and Middle East and Africa.
The bone grafts substitutes segment holds 26.5% of the market share in 2019 and is expected to be 27.0% by 2027 for the global Bone Grafts and Substitutes market.
The collective revenue of the bone grafts substitutes segment is estimated to be 7,624.2 over the forecast period for 2020-2027.
Bone graft substitutes are human-made or a manipulated versions of a natural product.
As an alternative to autograft and allograft, they are generally safe and can provide a foundation for the patient's body to produce its own bone.
Bone graft substitutes share similar properties with human bone, including a porous structure and/ or proteins to stimulate healing.
In January 2020, OrthoPediatrics Corp., a company focused exclusively on advancing the field of pediatric orthopedics, has launched the QuickPack, a fully synthetic bone graft substitute featuring a high viscosity, calcium phosphate cement that closely mimics the mineral phase of natural bone. With mechanical properties close to those of cancellous bone, QuickPack produces a calcium-deficient apatite that has similar composition and structure to natural bone mineral.
The allografts market is valued at USD 1,079.5 Mn in 2019 and is estimated to grow at a CAGR of 5.7 % over the forecast period to reach USD ** Mn by 2026. The allografts segment holds 40.9% of the market share in 2019 and is expected to be 43.3% by 2027 for the global Bone Grafts and Substitutes market. There are various forms of allografts, such as osteochondral, cortical, cancellous and highly processed bone derivatives such as demineralized bone matrix (DBX). Allografts are commonly used in hip, knee, or long bone reconstruction. Long bones include arms and legs. The advantage is there’s no additional surgery needed to acquire the bone. Allograft exhibits osteoconductive and sometimes osteoinductive potential depending on the preparation process. There are more than 200,000 cases involving allografts that are used per year in the US. The lack of donor site morbidity, general success of outcomes and decreased surgical times make allograft some alternatives to autologous bone graft (autograft). However, the high costs and risks such as viral transmission make allograft an imperfect substitute.
Rates of viral transmission from orthopedic allografts are based upon blood products and, fortunately, are exceeding rare. The risk of viral transmission associated with blood properly screened for hepatitis B one in 63,000, for Hepatitis C, is one in 100,000, and for HIV, it is less than one in 1,000,000.
The market players are launching new products to expand their portfolio, which leads to the strong growth of the market. For instance,
On January 9th, 2020, Royal Biologics, an orthobiologics company specializing in the research and advancement of regenerative cellular therapy and novel orthobiologic solutions, launched the MAGNUS, a DMSO-free viable cellular bone allograft. MAGNUS presents a unique solution to traditional viable cellular allograft technology as it utilizes a DMSO-free cryoprotectant. This novel approach to the viable cellular allograft market differentiates MAGNUS from all other technologies currently available.
In March 2018, Aziyo Biologics, Inc., a fully integrated regenerative medicine company, launched the OsteGro, an allograft bone matrix that supports new bone growth in orthopedic surgical procedures. The launch of OsteGro further expands the company’s bone repair franchise.
The cancellous allograft is produced in the form of small cuboid chips. They are used to pack osseous defects, such as those seen in the setting of total hip arthroplasty associated retroacetabular osteolysis. Like autogenous cancellous grafts, cancellous allografts confer little mechanical strength. Unlike the autografts, however, they are a relatively poor promoter of healing secondary to their preparation process, which leaves them devoid of many growth factors that foster osteoinduction. Unlike autologous cancellous graft incorporation, a local host inflammatory response drives cancellous allograft incorporation, leading to the production of an encapsulated layer of fibrous tissue around the graft. This fibrous tissue makes it more challenging for the host to deposit new osteoid and bone, delaying osseointegration for months to years and preventing its complete integration.
In 2011, Integra LifeSciences Holdings Corp launched the Integra™ Allograft Cancellous Sponge, a compressible bone graft composed of 100% cancellous bone. The sponge-like handling characteristics of Integra™ Allograft Cancellous Sponge allow it to absorb fluids like saline, blood or bone marrow aspirate.
Cortical allografts give rigid structural support, are readily available and can be used in conjunction with multiple other fracture repair techniques. Like cortical autografts, they can be used to fill large defects and, depending on their fixation's stability, allow for early weight-bearing even before bony incorporation has occurred. Cortical allografts are commonly employed in spine procedures, as their resistance to compressive strength allows them to be placed in areas requiring immediate load-bearing resistance. They are also frequently used to stabilize the femoral shaft in the setting of periprosthetic hip fractures. Cortical allograft incorporation, like cancellous allograft, involves an initial inflammatory cascade. However, after the initial inflammatory stages, its healing is more representative of its autogenous counterpart, with creeping substitution as the incorporation's key process. In December 2019, In2Bones Global, Inc. launched the AlloAid BioNail™, an engineered, sterile allograft implant designed to provide rigid, stable fixation during the hand's reconstructive surgery and foot. Derived from strong cortical allograft, the AlloAid BioNail provides osteoconductive properties to encourage bone remodeling and healing, thus enabling a more natural fixation.
Demineralized bone matrix:
Demineralized bone matrix (DBM) is a readily available and most popular form of bone graft, comprising approximately 50% of allografts performed in the US. Demineralized bone matrix is allograft bone that has undergone a process whereby the mineral content has been removed. Demineralization helps expose bone-forming proteins (collagen, growth factors) hidden within the bone structure to stimulate healing. DBM is a popular adjunct to spinal fusion procedures, the grafting of non-unions and the filling of bony defects. It is a form of highly-processed allograft consisting of collagens, non-collagenous proteins, BMPs and other growth factors that bestow it with both osteoinductive and osteoconductive properties. The osteoinductive properties of DBM are greater than those of cancellous or cortical allografts. Its osteoinductive properties stimulate healing through growth-factor-mediated differentiation of MSCs into osteoblasts. Most of the commercially available DBX is washed with hydrochloric acid. Several modern DBM preparations are mixed with cortical and/or cancellous bone chips to confer additional osteoconductive properties. DBM can be mixed with the regular bone to obtain more graft volume and is available in the chip, granule, gel, powder, or putty forms.
The market players are developing innovative products to expand their portfolio, which leads to the strong growth of the market. For instance, In August 2019, TheraCell, Inc., the 2nd Generation TheraFuze DBF® demineralized bone fiber technology inventor, planned to introduce a comprehensive portfolio of demineralized bone fiber solutions.
In July 2019, SeaSpine Holdings Corporation, a global medical technology company focused on surgical solutions for the treatment of spinal disorders, introduced its OsteoStrand™ and OsteoStrand™ Plus Demineralized Bone Fibers with its new integrated hydration syringe system. The new packaging allows the surgeon to seamlessly hydrate the DBM Fibers with blood, saline, or bone marrow aspirate (BMA) in a convenient, open-bore syringe system.
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