Bone Graft Substitutes Market Size, Share & Industry Analysis, By Type (Allograft, Demineralized Bone Matrix (DBM), Synthetic, and Xenograft), By Application (Spinal Fusion, Joint Reconstruction, Foot & Ankle, and Others), By End-user (Hospitals, Specialty Clinics, and Others), and Regional Forecast, 2024-2032

The global bone graft substitutes market size was valued at USD 3.81 billion in 2023 and is projected to grow from USD 4.04 billion in 2024 to USD 6.67 billion by 2032, exhibiting a CAGR of 6.5% during the forecast period (2024-2032). Bone graft substitutes are biologics that can be used as an alternative to autologous bone grafts. The substitutes consist of allograft, demineralized bone matrix, polymers, hydroxyapatite, and other materials. These substitutes are used in treating bone defects, union or non-union surgeries, and spinal fusion in orthopedics. Furthermore, various benefits of these substitutes, such as safety, biocompatibility, and osteoconductivity to fractured bones, have increased the adoption of these products over the past decade.

The global bone grafts and substitutes market growth is attributed to the increasing incidence of bone diseases such as bone infections and bone tumors and the growing number of orthopedic surgeries worldwide. Moreover, the rising demand for synthetic substitutes and various authorities’ surging number of product approvals are expected to fuel the market growth during the forecast timeframe. For instance, in September 2019, Biogennix LLC received 510(k) clearance from the U.S. FDA for Morpheus-C, a bone graft substitute made of type-1 bovine collagen.

COVID-19 IMPACT

The COVID-19 pandemic has decreased the adoption of substitutes due to lower patient volumes in hospitals and specialty clinics. COVID-19 care-related restrictions imposed by the government declined the number of patient visits and delayed elective surgeries, which impacted the sales of these substitutes. However, the relaxation of the regulations imposed by governments led to increased hospital admissions in 2021. Most trauma and spine-related elective surgeries were started in the healthcare facilities. Such resumption of surgical procedures positively impacted the demand for these substitutes in 2021.

Bone Graft Substitutes Market Trends

Increasing Adoption of Bone Graft Substitutes for Dental Implants to Boost Market Growth

The application of substitutes is expanding widely due to various benefits. For instance, it reduces the complications involved in bone grafting procedures at the donor site. In recent years, these substitutes have been increasingly used in dental implants.

• For instance, according to the article published by Dental Tribune International in June 2021, a large volume of patients demanded an implant procedure, which is a promising indicator for the growth of bone grafting.

Moreover, these substitutes helped increase the height and thickness of the jawbone, which enabled the successful placement of a dental implant and restored the normal dimensions of the jawline. Such benefits of these products increase the adoption of dental bone grafts, thereby fueling the overall bone graft substitutes market growth. Furthermore, prominent market players are actively focusing on development of advanced bone graft substitutes with enhanced biocompatibility and efficacy to meet the rising demand in dental implantalogy.

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Bone Graft Substitutes Market Growth Factors

Technological Advancements in Bone Graft Substitutes to Drive Market Growth

The substitutes have applications in various procedures such, as spinal fusion procedures for complex fractures and trauma surgeries. The graft substitutes act as an optimum treatment strategy in these procedures and are considered indispensable.

• For instance, according to the research published by NCBI in October 2019, approximately 30,000 Canadian and 900,000 American adults undergo spine surgery annually.

Such a substantial increase in trauma cases has been observed globally. Additionally, these trauma cases can only be treated and managed effectively with the administration of appropriate bone graft substitutes, ultimately increasing their global demand.

Increasing Adoption of Synthetic Bone Graft Substitutes to Boost Market Growth

The rising use of synthetic substitutes, such as polymer and ceramic, is anticipated to drive the market in the projected years. Several benefits such as reducing the risks involved in injury to the donor site and decreasing risks of complications, are increasing the adoption of synthetic substitutes, thereby spurring the market growth.

Synthetic substitutes consist of materials such as Beta-tri-calcium phosphate, calcium phosphate, and hydroxyapatite. The increasing preference for these products among developed countries is due to their similar chemical composition to human bone.

Furthermore, market players have increased their focus on introducing synthetic substitutes. As a result, the companies have been experiencing strong growth in their revenues.

• In January 2020, OrthoPediatrics Corp. introduced a synthetic bone graft substitute in the U.S. called QuickPack. It is highly viscous and contains calcium phosphate cement that closely resembles the mineral phase of a bone.

Such product launches are expected to increase the adoption of synthetic substitutes during the forecast period.

RESTRAINING FACTORS

Clinical Limitations of Bone Graft Substitutes to Hamper its Demand

The increasing clinical limitations associated with the substitutes include lack of bone formation or incomplete bone formation, adverse tissue reaction, and bone and soft tissue infection. Therefore, this factor is expected to limit the market growth during the forecast period.

Such limitations and increasing risks related to the usage of these products have directed the manufacturers and the U.S. FDA to recall the products. These recalls are expected to decrease the adoption of substitutes thereby, hampering the brand image of the companies.

• For instance, according to the article published by Becker’s Healthcare in June 2021, Aziyo Biologics recalled many of its FiberCel, an allograft product. The allograft was recalled after several patients who received it tested positive for tuberculosis.

Moreover, a number of companies were also asked by the regulatory bodies to hold their ongoing clinical trials for novel products due to the unsatisfactory results from their clinical studies.

Such product recalls of substitutes and postponement of clinical trials are challenging for the key players to escalate their growth.

Bone Graft Substitutes Market Segmentation Analysis

By Type Analysis

Increasing Product Launches to Drive the Synthetic Segment

Based on type, the market is segmented into allograft, synthetic, Demineralized Bone Matrix (DBM), and xenograft. The synthetic segment is further divided into product types such as polymer and ceramic.

The synthetic segment held the largest global bone graft substitutes market share in 2023 and is anticipated to expand at the highest CAGR over the forecast period. The large share of this segment is attributed to the increasing prevalence of bone-related diseases coupled with the high demand for synthetic products, especially in developed countries. Furthermore, the increasing product launches by the market players are expected to fuel segmental growth during the forecast timeframe.

• For instance, in February 2022, Orthofix Medical Inc. introduced a new synthetic bioactive bone graft solution called Opus B.A., used for cervical and lumbar spine fusion procedures.

The allograft segment is anticipated to expand at a substantial CAGR during the forecast period. The segmental growth is attributed to better treatment outcomes in patients by using allograft products. Moreover, market players are focusing on various strategies to expand their product offerings in the allograft segment, driving segmental growth in the coming years.

The demineralized bone matrix (DBM) accounted for a significant market share in 2023. This significant share can be attributed to the growing use of demineralized bone matrix (DBM) due to increasing events of trauma in the extremities and spine. Moreover, the high focus of key players on widening the portfolio of demineralized bone matrix (DBM) products is projected to boost the segment growth during the forecast period.

The xenograft segment is expected to grow at a considerable CAGR during the forecast period 2024-2032. This growth is primarily expected to be driven by advancements in medical technology and improvement in the safety and efficacy of xenograft bone grafts. Furthermore, advanced processing techniques to sterilize and preserve grafts, reduced risk of infection, and improved success rates are the major factors expected to boost the segment growth.

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By Application Analysis

Spinal Fusion Segment to Hold a Major Share Owing to Growing Adoption of Substitutes Products in Spinal Surgeries

By application, the market is segmented into spinal fusion, joint reconstruction, foot & ankle, and others.

In 2023, the spinal fusion segment accounted for the largest market share and is projected to register the highest CAGR during the forecast period. Patients suffering from spine-related diseases are anticipated to boost the growth of the market. Furthermore, the introduction of substitutes by market players for various types of spinal fusions, such as transforaminal lumbar interbody fusion and anterior lumbar interbody fusion, are expected to contribute to segmental growth in the coming years.

The joint reconstruction segment is expected to expand at a substantial growth rate during the forecast period. The growth is attributed to growing research studies for developing graft substitutes to enhance arthroplasty treatment. Furthermore, the larger patient population suffering from arthritis and other joint-related complications is expected to fuel the segmental growth in the coming years.

• For instance, according to the article published by the American Academy of Orthopedic Surgeons in June 2020, over 450,000 total hip replacements are performed each year in the U.S.

Such a large number of arthroplasty surgeries is expected to increase the adoption of these substitutes, thereby driving segmental growth.

By End-user Analysis

Hospitals to Hold a Major Share due to Increasing Orthopedic Procedures in these Settings

As per end-user, the market is segmented into hospitals, specialty clinics, and others.

In 2023, the hospitals segment held the largest market share and is expected to expand at a substantial CAGR during the forecast timeframe, 2024-2032. The segmental growth is attributed to a large number of orthopedists working in hospitals. Moreover, rising number of patient visits in hospitals to opt for various spinal and joint reconstruction surgeries is expected to drive the hospitals segment during the forecast timeframe.

• For instance, according to the article published by Healthline Media in April 2020, in the U.S., knee replacement surgery has become a routine procedure in many hospitals, and approximately 600,000 total knee replacement surgeries are performed annually.

The specialty clinics segment is projected to grow at the highest CAGR during the forecast period, 2024-2032. The segmental growth is due to growing number of orthopedic specialty clinics across several developed countries. Moreover, developing countries, such as India and China, focus on developing medical facilities such as specialty clinics to accommodate a larger patient pool. Such a strong focus on improving healthcare infrastructure is expected to support market growth in the long run.

REGIONAL INSIGHTS

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North America dominated the market with a revenue of USD 1.76 billion in 2023 and is expected to continue its dominance during the forecast timeframe. The surge in the launch of synthetic substitutes by the market players due to its rapid adoption across developed countries is expected to propel the market growth in North America. Moreover, the presence of a large patient pool affected by bone injuries, coupled with rising orthopedic surgeries in the region, is expected to propel the market growth.

The market in Europe held the second-highest share in 2021. The share is due to the increasing prevalence of severe bone fractures and spinal diseases. Furthermore, increasing favorable health reimbursement for bone graft substitutes procedures, significant R&D investment, and increasing focus of market players to introduce new products in the region are expected to increase the demand for these substitutes during the forecast timeframe.

• For instance, in March 2022, BBS-Bioactive Bone Substitutes Plc applied to the European Union for the C.E. marking of the Artebone bone filler substitute. Such approval procedures for new substitutes are expected to fuel the market in the long run.

The Asia Pacific market is expected to grow at the highest CAGR over the projected years. The highest CAGR of the region is attributed to the rising geriatric population and increasing prevalence of arthritis and joint diseases. Moreover, surging investments by the market players to expand their presence in the region are expected to drive market growth.

The Middle East & Africa and Latin America markets are expected to witness comparatively lower revenue growth during the forecast period. The growth is attributed to increasing healthcare expenditures and the growing incidence of bone fractures across these regions.

List of Key Companies in Bone Graft Substitutes Market

Companies with Technologically Advanced Product Portfolios to Hold Key Market Share

DePuy Synthes, Medtronic PLC, Zimmer Biomet, and Stryker are the key players in the market. These companies held a significant market share in 2023. The large market share of these companies is due to factors such as robust and diversified product portfolio, strong geographical presence, and large customer base across the world. Furthermore, strategic initiatives, such as acquisitions of other companies and new product launches, are expected to help key players in maintaining and strengthening their positions in the global market.

Other companies operating in this market include MTF Biologics, Smith & Nephew plc, and other small & medium-sized players. These companies are engaged in various strategic activities such as partnerships & collaborations, new product launches, and geographic expansions to gain market share in the coming years.

LIST OF KEY COMPANIES PROFILED:

• Medtronic PLC (Ireland)


• DePuy Synthes Companies (Johnson & Johnson Services, Inc.) (U.S.)


• Stryker (U.S.)


• Zimmer Biomet (U.S.)


• Smith & Nephew plc (U.K.)


• SeaSpine (U.S.)


• AlloSource (U.S.)


• Bioventus (U.S.)


• MTF Biologics (U.S.)


• Orthofix Holdings, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• October 2023: Orthofix Medical Inc. commercially launched OsteoCove, an advanced bioactive synthetic graft. This graft is available in a putty and strip configuration.


• July 2023: BONESUPPORT launched its next-generation antibiotic-eluting bone graft substitute, CERAMENT G, with additional features such as surface sterility.


• April 2023:  ZimVie Inc. launched RegenerOss CC Allograft and RegenerOss Bone Graft Plug in North America to be used in various dental applications.


• March 2022: MTF Biologics engaged in a partnership with Bone Biologics Corporation to distribute Bone Biologics Corporation’s Demineralized Bone Matrix in the market.


• February 2022: Orthofix Medical Inc. launched Opus BA, a synthetic bioactive bone graft solution, for cervical and lumbar spine fusion procedures.


• October 2021: AlloSource launched AlloMend Extra-Large (XL) Acellular Dermal Matrix, the newest addition to the AlloMend product line.


• July 2021: Orthofix Holdings, Inc. launched the first patient implants with the fiberFUSE Strip, an advanced demineralized fiber bone-graft solution containing cancellous bone.


• February 2020: GreenBone Ortho announced CE Mark approval for GreenBone Substitute bone graft, a naturally derived graft from rattan wood.


• December 2020: GRAFTYS announced its CE recertification in Europe and its Quality Management System certification in conformity with the Medical Device Single Audit Program (MDSAP) in Brazil, Australia, and the U.S. for the sterile calcium phosphate restorable substitutes used in bone grafts.

REPORT COVERAGE

The research report provides a detailed competitive landscape. It focuses on key aspects such as new product launches in the market, market dynamics, and pricing analysis of products. Additionally, it includes insights on funding scenarios pertaining to research and development of the product, market trends, and key industry developments such as mergers, partnerships, and acquisitions. Moreover, it provides analysis of different segments in various regions, profiles of key companies offering bone grafts and substitutes, and the impact of COVID-19 on the market. The report also encompasses qualitative and quantitative insights that contribute to the market growth.

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Report Scope & Segmentation