U.S. Bone Graft Substitutes Market Size, Share & Industry Analysis, By Type (Allograft, Demineralized Bone Matrix (DBM), Synthetic {Polymer, and Ceramic [Hydroxyapatite, Beta TCP, and Others]}, and Xenograft), By Application (Spinal Fusion, Joint Reconstruction, Foot & Ankle, and Others), By End-user (Hospitals, Specialty Clinics, and Others), and Forecast, 2024-2032

The U.S. bone graft substitutes market size was worth USD 1.62 billion in 2023 and is projected to grow at a CAGR of 6.8% during the forecast period.

Bone graft substitutes are medical devices made from synthetic or natural materials and used to promote bone healing and regeneration in cases of fractures, defects, or spinal fusions. Substitutes, such as hydroxyapatite and demineralized bone matrix, mimic the structural and biochemical properties of a bone, facilitating the body's natural bone formation processes.

The rising prevalence of orthopedic-related diseases is expected to increase the demand for demineralized bone, allograft, and other bone graft substitutes. Furthermore, the rising approval of products used in spinal fusion and other orthopedic procedures by regulatory bodies is expected to fuel the market’s growth in the long run.

• For instance, in January 2020, OrthoPediatrics Corp. launched QuickPack, a fully synthetic bone graft substitute in the U.S. The product has a high viscosity and calcium phosphate cement that closely mimics the mineral phase of natural bone.

The COVID-19 pandemic caused a decline in the U.S. bone graft substitutes market’s growth. This was mainly due to major delays in conducting elective and non-essential procedures in the country due to the restrictions imposed by the government. Furthermore, a majority of the healthcare resources were used to treat COVID-19 patients, which negatively impacted the market’s growth in 2020.

U.S. Bone Graft Substitutes Market Trends

Increasing Adoption of Bone Graft Substitutes for Dental Implants

In recent years, the market witnessed a sudden spike in the adoption of dental bone grafts in dental implant procedures due to the various benefits associated with them. These products help increase the jawbone's height and thickness, enabling the successful placement of bone graft substitutes and restoring the jawline's normal dimensions in many patients.

• For instance, according to an article published by Dental Tribune International in June 2021, a large volume of patients demanded implant procedures to improve their dental health and functionality by using artificial components. This is a promising indicator of the growth in the demand for bone grafting procedures.

U.S. Bone Graft Substitutes Market Growth Factors

Technological Advancements in Bone Graft Substitutes to Drive Market Growth

The growing prevalence of orthopedic disorders has encouraged the U.S. bone graft substitutes market players to increase their focus on technological advancements, such as antibiotic-eluting products. These products enable natural bone healing while reducing the recurrence of chronic osteomyelitis from antibiotic-sensitive microorganisms.

• For instance, in June 2021, Elute, Inc. announced that it had received its first clinical trial authorization from the U.S. FDA for using its antibiotic-eluting bone void filler. The product would treat bone infections as it has osteoconductive and antimicrobial properties.

RESTRAINING FACTORS

Clinical Limitations Associated With Bone Graft Substitutes to Limit Market Growth

The limitations associated with using substitutes include infection of the soft tissue & bone, severe tissue reactions, and lack of or incomplete bone formation. These disadvantages are expected to hamper the adoption of bone graft substitutes during the forecast timeframe.

Furthermore, the increasing awareness of the risks associated with these products has led to product recalls by manufacturers and the U.S. FDA. This can negatively impact the brand image of these companies, thereby reducing the adoption of these products.

In the U.S., it was estimated that the incidence of fracture and spine degeneration was 9,645,791 and 16,208,664, respectively.

U.S. Bone Graft Substitutes Market Segmentation Analysis

By Type Analysis

Based on type, the market is segmented into allograft, demineralized bone matrix (DBM), synthetic, and xenograft.

The synthetic segment held the highest market share in 2022 and is expected to record the highest CAGR during the forecast period. The increasing adoption of synthetic products, the surge in bone graft-related surgeries, and the high success rate of these products are expected to drive the dominance of this segment.

• For instance, in April 2019, Exactech announced the first successful surgery using its new InterSep calcium sulfate, a synthetic bone graft product.

The allograft segment held a significant share of the market in 2022. The segment's growth is due to the increasing prevalence of bone-related disorders and the growing focus of market players on launching allografts in the country.

By Application Analysis

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

The spinal fusion segment accounted for the largest U.S. bone graft substitutes market share in 2022. The segment’s growth is due to a notable increase in the number of lumbar fusion surgeries in hospitals. Furthermore, new product launches by market players for the treatment of spinal injuries are expected to boost the segment’s growth in the country.

In 2022, the joint reconstruction segment held a significant share of the market. The segment’s growth is attributed to a larger patient population suffering from arthritis and other joint-related complications.

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

By End-user Analysis

Based on end-user, the market is segmented into hospitals, specialty clinics, and others.

The specialty clinics segment is projected to record the highest CAGR during the forecast period of 2023-2030. The rising cases of osteosarcoma in the U.S. is expected to increase patient visits to specialty clinics, thereby propelling the segment's growth during the forecast period.

• For instance, according to the American Cancer Society, Inc., around 1,000 new cases of osteosarcoma were diagnosed in the U.S. in 2023. This factor is expected to increase the number of surgeries in specialty clinics, thereby spurring the segment’s growth.

In 2022, the hospital segment held the largest share of the market. The growth of this segment is attributed to the increasing number of hospitals in the country. Additionally, the increasing number of visits to hospitals of patients suffering from ankylosing spondylitis disorders and bone fractures will increase the demand for bone graft substitutes, thereby propelling the segment’s growth.

List of Key Companies in U.S. Bone Graft Substitutes Market

As far as the competitive landscape is concerned, the U.S. bone graft substitutes market depicts the presence of several reputed companies. Organizations such as DePuy Synthes, Medtronic, Stryker, and Zimmer Biomet are prominent players in the market. The apex positions held by these companies are attributed to their diversified product portfolios, strong geographical presence, and large customer base. Furthermore, strategic initiatives, such as new product launches, mergers, and acquisitions, are expected to help key players maintain and strengthen their positions in the market.

Some other companies with a considerable presence in the U.S. market include MTF Biologics, Smith & Nephew plc, and other small & medium-sized players. These companies are focusing on various strategies, such as launching new bone graft substitutes to strengthen their product portfolio, which is expected to increase their U.S. bone graft substitutes market share.

LIST OF KEY COMPANIES PROFILED:

• Medtronic (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:

• September 2023: Zimmer Biomet collaborated with HippoFi, a healthcare technology firm in California. The collaboration is aimed at introducing novel synthetic biomaterials for bone growth in 2024.


• June 2022: NuVasive received approval from the U.S. FDA for ATTRAX, its synthetic bone graft substitute. This product is used in interbody fusions of the thoracolumbar spine.


• March 2022: MTF Biologics partnered with Bone Biologics Corporation. The partnership was aimed at distributing Bone Biologics Corporation’s Demineralized Bone Matrix (DBM) in the country.

REPORT COVERAGE

The report provides a detailed analysis of the market. It focuses on key aspects, such as an overview of the technological advancements and prevalence of key disorders in the U.S. Additionally, it includes an overview of the key industry developments and the impact of COVID-19 on the market. Moreover, the report provides a comparative analysis of the product portfolio of key companies.

Report Scope & Segmentation