USD 2.80 Billion
Report ID:
SQMIG35A2257 |
Region:
Global |
Published Date: November, 2024
Pages:
219
|Tables:
64
|Figures:
75
Bone Graft Substitutes Market size was valued at USD 1.28 Billion in 2023 and is poised to grow from USD 1.37 Billion in 2024 to USD 2.29 Billion by 2032, growing at a CAGR of 6.70% during the forecast period (2025-2032).
The global market for bone graft substitutes is expected to experience substantial growth during the forecast period due to increasing demand for synthetic substitutes and the approval of new products by regulatory authorities. For instance, in July 2020, Baxter obtained clearance from the U.S. FDA for its Altapore Shape Bioactive Bone Graft, expanding its bone graft substitute lineup. The adoption of bone grafts and substitutes has been driven by their advantages, such as biocompatibility, safety, and ability to promote bone healing. The demand for biocompatible bone grafts is also on the rise as they help reduce adverse reactions. Synthetic grafts containing Hydroxyapatite (HAp) and Tricalcium Phosphate (TCP) have gained popularity due to their superior biocompatibility.
The market expansion is further supported by a favorable regulatory framework and efforts by market participants to develop new products with enhanced bioactivity, biocompatibility, and mechanical properties. For example, Graftys received certification for its bone void fillers and delivery systems, while Molecular Matrix launched the Osteo-P Synthetic Bone Graft Substitute with advanced technology for bone regeneration and repair. Additionally, the increasing adoption of minimally invasive procedures is driving the demand for bone grafts and substitutes. Surgeons prefer these procedures over traditional approaches due to their benefits, including shorter recovery time, reduced hospital stays, and smaller incisions. The number of minimally invasive orthopedic procedures performed in the United States has been steadily increasing, according to data from the American Academy of Orthopedic Surgeons (AAOS). Procedures such as arthroscopy, spine surgeries, fracture repair, and joint replacement contribute to the market's significant growth pace.
Global Market Size
USD 2.80 Billion
Largest Segment
Autografts
Fastest Growth
Autografts
Growth Rate
6.30% CAGR
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Global Bone Grafts and Substitutes Market is segmented by Material Type, Application, End User and Region. Based on Material Type, the market is segmented into Allograft, Synthetic. Based on Application, the market is segmented into Craniomaxillofacial, Dental, Foot & Ankle, Joint Reconstruction, Long Bone, and Spinal Fusion. Based on End User, the market is segmented into Hospitals, Specialty clinics, and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.
Analysis by Type
In terms of material type, the market is divided into allografts, synthetics, composites, polymers, and bone morphogenic proteins (BMP). Allografts accounted for the largest revenue share in the material type segment in 2023 and are expected to see significant growth during the forecast period. Allograft adoption is increasing due to properties like osteoconductivity and immediate structural support. Positive patient outcomes and recent allograft launches also contribute to this segment’s expansion. Allografts have the advantage of not requiring additional surgery for bone harvesting, leading to faster wound healing, shorter surgery times, and higher success rates. For example, a study published by NCBI in February 2022 reported allograft bone fusion success rates between 87% and 94.3%.
The synthetic segment is projected to experience the fastest growth. This growth is attributed to lower disease transmission risk, better biocompatibility, and greater patient acceptance compared to allografts. Within the synthetic segment, subcategories include ceramics, composites, polymers, and BMP. Rising orthopedic disorder prevalence and increased demand for synthetic products in developed countries are driving factors for this segment.
Analysis by Application
The global bone grafts and substitutes market is segmented by application into dental, craniomaxillofacial, joint reconstruction, foot & ankle, long bone, and spinal fusion. The spinal fusion segment held the largest market share in 2023, driven by the increasing adoption of bone graft materials for spondylosyndesis and the rising geriatric population prone to orthopedic ailments. This high number of elderly individuals is fueling demand for orthopedic solutions.
The dental segment is anticipated to witness the fastest CAGR growth over the forecast period due to the rising adoption of grafts for dental procedures. Bone grafts are used as scaffolds and fillers to facilitate bone formation and promote healing. The increasing acceptance of dental implant surgical procedures, along with advanced techniques such as bone grafts and bone regeneration, are projected to boost market growth. Moreover, the rising success rates of dental implants are also resulting in high demand for bone grafts and substitutes.
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North America dominated the global bone graft substitutes market. The region's dominance can be attributed to several factors, including advanced healthcare infrastructure, high healthcare expenditure, favorable reimbursement policies, and extensive research and development activities. The United States, in particular, plays a major role in driving market growth in North America, with a well-established healthcare system and a large patient population. Furthermore, the presence of key market players and their focus on developing innovative bone graft substitutes contribute to the region's dominance.
On the other hand, the Asia-Pacific region is experiencing rapid growth and is considered the fastest-growing market for bone graft substitutes. APAC market growth is driven by factors such as increasing healthcare expenditure, rising awareness about the benefits of bone graft substitutes, improving healthcare infrastructure, and a growing aging population. Countries like China, Japan, and India are witnessing significant market growth due to the increasing prevalence of orthopaedic conditions, rising disposable incomes, and a shift towards advanced healthcare technologies.
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Drivers
Increasing prevalence of orthopaedic conditions and musculoskeletal disorders
Demand For Minimally Invasive Procedures
The growing demand for minimally invasive orthopedic procedures is a key driving factor for the bone grafts and substitutes market. Advancements in medical technology are continuously improving the efficacy and safety of minimally invasive surgeries, leading surgeons to increasingly rely on innovative techniques and materials for bone grafting. These minimally invasive approaches offer benefits like reduced patient trauma, shorter recovery times, and better outcomes. As a result, there is a rising preference among patients and healthcare providers for minimally invasive bone grafting procedures that utilize advanced bone graft substitute materials. The ongoing research and development of more effective and accessible bone repair solutions is further fueling the adoption of minimally invasive techniques that leverage these innovative bone grafting substitutes. This growing preference for minimally invasive orthopedic procedures is a major driver propelling the expansion of the global bone grafts and substitutes market.
Restraints
High cost associated with these products
Regulatory Challenges
Safety and efficacy concerns, as well as regulatory hurdles for new products, are restraining factors for the bone grafting substitute market. Validating the safety and efficacy of bone graft materials necessitates high-quality clinical studies, which can be challenging and time-consuming. There are also potential risks and complications associated with bone grafting procedures that need to be carefully considered. From a regulatory perspective, obtaining approvals for new bone graft substitute products can be a lengthy process with stringent requirements around demonstrating safety and effectiveness. This creates barriers for companies looking to bring innovative materials and technologies to market. The need to comply with evolving regulations in different countries also adds complexity. These safety, efficacy and regulatory hurdles are limiting the pace at which new bone grafting substitutes can be developed and adopted, restraining the overall growth of this market segment.
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Global bone graft substitutes market is characterized by a diverse range of market players, including both established companies and emerging players. These players are focused on research and development activities to introduce innovative bone graft substitutes that offer enhanced biocompatibility, safety, and efficacy. Additionally, strategic collaborations, partnerships, and mergers and acquisitions are common strategies adopted by companies to strengthen their market position. The competitive landscape is driven by a continuous quest for technological advancements and the development of cost-effective solutions that cater to the evolving needs of healthcare providers and patients.
Bone Graft Substitutes Market Top Player’s Company Profiles
Bone Graft Substitutes Market Recent Developments
In May 2024, Irvine-based Biogennix, LLC, an osteobiologics company, has announced the receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded indications of its Agilon Moldable and Morpheus Moldable bone grafting products.
In Jan 2024, Cerapedics Inc., an orthopedics company at the forefront of bone repair innovation, has announced the submission of the final module in their Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the P-15 Peptide Enhanced Bone Graft. This submission marks a significant milestone for Cerapedics, as it could lead to the approval of their second Class III drug/device combination product designed for lumbar spine fusion with a TLIF indication.
In October 2023, Orthofix Medical Inc. (NASDAQ:OFIX), a global leader in spine and orthopedics, has announced the 510k clearance and full commercial launch of OsteoCove™, a cutting-edge bioactive synthetic graft.
In May 2023, Zimmer Biomet Holdings, Inc. announced the launch of its VIVIX 3D Printed Bone Matrix, a breakthrough bone graft substitute with a porous structure designed to mimic the natural bone environment.
In April 2023, Stryker Corporation acquired NuVasive, Inc., a leading provider of spine surgery solutions, expanding its product portfolio in the bone graft substitutes market and strengthening its presence in the spine care segment.
In February 2023, Osseus Fusion Systems received FDA clearance for its ARIES-TS spinal implant system, designed for use with autograft or bone graft substitutes in posterior lumbar interbody fusion (PLIF) surgeries.
In December 2022, Kuros Biosciences announced a collaboration with Johnson & Johnson Medical Devices Companies to co-develop innovative orthobiologic solutions for bone graft substitutes and regenerative medicine.
In September 2022, SeaSpine Holdings Corporation launched the Mariner MIS Posterior Fixation System, an innovative platform that combines pedicle screw fixation and bone grafting options for minimally invasive spinal fusion procedures.
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to our global bone graft substitutes market analysis, the increasing demand for synthetic substitutes, coupled with rising product approvals by regulatory authorities, is driving market expansion. Advantages such as biocompatibility, safety, and osteoconductivity have further propelled the adoption of bone grafts and substitutes. North America dominated the market, benefiting from advanced healthcare infrastructure and the presence of key players. Meanwhile, the Asia-Pacific region is the fastest-growing market, driven by increasing healthcare expenditure and a growing aging population. However, the high cost of bone graft substitutes remains a restraint. The market trend focuses on developing bioactive and tissue-engineered graft substitutes to enhance biocompatibility and accelerate bone healing.
Report Metric | Details |
---|---|
Market size value in 2022 | USD 1.2 billion |
Market size value in 2031 | USD 2.15 billion |
Growth Rate | 6.70% |
Base year | 2023 |
Forecast period | 2024-2031 |
Forecast Unit (Value) | USD Billion |
Segments covered |
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Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
Companies covered |
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Executive Summary
Market overview
Parent Market Analysis
Market overview
Market size
KEY MARKET INSIGHTS
COVID IMPACT
MARKET DYNAMICS & OUTLOOK
Market Size by Region
KEY COMPANY PROFILES
For the Bone Graft Substitutes Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Bone Graft Substitutes Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
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Report ID: SQMIG35A2257
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