Bone Grafts: Market Research Report
This report analyzes the US market for Bone Grafts in Millions of US$ by the following Product Segments: Standard Allografts, Machined Bone Allografts, Demineralized Bone Matrix (DBM), Bone Morphogenetic Protein (BMP), Platelet Concentrators, and Synthetic Bone Grafts. Annual estimates and forecasts are provided for the period 2009 through 2017. A six-year historic analysis is also provided for this market.The report profiles 47 companies including many key and niche players such as AlloSource, Biomet Inc, Interpore Cross International, BioMimetic Therapeutics Inc., DePuy Spine Inc., Exactech Inc., Integra LifeSciences Holdings Corporation, Integra OrthoBiologics, Lifelink Tissue Bank, LifeNet Health, Medtronic Inc., Medtronic Sofamor Danek Inc., Musculoskeletal Transplant Foundation, NovaBone Products LLC, NuVasive Inc., Orthovita Inc., Osiris Therapeutics Inc., RTI Biologics, Inc., Smith & Nephew Plc., Stryker Corporation, Orthovita, Inc., Synthes Inc., Wright Medical Technology, Inc., and Zimmer Holdings, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.
Contents
1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONSStudy Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
A. Standard Allografts
B. Machined Bone Allografts
C. Demineralized Bone Matrix (DBM)
D. Bone Morphogenetic Protein (BMP)
E. Platelet Concentrators
F. Synthetic Bone Grafts
2. INDUSTRY OVERVIEW
Bone Grafts: A Prelude
Orthobiologics Gain Traction in the Bone Grafts Market
Table 1: Worldwide Market for Orthobiologics (2010): Percentage Share Breakdown of Value Sales by Company for Medtronic/Osteotech, Synthes, J&J, Stryker, and Others (includes corresponding Graph/Chart)
Statistical Insights Into the World Orthopaedic Implants Market
Table 2: Worldwide Orthopaedic Market (2010E): Percentage Share Breakdown of Value Sales by Company for Stryker, J&J, Zimmer, Medtronic, and Others (includes corresponding Graph/Chart)
Table 3: Worldwide Market for Orthopaedic Implants in Spinal Procedures (2010): Percentage Share Breakdown of Value Sales by Company for Medtronic, J&J, Synthes, Stryker, and Others (includes corresponding Graph/Chart)
Table 4: Worldwide Market for Orthopaedic Implants for Reconstructive Procedures (2010): Percentage Share Breakdown of Value Sales by Company for Zimmer, J&J, Stryker, Smith & Nephew, and Others (includes corresponding Graph/Chart)
Table 5: Worldwide Market for Orthopaedic Implants for Trauma & Craniomaxillofacial Procedures (2010): Percentage Share Breakdown of Value Sales by Company for Synthes, Stryker, Smith & Nephew, J&J, and Others (includes corresponding Graph/Chart)
Hospital Pricing, Not GDP is the Key Driver of Growth
Orthopedic Implant Pricing Grows Independent of Medicare Reimbursement: Why?
Medicare Reimbursement Higher for Spinal Fusions With Growth Factors
Is Consolidation Blowing in the Wind?
Patient Safety Emerges to Become a Top Priority
Bone Grafts Termed as Tissues Suffer From Inconsistent Patient Outcomes
What Drives Physicians’ Choice of Bone Grafts?
Key Market Trends & Issues: A Review
Aging Population: A Strong Demographic Driver
Table 6: Population Over 65 Years and Above in North America, Western Europe and Eastern Europe for the year 2010(In Millions) (includes corresponding Graph/Chart)
Rising Incidences of Degenerative Intervertebral Disc Diseases
Table 7: Average Annual Number of Spinal Fusions Procedures in the United States & Europe for the Year 2005 & 2008 (in Thousands) (includes corresponding Graph/Chart)
Table 8: Osteoporosis Population in the US: 2002, 2005, 2008 & 2012 (includes corresponding Graph/Chart)
Table 9: Breakdown of Osteoporotic Fractures by Site in the US (includes corresponding Graph/Chart)
Rise in Revision Orthopaedic Surgeries
Rise in Spinal Fusions in Private Healthcare
Increasing Visibility of Orthobiological Products to Spur Grafting Options
Precision Machined Allograft Gain Surgeon Preference
Strong Prices Will Continue to Characterize Bone Graft Technologies
Unmet Clinical Needs to Foster R&D Engine
Synthetic Bone Grafts To Fan Growth…
Dental Bone Grafts On the Rise
Alliances with Organ Procurement Organizations: A Shot in the Arm
Advanced Allografts Encroaching into the Use of Autografts in Surgical Procedures
DBM: Strong Growth But Tough Competition
Adequate Reimbursement: An Impetus for Growth & Profitability
Table 10: Payer Mix for Spinal (Cervical) Fusion Procedures in the US (includes corresponding Graph/Chart)
Table 11: Payer Mix for Spinal (Lumbar) Fusion Procedures in the US (includes corresponding Graph/Chart)
Aging Baby Boomers Render a Decreased Donor Pool
Limited Availability of Donor Tissues
Intense Competition from Alternative Tissue Repair Therapies
Substitute Technologies Threaten to Replace Spinal Fusions
Growing Off-Label Use of Infuse Bone Graft Raises Eyebrows
Technology Innovations in Orthopedic Biomaterials: The Way to Go!
MPCs: Offer Promising Breakthroughs in Bone-Graft Substitute
Peptide Signaling Molecules to the Rescue
Prostaglandin Agonists: Emerging From their Drawbacks
Platelet Concentrate Systems
Synthetic Bone Grafts
Combination of Bone Marrow and Bone Graft Substitute
Stem Cell Therapy
Bone Morphogenetic Proteins
GEM OS®1 Shows Promise
geneX® Synthetic Bone Graft Substitute
ACCELL Total Bone Matrix
Tissue Recovery & Processing: A Structural Review
Tissue Banks
Table 12: Tissue Processing Market in the US (2006): Breakdown of Number of Donors by Select Processing Organization/Company - Musculoskeletal Transplant Foundation, Regeneration Technologies Inc, LifeNet, Allosource, Community Tissue Services, Osteotech, LifeLink and Tissue Banks International (includes corresponding Graph/Chart)
Table 13: Tissue Processing Market in the US (2006): Percentage Breakdown of Market Share of Processing Organization/Company - Musculoskeletal Transplant Foundation, Regeneration Technologies Inc, LifeNet, Allosource, Community Tissue Services, Osteotech, LifeLink, Tissue Banks International, and others (includes corresponding Graph/Chart)
Tissue Processing
Tissue Distribution
An Illustration of the Tissue Recovering, Processing, & Distribution Network
3. COMPETITION
Competitive Scenario: A Primer
The New Batting Order in Key Product Markets in the US
Standard Bone Allografts
Table 14: US Market for Standard Bone Allografts (2010): Percentage Market Share Breakdown of Leading Tissue Processors (includes corresponding Graph/Chart)
Machined Bone Allografts
Table 15: US Market for Machined Bone Allografts (2010): Percentage Market Share Breakdown of Leading Tissue Processors (includes corresponding Graph/Chart)
Demineralized Bone Matrix (DBM)
Table 16: US Market for Demineralized Bone Matrix (2010): Percentage Share Breakdown of Value Sales by Company (includes corresponding Graph/Chart)
Synthetic Bone Graft Substitutes
Table 17: US Market for Synthetic Bone Graft Substitutes (2010): Percentage Share Breakdown of Value Sales by Company – Orthovita, Wright Medical, Biomet, J&J and Others (includes corresponding Graph/Chart)
Platelet Concentration Systems
Table 18: US Market for Platelet Concentration Systems (2010): Percentage Market Share Breakdown of Value Sales of Key Players
Spinal Fusion
Table 19: US Spinal Fusion Market (2010): Percentage Market Share Breakdown of Value Sales by Company (includes corresponding Graph/Chart)
The New Batting Order in Key Product Markets in Europe
Acceptance of Synthetic Bone Grafts in Europe: An Uphill Task
EU directive 2003/32/EC
DBM-based Products in Europe & Rest of World
Standard Bone Allografts
Table 20: European Market for Standard Bone Allografts (2010): Percentage Market Share Breakdown of Leading Companies/Organizations (includes corresponding Graph/Chart)
Machined Bone Allografts
Table 21: European Market for Machined Bone Allografts (2010): Percentage Market Share Breakdown of Leading Companies/Organizations (includes corresponding Graph/Chart)
Demineralised Bone Matrix Market
Table 22: European Market for Demineralized Bone Matrix (2010): Percentage Market Share Breakdown of Leading Companies/Organizations (includes corresponding Graph/Chart)
Bone Graft Substitutes Market:
Table 23: European Market for Bone Graft Substitutes (2010): Percentage Share Breakdown of Value Sales by Leading Players (includes corresponding Graph/Chart)
4. REGULATORY ENVIRONMENT & REIMBURSEMENTS
Regulatory Issues
FDA Classification of Bone Products
Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
National Organ Transplant Act (NOTA)
Good Tissue Practices
Tissue Banking Regulation
FDA Regulations on Xenograft
DBM-based Products in US
Synthetic Bone Graft Substitutes
5. PRODUCT OVERVIEW
Bone Grafts: A Definition
Pricing Trends
Bone Grafts: A Peek Into their Mechanism of Action
Types of Bone Grafts
Scoring of Osteoconduction, Osteoinduction, and Osteogenesis Properties of Bone Grafts by Type
Autografts
Advantages
Disadvantages
Standard Allografts
Advantages
Disadvantages
Machined Bone Allografts
Commercially Available Allograft and Xenograft Bone Products
Demineralized Bone Matrix
Commercially Available Demineralized Bone Matrix Products
Bone Morphogenetic Proteins (BMPs)
Basic Functions of TGF-Beta
Commercially Available BMP-Products in the Marketplace
Infuse®
OP-1
Platelet Concentrators
Synthetic Bone Grafts
Collagen-based Matrices
Advantages
Disadvantages
Ceramic: A Material of Choice
Hydroxyapatite: A Major Calcium Phosphate Based Ceramic
Calcium Sulfate
Polymer Based Bone Grafts
Coral: A Valuable Synthetic Graft Material
Commercially Available Bone Substitutes Products
Application of Bone Grafts
Table 24: Worldwide Market for Orthopaedic Implants in Spinal Procedures (2010): Percentage Share Breakdown of Value Sales by Application – Thoracolumbar Interbody Devices, Vertebral Compression Fractures, Cervical, and Electrical Stimulation (includes corresponding Graph/Chart)
Spinal Fusion
Trauma & Reconstructive Surgeries
Trauma
Reconstructive Surgeries
Joint Revision Arthroplasty
Table 25: Worldwide Market for Orthopaedic Implants in Reconstructive Procedures (2010): Percentage Share Breakdown of Value Sales by Application – Knees, Hips, and Extremities (includes corresponding Graph/Chart)
Oral, Periodontal, and Cranio-Maxillofacial
Table 26: Worldwide Market for Orthopaedic Implants in Trauma & Craniomaxillofacial Procedures (2010): Percentage Share Breakdown of Value Sales by Application –Hip Fracture, Lower Extremity, Neuro & Craniomaxillofacial, Deformities, Pediatric & Foot and Upper Extremity (includes corresponding Graph/Chart)
6. PRODUCT LAUNCHES
Integra Receives FDA Clearance for Accell Evo3
Medtronic Introduces ARTISAN™ Space Maintenance System
RTI Biologics Introduces BioAdapt™ DBM Foam
Integra Unveils Trel-Xpress™ Demineralized Bone Matrix
Keystone Dental Introduces DynaMatrix™ Plus
Wright Introduces FUSIONFLEX™ Demineralized Moldable Scaffold
Micromedics Launches OsteoXpress 15cc Bone Graft Delivery Device
Bacterin Unveils OsteoSponge®SC
Integra Launches Allograft Cancellous Sponge
Orthovita Plans to Introduce Vitoss™ Bioactive Foam-2X Bone Graft Substitute
Circle Biologics Launches Autologous Platelet Concentrator Platform
Aesculap Implant Systems Introduces ProSpace™ DBM-D
RTI Biologics Unveils BioCAP Select™ and BTB Select®
Integra LifeSciences Rolls Out Advanced Orthobiologics Products
Integra LifeSciences Introduces Integra Mozaik™ Moldable Morsels
Wright Launches PRO-STIM™ Osteoinductive Bone Graft Substitute
Biocomposites Launches geneXds Invasive Delivery System
Straumann Unveils Straumann® MembraGel™
DePuy Spine Introduces HEALOS® Fx Injectable Bone Graft Replacement
Meta Biomed Launches BoneMedik-DM and BoneMedik-S
Straumann Unveils Roxolid™
ApaTech Rolls Out Actifuse® MIS Bone Graft Delivery System
IART Launches Compact Accell Evo3 Demineralized Bone Matrix
RTI Biologics Introduces CopiOs Implant for Dental Procedures
ETEX Unveils ‘EquivaBone’ Bone Graft Substitute
NovaBone Introduces New Type of Synthetic Bone Graft
Pioneer® Surgical Unleashes FortrOss™
Alphatec Launches ProFUSE
Medtronic Releases Nanostim Synthetic Bone Paste
NovaBone Unveils ‘NovaBone Putty’
RTI Introduces Fresh-Stored OC Allograft Range
Integra LifeSciences Unveils Smaller Size ‘Accell TBM®
Orthovita Launches VITOSS® Bioactive Foam Pack
NovaBone Launches ‘NovaBone Porous Morsels’
Wright Medical Group Introduces BIOFOAM
Integra LifeSciences Releases Accell Evo3
DePuy Spine Launches New Bone Graft Product
Medtronic Offers Progenix™ DBM Putty
Global Medical Launches Bone Graft Portfolio
Integra LifeSciences Introduces Mozaik™
Collagen Unveils 'OssiMend™ Bone Graft Matrix
Wright Medical Launches PRO-DENSE Injectable Regenerative Graft
ApaTech Introduces Actifuse ABX Easyfill Putty
ApaTech Releases Actifuse E-Z-Prep
RTI to Launch Sterling Xenograft and BioSet DBM
Medtronic Inc Unveils Mastergraft Matrix and Putty
Regeneration Technologies Inc Introduces Adjustable BTB Implant
Regeneration Technologies Inc Releases Pre-Shaped Achilles Tendons
7. RECENT INDUSTRY ACTIVITY
Stryker Takes Over Orthovita
NuVasive Signs Licensing Agreement with AlloSource
BioSET Commences Clinical Trials of AMPLEX™
Orthos Receives CE Approval for βGel Synthetic Bone Graft Substitute
Stryker Divests OP-1 Product Range
Medtronic Takes Over OsteoTech
Cerapedics Obtains CE Mark for i-FACTOR™ Flex Bone Graft
ETEX Receives FDA Approval for Carrigen® Porous Bone Substitute Material
Baxter International Acquires ApaTech
Institut Straumann Receives US FDA Approval for Emdogain®
Institut Straumann and LifeNet Health® Enter into Partnership
Etex Receives Approval from FDA for Using EquivaBone Bone Graft Replacement in Posterolateral Spine Fusion
Zimmer Dental Upgrades Its Regenerative Product Line
ETEX Enters into Distribution Agreement with Alphatec Spine
Progentix Orthobiology Signs Investment Agreement with NuVasive
Wright Medical Group Obtains 510K Clearance for Pro-Stim Injectable Osteoinductive Bone Graft Substitute
K2M Receives 510(k) Clearance for ALEUTIAN Spacer Systems
Medtronic Obtains FDA Approval for BRYAN®
Biocomposites Receives SFDA Approval for geneX
8. CORPORATE INITIATIVES IN THE RECENT PAST- A PERSPECTIVE BUILDER
Regeneration Technologies Merges with Tutogen Medical
Wright Medical Takes Over INBONE Technologies
NuVasive Acquires Osteocel Biologics
Integra LifeSciences Takes Over Theken
Osteotech Inks Distribution Contract with BioHorizons
Pioneer Surgical Secures FDA Approval for FortrOss
Inion Secures FDA Approval for Biodegradable Spine Products
Biocomposites Bags FDA Approval for geneX® Putty
IFGL Establishes Dental BioGraft Plant
Osteotech Receives FDA Approval for Plexur M™ Biocomposite
Millenium Signs an Asset Sale Agreement with Two Companies
INBONE Technologies Merges with Reiley Orthopedic
AlloSource Signs a License Agreement with IsoTis
Osteotech Inks Single Source Agreement for Allograft Products
Bonesupport Enters Into Distribution Agreement with Signus Medical
Tornier Takes Over DVO
Zimmer Holdings Acquires Endius Inc.
Wright Medical Group Takes Over Darco International
Integra LifeSciences Completes Acquisition of IsoTis
Synthes Gets FDA Clearance for Bone Graft Substitute
Collagen Receives 510(k) Clearance from FDA for SynOss™
ISTO Technologies Obtains 510(k) Clearance for InQu™
RTI Signs Supply Contract with Stryker
RTI Signs a 10-Year Supply Agreement with Zimmer Holdings
Medtronic Sofamor Danek Receives FDA Approval for INFUSE
Smith and Nephew Acquires Plus Orthopedics
Medtronic Signs Development Agreement with OsteoGenix
NuVasive Buys Technology from Radius Medical
AlloSource Join Hands with Osiris
Orthofix International Takes Over Blackstone Medical, Inc.
Vertebron Enters into a Distribution Agreement with medArtis
Exactech Gets FDA Approval for New Optecure™ Formulation
Osteotech and Premier Enter Into an Agreement
RTI Signs Production Agreement with Blackstone
Wright Medical's ALLOMATRIX Receives FDA Clearance
ApaTech Opens New Facility and Global Headquarters
Smith & Nephew Takes Over Osteo Biologics Inc.
CeraPedics LLC Partners with BioD LLC
Aastrom Biosciences Join Hands with Orthovita
IsoTis Signs Agreement with Alphatec Holdings
Osteo Biologics, Inc. Partners with Alphatec Spine
Pioneer Surgical Signs Supply Agreement with Regeneration Technologies
Aap Implantate Acquires FAME Medical
PrimeCell Therapeutics Collaborates with Regeneration Technologies
Medtronic Obtains Australian Nod for Spinal Fusion Device
Biomet Obtains FDA Approval for Regenerex Acetabular System Consent
IsoTis Bags FDA Clearance for Orthoblast II® and Accell Connexus™
9. FOCUS ON SELECT PLAYERS
AlloSource (USA)
Biomet Inc (USA)
Interpore Cross International (USA)
BioMimetic Therapeutics, Inc. (USA)
DePuy Spine, Inc. (USA)
Exactech, Inc. (USA)
Integra LifeSciences Holdings Corporation (USA)
Integra OrthoBiologics (USA)
Lifelink Tissue Bank (USA)
LifeNet Health (USA)
Medtronic, Inc. (USA)
Medtronic Sofamor Danek, Inc. (USA)
Musculoskeletal Transplant Foundation (USA)
NovaBone Products LLC (USA)
NuVasive, Inc. (USA)
Osiris Therapeutics, Inc. (USA)
RTI Biologics, Inc. (USA)
Smith & Nephew Plc (UK)
Stryker Corporation (USA)
Orthovita, Inc. (USA)
Synthes Inc (USA)
Wright Medical Technology, Inc (USA)
Zimmer Holdings, Inc (USA)
10. MARKET PERSPECTIVE
By Product
Table 27: US Recent Past, Current & Future Analysis for Bone Grafts by Product Segment – Standard Allografts, Machined Bone Allografts, Demineralized Bone Matrix (DBM), Bone Morphogenetic Protein (BMP), Platelet Concentrators, and Synthetic Bone Grafts Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart)
Table 28: US Historic Review for Bone Grafts by Product Segment – Standard Allografts, Machined Bone Allografts, Demineralized Bone Matrix (DBM), Bone Morphogenetic Protein (BMP), Platelet Concentrators, and Synthetic Bone Grafts Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart)
Table 29: US 15-Year Perspective for Bone Grafts by Product Segment – Percentage Breakdown of Dollar Sales for Standard Allografts, Machined Bone Allografts, Demineralized Bone Matrix (DBM), Bone Morphogenetic Protein (BMP), Platelet Concentrators, and Synthetic Bone Grafts for Years 2003, 2010 & 2017 (includes corresponding Graph/Chart)
By Application
Table 30: US Recent Past, Current & Future Analysis for Bone Grafts by End-Use Application – Spinal Procedures, and Trauma & Reconstruction Procedures Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart)
Table 31: US Historic Review for Bone Grafts by End-Use Application – Spinal Procedures, and Trauma & Reconstruction Procedures Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart)
Table 32: US 15-Year Perspective for Bone Grafts by End-Use Application – Percentage Breakdown of Dollar Sales for Spinal Procedures, and Trauma & Reconstruction Procedures for Years 2003, 2010 & 2017 (includes corresponding Graph/Chart)
COMPETITIVE LANDSCAPE
Total Companies Profiled: 47 (including Divisions/Subsidiaries - 63)
Region/CountryPlayers
The United States43
Europe
France
Germany
The United Kingdom
Rest of Europe
Asia-Pacific (Excluding Japan)
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