Bone Grafts

Publication Date	April 2009
Publisher	Global Industry Analysts
Product Type	Report
Pages	353
ISBN Number	not applicable
Product Code	GIA01239

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Summary

This report analyzes the US market for Bone Grafts in Millions of US$. The market for Bone Grafts is analyzed by the following segments: Standard Allografts, Machined Bone Allografts, Demineralized Bone Matrix (DBM), Bone Morphogenetic Protein (BMP), Platelet Concentrators, and Synthetic Bone Grafts. Annual forecasts are provided for the period of 2006 through 2015. A six-year historic analysis is also provided for this markets.The report profiles 59 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., Osteotech Inc., RTI Biologics, Inc., Smith & Nephew Plc., Stryker Corporation, 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.

Content

I. Introduction, Methodology & Product Definitions
- Study 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
II. A US Market Report
- 1.Industry Overview
  - Bone Grafts: A Prelude
  - Orthobiologics Gain Traction in the Bone Grafts Market
  - Statistical Insights into the World Orthopaedic Implants Market
  - 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
  - Rising Incidences of Degenerative Intervertebral Disc Diseases
  - 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
  - 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 OS1 Shows Promise
  - geneX Synthetic Bone Graft Substitute
  - ACCELL Total Bone Matrix
  - Tissue Recovery & Processing: A Structural Review
  - Tissue Banks
  - Tissue Processing
  - Tissue Distribution
  - An Illustration of the Tissue Recovering, Processing, & Distribution Network
- 2.Competition
  - Competitive Scenario: A Primer
  - The New Batting Order in Key Product Markets in the US
  - Standard Bone Allografts
  - Machined Bone Allografts
  - Demineralized Bone Matrix (DBM)
  - Synthetic Bone Graft Substitutes
  - Platelet Concentration Systems
  - Allograft Tendon/Ligament
  - Spinal Fusion
  - 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
  - Machined Bone Allografts
  - Demineralised Bone Matrix Market
  - Bone Graft Substitutes Market:
- 3.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
  - Reimbursement Issues
  - CMS Implements 2008 Hospital IPPS
  - CMS Proposal for 2007 Hospital IPPS
  - (i) Fracture Treatment
  - (ii) C-codes for Spine Devices
  - (iii) Revised Payment Rates for DRG 497, 498
- 4.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
  - 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
  - Spinal Fusion
  - Trauma & Reconstructive Surgeries
  - Trauma
  - Reconstructive Surgeries
  - Joint Revision Arthroplasty
  - Oral, Periodontal, and Cranio-Maxillofacial
- 5.Product Launches
  - 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
  - Millenium Biologix Corporation Launches Primacoll
  - Millenium Biologix Corporation Unveils Skelite Bone Graft Substitute
  - Orthovita Inc Releases VITOSS Foam Pack
  - Osteotech Launches Grafton(R) DBM
  - ApaTech Introduces Actifuse
  - Osiris Unleashes Osteocel Line of Products
  - OsteoBiologics Introduces TruWedge BGS
  - Isotis Orthobiologics Releases OsSatura TCP
  - Orthovita Launches Vitoss Scaffold Foam Flow
  - Stellar Introduces Skelite Bone Void Filler
  - Wright Medical Launches OSTEOSET DBM
  - Wright Medical Group Releases MIIG X3
- 6.Recent Industry Activity
  - 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
  - Orthofix Signs Distribution Contract with Berkeley Advanced Biomaterials
  - Kensey Nash and Orthovita Enter into Agreement
  - Aap Implantate Acquires Osartis and Majority Stakes in ADC
  - Alphatec Spine Takes over Cortek
  - IsoTis and PLUS Orthopedics Enter into Distribution Agreement
  - OsteoBiologics Inks Distribution Agreement with ConMed Linvatec
  - Biomet Granted Approval for Ceramic-on-Ceramic Hip System
  - IsoTis Granted 510(k) Clearance for DynaGraft II
  - Ceramisys Obtains EU Approval for Bone Graft Substitutes
  - Biomet Inc Acquires Interpore International
  - Ascension Orthopedics Signs Supply Agreement with Curasan AG
  - Blackstone Pens a Supply Contract with Berkeley
  - ApaTech's Pore-Si Bone Graft Gains Approval from FDA
  - Wright Medical Bags FDA Approval for ALLOMATRIX Products
  - FDA Offers Clearance to Medtronic's Infuse Bone Graft
  - DePuy Acquires Orquest's Assets
- 7.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)
  - Orthovita Inc (USA)
  - Osiris Therapeutics Inc (USA)
  - Osteotech Inc (USA)
  - RTI Biologics, Inc. (USA)
  - Smith & Nephew Plc (UK)
  - Stryker Corporation (USA)
  - Synthes Inc (USA)
  - Wright Medical Technology, Inc (USA)
  - Zimmer Holdings, Inc (USA)
- 8.Market Perspective
  - by Product
  - by Application
III. Competitive Landscape
List of Tables
- Table 1: Worldwide Market for Orthobiologics (2007): Percentage Share Breakdown of Value Sales by Company- Medtronic, Synthes, J&J, Osteotech, Stryker, and Others (includes corresponding Graph/Chart)
- Table 2: Worldwide Orthopaedic Market (2007): Percentage Share Breakdown of Value Sales by Company - Stryker, J&J, Zimmer, Medtronic, Synthes, Smith & Nephew, Biomet and Others (includes corresponding Graph/Chart)
- Table 3: Worldwide Market for Orthopaedic Implants in Spinal Procedures (2007): Percentage Share Breakdown of Value Sales by Company - Medtronic, J&J, Synthes, Stryker, Biomet, Zimmer, and Others (includes corresponding Graph/Chart)
- Table 4: Worldwide Market for Orthopaedic Implants for Reconstructive Procedures (2007): Percentage Share Breakdown of Value Sales by Company - Zimmer, J&J, Stryker, Smith & Nephew, Biomet and Others (includes corresponding Graph/Chart)
- Table 5: Worldwide Market for Orthopaedic Implants for Trauma & Craniomaxillofacial Procedures (2007): Percentage Share Breakdown of Value Sales by Company - Synthes, Stryker, Smith & Nephew, J&J, Zimmer, Biomet and Others (includes corresponding Graph/Chart)
- Table 6: Population over 65 Years and above in North America, Western Europe and Eastern Europe for the year 2007 (in Millions) (includes corresponding Graph/Chart)
- Table 7: Average Annual Number of Spinal Fusions Procedures in the United States & Europe for the Year 2005 & 2008 (in Thousands)
- 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)
- 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)
- 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)
- Table 14: US Market for Standard Bone Allografts (2006): Percentage Market Share Breakdown of Leading Tissue Processors - Musculoskeletal Transplant Foundation, Regeneration Technologies Inc, Lifenet, Allosource, Lifelink, Osteotech and Tutogen Medical (includes corresponding Graph/Chart)
- Table 15: US Market for Machined Bone Allografts (2006): Percentage Market Share Breakdown of Leading Tissue Processors - Musculoskeletal Transplant Foundation (MTF), Regeneration Technologies, Lifenet, Osteotech Inc, Allosource, and Tutogen Medical (includes corresponding Graph/Chart)
- Table 16: US Market for Demineralized Bone Matrix (2006): Percentage Share Breakdown of Value Sales by Company- Synthes, Osteotech, RTI, J&J, Biomet, Wright Medical Group, and Others (includes corresponding Graph/Chart)
- Table 17: US Market for Synthetic Bone Graft Substitutes (2006): Percentage Share Breakdown of Value Sales by Company - Orthovita, Wright Medical, Biomet, J&J and Others (includes corresponding Graph/Chart)
- Table 18: US Market for Platelet Concentration Systems (2006): Percentage Share Breakdown of Value Sales of Key Players -DePuy, and Interpore Cross
- Table 19: US Market for Allograft Tendon/Ligament (2006): Percentage Market Share Breakdown of Major Companies/Organizations - Musculoskeletal Transplant Foundation, Arthrex, RTI, and Others (includes corresponding Graph/Chart)
- Table 20: US Spinal Fusion Market (2006): Percentage Share Breakdown of Value Sales by Company - Medtronic, DePuy Spine, Stryker Spine, Zimmer, Biomet and Others (includes corresponding Graph/Chart)
- Table 21: European Market for Standard Bone Allografts (2007): Percentage Market Share Breakdown of Leading Companies/Organizations - Musculoskeletal Transplant Foundation, RTI Biologics Inc, LifeNet Health, Osteotech Inc, Allosource, and Others (includes corresponding Graph/Chart)
- Table 22: European Market for Machined Bone Allografts (2007): Percentage Market Share Breakdown of Leading Companies/Organizations - Musculoskeletal Transplant Foundation, RTI Biologics, Osteotech Inc and Others (includes corresponding Graph/Chart)
- Table 23: European Market for Demineralized Bone Matrix (2007): Percentage Market Share Breakdown of Leading Companies/Organizations - Osteotech Inc, Musculoskeletal Transplant Foundation, RTI Biologics Inc, Wright Medical Technology and Others (includes corresponding Graph/Chart)
- Table 24: European Market for Bone Graft Substitutes (2007): Percentage Share Breakdown of Value Sales by Leading Players - Interpore Cross International, Orthovita Inc, Wright Medical Technology Inc, Zimmer Inc, Medtronic Sofamer Danek, DePuy Inc, Smith & Nephew, and Others (includes corresponding Graph/Chart)
- Table 25: CMS Payment Rates for DRG 497, 498 for the years 2002 & 2007
- Table 26: Worldwide Market for Orthopaedic Implants in Spinal Procedures (2007): Percentage Share Breakdown of Value Sales by Application - Thoracolumbar Interbody Devices, Vertebral Compression Fractures, Cervical, and Electrical Stimulation (includes corresponding Graph/Chart)
- Table 27: Worldwide Market for Orthopaedic Implants in Reconstructive Procedures (2007): Percentage Share Breakdown of Value Sales by Application - Knees, Hips, and Extremities (includes corresponding Graph/Chart)
- Table 28: Worldwide Market for Orthopaedic Implants in Trauma & Craniomaxillofacial Procedures (2007): Percentage Share Breakdown of Value Sales by Application -Hip Fracture, Lower Extremity, Neuro & Craniomaxillofacial, Deformities, Pediatric & Foot and Upper Extremity (includes corresponding Graph/Chart)
- Table 29: 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 forYears 2006 through 2015 (includes corresponding Graph/Chart)
- Table 30: 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 forYears 2000 through 2005 (includes corresponding Graph/Chart)
- Table 31: US 10-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 2006, 2009 & 2015 (includes corresponding Graph/Chart)
- Table 32: 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 2006 through 2015 (includes corresponding Graph/Chart)
- Table 33: 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 2000 through 2005 (includes corresponding Graph/Chart)
- Table 34: US 10-Year Perspective for Bone Grafts by End-Use Application - Percentage Breakdown of Dollar Sales for Spinal Procedures, and Trauma & Reconstruction Procedures for Years 2006, 2009 & 2015