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Published by: Global Industry Analysts
Published: Apr. 1, 2009 - 353 Pages
Table of Contents
- 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
- Table 1: Worldwide Market for Orthobiologics (2007): Percentage Share Breakdown of Value Sales byCompany- Medtronic, Synthes, J&J, Osteotech,Stryker, and Others (includes correspondingGraph/Chart)
- Statistical Insights Into the World OrthopaedicImplants Market
- 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 correspondingGraph/Chart)
- Table 3: Worldwide Market for Orthopaedic Implants in Spinal Procedures (2007): Percentage Share Breakdownof 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 byCompany - Synthes, Stryker, Smith & Nephew,J&J, Zimmer, Biomet and Others (includescorresponding Graph/Chart)
- Hospital Pricing, Not GDP is the Key Driver of Growth
- Orthopedic Implant Pricing Grows Independent ofMedicare Reimbursement: Why?
- Medicare Reimbursement Higher for Spinal FusionsWith Growth Factors
- Is Consolidation Blowing in the Wind?
- Patient Safety Emerges to Become a Top Priority
- Bone Grafts Termed as Tissues Suffer From InconsistentPatient 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 inNorth America, Western Europe and Eastern Europefor the year 2007 (In Millions) (includescorresponding Graph/Chart)
- Rising Incidences of Degenerative IntervertebralDisc Diseases
- Table 7: Average Annual Number of Spinal Fusions Procedures in the United States & Europe forthe Year 2005 & 2008 (in Thousands)
- Table 8: Osteoporosis Population in the US: 2002,2005, 2008 & 2012 (includes correspondingGraph/Chart)
- Table 9: Breakdown of Osteoporotic Fractures bySite in the US (includes correspondingGraph/Chart)
- Rise in Revision Orthopaedic Surgeries
- Rise in Spinal Fusions in Private Healthcare
- Increasing Visibility of Orthobiological Products toSpur Grafting Options
- Precision Machined Allograft Gain Surgeon Preference
- Strong Prices Will Continue to Characterize Bone GraftTechnologies
- 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 ofAutografts in Surgical Procedures
- DBM: Strong Growth But Tough Competition
- Adequate Reimbursement: An Impetus for Growth &Profitability
- Table 10: Payer Mix for Spinal (Cervical) FusionProcedures in the US (includes correspondingGraph/Chart)
- Table 11: Payer Mix for Spinal (Lumbar) FusionProcedures in the US (includes correspondingGraph/Chart)
- Aging Baby Boomers Render a Decreased Donor Pool
- Limited Availability of Donor Tissues
- Intense Competition from Alternative Tissue RepairTherapies
- Substitute Technologies Threaten to Replace SpinalFusions
- Growing Off-Label Use of Infuse Bone Graft RaisesEyebrows
- Technology Innovations in Orthopedic Biomaterials:The Way to Go!
- MPCs: Offer Promising Breakthroughs in Bone-GraftSubstitute
- Peptide Signaling Molecules to the Rescue
- Prostaglandin Agonists: Emerging From theirDrawbacks
- Platelet Concentrate Systems
- Synthetic Bone Grafts
- Combination of Bone Marrow and Bone GraftSubstitute
- 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
- 2.Competition
- Competitive Scenario: A Primer
- The New Batting Order in Key Product Marketsin the US
- Standard Bone Allografts
- Table 14: US Market for Standard Bone Allografts (2006): Percentage Market Share Breakdown ofLeading Tissue Processors - Musculoskeletal Transplant Foundation, Regeneration Technologies Inc, Lifenet, Allosource, Lifelink, Osteotech and Tutogen Medical (includes corresponding Graph/Chart)
- Machined Bone Allografts
- 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)
- Demineralized Bone Matrix (DBM)
- 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 (includescorresponding Graph/Chart)
- Synthetic Bone Graft Substitutes
- Table 17: US Market for Synthetic Bone Graft Substitutes (2006): Percentage Share Breakdown of Value Sales by Company - Orthovita, Wright Medical, Biomet, J&Jand Others (includes corresponding Graph/Chart)
- Platelet Concentration Systems
- Table 18: US Market for Platelet Concentration Systems (2006): Percentage Share Breakdown of Value Sales ofKey Players -DePuy, and Interpore Cross
- Allograft Tendon/Ligament
- 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)
- Spinal Fusion
- Table 20: US Spinal Fusion Market (2006): Percentage Share Breakdown of Value Sales by Company - Medtronic, DePuy Spine, Stryker Spine, Zimmer, Biomet andOthers (includes corresponding Graph/Chart)
- The New Batting Order in Key Product Marketsin 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 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)
- Machined Bone Allografts
- Table 22: European Market for Machined Bone Allografts (2007): Percentage Market Share Breakdown of Leading Companies/Organizations - Musculoskeletal Transplant Foundation, RTI Biologics, Osteotech Inc andOthers (includes corresponding Graph/Chart)
- Demineralised Bone Matrix Market
- 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)
- Bone Graft Substitutes Market:
- 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)
- 3.Regulatory Environment & Reimbursements
- Regulatory Issues
- FDA Classification of Bone Products
- Human Cells, Tissues and Cellular and Tissue-BasedProducts (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
- Table 25: CMS Payment Rates for DRG 497, 498for the years 2002 & 2007
- 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, andOsteogenesis Properties of Bone Grafts by Type
- Autografts
- Advantages
- Disadvantages
- Standard Allografts
- Advantages
- Disadvantages
- Machined Bone Allografts
- Demineralized Bone Matrix
- Commercially Available Demineralized Bone MatrixProducts
- Bone Morphogenetic Proteins (BMPs)
- Basic Functions of TGF-Beta
- Commercially Available BMP-Productsin the Marketplace
- Infuse®
- OP-1
- Platelet Concentrators
- Synthetic Bone Grafts
- Collagen-based Matrices
- Advantages
- Disadvantages
- Ceramic: A Material of Choice
- Hydroxyapatite: A Major Calcium PhosphateBased Ceramic
- Calcium Sulfate
- Polymer Based Bone Grafts
- Coral: A Valuable Synthetic Graft Material
- Commercially Available Bone Substitutes Products
- Application of Bone Grafts
- 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 correspondingGraph/Chart)
- Spinal Fusion
- Trauma & Reconstructive Surgeries
- Trauma
- Reconstructive Surgeries
- Joint Revision Arthroplasty
- Table 27: Worldwide Market for Orthopaedic Implants in Reconstructive Procedures (2007): PercentageShare Breakdown of Value Sales by Application - Knees, Hips, and Extremities (includescorresponding Graph/Chart)
- Oral, Periodontal, and Cranio-Maxillofacial
- Table 28: Worldwide Market for Orthopaedic Implantsin 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)
- 5.Product Launches
- RTI Biologics Introduces CopiOs Implant forDental 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 InjectableRegenerative 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 AdjustableBTB Implant
- Regeneration Technologies Inc Releases Pre-ShapedAchilles Tendons
- Millenium Biologix Corporation Launches Primacoll
- Millenium Biologix Corporation Unveils SkeliteBone 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 BiodegradableSpine 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 withTwo Companies
- INBONE Technologies Merges with Reiley Orthopedic
- AlloSource Signs a License Agreement with IsoTis
- Osteotech Inks Single Source Agreement forAllograft Products
- Bonesupport Enters Into Distribution Agreement withSignus 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 forSynOss™
- ISTO Technologies Obtains 510(k) Clearance for InQu™
- RTI Signs Supply Contract with Stryker
- RTI Signs a 10-Year Supply Agreement withZimmer Holdings
- Medtronic Sofamor Danek Receives FDA Approval forINFUSE
- Smith and Nephew Acquires Plus Orthopedics
- Medtronic Signs Development Agreement withOsteoGenix
- NuVasive Buys Technology from Radius Medical
- AlloSource Join Hands with Osiris
- Orthofix International Takes Over Blackstone Medical, Inc.
- Vertebron Enters into a Distribution Agreement withmedArtis
- 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 ReceivesFDA 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 withRegeneration Technologies
- Aap Implantate Acquires FAME Medical
- PrimeCell Therapeutics Collaborates with RegenerationTechnologies
- Medtronic Obtains Australian Nod for Spinal Fusion Device
- Biomet Obtains FDA Approval for Regenerex AcetabularSystem Consent
- IsoTis Bags FDA Clearance for Orthoblast II® andAccell Connexus™
- Orthofix Signs Distribution Contract with BerkeleyAdvanced Biomaterials
- Kensey Nash and Orthovita Enter Into Agreement
- Aap Implantate Acquires Osartis and Majority Stakesin ADC
- Alphatec Spine Takes Over Cortek
- IsoTis and PLUS Orthopedics Enter Into DistributionAgreement
- OsteoBiologics Inks Distribution Agreement withConMed Linvatec
- Biomet Granted Approval for Ceramic-On-CeramicHip 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 withCurasan 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
- 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 Figuresin US$ Million for Years 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 for Years 2000 through 2005(includes corresponding Graph/Chart)
- Table 31: US 10-Year Perspective for Bone Grafts byProduct Segment - Percentage Breakdown of Dollar Salesfor Standard Allografts, Machined Bone Allografts, Demineralized Bone Matrix (DBM), Bone Morphogenetic Protein (BMP), Platelet Concentrators, and SyntheticBone Grafts for Years 2006, 2009 & 2015 (includescorresponding Graph/Chart)
- By Application
- Table 32: US Recent Past, Current & Future Analysis forBone Grafts by End-Use Application - Spinal Procedures,and Trauma & Reconstruction Procedures Independently Analyzed with Annual Sales Figures in US$ Million forYears 2006 through 2015 (includes correspondingGraph/Chart)
- Table 33: US Historic Review for Bone Grafts by End-Use Application - Spinal Procedures, and Trauma & Reconstruction Procedures Independently Analyzed with Annual SalesFigures in US$ Million for Years 2000 through 2005(includes corresponding Graph/Chart)
- Table 34: US 10-Year Perspective for Bone Grafts byEnd-Use Application - Percentage Breakdown ofDollar Sales for Spinal Procedures, and Trauma & Reconstruction Procedures for Years 2006,2009 & 2015
- III. COMPETITIVE LANDSCAPE
- Total Companies Profiled: 59 (including Divisions/Subsidiaries - 73)
- Region/Country Players
- The United States
- Canada
- Europe
- France
- Germany
- The United Kingdom
- Rest of Europe
- Asia-Pacific (Excluding Japan)
- Middle East
- Africa
AbstractThis 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.
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