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Bone Grafts

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US $ 13500 PDF By E-mail (Global License to Company and its Fully-owned Subsidiaries)


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Abstract

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.

Table of Contents

1. 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

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(r)1 Shows Promise
  • geneX(r) 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(r)
      • 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(tm) Space Maintenance System
  • RTI Biologics Introduces BioAdapt(tm) DBM Foam
  • Integra Unveils Trel-Xpress(tm) Demineralized Bone Matrix
  • Keystone Dental Introduces DynaMatrix(tm) Plus
  • Wright Introduces FUSIONFLEX(tm) Demineralized Moldable Scaffold
  • Micromedics Launches OsteoXpress 15cc Bone Graft Delivery Device
  • Bacterin Unveils OsteoSponge(r)SC
  • Integra Launches Allograft Cancellous Sponge
  • Orthovita Plans to Introduce Vitoss(tm) Bioactive Foam-2X Bone Graft Substitute
  • Circle Biologics Launches Autologous Platelet Concentrator Platform
  • Aesculap Implant Systems Introduces ProSpace(tm) DBM-D
  • RTI Biologics Unveils BioCAP Select(tm) and BTB Select(r)
  • Integra LifeSciences Rolls Out Advanced Orthobiologics Products
  • Integra LifeSciences Introduces Integra Mozaik(tm) Moldable Morsels
  • Wright Launches PRO-STIM(tm) Osteoinductive Bone Graft Substitute
  • Biocomposites Launches geneXds Invasive Delivery System
  • Straumann Unveils Straumann(r) MembraGel(tm)
  • DePuy Spine Introduces HEALOS(r) Fx Injectable Bone Graft Replacement
  • Meta Biomed Launches BoneMedik-DM and BoneMedik-S
  • Straumann Unveils Roxolid(tm)
  • ApaTech Rolls Out Actifuse(r) 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(r) Surgical Unleashes FortrOss(tm)
  • 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(r)
  • Orthovita Launches VITOSS(r) 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(tm) DBM Putty
  • Global Medical Launches Bone Graft Portfolio
  • Integra LifeSciences Introduces Mozaik(tm)
  • Collagen Unveils 'OssiMend(tm) 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(tm)
  • Orthos Receives CE Approval for ƒÀGel Synthetic Bone Graft Substitute
  • Stryker Divests OP-1 Product Range
  • Medtronic Takes Over OsteoTech
  • Cerapedics Obtains CE Mark for i-FACTOR(tm) Flex Bone Graft
  • ETEX Receives FDA Approval for Carrigen(r) Porous Bone Substitute Material
  • Baxter International Acquires ApaTech
  • Institut Straumann Receives US FDA Approval for Emdogain(r)
  • Institut Straumann and LifeNet Health(r) 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(r)
  • 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(r) Putty
  • IFGL Establishes Dental BioGraft Plant
  • Osteotech Receives FDA Approval for Plexur M(tm) 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(tm)
  • ISTO Technologies Obtains 510(k) Clearance for InQu(tm)
  • 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(tm) 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(r) and Accell Connexus(tm)

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)
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