Bone Grafts

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 by Company- Medtronic, Synthes, J&J, Osteotech, Stryker, and Others (includes corresponding Graph/Chart)
• Statistical Insights Into the World Orthopaedic Implants 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 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)
• 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 2007 (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)
• 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

2. 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 (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)
• 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 (includes corresponding 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&J and Others (includes corresponding Graph/Chart)
• Platelet Concentration Systems
• Table 18: US Market for Platelet Concentration Systems (2006): Percentage Share Breakdown of Value Sales of Key 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 and Others (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 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 and Others (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-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
• Table 25: CMS Payment Rates for DRG 497, 498 for 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, 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(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 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)
• Spinal Fusion
• Trauma & Reconstructive Surgeries
• Trauma
• Reconstructive Surgeries
• Joint Revision Arthroplasty
• 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)
• Oral, Periodontal, and Cranio-Maxillofacial
• 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)

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(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
• 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(tm)
• Osiris Unleashes Osteocel Line of Products
• OsteoBiologics Introduces TruWedge BGS
• Isotis Orthobiologics Releases OsSatura TCP
• Orthovita Launches Vitoss Scaffold Foam Flow
• Stellar Introduces Skelite(tm) Bone Void Filler
• Wright Medical Launches OSTEOSET(r) DBM
• Wright Medical Group Releases MIIG(tm) 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(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)
• 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(r) 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 Figures in 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 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)
• By Application
• 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

COMPETITIVE LANDSCAPE