Bone Grafts - A US Market Analysis

1.METHODOLOGY
Study Reliability and Reporting Limitations
Disclaimers
Quantitative Techniques & Reporting Level
2.MARKET OVERVIEW AND OUTLOOK
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 Fusionn 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-GraftSubstitute
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
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
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:
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
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
5.PRODUCT FACTS
A. Standard Allografts
B. Machined Bone Allografts
C. Demineralized Bone Matrix (DBM)
D. Bone Morphogenetic Protein (BMP)
E. Platelet Concentrators
F. Synthetic Bone Grafts
6.CORPORATE DEVELOPMENTS
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
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
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
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
7.MAJOR 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.GLOBAL MARKET ANALYTICS53
Table 1: Percentage Breakdown of Orthobiologics Manufacturer Value Sales in the World –
Table 2: Percentage Breakdown of Orthopaedic Manufacturer Value Sales in the World –
Table 3: Market Shares of Leading Companies in the Global Market for Orthopaedic Implants in Spinal Procedures –
Table 4: Market Shares of Leading Companies in the Global Market for Orthopaedic Implants in Reconstructive Procedures –
Table 5: Market Shares of Leading Companies in the Global Market for Orthopaedic Implants in Trauma & Craniomaxillofacial Procedures –
Table 6: Breakdown of Osteoporotic Fractures by Site in the US
Table 7: Payer Mix for Spinal (Cervical) Fusion Procedures in the US
Table 8: Payer Mix for Spinal (Lumbar) Fusion Procedures in the US
Table 9: Breakdown of Number of Tissue Processing Donors by Select Processing Organization/Company in the US –
Table 10: Leading Organizations/Companies in the US Tissue Processing Market by Market Share-
Table 11: Market Shares of Leading Tissue Processors in the US Standard Bone Allografts Market -
Table 12: Market Shares of Leading Tissue Processors in the US Machined Bone Allografts Market –
Table 13: Market Shares of Demineralized Bone Matrix Manufacturer Value Sales in the US –
Table 14: Market Shares of Synthetic Bone Graft Substitutes Manufacturer Value Sales in the US –
Table 15: Market Shares of Leading Platelet Concentration Systems Manufacturer Value Sales in the US –
Table 16: Market Shares of Leading Allograft Tendon/Ligament Companies/Organizations in the US –
Table 17: Market Shares of Spinal Fusion Manufacturers in the US –
Table 18: Market Shares of Leading Companies/Organizations in the European Standard Bone Allografts Market -
Table 19: Market Shares of Leading Companies/Organizations in the European Machined Bone Allografts Market -
Table 20: Market Shares of Leading Companies/Organizations in the European Demineralized Bone Matrix Market -
Table 21: Market Shares of Leading Players in the European Bone Graft Substitutes Market - 2007
Table 22: Bone Grafts Market by Product Segment in the US: 2007-2015 (Sales in US$ Million)
Table 23: Percentage Breakdown of Bone Grafts Market by Product Segment in the US for the Years 2009 &
Table 24: Bone Grafts Market by End-Use Application in the US: 2007-2015 (Sales in US$ Million)
Table 25: Percentage Breakdown of Bone Grafts Market by End-Use Application in the US for the Years 2009 & 2012
Companies Profiled