US Bone Grafts Industry

• Publication date: October 2011

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 includ...

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.

Blood Supply, Tissue Banking And Transplantation Industry in the United States

1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS 1
Study Reliability and Reporting Limitations 1
Disclaimers 2
Data Interpretation & Reporting Level 3
Quantitative Techniques & Analytics 3
Product Definitions and Scope of Study 3
A. Standard Allografts 3
B. Machined Bone Allografts 4
C. Demineralized Bone Matrix (DBM) 4
D. Bone Morphogenetic Protein (BMP) 4
E. Platelet Concentrators 4
F. Synthetic Bone Grafts 4

2. INDUSTRY OVERVIEW 5
Bone Grafts: A Prelude 5
Orthobiologics Gain Traction in the Bone Grafts Market 5
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) 6
Statistical Insights Into the World Orthopaedic Implants Market 7
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) 7

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) 7

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) 7

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) 8
Hospital Pricing, Not GDP is the Key Driver of Growth 8
Orthopedic Implant Pricing Grows Independent of Medicare
Reimbursement: Why? 8
Medicare Reimbursement Higher for Spinal Fusions With Growth
Factors 9
Is Consolidation Blowing in the Wind? 9
Patient Safety Emerges to Become a Top Priority 9
Bone Grafts Termed as Tissues Suffer From Inconsistent Patient
Outcomes 10
What Drives Physicians’ Choice of Bone Grafts? 10
Key Market Trends & Issues: A Review 10
Aging Population: A Strong Demographic Driver 10
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) 11
Rising Incidences of Degenerative Intervertebral Disc Diseases 12
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) 12

Table 8: Osteoporosis Population in the US: 2002, 2005,
2008 & 2012 (includes corresponding Graph/Chart) 12

Table 9: Breakdown of Osteoporotic Fractures by Site in the
US (includes corresponding Graph/Chart) 13
Rise in Revision Orthopaedic Surgeries 13
Rise in Spinal Fusions in Private Healthcare 13
Increasing Visibility of Orthobiological Products to Spur
Grafting Options 13
Precision Machined Allograft Gain Surgeon Preference 13
Strong Prices Will Continue to Characterize Bone Graft
Technologies 14
Unmet Clinical Needs to Foster R&D Engine 14
Synthetic Bone Grafts To Fan Growth 14
Dental Bone Grafts On the Rise 15
Alliances with Organ Procurement Organizations: A Shot in the
Arm 15
Advanced Allografts Encroaching into the Use of Autografts in
Surgical Procedures 15
DBM: Strong Growth But Tough Competition 16
Adequate Reimbursement: An Impetus for Growth & Profitability 16
Table 10: Payer Mix for Spinal (Cervical) Fusion Procedures
in the US (includes corresponding Graph/Chart) 16

Table 11: Payer Mix for Spinal (Lumbar) Fusion Procedures in
the US (includes corresponding Graph/Chart) 17
Aging Baby Boomers Render a Decreased Donor Pool 17
Limited Availability of Donor Tissues 17
Intense Competition from Alternative Tissue Repair Therapies 17
Substitute Technologies Threaten to Replace Spinal Fusions 18
Growing Off-Label Use of Infuse Bone Graft Raises Eyebrows 18
Technology Innovations in Orthopedic Biomaterials: The Way to Go! 18
MPCs: Offer Promising Breakthroughs in Bone-Graft Substitute 18
Peptide Signaling Molecules to the Rescue 19
Prostaglandin Agonists: Emerging From their Drawbacks 19
Platelet Concentrate Systems 19
Synthetic Bone Grafts 20
Combination of Bone Marrow and Bone Graft Substitute 20
Stem Cell Therapy 21
Bone Morphogenetic Proteins 21
GEM OS®1 Shows Promise 21
geneX® Synthetic Bone Graft Substitute 22
ACCELL Total Bone Matrix 22
Tissue Recovery & Processing: A Structural Review 22
Tissue Banks 22
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) 23

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) 24
Tissue Processing 24
Tissue Distribution 25
An Illustration of the Tissue Recovering, Processing, &
Distribution Network 26

3. COMPETITION 27
Competitive Scenario: A Primer 27
The New Batting Order in Key Product Markets in the US 27
Standard Bone Allografts 27
Table 14: US Market for Standard Bone Allografts (2010):
Percentage Market Share Breakdown of Leading Tissue
Processors (includes corresponding Graph/Chart) 27
Machined Bone Allografts 27
Table 15: US Market for Machined Bone Allografts (2010):
Percentage Market Share Breakdown of Leading Tissue
Processors (includes corresponding Graph/Chart) 28
Demineralized Bone Matrix (DBM) 28
Table 16: US Market for Demineralized Bone Matrix (2010):
Percentage Share Breakdown of Value Sales by Company
(includes corresponding Graph/Chart) 28
Synthetic Bone Graft Substitutes 29
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) 29
Platelet Concentration Systems 29
Table 18: US Market for Platelet Concentration Systems
(2010): Percentage Market Share Breakdown of Value Sales of
Key Players 29
Spinal Fusion 30
Table 19: US Spinal Fusion Market (2010): Percentage
Market Share Breakdown of Value Sales by Company (includes
corresponding Graph/Chart) 30
The New Batting Order in Key Product Markets in Europe 30
Acceptance of Synthetic Bone Grafts in Europe: An Uphill Task 30
EU directive 2003/32/EC 30
DBM-based Products in Europe & Rest of World 31
Standard Bone Allografts 31
Table 20: European Market for Standard Bone Allografts
(2010): Percentage Market Share Breakdown of Leading
Companies/Organizations (includes corresponding
Graph/Chart) 31
Machined Bone Allografts 31
Table 21: European Market for Machined Bone Allografts
(2010): Percentage Market Share Breakdown of Leading
Companies/Organizations (includes corresponding
Graph/Chart) 31
Demineralised Bone Matrix Market 32
Table 22: European Market for Demineralized Bone Matrix
(2010): Percentage Market Share Breakdown of Leading
Companies/Organizations (includes corresponding
Graph/Chart) 32
Bone Graft Substitutes Market: 32
Table 23: European Market for Bone Graft Substitutes
(2010): Percentage Share Breakdown of Value Sales by
Leading Players (includes corresponding Graph/Chart) 32

4. REGULATORY ENVIRONMENT & REIMBURSEMENTS 33
Regulatory Issues 33
FDA Classification of Bone Products 33
Human Cells, Tissues and Cellular and Tissue-Based Products
(HCT/Ps) 33
National Organ Transplant Act (NOTA) 34
Good Tissue Practices 34
Tissue Banking Regulation 34
FDA Regulations on Xenograft 35
DBM-based Products in US 35
Synthetic Bone Graft Substitutes 35

5. PRODUCT OVERVIEW 36
Bone Grafts: A Definition 36
Pricing Trends 36
Bone Grafts: A Peek Into their Mechanism of Action 36
Types of Bone Grafts 37
Scoring of Osteoconduction, Osteoinduction, and Osteogenesis
Properties of Bone Grafts by Type 37
Autografts 37
Advantages 38
Disadvantages 38
Standard Allografts 38
Advantages 39
Disadvantages 39
Machined Bone Allografts 39
Commercially Available Allograft and Xenograft Bone Products 40
Demineralized Bone Matrix 40
Commercially Available Demineralized Bone Matrix Products 41
Bone Morphogenetic Proteins (BMPs) 41
Basic Functions of TGF-Beta 41
Commercially Available BMP-Products in the Marketplace 42
Infuse® 42
OP-1 42
Platelet Concentrators 42
Synthetic Bone Grafts 43
Collagen-based Matrices 43
Advantages 43
Disadvantages 44
Ceramic: A Material of Choice 44
Hydroxyapatite: A Major Calcium Phosphate Based Ceramic 44
Calcium Sulfate 45
Polymer Based Bone Grafts 45
Coral: A Valuable Synthetic Graft Material 45
Commercially Available Bone Substitutes Products 46
Application of Bone Grafts 48
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) 48
Spinal Fusion 48
Trauma & Reconstructive Surgeries 49
Trauma 49
Reconstructive Surgeries 49
Joint Revision Arthroplasty 49
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) 49
Oral, Periodontal, and Cranio-Maxillofacial 50
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) 50

6. PRODUCT LAUNCHES 51
Integra Receives FDA Clearance for Accell Evo3 51
Medtronic Introduces ARTISAN™ Space Maintenance System 51
RTI Biologics Introduces BioAdapt™ DBM Foam 51
Integra Unveils Trel-Xpress™ Demineralized Bone Matrix 51
Keystone Dental Introduces DynaMatrix™ Plus 52
Wright Introduces FUSIONFLEX™ Demineralized Moldable Scaffold 52
Micromedics Launches OsteoXpress 15cc Bone Graft Delivery Device 52
Bacterin Unveils OsteoSponge®SC 52
Integra Launches Allograft Cancellous Sponge 53
Orthovita Plans to Introduce Vitoss™ Bioactive Foam-2X Bone
Graft Substitute 53
Circle Biologics Launches Autologous Platelet Concentrator
Platform 53
Aesculap Implant Systems Introduces ProSpace™ DBM-D 53
RTI Biologics Unveils BioCAP Select™ and BTB Select® 54
Integra LifeSciences Rolls Out Advanced Orthobiologics Products 54
Integra LifeSciences Introduces Integra Mozaik™ Moldable Morsels 54
Wright Launches PRO-STIM™ Osteoinductive Bone Graft Substitute 55
Biocomposites Launches geneXds Invasive Delivery System 55
Straumann Unveils Straumann® MembraGel™ 55
DePuy Spine Introduces HEALOS® Fx Injectable Bone Graft
Replacement 56
Meta Biomed Launches BoneMedik-DM and BoneMedik-S 56
Straumann Unveils Roxolid™ 56
ApaTech Rolls Out Actifuse® MIS Bone Graft Delivery System 57
IART Launches Compact Accell Evo3 Demineralized Bone Matrix 57
RTI Biologics Introduces CopiOs Implant for Dental Procedures 57
ETEX Unveils ‘EquivaBone’ Bone Graft Substitute 57
NovaBone Introduces New Type of Synthetic Bone Graft 58
Pioneer® Surgical Unleashes FortrOss™ 58
Alphatec Launches ProFUSE 58
Medtronic Releases Nanostim Synthetic Bone Paste 58
NovaBone Unveils ‘NovaBone Putty’ 58
RTI Introduces Fresh-Stored OC Allograft Range 59
Integra LifeSciences Unveils Smaller Size ‘Accell TBM® 59
Orthovita Launches VITOSS® Bioactive Foam Pack 59
NovaBone Launches ‘NovaBone Porous Morsels’ 59
Wright Medical Group Introduces BIOFOAM 59
Integra LifeSciences Releases Accell Evo3 59
DePuy Spine Launches New Bone Graft Product 60
Medtronic Offers Progenix™ DBM Putty 60
Global Medical Launches Bone Graft Portfolio 60
Integra LifeSciences Introduces Mozaik™ 60
Collagen Unveils 'OssiMend™ Bone Graft Matrix 61
Wright Medical Launches PRO-DENSE Injectable Regenerative Graft 61
ApaTech Introduces Actifuse ABX Easyfill Putty 61
ApaTech Releases Actifuse E-Z-Prep 61
RTI to Launch Sterling Xenograft and BioSet DBM 61
Medtronic Inc Unveils Mastergraft Matrix and Putty 62
Regeneration Technologies Inc Introduces Adjustable BTB Implant 62
Regeneration Technologies Inc Releases Pre-Shaped Achilles
Tendons 62

7. RECENT INDUSTRY ACTIVITY 63
Stryker Takes Over Orthovita 63
NuVasive Signs Licensing Agreement with AlloSource 63
BioSET Commences Clinical Trials of AMPLEX™ 63
Orthos Receives CE Approval for ßGel Synthetic Bone Graft
Substitute 63
Stryker Divests OP-1 Product Range 64
Medtronic Takes Over OsteoTech 64
Cerapedics Obtains CE Mark for i-FACTOR™ Flex Bone Graft 64
ETEX Receives FDA Approval for Carrigen® Porous Bone
Substitute Material 64
Baxter International Acquires ApaTech 65
Institut Straumann Receives US FDA Approval for Emdogain® 65
Institut Straumann and LifeNet Health® Enter into Partnership 65
Etex Receives Approval from FDA for Using EquivaBone Bone
Graft Replacement in Posterolateral Spine Fusion 65
Zimmer Dental Upgrades Its Regenerative Product Line 66
ETEX Enters into Distribution Agreement with Alphatec Spine 66
Progentix Orthobiology Signs Investment Agreement with NuVasive 66
Wright Medical Group Obtains 510K Clearance for Pro-Stim
Injectable Osteoinductive Bone Graft Substitute 66
K2M Receives 510(k) Clearance for ALEUTIAN Spacer Systems 67
Medtronic Obtains FDA Approval for BRYAN® 67
Biocomposites Receives SFDA Approval for geneX 67

8. CORPORATE INITIATIVES IN THE RECENT PAST- A PERSPECTIVE BUILDER 68
Regeneration Technologies Merges with Tutogen Medical 68
Wright Medical Takes Over INBONE Technologies 68
NuVasive Acquires Osteocel Biologics 68
Integra LifeSciences Takes Over Theken 68
Osteotech Inks Distribution Contract with BioHorizons 68
Pioneer Surgical Secures FDA Approval for FortrOss 69
Inion Secures FDA Approval for Biodegradable Spine Products 69
Biocomposites Bags FDA Approval for geneX® Putty 69
IFGL Establishes Dental BioGraft Plant 69
Osteotech Receives FDA Approval for Plexur M™ Biocomposite 69
Millenium Signs an Asset Sale Agreement with Two Companies 69
INBONE Technologies Merges with Reiley Orthopedic 70
AlloSource Signs a License Agreement with IsoTis 70
Osteotech Inks Single Source Agreement for Allograft Products 70
Bonesupport Enters Into Distribution Agreement with Signus
Medical 70
Tornier Takes Over DVO 70
Zimmer Holdings Acquires Endius Inc. 70
Wright Medical Group Takes Over Darco International 71
Integra LifeSciences Completes Acquisition of IsoTis 71
Synthes Gets FDA Clearance for Bone Graft Substitute 71
Collagen Receives 510(k) Clearance from FDA for SynOss™ 71
ISTO Technologies Obtains 510(k) Clearance for InQu™ 71
RTI Signs Supply Contract with Stryker 71
RTI Signs a 10-Year Supply Agreement with Zimmer Holdings 72
Medtronic Sofamor Danek Receives FDA Approval for INFUSE 72
Smith and Nephew Acquires Plus Orthopedics 72
Medtronic Signs Development Agreement with OsteoGenix 72
NuVasive Buys Technology from Radius Medical 72
AlloSource Join Hands with Osiris 72
Orthofix International Takes Over Blackstone Medical, Inc. 73
Vertebron Enters into a Distribution Agreement with medArtis 73
Exactech Gets FDA Approval for New Optecure™ Formulation 73
Osteotech and Premier Enter Into an Agreement 73
RTI Signs Production Agreement with Blackstone 73
Wright Medical's ALLOMATRIX Receives FDA Clearance 74
ApaTech Opens New Facility and Global Headquarters 74
Smith & Nephew Takes Over Osteo Biologics Inc. 74
CeraPedics LLC Partners with BioD LLC 74
Aastrom Biosciences Join Hands with Orthovita 74
IsoTis Signs Agreement with Alphatec Holdings 74
Osteo Biologics, Inc. Partners with Alphatec Spine 75
Pioneer Surgical Signs Supply Agreement with Regeneration
Technologies 75
Aap Implantate Acquires FAME Medical 75
PrimeCell Therapeutics Collaborates with Regeneration
Technologies 75
Medtronic Obtains Australian Nod for Spinal Fusion Device 75
Biomet Obtains FDA Approval for Regenerex Acetabular System
Consent 75
IsoTis Bags FDA Clearance for Orthoblast II® and Accell Connexus™ 75

9. FOCUS ON SELECT PLAYERS 76
AlloSource (USA) 76
Biomet Inc (USA) 76
Interpore Cross International (USA) 77
BioMimetic Therapeutics, Inc. (USA) 77
DePuy Spine, Inc. (USA) 77
Exactech, Inc. (USA) 77
Integra LifeSciences Holdings Corporation (USA) 78
Integra OrthoBiologics (USA) 78
Lifelink Tissue Bank (USA) 78
LifeNet Health (USA) 79
Medtronic, Inc. (USA) 79
Medtronic Sofamor Danek, Inc. (USA) 79
Musculoskeletal Transplant Foundation (USA) 80
NovaBone Products LLC (USA) 80
NuVasive, Inc. (USA) 80
Osiris Therapeutics, Inc. (USA) 80
RTI Biologics, Inc. (USA) 81
Smith & Nephew Plc (UK) 81
Stryker Corporation (USA) 81
Orthovita, Inc. (USA) 82
Synthes Inc (USA) 82
Wright Medical Technology, Inc (USA) 82
Zimmer Holdings, Inc (USA) 83

10. MARKET PERSPECTIVE 84
By Product 84
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) 84

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) 85

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) 86
By Application 87
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) 87

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) 88

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) 89


COMPETITIVE LANDSCAPE

Total Companies Profiled: 47 (including Divisions/Subsidiaries - 63)

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Region/Country Players
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The United States 43
Europe 17
France 2
Germany 1
The United Kingdom 3
Rest of Europe 11
Asia-Pacific (Excluding Japan) 2
Africa 1
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