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Bone Grafts

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

Abstract

This 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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