Spinal Orthopaedics: A bright future for new technologies?

Spinal Orthopaedics: A bright future for new technologies? published by Espicom Business Intelligence in September, 2008. This report consists of Pages: 242 and the price starts from US $ 2265.

Introduction

Abstract

Spinal motion preservation is just one of the hot topics to capture the industry' s attention - but what are the relative strengths and weaknesses of the new approaches and to what degree will they impact fusion as the preferred treatment of choice in the future?

The array of non-fusion technologies being introduced to the market offers a great deal of promise for spinal surgery patients.

However, despite the fact that some of these technologies have been in use in Europe and other international markets for many years, the clinical outcomes data available are extremely limited in proportion to the tens of thousands of fusion procedures performed.

In addition, as regulatory clearance criteria in the US and Japan are by far the most rigorous in the world, the paucity of well-designed studies to prove the safety and effectiveness of artificial discs has hindered the launch of motion preservation products, and therefore growth, in these markets.

Competing technologies are changing the treatment landscape

Although there has been much focus in recent years on the potential of total or partial spinal disc replacement technologies, these devices have so far failed to live up to expectations. There clearly is a need for a viable alternative to fusion and a more promising motion preservation option, dynamic stabilisation, may provide a solution for some patients. Dynamic stabilisation preserves the intervertebral disc and vertebral structure, while also enabling a minimally-invasive posterior approach.

In addition to treatments for degenerative disc disease and deformity, the treatment of vertebral compression fractures is becoming increasingly important. Fractures are often caused by osteoporosis or cancer and their number is therefore increasing with the ageing of the population. Minimally-invasive treatments, such as vertebroplasty and kyphoplasty, that work quickly to stabilise fractures and relieve pain are being rapidly adopted and this segment of the spinal market, termed the ageing spine category, is becoming a major focus for spinal manufacturers.

• Comprehensive market forecasts of key technology sectors to 2012
• A thorough review of the spinal orthopaedic market worldwide
• An examination of key products:
  • Fusion
  • Biologic Products
  • Dynamic Stabilisation
  • Total/Partial Disc Replacement
  • Annular Repair
  • Facet Replacement
  • Fracture Treatment
• A competitive review and market share estimates for the 12 leading companies
• A review of 71 companies developing novel spinal treatments and technologies

• What factors will drive the nucleus replacement market to revenues of $450 million in 2012?
• What impact will the increasing use of minimally- invasive surgical techniques have on the disc fusion sector?
• What % of the global market will dynamic stabilisation systems command in 2012?
• What is the potential for minimally-invasive spinal technology?
• How might Synthes and DePuy challenge Medtronic' s domination of the spinal sector?
• Which emerging US company successfully launched a lumbar TDR product in Europe in May 2008?
• Why is industry interest in vertebral compression fractures increasing?

Table of Contents

• EXECUTIVE SUMMARY
• OVERVIEW
• THE SPINAL SURGERY MARKET
• Global Spinal Market by Procedure, 2006-2007 (US$ million)
  • Fig.1: Global Spinal Market by Procedure, 2007
• Global Spinal Market by Region, 2006-2007 (US$ million)
  • Fig.2: Global Spinal Market by Region, 2007
• United States
• US Clinical Procedures by CCS Code 158 (Spinal Fusion), 1996-2006
• Europe
• Asia-Pacific Region
• MARKET PLAYERS
  • Fig.3: Global Spinal Market Shares, 2007*
  • Fig.4: Global Spinal Market Shares, 2006*
• Manufacturers' Spinal Sales, 2003-2008 (US$ million)*
• Companies Ranked by Spinal Sales Growth, 2006-2007 (US$ million)
• MARKET DYNAMICS
• Gaining Clinical Evidence
• SPORT Study
• Intervertebral Disc Herniation
• Degenerative Spondylolisthesis
• Spinal Stenosis
• Increasing Competition
• The Role of Private Equity
• Major Private Equity Companies' Spinal Portfolios
• Industry Consolidation
• Major Spinal Acquisitions, 2006-2008
• FUTURE TRENDS AND FORECASTS
  • Fig.5: Global Spinal Market, 2006-2015 (US$ million)
• Global Spinal Market by Procedure Type, 2007-2013 (US$ million)
  • Fig.6: Global Spinal Market, 2006-2015 (US$ million)
  • Fig.7: Global Spinal Market by Procedure, 2013
• SPINAL PRODUCTS AND TECHNOLOGIES
• SPINAL FUSION
• The Fusion Market
  • Fig.8: Global Spinal Fusion Market, 2006-2013 (US$ million)
• Fusion: Market Drivers, Restraints & Future Opportunities
• Thoracolumbar Products
• Product Highlights
• Abbott' s Universal Clamp
• Alphatec' s Zodiac Line
• Amedica' s Valeo Pedicle Screw System
• Custom Spine' s ISSYS Products
• DePuy' s Expedium Products
• Globus Medical' s Reverse and Gateway Systems
• Life Spine' s Lynx Cross Connector System
• MEDICREA' s PASS Products
• Medtronic Products
• Pioneer Surgical Technology' s LowTop Pedicle Screw System
• SIGNUS Medizintechnik' s TPN
• Stryker' s Xia Spinal System
• Surgicraft' s Products
• Synthes' Pangea Degenerative Spine System
• US Spine' s Facet Fixation System
• X-spine Systems' Capless Pedicle Screw Systems
• New Anterior Lumbar Plates
• Interbody Devices
• Product Highlights
• Alphatec' s Novel Spinal Spacer Systems
• Amedica' s Valeo and Arx System
• Globus Medical' s NIKO Corpectomy Spacer System
• K2M' s Aleutian Systems
• LDR Holdings' ROI Partial VBRs
• Medtronic' s Capstone
• RSB Spine' s InterPlate VBRs
• Spinal Elements' VBRs
• Stryker' s AVS PL PEEK Spacers
• Synthes' Products
• Vertebration' s XYcor Spinal Implant
• Cervical Products
• New Anterior Cervical Plate Systems
• Spinal Elements' Mosaic Spinal Implant System
• MEDICREA' s C-JAWS
• Minimally-Invasive Spinal Fusion
• MIS Fusion: Market Drivers, Restraints & Future Opportunities
• Leading Products and New Innovations
• Abbott' s Minimally-Invasive Systems
• Alphatec' s Illico Minimally Invasive System
• Biomet' s VuePASS Portal Access Surgical System
• coLigne' s Erriva ELIF
• DePuy' s MIS Products
• Globus Medical' s MARS Minimal Access Retractor System
• Innovative Spinal Technologies' Paramount Systems
• Interventional Spine' s MIS Products
• K2M' s Serengeti Minimally Invasive Retractor System
• Medtronic Minimal Access Spinal Technologies
• NuVasive Maximum Access Surgery
• Pioneer Surgical Technology' s Quantum MIS Rodding System
• Spinal Elements' Mercury Spinal System
• Stryker' s MANTIS
• TranS1' s MIS Approach
• VertiFlex' Silverbolt MIS Systems
• Zimmer' s Endius Products
• BIOLOGIC PRODUCTS
• Orthobiologics Market by Product, 2007-2012 (US$ million)
• Orthobiologics Market by Region 2007-2012
  • Fig.9: Global Orthobiologics Market Shares, 2007
• Bone Graft Substitutes
• Spinal Biologics: Market Drivers, Restraints & Future Opportunities
• Allograft
• Demineralised Bone Matrix
• Bone Morphogenetic Proteins
• Medtronic' s Infuse Bone Graft
• Medtronic' s InductOs
• Stryker' s OP-1
• Synthetic Bone Grafts
• New Synthetic Bone Grafts
• Cell-Based Products
• NuVasive' s Osteocel
• SpineSmith' s Fusionary
• Technologies in Development
• Orthovita' s Cortoss Bone Augmentation Material
• Other Biologic Spinal Products
• co.don' s chondrotransplant DISC
• ISTO Technologies' NuQu Injectable Cell-Based Therapy
• Spinal Restoration' s Biostat Disc Augmentation System
• SpineOvations' DiscSeal
• Integra LifeSciences' DuraGen Plus Adhesion Barrier Matrix
• DYNAMIC STABILISATION
  • Fig.10: Dynamic Stabilisation Market, 2006-2013 (US$ million)
• Dynamic Stabilisation: Market Drivers, Restraints & Future Opportunities
• Pedicle Screw-Based Systems
• Pedicle Screw-Based Systems - Competitive Landscape
• Zimmer' s Dynesys Dynamic Stabilization System
• Zimmer DTO Implant
• Scient' x' Isobar Products
• Paradigm Spine' s coflex Devices
• Paradigm Spine' s DSS System
• SpineVision' s FlexPLUS
• Disc Motion Technologies' True TSMS
• Interventional Spine' s PercuDyn
• Applied Spine Technologies' Stabilimax NZ
• Vertiflex' Dynabolt Dynamic Stabilization System
• Eden Spine' s FX-1 System
• ulrich Medical' s cosmic Products
• Products in Development
• DePuy' s Expendium Dynamic Rod System
• Globus Medical' s Transition Posterior Dynamic Stabilization System
• Innovative Spinal Technologies' Axient Total Dynamic Fixation
• Interspinous Spacer Systems
• Interspinous Spacers - Competitive Landscape
• Medtronic/Kyphon' s X-STOP Interspinous Process Decompression System
• Abbott' s Wallis System
• Medtronic' s DIAM Spinal Stabilization System
• Medtronic/Kyphon' s Aperius PercLID
• VertiFlex' Superion
• Synthes' In-Space
• Orthofix' InSWing
• Globus Medical' s FLEXUS Interspinous Spacer
• Pioneer Surgical Technology' s BacJac
• Eden Spine' s Wellex Interspinous Technology
• GMReis' Dynafix Interspinous Dynamic Fixation System
• TOTAL DISC REPLACEMENT
  • Fig.11: Global TDR Market, 2006-2013 (US$ million)
• Lumbar Discs
• Market Potential and Future Opportunities
  • Fig.12: Lumbar TDR Market, 2006-2013 (US$ million)
• Lumbar TDR: Market Drivers, Restraints & Future Opportunities
• Lumbar TDR Products and Technologies
• Lumbar TDR: Competitive Landscape
• DePuy' s Charite Artificial Disc
• Synthes' ProDisc-L
• Medtronic' s Maverick Artificial Lumbar Disc
• Nexgen Spine' s Physio-L
• Stryker' s FlexiCore Artificial Lumbar Disc
• SpinalMotion' s Kineflex
• Aesculap' s Activ-L Artificial Lumbar Disc
• Disc Motion Technologies' TrueDisc Posterior Artificial Disc
• LDR Holdings' Mobidisc
• Zimmer' s Dynardi Artificial Lumbar Disc
• Products in Development
• Cervical Discs
  • Fig.13: Cervical TDR Market, 2006-2013 (US$ million)
• Cervical TDR: Market Drivers, Restraints & Future Opportunities
• Cervical TDR Products and Technologies
• Cervical TDRs - Competitive Landscape
• Synthes' ProDisc-C
• Medtronic' s Prestige Cervical Disc
• Medtronic' s Prestige LP Cervical Disc
• Medtronic' s Bryan Cervical Disc System
• Scient' x' Discocerv
• Cervitech' s PCM Artificial Cervical Disc
• LDR' s Mobi-C
• Globus Medical' s Secure-C
• SpinalMotion' s Kineflex|C
• DePuy' s Discover Cervical Disc
• Spinal Kinetics' M6-C
• Vertebron' s CMP
• Osteon' s MCD Mobile Cervical Disc
• Aesculap' s Activ-C
• Products in Development
• PARTIAL DISC REPLACEMENT
• Nucleus Replacement
  • Fig.14: Nucleus Replacement Market, 2006-2013 (US$ million)
• Nucleus Replacement: Market Drivers, Restraints and Future Opportunities
• Nucleus Replacement Products and Technologies
• Nucleus Replacement - Competitive Landscape
• Raymedica' s Products
• Disc Dynamics' Dascor Disc Arthroplasty System
• Pioneer Surgical Technology' s NuBac Intradiscal Arthroplasty System
• Sinitec' s SINUX ANR
• Products in Development
• NuVasive' s NeoDisc Cervical Partial Disc Replacement
• TranS1' s PDR Lumbar Partial Disc Replacement
• NUCLEUS REMOVAL
• FACET REPLACEMENT
• Archus Orthopedics' Total Facet Arthroplasty Systems
• Facet Solutions' Anatomic Facet Replacement System
• Spinal Elements' Zyre Facet Arthroplasty System
• Gerraspine' s FENIX Facet Implant
• TOTAL POSTERIOR ARTHROPLASTY
• TOPS-on-Fusion System
• ANNULAR REPAIR
• Anulex Technologies' Inclose and Xclose Systems
• Intrinsic Therapeutics' Barricaid
• Arthro Kinetics' AnReS
• FRACTURE TREATMENT
• Current Options
• VCF Treatment Options: Vertebroplasty vs Kyphoplasty
• Market Players
  • Fig.15: VCF Treatment Market, 2006-2013 (US$ million)
• Vertebroplasty
• ArthroCare - Parallax Medical and Cavity SpineWand
• Kyphoplasty and Kyphon
  • Fig.16: Kyphon: Kyphoplasty Procedure Growth, 2000-2006
  • Fig.17: Kyphon' s Revenue, Y/E 31st December 2000-2006 (US$ million)
• Kyphon' s SKy Bone Expander System
• Spine Wave' s StaXx FX Structural Kyphoplasty System
• Cement & Cement Delivery Systems
• DePuy' s Confidence Spinal Cement System
• Biomet' s VCF Products
• Orthovita' s Cortoss Bone Augmentation Material
• Spineology' s OptiMesh
• Products in Development
• Alphatec' s OsseoFix Spinal Fracture Reduction System
• AOI Medical' s Ascendx VCF Reduction System
• SPINAL IMPLANT MANUFACTURERS
• THE MARKET LEADERS
• Abbott
• Abbott: Recent Spinal Product Approvals
• Alliances
• Replication Medical
• AlloSource
• Invibio
• Financial Performance
• Abbott Revenue, 2004-2007 (US$ million)
  • Fig.18: Abbott Spine Sales, 2004-2007 (US$ million)*
• Alphatec Holdings
• Alphatec: Recent Product Approvals
• R&D Projects
• Alliances
• DePuy
• Scient' x
• Stout Medical Group
• Progressive Spinal Technologies
• JGMG Bengochea
• Roger P Jackson, MD
• Biomet
• Hansen A Yuan
• Invibio
• Financial Performance
• Alphatec Revenue, 2004-2007 (US$ million)
• B Braun/Aesculap
• Alliances
• Premier
• Inion
• Integra OrthoBiologics
• Allez Spine
• Financial Performance
• B Braun Revenue, 2004-2007 (US$ million)
• Biomet
• Alliances
• Premier
• Alphatec Holdings
• Altiva
• Financial Performance
• Biomet Revenue, 2005-2008 (US$ million)
  • Fig.19: Biomet: Spinal Revenue, 1998-2008 (US$ million)
• DePuy
• DePuy: Recent Spinal Product Launches
• R&D Projects
• Alliances
• Alphatec Holdings
• Biomerix
• Axial Biotech
• Archus Orthopedics
• Sinitec
• Osteotech and LifeNet
• FzioMed
• Harvest Technologies
• DJO
• Biedermann Motech GmbH
• Legal Proceedings
• Financial Performance
• DePuy Revenue, 2004-2007 (US$ million)
• Globus Medical
  • Fig.20: Globus Medical' s Revenue, 2003-2008 (US$ million)
• Globus: Recent Product Approvals
• R&D Projects
• Medtronic
• Medtronic: Recent Spinal Product Approvals
• R&D Projects
• Alliances
• Chinese Spine and Orthopaedics Joint Venture
• Orthofix International (Blackstone Medical)
• Kensey Nash
• aap Implantate
• RTI Biologics
• Premier
• Wyeth, Integra OrthoBiologics and Astellas
• Axial Biotech
• Purdue Research Foundation
• Kyphon Agreements
• Financial Performance
  • Fig.21: Medtronic' s Spinal Sales by Product Area, 2008
  • Fig.22: Medtronic' s Spinal Sales by Region, 2008
• Medtronic' s Spinal Revenue, 2007-2008 (US$ million)
  • Fig.23: Kyphon' s Revenue, Y/E 31st December 2000-2006 (US$ million)
• NuVasive
• NuVasive: Recent Product Launches
• R&D Projects
• Alliances
• Orthofix/Blackstone Medical
• Theken Spine
• Maxigen Biotech
• Tissue Banks International and AlloSource
• Pearsalls
• Invibio
• Peak Industries
• Financial Performance
  • Fig.24: NuVasive' s Revenue, 2003-2007 (US$ million)
• Orthofix International
• R&D Projects
• Alliances
• Musculoskeletal Transplant Foundation
• RTI Biologics
• UnitedHealth
• NuVasive
• Innovative Spinal Technologies
• Legal Proceedings
• Financial Performance
• Orthofix Revenue By Product, 2004-2007 (US$ million)
• Orthofix Spine Sales by Segment, 2004-2007 (US$ million)
• Stryker
• Stryker: Recent Spinal Product Launches
• R&D Projects
• Next-generation Spinal Implants
• New Indications for OP-1
• Alliances
• LifeCell
• Mayo Clinic
• Financial Performance
• Stryker Revenue, 2005-2007 (US$ million)
  • Fig.25: Stryker Sales by Product Line, 2007*
  • Fig.26: Stryker' s Spinal Sales, 2003-2007 (US$ million)
• Synthes
• Synthes: Recent Spinal Product Launches
• Alliances
• Innovative Spinal Technologies
• MTF (Musculoskeletal Transplant Foundation)
• Financial Performance
• Synthes Revenue, 2004-2007 (US$ million)
• Zimmer
• Zimmer: Recent Spinal Product Approvals
• Spinal R&D Projects
• Alliances
• U&I Corporation
• RTI Biologics
• Financial Performance
• Zimmer Revenue, 2004-2007 (US$ million)
• Zimmer Spine Sales by Region, 2004-2007 (US$ million)
• EMERGING PLAYERS
• Allez Spine
• Altiva (Exactech)
• Amedica
• Amedica: Recent Spinal Product Launches
• Anulex Technologies
• AOI Medical
• Applied Spine Technologies
• Archus Orthopedics
• ArthroCare
• Financial Performance
• ArthroCare Revenue: 2005-2007 (US$ million)*
• Arthro Kinetics
• Financial Performance
• Arthro Kinetics Revenue, 2005-2007 (EUR million)*
• Atlas Spine
• AxioMed Spine
• Benvenue Medical
• Biomerix
• Cervitech
• co.don
• coLigne
• CoreSpine Technologies
• Corin
• CryoLife
• Custom Spine
• Disc Dynamics
• Disc Motion Technologies
• Dynamic Spine
• Eden Spine
• Facet Solutions
• Gentis
• Gerraspine
• GMReis
• Impliant
• Inion
• Inion Revenue, 2006-2007 (EUR million)*
• Innovative Spinal Technologies
• Interventional Spine
• Intrinsic Therapeutics
• K2M
• K2M: Recent Product Launches
• Kensey Nash
• Lanx
• LDR Holding
• LDR: Recent Product Launches
• Life Spine
• MEDICREA International
• Nexgen Spine
• Osteon
• Paradigm Spine
• Pioneer Surgical Technology
• Pioneer: Recent Product Launches
• Ranier Technology
• Raymedica
• Replication Medical
• RSB Spine
• Scient' x
• Scient' x Revenue, 2004-2006 (US$ million)
• SeaSpine
• SIGNUS Medizintechnik
• Sinitec
• Smart Disc
• Spinal Elements
• Spinal Kinetics
• SpinalMotion
• Spinal Restoration
• SpineMedica
• Spineology
• SpineOvations
• SpineSmith
• SpineVision
• Spine Wave
• Surgicraft
• Theken Group (Integra LifeSciences)
• Theken Spine
• Theken Spine: Recent Spinal Product Approvals
• Theken Disc
• TranS1
• Financial Performance
• TranS1 Revenue, 2005-2007 (US$ million)*
• ulrich medical
• US Spine
• Vertebration
• Verterbron
• VertiFlex
• X-spine
• APPENDICES
• APPENDIX 1 - LIST OF ABBREVIATIONS
• APPENDIX 2 - REPORT METHODOLOGY
• Secondary Sources
• Primary Sources
• Market forecasts

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