Thu 1 Oct 2009
Spine Surgery Worldwide 2008-2017: Products, Technologies, Markets and Opportunities
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This report details the complete range of products and technologies in spine surgery, including the surgical management of spine disorders, diseases and trauma, with treatments including use of grafts, demineralized bone, fusion, stabilization, disc replacement, nucleus replacement, vertebroplasty, kyphoplasty, imaging, minimally invasive surgical technologies, energy-based therapies and biologics. The report details current clinical and technology developments in the huge and rapidly growing spine surgery technologies worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity.
This report is a detailed market and technology assessment and forecast of the products and technologies in the management of diseases and disorders of the spine. The report describes diseases and disorders of the spine, encompassing congenital disorders, inflammatory and infectious diseases; degenerative diseases; herniations, stenoses, myelopathies and other “mechanical” disorders of the spine; spinal trauma; tumors of the spine; and others. The report characterizes the patient populations, their current clinical management, and trends in clinical management as new techniques and technologies are expected to be developed and emerge. The report details the currently available products and technologies, and manufacturer offerings. The report details products and technologies under development and markets for each in spine surgery. The report provides a current and forecast assessment of the worldwide markets for these technologies, with geographic segmentation by U.S. & Canada, European Union (detailing France, United Kingdom, Germany, Italy and Spain), Japan and Rest of World. The report provides emphasis on the market impact of new technologies through the coming decade, profiling nearly 100 active companies in this industry, with comprehensive detail on key companies, providing data on their current products, current market position and products under development.
Table of Contents:
Executive Summary
Non-fusion products
Disc arthroplasty (total disc replacement)
Nuclear arthroplasty
European Union
Asia-Pacific
Rest of World
Selected company-related events
Medtronic
LDR Spine
Synthes Spine
Disc Motion Technologies
Spine Structure
Products and technologies
CMS, carriers reverse decision on artificial discs
Cost effectiveness
Section 1: The Spine: Structure, Disorders, Treatment
1.1 Overview: Spine Structure
1.2 Diseases and disorders of the spine
1.2.1 Congenital Disorders
1.2.2 Inflammatory and Infectious Diseases of the Spine
1.2.3 Degenerative Diseases of the Spine
1.2.4 Mechanical Disorders of the Spine
1.2.5 Spinal Trauma
1.2.6 Tumors of the Spine
1.3 Spine management
1.3.1 Clinical: the SPORT Study
1.3.2 Diagnostic studies
1.3.3 Surgical procedures of the spine
1.3.4 Minimally Invasive Procedures
1.3.5 Minimally Invasive Bone Grafting Procedures
1.3.6 Acupuncture for treatment of chronic low back pain
Section 2: Products and Technologies
2.1 Bone grafts and bone graft substitutes
2.2 Demineralized bone matrix (DBM)
2.2.1 Particle based DBM
2.2.2 Biomimetic matrix bone substitute
2.2.3 Bone morphogenic proteins (BMPs)
2.3 Spinal fusion and fixation products and technologies
2.3.1 Spine surgery instrumentation
2.3.2 Cervical fusion devices
2.3.3 Interbody fusion devices
2.3.4 Posterior dynamic stabilization systems
2.4 Non-fusion products and technologies
2.4.1 Disc arthroplasty
2.4.2 Nuclear arthroplasty and nuclear disc prostheses
2.4.3 Facet repair and replacement
2.5 Vertebroplasty and kyphoplasty
2.5.1 Vertebral compression fracture treatment technologies
2.6 Advances in spinal image-guided surgery
2.6.1 Medtronic’s StealthStation
2.6.2 GE Healthcare’s Fluoro-Spine
2.6.3 Elekta’s Axesse system
2.6.4 Zimmer’s ORTHOsoft Navitrack® FluoroSpine® System
2.7 Products and technologies for minimally invasive spinal surgery
2.7.1 ArthroCare’s spineWand
2.7.2 Medtronic’s MAST™ portfolio
2.7.3 NuVasive’s Maximum Access Surgery (MAS)
2.7.4 Abbott Spine’s Harmony Retractor
2.7.5 Globus transforaminal TDR device
2.8 Energy-based therapies
2.8.1 Bone growth stimulators
2.8.2 Intradiscal Electrothermal Therapy (IDET)
2.9 Biologics
Section 3: Market Size, Forecast and Competitor Shares
3.1 Global market size, forecast and competitor shares
3.2 USA & Canada
3.2.1 Bone grafts and bone graft substitutes
3.2.2 Spinal fusion and fixation products
3.2.3 Non-fusion products
3.2.4 Vertebroplasty and Kyphoplasty
3.2.5 Interspinous process spacers (ISP)
3.2.6 Computer assisted image guided surgery products
3.3 European Union
3.3.1 United Kingdom
3.3.2 France
3.3.3 Germany
3.3.4 Italy
3.3.5 Spinal fusion and fixation products
3.3.6 Non-fusion products
3.3.7 Total disc replacement
3.3.8 Nucleus replacement
3.3.9 Interspinous process spacers (ISPs)
3.3.10 Kyphoplasty
3.3.11 Image Guided Surgery Products Market
3.4 Asia-Pacific
3.4.1 Spinal fusion and fixation products
3.4.2 Non-fusion products
3.4.3 Image guided surgery products
3.5 Rest of World
Section 4: Regulatory, Cost and Reimbursement Issues
4.1 Regulatory Issues Associated with Spine Treatments, Materials and Methods
4.1.1 Regulatory issues regarding off-label usage
4.1.2 Changes to European Device Safety Regulations
4.1.3 NICE and dynamic stabilization procedures
4.2 Reimbursement Developments
4.2.1 CMS, carriers reverse decision on artificial discs
4.2.2 CMS reverses stand on two spinal fusion procedures
4.2.3 ArthroCare and DiscoCare
4.2.4 Bone growth factor reimbursement issues
4.2.5 CMS investigates Thermal Intradiscal Therapy
4.2.6 CMS announces new ICD-9-CM spinal procedure codes
4.2.7 Wellmark and energy-based treatments
4.3 Cost effectiveness
Section 5: Company Profiles
5.1 Abbott Spine
5.2 AlloSource
5.3 Alphatec Holdings, Inc.
5.4 Altiva Corporation
5.5 Anulex Technologies, Inc.
5.6 ApaTech
5.7 Applied Spine Technologies
5.8 ArthroCare Corporation
5.9 A-Spine Holding Group Corporation
5.10 Axial Biotech
5.11 AxioMed Spine Corporation
5.12 B. Braun/Aesculap, Inc.
5.13 BioAssets Development Corporation
5.14 Biomet
5.15 Biorthex, Inc.
5.16 Blackstone Medical, Inc
5.17 BrainLAB
5.18 Cardinal Health
5.19 Cervitech
5.20 Changzhou Kanghui
5.21 Co.Don AG
5.22 CoLigne AG
5.23 Cook Group
5.24 CoreSpine Technologies LLC
5.25 Corin Group
5.26 Cortek, Inc
5.27 Cryolife, Inc.
5.28 Cyberkinetics Neurotechnology Systems
5.29 Cytori Therapeutics
5.30 DePuy Spine/J&J
5.31 Disc Dynamics
5.32 Disc Motion Technologies
5.33 Encore Medical Corporation / DJO Surgical (ReAble Therapeutics)
5.34 Facet Solutions
5.35 Fixano (Small Bone Innovations)
5.36 GE Healthcare
5.37 Gentis, Inc
5.38 Globus Medical
5.39 GMReis
5.40 HydroCision
5.41 [Innovative Spinal Technologies — ceased operations January 2009]
5.42 Integra LifeSciences
5.43 Integra Radionics
5.44 Interpore Cross
5.45 Interventional Spine
5.46 Invibio
5.47 LDR Holding Corporation
5.48 LifeNet Health, Inc.
5.49 Mazor Surgical Technologies Ltd
5.50 Medtronic, Inc
5.51 Medtronic Sofamor Danek
5.52 Medtronic Surgical Navigation
5.53 Mekanika, Inc.
5.54 Merck & Co., Inc.
5.55 MiMedx
5.56 Misonix
5.57 MTF (Musculoskeletal Transplant Foundation)
5.58 NPS Pharmaceuticals
5.59 N Spine, Inc. (Synthes)
5.60 NuVasive, Inc.
5.61 Ortho Development Corporation
5.62 Orthofix International, N.V.
5.63 OrthoVita
5.64 Osiris Therapeutics
5.65 Osteotech, Inc.
5.66 Ortosintese
5.67 Paradigm Spine, LLC
5.68 Pitkar
5.69 Praxim
5.70 Ranier Technology Limited
5.71 Raymedica, Inc.
5.72 Regeneration Technologies, Inc
5.73 Scient’X
5.74 SeaSpine, Inc.
5.75 Sharma Surgical
5.76 Small Bone Innovations, LLC
5.77 Smart Disc
5.78 Smith & Nephew
5.79 SpinalMotion
5.80 SpineMedica Corporation
5.81 Spineology
5.82 SpineOvations
5.83 SpineVision Inc
5.84 Spine Wave, Inc.
5.85 Stryker Corporation
5.86 Stryker Instruments
5.87 Stryker Spine
5.88 Synthes Spine Solutions
5.89 Theken Spine
5.90 TranS1, Inc.
5.91 Trimedyne, Inc.
5.92 Ulrich Medical GmbH
5.93 Valleylab
5.94 Vertebron Inc.
5.95 Waston Medical
5.96 Wright Medical Technology
5.97 X-spine Systems, Inc.
5.98 Zimmer Spine
Appendix: Company Directory
List of Exhibits
Exhibit ES-1: Total Global Spine Surgery Market, 2008-2017
Exhibit ES-2: Total Global Spine Surgery Market, 2008-2017
Exhibit ES-3: Global Spine Surgery Market by Segment, in USD Terms
Exhibit ES-4: Global Spine Surgery Market by Percentage and Segments, 2008
Exhibit ES-5: Major Spine Market Segments, 2008-2017
Exhibit ES-6: Key Factors Driving Growth in the Global Spine Surgery Market
Exhibit ES-7: Global Spine Surgery Market Shares, 2008
Exhibit ES-8: US & Canadian Market for Spine Surgery Devices
Exhibit ES-9: US Company Market Shares for Spine Surgery Devices, 2008
Exhibit ES-10: Total Global Spine Surgery Market, by Region, 2008
Exhibit ES-11: Total EU Spine Surgery Market, 2008-2017
Exhibit ES-12: Total EU Spine Surgery Market, 2008-2017
Exhibit ES-13: EU Spine Surgery Market Shares, 2008
Exhibit ES-14: Asia-Pacific: Total Spine Surgery Market, 2008-2017
Exhibit ES-15: Asia-Pacific: Total Spine Surgery Market, 2008-2017
Exhibit ES-16: Asia-Pacific: Spine Surgery Market Shares, 2008
Exhibit ES-17: Rest of World Spine Surgery Market Shares, 2008
Exhibit ES-18: ROW, Spine Surgery Markets, 2008-2017
Exhibit ES-19: Lateral and Posterior Views of the Spine
Exhibit ES-20: Human Spine Structure Showing Vertebrae, Intervertebral Discs, and Spinal Cord
Exhibit ES-21: US Census figures and projections, ages 65 and up, 1900-2050.
Exhibit ES-22: Number & Percentage of U.S. Population over Age 65, 1910–2050
Exhibit ES-23: Mechanical Disorders of the Spine
Exhibit ES-24: Start-up companies and areas of interest
Exhibit ES-25: CPT spinal fusion codes now allowed by CMS
Exhibit ES-26: Summary of CMS Medicare cost data
Exhibit 1-1: Lateral and Posterior Views of the Spine
Exhibit 1-2: Human Spine Structure Showing Vertebrae, Intervertebral Discs, and Spinal Cord
Exhibit 1-3: Components of the Human Spine
Exhibit 1-4: US Census figures and projections, ages 65 and up, 1900-2050.
Exhibit 1-5: Number & Percentage of U.S. Population over Age 65, 1910–2050
Exhibit 1-6: Congenital Disorders of the Spine
Exhibit 1-7: Inflammatory and Infectious Diseases of the Spine
Exhibit 1-8: Degenerative Diseases of the Spine
Exhibit 1-9: Estimated Annual Number of Fractures Due to Osteoporosis in the U.S. (Total: Over 1.5 Million)
Exhibit 1-10: Mechanical Disorders of the Spine
Exhibit 1-11: Location, Effects, and Incidence of Major Lumbar Disc Herniations
Exhibit 1-12: Clinical Features—Radiculopathy by Spinal Level
Exhibit 1-13: Causes of Trauma to Spinal Regions
Exhibit 1-14: Tumors of the Spine
Exhibit 1-15: Traditional (“Open”) Spinal Procedures
Exhibit 1-16: Estimated Number of Spinal Fusion Procedures Performed in the U.S., 2005–2015
Exhibit 1-17: Minimally Invasive Spinal Procedures
Exhibit 2-1: Spinal Allografts: Vendors and Products
Exhibit 2-2: Hydroxyapatite Bone Substitutes: Vendors, Products
Exhibit 2-3: Bone growth stimulatory proteins, peptides and devices
Exhibit 2-4: Fusion instrumentation companies
Exhibit 2-5: Developers of Interspinous Process Spacers
Exhibit 2-6: Developers of Total Disc Replacements
Exhibit 2-7: Artificial Cervical Discs Currently in US Clinical Trials
Exhibit 2-8: Artificial Cervical Discs Currently Available in the EU
Exhibit 2-9: Total disc replacement devices
Exhibit 2-10: Developers of Prosthetic Disc Nuclei
Exhibit 2-11: Nucleus replacement implants
Exhibit 2-12: Current nucleus arthroplasty motion preservation IDE pilot studies
Exhibit 2-13: Bone growth stimulatory proteins, peptides and devices
Exhibit 2-14: Cellular therapies: manufacturers and product
Exhibit 2-15: Other start-up companies and areas of interest
Exhibit 3-1: Total Global Spine Surgery Market, 2008-2017
Exhibit 3-2: Total Global Spine Surgery Market, 2008-2017
Exhibit 3-3: Global Spine Surgery Market by Segment, in USD Terms
Exhibit 3-4: Global Spine Surgery Market by Percentage and Segments, 2008
Exhibit 3-5: Key Factors Driving Growth in the Global Spine Surgery Market
Exhibit 3-6: Major Spine Market Segments, 2008-2017
Exhibit 3-7: Global Spine Surgery Market Shares, 2008
Exhibit 3-8: US & Canadian Market for Spine Surgery Devices
Exhibit 3-9: US & Canadian Market for Spine Surgery Devices
Exhibit 3-10: US Company Market Shares for Spine Surgery Devices, 2008
Exhibit 3-11: Usage of Bone Grafts and Bone Graft Substitutes in Spinal Fusion Procedures (excluding BMPs)
Exhibit 3-12: US Market for Bone Graft Substitutes
Exhibit 3-13: US Market for Spine-Related Orthobiologics, 2008-2017
Exhibit 3-14: US & Canadian Market for Spinal Fusion and Fixation Devices
Exhibit 3-14B: US & Canadian Spinal Fusion Procedures by Segment (Cervical, Lumbar, Thoracic), 2008-2017
Exhibit 3-15: Number of Spinal Fusions
Exhibit 3-16: US & Canadian Market for Spinal Fusion and Fixation Devices
Exhibit 3-17: US Market Shares, Spinal Fusion and Fixation Devices, 2008
Exhibit 3-18: US Market Shares, Spinal Fusion and Fixation Devices, 2008
Exhibit 3-19 Total US Non-Fusion Device Market
Exhibit 3-20: Total US Non-Fusion Device Market
Exhibit 3-21: US Annulus Repair Market, 2009-2015
Exhibit 3-22: US Annulus Repair Market, 2009-2015
Exhibit 3-23: Total Market for Disc Arthroplasty (Cervical Plus Thoracolumbar)
Exhibit 3-24: US Market for Cervical Disc Replacement
Exhibit 3-25: US Market for Cervical Disc Replacement
Exhibit 3-26: US Market for Thoracolumbar Disc Replacement
Exhibit 3-27: US Market for Thoracolumbar Disc Replacement
Exhibit 3-28: US & Canadian Markets for Nuclear Arthroplasty
Exhibit 3-29: US Market for Nucleus Replacement
Exhibit 3-30: Total US Market for Vertebroplasty and Kyphoplasty
Exhibit 3-31: US Market for Vertebroplasty
Exhibit 3-32: US Market for Vertebroplasty
Exhibit 3-33: US Market for Kyphoplasty
Exhibit 3-34: US Market for Kyphoplasty
Exhibit 3-35: 2008 US Market Shares, Combined Vertebroplasty/Kyphoplasty
Exhibit 3-36: US Interspinous Process Spacers Market, 2008-2017
Exhibit 3-37: US Interspinous Process Spacers Market, 2008-2017
Exhibit 3-38: US Market for Image Guided Surgery Devices
Exhibit 3-39: US Market for Image Guided Surgery Devices
Exhibit 3-40: US Competitor Shares, Image Guided Surgery Devices, 2008
Exhibit 3-41: Total Global Spine Surgery Market, by Region, 2008
Exhibit 3-42: Total EU Spine Surgery Market, 2008-2017
Exhibit 3-43: Total EU Spine Surgery Market, 2008-2017
Exhibit 3-44: EU Spine Surgery Market by Segment, in USD
Exhibit 3-45: EU Spine Surgery Market by Percentage and Segments, 2008
Exhibit 3-46: EU Spine Surgery Market Shares, 2008
Exhibit 3-47: United Kingdom: Total Spine Surgery Market, 2008-2017
Exhibit 3-48: United Kingdom: Total Spine Surgery Market, 2008-2017
Exhibit 3-49: UK: Total Spine Surgery Market Shares, 2008
Exhibit 3-50: France: Total Spine Surgery Market, 2008-2017
Exhibit 3-51: France: Total Spine Surgery Market, 2008-2017
Exhibit 3-52: France: Total Spine Surgery Market Shares, 2008
Exhibit 3-53: Germany: Total Spine Surgery Market, 2008-2017
Exhibit 3-54: Germany: Total Spine Surgery Market, 2008-2017
Exhibit 3-55: Germany: Total Spine Surgery Market Shares, 2008
Exhibit 3-56: Italy: Total Spine Surgery Market, 2008-2017
Exhibit 3-57: Italy: Total Spine Surgery Market, 2008-2017
Exhibit 3-58: Italy: Total Spine Surgery Market Shares, 2008
Exhibit 3-59: Total EU Spine Fusion and Fixation Market, 2008-2017
Exhibit 3-60: Total EU Spine Fusion and Fixation Market, 2008-2017
Exhibit 3-61: United Kingdom: Spinal Fusion and Fixation Market, 2008-2017
Exhibit 3-62: France: Spinal Fusion and Fixation Market, 2008-2017
Exhibit 3-63: Germany: Spinal Fusion and Fixation Market, 2008-2017
Exhibit 3-64: Italy: Spine Fusion and Fixation Market, 2008-2017
Exhibit 3-65: Total EU Non-Fusion Market, 2008-2017
Exhibit 3-66: Total EU Non-Fusion Market, 2008-2017
Exhibit 3-67: United Kingdom: Non-fusion Products Market, 2008-2017
Exhibit 3-68: France: Total Non-Fusion Products Market, 2008-2017
Exhibit 3-69: Germany: Total Non-fusion Market, 2008-2017
Exhibit 3-70: Italy: Non-fusion Products Market, 2008-2017
Exhibit 3-71: Total EU Disc Replacement Market, 2008-2017
Exhibit 3-72: Total EU Disc Replacement Market, 2008-2017
Exhibit 3-73: United Kingdom: Total Disc Replacement Market, 2008-2017
Exhibit 3-74: France: Total Disc Replacement Market, 2008-2017
Exhibit 3-75: Germany: Total Disc Replacement Market, 2008-2017
Exhibit 3-76: Italy: Total Disc Replacement Market, 2008-2017
Exhibit 3-77: Total EU Nucleus Replacement Market, 2008-2017
Exhibit 3-78: Total EU Nucleus Replacement Market, 2008-2017
Exhibit 3-79: United Kingdom: Nucleus Replacement Market, 2008-2017
Exhibit 3-80: France: Nucleus Replacement Market, 2008-2017
Exhibit 3-81: Germany: Nucleus Replacement Market, 2008-2017
Exhibit 3-82: Italy: Nucleus Replacement Market, 2008-2017
Exhibit 3-83: Total EU Interspinous Process Spacers (ISPs) Market, 2008-2017
Exhibit 3-84: Total EU Interspinous Process Spacers (ISPs) Market, 2008-2017
Exhibit 3-85: United Kingdom: Interspinous Process Spacers Market, 2008-2017
Exhibit 3-86: France: Interspinous Process Spacers Market, 2008-2017
Exhibit 3-87: Germany: Total Spine Surgery Market, 2008-2017
Exhibit 3-88: Italy: Interspinous Process Spacers Market, 2008-2017
Exhibit 3-89: Total EU Kyphoplasty Market, 2008-2017
Exhibit 3-90: Total EU Vertebroplasty/Kyphoplasty Market, 2008-2017
Exhibit 3-91: United Kingdom: Vertebroplasty/Kyphoplasty Market, 2008-2017
Exhibit 3-92: France: Vertebroplasty/Kyphoplasty Market, 2008-2017
Exhibit 3-93: Germany: Vertebroplasty/Kyphoplasty Market, 2008-2017
Exhibit 3-94: Italy: Vertebroplasty/Kyphoplasty Market, 2008-2017
Exhibit 3-95: EU Market for Computer Assisted Image Guided Surgery Products, 2008-2017
Exhibit 3-96: United Kingdom: Image Guided Surgery Market, 2008-2017
Exhibit 3-97: France: Image Guided Surgery Market, 2008-2017
Exhibit 3-98: Germany: Image Guided Surgery Market, 2008-2017
Exhibit 3-99: Italy: Image Guided Surgery Market, 2008-2017
Exhibit 3-100: Asia-Pacific: Total Spine Surgery Market, 2008-2017
Exhibit 3-101: Asia-Pacific: Total Spine Surgery Market, 2008-2017
Exhibit 3-102: Asia-Pacific: Spine Surgery Market Shares, 2008
Exhibit 3-103: Asia-Pacific: Spinal Fusion and Fixation Market, 2008-2017
Exhibit 3-104: Asia-Pacific: Spinal Fusion and Fixation Market, 2008-2017
Exhibit 3-105: Asia-Pacific: Non-fusion Products Market, 2008-2017
Exhibit 3-106: Asia-Pacific: Non-fusion Products Market, 2008-2017
Exhibit 3-107: Asia-Pacific: Spinal Fusion vs. Non Fusion Markets, 2008 vs. 2017
Exhibit 3-108: Asia-Pacific: Total Disc Replacement Market, 2008-2017
Exhibit 3-109: Asia-Pacific: Total Disc Replacement Market, 2008-2017
Exhibit 3-110: Asia-Pacific: Nucleus Replacement Market, 2008-2017
Exhibit 3-111: Asia-Pacific: Nucleus Replacement Market, 2008-2017
Exhibit 3-112: Asia-Pacific: Interspinous Processes Market, 2008-2017
Exhibit 3-113: Asia-Pacific: Interspinous Processes Market, 2008-2017
Exhibit 3-114: Asia-Pacific: Vertebroplasty/Kyphoplasty Market, 2008-2017
Exhibit 3-115: Asia-Pacific: Vertebroplasty/Kyphoplasty Market, 2008-2017
Exhibit 3-116: Asia-Pacific: Image Guided Surgery Market, 2008-2017
Exhibit 3-117: Asia-Pacific: Image Guided Surgery Market, 2008-2017
Exhibit 3-118: Rest of World Spine Surgery Market Shares, 2008
Exhibit 3-119: ROW, Spine Surgery Markets, 2008-2017
Exhibit 3-120: ROW, Spine Surgery Markets, 2008-2017
Exhibit 3-121: ROW: Fusion and Fixation Market, 2008-2017
Exhibit 3-122: ROW: Fusion and Fixation Market, 2008-2017
Exhibit 3-123: ROW: Non-Fusion Market, 2008-2017
Exhibit 3-124: ROW: Total Disc Replacement Market, 2008-2017
Exhibit 3-125: ROW: Nucleus Replacement Market, 2008-2017
Exhibit 3-126: ROW: Interspinous Process Spacers Market, 2008-2017
Exhibit 3-127: ROW: Vertebroplasty/Kyphoplasty Market, 2008-2017
Exhibit 3-128: ROW: Image-Guided Surgery Market, 2008-2017
Exhibit 4-1: CPT spinal fusion codes now allowed by CMS
Exhibit 4-2: BCBSNC coverage of bone morphogenetic protein
Exhibit 4-3: New CMS codes for spinal motion preservation
Exhibit 4-4: Summary of CMS Medicare cost data
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