Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017

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 NavitrackR FluoroSpineR 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
• 5.34 Facet Solutions
• 5.35 Fixano
• 5.36 GE Healthcare
• 5.37 Gentis, Inc
• 5.38 Globus Medical
• 5.39 GMReis
• 5.40 HydroCision
• 5.41 Innovative Spinal Technologies
• 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 3-15: 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