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NOTE: THE REPORT DESCRIBED BELOW HAS BEEN UPDATED BY
REPORT #M510,
Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide · 330 Pages · 168 Exhibits · Published March 2005 · Report #M501 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 the specific diseases and disorders of the spine, characterizing 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 the manufacturers offering them. 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 U.S., Western Europe and Pacific Rim markets for these technologies, with particular emphasis on the market impact of new technologies through the coming decade, and provides coverage of over 40 active companies in this industry detailing their current products, current market position and products under development. Table of Contents Section 1: Executive Summary
Section 2: Introduction to the Spine
Section 3: Diseases and Disorders of the Spine
Section 4: Surgical Procedures of the Spine
Section 5: Bone Grafts and Bone Graft Substitutes
Section 6: Instrumented Spinal Fusion
Section 7: Non-Fusion Spinal Technology Dynamic Stabilization
Section 8: Disc Arthroplasty
Section 9: Image-Guided Surgery Systems
Section 10: Minimally Invasive Surgery
Section 11: Developments in Energy-Based Therapies
Section 12: Companies exploring alternate treatment Technologies
Section 13: Vertebroplasty and Kyphoplasty
Section 14: Regulatory, Cost, and Reimbursement Issues
ENDNOTES
List of Exhibts
Exhibit 1‑1: Growth in the Spine-Related Orthobiologics Market in the U.S., 2001–2013 ($ Billions) Exhibit 1‑2: Percentage of Worldwide Spine Market Revenues, by Spine Region or Agent (Estimated Total $3.5 Billion) Exhibit 1‑3: Spinal Conditions and Disorders That Can Require Surgical Intervention Exhibit 1‑4: Estimated Annual Number of Fractures Due to Osteoporosis in the U.S. (Total: Over 1.5 Million) Exhibit 1‑5: Older Population by Age, 1900 to 2050 Exhibit 1‑6: Number and Percentage of U.S. Population over Age 65, 1910–2050 Exhibit 1‑7: Open and Minimally-Invasive Spinal Procedures Exhibit 1‑8: Bone Cell Types and Functions Exhibit 1‑9: Types of Spinal Bone Grafts Exhibit 1‑10: Companies Marketing Standard Fusion Instrumentation Products Exhibit 1‑11: Companies Marketing Interbody Fusion Devices and Vertebral Replacement Devices Exhibit 1‑12: Companies Marketing Structural Allograft Products Exhibit 1‑13: Estimated Growth of Spinal Fusion Procedures in the U.S., 2001–2013 Exhibit 1‑14: Companies Developing Non-Fusion Instrumentation Exhibit 1‑15: Companies Developing Disc and Disc Nucleus Replacement Technologies Exhibit 1‑16: Potential Advantages and Disadvantages of Selected Total Disc and Nucleus Replacement Designs Exhibit 1‑17: U.S. Market Forecast for Cervical and Lumbar Total Disc Replacement, 2004–2013 Exhibit 1‑18: Companies Marketing Image-Guided and Minimally Invasive Access Systems Exhibit 1‑19: Issues to Address in the Development of Image-Guided Spine Surgery Exhibit 1‑20: Companies Marketing or Developing Energy-Based Therapy Devices Exhibit 1‑21: Companies Developing Alternate Treatment Technologies for Spine Disorders Exhibit 1‑22: Criteria for Expedited Review of Premarket Submissions Exhibit 1‑23: Device Review User Fees for 2005 Exhibit 2‑1: Lateral and Posterior Views of the Spine Exhibit 2‑2: Human Spine Structure Showing Vertebrae, Intervertebral Discs, and Spinal Cord Exhibit 2‑3: Components of the Human Spine Exhibit 3‑1: Older Population by Age, 1900 to 2050 Exhibit 3‑2: Number and Percentage of U.S. Population over Age 65, 1910–2050 Exhibit 3‑3: Congenital Disorders of the Spine Exhibit 3‑4: Inflammatory and Infectious Diseases of the Spine Exhibit 3‑5: Degenerative Diseases of the Spine Exhibit 3‑6: Estimated Annual Number of Fractures Due to Osteoporosis in the U.S. (Total: Over 1.5 Million) Exhibit 3‑7: Mechanical Disorders of the Spine Exhibit 3‑8: Location, Effects, and Incidence of Major Lumbar Disc Herniations Exhibit 3‑9: Clinical Features—Radiculopathy by Spinal Level Exhibit 3‑10: Causes of Trauma to Spinal Regions Exhibit 3‑11: Tumors of the Spine Exhibit 4‑1: Traditional (“Open”) Spinal Procedures Exhibit 4‑2: Estimated Number of Spinal Fusion Procedures Performed in the U.S., 2001–2013 Exhibit 4‑3: Minimally Invasive Spinal Procedures Exhibit 5‑1: Bone Cell Types and Functions Exhibit 5‑2: Types of Spinal Bone Grafts Exhibit 5‑3: Companies Marketing Allograft and Allograft-Based Bone Graft Products Exhibit 5‑4: Companies Marketing Ceramic-Based Bone Graft Products Exhibit 5‑5: Companies Marketing Polymer-Based Bone Graft Products Exhibit 5‑6: Companies Developing Factor-Based Bone Graft Products Exhibit 5‑7: Companies Developing Cell-Based Bone Graft Products Exhibit 5‑8: Companies Developing New Bone Graft Technologies: Improved Delivery Systems Exhibit 5‑9: Companies Developing New Bone Graft Technologies: Synthetic Materials Exhibit 5‑10: Companies Developing New Bone Graft Technologies: Synthetic Growth Factors Exhibit 5‑11: Companies Developing New Bone Graft Technologies: Improving Implant Technology Exhibit 5‑12: Companies Developing New Bone Graft Technologies: Gene Therapy Exhibit 5‑13: Autograft, Allograft, and DBM Fusion Procedures, 2002–2013 Exhibit 5‑14: Growth in the Spine-Related Orthobiologics Market in the U.S., 2001–2013 ($ Billions) Exhibit 5‑15: Anticipated Percentage Increase in the Use of BMPs in Spinal Fusion Procedures, 2003–2013 Exhibit 5‑16: Reasons Driving Investor Financing for Companies Marketing Current or Potential BoneGraft Treatments Exhibit 6‑1: Companies Marketing Standard Fusion Instrumentation Products Exhibit 6‑2: Cervical Fusion Procedures Utilizing Standard Instrumentation, 2002–2013 Exhibit 6‑3: Lumbar Fusion Procedures Utilizing Standard Instrumentation, 2002–2013 Exhibit 6‑4: Thoracic Fusion Procedures Utilizing Standard Instrumentation, 2002–2013 Exhibit 6‑5: Companies Marketing Interbody Fusion Devices and Vertebral Replacement Devices Exhibit 6‑6: Cervical Fusion Procedures Utilizing Cages, 2002–2013 Exhibit 6‑7: Lumbar Fusion Procedures Utilizing Cages, 2002–2013 Exhibit 6‑8: Thoracic Fusion Procedures Utilizing Cages, 2002–2013 Exhibit 6‑9: Companies Marketing Structural Allograft Products Exhibit 6‑10: Cervical Fusion Procedures Utilizing Structural Allograft Implants, 2002–2013 Exhibit 6‑11: Lumbar Fusion Procedures Utilizing Structural Allograft Implants, 2002–2013 Exhibit 6‑12: Thoracic Fusion Procedures Utilizing Structural Allograft Implants, 2002–2013 Exhibit 6‑13: Total Cervical Fusion Procedures/Products Market, 2002–2013 Exhibit 6‑14: Total Lumbar Fusion Procedures/Products Market, 2002–2013 Exhibit 6‑15: Total Thoracic Fusion Procedures/Products Market, 2002–2013 Exhibit 6‑16: Companies Developing New Instrumented Fusion Products Exhibit 6‑17: Estimated Growth of Spinal Fusion Procedures in the U.S., 2001–2013 Exhibit 6‑18: Estimated Number of Spinal Fusion Procedures Performed in the U.S., 2001–2013 Exhibit 6-19: U.S. Instrumented Fusion, Market Forecast, 2004-2009 Exhibit 6-20: Global Instrumented Fusion, Market Forecast, 2004-2009 Exhibit 6-21: European Instrumented Fusion, Market Forecast, 2004-2009 Exhibit 6-22: Asian Instrumented Fusion, Market Forecast, 2004-2009 Exhibit 6-23: U.S. Instrumented Fusion, Market Share by Supplier Exhibit 6-24: Global Instrumented Fusion, Market Share by Supplier Exhibit 6-25: US Interbody Fusion, Market Forecast, 2004-2009 Exhibit 6-26: Global Interbody Fusion, Market Forecast, 2004-2009 Exhibit 6-27: European Interbody Fusion, Market Forecast, 2004-2009 Exhibit 6-28: Asian Interbody Fusion, Market Forecast, 2004-2009 Exhibit 6-29: U.S. Interbody Fusion, Market Share by Supplier Exhibit 6-30: Global Interbody Fusion, Market Share by Supplier Exhibit 6-31: U.S. Structural Allograft, Market Forecast, 2004-2009 Exhibit 6-32: Global Structural Allograft, Market Forecast, 2004-2009 Exhibit 6-33: European Structural Allograft, Market Forecast, 2004-2009 Exhibit 6-34: Asian Structural Allograft, Market Forecast, 2004-2009 Exhibit 6-35: U.S. Structural Allograft, Market Share by Supplier Exhibit 6-36: Global Structural Allograft, Market Share by Supplier Exhibit 6‑37: Reasons Driving Investor Financing of Companies Marketing Instrumented Spinal Fusion Products Exhibit 6‑38: Growth in the Spine-Related Orthobiologics Market in the U.S., 2001-2013 ($ Billions) Exhibit 7-1: Companies Developing Non-Fusion Technologies Exhibit 7-2: Interspinous Process Spacers for Dynamic Posterior Stabilization Clinical Status Exhibit 7-3: Clinical Applications for Interpinous Process Spacer Exhibit 7-4: Interspinous Process Spacers Forecast for 2004-2013 Exhibit 7-5: Global Interspinous Spacer, Market Forecast, 2004-2009 Exhibit 7-6: European Interspinous Spacer, Market Forecast, 2004-2009 Exhibit 7-7: Asian Interspinous Spacer, Market Forecast, 2004-2009 Exhibit 7-8: Global Interspinous Spacer, Market Share by Supplier Exhibit 7-9: Dynamic Posterior Stabilization Pedicle Screw Systems, Clinical Status Exhibit 7-10: Clinical Applications for Pedicle Screw Based Dynamic Stabilization Systems Exhibit 7-11: U.S. Forecast for Pedicle Screw Based Dynamic Stabilization Systems Exhibit 7-12: Global Dynamic Stabilization, Market Forecast, 2004-2009 Exhibit 7-13: European Dynamic Stabilization, Market Forecast, 2004-2009 Exhibit 7-14: Asian Dynamic Stabilization, Market Forecast, 2004-2009 Exhibit 7-15: Facet Replacement Clinical Study Status Exhibit 7-16: Forecast for Facet Replacement Exhibit 8‑1: Human Spine Structure Showing Vertebrae, Intervertebral Discs, and Spinal Cord Exhibit 8‑2: Number of Discectomy Procedures Performed in the U.S., 2002–2013 Exhibit 8‑3: Potential Advantages and Disadvantages of Selected Total Disc and Nucleus Replacement Designs Exhibit 8‑4: Companies Developing Disc Technologies Exhibit 8‑5: Reasons Driving Investor Financing of Companies Developing New Disc Therapies Exhibit 8‑6: Clinical Trial Status for Various Disc Arthroplasty Products Exhibit 8‑7: Estimated Selling Price of Disc Technologies Exhibit 8‑8: Disc Replacement Procedures Forecast, 2004–2013 Exhibit 8‑9: Lumbar Total Disc Market Entry Exhibit 8‑10: U.S. Market Forecast for Lumbar Total Disc Replacement, 2004–2013* Exhibit 8‑11: Cervical Total Disc Replacement Market Entry Exhibit 8‑12: U.S. Market Forecast for Cervical Total Disc Replacement, 2004–2013* Exhibit 8-13: US Artificial Disc, Market Forecast, 2004-2009 Exhibit 8-14: Global Artificial Disc, Market Forecast, 2004-2009 Exhibit 8-15: European Artificial Disc, Market Forecast, 2004-2009 Exhibit 8-16: Asian Artificial Disc, Market Forecast, 2004-2009 Exhibit 8-17: Global Artificial Disc, Market Share by Supplier Exhibit 8-18: U.S. Nucleus Replacement, Market Forecast, 2004-2009 Exhibit 8-19: Global Nucleus Replacement, Market Forecast, 2004-2009 Exhibit 8-20: European Nucleus Replacement, Market Forecast, 2004-2009 Exhibit 8-21: Asian Nucleus Replacement, Market Forecast, 2004-2009 Exhibit 8‑22: Nucleus Replacement Device Market Entry Exhibit 8‑23: Estimated Market Entry for Annulus Repair Technology Exhibit 8‑17: U.S. Market Forecast for Annulus Repair, 2009–2013 Exhibit 9‑1: Issues to Address in the Development of Image-Guided Spine Surgery Exhibit 9‑2: Companies Marketing Spinal Image-Guided Systems Exhibit 9‑3: Companies Marketing Image-Guided Systems Outside of the Spine Field Exhibit 9-4: Global Image Guided Surgery, Market Forecast, 2004-2009 Exhibit 9-5: U.S. Image Guided Surgery, Market Forecast, 2004-2009 Exhibit 9-6: Global Image Guided Surgery, Market Share by Supplier Exhibit 9-7: US Image Guided Surgery, Market Share by Supplier Exhibit 9-8: European Image Guided Surgery, Market Forecast, 2004-2009 Exhibit 9-9: Asian Image Guided Surgery, Market Forecast, 2004-2009 Exhibit 10‑1: Companies Marketing Minimally Invasive Access Systems Exhibit 10-2: Global Minimally Invasive Fusion, Market Forecast, 2004-2009 Exhibit 10-3: US Minimally Invasive Fusion, Market Forecast, 2004-2009 Exhibit 10-4: Global Minimally Invasive Fusion, Market Share by Supplier Exhibit 10-5: US Minimally Invasive Fusion, Market Share by Supplier Exhibit 10-6: European Image Guided Surgery, Market Forecast, 2004-2009 Exhibit 10-7: Asian Image Guided Surgery, Market Forecast, 2004-2009 Exhibit 11‑1: Companies Marketing or Developing Energy-Based Therapy Devices Exhibit 12‑1: Companies Developing Drugs to Treat Spine Disorders Exhibit 13‑1: Percentage of Vertebral Compression Fractures By Cause in the U.S., 2003 Exhibit 13‑2: Companies Participating in the Kyphoplasty and Vertebroplasty Market Exhibit 13‑3: Older Population by Age in the U.S., 2000–2020 Exhibit 13‑4: U.S. Market Share by Supplier, 2003 Exhibit 13‑5: Projected Growth in Vertebroplasty Procedures in the U.S., 2003–2013 Exhibit 13‑6: Countries Having at Least 10% of Their Population Age 65 and Over, by Population Totals and Percentages, 2003 Exhibit 13‑7: International Market Share by Supplier, 2003 Exhibit 13‑8: Projected Growth in Vertebroplasty Procedures Internationally, 2003–2013 Exhibit 13‑9: Projected Growth in Vertebroplasty Procedures in Europe, 2003–2013 Exhibit 13‑10: Projected Growth in Vertebroplasty Procedures in Asia, 2003–2013 Exhibit 14‑1: Presubmission Product Development Timeline Exhibit 14‑2: Criteria for Expedited Review of Premarket Submissions Exhibit 14‑3: Summary of Cervical System Types, Product Codes, and Indications for Use Exhibit 14‑4: Summary of Non-Cervical System Types, Product Codes, and Indications for Use Exhibit 14‑5: Device Review User Fees for 2005 Exhibit 14‑6: Aetna Coverage Information for Certain Therapies Exhibit 14‑7: MIRA’s Proposed Solutions to Current Medicare Problems
Spine Surgery: Technologies, Products, Markets &
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