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NOTE:  THE REPORT DESCRIBED BELOW HAS BEEN UPDATED BY REPORT #M510,
"Spine Surgery Worldwide, 2008-2017"
PUBLISHED March 2008

See this
link


 

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

1.1       Diseases and Disorders of the Spine

1.2       Surgical Procedures of the Spine

1.3       Bone Grafts and Bone Graft Substitutes

1.4       Instrumented Spinal Fusion

1.5       Non-Fusion Spinal Instrumentation

1.6       Disc Arthroplasty

1.7       Advances in Image-Guided Surgical Systems

1.8       Developments in Energy-Based Therapies

1.9       Companies Exploring Alternate Treatment Technologies

1.10     Regulatory, Cost, and Reimbursement Issues

1.10.1        Regulatory Issues Specific to Certain Spine Materials

1.10.2        Pertinent Information from May 3, 2004 FDA New Guidance Document for Spinal Systems

1.10.3        Device Application Fees Established in Connection with the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

1.10.3.1     Device Fee Calculations

Section 2:        Introduction to the Spine

2.1       Overview: Spine Structure

Section 3:        Diseases and Disorders of the Spine

3.1       Congenital Disorders

3.1.1          Kyphosis (hyperkyphosis)

3.1.2          Lordosis

3.1.3          Scheuermann’s Kyphosis

3.1.4          Scoliosis

3.2       Inflammatory and Infectious Diseases of the Spine

3.2.1          Diskitis

3.2.2          Sacroiliitis

3.2.3          Arachnoiditis

3.3       Degenerative Diseases of the Spine

3.3.1          Degenerative Disk Disease

3.3.2          Spinal Stenosis

3.3.3          Osteoporosis

3.3.4          Rheumatoid Arthritis

3.4       Mechanical Disorders of the Spine

3.4.1          Herniated Discs

3.4.2          Spinal Stenosis

3.4.3          Myelopathy

3.4.4          Radiculopathy

3.4.5          Spondylolysis

3.4.6          Spondylolisthesis

3.5       Spinal Trauma

3.5.1          Cervical

3.5.2          Thoracic

3.5.3          Lumbar

3.6       Tumors of the Spine

3.6.1          Benign spinal tumors

3.6.2          Malignant spinal tumors

Section 4:        Surgical Procedures of the Spine

4.1       Traditional (“Open”) Procedures

4.1.1          Anterior Cervical Discectomy and Fusion

4.1.2          Anterior Lumbar Interbody Fusion (ALIF)

4.1.3          Cervical Corpectomy

4.1.4          Cervical Foraminotomy

4.1.5          Cervical Laminoplasty

4.1.6          Decompressive Lumbar Laminectomy

4.1.7          Interbody Fusion with Cages (interbody fusion devices)

4.1.8          Posterior Lumbar Interbody Fusion (PLIF)

4.1.9          Spinal Fusion

4.1.10        Posterolateral Gutter Spine Fusion

4.1.11        Transforaminal Lumbar Interbody Fusion (TLIF)

4.2       Minimally Invasive Procedures

4.2.1          Vertebroplasty

4.2.2          Kyphoplasty

4.2.3          Microscopic Discectomy

4.2.4          Disc Decompression

4.2.5          Endoscopic Scoliosis Surgery

4.2.6          Minimally Invasive Bone Grafting Procedures

Section 5:        Bone Grafts and Bone Graft Substitutes

5.1       Spine Bone Grafts

5.1.1          Autografts

5.1.2          Allografts and Allograft-Based Bone Graft Substitutes

5.1.3          Market Participants

5.1.3.1       AlloSource

5.1.3.2       Cortek, Inc.

5.1.3.3       DePuy Spine, Inc.

5.1.3.4       Endius, Inc.

5.1.3.5       LifeNet

5.1.3.6       MTF (Musculoskeletal Transplant Foundation)

5.1.3.7       Osteotech, Inc.

5.1.3.8       Tutogen Medical, Inc.

5.1.3.9       Wright Medical Technology, Inc.

5.1.3.10     Zimmer Spine

5.1.4          Ceramic-Based Bone Graft Substitutes

5.1.5          Market Participants

5.1.5.1       Corin Group

5.1.5.2       DePuy Spine, Inc.

5.1.5.3       ETEX Corporation

5.1.5.4       Interpore Cross International

5.1.5.5       IsoTis OrthoBiologics

5.1.5.6       Orthovita, Inc.

5.1.5.7       NeuColl, Inc.

5.1.5.8       Spinal Concepts

5.1.5.9       Stryker Spine

5.1.5.10     Synthes-Stratec

5.1.5.11     Therics, Inc.

5.1.5.12     Wright Medical Technology, Inc.

5.1.5.13     Zimmer Spine

5.1.6          Polymer-Based Bone Graft Substitutes

5.1.7          Market Participants

5.1.7.1       Biocomposites

5.1.7.2       Cambridge Scientific, Inc.

5.1.7.3       Integra LifeSciences

5.1.7.4       OsteoBiologics, Inc.

5.1.8          Factor-Based Bone Graft Substitutes

5.1.9          Market Participants

5.1.9.1       DePuy Spine, Inc.

5.1.9.2       Interpore Cross International

5.1.9.3       Medtronic Sofamor Danek

5.1.10        Orquest, Inc.

5.1.10.1     Stryker Biotech

5.1.10.2     Verigen

5.1.11        Cell-Based Bone Graft Substitutes

5.1.12        Market Participants

5.1.12.1     Aastrom Biosciences, Inc.

5.1.12.2     MacroPore Biosurgery

5.1.12.3     Osiris Therapeutics, Inc.

5.1.12.4     Spinal Concepts, Inc.

5.2       Emerging Bone Graft Technologies

5.2.1          Developing Improved Delivery Systems

5.2.2          Developing Synthetic Bone Graft Materials

5.2.3          Developing Synthetic Growth Factors

5.2.4          Improving Bone Implant Technology

5.2.5          Exploring Gene Therapy Treatments

5.3       Market Analysis

Section 6:        Instrumented Spinal Fusion

6.1       Market Participants: Standard Instrumentation Products

6.1.1          A-Spine USA, Inc.

6.1.2          Alphatec Manufacturing, Inc.

6.1.3          Altiva Corporation

6.1.4          B. Braun Aesculap, Inc.

6.1.5          Blackstone Medical, Inc.

6.1.6          Cloward Instrument Corporation

6.1.7          Co-Ligne AG

6.1.8          Corin Group

6.1.9          DePuy Spine

6.1.10        EBI, L.P.

6.1.11        Encore Medical Corporation

6.1.12        Endius, Inc.

6.1.13        Interpore Cross International

6.1.14        MacroPore Biosurgery Inc.

6.1.15        Medtronic Sofamor Danek

6.1.16        Ortho Development Corporation

6.1.17        Orthovita, Inc.

6.1.18        Osteoimplant Technology, Inc.

6.1.19        Osteotech, Inc.

6.1.20        Scient’X

6.1.21        SeaSpine, Inc.

6.1.22        Spinal Concepts

6.1.23        Spineology Inc.

6.1.24        Spine Vision Inc.

6.1.25        Stryker Spine

6.1.26        Synthes-Stratec

6.1.27        Vertebron Inc.

6.1.28        Zimmer Spine

6.2       Economic Forecast for Standard Fusion Instrumentation: Data Tables for Cervical, Lumbar, and Thoracic Spine Segments

6.3       Market Participants: Interbody Fusion and Vertebral Body Replacement Devices

6.3.1          A-Spine USA,Inc.

6.3.2          B. Braun Aesculap

6.3.3          Corin Group

6.3.4          Cortek, Inc.

6.3.5          DePuy Spine

6.3.6          Disc-O-Tech Medical Technologies, Ltd.

6.3.7          EBI, L.P.

6.3.8          Interpore Cross International

6.3.9          Medtronic Sofamor Danek

6.3.10        NuVasive, Inc.

6.3.11        Orthovita, Inc.

6.3.12        Osteoimplant Technology, Inc.

6.3.13        Osteotech, Inc.

6.3.14        Scient’X

6.3.15        Spinal Concepts

6.3.16        Spineology Inc.

6.3.17        Stryker Spine

6.3.18        Zimmer Spine

6.4       Economic Forecast for Interbody Fusion Devices: Data Tables for Cervical, Lumbar, and Thoracic Spine Segments

6.5       Market Participants: Structural Allograft Products

6.5.1          Allosource®

6.5.2          B. Braun Aesculap

6.5.3          Endius, Inc.

6.5.4          NuVasive, Inc.

6.5.5          MTF (Musculoskeletal Transplant Foundation)

6.5.6          Ortho Development Corporation

6.5.7          Osteotech, Inc.

6.5.8          Regeneration Technologies, Inc.

6.5.9          Spinal Concepts

6.5.10        Stryker Spine

6.6       Economic Forecast for Structural Allograft Implants: Data Tables for Cervical, Lumbar, and Thoracic Spine Segments

6.7       Economic Forecast Totals: Data Tables for Standard Instrumentation Cages, and Structural Allograft Implants for Cervical, Lumbar, and Thoracic Spine Segments

6.8       Minimal Access Spinal Instrumentation and Approaches

6.9       Market Participants: New Instrumented Fusion Products

6.9.1          Biorthex Inc.

6.9.2          Vertebron Inc.

6.10     Market Analysis

6.11     Orthobiologics: Economic Forecast, 2001–2013

Section 7:        Non-Fusion Spinal Technology Dynamic Stabilization

7.1       Dynamic Posterior Stabilization Interspinous Process Spacers

7.1.1          Fixano

7.1.2          St. Francis Medical Technologies, Inc.

7.1.3          Spine Next / Abbott Labs

7.1.4          Medtronic, Inc.

7.2       Market Analysis for Interspinous Process Spacers

7.3       Dynamic Posterior Stabilization Pedicle Screw Systems

7.3.1          Applied Spine Tech

7.3.2          Biorthex, Inc.

7.3.3          Mekanika, Inc.

7.3.4          Scient’x

7.3.5          Zimmer Spine

7.4       Market Analysis for Pedicle Screw Based Dynamic Stabilization Systems

7.5       Facet Replacement Technology Developments

7.5.1          Archus Orthopedics, Inc.

7.5.2          Facet Solutions, Inc.

7.5.3          Gerra Spine Group

7.5.4          Quantum Orthopedics

7.6       Market Analysis

Section 8:        Disc Arthroplasty

8.1       Overview: Intervertebral Discs of the Spine

8.2       Spinal Disc Disorders

8.2.1          Degenerative Disc Disease

8.2.2          Herniated Discs

8.3       Current Treatment Options for Spinal Disc Disorders

8.3.1          Non-surgical Treatment

8.3.2          Surgical Interventions

8.3.2.1       Discectomy

8.3.2.2       Spinal Fusion

8.3.3          Emerging Disc Replacement Technologies

8.3.4          Market Participants

8.3.4.1       AxioMed Spine Corporation

8.3.4.2       Biomet

8.3.4.3       Biorthex Inc.

8.3.4.4       Co.Don AG

8.3.4.5       Cryolife, Inc.

8.3.4.6       DePuy Spine

8.3.4.7       Disc Augmentation Technologies

8.3.4.8       Disc Dynamics Inc.

8.3.4.9       Dynamic Spine, LLC

8.3.4.10     Endospine Kinetics Limited

8.3.4.11     Gentis, Inc.

8.3.4.12     LDR Medical

8.3.4.13     Medtronic Sofamor Danek

8.3.4.14     NuVasive, Inc.

8.3.4.15     Orthonics, Inc.

8.3.4.16     Pearsalls Ltd

8.3.4.17     Ranier Technology Limited

8.3.4.18     Raymedica, Inc.

8.3.4.19     Replication Medical, Inc.

8.3.4.20     Scient’x

8.3.4.21     Synthes/Spine Solutions

8.3.4.22     Spine Wave, Inc.

8.3.4.23     Stryker Corporation

8.3.4.24     Theken

8.3.4.25     Vertebron Inc.

8.3.4.26     Zimmer Spine

8.3.5          Market Analysis

8.3.5.1       Companies First to Market with Lumbar Total Disc Replacements

8.3.5.2       Lumbar Disc Market Analysis

8.3.5.3       Economic Forecast for the Lumbar Disc Market

8.3.5.4       Cervical Disc Replacement Market Analysis

8.3.5.5       Nucleus Replacement Market Analysis

8.3.5.6       Leading Nucleus Replacement Companies

8.3.5.7       Companies Developing Annular Repair Technology

8.3.5.7.1       Ampac Biotechnology, Inc.

8.3.6.7.2          Anulex Technologies, Inc.

8.3.6.7.3          Intrinsic Therapeutics

8.3.6.7.4          Orthonics, Inc.

8.3.6.7.5          Spinal Labs

8.3.5.8       Annular Repair Market Analysis

Section 9:        Image-Guided Surgery Systems

9.1       Image-Guided Spine Surgery Procedures

9.2       Market Participants

9.2.1          BrainLAB

9.2.2          EBI Medical/Biomet

9.2.3          DePuy Spine

9.2.4          GE Healthcare

9.2.5          Medtronic SNT

9.2.6          NuVasive

9.2.7          OrthoSoft

9.2.8          Praxim

9.2.9          Radionics/TYCO

9.2.10        Schaerer Mayfield

9.2.11        Stryker

9.2.12        Z-Kat

9.3       Image-Guided Surgery Technologies Beyond Spine

9.4       Market Analysis

Section 10:      Minimally Invasive Surgery

10.1     Minimal Access Spinal Instrumentation and Approaches

10.2     Market Participants

10.2.1        DePuy Spine/J&J

10.2.2        EBI/Biomet

10.2.3        Endius, Inc.

10.2.4        Mazor Surgical Technologies Ltd.

10.2.5        Medtronic Sofamor Danek

10.2.6        NuVasive, Inc.

10.2.7        Spinal Concepts

10.2.8        TranS1, Inc.

10.3     Market Analysis

Section 11:      Developments in Energy-Based Therapies

11.1     Surgical Procedures That Use Energy-Based Therapies

11.1.1        Microdiscectomies

11.1.1.1     Intradiscal Electrothermal Therapy (IDET)

11.1.1.2     Radio-Frequency Ablation and Coagulation-Assisted Microdiscectomies

11.1.1.3     Selective Endoscopic Discectomies

11.2     Market Participants: Energy-Based Therapy Devices

11.2.1        Arthrocare Corporation

11.2.2        Endospine Kinetics Limited

11.2.3        HydroCision

11.2.4        Smith & Nephew

11.2.5        Stryker Instruments

11.2.6        Trimedyne, Inc.

11.2.7        Valleylab

11.3     Emerging Energy-Based Therapy Technologies

11.3.1        Misonix

Section 12:      Companies exploring alternate treatment Technologies

12.1     Market Participants

12.1.1        Merck & Co., Inc.

12.1.2        NPS Pharmaceuticals

Section 13:      Vertebroplasty and Kyphoplasty

13.1     The Mechanics of Vertebral Compression Fractures

13.2     Percutaneous Vertebroplasty as Treatment for Vertebral Compression Fractures due to Osteoporosis

13.3     Vertebroplasty

13.4     Kyphoplasty

13.5     Potential Complications of Vertebroplasty Procedures

13.5.1        Complications Reported with the Use of Bone Cements and Bone Void Fillers

13.6     Market Participants

13.6.1        Arthrocare/Parallax Medical, Inc.

13.6.2        Biomet/Interpore Cross

13.6.3        Cardinal Health

13.6.4        Cook

13.6.5        Disc-O-Tech Medical Technologies, Ltd.

13.6.6        Integra LifeSciences

13.6.7        Jupiter Surgical Systems

13.6.8        Kyphon Inc.

13.6.9        OrthoVita

13.6.10      Spineology Inc.

13.6.11      Stryker Spine

13.6.12      Wright Medical

13.7     Market Analysis: Domestic Market

13.8     International Market Opportunities for Vertebroplasty

Section 14:      Regulatory, Cost, and Reimbursement Issues

14.1     Regulatory Approval Issues Associated with Spine Fusion Materials and Methods

14.1.1        Regulatory Issues Specific to Certain Spine Materials

14.1.2        Pertinent Information from May 3, 2004 FDA New Guidance Document for Spinal Systems

14.1.3        Updated System Type, Product Code, and Indications for Use Information

14.1.4        Device Application Fees Established in Connection with the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

14.1.4.1     Device Fee Calculations

14.1.4.2     Potential Impact of Device User Fees

14.2     Cost Effectiveness

14.3     Reimbursement Developments

14.3.1        Insurance Coverage

14.3.2        Medicare Innovation and Responsiveness Act (MIRA)

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 & Opportunities, Worldwide
Published March 2005
 

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Methodology.
MedMarket Diligence Reports are produced through primary and secondary research. Data is gathered from published sources on products and technologies on the market and under development.  Clinicians and industry representatives are interviewed for their knowledge and insights on product development, market development, clinical practice and trends associated with the evolving use of technologies. Secondary data is used to corroborate and support assessments and projections.  Reports are written and researched by industry insiders, whose familiarity with the companies, industry dynamics and other marketplace specifics facilitate the research process and ensure high quality and thorough reports.

 

 Contact: Patrick Driscoll, (949) 859-3401.

Copyright © 2006 MedMarket Diligence, LLC. All rights reserved.
Revised: 02/16/11

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