U.S. MARKETS FOR SPINAL DISC REPAIR AND REPLACEMENT TECHNOLOGIES

Published by	Life Science Intelligence, Inc.
Published	May, 2008	Product code	74173
Content info	103 Pages / 40 Exhibits
Price	US $ 3900 Hard Copy (Single Site User License) Read Only US $ 3900 PDF by E-mail (Single Site User License) Read Only US $ 4650 Hard Copy & PDF by E-mail (Single Site User License) Read Only US $ 7020 Hard Copy (Corporate License) Read Only US $ 7020 PDF by E-mail (Corporate License) Read Only US $ 7770 Hard Copy & PDF by E-mail (Corporate License) Read Only

Introduction
Related Reports

U.S. MARKETS FOR SPINAL DISC REPAIR AND REPLACEMENT TECHNOLOGIES published by Life Science Intelligence, Inc. in May, 2008. This report consists of 103 Pages / 40 Exhibits and the price starts from US $ 3900.

Introduction

Abstract

U.S. MARKETS FOR SPINAL DISC REPAIR AND REPLACEMENT TECHNOLOGIES

To date, the growth of the U.S. market for artificial disc replacements has been disappointing. Initially, these technologies were expected to rapidly penetrate the market for spinal fusion patients due to their potential to: preserve motion, limit further degeneration, and avoid the need for fusion. Since the approval of DePuy Spines' Charite for lumbar disc replacement in October 2004 however, growth has been restrained by reimbursement challenges, limited long-term data, and the need to use an anterior approach for lumbar disc replacement.

Despite these challenges, manufacturers continue to pursue the enormous opportunity in artificial discs, and by 2013, a number of products should be approved which will feature different designs and allow alternative approaches to the lumbar spine. According to this new report by Life Science Intelligence (LSI), growth in lumbar disc replacements will increase due to positive developments in reimbursement, favorable clinical results, and the use of alternatives to the anterior approach.

In the market for cervical disc replacements, where growth has also been limited by reimbursement challenges and clinical concerns, the introduction of devices with different designs, the use of a familiar approach, and the increasing performance of multiple-level replacements during a single procedure will drive greater adoption.

As analyzed in this report, emerging markets such as annulus repair and nucleus repair/replacement could begin to limit the growth of artificial discs towards the end of the forecast period. Annulus repair, which can be used as a simple adjunct to discectomy, will see rapid adoption through 2013, particularly among newer surgeons. The market for nucleus replacement products, which should see some steady growth after 2010, is expected to grow substantially after the introduction of biological repair products, which could occur as early as 2012. By reducing the need for total disc replacement, these technologies will contribute to slower growth in the market for artificial discs after 2013.

1. Executive Summary

1.1 Total Disc Replacement
- 1.1.1 Total Disc Replacement in the Cervical Spine
  - 1.1.1.1 Factors Driving Adoption
  - 1.1.1.1.1 Positive Clinical Results
  - 1.1.1.1.2 Potential to Reduce Degeneration
  - 1.1.1.1.3 Familiar Approach
  - 1.1.1.1.4 Multi-Level Disc Replacement
  - 1.1.1.2 Barriers to Adoption
  - 1.1.1.2.1 Reimbursement Challenges
  - 1.1.1.2.2 Clinical Challenges
  - 1.1.1.2.3 Device Longevity and Wear Debris
- 1.1.2 Total Disc Replacement in the Lumbar Spine
1.2 Repair and Replacement Products for the Annulus and Nucleus
- 1.2.1 Annular Repair
- 1.2.2 Nuclear Repair/Replacement

2. Total Disc Replacement in the Cervical Spine

2.1 The Procedure
2.2 Clinical Goals and Results to Date
- 2.2.1 Motion Preservation
- 2.2.2 Adjacent Level Disease
- 2.2.3 Multi-Level Disc Replacement
- 2.2.4 Device Longevity
2.3 Device Approvals
2.4 Reimbursement
- 2.4.1 Physician Coding and Payment
2.5 Cervical Disc Replacement Companies and Products
- 2.5.1 Advanced Prosthetic Technologies
- 2.5.2 Amedica
- 2.5.3 Biomet
- 2.5.4 Cervitech
- 2.5.5 DePuy Spine
- 2.5.6 Globus Medical
- 2.5.7 LDR Spine
- 2.5.8 Medtronic Sofamor Danek
- 2.5.9 Orthofix/Blackstone Medical
- 2.5.10 Scient' x USA
- 2.5.11 SeaSpine
- 2.5.12 Spinal Kinetics
- 2.5.13 Spinal Motion
- 2.5.14 Stryker Spine
- 2.5.15 Synthes
- 2.5.16 Vertebron
2.6 Procedure Forecast and Market Analysis

Exhibit 2-1: Selected Studies and Conclusions of Cervical Disc Replacement
Exhibit 2-2: Conditions and Explanations to FDA Approval for the Bryan Cervical Disc
Exhibit 2-3: ICD-9 Codes for Cervical Disc Arthroplasty, Diagnosis and Treatment
Exhibit 2-4: Diagnosis-Related Groups for Cervical Disc Arthroplasty (MDC, Relative Weight, Medicare Payment)
Exhibit 2-5: Selected Suppliers and Status of Cervical Disc Replacement Products, 2008
Exhibit 2-6: Cervical Disc Replacements, U.S. Procedure Forecast, 2007-2013E
Exhibit 2-7: U.S. Cervical Disc Replacements by Level, 2007-2013E
Exhibit 2-8: Cervical Disc Replacement, U.S. Market Forecast, 2007-2013E
Exhibit 2-9: Cervical Disc Replacement Units, U.S. Market Forecast by Product Type, 2007-2013E
Exhibit 2-10: Cervical Disc Replacement Sales, U.S. Market Forecast by Product Type, 2007-2013E

3. Total Disc Replacement in the Lumbar Spine

3.1 Clinical Goals
- 3.1.1 Preserving Motion
- 3.1.2 Reducing the Rate of Degeneration in Adjacent Segments
3.2 The Procedure
3.3 Clinical Results
3.4 Reimbursement
3.5 Companies and Products
- 3.5.1 Aesculap
- 3.5.2 AxioMed Spine
- 3.5.3 Biomet
- 3.5.4 DePuy Spine
- 3.5.5 Disc Motion Technologies
- 3.5.6 Eden Spine/FlexisMed
- 3.5.7 ErgoSpine
- 3.5.8 LDR Spine
- 3.5.9 Medtronic Sofamor Danek
- 3.5.10 Nexgen Spine
- 3.5.11 NuVasive
- 3.5.12 Ranier Technology
- 3.5.13 Spinal Motion
- 3.5.14 Stryker Spine
- 3.5.15 Synthes
- 3.5.16 Theken Disc
- 3.5.17 US Spine
3.6 Procedure Forecast
3.7 Market Analysis

Exhibit 3-1: Results of Lumbar Total Disc Replacement Products in Clinical Trials
Exhibit 3-2: U.S. Suppliers of Total Disc Replacements for the Lumbar Spine, 2008
Exhibit 3-3: Total Disc Replacement in the Lumbar Spine, U.S. Procedure Forecast, 2007-2013E
Exhibit 3-4: Lumbar Disc Replacements by Approach, U.S. Procedure Forecast, 2007-2013E
Exhibit 3-5: Lumbar Disc Replacements by Level, U.S. Procedure Forecast, 2007-2013E
Exhibit 3-6: Total Disc Replacement in the Lumbar Spine, U.S. Market Forecast, 2007-2013E
Exhibit 3-7: U.S Market for Lumbar Total Disc Replacement, Limiters & Drivers
Exhibit 3-8: Total Disc Replacement in the Lumbar Spine, U.S. Market Forecast by Product Design, 2007-2013E
Exhibit 3-9: Total Disc Replacement in the Lumbar Spine, U.S. Market Forecast by Approach, 2007-2013E

4. Products for the Annulus and Nucleus

4.1 Annular Repair
- 4.1.1 Clinical Results
- 4.1.2 Annular Repair Techniques
- 4.1.3 Reimbursement
- 4.1.4 Companies and Products
  - 4.1.4.1 Anulex Technologies
  - 4.1.4.2 Intrinsic Therapeutics
  - 4.1.4.3 Orthopeutics
- 4.1.5 Procedure Forecast
- 4.1.6 Market Analysis
4.2 Nucleus Repair and Replacement
- 4.2.1 Types of Nucleus Repair/Replacement
- 4.2.2 Clinical Results
- 4.2.3 Reimbursement
- 4.2.4 Companies and Products
- 4.2.5 Procedure Forecast
- 4.2.6 Market Analysis

Exhibit 4-1: Selected Studies and Conclusions of Re-Herniation Following Discectomy
Exhibit 4-2: Benefits, Disadvantages and Rationale of Annular Repair
Exhibit 4-3: Reimbursement Codes for Annular Repair (Inpatient Hospital Codes, Physician Services, Alternative Codes), 2007
Exhibit 4-4: Selected Suppliers of Annulus Repair Products, 2008
Exhibit 4-5: Anulex Technologies' Xclose Tissue Repair System
Exhibit 4-6: U.S. Procedure Volumes for Annular Repair, 2007-2013E
Exhibit 4-7: Factors Driving the Adoption of Annular Repair Products in the U.S.
Exhibit 4-8: Annular Repair Products, U.S. Market Forecast, 2007-2013E
Exhibit 4-9: U.S. Annular Repair Market Forecast by Product Type, 2007-2013E
Exhibit 4-10: Approaches to Repairing or Replacing the Nucleus
Exhibit 4-11: Potential Advantages and Disadvantages of Nuclear Repair/Replacement
Exhibit 4-12: Selected Suppliers of Nuclear Repair/Replacement Products, 2008
Exhibit 4-13: U.S. Procedure Volumes for Nuclear Repair/Replacement, 2007-2013E
Exhibit 4-14: Factors Influencing the Adoption of Nuclear Repair/Replacement
Exhibit 4-15: U.S. Procedure Forecast by Type for Nuclear Repair or Replacement, 2007-2013E
Exhibit 4-16: Nuclear Repair/Replacement Products, U.S. Market Forecast, 2007-2013E
Exhibit 4-17: U.S. Nuclear Repair/Replacement Market Forecast by Product Type, 2007-2013E