U.S. Markets for Spinal Disc Repair and Replacement Technologies

Published January 2008 | 103 Pages | 40 Exhibits | Forecasts Through 2013


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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.

Companies Covered

Arthro Kinetics
AxioMed Spine
DePuy Spine
Disc Dynamics
Disc Motion Technologies
Eden Spine/FlexisMed
Globus Medical
Intrinsic Therapeutics
ISTO Technologies
LDR Spine
Medtronic Sofamor Danek
Nexgen Spine
Orthofix/Blackstone Medical
Pioneer Surgical
Ranier Technology
Replication Medical
Scient'x USA
Spinal Kinetics
Spinal Motion
Spine Wave
Stryker Spine
Theken Disc
US Spine
Vertebral Technologies
Zimmer Spine

Table of Contents

1. Executive Summary
1.1 Total Disc Replacement
1.1.1 Total Disc Replacement in the Cervical Spine Factors Driving Adoption Positive Clinical Results Potential to Reduce Degeneration Familiar Approach Multi-Level Disc Replacement Barriers to Adoption Reimbursement Challenges Clinical Challenges 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 Anulex Technologies Intrinsic Therapeutics 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

Select Companies Covered
1. Abbott Spine
2. Advanced Prosthetic Technologies
3. Aesculap
4. Amedica
5. Anulex Technologies
6. Arthro Kinetics
7. AxioMed Spine
8. Biomet
9. Cervitech
10. co.don
11. CryoLife
12. DePuy Spine
13. Disc Dynamics
14. Disc Motion Technologies
15. Eden Spine/FlexisMed
16. ErgoSpine
17. Gentis
18. Globus Medical
19. Intrinsic Therapeutics
20. ISTO Technologies
21. LDR Spine
22. Medtronic Sofamor Danek
23. Nexgen Spine
24. NuVasive
25. Orthofix/Blackstone Medical
26. Orthopeutics
27. Pioneer Surgical
28. Ranier Technology
29. Raymedica
30. Replication Medical
31. Scient'x USA
32. SeaSpine
33. Spinal Kinetics
34. Spinal Motion
35. SpineMedica
36. SpineSmith
37. Spine Wave
38. Stryker Spine
39. Synthes
40. Theken Disc
41. TranS1
42. US Spine
43. Vertebral Technologies
44. Vertebron
45. Zimmer Spine

EMT Database Companies. Report purchase includes full electronic access to recent In3 investor/partnering conference presentations and company submitted executive summaries for select companies listed below:

1. AxioMed Spine
2. CryoLife
3. Disc Dynamics
4. Disc Motion Technologies
5. Eden Spine/FlexisMed
6. ErgoSpine
7. Gentis
8. ISTO Technologies
9. LDR Spine
10. Nexgen Spine
11. Orthopeutics
12. Ranier Technology
13. Raymedica
14. Scient'x USA
15. SeaSpine
16. Theken Disc
17. TranS1
18. US Spine

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