An estimated 50 million people in the United States (U.S.) suffer from back pain. In 2004, more than 1 million spine surgeries were performed in the U.S.—far more than the number of hip and knee replacements combined. Factors driving the growth of the spine surgery products market include growing numbers of people with degenerative disc disease, which typically is caused by gradual disc damage and often results in disc herniation and chronic, debilitating lower back pain. It is most common among otherwise healthy people in their 30s or 40s and affects approximately half of the U.S. population age 40 and older.

Degenerative disc disease has promoted an industry built on spinal fusion products and technologies; however, the spinal implants and products market has taken a complete about-turn by focusing on new technologies that maintain rather than prevent motion at the disc space. Although spinal fusion has generally worked well in alleviating back pain in the majority of patients, results are limited. Published data indicate that while 75% of lumbar fusion patients receive clinical benefit, only 50% experience significant relief of pain or complete recovery of function. Ten-year reoperation rates are reported at approximately 10%. This has led surgeons to seek new spinal technologies, such as total disc replacement, and other emerging products and systems, such as nucleus replacement, dynamic stabilization devices, and minimally invasive spinal surgery techniques—all of which have the potential to reduce pain and improve motion and long-term outcomes.

This report focuses on three core emerging spinal motion preserving device areas including: artificial discs (cervical and lumbar), nucleus replacement, and dynamic stabilization. Another nonfusion segment, minimally invasive (MI) discectomy, is also discussed. These products defined a U.S. spinal products market worth an estimated $186 million in 2004 (including MI discectomy and dynamic stabilization cleared as an “adjunct to fusion”). This dynamic market is growing at an extremely fast pace, at a compound annual rate of 50%, and is projected to reach more than $1.5 billion in the year 2009 due to rapid sales of next-generation artificial discs and the U.S. Food and Drug Administration’s expected approval of dynamic stabilization devices for nonfusion indications.

This Medtech Insight report includes analyses of current and emerging spinal products and technologies and presents competitors, market forecasts, and market opportunities. Covered topics include: total disc replacements (cervical and lumbar spinal discs), disc nucleus replacements, dynamic stabilization devices, and directed energy-based disc ablation and denervation products.

TABLE OF CONTENTS

EXECUTIVE SUMMARY

i.   Artificial Cervical Discs Market

ii.   Artificial Lumbar Discs Market

iii.  Disc Nucleus Replacement Products

iv.  Dynamic Stabilization Devices

v.  Minimally Invasive Discectomy Products

1. CLINICAL OVERVIEW

1.1 The Human Spine

1.2 Disc Herniation

1.3 Spinal Disorders

1.3.1 Degenerative Disc Disease

1.3.1.1 Facet Joint Degeneration

1.3.2 Spondylolisthesis

1.3.3 Stenosis

2. DEGENERATIVE DISC DISEASE PAIN MANAGEMENT AND TREATMENT

2.1 Nonsurgical Pain Management

2.1.1 Acupuncture

2.1.2 Bracing and Traction

2.1.2.1 Pneumatic Vests

2.1.3 Chiropractic Manipulation

2.1.4 Electrical Stimulation

2.1.4.1 Transcutaneous Electrical Nerve Stimulation

2.1.4.2 Neurostimulation

2.1.5 Intrathecal Pain Pumps

2.1.6 Nerve Block

2.1.7 Pharmaceuticals

2.1.7.1 Over-the-Counter Medications

2.1.7.2 Prescription Medications

2.1.8 Physical Therapy

2.1.8.1 McKenzie Exercises

2.1.8.2 Dynamic Lumbar Stabilization Exercises

2.2 Spine Surgery

2.2.1 Discectomy

2.2.1.1 Microdiscectomy

2.2.1.2 Microendoscopic Discectomy

2.2.1.3 Open Discectomy

2.2.1.4 Percutaneous Discectomy

2.2.1.5 IntraDiscal ElectroThermal Therapy

2.2.2 Spinal Fusion

2.2.2.1 Instrumented Fusion

2.2.2.2 Interbody Fusion

2.2.2.2.1 Anterior Lumbar Interbody Fusion

2.2.2.2.2 Posterior Lumbar Interbody Fusion

2.2.2.2.3 Transforaminal Lumbar Interbody Fusion

2.3 Emerging Spinal Motion Preserving Technologies

2.3.1 Artificial Discs

2.3.1.1 Disc Replacement Technology

2.3.1.2 First-Generation Technologies

2.3.1.3 Acquisitions

2.3.1.4 Clinical Status

3. CERVICAL DISCS

3.1 Products

3.1.1 Abbott Spine/Abbott Laboratories

3.1.2 Cervitech

3.1.3 EBI/Biomet

3.1.4 Globus Medical

3.1.5 LDR Spine/LDR Médical

3.1.6 Medtronic Sofamor Danek/Medtronic

3.1.7 NuVasive

3.1.8 Scient’x/Ideal Medical Products

3.1.9 Spinal Kinetics

3.1.10 SpinalMotion

3.1.11 Stryker Spine/Stryker

3.1.12 Synthes

3.1.13 VERTEBRON

3.1.14 X-spine Systems

3.2 Market Analysis

4. LUMBAR DISCS

4.1 Products

4.1.1 Abbott Spine/Abbott Laboratories

4.1.2 AxioMed Spine

4.1.3 DePuy Spine/Johnson& Johnson

4.1.4 EBI/Biomet

4.1.5 LDR Spine/LDR Médical

4.1.6 Medtronic Sofamor Danek/Medtronic

4.1.7 Ranier Technology

4.1.8 SpinalMotion

4.1.9 Stryker Spine/Stryker

4.1.10 Synthes

4.1.11 Theken Disc

4.1.12 U.S. Spinal Technologies

4.1.13 VERTEBRON

4.2 Market Analysis

5. NUCLEUS REPLACEMENT PRODUCTS

5.1 Products

5.1.1 CryoLife

5.1.2 Disc Dynamics

5.1.3 Dynamic Spine

5.1.4 EBI/Biomet

5.1.5 Medtronic Sofamor Danek/Medtronic

5.1.6 Orthonics

5.1.7 Pioneer Surgical Technology

5.1.8 Raymedica

5.1.9 Replication Medical

5.1.10 SpineMedica

5.1.11 Spine Wave

5.1.12 Stryker Spine/Stryker

5.1.13 Synthes

5.1.14 Zimmer

5.2 Market Analysis

6. DYNAMIC STABILIZATION DEVICES

6.1 Types of Devices

6.1.1 Indications

6.1.2 Regulatory Status

6.2 Interspinous Process Spacers

6.2.1 Abbott Spine/Abbott Laboratories

6.2.2 Biomet Europe

6.2.3 Medtronic Sofamor Danek/Medtronic

6.2.4 Paradigm Spine

6.2.5 St. Francis Medical Technologies

6.3 Posterior Dynamic Stabilization Systems

6.3.1 Abbott Spine/Abbott Laboratories

6.3.2 Applied Spine Technologies

6.3.3 Globus Medical

6.3.4 Innovative Spinal Technologies

6.3.5 Mekanika

6.3.6 N Spine

6.3.7 Paradigm Spine

6.3.8 Scient’x/Ideal Medical Products

6.3.9 Zimmer Spine/Zimmer

6.3.10 Other Dynamic Stabilization Programs

6.4 Facet Replacement

6.4.1 Archus Orthopedics

6.4.2 Facet Solutions

6.4.3 Impliant

6.4.4 Quantum Orthopedics

6.5 Market Analysis

6.5.1 Interspinous Process Spacers Market

6.5.2 Posterior Dynamic Stabilization Products Market

6.5.3 Facet Replacement Products Market

7. MINIMALLY INVASIVE DISCECTOMY DEVICES

7.1 Directed Energy-Based Disc Ablation and Denervation

7.1.1 Products

7.1.1.1 ArthroCare

7.1.1.2 Clarus Medical

7.1.1.3 Laserscope

7.1.1.4 Smith & Nephew

7.1.1.5 Stryker Instruments/Stryker

7.1.1.6 Trimedyne

7.1.1.7 Valleylab/Tyco International

7.1.2 Market Analysis

7.1.3 Competitive Analysis

7.2 Mechanical Endoscopic/Percutaneous Discectomy

7.2.1 Products

7.2.1.1 Clarus Medical

7.2.1.2 Endius

7.2.1.3 HydroCision

7.2.1.4 Medtronic Sofamor Danek/Medtronic

7.2.1.5 Stryker Instruments/Stryker

7.2.2 Market Analysis

7.2.3 Competitive Analysis

8. COMPANY PROFILES

8.1     Abbott Spine, Inc./Abbott Laboratories

8.2     Applied Spine Technologies, Inc.

8.3     ArthroCare Corporation

8.4     DePuy Spine, Inc./Johnson & Johnson

8.5     Dynamic Spine, Inc.

8.6     EBI LP/Biomet, Inc.

8.7     Globus Medical, Inc.

8.8     Innovative Spinal Technologies, Inc.

8.9     LDR Spine U.S.A, Inc./LDR Médical

8.10    Medtronic Sofamor Danek, Inc./Medtronic, Inc.

8.11    NuVasive, Inc.

8.12    Orthonics, Inc.

8.13    Raymedica, Inc.

8.14    Smith & Nephew PLC

8.15    Spine Wave, Inc.

8.16    St. Francis Medical Technologies, Inc.

8.17    Stryker Spine/Stryker Corporation9

8.18    Synthes AG

8.19    Theken Group LLC

8.20    Zimmer Spine, Inc./Zimmer, Inc.

APPENDIX:  COMPANY LISTING

LIST OF EXHIBITS

Exhibit ES-1:    Differentiating Features of First-Generation Total Disc Replacements

Exhibit ES-2:    Potential Benefits of Partial Nucleus Replacement

Exhibit ES-3:    How Dynamic Stabilization Devices Relieve Back Pain

Exhibit ES-4:    Emerging Spinal Motion Preserving Technologies

Exhibit ES-5:    Spinal Motion Preserving and Nonfusion Devices, Market Forecast, by Segment, 2004-2009

Exhibit ES-6:    Artificial Cervical Discs, Market Forecast, 2004-2009

Exhibit ES-7:    Characteristics of First-Generation Artificial Lumbar Discs

Exhibit ES-8:    Artificial Lumbar Discs, Market Forecast, 2004-2009

Exhibit ES-9:    Nucleus Replacement Products, Market Forecast, 2004-2009

Exhibit ES-10:   Dynamic Stabilization Devices, Market Forecast, by Segment, 2004-2009

Exhibit ES-11:   Directed Energy-Based Disc Ablation and Denervation Products, Market Forecast, 2004-2009

Exhibit ES-12:   Mechanical Endoscopic/Percutaneous Discectomy Products, Market Forecast, 2004-2009

Exhibit 2-1:      Methods of Lumbar Fusion

Exhibit 2-2:      Emerging Spinal Motion Preserving Technologies

Exhibit 2-3:      Differentiating Features of First-Generation Total Disc Replacements

Exhibit 2-4:      Important Mechanical Properties of Artificial Discs

Exhibit 2-5:      Artificial Discs Market, Recent Acquisitions

Exhibit 2-6:      First Artificial Discs to Reach the United States Market, 2006-2008

Exhibit 2-7:      2005, Artificial Discs, Suppliers and Regulatory Status

Exhibit 3-1:      2005, Selected Cervical Discs

Exhibit 3-2:      Cervical Artificial Discs, Market Forecast, 2004-2009

Exhibit 4-1:      Characteristics of First-Generation Artificial Lumbar Discs

Exhibit 4-2:      2005, Selected Lumbar Discs

Exhibit 4-3:      Comparison of AxioMed Spine’s Freedom Lumbar Disc with First-Generation Disc Replacement Technology

Exhibit 4-4:      Indications and Contraindications for Disc Replacement Surgery with the SB Charité III

Exhibit 4-5:      Comparison of Investigational Device Exemption Trials of Lumbar Discs Closest to Market

Exhibit 4-6:      Lumbar Artificial Discs, Market Forecast, 2004-2009

Exhibit 5-1:      Degenerative Changes Following Discectomy

Exhibit 5-2:      Potential Benefits of Partial Nucleus Replacement

Exhibit 5-3:      2005, Selected Nucleus Replacement Products

Exhibit 5-4:      Potential Benefits of Disc Dynamics’ DASCOR Disc Arthroplasty System

Exhibit 5-5:      Properties of Spine Wave’s NuCore Injectable Disc Nucleus

Exhibit 5-6:      Nucleus Replacement Products, Market Forecast, 2004-2009

Exhibit 6-1:      Anatomic Changes Achieved by Dynamic Stabilization Devices

Exhibit 6-2:      2005, Selected Dynamic Stabilization Products and Indications

Exhibit 6-3:      2005, Interspinous Spacers, Regulatory Status for Nonfusion Applications

Exhibit 6-4:      2005, Selected Pedicle Screw-Based Posterior Dynamic Stabilization Devices, Regulatory Status

Exhibit 6-5:      2005, Selected Interspinous Process Spacers

Exhibit 6-6:      Abbott Spine/Abbott Laboratories’ Wallis System, Summary of Investigational Device Exemption Trial

Exhibit 6-7:      2005, Selected Posterior Dynamic Stabilization Systems

Exhibit 6-8:      The M-Brace Patient Treatment Spectrum

Exhibit 6-9:      Dynamic Stabilization Devices, Market Forecast, by Segment, 2004-2009

Exhibit 6-10:     Interspinous Devices/Spacers, Market Forecast, 2004-2009

Exhibit 6-11:     Pedicle Screw-Based Dynamic Stabilization Devices, Market Forecast, 2004-2009

Exhibit 6-12:     Facet Replacement Devices, Market Forecast, 2004-2009

Exhibit 7-1:      2005, Selected Directed Energy-Based Disc Ablation and Denervation Products

Exhibit 7-2:      Directed Energy-Based Disc Ablation and Denervation Products, Market Forecast, 2004-2009

Exhibit 7-3:      2004, Directed Energy-Based Disc Ablation and Denervation Products Market, Share by Supplier

Exhibit 7-4:      2005, Selected Mechanical Endoscopic/Percutaneous Discectomy Products

Exhibit 7-5:      Mechanical Endoscopic/Percutaneous Discectomy Products, Market Forecast, 2004-2009

Exhibit 7-6:      2004, Mechanical Endoscopic/Percutaneous Discectomy Products Market, Share by Supplier

Copyright 2005, Medtech Insight, LLC