THE U.S. MARKET FOR SPINAL FUSION ORTHOBIOLOGICS, BONE GROWTH STIMULATION, DISC NUCLEUS ALTERING DEVICES, AND VERTEBROPLASTY/KYPHOPLASTY PRODUCTS

201 Pages | 57 Exhibits | 2007 Analysis | Forecasts Through 2012

OVERVIEW:
In 2006, more than $1.8 billion was spent on orthobiologics for spinal fusion, as well as bone growth stimulation, intradiscal electrothermal nucleoplasty, and vertebroplasty/kyphoplasty products in the United States (U.S.). Sales of these products are expected to grow at a compound annual rate of 12.3% during the forecast period covered by this report, reaching more than $3.7 billion in the year 2012.

This new report from Medtech Insight includes analyses of products, technologies, current and forecast markets, competitors, and opportunities in the U.S. spinal fusion, disc decompression, and spine fracture repair products market. These products are used to treat a range of spinal disorders including abnormal curvature of the spine, degenerative disc disease, disc herniation, spondylolisthesis, stenosis, tumors, and vertebral fractures. It is estimated that more than 70% of the entire U.S. population will be affected by low back pain over the course of their life. Incidence of spine disorders totaled approximately 75,000 in 2006 and are expected to increase to over 90,000 in the year 2012.

Spinal fusion products covered in this report include allografts, bone graft substitutes, bone morphogenetic proteins, and bone growth stimulation devices, as well as vertebroplasty/kyphoplasty and intradiscal electrothermal nucleoplasty products.

TABLE OF CONTENTS:

EXECUTIVE SUMMARY

i.             Clinical Overview

ii.             The U.S. Market for Spinal Fusion Allograft Materials

iii.           The U.S. Market for Synthetic Spinal Fusion Bone Graft Substitutes

iv.           The U.S. Market for Bone Morphogenetic Proteins Used in Spinal Fusion Procedures

v.           The U.S. Market for Disc Altering Products and Agents

vi.           The U.S. Market for Spinal Fusion Bone Growth Stimulation Products

vii.         The U.S. Market for Vertebroplasty and Kyphoplasty Products

viii.       Combined Market Forecast

 

Exhibit ES-1:       Incidence of Spinal Disorders, 2006-2012

Exhibit ES-2:       Spinal Fusion, Procedure Volumes Forecast, 2006-2012

Exhibit ES-3:       Allografts for Spinal Fusion, Market Forecast, 2006-2012

Exhibit ES-4:       Synthetic Spinal Fusion Bone Graft Substitutes, Market Forecast, 2006-2012

Exhibit ES-5:       INFUSE Bone Graft and Demineralized Bone Matrix, Market Forecast, 2006-2012

Exhibit ES-6:       Nucleoplasty and Intradiscal Electrothermal Annuloplasty Products, Market Forecast, 2006-2012

Exhibit ES-7:       Spinal Fusion Bone Growth Stimulators, Market Forecast, 2006-2012

Exhibit ES-8:       Kyphoplasty/Vertebroplasty Products, Market Forecast, 2006-2012

Exhibit ES-9:       Spinal Fusion Orthobiologics, Bone Stimulation, Disc Nucleus Altering Devices, and Vertebroplasty/Kyphoplasty Products, Combined Market Forecast, 2006-2012

 

1. CLINICAL OVERVIEW

1.1 The Human Spine

1.2 Bone Structure and Function

1.2.1 Bone Formation

1.2.2 Cellular Framework

1.2.2.1 Osteoblasts

1.2.2.2 Osteocytes

1.2.3 The Fracture Healing Process

1.2.4 Factors Affecting Bone Physiology

1.2.4.1 The Effect of Physical Stress on Bone Remodeling

1.2.4.2 Age and Gender

1.2.4.3 Physical Activity

1.2.4.4 Cigarette Smoking, Alcohol, and Caffeine

1.2.4.5 Nutritional Deficiencies

1.3 Selected Spinal Disorders

1.3.1 Disc Herniation

1.3.2 Degenerative Disc Disease

1.3.2.1 Arthritis

1.3.2.1.1 Osteoarthritis

1.3.2.1.2 Rheumatoid Arthritis

1.3.2.1.3 Ankylosing Spondylitis

1.3.2.2 Osteoporosis

1.3.2.3 Spondylosis

1.3.3 Abnormal Curvature of the Spine

1.3.3.1 Scoliosis

1.3.3.2 Kyphosis and Lordosis

1.3.4 Spondylolisthesis

1.3.5 Stenosis

1.3.6 Spinal Tumors

1.3.7 Traumatic Spinal Injuries

1.3.8 Vertebral Fractures

1.4 Spine Treatment Options

1.4.1 Spinal Decompression

1.4.1.1 Corpectomy

1.4.1.2 Discectomy

1.4.1.3 Facetotomy

1.4.1.4 Foraminotomy/Foraminectomy

1.4.1.5 Laminotomy/Laminectomy

1.4.2 Spinal Fusion

1.4.2.1 Instrumented versus Noninstrumented Spinal Fusion

1.4.2.1.1 Noninstrumented Spinal Fusion

1.4.2.1.2 Instrumented Spinal Fusion

1.4.2.2 Types of Fusion

1.4.2.2.1 Cervical Fusion

1.4.2.2.2 Anterior Cervical Fusion

1.4.2.2.3 Posterior Cervical Fusion

1.4.2.2.4 Interbody Fusion

1.4.2.2.5 Lumbar Fusion

1.4.2.2.5.1 Anterior Lumbar Interbody Fusion

1.4.2.2.5.2 Posterior Lumbar Interbody Fusion

1.4.2.2.5.3 Transforaminal Lumbar Interbody Fusion

1.4.2.2.6 Posterolateral Fusion

1.4.2.2.7 360-Degree Fusion

1.4.2.2.8 Thoracic and Thoracolumbar Fusion

1.4.2.2.9 Percutaneous or Minimally Invasive Fusion

1.4.3 Dynamic Fixation

1.5 Market Dynamics

1.5.1 The Aging Population

1.5.2 Third-Party Payers

1.5.3 The Centers for Medicare & Medicaid Services

1.5.4 Federal Oversight of Physician/Corporate Relationships

1.5.5 Procedure Volumes Forecast

 

Exhibit 1-1:           The Human Spine

Exhibit 1-2:           Collagen

Exhibit 1-3:           Hydroxyapatite Structure

Exhibit 1-4:           Bone Structure

Exhibit 1-5:           Bone Density Averages in the General Population

Exhibit 1-6:           Bone Density Averages in Olympic Athletes in Comparison with the General Population

Exhibit 1-7:           Bone Density in Normal and Osteoporotic Bone Tissue

Exhibit 1-8:           Incidence of Spinal Disorders, 2006-2012

Exhibit 1-9:           Noninstrumented Spinal Fusion

Exhibit 1-10:       United States Population Growth Trends

Exhibit 1-11:       Combined Anterior/Posterior Spinal Fusion, Average Medicare Reimbursement Levels, Diagnosis-Related Group 496

Exhibit 1-12:       Spinal Fusion (Excluding Cervical with Complications and/or Comorbidities), Average Medicare Reimbursement Levels, Diagnosis-Related Group 497

Exhibit 1-13:       Spinal Fusion, (Excluding Cervical without Complications and/or Comorbidities), Average Medicare Reimbursement Levels, Diagnosis-Related Group 498

Exhibit 1-14:       Cervical Spinal Fusion with Complications and/or Comorbidities, Average Medicare Reimbursement Levels, Diagnosis-Related Group 519

Exhibit 1-15:       Cervical Spinal Fusion without Complications and/or Comorbidities, Average Medicare Reimbursement Levels, Diagnosis-Related Group 520

Exhibit 1-16:       Spinal Fusion, Procedure Volumes Forecast, 2006-2012

 

2. THE U.S. MARKET FOR SPINAL FUSION ALLOGRAFT MATERIALS

2.1 Regulations Governing Allograft Providers

2.1.1 National Organ Transplant Act

2.1.2 United States Food and Drug Administration Requirements

2.2 Processing Bone

2.2.1 Recovering Tissue

2.2.2 Processing Tissue

2.3 Allograft Materials

2.3.1 Support Structures

2.3.2 Osteoconductive Fillers

2.3.3 Osteoinductive Materials

2.4 Market Analysis

2.4.1 Allograft Structural Elements

2.4.2 Allograft Fillers

2.4.3 Demineralized Bone Matrix

2.5 Competitive Analysis

 

Exhibit 2-1:           Spinal Fusion and Fusion-Related Autograft Procedures, 1995, 2000, 2005, and 2012

Exhibit 2-2:           2007, Selected Allograft Products

Exhibit 2-3:           Allograft Products for Spinal Fusion, Market Forecast, 2006-2012

Exhibit 2-4:           Allograft Products for Spinal Fusion, Market Segment Shares, 2006 and 2012

Exhibit 2-5:           2006, Comparison of Allograft Sales, by Distribution Channel

Exhibit 2-6:           2006, Market for Allograft Products for Spinal Fusion, Share by Supplier

 

3. THE U.S. MARKET FOR SYNTHETIC SPINAL FUSION BONE GRAFT SUBSTITUTES

3.1 Products

3.2 Market Analysis

3.3 Competitive Analysis

 

Exhibit 3-1:           2007, Selected Synthetic Bone Graft Substitutes

Exhibit 3-2:           Synthetic Spinal Fusion Bone Graft Substitutes, Market Forecast, 2006-2012

Exhibit 3-3:           2006, Synthetic Spinal Fusion Bone Graft Substitutes Market, Share by Supplier

 

4. THE U.S. MARKET FOR BONE MORPHEGENTIC PROTEINS USED IN SPINAL FUSION PROCEDURES

4.1 Clinical Overview

4.2 INFUSE Bone Graft

4.2.1 Market Analysis for INFUSE Bone Graft

4.3 Emerging Products

4.3.1 Osteogenic Protein-1:   Recombinant Human Bone Morphogenetic Protein-7

4.3.2 UCB-1

4.3.3 P-15 Peptide

4.3.4 ST01

4.3.5 AC-100

 

Exhibit 4-1:           Selected Bone Morphogenetic Proteins

Exhibit 4-2:           INFUSE Bone Graft and Demineralized Bone Matrix Products, Market and Procedure Volumes Trends for Spinal Fusion, 2006-2012

Exhibit 4-3:           Utilization of INFUSE Bone Graft and Demineralized Bone Matrix Products, Historic Market and Procedure Volumes for Spinal Fusion, 2003-2006

Exhibit 4-4:           INFUSE Bone Graft and Demineralized Bone Matrix Products, Market Forecast, 2006-2012

Exhibit 4-5:           Clinical Efficacy of Osteogenic Protein-1

 

5. THE U.S. MARKET FOR DISC ALTERING PRODUCTS AND AGENTS

5.1 Intradiscal Electrothermal Therapy

5.2 Plasma Disc Decompression

5.3 Market Analysis

5.4 Competitive Analysis

5.5 Anti-Inflammatory and Analgesic Treatments

5.5.1 Oral Anti-Inflammatory Agents

5.5.2 Cortisone Injections

5.5.3 Locally Controlled Analgesic

5.5.4 Chymopapain

5.5.5 Collagen Cross-Linking Therapy

5.5.6 Tumor Necrosis Factor

 

Exhibit 5-1:           2007, Selected Nucleoplasty and Intradiscal Electrothermal Annuloplasty Products

Exhibit 5-2:           Nucleoplasty and Intradiscal Electrothermal Annuloplasty Products, Market Forecast, 2006-2012

Exhibit 5-3:           2006, Nucleoplasty and Intradiscal Electrothermal Annuloplasty Products Market, Share by Supplier

 

6. THE U.S. MARKET FOR SPINAL FUSION BONE GROWTH STIMULATION PRODUCTS

6.1 Pulsed Electromagnetic Field Stimulators

6.2 Capacitive Coupling Electromagnetic Field Stimulators

6.3 Ultrasound-Based Bone Growth Stimulators

6.4 Level of Reimbursement

6.5 Market Analysis

6.6 Competitive Analysis

 

Exhibit 6-1:           Bone Growth Stimulation Products

Exhibit 6-2:           2007, Selected Spine Bone Growth Stimulation Products

Exhibit 6-3:           Spinal Fusion Bone Growth Stimulation Products, Market Forecast, 2006-2012

Exhibit 6-4:           2006, Spinal Fusion Bone Growth Stimulation Products Market, Share by Supplier

 

7. THE U.S. MARKET FOR KYPHOPLASTY AND VERTEBROPLASTY PRODUCTS

7.1 Vertebroplasty

7.1.1 Vertebroplasty Products

7.1.1.1 Polymethylmethacrylate Alternatives

7.2 Kyphoplasty

7.2.1 Kyphoplasty Products

7.3 Emerging Vertebral Augmentation Products

7.3.1 Vessel-X

7.3.2 OptiMesh 1500

7.3.3 StaXx FX

7.4 Market Analysis

7.5 Competitive Analysis

 

Exhibit 7-1:           The Vertebroplasty Procedure

Exhibit 7-2:           Vertebroplasty Indications and Contraindications

Exhibit 7-3:           2007, Selected Vertebroplasty Products

Exhibit 7-4:           The Kyphoplasty Procedure

Exhibit 7-5:           2007, Selected Kyphoplasty Products

Exhibit 7-6:           2007, Selected Emerging Vertebral Augmentation Products

Exhibit 7-7:           2006, Kyphoplasty/Vertebroplasty Potential Treatment Market

Exhibit 7-8:           Kyphoplasty/Vertebroplasty Products, Market Forecast, 2006-2012

Exhibit 7-9:           2006, Kyphoplasty Medicare Reimbursement, Professional Fees

Exhibit 7-10:       2006, Vertebroplasty Medicare Reimbursement, Professional Fees

Exhibit 7-11:       2006, Kyphoplasty/Vertebroplasty Products Market, Share by Supplier

 

8. COMPANY PROFILES

8.1 ArthroCare Corporation

8.2 Biomet, Inc.

8.3 Blackstone Medical, Inc./Orthofix SRL

8.4 DePuy Spine, Inc./Johnson & Johnson

8.5 DJO, Inc.

8.6 Kyphon, Inc.

8.7 Medtronic, Inc.

8.8 Musculoskeletal Transplant Foundation

8.9 Orthovita, Inc.

8.10 Osteotech, Inc.

8.11 Regeneration Technologies, Inc.

8.12 Smith & Nephew PLC   8-16

8.13 Spine Wave, Inc. 8-17

8.14 Stryker Corporation   8-18

 

APPENDIX:         COMPANY LISTING



COMPANIES COVERED:

  1. ArthroCare Corporation
  2. Biomet, Inc.
  3. Blackstone Medical, Inc./Orthofix SRL
  4. DePuy Spine, Inc./Johnson & Johnson
  5. DJO, Inc.
  6. Kyphon, Inc.
  7. Medtronic, Inc.
  8. Musculoskeletal Transplant Foundation
  9. Orthovita, Inc.
  10. Osteotech, Inc.
  11. Regeneration Technologies, Inc.
  12. Smith & Nephew PLC
  13. Spine Wave, Inc.
  14. Stryker Corporation
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