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United States Markets for Osteobiologic and Bone Growth Stimulation Products for Spine Surgery
Report #A336 - November 2012
160 Pages – 43 Exhibits – 8 Company Profiles

According to the United States (U.S.) Department of Health & Human Services, back pain accounts for approximately 13.4 million physician office visits and 3.7 million emergency room visits annually. Degeneration of an intervertebral disc that results in functionally limiting low back pain is a common condition that prompts patients to seek treatment. To eliminate or reduce pain and restore quality of life, patients with acute, debilitating pain may require spinal fusion.

During the forecast period covered by this report, the combined U.S. market for osteobiologic and bone growth stimulation products for spine surgery is projected to increase at a compound annual rate of 2.8%, reaching an estimated $2,110.5 million in the year 2016.

This dynamic new report from Medtech Insight includes analyses of the U.S. markets for allograft bone products, electrical osteogenic stimulators, recombinant human bone morphogenetic proteins, and synthetic bone grafts used in spine surgery. Also included in this report are company profiles of the leading competitors in these markets, as well as a clinical overview of the most common spinal diseases/disorders for which spinal fusion is indicated.

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United States Markets for Osteobiologic and Bone Growth Stimulation Products for Spine Surgery

A336

November 2012

$3,750
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Methodology

Reports are produced exclusively by Medtech Insight, through extensive primary and secondary research among the clinicians, researchers, and competitors in the marketplace, and draw upon the industry expertise of a network of industry insiders. Medtech Insight exhaustively corroborates the data as a baseline for completing forward-looking analysis and providing insight into product, technology and market evolution.

 

TABLE OF CONTENTS

 

EXECUTIVE SUMMARY

i.          Selected Spinal Disorders

a.         Degenerative Disc Disease

b.         Disc Herniation

c.         Spinal Tumors

d.         Traumatic Spinal Injuries

ii.          Allograft Bone Products Used in Spine Surgery

a.         Market Analysis

iii.         Synthetic Bone Graft Products Used in Spinal Fusion

a.         Market Analysis

iv.         Recombinant Human Bone Morphogenetic Proteins Used in Spinal Fusion

a.         Market Analysis

v.         Electrical Osteogenic Stimulators Used in Spinal Fusion

a.         Market Analysis

vi.         Combined Market Forecast

vii.        Methodology

 

Exhibit ES-1:    Prevalence of Selected Spinal Disorders, 2011-2016

Exhibit ES-2:    Incidence of Selected Spinal Disorders, 2011-2016

Exhibit ES-3:    Allograft Bone Products Used in Spine Surgery, Market Forecast, 2011-2016

Exhibit ES-4:    Synthetic Bone Graft Substitutes Used in Spinal Fusion, Market Forecast, 2011-2016

Exhibit ES-5:    Recombinant Human Bone Morphogenetic Protein Products, Market Forecast, 2011-2016

Exhibit ES-6:    Electrical Osteogenic Stimulators Used in Spinal Fusion, Market Forecast, 2011-2016

Exhibit ES-7:    Osteobiologic and Bone Growth Stimulation Products for Spine Surgery, Combined Market Forecast, 2011-2016

 

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

1.2.2.3 Osteoclasts

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 Obesity

1.2.4.5 Cigarette Smoking, Alcohol, and Caffeine

1.2.4.6 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 Facetectomy

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 Instrumented Spinal Fusion

1.4.2.1.2 Noninstrumented 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 Posterior Dynamic Stabilization

1.5 Market Dynamics

1.5.1 Demographics

1.5.2 Reimbursement

1.5.3 Patient Protection and Affordable Care Act

1.5.4 Federal Oversight of Physician/Corporate Relationships

1.5.5 Procedure Volumes Forecast

 

Exhibit 1-1:      The Human Spine

Exhibit 1-2:      The Structure of Collagen

Exhibit 1-3:      The Structure of Hydroxyapatite

Exhibit 1-4:      The Structure of Bone

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:      Number of Overweight and Obese People, 2011 and 2016

Exhibit 1-8:      A Herniated Disc

Exhibit 1-9:      Bone Density in Normal and Osteoporotic Bone Tissue

Exhibit 1-10:    Prevalence of Selected Spinal Disorders, 2011-2016

Exhibit 1-11:    Incidence of Selected Spinal Disorders, 2011-2016

Exhibit 1-12:    The Anatomy of a Spinal Segment

Exhibit 1-13:    Noninstrumented Spinal Fusion

Exhibit 1-14:    United States Population Growth Trends

Exhibit 1-15:    Spinal Fusion Diagnosis-Related Groups and Associated Medicare Reimbursement

Exhibit 1-16:    Spinal Fusion, Procedure Volumes Forecast, 2010-2016

 

2. ALLOGRAFT BONE PRODUCTS USED IN SPINE SURGERY

2.1 Regulations Governing Allograft Providers

2.2 Processing Allograft Bone

2.2.1 Tissue Recovery

2.2.2 Tissue Processing

2.3 Allograft Forms

2.3.1 Support Structures

2.3.2 Osteoconductive Fillers

2.3.3 Osteoinductive Materials

2.4 Allograft Tissue Providers

2.5 Market Analysis

2.5.1 Allograft Structural Elements

2.5.2 Allograft Fillers

2.5.3 Demineralized Bone Matrix

2.6 Competitive Analysis

 

Exhibit 2-1:      2012, Selected Allograft Bone Products Used in Spine Surgery

Exhibit 2-2:      2012, Selected Demineralized Bone Matrix Products

Exhibit 2-3:      2011, Comparison of Allograft Sales, by Distribution Channel

Exhibit 2-4:      Allograft Bone Products Used in Spine Surgery, Market Forecast, 2011-2016

Exhibit 2-5:      Allograft Bone Products Used in Spine Surgery, Market Segment Shares, 2011 and 2016

Exhibit 2-6:      2011, Market for Allograft Bone Products Used in Spine Surgery, Share by Supplier

 

3. SYNTHETIC BONE GRAFT PRODUCTS USED IN SPINAL FUSION

3.1 Products

3.2. Emerging Products

3.3 Market Analysis

3.4 Competitive Analysis

 

Exhibit 3-1:      2012, Selected Synthetic Bone Graft Products Used in Spinal Fusion

Exhibit 3-2:      Synthetic Bone Graft Substitutes Used in Spinal Fusion, Market Forecast, 2011-2016

Exhibit 3-3:      2011, Market for Synthetic Bone Graft Substitutes Used in Spinal Fusion, Share by Supplier

 

4. RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEINS USED IN SPINAL FUSION

4.1 Products

4.1.1 Infuse Bone Graft

4.1.2 Osteogenic Protein-1

4.2 Emerging Products

4.3 Market Analysis

 

Exhibit 4-1:      Selected Bone Morphogenetic Proteins

Exhibit 4-2:      2012, Selected Recombinant Human Bone Morphogenetic Protein Products

Exhibit 4-3:      Recombinant Human Bone Morphogenetic Protein Products, Market Forecast, 2011-2016

 

5. ELECTRICAL OSTEOGENIC STIMULATORS USED IN SPINAL FUSION

5.1 Direct Current Electrical Osteogenic Stimulation

5.2 Capacitive Coupling Electrical Osteogenic Stimulation

5.3 Combined Magnetic Field Osteogenic Stimulation

5.4 Pulsed Electromagnetic Field Osteogenic Stimulation

5.5 Reimbursement

5.6 Products

5.7 Market Analysis

5.8 Competitive Analysis

 

Exhibit 5-1:      Direct Current Osteogenic Stimulators

Exhibit 5-2:      Capacitive Coupling Osteogenic Stimulator

Exhibit 5-3:      Combined Magnetic Field Osteogenic Stimulator

Exhibit 5-4:      External Pulsed Electromagnetic Field Osteogenic Stimulators

Exhibit 5-5:      Selected Indications for Electrical Osteogenic Stimulation Used in Spinal Fusion

Exhibit 5-6:      2012, Electrical Osteogenic Stimulator Products Used in Spinal Fusion

Exhibit 5-7:      Electrical Osteogenic Stimulators Used in Spinal Fusion, Market Forecast, 2011-2016

Exhibit 5-8:      2011, Market for Electrical Osteogenic Stimulators Used in Spinal Fusion, Share by Supplier

 

6. COMPANY PROFILES

6.1       AlloSource, Inc.

6.2       Biomet, Inc.

6.3       Integra LifeSciences Corporation

6.4       LifeNet Health, Inc.

6.5       Medtronic, Inc.

6.6       Musculoskeletal Transplant Foundation

6.7       Orthofix International NV

6.8       Stryker Corporation

 

APPENDIX: COMPANY LISTING

 

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