Published January 2004 | 399 Pages | 110 Exhibits | Forecasts Through 2008
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ArthroCare Corporation
Biomet, Inc/Interpore Spine, Ltd
Eli Lilly & Company
GE Healthcare
Hologic, Inc
Kyphon, Inc
Ligand Pharmaceuticals, Inc
Merck & Company, Inc
Novartis AG
NPS Pharmaceuticals, Inc
OSI Systems, Inc
Ostex International, Inc
Quidel Corporation
Servier Group
Spineology, Inc
Stryker Corporation
Synthes, Inc
Unigene Laboratories, Inc
Wright Medical Group, Inc
Wyeth
EXECUTIVE SUMMARY
Overview of Osteoporosis
Diagnosis
Drug Therapy
Fracture Management
Companies
Summary Exhibit 1: U.S. Market for Osteoporosis Products, 2002-2008
Summary Exhibit 2: Patient Forecast for Osteoporosis and Osteopenia Prevalence, 2002-2008
Summary Exhibit 3: U.S. Market for Osteoporosis Diagnostic Products, 2002-2008
Summary Exhibit 4: U.S. Market for Osteoporosis Drugs, 2002-2008
Summary Exhibit 5: U.S. Market for Osteoporosis Fracture Management, 2002-2008
1.0 OVERVIEW OF OSTEOPOROSIS
1.1 Bone Structure
1.2 Bone Metabolism & Remodeling
1.3 Definition of Osteoporosis
1.4 Pathophysiology and Etiology of Osteoporosis
1.5 Risk Factors
1.6 Prevalence
1.7 Clinical Manifestations, Morbidity and Economic Impact
1.8 Diagnosis and Screening
1.9 Treatment
1.10 Male Osteoporosis
Exhibit 1-1: Distribution of Trabecular Bone in the Body
Exhibit 1-2: Structural Elements of Bone & Their Function
Exhibit 1-3: Effect of Select Growth Factors on Bone Formation and Resorption
Exhibit 1-4: Illustration of the Bone Remodeling Process
Exhibit 1-5: Types of Osteoporosis
Exhibit 1-6: Relationship Between Bone Mass and Fracture Risk
Exhibit 1-7: Stages of Bone Mass in The Female Life Cycle
Exhibit 1-8: Risk Factors for Osteoporosis
Exhibit 1-9: Prevalence and Relative Risks of Selected Risk Factors
Exhibit 1-10: Prevalence Data in Females from NHANES III
Exhibit 1-11: Osteopenia and Osteporosis Prevalence in Males from NHANES III
Exhibit 1-12: Osteoporosis Prevalence from the WHO Study
Exhibit 1-13: Patient Forecast for Osteoporosis and Osteopenia Prevalence, 2002-2008.1-21
Exhibit 1-14: Osteoporosis Attribution Probabilities by Fracture Type, Gender and Age in a White Population
Exhibit 1-15: Health Resources Utilized by Osteoporotic Fractures in the U.S., 1995
Exhibit 1-16: Medical Expenditures Attributable to Osteoporotic Fractures in the U.S., 1995
Exhibit 1-17: Osteoporotic Fracture Cost-of-Illness Studies in the U.S., 1995
Exhibit 1-18: Frequency Physicians Recommending Bone Density Testing to Postmenopausal Patients, 2001
Exhibit 1-19: Overview of Osteoporosis Treatments
2.0 DIAGNOSIS
2.1 Bone Densitometry
2.1.1 Indications
2.1.2 Bone Densitometry Products
2.1.2.1 Central Bone Densitometry Systems
2.1.2.1.1 Hologic
2.1.2.1.2 GE Healthcare
2.1.2.1.3 CooperSurgical
2.1.2.2 Peripheral Bone Densitometry Systems
2.1.2.3 Software-Based Systems
2.1.2.3.1 Central QCT
2.1.2.3.2 X-Ray Systems
2.1.2.4 Reimbursement
2.1.2.5 Procedure Forecast
2.1.2.6 Market Analysis
2.1.2.6.1 Central Systems
2.1.2.6.2 Peripheral Systems
2.1.2.6.3 Supplier Shares
2.1.2.6.4 Software-Based Systems
2.2 Biochemical Markers
2.2.1 Products & Suppliers
2.2.2 Reimbursement
2.2.3 Market Analysis
2.3 Genetic Testing
2.4 Bone-Fragility
2.4.1 Bone Connectivity
2.4.1.1 Histomorphometry
2.4.1.2 Microcomputed Tomography (CT)
2.4.2 Bone Geometry
Exhibit 2-1: WHO-Guided Diagnostic Standards for Osteoporosis
Exhibit 2-2: Comparison of Major Diagnostic Approaches for Osteoporosis
Exhibit 2-3: Imaging Techniques for Osteoporosis Diagnosis, 2004
Exhibit 2-4: Examples of DEXA Systems
Exhibit 2-5: Hologic's Sahara Quantitative Ultrasound System
Exhibit 2-6: Selected Central DEXA Systems, 2004
Exhibit 2-7: Hologic's QDR Systems
Exhibit 2-8: GE Healthcare's Densitometry Products
Exhibit 2-9: CooperSurgical's Densitometry Systems
Exhibit 2-10: Comparison of Selected Peripheral Bone Densitometer Systems, 2004
Exhibit 2-11: Selected Peripheral Bone Densitometer Systems
Exhibit 2-12: CPT Codes for Bone Densitometry, 2004
Exhibit 2-13: U.S. Central DEXA Bone Densitometry Tests, Procedure Forecast, 2002-2008
Exhibit 2-14: U.S. Bone Densitometry Market Overview, 2002-2008
Exhibit 2-15: U.S. Market for Central Bone Densitometry Systems, 2002-2008
Exhibit 2-16: U.S. Market for Peripheral Bone Densitometry Systems, 2002-2008
Exhibit 2-17: U.S. Bone Densitometry Market, Supplier Shares, 2003
Exhibit 2-18: Selected Biochemical Markers for Bone Remodeling, 2004
Exhibit 2-19: Selected Biochemical Marker Tests for Bone Remodeling, 2004
Exhibit 2-20: CPT Codes for Bone Turnover Biochemical Marker Assays, 2004
Exhibit 2-21: Biochemical Markers for Bone Turnover, Market Forecast, 2002-2008
Exhibit 2-22: Bone Marker Supplier Shares, 2003
Exhibit 2-23: Comparison of Bone Connectivity in Normal and Osteoporotic Bone
Exhibit 2-24: Example of Microcomputed Tomography Images
Exhibit 2-25: Selected Manufacturers of In Vivo Micro-CT Systems, 2004
Exhibit 2-26: Definition of Hip Geometrical Parameters
3.0 DRUG THERAPY
3.1 Pharmacologic Approaches and Products
3.1.1 Antiresorptive Agents
3.1.1.1 Hormone Replacement Therapy
3.1.1.1.1 Treatment
3.1.1.1.2 Side Effects
3.1.1.1.3 Administration
3.1.1.1.4 Products
3.1.1.1.5 WHI Impact
3.1.1.2 Selective Estrogen Receptor Modulators (SERMs)
3.1.1.2.1 Raloxifene
3.1.1.2.2 Lasofoxifene
3.1.1.2.3 Bazedoxifene
3.1.1.2.4 Arzoxifene
3.1.1.2.5 Ospemifene/Fispemifene
3.1.1.2.6 MDL 103,323
3.1.1.2.7 SERM 3471
3.1.1.3 Selective Tissue Estrogenic Activity Regulator
3.1.1.4 Calcitonin
3.1.1.4.1 Miacalcin
3.1.1.4.2 Fortical
3.1.1.4.3 Nastech’s Calcitonin Nasal Spray
3.1.1.4.4 New Drug Development
3.1.1.5 Bisphosphonates
3.1.1.5.1 Alendronate
3.1.1.5.2 Risedronate
3.1.1.5.3 Ibandronate
3.1.1.5.4 Off-Label Drugs
3.1.1.5.5 New Drug Development
3.1.1.6 Osteoprotegerin/AMG 162
3.1.1.7 Non-antimicrobial Tetracycline Derivatives
3.1.1.8 Cathepsin K Inhibitors
3.1.2 Bone Forming Drugs
3.1.2.1 Sodium Fluoride
3.1.2.2 Recombinant Human Parathyroid Hormone
3.1.2.2.1 Teriparatide (Forteo)
3.1.2.2.2 PREOS
3.1.2.2.3 New Drug Development
3.1.2.3 Selective Androgen Receptor Modulators
3.1.2.3.1 LGD2226
3.1.2.3.2 Ostarine
3.1.2.4 Statin Drugs
3.1.2.5 Calcilytics
3.1.3 Other Emerging Drug Treatments
3.1.3.1 Peptide Growth Factors
3.1.3.2 Strontium Renelate (Protelos)
3.1.3.3 Novel Drug Discovery Platform (Velcura)
3.1.4 Market Analysis
3.1.4.1 By Therapeutic Approach
3.1.4.1.1 HRT
3.1.4.1.2 SERMs
3.1.4.1.3 Bisphosphonates
3.1.4.1.4 Calcitonin
3.1.4.1.5 PTH
3.1.4.2 By Supplier
3.1.4.3 Emerging Therapies
3.1.4.4 Potential Impacting Factors
3.2 Gene Therapy
3.2.1 The Search for Osteoporotic Genes
3.2.1.1 Celltech/Amgen
3.2.1.2 deCODE Genetics/Roche
3.2.1.3 Oscient Pharmaceuticals
3.2.2 Emerging Gene Therapies for Osteoporosis
Exhibit 3-1: Major Pharmacologic Approaches for Managing Osteoporosis
Exhibit 3-2: Current Available Drug Therapy Options for Osteoporosis, 2004
Exhibit 3-3: Selected FDA-Approved Osteoporosis Drugs, 2004
Exhibit 3-4: Emerging Drug Therapy Options for Osteoporosis, 2004
Exhibit 3-5: Selected Pipeline Osteoporosis Drugs, 2004
Exhibit 3-6: Selected Hormone Replacement Therapy Products, 2004
Exhibit 3-7: Current and Emerging SERMs Targeting Osteoporosis, 2004
Exhibit 3-8: Selected Clinical Trials of Current and Emerging SERMs, 2004
Exhibit 3-9: Selected Current and Emerging Bisphosphonates, 2004
Exhibit 3-10: Selected Clinical Trials of Current and Emerging Bisphosphonates, 2004
Exhibit 3-11: Selected Studies of Growth Factors and Their Relationship with Osteoporosis
Exhibit 3-12: U.S. Market for Osteoporosis Drugs, 2002-2008
Exhibit 3-13: U.S. Market for Osteoporosis Drugs, Supplier Shares, 2003
Exhibit 3-14: Estimated Sales Potential for Emerging Therapeutic Drugs
4.0 FRACTURE MANAGEMENT
4.1 Hip Fractures
4.1.1 Internal Fixation
4.1.2 Joint Replacement (Arthroplasty)
4.1.3 Hip Resurfacing
4.1.4 Choice of Treatment
4.1.5 Procedure and Market Forecast
4.2 Vertebral Compression Fractures
4.2.1 Vertebroplasty
4.2.1.1 Technique
4.2.1.2 Setting and Specialties
4.2.1.3 Indications/Contraindications
4.2.1.4 Clinical Experience
4.2.1.5 Product Requirements
4.2.1.6 Procedure Cost and Reimbursement
4.2.2 Kyphoplasty
4.2.2.1 Technique
4.2.2.2 Setting and Specialties
4.2.2.3 Product Requirements
4.2.2.4 Procedure Cost
4.2.2.5 Patient Profile
4.2.2.6 Potential Advantages and Limitations
4.2.2.7 Contraindications
4.2.2.8 Clinical Experience
4.2.2.9 Complications
4.2.2.10 Regulatory Issues
4.2.2.11 Reimbursement
4.2.3 Lordoplasty
4.2.4 Products and Suppliers
4.2.4.1 Bone Cements
4.2.4.1.1 PMMA
4.2.4.1.2 Calcium Phosphate Cements
4.2.4.1.3 Composite Cements (CORTOSS)
4.2.4.1.4 Calcified Triglycerides (Kryptonite)
4.2.4.1.5 Other Biomaterials
4.2.4.1.6 Regulatory Issues
4.2.4.2 Cement Delivery Systems
4.2.4.3 Augmentation Devices
4.2.4.3.1 Kyphon
4.2.4.3.2 ArthroCare Spine
4.2.4.3.3 Disc-O-Tech Medical Technologies
4.2.4.3.4 Spineology
4.2.4.3.5 Spine Wave
4.2.4.3.6 Other Technologies
4.2.4.4 Robotic Systems
4.2.5 Market Analysis
4.2.5.1 Procedure Forecast
4.2.5.2 Market Forecast
4.2.5.2.1 Augmentation Devices
4.2.5.2.2 Cement Delivery
4.2.5.2.3 Bone Cements
4.2.5.3 Supplier Shares
4.3 Other Fractures
Exhibit 4-1: Selected Treatment Approaches for Osteoporotic Fractures
Exhibit 4-2: Anatomy of the Hip Joint
Exhibit 4-3: Types of Fractures of the Proximal Femur (Hip Fractures)
Exhibit 4-4: Garden Classification of Femoral Neck Fractures
Exhibit 4-5: General Classification of Hip (Proximal Femur) Fractures
Exhibit 4-6: Risk Factors for Hip Fractures and Their Relative Risks
Exhibit 4-7: Annual Risk of Hip Fracture by Number of Risk Factors and Age-Specific Calcaneal Bone Density
Exhibit 4-8: Comparison of Surgical Options for Hip Fracture Management
Exhibit 4-9: Selected Products and Suppliers of Internal Fixation Devices for Hip Fracture
Exhibit 4-10: Selected Internal Fixation Products for Hip Fracture
Exhibit 4-11: Hip Arthroplasty Approaches and Related Product Types
Exhibit 4-12: Selected Hip Reconstruction Products and Suppliers, 2004
Exhibit 4-13: Selected Hip Replacement Products
Exhibit 4-14: Prospective Clinical Studies Comparing Hemi-Arthroplasty and Internal Fixation for Displaced Femoral Fractures
Exhibit 4-15: Cost-Effectiveness of Interventions for Displaced Femoral Neck Fractures in the Elderly
Exhibit 4-16: Surgical Management of Hip Fractures, Procedure Forecast by Fracture Type and Treatment Modality, 2002-2008
Exhibit 4-17: Hip Fixation Products, Supplier Shares, 2003
Exhibit 4-18: Market Forecast for Hip Fracture Products by Segment, 2002-2008
Exhibit 4-19: Structure of the Vertebrae
Exhibit 4-20: The Spine
Exhibit 4-21: Comparison of Vertebral Fracture Management Approaches
Exhibit 4-22: Approaches to the Spine for Vertebroplasty
Exhibit 4-23: Vertebral Compression Fracture, Pre- and Post-Treatment
Exhibit 4-24: Indications and Contraindications for Vertebroplasty
Exhibit 4-25: Selected Pain Outcomes Following Vertebroplasty
Exhibit 4-26: Overview of Recent Vertebroplasty Clinical Studies in Osteoporotic Patients
Exhibit 4-27: Suggested Thresholds for Selected Vertebroplasty Complications
Exhibit 4-28: Selected Reimbursement Codes for Vertebroplasty
Exhibit 4-29: ICD-9 Codes that Support Medical Necessity for Vertebroplasty
Exhibit 4-30: Kyphoplasty Procedure
Exhibit 4-31: Comparison of Cement Leakage with Kyphoplasty and Vertebroplasty
Exhibit 4-32: Selected Pain Outcomes Following Kyphoplasty
Exhibit 4-33: Overview of Selected Recent Kyphoplasty Clinical Studies
Exhibit 4-34: Comparison of Bone Cement Types
Exhibit 4-35: Selected Bone Cements for Percutaneous Vertebral Augmentation, 2004
Exhibit 4-36: Selected Cement Delivery Systems for Percutaneous Vertebral Augmentation, 2004
Exhibit 4-37: Selected Vertebral Augmentation Devices, 2004
Exhibit 4-38: Kyphon's KyphX System
Exhibit 4-39: Disc-O-Tech's Kyphoplasty Products
Exhibit 4-40: Spineology's OptiMesh System
Exhibit 4-41: Spine Wave's Stackable Wafer Vertebral Fracture Reduction System
Exhibit 4-42: Robotic Systems for Percutaneous Vertebral Augmentation
Exhibit 4-43: Mazor Surgical Technologies' SpineAssist
Exhibit 4-44: Percutaneous Vertebral Augmentation, Procedure Forecast, 2002-2008
Exhibit 4-45: Percutaneous Vertebral Augmentation, Market Forecast, 2002-2008
Exhibit 4-46: Percutaneous Vertebral Augmentation, Supplier Shares, 2003
5.0 COMPANY PROFILES
5.1 ArthroCare Corporation
5.2 Biomet, Inc/Interpore Spine, Ltd
5.3 GE Healthcare
5.4 Hologic, Inc
5.5 Kyphon, Inc
5.6 Ligand Pharmaceuticals, Inc
5.7 Eli Lilly & Company
5.8 Merck & Company, Inc
5.9 Novartis AG
5.10 NPS Pharmaceuticals, Inc
5.11 OSI Systems, Inc
5.12 Ostex International, Inc
5.13 Quidel Corporation
5.14 Servier Group
5.15 Spineology, Inc
5.16 Stryker Corporation
5.17 Synthes, Inc
5.18 Unigene Laboratories, Inc
5.19 Wright Medical Group, Inc
5.20 Wyeth
APPENDIX: COMPANY LIST
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