Table of Contents

1. OVERVIEW OF OSTEOPOROSIS …………………………………………………….. 1-1
1.1 Incidence, Prevalence, and Cost………………………………………………. 1-2
1.2 Types of Osteoporosis…………………………………………………………….. 1-6
1.3 Risk Factors ………………………………………………………………………….. 1-8
Exhibit 1-1: Osteoporotic Bone and Normal Bone………………………………………… 1-3
Exhibit 1-2: 2012, Osteoporosis-Caused Fracture Incidence, by Site ……………… 1-5
Exhibit 1-3: Osteoporosis or Low Bone Mass in Women Age 50 and Older,
by Race and Ethnicity……………………………………………………………… 1-7
Exhibit 1-4: Types of Osteoporosis…………………………………………………………….. 1-9
Exhibit 1-5: Leading Risk Factors for Osteoporosis…………………………………….. 1-10
2013 Elsevier Business Intelligence i #A331
Women’s Health: Trends and Opportunities in the
U.S. Osteoporosis Management Market Table of Contents
2. BONE DENSITOMETRY PRODUCTS MARKET …………………………………. 2-1
2.1 Bone Densitometry Overview …………………………………………………… 2-1
2.1.1 Dual-Energy X-Ray Absorptiometry ……………………………. 2-3
2.1.2 Single-Energy X-Ray Absorptiometry………………………….. 2-5
2.1.3 Radiographic Absorptiometry …………………………………….. 2-5
2.1.4 Quantitative Computed Tomography…………………………… 2-5
2.1.5 Quantitative Ultrasound…………………………………………….. 2-6
2.1.6 Hospital-Based Densitometry Systems ……………………….. 2-9
2.1.7 Office-Based Densitometry Systems…………………………… 2-9
2.1.8 Software-Based Densitometry Systems ………………………. 2-9
2.2 Densitometry Products ………………………………………………………….. 2-10
2.2.1 BeamMed……………………………………………………………… 2-10
2.2.2 CompuMed……………………………………………………………. 2-10
2.2.3 CooperSurgical/The Cooper Companies……………………. 2-11
2.2.4 Furuno USA/Furuno Electric Company ……………………… 2-12
2.2.5 GE Healthcare/General Electric Company …………………. 2-12
2.2.6 Hologic …………………………………………………………………. 2-12
2.2.7 Lone Oak Medical Technologies ………………………………. 2-13
2.2.8 Sectra…………………………………………………………………… 2-13
2.3 Reimbursement ……………………………………………………………………. 2-23
2.4 Market Analysis ……………………………………………………………………. 2-23
2.5 Competitive Analysis …………………………………………………………….. 2-27
Exhibit 2-1: Comparison of Biochemical Markers and Bone Densitometry
as Tools for Diagnosing and Monitoring Osteoporosis …………………. 2-2
Exhibit 2-2: Imaging Technologies Used to Diagnose Osteoporosis……………….. 2-7
Exhibit 2-3: 2013, Selected Bone Densitometry Systems ……………………………. 2-14
Exhibit 2-4: The Sunlight MiniOmni Bone Sonometer …………………………………. 2-16
Exhibit 2-5: The Norland Family of Dual-Energy X-Ray
Absorptiometry Systems………………………………………………………… 2-17
Exhibit 2-6: The Lunar iDXA Dual-Energy X-Ray Absorptiometry System ……… 2-18
Exhibit 2-7: The Discovery Dual-Energy X-Ray Absorptiometry System………… 2-19
Exhibit 2-8: The OsteoGram Radiographic Absorptiometry System………………. 2-20
Exhibit 2-9: The CM-200 Quantitative Ultrasound Bone
Densitometry System ……………………………………………………………. 2-21
Exhibit 2-10: The Accudxa2 Dual-Energy X-Ray Absorptiometry System………… 2-22
Exhibit 2-11: Hospital-Based Bone Densitometry Systems,
Market Forecast, 2012-2017 ………………………………………………….. 2-25
Exhibit 2-12: Office-Based Bone Densitometry Systems,
Market Forecast, 2012-2017 ………………………………………………….. 2-26
Exhibit 2-13: Total Bone Densitometry Systems,
Market Forecast, 2012-2017 ………………………………………………….. 2-28
Exhibit 2-14: 2012, Bone Densitometry Systems Market,
Share by Supplier…………………………………………………………………. 2-29
3. BONE REMODELING BIOCHEMICAL MARKER TESTS MARKET………. 3-1
3.1 Biochemical Markers Overview ………………………………………………… 3-1
3.1.1 Types of Bone Turnover Markers……………………………….. 3-2
3.1.2 Applications…………………………………………………………….. 3-2
3.2 Biochemical Marker Testing Products ……………………………………….. 3-6
3.2.1 Alere………………………………………………………………………. 3-6
3.2.2 Beckman Coulter……………………………………………………… 3-6
3.2.3 Roche Diagnostics/Roche …………………………………………. 3-6
3.2.4 Immunodiagnostic Systems……………………………………….. 3-7
3.2.5 Orion Diagnostica/Orion Group ………………………………….. 3-7
3.2.6 Quidel…………………………………………………………………….. 3-8
3.3 Reimbursement ……………………………………………………………………… 3-8
3.4 Market Analysis ……………………………………………………………………. 3-13
3.5 Competitive Analysis …………………………………………………………….. 3-14
Exhibit 3-1: The Bone Remodeling Cycle……………………………………………………. 3-3
Exhibit 3-2: Comparison of Selected Bone Remodeling
Biochemical Marker Tests ……………………………………………………….. 3-4
Exhibit 3-3: 2013, Selected Bone Remodeling Biochemical Marker Tests ……….. 3-9
Exhibit 3-4: Bone Remodeling Biochemical Marker Tests,
Market Forecast, 2012-2017 ………………………………………………….. 3-15
Exhibit 3-5: 2012, Bone Remodeling Biochemical Marker Tests Market,
Share by Supplier…………………………………………………………………. 3-16
4. OSTEOPOROSIS PHARMACEUTICAL TREATMENTS MARKET………… 4-1
4.1 Clinical Overview……………………………………………………………………. 4-1
4.1.1 Antiresorptive Drugs…………………………………………………. 4-2
4.1.1.1 Bisphosphonates……………………………………….. 4-2
4.1.1.1.1 Alendronate …………………………… 4-3
4.1.1.1.2 Ibandronate……………………………. 4-5
4.1.1.1.3 Risedronate …………………………… 4-6
4.1.1.1.4 Zoledronate……………………………. 4-7
4.1.1.2 Salmon Calcitonins…………………………………….. 4-8
4.1.1.2.1 Novartis…………………………………. 4-9
4.1.1.2.2 Unigene Laboratories…………….. 4-10
4.1.1.2.3 Emerging Drugs……………………. 4-10
4.1.1.3 Estrogen/Hormone Therapy ………………………. 4-15
4.1.1.4 Receptor Activator of Nuclear Factor
KappaB Ligand Inhibitors ………………………….. 4-17
4.1.1.5 Estrogen Agonists/Antagonists…………………… 4-17
4.1.1.5.1 Emerging Drugs……………………. 4-19
4.1.1.5.1.1 Pfizer ……………….. 4-19
4.1.1.5.1.2 EndoCeutics ……… 4-20
4.1.1.6 Other Emerging Antiresorptives …………………. 4-20
4.1.1.6.1 Cathepsin K Inhibitors……………. 4-20
4.1.1.6.2 Monoclonal Antibodies…………… 4-21
4.1.1.6.2.1 Alethia
Biotherapeutics….. 4-21
4.1.1.6.2.2 Novo Nordisk…….. 4-21
4.1.2 Bone-Forming Drugs ………………………………………………. 4-21
4.1.2.1 Synthetic Parathyroid Hormone………………….. 4-22
4.1.2.1.1 Forteo …………………………………. 4-22
4.1.2.1.2 Pipeline Drugs………………………. 4-23
4.1.2.1.2.1 Radius Health……. 4-24
4.1.2.2 Other Emerging Anabolic Drugs…………………. 4-25
4.1.2.2.1 Serotonin Inhibitors……………….. 4-25
4.1.3 Bone Morphogenetic Proteins ………………………………….. 4-26
4.1.4 Dual-Action Bone Agents ………………………………………… 4-26
4.1.4.1 Strontium Ranelate…………………………………… 4-27
4.1.4.2 Strontium Malonate ………………………………….. 4-28
4.1.5 Gene Therapy ……………………………………………………….. 4-28
4.2 Market Analysis ……………………………………………………………………. 4-29
4.2.1 Estrogen/Hormone Therapy Drugs……………………………. 4-35
4.2.2 Osteoporosis Drugs………………………………………………… 4-38
4.2.2.1 Bone-Building Drugs ………………………………… 4-39
4.2.2.2 Bisphosphonates……………………………………… 4-40
4.2.2.3 Receptor Activator of Nuclear Factor
KappaB Ligand Inhibitors ………………………….. 4-40
4.2.2.4 Salmon Calcitonin ……………………………………. 4-40
4.3 Competitive Analysis …………………………………………………………….. 4-41
Exhibit 4-1: 2013, Selected Pharmaceutical Treatments for Osteoporosis……… 4-11
Exhibit 4-2: 2013, Selected Emerging Pharmaceutical Treatments
for Osteoporosis …………………………………………………………………… 4-30
Exhibit 4-3: Estrogen/Hormone Therapy and Osteoporosis Drugs,
Market Forecast, 2012-2017 ………………………………………………….. 4-33
Exhibit 4-4: 2012, Estrogen/Hormone Therapy and Osteoporosis Drugs,
Sales by Product Category…………………………………………………….. 4-36
Exhibit 4-5: United States Patent Status of Selected Estrogen/
Hormone Therapy Drugs……………………………………………………….. 4-42
Exhibit 4-6: United States Patent Status of Selected Osteoporosis Drugs ……… 4-43
Exhibit 4-7: 2012, Estrogen/Hormone Therapy and Osteoporosis
Drugs Market, Share by Supplier ……………………………………………. 4-47
5. COMPANY PROFILES…………………………………………………………………….. 5-1
5.1 Alere, Inc. ……………………………………………………………………………… 5-1
5.2 The Cooper Companies, Inc…………………………………………………….. 5-1
5.3 GE Healthcare/General Electric Company …………………………………. 5-2
5.4 Hologic, Inc……………………………………………………………………………. 5-3
5.5 Eli Lilly and Company ……………………………………………………………… 5-5
5.6 Novartis AG …………………………………………………………………………… 5-7
5.7 Pfizer, Inc. …………………………………………………………………………….. 5-7
5.8 Roche Holding AG………………………………………………………………….. 5-9