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Table of Contents

1. Executive Summary
1.1 Bone Metabolism Disorders: Market Review
1.2 Overview of Chapters in this Report
1.3 Research & Analysis Methods

2. Bone Metabolism Disorders: Causes, Effects, Diagnosis and Treatments
2.1 Bone is a Living Tissue
2.1.1 Bone Structure
2.1.2 Bone Remodelling
2.1.3 Regulation of Bone Remodelling
2.1.3.1 Factors Affecting Bone Metabolism
2.1.3.2 Parathyroid Hormone (PTH)
2.1.3.3 Calcitonin
2.1.3.4 Vitamin D/Calcitriol
2.1.3.5 Other Hormones
2.1.3.6 Local Cell Signalling Factors
2.1.3.7 Physical Stress
2.1.4 Bone Growth and Remodelling
2.2 Bone Metabolism Disorders
2.2.1 Osteoporosis
2.2.1.1 Osteoporosis Leads to Bone Fractures
2.2.1.2 Causes of Osteoporosis
2.2.1.3 Osteoporosis Risk Factors
2.2.1.4 Diagnosis of Osteoporosis
2.2.1.5 Osteoporosis Screening
2.2.1.6 Prevalence of Osteoporosis
2.2.1.7 Counting the Cost of Osteoporosis
2.2.2 Paget's Disease of Bone
2.2.2.1 Paget's Disease is a Chronic Skeletal Disorder
2.2.2.2 The Cause of Paget's Disease
2.2.2.3 Diagnosis of Paget's Disease
2.2.2.4 Prevalence of Paget's Disease
2.2.3 Bone Metastases
2.2.4 Primary Hyperparathyroidism
2.2.5 Secondary Hyperparathyroidism and Renal Osteodystrophy
2.3 Treatment of Bone Metabolism Disorders
2.3.1 Bisphosphonates
2.3.2 Vitamin D or K Analogues
2.3.3 Selective Oestrogen-Receptor Modulators (SERMs)
2.3.4 Parathyroid Hormones (PTH)
2.3.5 Calcimimetics
2.3.6 Calcitonins
2.3.7 Strontium Compounds
2.3.8 Calcium and Vitamin D Supplements

3. The World Bone Metabolism Disorders Market, 2010-2025
3.1 The Bone Metabolism Drug Market Will Expand from 2010
3.2 Osteoporosis Dominates the Bone Metabolism Market Currently
3.3 Bisphosphonates Led the Bone Metabolism Market in 2009
3.4 Bisphosphonates Will Gradually Lose Market Share from 2010 to 2025
3.5 Key Industrial Players in the Bone Metabolism Market
3.6 Leading Brands in the Bone Metabolism Market: Forecasts and Discussions
3.6.1 The Top 15 Bone Metabolism Drugs in 2009
3.6.2 Actonel/Optinate Will Fall From Top Position
3.6.3 Zometa/Aclasta/Reclast: Sales Prospects
3.6.4 Bonviva/Boniva/Bondronat: Sales Prospects
3.6.5 Fosamax/Fosamax Plus D: Increasingly Impacted by Generic Competition
3.6.6 Evista: Sales Peaked in 2008
3.6.7 Forteo/Forsteo: Sustained Growth for a Bone Anabolic Agent
3.6.8 Zemplar: Sales Prospects
3.6.9 Sensipar/Mimpara: Amgen’s Calcimimetic
3.6.10 Protelos: Sales Prospects
3.6.11 Hectorol: Sales Prospects
3.6.12 Teiroc/Bonalon: Sales Prospects
3.6.13 Benet: Sales Prospects
3.6.14 Miacalcin/Miacalcic: Sales Prospects
3.6.15 Elcitonin: Sales Prospects
3.6.16 Alfarol (Alfacalcidol, Chugai)
3.6.17 Preotact Has a Limited Market?
3.6.18 Generic Alendronate
3.7 Approvals in the Bone Metabolism Disorders Market in 2009
3.7.1 Fabyln (Lasofoxifene, Pfizer/Ligand)
3.7.2 Conbriza/Viviant (Bazedoxifene, Wyeth/Ligand)

4. SWOT Analysis of the Bone Metabolism Disorders Market
4.1 SWOT Analysis of the Market
4.2 Strengths of the Bone Metabolism Pharmaceutical Sector
4.3 Generic Competition is the Principal Challenge Facing the Bone Metabolism Sector
4.4 Opportunities for the Bone Metabolism Disorders Market
4.5 Threats to the Bone Metabolism Disorders Market
4.5.1 Drug Side-Effect Publicity
4.5.2 Reimbursement for Bone Metabolism Drugs

5. Geographical Profile of the Bone Metabolism Market, 2010-2025
5.1 North America Led the Bone Metabolism Market in 2009
5.2 Leading Bone Metabolism Country Markets, 2009
5.3 Bone Metabolism Market Forecasts for Leading Countries, 2010-2025
5.4 China and India Will Have Highest Growth from 2010-2025

6. The Bone Metabolism Disorders R&D Pipeline
6.1 Strong Pipeline for Bone Metabolism Disorders
6.2 Reformulations and Novel Therapeutic Agents
6.2.1 Pipeline Developments to Improve Formulations
6.2.2 Bone Anabolic Agents in the Pipeline
6.3 RANKL Inhibitors and Cathepsin K Inhibitors
6.4 Key Pipeline Products: Registration Stage
6.4.1 Prolia (Denosumab/ AMG 162) (Amgen)
6.4.1.1 Prolia is an Effective Treatment for Osteoporosis and Bone Metastases
6.4.1.2 Biologics Licence Application (BLA) for Prolia Submitted in 2009
6.4.1.3 Launch of Prolia Expected in H2 2010
6.4.2 Eldecalcitol (ED-71, Chugai)
6.5 Key Pipeline Products: Phase III
6.5.1 Odanacatib (MK 0822, Merck & Co)
6.5.2 EX101 Effervescent Alendronate (EffRx/Nycomed)
6.5.3 SM021 (Salmon Calcitonin, Novartis)
6.6 Key Pipeline Products: Phase II
6.6.1 JTT-305 (Japan Tobacco)
6.6.2 SAN-134 (Sanos Bioscience)
6.6.3 BA058 (PTHrP Analogue, Radius Health/Ipsen)
6.6.4 ONO-5334 (Ono)
6.6.5 BN003/CaPTHymone (Oral PTH, Bone Medical/Axcess)
6.6.6 ViaDerm -hPTH (PTH, TransPharma/Eli Lilly)
6.6.7 Strontium Malonate (Osteologix)
6.6.8 Capsitonin (Oral Calcitonin, Bone Medical)
6.6.9 AMG 785 (CDP-8581) (Amgen/UCB)
6.7 Key Pipeline Products: Phase I
6.7.1 ACE-011 (Acceleron Pharma)

7. Interviews with Experts on Bone Disorders
7.1 Interview with Dr Stuart Silverman, Medical Director of the Osteoporosis Medical Center, OMC Clinical Research Center, CA, US
7.1.1 Unmet Needs in the Osteoporosis Market
7.1.2 New Bone Anabolic Agents
7.1.3 The Difficulties of Developing New Osteoporosis Drugs
7.1.4 Current Pipeline Drugs for Osteoporosis
7.1.5 Decline of Bisphosphonates
7.2 Interview with Dr Matthew Drake, Mayo Clinic, MN, US
7.2.1 Unmet Needs for Osteoporosis Patients
7.2.2 Future Bone Anabolic Agents
7.2.3 Potential in the Late-Stage Osteoporosis Pipeline
7.2.4 Intricacies of Developing New Osteoporosis Drugs
7.2.5 Side-Effects of Established Bone Metabolism Disorder Drugs
7.2.6 The Development of Drugs to Prevent Osteoporosis
7.2.7 Growth Opportunities in the Osteoporosis Market
7.3 Interview with Dr Jasbir Seehra, Chief Scientific Officer, Senior Vice President and Founder, Acceleron Pharma, Inc., MA, US
7.3.1 Unmet Needs in Osteoporosis Patients
7.3.2 On ACE-011 Fulfilling Unmet Needs in the Market
7.3.3 On ACE-011 in Comparison With Current Therapies
7.3.4 Advantages and Disadvantages of ACE-011 Compared with Other Pipeline Drugs

8. Conclusions
8.1 The Bone Metabolism Disorders Market 2010-2025 - What will the Future Hold?
8.2 Growth Drivers for the Bone Metabolism Disorders Market
8.3 Closing Thoughts on the Industry and Market

List of Tables
Table 2.1 Hormones Involved in Bone Metabolism
Table 2.2 Worldwide Prevalence of Osteoporosis
Table 2.3 Bone Metabolism Disorder Therapies, 2010
Table 3.1 Bone Metabolism Disorders: World Pharmaceutical Sales, 2009-2025
Table 3.2 Bone Metabolism Disorders: World Sales and Market Shares by Disease Area, 2009
Table 3.3 Bone Metabolism Disorders: World Sales and Market Shares by Drug Class, 2009
Table 3.4 Bisphosphonates: World Sales and Market Shares by Brand, 2009
Table 3.5 Bone Metabolism Disorders: World Sales by Drug Class, 2009-2025
Table 3.6 Bone Metabolism Disorders: World Sales and Market Shares by Manufacturer, 2009
Table 3.7 Leading Bone Metabolism Disorders Brands: World Sales, 2009
Table 3.8 Leading Bone Metabolism Disorders Brands: World Sales, 2009-2025
Table 3.9 Generic Alendronate Manufacturers, 2009
Table 4.1 SWOT Chart for the Bone Metabolism Disorders Sector, 2010
Table 4.2 Expected Patent Expiries in the Bone Metabolism Market
Table 5.1 Bone Metabolism Disorders: World Sales and Market Shares by Geographical Region, 2009
Table 5.2 Leading Bone Metabolism Country Markets: Sales and Market Shares, 2009
Table 5.3 Leading Bone Metabolism Country Markets: Sales, 2009-2025
Table 5.4 Population Aged 65 or Over: US, Japan, China and India, 2009-2025
Table 6.1 Bone Metabolism Disorders: R&D Pipeline, 2010
Table 6.2 Disadvantages of Current Anabolic Bone Agents, 2010
Table 8.1 Leading Bone Metabolism Country Markets: World Market Shares, 2009 and 2025

List of Figures
Figure 2.1 Appearance of Healthy Bone
Figure 2.2 Bone Affected by Osteoporosis
Figure 2.3 Bones Commonly Affected by Paget's Disease
Figure 3.1 Bone Metabolism Disorders: World Pharmaceutical Sales, 2009-2025
Figure 3.2 Bone Metabolism Disorders: World Market Shares by Disease Area, 2009
Figure 3.3 Bone Metabolism Disorders: World Market Shares by Drug Class, 2009
Figure 3.4 Bisphosphonates: World Market Shares by Brand, 2009
Figure 3.5 Bone Metabolism Disorders: World Sales by Drug Class, 2009-2025
Figure 3.6 Bone Metabolism Disorders: World Market Shares by Drug Class, 2015
Figure 3.7 Bone Metabolism Disorders: World Market Shares by Drug Class, 2020
Figure 3.8 Bone Metabolism Disorders: World Market Shares by Drug Class, 2025
Figure 3.9 Bone Metabolism Disorders: World Market Shares by Manufacturer, 2009
Figure 3.10 Leading Bone Metabolism Disorders Brands, 2009
Figure 3.11 Actonel/Optinate: World Sales, 2009-2025
Figure 3.12 Leading Bone Metabolism Brands (Bisphosphonates): World Sales, 2009-2025
Figure 3.13 Zometa/Aclasta/Reclast: World Sales, 2009-2025
Figure 3.14 Bonviva/Boniva/Bondronat: World Sales, 2009-2025
Figure 3.15 Fosamax/Fosamax Plus D: World Sales, 2009-2025
Figure 3.16 Leading Bone Metabolism Brands (Non-Bisphosphonates): World Sales, 2009-2025
Figure 3.17 Evista: World Sales, 2009-2025
Figure 3.18 Forteo/Forsteo: World Sales, 2009-2025
Figure 3.19 Zemplar: World Sales, 2009-2025
Figure 3.20 Sensipar/Mimpara: World Sales, 2009-2025
Figure 3.21 Protelos: World Sales, 2009-2025
Figure 3.22 Hectorol: World Sales, 2009-2025
Figure 5.1 Bone Metabolism Disorders: World Market Shares by Geographical Region, 2009
Figure 5.2 Bone Metabolism Disorders: World Market Shares for Leading Countries, 2009
Figure 5.3 Leading Bone Metabolism Country Markets (Higher Group): Sales, 2009-2025
Figure 5.4 Leading Bone Metabolism Country Markets (Lower Group): Sales, 2009-2025
Figure 5.5 Bone Metabolism Disorders: World Market Shares for Leading Countries, 2015
Figure 5.6 Bone Metabolism Disorders: World Market Shares for Leading Countries, 2020
Figure 5.7 Bone Metabolism Disorders: World Market Shares for Leading Countries, 2025
Figure 8.1 Bone Metabolism Disorders: World Sales, 2009-2025