Table of Contents
1. Executive Summary
2. Bone Metabolism Disorders: Causes, Diagnosis and Treatment
- 2.1 Bone is a Living Dynamic 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 During the Life-Cycle
- 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 and K Analogues/Calcimimetics
- 2.3.3 Selective Oestrogen-Receptor Modulators (SERMs)
- 2.3.4 Parathyroid Hormones (PTH)
- 2.3.5 Calcitonins
- 2.3.6 Strontium Compounds
- 2.3.7 Hormone Replacement Therapy (HRT)
- 2.3.8 Calcium and Vitamin D Supplements
3. The World Bone Metabolism Disorder Market
- 3.1 The Bone Metabolism Market Will Grow 2023
- 3.2 Osteoporosis Dominates the Bone Metabolism Market
- 3.3 Bisphosphonates Lead the Bone Metabolism Market in 2007
- 3.4 Bisphosphonates Will Gradually Lose Market Share during 2008-2023
- 3.5 Key Industrial Players in the Bone Metabolism Market
- 3.6 Leading Brands in the Bone Metabolism Market
- 3.6.1 The Top 14 Bone Metabolism Drugs in 2007
- 3.6.2 Fosamax: A Fall from Top Position in 2008
- 3.6.3 Actonel/Optinate: Increasingly Impacted by Generic Competition
- 3.6.4 Zometa/Aclasta/Reclast (Zoledronate, Novartis): Further Growth
Predicted
- 3.6.5 Bonviva/Boniva/Bondronat (Ibandronate, Roche/GSK): Strong Growth
in Near Term
- 3.6.6 Bonalon/Teiroc (Alendronate, Teijin)
- 3.6.7 Benet (Risedronate, Takeda)
- 3.6.8 Bonefos (Clodronate, Bayer)
- 3.6.9 Generic Alendronate
- 3.6.10 Zemplar: New Formulations and Indications
- 3.6.11 Sensipar/Mimpara: Amgen' s Calcimimetic
- 3.6.12 Alfarol (Alfacalcidol, Chugai)
- 3.6.13 Rocaltrol (Calcitriol, Roche)
- 3.6.14 Glakay (Vitamin K2, Eisai)
- 3.6.15 Evista: Only Slight Growth Predicted
- 3.6.16 Forteo/Forsteo: Strong Growth for a Bone Anabolic Agent
- 3.6.17 Preotact Will Not Challenge Forteo
- 3.6.18 Miacalcin/Miacalcic (Salmon Calcitonin, Novartis)
- 3.6.19 Elcitonin (Eel Calcitonin Derivative, Asahi Kasei)
- 3.6.20 Fortical (Salmon Calcitonin, Upsher-Smith)
- 3.6.21 Protelos (Strontium Ranelate, Servier)
- 3.6.22 Hormone Replacement Therapy (HRT)
- 3.6.23 The Leading Calcium and Vitamin D Supplements
4. SWOT Analysis of the Bone Metabolism Disorder Market
- 4.1 Analysis of the Market
- 4.2 Key Strengths of the Bone Metabolism Pharmaceutical Industry
- 4.3 Generic Competition is the Key Weakness Facing the Bone Metabolism
Pharmaceutical Industry
- 4.4 Key Opportunities for the Bone Metabolism Market
- 4.5 Key Threats to the Bone Metabolism Market
- 4.5.1 Drug Side-Effect Publicity
- 4.5.2 Reimbursement of Bone Metabolism Drugs
5. Geographical Profile of the Bone Metabolism Market
- 5.1 North America Lead the Bone Metabolism Market in 2007
- 5.2 Leading Bone Metabolism Country Markets, 2007
- 5.3 Bone Metabolism Market Forecast for Leading Countries, 2008-2023
- 5.4 China and India Will Have Highest Growth in 2008-2023
6. The Bone Metabolism Disorder Pipeline
- 6.1 The Bone Metabolism Pipeline is Well-Stocked
- 6.2 More Convenient Formulations and Novel Therapeutics Fill the Bone
Metabolism Pipeline
- 6.2.1 Pipeline Developments to Improve Formulations
- 6.2.2 Pipeline Bone Anabolic Agents
- 6.3 Monoclonal Antibodies and Cathepsin K Inhibitors will be the First
Novel Therapeutics to Reach Market
- 6.4 Key Pipeline Products: Registration Stage
- 6.4.1 Fablyn (Lasofoxifene, Pfizer/Ligand)
- 6.4.2 Viviant (Bazedoxifene, Wyeth)
- 6.5 Key Pipeline Products: Phase III
- 6.5.1 Denosumab/AMG 162 (Amgen)
- 6.5.1.1 Denosumab is a Pipeline Product for Osteoporosis and Bone
Metastases
- 6.5.1.2 Osteoporosis Clinical Trials
- 6.5.1.3 Bone Metastases Clinical Trials
- 6.5.1.4 Launch of Denosumab Expected in 2009-2010
- 6.5.2 Odanacatib (MK 0822, Merck & Co.)
- 6.5.3 Aprela (Conjugated Oestrogenic Substances/Bazedoxifene, Wyeth)
- 6.5.4 Arzoxifene (Eli Lilly)
- 6.5.5 Recalbon (ONO-5920/YM529, Minodronate, Ono/Astellas)
- 6.5.6 ED-71 (Eldecalcitol Chugai)
- 6.5.7 SMC021 (Salmon Calcitonin, Novartis/Nordic
Bioscience/Unigene/Emisphere)
- 6.6 Key Pipeline Products: Phase II
- 6.6.1 ACE-011 (Acceleron Pharma)
- 6.6.2 BA058 (PTHrP Analogue, Radius Health/Ipsen)
- 6.6.3 Ronacaleret/751689 (GSK/NPS)
- 6.6.4 ONO-5334 (Ono)
- 6.6.5 rhPTH (Recombinant Human PTH, Green Cross)
- 6.6.6 BN003/CaPTHymone (Oral PTH, Bone Medical/Axcess)
- 6.6.7 ViaDerm-hPTH (PTH, TransPharma/Eli Lilly)
- 6.6.8 NBS-101 (Strontium Malonate, Osteologix)
- 6.6.9 Capsitonin (Oral Calcitonin, Bone Medical)
7. Conclusions
Appendix A
Appendix B
- Visiongain Report Evaluation Form
List of Tables
- Table 2.1 Hormones Involved in Bone Metabolism
- Table 2.2 Worldwide Prevalence of Osteoporosis
- Table 2.3 Bone Metabolism Disease Therapies
- Table 3.1 World Bone Metabolism Disorder Pharmaceutical Sales ($m)
2007-2023
- Table 3.2 World Bone Metabolism Market Share by Disorder, 2007
- Table 3.3 World Bone Metabolism Market Share by Drug Class, 2007
- Table 3.4 World Bone Metabolism Disorder Sales ($m) by Drug Class,
2007-2023
- Table 3.5 World Bone Metabolism Disorder Market Share by Manufacturer, 2007
- Table 3.6 Leading Bone Metabolism Disorder Brands, 2007
- Table 3.7 Leading Bone Metabolism Disorder Brand Sales ($m), 2007- 2023
- Table 3.8 Key Generic Alendronate Manufacturers, 2007
- Table 3.9 Largest-Selling HRT Products, 2007
- Table 4.1 SWOT Chart for Bone Metabolism Disorder Market
- Table 4.2 Selected Expected Patent-Expiries in the Bone Metabolism Market
2008-2023
- Table 4.3 Premarin Sales Revenue 2002-2004
- Table 5.1 World Bone Metabolism Disorder Market Share by Geographical
Area, 2007
- Table 5.2 Top Bone Metabolism Country Markets, 2007
- Table 5.3 Leading Bone Metabolism Country Markets, 2007-2023
- Table 5.4 Population Aged 65 or Over: US, Japan China and India, 2007-2023
- Table 6.1 The Bone Metabolism Disorder Pipeline
- Table 7.1 Leading Bone Metabolism Country Markets 2007 and 2023
List of Figures
- Figure 2.1 Appearance of Healthy Bone
- Figure 2.2 Bone Affected by Osteoporosis
- Figure 2.3 Bones Commonly Affected by Paget' s Disease
- Figure 3.1 World Bone Metabolism Disorder Pharmaceutical Sales ($m)
2007-2023
- Figure 3.2 World Bone Metabolism Market Share by Disorder, 2007
- Figure 3.3 World Bone Metabolism Disorder Market Share by Drug Class, 2007
- Figure 3.4 World Bone Metabolism Disorder Sales ($m) by Drug Class,
2007-2023
- Figure 3.5 World Bone Metabolism Disorder Market Share by Drug Class, 2013
- Figure 3.6 World Bone Metabolism Disorder Market Share by Drug Class, 2018
- Figure 3.7 World Bone Metabolism Disorder Market Share by Drug Class, 2023
- Figure 3.8 World Bone Metabolism Disorder Market Share by Manufacturer,
2007
- Figure 3.9 Leading Bone Metabolism Disorder Brands, 2007
- Figure 3.10 Leading Bone Metabolism Brand Sales ($m) (Bisphosphonates),
2007-2023
- Figure 3.11 Leading Bone Metabolism Brand Sales (Non-Bisphosphonates),
2007-2023
- Figure 3.12 Fosamax/Fosamax Plus D Worldwide Sales Forecast ($m), 2007-2023
- Figure 3.13 Actonel/Optinate Worldwide Sales Forecast ($m), 2007-2023
- Figure 3.14 Zometa/Aclasta/Reclast Worldwide Sales Forecast ($m), 2007-2023
- Figure 3.15 Bonviva/Boniva/Bondronat Worldwide Sales Forecast ($m),
2007-2023
- Figure 3.16 Zemplar Worldwide Sales Forecast ($m), 2007-2023
- Figure 3.17 Sensipar/Mimpara Worldwide Sales Forecast ($m), 2007- 2023
- Figure 3.18 Evista Worldwide Sales Forecast ($m), 2007-2023
- Figure 3.19 Forteo/Forsteo Worldwide Sales Forecast ($m), 2007-2023
- Figure 3.20 Miacalcin/Miacalcic Worldwide Sales Forecast ($m), 2007- 2023
- Figure 3.21 Protelos Worldwide Sales Forecast ($m), 2007-2023
- Figure 5.1 World Bone Metabolism Disorder Market Share by Geographical
Area, 2007
- Figure 5.2 World Bone Metabolism Disorder Market Share by Leading
Countries, 2007
- Figure 5.3 Leading Bone Metabolism Country Markets, 2007-2023: Higher Group
- Figure 5.4 Leading Bone Metabolism Country Markets, 2007-2023: Lower Group
- Figure 5.5 World Bone Metabolism Disorder Market Share by Leading
Countries, 2013
- Figure 5.6 World Bone Metabolism Disorder Market Share by Leading
Countries, 2018
- Figure 5.7 World Bone Metabolism Disorder Market Share by Leading
Countries, 2023
- Figure 7.1 Bone Metabolism Disorder Market, 2007-2023
Companies Listed
- Abbott Laboratories
- Abiogen
- Acceleron Pharma
- American College of Physicians
- Amgen
- Asahi Kasei
- Astellas
- Axcess
- Banyu
- Barr
- Bayer
- Bone Medical
- British Geriatrics Society
- British Orthopaedic Association
- Celgene
- Chugai (part of Roche Group)
- Daiichi Sankyo
- Dr.Reddy' s
- Eisai
- Eli Lilly
- Emisphere Technologies
- Esteve
- European Medicines Agency (EMEA)
- Food and Drug Administration (FDA)
- Green Cross
- GlaxoSmithKline (GSK)
- International Osteoporosis Foundation
- Ipsen
- Kirin Brewery
- Leo Pharma
- Ligand
- Merck & Co.
- Nordic Bioscience
- Novartis
- Novo Nordisk
- NPS
- Nycomed
- Ono
- Osteologix
- Preventive Services Task Force (USPSTF)
- Proctor & Gamble
- Radius Health
- Ratiopharm
- Roche
- Sandoz (Novartis)
- Sanofi-Aventis
- Servier
- Shire
- Sigma (Australia)
- Stada
- Taisho
- Takeda
- Teijin
- Teva
- TransPharma
- Unigene
- Upsher-Smith
- Watson
- World Health Organisation (WHO)
- Wyeth
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