Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 8
2 Introduction 10
2.1 Disease Introduction 11
2.2 Epidemiology 11
2.3 Symptoms 12
2.4 Etiology and Pathophysiology 14
2.4.1 Pathophysiology 14
2.5 Diagnosis 15
2.6 Disease Stages 17
2.7 Prognosis 20
2.8 Treatment Options 21
2.8.1 Treatment Algorithm 21
2.8.2 Pharmacological Treatments 22
2.8.3 Non-Pharmacological Treatments 24
2.8.4 Exercise 24
2.8.5 Dietary Interventions 24
3 Marketed Products 26
3.1 Overview 26
3.2 Bisphosphonates 26
3.2.1 Risedronate – Warner Chilcott 26
3.2.2 Alendronate – Merck & Co 28
3.2.3 Boniva (ibandronate) – Roche 29
3.2.4 Zoledronic Acid – Novartis 30
3.2.5 Recalbon/Bonoteo (minodronate) – Ono and Astellas Pharma 31
3.2.6 Etidronate – Procter & Gamble and Sumitomo Pharmaceuticals 32
3.3 Dual-Acting Non-Bisphosphonates 33
3.3.1 Strontium Ranelate – Servier 33
3.4 Selective Estrogen Receptor Modulators 34
3.4.1 Evista (raloxifene) – Eli Lilly 34
3.4.2 Viviant (bazedoxifene) – Ligand and Pfizer 35
3.5 Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Inhibitor 36
3.5.1 Prolia (denosumab) – Amgen 36
3.6 Calcitonins 37
3.6.1 Calcitonin-salmon 37
3.7 Parathyroid Hormone 38
3.7.1 Forteo (teriparatide) – Eli Lilly 38
3.8 Comparative Efficacy and Safety of Marketed Products 39
4 Pipeline Analysis 43
4.1 Overview 43
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 44
4.3 Pipeline by Molecular Target 46
4.4 Promising Pipeline Candidates 49
4.4.1 Romosozumab (AMG-785) – Amgen 49
4.4.2 Abaloparatide-SC (BA-058-SC) – Radius Health 52
4.4.3 Odanacatib (MK-0822 ) – Merck & Co 55
4.4.4 Uni-PTH – Uni-Bio Science 57
4.5 Comparative Efficacy and Safety of Pipeline Products 59
4.6 Product Competitiveness Framework 60
5 Clinical Trial Analysis 62
5.1 Failure Rate 62
5.1.1 Overall Failure Rate 62
5.1.2 Failure Rate by Phase and Molecule Type 64
5.1.3 Failure Rate by Phase and Molecular Target 64
5.2 Clinical Trial Duration 65
5.2.1 Clinical Trial Duration by Molecule Type 65
5.2.2 Clinical Trial Duration by Molecular Target 67
5.3 Clinical Trial Size 68
5.3.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 68
5.3.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 70
5.4 Competitive Clinical Trials Metrics Analysis 72
6 Multi-Scenario Forecast 74
6.1 Geographical Markets 74
6.2 Asia-Pacific Market 75
6.3 India 76
6.3.1 Treatment Usage Patterns 76
6.3.2 Annual Cost of Therapy 78
6.3.3 Market Size 79
6.4 China 80
6.4.1 Treatment Usage Patterns 80
6.4.2 Annual Cost of Therapy 81
6.4.3 Market Size 82
6.5 Australia 83
6.5.1 Treatment Usage Patterns 83
6.5.2 Annual Cost of Therapy 84
6.5.3 Market Size 86
6.6 South Korea 87
6.6.1 Treatment Usage Patterns 87
6.6.2 Annual Cost of Therapy 88
6.6.3 Market Size 89
6.7 Japan 90
6.7.1 Treatment Usage Patterns 90
6.7.2 Annual Cost of Therapy 91
6.7.3 Market Size 92
7 Drivers and Barriers 93
7.1 Drivers 93
7.1.1 Rising Prevalence 93
7.1.2 Increasing Health Insurance Coverage for Aged Population 93
7.1.3 Increasing Public and Policymaker Awareness 93
7.1.4 Promising Late-Stage Pipeline Products can Change the Treatment Paradigm 94
7.2 Barriers 94
7.2.1 Impending Patent Cliffs and Generic Erosion 94
7.2.2 Low Diagnosis and Treatment Rates 94
7.2.3 Non-Availability or Lack of Benefits for Combination Anabolic and Antiresorptive Therapies 94
7.2.4 Competition from Traditional Medicines 95
8 Deals and Strategic Consolidations 96
8.1 Licensing Deals 96
8.1.1 Deals by Region and Value 96
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 97
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 97
8.1.4 Key Licensing Deals 100
8.2 Co-Development Deals 102
8.2.1 Deals by Region and Value 102
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 103
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 104
8.2.4 Key Co-Development Deals 105
9 Appendix 107
9.1 All Pipeline Drugs by Stage of Development 107
9.1.1 Discovery 107
9.1.2 Preclinical 109
9.1.3 Investigational New Drug/ Clinical Trial Authorization-Filed 111
9.1.4 Phase I 111
9.1.5 Phase II 112
9.1.6 Phase III 112
9.1.7 Pre-registration 112
9.2 Market Forecasts to 2021 113
9.2.1 Asia-Pacific 113
9.2.2 India 113
9.2.3 China 114
9.2.4 Australia 114
9.2.5 South Korea 115
9.2.6 Japan 115
9.3 Bibliography 116
9.4 Abbreviations 127
9.5 Research Methodology 128
9.5.1 Secondary Research 129
9.5.2 Marketed Product Profiles 129
9.5.3 Late-Stage Pipeline Candidates 130
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 130
9.5.5 Product Competitiveness Framework 130
9.5.6 Pipeline Analysis 130
9.5.7 Forecasting Model 131
9.5.8 Deals Data Analysis 132
9.6 Contact Us 132
9.7 Disclaimer 133