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Osteoporosis: Global Drug Forecast and Market Analysis to 2027

  • Published Date: 06 Apr 2018
  • Number of Pages: 198
  • Category: Pharmaceuticals
  • Country: Global

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Osteoporosis: Global Drug Forecast and Market Analysis to 2027

Summary

Osteoporosis is a disease in which the density and quality of bone are reduced over time. In a natural process known as remodeling, some of the bone cells dissolve (resorption) and new bone cells grow back (formation). For people with osteoporosis, bone loss outpaces the growth of new bone. Consequently, bones become more porous and fragile, leading to weakness of the skeleton and an increased risk of hip, spine, and wrist fractures. Osteoporosis is often referred to as a silent disease, because the loss of bone occurs progressively and often there are no symptoms until the first fracture occurs.

Despite being a market currently monopolized by generics, osteoporosis is expected to undergo substantial change between 2017 and 2027. Clear changes are already being seen with the recent launch of Radius Healths Tymlos (abaloparatide) in the US in 2017. Anabolic agents are likely to further revolutionize the market with the arrival of a novel sclerostin inhibitor, Evenity (romosozumab), and teriparatide biosimilars. This diversification of the anabolic offering will increase competition in this space, driving down high price tags and potentially bolstering the use of these therapies up the treatment paradigm. The launch of Evenity will keep Amgen a key player in the osteoporosis market as they lose patent protection of current market leading therapy, Prolia (denosumab). The arrival of new anabolic agents and the loss of patent protection for key branded therapies will shape the osteoporosis market over the forecast period. However, poor diagnosis rates, badly perceived drug side effects, and low compliance rates will continue to prove major barriers to growth over the next 10 years.

Key Questions Answered

- What are the key osteoporosis treatments in 2017?
- When will the late stage pipeline products launch, and how will it affect drug sales and the overall osteoporosis market in the 7MM?
- Which unmet needs will remain unaddressed in the forecast period and what opportunities remain for pharmaceutical companies?

Scope

- Overview of osteoporosis, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized osteoporosis therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in four patient segments (postmenopausal, male, glucocorticoid-induced and osteopenia) forecast from 2017 to 2027.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the osteoporosis therapeutics market
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for osteoporosis therapy. The most promising candidates in Phase III development are profiled.
- Analysis of the current and future market competition in the global osteoporosis therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global osteoporosis therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global osteoporosis therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Publisher Name : GlobalData


1.1 List of Tables 7
1.2 List of Figures 9
2 Osteoporosis: Executive Summary 10
2.1 Sales for Osteoporosis by Region, 2017-2027 11
2.2 Anabolic Therapy Will Be the Product of Choice for Future Players 12
2.3 Low Diagnosis Rates and Compliance Leave Key Unmet Needs in the Osteoporosis Market 14
2.4 Current Market Leader Prolia Will Make Way for New Anabolic Therapies 15
2.5 Biosimilars Will Dominate the Market in 2027 16
2.6 What Do Physicians Think? 18
3 Introduction 19
3.1 Catalyst 19
3.2 Related Reports 19
4 Disease Overview 20
4.1 Etiology and Pathophysiology 20
4.1.1 Etiology 21
4.1.2 Pathophysiology 24
4.2 Classification 26
4.3 Symptoms 26
4.4 Prognosis 27
4.5 Quality of Life 27
5 Epidemiology 29
5.1 Disease Background 29
5.2 Risk Factors and Comorbidities 30
5.3 Global and Historical Trends 31
5.4 Forecast Methodology 33
5.4.1 Sources 33
5.4.2 Forecast Assumptions 37
5.5 Epidemiological Forecast for Osteoporosis (2017-2027) 45
5.5.1 Total Prevalent Cases of Osteoporosis 45
5.5.2 Age-Specific Total Prevalent Cases of Osteoporosis 46
5.5.3 Sex-Specific Total Prevalent Cases of Osteoporosis 47
5.5.4 Total Prevalent Cases of Osteoporosis by Primary and Secondary Osteoporosis 48
5.5.5 Total Prevalent Cases of Primary Osteoporosis by Type 49
5.5.6 Total Prevalent Cases of Osteoporosis Secondary to Glucocorticoid Use 50
5.5.7 Diagnosed Prevalent Cases of Osteoporosis 51
5.5.8 Age-Specific Diagnosed Prevalent Cases of Osteoporosis 52
5.5.9 Sex-Specific Diagnosed Prevalent Cases of Osteoporosis 52
5.5.10 Diagnosed Prevalent Cases of Osteoporosis by Primary and Secondary Osteoporosis 53
5.5.11 Diagnosed Prevalent Cases of Primary Osteoporosis by Type 54
5.5.12 Diagnosed Prevalent Cases of Osteoporosis Secondary to Glucocorticoid Use 55
5.5.13 Total Prevalent Cases and Diagnosed Prevalent Cases of Osteopenia 55
5.6 Discussion 56
5.6.1 Epidemiological Forecast Insight 56
5.6.2 Limitations of the Analysis 57
5.6.3 Strengths of the Analysis 57
6 Disease Management 58
6.1 Diagnosis Overview 58
6.2 Treatment Overview 59
6.2.1 Treatment Guidelines 59
6.2.2 Disease Management 60
6.3 US 65
6.4 5EU 67
6.5 Japan 69
7 Competitive Assessment 73
7.1 Overview 73
7.2 Bisphosphates 74
7.2.1 Overview 74
7.2.2 Efficacy 77
7.2.3 Safety 77
7.2.4 SWOT Analysis 78
7.2.5 Forecast 78
7.3 Prolia (Denosumab) 79
7.3.1 Overview 79
7.3.2 Efficacy 81
7.3.3 Safety 82
7.3.4 SWOT Analysis 84
7.3.5 Forecast 84
7.4 Parathyroid Hormones 85
7.4.1 Forteo (Teriparatide) 85
7.4.2 Tymlos (Abaloparatide) 93
7.5 SERMs 101
7.5.1 Evista (Raloxifene Hydrochloride) and Generics 101
7.5.2 Viviant (Bazedoxifene) 108
7.5.3 Duavee (Bazedoxifene Acetate + Conjugated Estrogens) 111
7.6 Other Therapies for the Treatment of Osteoporosis 115
7.6.1 Miacalcin/Fortical (Salmon Calcitonin) 115
7.6.2 Protelos and Generics (Strontium Ranelate) 116
7.6.3 Estrogen/Hormone Replacement Therapies 117
8 Opportunity Analysis and Unmet Needs 118
8.1 Overview 118
8.2 Earlier Disease Detection and Treatment 119
8.2.1 Unmet Need 119
8.3 Improved Compliance 120
8.3.1 Unmet Need 120
8.3.2 Gap Analysis 121
8.3.3 Opportunity 122
8.4 Improved Safety Profile of Long-Term Treatments 122
8.4.1 Unmet Need 122
8.4.2 Gap Analysis 123
8.4.3 Opportunity 123
8.5 Therapies that Stimulate Bone Formation 123
8.5.1 Unmet Need 123
8.5.2 Gap Analysis 124
8.5.3 Opportunity 124
9 Pipeline Assessment 125
9.1 Overview 125
9.2 Clinical Trial Mapping 126
9.3 Promising Drugs in Clinical Development 128
9.3.1 Evenity (Romosozumab) 130
9.4 Other Drugs in Development 140
9.5 Biosimilars 140
9.5.1 Teriparatide Biosimilars 140
9.5.2 Denosumab Biosimilars 142
10 Current and Future Players 143
10.1 Overview 143
10.2 Trends in Corporate Strategy 145
10.3 Company Profiles 147
10.3.1 Amgen 147
10.3.2 Eli Lilly 148
10.3.3 Radius Health 150
10.3.4 UCB 151
11 Market Outlook 153
11.1 Global Markets 153
11.1.1 Forecast 153
11.1.2 Drivers and Barriers - Global Issues 158
11.2 US 158
11.2.1 Forecast 158
11.2.2 Key Events 160
11.2.3 Drivers and Barriers 161
11.3 5EU 161
11.3.1 Forecast 161
11.3.2 Key Events 164
11.3.3 Drivers and Barriers 165
11.4 Japan 165
11.4.1 Forecast 165
11.4.2 Key Events 167
11.4.3 Drivers and Barriers 168
12 Appendix 169
12.1 Bibliography 169
12.2 Abbreviations 177
12.3 Methodology 179
12.3.1 Forecasting Methodology 179
12.3.2 Diagnosed Patients 179
12.3.3 Percent Drug-Treated Patients 179
12.3.4 Drugs Included in Each Therapeutic Class 180
12.3.5 Launch and Patent Expiry Dates 181
12.3.6 General Pricing Assumptions 182
12.3.7 Individual Drug Assumptions 183
12.3.8 Generic Erosion 189
12.3.9 Pricing of Pipeline Agents 189
12.4 Primary Research 191
12.4.1 KOLs 191
12.4.2 Primary Research - Prescriber Survey 193
12.5 About the Authors 194
12.5.1 Analyst 194
12.5.2 Therapy Area Director 194
12.5.3 Epidemiologist 194
12.5.4 Managing Epidemiologist 195
12.5.5 Global Director of Therapy Analysis and Epidemiology 195
12.5.6 Global Head and EVP of Healthcare Operations and Strategy 196
12.6 About GlobalData 197
12.7 Contact Us 197
12.8 Disclaimer 197

List Of Tables

1.1 List of Tables
Table 1: Osteoporosis: Key Metrics in the 7MM 10
Table 2: Etiology of Primary Osteoporosis 22
Table 3: Etiology of Secondary Osteoporosis 23
Table 4: Diagnosis Classification of Osteoporosis 26
Table 5: Symptoms of Osteoporosis 27
Table 6: Risk Factors and Comorbidities for Osteoporosis 30
Table 7: 7MM Total Prevalent Cases of Osteoporosis by Primary Osteoporosis and Secondary Osteoporosis, Both Sexes, Ages 30 Years, N, 2017 49
Table 8: 7MM, Total Prevalent Cases of Primary Osteoporosis by Type, Ages 30 Years, N, 2017 49
Table 9: 7MM Diagnosed Prevalent Cases of Osteoporosis by Primary Osteoporosis and Secondary Osteoporosis, Both Sexes, Ages 30 Years, N, 2017 54
Table 10: 7MM, Diagnosed Prevalent Cases of Primary Osteoporosis by Type, Ages 30 Years, N, 2017 54
Table 11: 7MM Total Prevalent Cases and Diagnosed Prevalent Cases of Osteopenia, Both Sexes, Ages 30 Years, N, 2017 56
Table 12: Diagnostic Tests for Osteoporosis 58
Table 13: Diagnosis Classification of Osteoporosis 59
Table 14: Treatment Guidelines for Osteoporosis 60
Table 15: Country Profile - US 67
Table 16: Country Profile - 5EU 69
Table 17: Country Profile - Japan 72
Table 18: Marketed Products for Osteoporosis 74
Table 19: Product Profile - Bisphosphates 75
Table 20: Summary of the Bisphosphates Currently Used for the Treatment of Osteoporosis 77
Table 21: SWOT Analysis - Bisphosphates, 2017 78
Table 22: Product Profile - Prolia 79
Table 23: Efficacy Results from Phase III Study of Prolia for the Treatment of Postmenopausal Osteoporosis 81
Table 24: Efficacy Results from Phase III Study of Prolia as a Treatment to Increase Bone Mass in Men with Osteoporosis 82
Table 25: Adverse Events Reported in 2% of Patient Population in Phase III Trial for Prolia in Postmenopausal Osteoporosis 83
Table 26: SWOT Analysis - Prolia, 2017 84
Table 27: Product Profile - Forteo 86
Table 28: Efficacy Results from the Phase III Study of Forteo for the treatment of Postmenopausal Osteoporosis 88
Table 29: Efficacy Results from Phase III Study of Forteo for the Treatment of Osteoporosis in Men 89
Table 30: Efficacy Results from Phase III Study of Forteo for the Treatment of Glucocorticoid-Induced Osteoporosis 89
Table 31: Adverse Events Reported in 2% of Patients Treated with Forteo from Two Pivotal Phase III Trials 91
Table 32: Adverse Events Reported in 2% of Patients Treated with Forteo from Two Pivotal Phase III Trials 92
Table 33: SWOT Analysis - Forteo, 2017 92
Table 34: Product Profile - Tymlos 94
Table 35: Efficacy Results after 18 months of Tymlos Therapy in Phase III Clinical trial, ACTIVE 97
Table 36: Adverse Events Reported in 5% of Patients in ACTIVE Clinical Trial 99
Table 37: SWOT Analysis - Tymlos, 2017 100
Table 38: Product Profile - Evista and Generics 102
Table 39: Raloxifene Hydrochloride Generics Marketed in the 7MM 103
Table 40: Adverse Reactions Reported in Clinical Trials Assessing Evista for the Prevention of Osteoporosis 105
Table 41: Adverse Reactions Reported in Clinical Trials Assessing Evista for the Prevention of Osteoporosis 106
Table 42: SWOT Analysis - Evista, 2017 107
Table 43: Product Profile - Viviant 108
Table 44: SWOT Analysis - Vivant, 2017 110
Table 45: Product Profile - Duavee 111
Table 46: Summary of the SMART Program Investigating Duavee for the Prevention of Postmenopausal Osteoporosis 113
Table 47: Adverse Reactions Reported in 5% of Patients in SMART Clinical Trials 114
Table 48: SWOT Analysis - Duavee, 2017 115
Table 49: Summary of Osteoporosis Agents that Have Been Discontinued or Are Considered Inactive 128
Table 50: Product Profile - Evenity 131
Table 51: Efficacy Results from Phase III FRAME Study of Evenity vs. Placebo for the Treatment of Osteoporosis 134
Table 52: Efficacy Results from Phase III ARCH Study of Evenity vs. Alendronate for the Treatment of Osteoporosis 135
Table 53: Safety Results from Phase III FRAME Study of Evenity vs. Placebo for the Treatment of Osteoporosis 136
Table 54: Safety Results from Phase III ARCH Study of Evenity vs. Alendronate for the Treatment of Osteoporosis 137
Table 55: SWOT Analysis - Evenity, 2017 139
Table 56: Early-Stage Drugs in Clinical Development for Osteoporosis in the 7MM, 2018 140
Table 57: Teriparatide Biosimilars in Development, 2018 141
Table 58: Key Companies in the Osteoporosis Market in the 7MM, 2018 143
Table 59: Amgens Osteoporosis Portfolio Assessment, 2018 148
Table 60: Eli Lillys Osteoporosis Assessment, 2018 149
Table 61: Radius Healths Osteoporosis Assessment, 2018 151
Table 62: UCBs Osteoporosis Assessment, 2018 152
Table 63: Osteoporosis Market - Global Drivers and Barriers, 2017-2027 158
Table 64: Key Events Impacting Sales for Osteoporosis in the US, 2017-2027 160
Table 65: Osteoporosis Market - Drivers and Barriers in the US, 2017-2027 161
Table 66: Key Events Impacting Sales for Osteoporosis in the 5EU, 2017-2027 164
Table 67: Osteoporosis Market - Drivers and Barriers in the 5EU, 2017-2027 165
Table 68: Key Events Impacting Sales for Osteoporosis in Japan, 2017-2027 167
Table 69: Osteoporosis Market - Drivers and Barriers in Japan, 2017-2027 168
Table 70: Key Historical and Projected Launch Dates for Osteoporosis 181
Table 71: Key Historical and Projected Patent Expiry Dates for Osteoporosis 182
Table 72: Annual Cost of Oral Bisphosphates 183
Table 73: Annual Cost of IV Bisphosphates 184
Table 74: Annual Cost of Prolia (Denosumab) 185
Table 75: Annual Cost of Evista (Raloxifene) 185
Table 76: Annual Cost of Viviant (Bazedoxifene) 186
Table 77: Annual Cost of Duavee (Bazedoxifene + Conjugated Estrogen) 187
Table 78: Annual Cost of Oral Bisphosphates 187
Table 79: Annual Cost of Forteo (Teriparatide) 188
Table 80: Annual Cost of Tymlos (Abaloparatide) 189
Table 81: Predicted Annual Cost of Evenity (Romosozumab) 190
Table 82: High-Prescribing Physicians (Non-KOLs), Surveyed by Country, 2018 193

List Of Figures

1.2 List of Figures
Figure 1: 7MM Sales Forecast for Osteoporosis, by Country, 2017 and 2027 12
Figure 2: Global Sales of Branded Osteoporosis Products, by Company, 2017-2027 13
Figure 3: Unmet Needs for the Treatment of Osteoporosis, 2017 14
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in Osteoporosis, 2017-2027 16
Figure 5: Global (7MM) Sales Forecast by Drug Class for Osteoporosis, 2017-2027 17
Figure 6: Etiology of Osteoporosis 21
Figure 7: 7MM, Age-Standardized Total Prevalence of Osteoporosis, Men and Women, Ages 30 Years, 2017 32
Figure 8: 7MM, Age-Standardized Diagnosed Prevalence of Osteoporosis, Men and Women, Ages 30 Years, 2017 32
Figure 9: 7MM, Sources Used and Not Used to Forecast Total Prevalent Cases of Osteoporosis 34
Figure 10: 7MM, Sources Used to Forecast Total Prevalent Cases and Diagnosed Prevalent Cases of Primary and Secondary Osteoprosis 35
Figure 11: 7MM, Sources Used to Forecast Total Prevalent Cases of Osteopenia 35
Figure 12: 7MM, Sources Used to Forecast Diagnosed Prevalent Cases of Osteoporosis 36
Figure 13: 7MM, Sources Used to Forecast Diagnosed Prevalent Cases of Osteopenia 36
Figure 14: 7MM, Total Prevalent Cases of Osteoporosis, Both Sexes, Ages 30 Years, N, 2017 46
Figure 15: 7MM, Age-Specific Total Prevalent Cases of Osteoporosis, Both Sexes, Ages 30 Years, N, 2017 47
Figure 16: 7MM, Sex-Specific Total Prevalent Cases of Osteoporosis, Both Sexes, Ages 30 Years, N, 2017 48
Figure 17: 7MM, Total Prevalent Cases of Osteoporosis Secondary to Glucocorticoid Use, Both Sexes, Ages 30 Years, N, 2017 50
Figure 18: 7MM, Diagnosed Prevalent Cases of Osteoporosis, Both Sexes, Ages 30 Years, N, 2017 51
Figure 19: 7MM, Age-Specific Diagnosed Prevalent Cases of Osteoporosis, Both Sexes, Ages 30 Years, N, 2017 52
Figure 20: 7MM, Sex-Specific Diagnosed Prevalent Cases of Osteoporosis, Both Sexes, Ages 30 Years, N, 2017 53
Figure 21: 7MM, Diagnosed Prevalent Cases of Osteoporosis Secondary to Glucocorticoid Use, Both Sexes, Ages 30 Years, N, 2017 55
Figure 22: Osteoporosis Treatment Algorithm 62
Figure 23: Level of Use versus Line of Therapy for Currently Marketed Therapies for Osteoporosis 64
Figure 24: Unmet Needs for the Treatment of Osteoporosis, 2017 119
Figure 25: Overview of the Development Pipeline in Osteoporosis, March 2018 126
Figure 26: Osteoporosis Therapeutics - Ongoing Clinical Trials by Development Stage, January 2018 127
Figure 27: Osteoporosis - Key Phase IIB-III Clinical Trials, 2017 129
Figure 28: Competitive Assessment of Late-Stage Pipeline Agents in Osteoporosis, 2017-2027 130
Figure 29: Clinical and Commercial Positioning - Evenity, 2017 138
Figure 30: Global Sales of Branded Osteoporosis Products by Company, 2017-2027 144
Figure 31: Company Portfolio Gap Analysis in Osteoporosis, 2017-2027 145
Figure 32: Global (7MM) Sales Forecast by Country for Osteoporosis in 2017 and 2027 154
Figure 33: Global (7MM) Sales Forecast by Drug Class for Osteoporosis in 2017 and 2027 155
Figure 34: Global (7MM) Sales Forecast by Drug Class for Osteoporosis, 2017-2027 156
Figure 35: Global (7MM) Sales Forecast by Osteoporosis Patient Segment, 2017-2027 157
Figure 36: US Sales Forecast by Drug Class for Osteoporosis in 2017 and 2027 159
Figure 37: 5EU Sales Forecast by Country for Osteoporosis in 2017 and 2027 162
Figure 38: 5EU Sales Forecast by Drug Class for Osteoporosis in 2017 and 2027 163
Figure 39: Japan Sales Forecast by Drug Class for Osteoporosis in 2017 and 2027 166

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