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Osteoporosis: Global Drug Forecast and Market Analysis to 2027

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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 Health's 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.

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Table Of Content

Scope

1 Table of Contents

1 Table of Contents 2

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 Figure

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


List Of Table

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: Amgen's Osteoporosis Portfolio Assessment, 2018 148

Table 60: Eli Lilly's Osteoporosis Assessment, 2018 149

Table 61: Radius Health's Osteoporosis Assessment, 2018 151

Table 62: UCB's 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

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Products and Companies


Companies

Amgen

Eli Lilly

Radius Health

UCB