Osteoporosis Market and Forecast Analysis

CONTENTS

9 FORECAST: OSTEOPOROSIS (Published on 31 May 2017)
9 OVERVIEW
10 EXECUTIVE SUMMARY
11 MARKET OVERVIEW AND TRENDS
28 MARKET DEFINITION AND METHODOLOGY
35 ACTONEL (RISEDRONATE)
40 BONIVA (IBANDRONATE)
45 DUAVEE ([CONJUGATED ESTROGENS + BAZEDOXIFENE])
48 EDIROL (ELDECALCITOL)
52 EVENITY (ROMOSOZUMAB)
55 EVISTA (RALOXIFENE)
58 FORTEO (TERIPARATIDE) AND MOVYMIA (TERIPARATIDE)
65 FOSAMAX (ALENDRONATE)
70 PROLIA (DENOSUMAB)
76 RECLAST (ZOLEDRONIC ACID)
79 TYMLOS (ABALOPARATIDE)
83 PRIMARY RESEARCH METHODOLOGY

85 TREATMENT: OSTEOPOROSIS (Published on 23 March 2017)
85 OVERVIEW
86 EXECUTIVE SUMMARY
87 PRIMARY RESEARCH METHODOLOGY
90 DISEASE DEFINITION AND DIAGNOSIS
96 PATIENT SEGMENTATION
97 CURRENT TREATMENT OPTIONS
100 PRESCRIBING TRENDS
103 TREATMENT TRENDS IN OSTEOPENIA
110 TREATMENT TRENDS IN OSTEOPOROSIS
117 TREATMENT TRENDS IN SEVERE OSTEOPOROSIS
121 COMPLIANCE RATES
122 UNMET NEEDS IN OSTEOPOROSIS

123 EPIDEMIOLOGY: OSTEOPOROSIS (Published on 02 January 2019)
123 OVERVIEW
124 DISEASE BACKGROUND
126 METHODOLOGY
130 FORECAST: OSTEOPENIA
135 FORECAST: OSTEOPOROSIS
140 BIBLIOGRAPHY
141 APPENDIX: ADDITIONAL SOURCES

142 MARKETED DRUGS: OSTEOPOROSIS (Published on 09 March 2018)
142 OVERVIEW
143 PRODUCT OVERVIEW
144 BISPHOSPHONATES
147 ESTROGENS AND SERMS
150 CALCITONIN
152 ANABOLIC THERAPIES
153 OTHER DRUG CLASSES
154 PRODUCT PROFILE: FORTEO
167 PRODUCT PROFILE: PROLIA
178 PRODUCT PROFILE: TYMLOS

188 PIPELINE: OSTEOPOROSIS (Published on 09 March 2018)
188 OVERVIEW
189 CLINICAL PIPELINE OVERVIEW
190 COMPARATOR THERAPY
195 RECENTLY DISCONTINUED DRUGS
199 ADDITIONAL PHARMA INTELLIGENCE PIPELINE RESOURCES
200 PRODUCT PROFILE (LATE STAGE): EVENITY

LIST OF FIGURES
11 Figure 1: Osteoporosis drug sales across the US, Japan, and five major EU markets, by country, 2016–25
13 Figure 2: Osteoporosis sales in the US, by class, 2016–25
17 Figure 3: Osteoporosis sales for Edirol, generic eldecalcitol, Forteo, and Evenity in Japan, by product, 2016–25
25 Figure 4: Osteoporosis sales for Forteo, Movymia, biosimilar teriparatide, Evenity, and Tymlos across the US, Japan, and five major EU markets, 2016–25
26 Figure 5: Osteoporosis sales for branded and generic bisphosphonates across the US, Japan, and five major EU markets, 2016–25
30 Figure 6: Patient-based forecast methodology for osteoporosis
32 Figure 7: Price sources and calculations, by country
36 Figure 8: Actonel sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
38 Figure 9: Generic risedronate sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
41 Figure 10: Boniva sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
43 Figure 11: Generic ibandronate sales for osteoporosis across the US, Germany, Italy, Spain, and the UK, by country, 2016–25
46 Figure 12: Duavee sales for osteoporosis across the US and Italy, by country, 2016–25
49 Figure 13: Edirol sales for osteoporosis in Japan, 2016–25
50 Figure 14: Generic eldecalcitol sales for osteoporosis in Japan, 2016–25
53 Figure 15: Evenity sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
56 Figure 16: Evista sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
59 Figure 17: Forteo sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
61 Figure 18: Movymia sales for osteoporosis across the five major EU markets, by country, 2016–25
63 Figure 19: Biosimilar teriparatide sales for osteoporosis in the US, 2016–25
66 Figure 20: Fosamax sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
68 Figure 21: Generic alendronate sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
71 Figure 22: Prolia sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
73 Figure 23: Biosimilar denosumab sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
77 Figure 24: Reclast sales for osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
80 Figure 25: Tymlos sales for osteoporosis across the US and five major EU markets, by country, 2016–25
93 Figure 26: Percentage of patients with low bone mass diagnosed at each disease subtype for the US, Japan, and five major EU markets
96 Figure 27: Segmentation of patients suffering from low bone mass in the US, Japan, and five major EU markets, by disease severity and country
102 Figure 28: Percentage of patients receiving each line of therapy, by severity
103 Figure 29: Percentage of diagnosed patients receiving each type of therapy for the treatment of osteopenia, by country
104 Figure 30: Percentage of diagnosed patients receiving each class of pharmacological therapy for the first-line treatment of osteopenia, by country
105 Figure 31: Top three first-line treatment regimens for osteopenia patients, by country
110 Figure 32: Percentage of diagnosed patients receiving each type of therapy for the treatment of osteoporosis, by country
112 Figure 33: Percentage of diagnosed patients receiving each class of pharmacological therapy for the first-line treatment of osteoporosis, by country
113 Figure 34: Top three first-line treatment regimens for osteoporosis patients, by country
114 Figure 35: Top three second-line treatment regimens for osteoporosis patients, by country
115 Figure 36: Top three third-line treatment regimens for osteoporosis patients, by country
117 Figure 37: Top three first-line treatment regimens for severe osteoporosis patients, by country
119 Figure 38: Top three second-line treatment regimens for severe osteoporosis patients, by country
120 Figure 39: Percentage of diagnosed patients receiving each class of pharmacological therapy for the third-line treatment of severe osteoporosis, by country
121 Figure 40: Compliance rates of patients suffering from low bone mass in the US, Japan, and five major EU markets, by country and disease subtype
122 Figure 41: Key unmet needs in osteoporosis treatment across the US, Japan, and five major EU markets
134 Figure 42: Trends in total prevalent cases of osteopenia in the US, Japan, and five major EU markets, by country, 2018–38
139 Figure 43: Trends in total prevalent cases of osteoporosis in the US, Japan, and five major EU markets, by country, 2018–38
161 Figure 44: Forteo for osteoporosis – SWOT analysis
162 Figure 45: Datamonitor Healthcare’s drug assessment summary of Forteo for osteoporosis
163 Figure 46: Datamonitor Healthcare’s drug assessment summary of Forteo for osteoporosis
172 Figure 47: Prolia for osteoporosis – SWOT analysis
173 Figure 48: Datamonitor Healthcare’s drug assessment summary of Prolia for osteoporosis
174 Figure 49: Datamonitor Healthcare’s drug assessment summary of Prolia for osteoporosis
182 Figure 50: Tymlos for osteoporosis – SWOT analysis
183 Figure 51: Datamonitor Healthcare’s drug assessment summary of Tymlos for osteoporosis
184 Figure 52: Datamonitor Healthcare’s drug assessment summary of Tymlos for osteoporosis
205 Figure 53: Evenity for osteoporosis – SWOT analysis
206 Figure 54: Datamonitor Healthcare’s drug assessment summary of Evenity for osteoporosis
207 Figure 55: Datamonitor Healthcare’s drug assessment summary of Evenity for osteoporosis

LIST OF TABLES
12 Table 1: Osteoporosis drug sales across the US, Japan, and five major EU markets, by country ($m), 2016–25
14 Table 2: Osteoporosis sales in the US, by brand and class ($m), 2016–25
18 Table 3: Osteoporosis sales in Japan, by brand and class ($m), 2016–25
21 Table 4: Osteoporosis sales in the five major EU markets, by brand and class ($m), 2016–25
29 Table 5: Summary of drug classes and molecules in Datamonitor Healthcare’s osteoporosis patient-based forecast
33 Table 6: Exchange rates used for calculating prices
33 Table 7: Patent expiry dates for key marketed brands in osteoporosis across the US, Japan, and five major EU markets, by country, 2016–25
34 Table 8: Estimated launch dates for key late-stage osteoporosis pipeline candidates in the US, Japan, and five major EU markets, by country, 2016–25
37 Table 9: Actonel sales for osteoporosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
39 Table 10: Generic risedronate sales for osteoporosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
42 Table 11: Boniva sales for osteoporosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
44 Table 12: Generic ibandronate sales for osteoporosis across the US, Germany, Italy, Spain, and the UK, by country ($m), 2016–25
46 Table 13: Duavee sales for osteoporosis across the US and Italy, by country ($m), 2016–25
49 Table 14: Edirol sales for osteoporosis in Japan ($m), 2016–25
50 Table 15: Generic eldecalcitol sales for osteoporosis in Japan ($m), 2016–25
54 Table 16: Evenity sales for osteoporosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
57 Table 17: Evista sales for osteoporosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
60 Table 18: Forteo sales for osteoporosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
62 Table 19: Movymia sales for osteoporosis across the five major EU markets, by country ($m), 2016–25
63 Table 20: Biosimilar teriparatide sales for osteoporosis in the US ($m), 2016–25
67 Table 21: Fosamax sales for osteoporosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
69 Table 22: Generic alendronate sales for osteoporosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
72 Table 23: Prolia sales for osteoporosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
74 Table 24: Biosimilar denosumab sales for osteoporosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
78 Table 25: Reclast sales for osteoporosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
81 Table 26: Tymlos sales for osteoporosis across the US and five major EU markets, by country ($m), 2016–25
83 Table 27: Physicians surveyed for the osteoporosis primary research study, 2016
87 Table 28: Physicians surveyed for the osteoporosis primary research study, 2016
90 Table 29: World Health Organization definitions of bone mass based on BMD
92 Table 30: Clinical risk factors included in FRAX scoring
97 Table 31: Selected bisphosphonates products for the treatment of osteoporosis across the US, Japan, and five major EU markets
98 Table 32: Selected SERMs and estrogen products for the treatment of osteoporosis across the US, Japan, and five major EU markets
98 Table 33: Calcitonin products for the treatment of osteoporosis across the US, Japan, and five major EU markets
99 Table 34: Other drugs available for the treatment of osteoporosis across the US, Japan, and five major EU markets
101 Table 35: Low bone mass patients treated with pharmacological therapy in the US, Japan, and five major EU markets, by country (%)
107 Table 36: Top three third-line treatment regimens for osteopenia patients, by country (%)
127 Table 37: Sources used for the epidemiological analysis of osteopenia and osteoporosis in the US, Japan, and five major EU markets, by country
131 Table 38: Total prevalent cases of osteopenia in the US, Japan, and five major EU markets, by country, 2018–38
136 Table 39: Total prevalent cases of osteoporosis in the US, Japan, and five major EU markets, by country, 2018–38
143 Table 40: Key marketed drugs for osteoporosis
144 Table 41: Bisphosphonate class overview
147 Table 42: Estrogens/SERMs class overview
150 Table 43: Salmon calcitonin class overview
152 Table 44: Anabolic class overview
153 Table 45: Other drug classes overview
154 Table 46: Forteo drug profile
156 Table 47: Forteo pivotal trial data in osteoporosis
159 Table 48: Forteo late-phase trial data in osteoporosis
167 Table 49: Prolia drug profile
169 Table 50: Prolia pivotal trial data in osteoporosis
171 Table 51: Prolia late-phase trial data in osteoporosis
179 Table 52: Tymlos drug profile
180 Table 53: Tymlos Phase III trial data in osteoporosis
181 Table 54: Tymlos planned Phase III trials in osteoporosis
189 Table 55: Phase III pipeline products in development for osteoporosis
191 Table 56: Forteo drug profile
193 Table 57: Forteo trial data in osteoporosis
195 Table 58: Late-stage compounds that were recently discontinued for osteoporosis
196 Table 59: Odanacatib drug profile
197 Table 60: Odanacatib trial data in osteoporosis
201 Table 61: Evenity drug profile
203 Table 62: Evenity pivotal trial data in osteoporosis
204 Table 63: Evenity other late-phase trials in osteoporosis