Pipeline Insight: Osteoporosis - Intermittent dosing drives market growth
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the osteoporosis market - page 4
- Key metrics - page 5
- Datamonitor Pipeline Assessment Summary - page 6
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS - page 8
- Pipeline overview - page 10
- Traditional, well-stocked pipeline - page 10
- Growing PTH class hints at upcoming innovation - page 11
- Reformulation as a substitute for innovation - page 12
- Osteoporosis drug development not limited to big pharma - page 12
- Key companies involved in the osteoporosis pipeline - page 12
- Merck & Co.: coping with change - page 12
- Merck's line expands, but the patent is wide open - page 13
- Limited hope in the pipeline - page 14
- Novartis: an old player with new strategies - page 14
- Osteoporosis indication a key driver in Zometa growth - page 14
- New classes and patent expiration represent threats - page 15
- GlaxoSmithKline: A newcomer with a long-term approach - page 17
- Boniva as a learning curve - page 17
- Pipeline hints at future success - page 17
- Merck & Co.: coping with change - page 12
- Key R&D company strategies - page 17
- Optimizing administration - page 18
- Yearly dosing has potential as the next stage in intermittent dosing - page 18
- Options in delivery mode maintain whole brand sales - page 19
- The addition of mineral supplements: calcium and vitamin D - page 19
- Additional dose calcium satisfies physicians' demands - page 20
- Combining vitamin D aids Merck's key brand's lifecycle - page 21
- Genericization: if you can not beat them, join them - page 21
- Optimizing administration - page 18
- Pipeline overview - page 10
- CHAPTER 3 OSTEOPOROSIS - MARKET POTENTIAL - page 23
- Definition of osteoporosis - page 23
- Etiology of osteoporosis - page 24
- Osteoporosis classification: primary and secondary - page 24
- Pathology and complications - page 25
- Development of osteoporosis drugs - page 26
- Etiology of osteoporosis - page 24
- Segmentation of osteoporosis - page 27
- Severity - page 27
- Gender: osteoporosis in men - page 29
- Niche populations - page 29
- Glucocorticoid-induced osteoporosis - page 30
- Paget's disease - page 31
- CNS disorder-related fracture risk - page 32
- Ethnic diversity - page 33
- Prostate cancer - page 33
- Premature menopause - page 34
- HIV - page 35
- Anorexia nervosa - page 35
- Epidemiology of osteoporosis - page 36
- Methodological difficulties in assessing prevalence - page 36
- Prevalence of osteoporosis and osteopenia in postmenopausal women - page 37
- Overview of the prevalence of osteoporosis and osteopenia in postmenopausal women - page 38
- US - page 41
- Japan - page 41
- France - page 42
- Germany - page 43
- Italy - page 43
- Spain - page 44
- UK - page 45
- Prevalence of osteoporosis and osteopenia in men - page 45
- Introduction - page 45
- Overview of the prevalence of osteoporosis/osteopenia in men - page 46
- US - page 47
- Japan - page 48
- France - page 48
- Germany - page 49
- Italy - page 49
- Spain - page 49
- UK - page 50
- Osteoporotic fractures, their implications and minor risk groups - page 50
- Introduction - page 50
- Limitations of fracture prevalence data - page 51
- Overview of fracture prevalence - page 51
- US - page 52
- Japan - page 53
- France - page 53
- Germany - page 54
- Italy - page 54
- Spain - page 54
- UK - page 55
- Epidemiological trends - page 56
- Unmet needs in osteoporosis - page 58
- Unmet clinical needs - page 58
- Need for improved compliance - page 58
- Need for efficacy at least equivalent to Fosamax and Actonel - page 60
- Need for surrogate endpoint efficacy - page 61
- Need for efficacy at the hip - page 62
- Unmet environmental needs - page 62
- Need for increased patient identification, treatment rates and use of appropriate treatments in each patient - page 63
- Need for primary prevention in osteoporosis - preventing the first fracture reduces the future fracture burden - page 64
- Need for greater recognition of secondary causes of osteoporosis - page 66
- Need for greater recognition of male osteoporosis and causes of secondary osteoporosis in men for screening or case-finding purposes - page 67
- Unmet clinical needs - page 58
- Definition of osteoporosis - page 23
- CHAPTER 4 R&D APPROACH - page 68
- Classification of pipeline products - page 68
- Bisphosphonates - page 68
- Mechanism of action - page 69
- Class breakdown - page 70
- The gold standard therapy: Fosamax - page 70
- Bisphosphonates threatened by genericization - page 71
- Pipeline bisphosphonates - page 73
- SERMs - page 73
- Mechanism of action - page 73
- Pipeline SERMs - page 74
- Calcitonins - page 74
- Mechanism of action - page 75
- Pipeline calcitonins - page 76
- Parathyroid hormone (PTH) and analogues - page 76
- Mechanism of action - page 77
- Pipeline PTH - page 77
- Dual action bone agents (strontium ranelate) - page 78
- Mechanism of action - page 78
- Pipeline DABAs - page 79
- Hormone replacement therapy (HRT) - page 79
- Mechanism of action - page 79
- Class breakdown - page 79
- Pipeline hormonal therapies - page 80
- Vitamin D - page 80
- Mechanism of action - page 81
- Pipeline vitamin D - page 82
- Other mechanisms of action - page 82
- Monoclonal antibodies - page 83
- Cathepsin K inhibitors - page 83
- Bisphosphonates - page 68
- Clinical trial design in osteoporosis - page 84
- Clinical trial guidelines - page 84
- Pre-clinical planning: use of animal models - page 84
- Prevention and treatment: the implications for endpoint selection - page 85
- Trial design and study population - page 86
- Osteoporosis trial design and execution: can anything replace fracture data? - page 86
- Problems with definitions: a need for greater consistency - page 86
- Large-scale trials: can surrogate endpoints ever predict fracture risk? - page 86
- The ethics of placebo-controlled trials: is there a realistic alternative? - page 87
- Recruiting the right study population - page 88
- Clinical trial guidelines - page 84
- Clinical trial endpoints in osteoporosis - page 88
- Fracture rate - page 89
- Significance of fracture rate as an endpoint - page 89
- Considerations with fracture endpoints - page 90
- Changes in BMD - page 91
- Significance of BMD as an endpoint - page 91
- Limitations of BMD as a clinical trial endpoint - page 92
- Biochemical markers of bone turnover - page 93
- How useful are bone markers? - page 94
- Limitations in the use of bone-specific markers - page 94
- Surrogate endpoints: predicting fracture risk - page 95
- Changes in bone microarchitecture - page 95
- Problems associated with microarchitecture assessment - page 96
- Fracture rate - page 89
- Classification of pipeline products - page 68
- CHAPTER 5 BISPHOSPHONATE LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 97
- Comparative forecasts - page 97
- Comparative Datamonitor drug assessment summaries - page 98
- Overview for bisphosphonates - page 98
- Definition of current comparator therapy - Fosamax - page 99
- Clinical trial data - page 100
- Definition of current comparator therapy - Fosamax - page 99
- Aclasta/Reclast (zoledronate/zoledronic acid) - page 102
- Drug profile - page 102
- Clinical trial data - page 102
- Patient potential - page 104
- Marketing factors - page 108
- Satisfaction of unmet needs - page 109
- Forecasts to 2016 - page 110
- Datamonitor drug assessment summary - page 113
- Drug profile - page 102
- Bisponal/ONO-5920 (minodronic acid hydrate) - page 113
- Drug profile - page 113
- Clinical trial data - page 114
- Patient potential - page 116
- Market potential - page 117
- Satisfaction of unmet needs - page 117
- Forecasts to 2016 - page 118
- Datamonitor drug assessment summary - page 120
- Drug profile - page 113
- MER-103 (alendronate sodium) - page 120
- Drug profile - page 120
- Clinical trial data - page 121
- Patient potential - page 122
- Market potential - page 123
- Satisfaction of unmet needs - page 123
- Forecasts to 2016 - page 124
- Datamonitor drug assessment summary - page 126
- Drug profile - page 120
- Other drugs in the bisphosphonate class - page 126
- Nerixia (neridronic acid) - page 126
- Abiogen's expertise may offset a halting development - page 126
- Nerixia (neridronic acid) - page 126
- CHAPTER 6 SERMS LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 128
- Overview for SERMs - page 128
- Definition of current comparator therapy - Evista - page 129
- Bazedoxifene - page 131
- Drug profile - page 131
- Clinical trial data for the treatment of osteoporosis - page 132
- Clinical trial data for the prevention of osteoporosis - page 132
- Patient potential - page 134
- Marketing factors - page 135
- Satisfaction of unmet needs - page 137
- Forecasts to 2016 - page 138
- Datamonitor drug assessment summary - page 140
- Drug profile - page 131
- Other drugs in the SERM class - page 140
- Arzoxifene (LY353381) - page 140
- Lilly's Evista follow on? - page 140
- PSK-3471 - page 142
- Arzoxifene (LY353381) - page 140
- Overview for SERMs - page 128
- CHAPTER 7 CALCITONIN LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 143
- Overview for calcitonins - page 143
- Definition of current comparator therapy - Miacalcin - page 143
- Clinical trial data - page 144
- Definition of current comparator therapy - Miacalcin - page 143
- BN-002 - page 145
- Drug profile - page 145
- Clinical trial data - page 146
- Patient potential - page 147
- Marketing factors - page 148
- Satisfaction of unmet needs - page 149
- Forecasts to 2016 - page 149
- Datamonitor drug assessment summary - page 151
- Drug profile - page 145
- Overview for calcitonins - page 143
- CHAPTER 8 PTH LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 153
- Comparative forecasts - page 153
- Comparative Datamonitor drug assessment summaries - page 153
- Overview of PTH - page 154
- Definition of current comparator therapy - Forteo - page 155
- hPTH (1-34) - page 157
- Drug profile - page 157
- Clinical trial data - page 157
- Patient potential - page 158
- Marketing factors - page 159
- Satisfaction of unmet needs - page 159
- Forecasts to 2016 - page 160
- Datamonitor drug assessment summary - page 162
- Drug profile - page 157
- Ostabolin-C - page 162
- Drug profile - page 162
- Clinical trials - page 163
- Patient potential - page 164
- Marketing potential - page 164
- Satisfaction of unmet need - page 165
- Forecasts to 2016 - page 165
- Datamonitor drug assessment summary - page 167
- Drug profile - page 162
- Other drugs in the PTH class - page 168
- MBRI-93.02 (hPTH) - page 168
- Unhampered development will allay looming class competition - page 168
- MBRI-93.02 (hPTH) - page 168
- CHAPTER 9 OTHER DRUGS LATE-STAGE ANALYSIS AND FORECASTS - page 170
- Comparative forecasts - page 170
- Comparative Datamonitor drug assessment summaries - page 170
- Overview of 'other drugs' - page 171
- Definition of current comparator therapy - page 172
- Denosumab (AMG-162) - page 172
- Drug profile - page 172
- Clinical trial data - page 173
- Patient potential - page 176
- Marketing potential - page 176
- Satisfaction of unmet needs - page 178
- Forecasts to 2016 - page 178
- Datamonitor drug assessment summary - page 180
- Drug profile - page 172
- ED-71 - page 181
- Drug profile - page 181
- Clinical trial data - page 182
- Patient potential - page 184
- Marketing potential - page 184
- Satisfaction of unmet needs - page 185
- Forecasts to 2016 - page 186
- Datamonitor drug assessment summary - page 187
- Drug profile - page 181
- Other drugs in the class - page 188
- MK-0822 - page 188
- Merck diversifies to cathepsin K inhibitors in the event of falling bisphosphonate sales - page 188
- NBS-101 - page 189
- Clinical and commercial doubt surrounds DABA - page 189
- SHT-546 - page 190
- MK-0822 - page 188
- CHAPTER 10 INNOVATIVE EARLY-STAGE PROJECTS - page 192
- Key Phase I compounds in osteoporosis - page 192
- ACE-011 - page 193
- Potential to pioneer the provision of anti-resorptive and anabolic activity - page 193
- Changing the face of osteoporosis treatment - page 193
- Acceleron should optimize interest in ACE-011 - page 193
- Potential to pioneer the provision of anti-resorptive and anabolic activity - page 193
- 2MD - page 194
- A high risk strategy for Pfizer - page 194
- Early results indicate a potent anabolic agent - page 194
- ED-71's progress represents a useful guide - page 194
- A high risk strategy for Pfizer - page 194
- Raloxifene (extended release) - page 195
- A reformulation to rival Evista - page 195
- Proprietary technology improves bioavailability - page 195
- External influences on SERM commercialization must be considered - page 196
- A reformulation to rival Evista - page 195
- BIBLIOGRAPHY - page 197
- Journal papers and conference abstracts - page 197
- Websites - page 204
- APPENDIX A - page 207
- Methodology - page 207
- Datamonitor forecast methodology - page 207
- Market sizing - page 207
- Estimated 2006 sales revenue - page 208
- Osteoporosis specific sales calculations - page 208
- Product forecasts - page 208
- Estimation of launch dates - page 209
- Definition of a standard unit - page 209
- Japanese market data - page 209
- Patient expiry and generic assumptions - page 209
- Datamonitor drug assessment summary - page 212
- Datamonitor forecast methodology - page 207
- Contributing experts - page 213
- Report methodology - page 214
- Methodology - page 207
- APPENDIX B - page 215
- About Datamonitor - page 215
- About Datamonitor Healthcare - page 215
- Datamonitor Healthcare's therapy area capabilities - page 216
- About the Women's Health analysis team - page 217
- Disclaimer - page 218
- About Datamonitor - page 215
- List of Tables
- Table 1: Forecast key pipeline products for osteoporosis in the seven major markets ($), 2006-2016 - page 5
- Table 2: R&D pipeline in osteoporosis, 2007 - page 8
- Table 3: Causes of secondary (Type III) osteoporosis - page 25
- Table 4: World Health Organization classification of osteoporotic bone loss - page 28
- Table 5: Epidemiology overview of osteoporosis - page 39
- Table 6: Prevalence of osteopenia and osteoporosis in postmenopausal women across the seven major markets, 2007 - page 40
- Table 7: Prevalence of osteopenia and osteoporosis in men over 50 in the seven major markets, 2007 - page 47
- Table 8: Prevalence of vertebral fractures in men and women over 50 in the seven major markets, 2007 - page 52
- Table 9: UN projected population aged 50 years and over in 2017 - page 56
- Table 10: Summary of therapeutic classes in osteoporosis, by ATC code in alphabetical order - page 68
- Table 11: Overview of currently marketed bisphosphonates indicated for use in osteoporosis treatment and prevention, 2007 - page 69
- Table 12: Overview of currently marketed SERM indicated for use in osteoporosis treatment and prevention, 2007 - page 73
- Table 13: Overview of currently marketed calcitonins indicated for use in osteoporosis treatment and prevention, 2007 - page 74
- Table 14: Overview of currently marketed PTH drugs indicated for use in osteoporosis treatment and prevention, 2007 - page 76
- Table 15: Overview of currently marketed DABA products indicated for use in osteoporosis treatment and prevention, 2007 - page 78
- Table 16: Quantitative measures used for clinical efficacy endpoints in osteoporosis - page 89
- Table 17: Summary of the biochemical markers of bone resorption and formation used to measure rate of bone turnover - page 93
- Table 18: Late-stage bisphosphonates in development for osteoporosis - page 99
- Table 19: Fosamax: key facts - page 99
- Table 20: Defining the gold standard: key clinical trial results for Fosamax - page 101
- Table 21: Novartis's HORIZON trial design, 2003 - page 103
- Table 22: Key events, approval and launch dates impacting Aclasta revenue forecasts for osteoporosis in the seven major markets, 2007-2016 - page 111
- Table 23: Key events, approval and launch dates impacting Bisponal revenue forecasts for osteoporosis in the seven major markets, 2007-2016 - page 118
- Table 24: Key events, approval and launch dates impacting MER-103 revenue forecasts for osteoporosis in the seven major markets, 2007-2016 - page 124
- Table 25: Late-stage SERMs in development for osteoporosis - page 128
- Table 26: Evista key facts - page 129
- Table 27: Key events, approval and launch dates impacting bazedoxifene revenue forecasts for osteoporosis in the seven major markets, 2007-2016 - page 138
- Table 28: Late-stage calcitonins in development for osteoporosis - page 143
- Table 29: Miacalcin: key facts - page 144
- Table 30: Forthcoming trials for BN-002 - page 146
- Table 31: Key events, approval and launch dates impacting BN-002 revenue forecasts for osteoporosis in the seven major markets, 2007-2016 - page 150
- Table 32: Late-stage PTH in development for osteoporosis - page 155
- Table 33: Forteo: key facts - page 155
- Table 34: Key events, approval and launch dates impacting hPTH revenue forecasts for osteoporosis in the seven major markets, 2007-2016 - page 160
- Table 35: Key events, approval and launch dates impacting Ostabolin-C revenue forecasts for osteoporosis in the seven major markets, 2007-2016 - page 166
- Table 36: Other late-stage drugs in development for osteoporosis - page 172
- Table 37: Key events, approval and launch dates impacting Denosumab revenue forecasts for osteoporosis in the seven major markets, 2007-2016 - page 179
- Table 38: Key events, approval and launch dates impacting ED-71 revenue forecasts for osteoporosis in the seven major markets, 2007-2016 - page 186
- Table 39: Drugs in Phase I and preclinical development for osteoporosis, 2007 - page 192
- Table 40: Summary of therapeutic classes in osteoporosis, by ATC code in alphabetical order - page 207
- Table 41: Estimation of launch dates by phase of development - page 209
- Table 42: Estimated generic discounts by country, 2006* - page 210
- Table 43: Estimates of brand erosion by following patent expiry by country - page 211
- Table 44: Weightings of research and clinical factors used for pipeline drug assessment - page 212
- Table 45: Weightings of commercial factors used for pipeline drug assessment - page 213
- List of Figures
- Figure 1: Datamonitor's osteoporosis drug assessment summary for the seven major markets, 2007-2016 - page 6
- Figure 2: Osteoporosis pipeline breakdown by development phase, 2007 - page 10
- Figure 3: The osteoporosis pipeline by phase and class of drug, 2007 - page 11
- Figure 4: Osteoporosis drugs and their overlap into other indications - page 27
- Figure 5: Unmet clinical needs in osteoporosis, 2007 - page 58
- Figure 6: Unmet environmental needs in osteoporosis, 2007 - page 63
- Figure 7: Schematic showing steps of vitamin D activation - page 82
- Figure 8: Datamonitor's comparative forecast of sales for the bisphosphonates across the seven major markets ($m), 2007-2016e - page 97
- Figure 9: Datamonitor's competitive positioning analysis for Aclasta, MER-103 and Bisponal in the seven major markets, 2007-2016 - page 98
- Figure 10: Datamonitor's forecast of sales for Aclasta across the seven major markets ($m), 2007-2016 - page 112
- Figure 11: Datamonitor's competitive positioning analysis for Aclasta in the seven major markets, 2007-2016 - page 113
- Figure 12: Datamonitor's forecast of sales for Bisponal across the seven major markets ($m), 2007-2016 - page 119
- Figure 13: Datamonitor's competitive positioning analysis for Bisponal in the seven major markets, 2007-2016 - page 120
- Figure 14: Datamonitor's forecast of sales for MER-103 across the seven major markets ($m), 2007-2016 - page 125
- Figure 15: Datamonitor's competitive positioning analysis for MER-103 in the seven major markets, 2007-2016 - page 126
- Figure 16: Datamonitor's forecast of sales for bazedoxifene across the seven major markets ($m), 2007-2016 - page 139
- Figure 17: Datamonitor's competitive positioning analysis for bazedoxifene in the seven major markets, 2007-2016 - page 140
- Figure 18: Datamonitor's forecast of sales for BN-002 across the seven major markets ($m), 2007-2016 - page 151
- Figure 19: Datamonitor's competitive positioning analysis for BN-002 in the seven major markets, 2007-2016 - page 152
- Figure 20: Datamonitor's comparative forecast of sales for PTH across the seven major markets ($m), 2007-2016 - page 153
- Figure 21: Datamonitor's competitive positioning analysis for Ostabolin-C and hPTH in the seven major markets, 2007-2016 - page 154
- Figure 22: Datamonitor's forecast of sales for hPTH across the seven major markets ($m), 2007-2016 - page 161
- Figure 23: Datamonitor's competitive positioning analysis for hPTh in the seven major markets, 2007-2016 - page 162
- Figure 24: Datamonitor's forecast of sales for Ostabolin-C across the seven major markets ($m), 2007-2016 - page 167
- Figure 25: Datamonitor's competitive positioning analysis for Ostabolin-C in the seven major markets, 2007-2016 - page 168
- Figure 26: Datamonitor's comparative forecast of sales for 'other drugs' across the seven major markets ($m), 2007-2016 - page 170
- Figure 27: Datamonitor's competitive positioning analysis for Denosumab and ED-71 in the seven major markets, 2007-2016 - page 171
- Figure 28: Datamonitor's forecast of sales for Denosumab across the seven major markets ($m), 2007-2016 - page 180
- Figure 29: Datamonitor's competitive positioning analysis for Denosumab in the seven major markets, 2007-2016 - page 181
- Figure 30: Datamonitor's forecast of sales for ED-71 across the seven major markets ($m), 2007-2016 - page 187
- Figure 31: Datamonitor's competitive positioning analysis for ED-71 in the seven major markets, 2007-2016 - page 188
Other users found this report page using the following search terms: osteoporosis bone menopause osteoporosis pipeline denosumab market atc datamonitor patent class pth share
If you can't find a report that meets your needs contact LeadDiscovery. We are one of the few report providers with extensive drug development experience and we frequently use this knowledge to help clients source the most appropriate reports or produce reports for them from scratch.