Pipeline Insight: Endometriosis - Growing the Patient Population is Key to Unlocking the Market's Co
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Women's Health pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the endometriosis market - page 4
- CHAPTER 2 PATIENT POTENTIAL - page 15
- Definition of endometriosis - page 15
- Classification of endometriosis - page 16
- Evolution of the classification system - page 17
- Etiology of endometriosis - theories abound - page 18
- Retrograde menstruation and implantation - page 19
- Lymphatic/vascular dissemination - page 19
- Developmental coelomic metaplasia - page 20
- Genetic predisposition - page 20
- Environmental factors - page 21
- Immunological susceptibility - page 21
- Dynamic progression of endometriosis - page 22
- Symptomatology - page 23
- Classification of endometriosis - page 16
- Segmentation of endometriosis - page 24
- Endometriosis and infertility - page 24
- Recurrence in endometriosis - page 25
- Epidemiology of endometriosis - page 26
- Prevalence estimates - page 26
- Prevalence of endometriosis in the general population - page 28
- Prevalence of endometriosis in the gynecologic population - page 28
- Limitations of epidmiology analysis - page 32
- Prevalence estimates - page 26
- Unmet need in endometriosis - page 33
- Need for more effective therapeutic options - page 33
- Potential to address fertility outcomes - page 34
- Long-term treatment and recurrence - page 35
- Need for drugs with improved tolerability and fewer side effects - page 36
- Need for greater awareness among PCPs and public - page 37
- Perception of symptoms as 'normal' limits the presented population - page 37
- Poor awareness among PCPs lengthens time to diagnosis - page 37
- Need for a non-invasive diagnostic test - page 39
- Need for more effective therapeutic options - page 33
- Definition of endometriosis - page 15
- CHAPTER 3 R&D APPROACH - page 42
- Classification of pipeline products - page 42
- GnRH agonists - page 43
- GnRH agonist overview - page 44
- Lupron - the gold standard - page 45
- GnRH antagonists - page 48
- Danazol - page 49
- Efficacy - page 49
- Side effects - page 50
- Hormonal contraceptives - page 52
- Combined oral contraceptives - page 52
- Progestogen therapy - page 54
- Gestrinone - page 55
- GnRH agonists - page 43
- Clinical trial design in endometriosis - page 56
- Study parameters, definitions and methodology - page 56
- Placebo or active control? - page 56
- Trial size - page 57
- Length of study - page 58
- Clinical trial endpoints in endometriosis - page 59
- Symptom reduction - pain - page 59
- Improving complications - infertility - page 59
- QoL and patient satisfaction - page 60
- Regression of disease - page 60
- Classification of pipeline products - page 42
- CHAPTER 4 ENDOMETRIOSIS PIPELINE ANALYSIS - page 62
- Pipeline overview - page 62
- Key companies involved in the endometriosis pipeline - page 63
- Schering AG - page 63
- Marketed products do not target endometriosis - page 63
- Expanding women's health indication coverage - page 63
- TAP Pharmaceuticals - page 65
- Schering AG - page 63
- Strategies for success - page 66
- Tapping into the market - TAP's continuing investment in marketing and product line extension - page 66
- Dedicated detailing approach - page 66
- Continuing innovation - page 66
- Tapping into the market - TAP's continuing investment in marketing and product line extension - page 66
- Pipeline SWOT analysis: comparative parameters and definitions - page 68
- External factors - page 68
- Internal factors - page 70
- CHAPTER 5 GNRH ANTAGONIST LATE-STAGE DRUG ANALYSIS & FORECASTS - page 74
- Overview for GnRH antagonists - page 75
- Pipeline summary - page 75
- Definition of current comparator therapy - page 75
- Lupron - page 75
- Plenaxis (abarelix depot F) - page 78
- Profile - page 78
- Drug overview - page 81
- Clinical trial data - page 81
- Datamonitor comment - page 83
- Patient potential - page 84
- Marketing factors - page 84
- Satisfaction of unmet needs - page 86
- Forecasts to 2014 - page 87
- Profile - page 78
- Cetrorelix - page 88
- Profile - page 88
- Drug overview - page 90
- Clinical trial data - page 90
- Patient potential - page 92
- Marketing factors - page 92
- Satisfaction of unmet needs - page 93
- Forecasts to 2014 - page 94
- Profile - page 88
- Other drugs in the GnRH agonist/antagonist class - page 96
- Avorelin - page 96
- Sufugolix - page 96
- Comparison of key compounds in the GnRH agonist/antagonist class - page 96
- External factors - page 96
- Internal factors - page 97
- Drug profile - page 97
- Company - page 98
- Overview for GnRH antagonists - page 75
- CHAPTER 6 SELECTIVE PROGESTERONE RECEPTOR MODULATOR CLASS LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 100
- Overview - page 100
- Pipeline summary - page 100
- Definition of current comparator therapy - page 100
- Lupron - page 100
- Asoprisnil - page 101
- Profile - page 101
- Drug overview and clinical trial data - page 103
- Patient potential - page 104
- Marketing factors - page 104
- Satisfaction of unmet needs - page 106
- Forecasts to 2014 - page 107
- Profile - page 101
- Comparison of key compounds in the SPRM class - page 109
- External factors - page 109
- Internal factors - page 110
- Drug profile - page 110
- Company - page 110
- Overview - page 100
- CHAPTER 7 HORMONALS/ANTI-HORMONALS LATE-STAGE ANALYSIS AND FORECASTS - page 113
- Overview for hormonals - page 113
- Pipeline summary - page 113
- Definition of current comparator therapy - page 113
- Lupron - page 113
- Endometrion (dienogest) - page 114
- Profile - page 114
- Drug overview - page 117
- Clinical trial data - page 117
- Patient potential - page 123
- Marketing factors - page 124
- Satisfaction of unmet needs - page 126
- Forecasts to 2014 - page 127
- Profile - page 114
- Libra (deslorelin, estradiol and testosterone) - page 127
- Profile - page 127
- Drug overview - page 130
- Clinical trial data - page 130
- Patient potential - page 132
- Marketing factors - page 132
- Satisfaction of unmet needs - page 133
- Forecasts to 2014 - page 134
- Profile - page 127
- Comparison of key compounds in the hormonal/antihormonal class - page 134
- External factors - page 134
- Internal factors - page 135
- Drug profile - page 135
- Company - page 135
- Overview for hormonals - page 113
- CHAPTER 8 OTHER DRUGS LATE-STAGE ANALYSIS AND FORECASTS - page 138
- Overview for 'Other' class drugs - page 138
- Pipeline summary - page 138
- Definition of current comparator therapy - page 138
- Lupron - page 138
- FP1096 - page 139
- Profile - page 139
- Clinical trial data - page 141
- Patient potential - page 143
- Marketing factors - page 143
- Satisfaction of unmet needs - page 144
- Forecasts to 2014 - page 145
- Profile - page 139
- Comparison of key compounds in the 'other' class - page 146
- External factors - page 146
- Drug profile - page 146
- Company - page 146
- External factors - page 146
- Other drugs in the 'other' class - page 148
- Chronodyne (terbutaline) - page 148
- Overview for 'Other' class drugs - page 138
- CHAPTER 9 INNOVATIVE EARLY-STAGE PROJECTS - page 150
- Key Phase I and preclinical compounds in endometriosis - page 150
- GnRH antagonists - page 150
- Teverelix - page 150
- NBI-42902, NBI-56418 and other candidates - page 151
- TAK-810 - page 153
- GnRH agonists - page 153
- Leuprolide (inhaled) - page 153
- Eligard - page 153
- Antiprogestins - page 154
- Progenta - page 155
- GnRH antagonists - page 150
- Endometriosis market size estimate - page 155
- Methodology - page 155
- Key research impacts on endometriosis - page 159
- Will aromatase inhibitors offer the market anything new? Femara well placed to be first to market - page 159
- Key Phase I and preclinical compounds in endometriosis - page 150
- APPENDIX A - page 161
- Contributing experts - page 161
- Report methodology - page 161
- Japanese market data - page 161
- Regional launch dates for new products - page 161
- Standard units - page 161
- Pricing forecasts - page 162
- Bibliography - page 162
- APPENDIX B - page 166
- About Datamonitor - page 166
- About Datamonitor Healthcare - page 166
- Datamonitor Healthcare's research and analysis methodologies - page 167
- Datamonitor Healthcare's therapy area capabilities - page 167
- About the Disease analysis team - page 168
- Key therapy team members - page 169
- Name, Director Disease - page 169
- Disclaimer - page 170
- About Datamonitor - page 166
- List of Tables
- Table 1: Frequency and location of endometriosis implants in the pelvis - page 16
- Table 2: Frequency of symptoms among surgically diagnosed endometriosis patients - page 23
- Table 3: Common symptoms of endometriosis and other conditions - page 24
- Table 4: Epidemiology overview of endometriosis - page 27
- Table 5: Endometriosis prevalence in the general population (000s and %), 2004 - page 28
- Table 6: Endometriosis prevalence in the CPP (gynecologic) population (000s and %), 2004 - page 29
- Table 7: Endometriosis prevalence in the infertile (gynecologic) population (000s and %), 2004 - page 31
- Table 8: Overview of drug classes used to treat endometriosis - page 43
- Table 9: Overview of key marketed GnRH agonists - page 44
- Table 10: GnRH agonist sales by molecule in the seven major markets ($m), 2003 - page 45
- Table 11: TAP Lupron product range - page 46
- Table 12: Overview of marketed GnRH antagonists - page 48
- Table 13: Summary of endometriosis treatment with danazol - page 50
- Table 14: Incidence of side effects associated with danazol therapy - page 51
- Table 15: R&D pipeline in endometriosis, 2004 - page 62
- Table 16: Opportunities, factors and weightings - page 68
- Table 17: Opportunity/threat factors, scoring definitions - page 69
- Table 18: Strength/weakness, factors and weightings - page 70
- Table 19: Strengths/weakness, scoring definitions for drug factors - page 71
- Table 20: Strength/weakness, scoring definition for company factors - page 71
- Table 21: Side-effect scoring table for SWOT analysis - page 72
- Table 22: Key products in late-stage R&D pipeline for GnRH antagonists, 2004 - page 75
- Table 23: Lupron SWOT analysis score - page 76
- Table 24: Plenaxis SWOT analysis scores - page 80
- Table 25: Cetrorelix SWOT analysis scores - page 89
- Table 26: Key products in late-stage R&D pipeline for SPRMs, 2004 - page 100
- Table 27: Asoprisnil SWOT analysis scores - page 102
- Table 28: Key products in late-stage R&D pipeline for hormonals/anti-hormonals, 2004 - page 113
- Table 29: Endometrion SWOT analysis scores - page 116
- Table 30: Key findings of four months post-operative treatment of endometriosis with dienogest vs. Decapeptyl - page 119
- Table 31: Libra SWOT analysis scores - page 129
- Table 32: Key products in late-stage R&D pipeline for other drugs, 2004 - page 138
- Table 33: FP1096 SWOT analysis scores - page 140
- Table 34: Drugs in phase I and preclinical development for endometriosis, 2004 - page 150
- Table 35: Summary of presentation and diagnosis rates among obgyns used in endometriosis market estimate calculations - page 157
- Table 36: Summary of presentation and diagnosis rates among PCPs used in endometriosis market value estimate calculations - page 157
- Table 37: Estimated market value of endometriosis treatment by class, based on Obgyn presentation rates, 2003 - page 158
- Table 38: Estimated market value of endometriosis treatment by class, based on PCP presentation rates, 2003 - page 159
- List of Figures
- Figure 1: Prevalence of CPP and endometriosis in the female population aged 15(49 years (000s), 2004 - page 30
- Figure 2: Prevalence of infertility and endometriosis in the female population aged 15(49 years (000s), 2004 - page 32
- Figure 3: Unmet needs in endometriosis, 2004 - page 41
- Figure 4: Schering AG's marketed and pipeline portfolio candidates for endometriosis treatment - page 64
- Figure 5: Endometriosis late-stage pipeline SWOT comparison - page 73
- Figure 6: Lupron SWOT comparison - page 75
- Figure 7: Plenaxis SWOT comparison - page 79
- Figure 8: Cetrorelix SWOT comparison - page 88
- Figure 9: Dynamic representation of the competitive positioning of pipeline GnRH antagonists against Lupron in the endometriosis market - page 99
- Figure 10: Asoprisnil SWOT comparison - page 101
- Figure 11: Dynamic representation of the competitive positioning of asoprisnil against Lupron in the endometriosis market - page 112
- Figure 12: Endometrion SWOT comparison - page 115
- Figure 13: Libra SWOT comparison - page 127
- Figure 14: Dynamic representation of the competitive positioning of dienogest and Libra against Lupron in the endometriosis market - page 137
- Figure 15: FP1096 SWOT comparison - page 139
- Figure 16: Dynamic representation of the competitive positioning of FP1096 against Lupron in the endometriosis market - page 148
- Figure 17: Overview of estimated endometriosis market size methodology - page 156
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