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Endometriosis - Growing the Patient Population is Key to Unlocking the Markets Commercial Potential
Datamonitor
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Insight into the endometriosis market 4
CHAPTER 2 PATIENT POTENTIAL 15
Definition of endometriosis 15
Classification of endometriosis 16
Evolution of the classification system 17
Endometriosis – theories abound 18
Retrograde menstruation and implantation 19
Lymphatic/vascular dissemination 19
Developmental coelomic metaplasia 20
Genetic predisposition 20
Environmental factors 21
Immunological susceptibility 21
Dynamic progression of endometriosis 22
Symptomatology 23
Segmentation of endometriosis 24
Endometriosis and infertility 24
Recurrence in endometriosis 25
Epidemiology of endometriosis 26
Prevalence estimates 26
Prevalence of endometriosis in the general population 28
Prevalence of endometriosis in the gynecologic population 28
Limitations of epidmiology analysis 32
Unmet need in endometriosis 33
Need for more effective therapeutic options 33
Potential to address fertility outcomes 34
Long-term treatment and recurrence 35
Need for drugs with improved tolerability and fewer side effects 36
Need for greater awareness among PCPs and public 37
Perception of symptoms as 'normal' limits the presented population 37
Poor awareness among PCPs lengthens time to diagnosis 37
Need for a non-invasive diagnostic test 39
CHAPTER 3 R&D APPROACH 42
Classification of pipeline products 42
GnRH agonists 43
GnRH agonist overview 44
Lupron – the gold standard 45
GnRH antagonists 48
Danazol 49
Efficacy 49
Side effects 50
Hormonal contraceptives 52
Combined oral contraceptives 52
Progestogen therapy 54
Gestrinone 55
Clinical trial design in endometriosis 56
Study parameters, definitions and methodology 56
Placebo or active control? 56
Trial size 57
Length of study 58
Clinical trial endpoints in endometriosis 59
Symptom reduction – pain 59
Improving complications – infertility 59
QoL and patient satisfaction 60
Regression of disease 60
CHAPTER 4 ENDOMETRIOSIS PIPELINE ANALYSIS 62
Pipeline overview 62
Key companies involved in the endometriosis pipeline 63
Schering AG 63
Marketed products do not target endometriosis 63
Expanding women's health indication coverage 63
TAP Pharmaceuticals 65
Strategies for success 66
Tapping into the market – TAP's continuing investment in marketing and product line extension 66
Dedicated detailing approach 66
Continuing innovation 66
Pipeline SWOT analysis: comparative parameters and definitions 68
External factors 68
Internal factors 70
CHAPTER 5 GNRH ANTAGONIST LATE-STAGE DRUG ANALYSIS & FORECASTS 74
Overview for GnRH antagonists 75
Pipeline summary 75
Definition of current comparator therapy 75
Lupron 75
Plenaxis (abarelix depot F) 78
Profile 78
Drug overview 81
Clinical trial data 81
Comment 83
Patient potential 84
Marketing factors 84
Satisfaction of unmet needs 86
Forecasts to 2014 87
Cetrorelix 88
Profile 88
Drug overview 90
Clinical trial data 90
Patient potential 92
Marketing factors 92
Satisfaction of unmet needs 93
Forecasts to 2014 94
Other drugs in the GnRH agonist/antagonist class 96
Avorelin 96
Sufugolix 96
Comparison of key compounds in the GnRH agonist/antagonist class 96
External factors 96
Internal factors 97
Drug profile 97
Company 98
CHAPTER 6 SELECTIVE PROGESTERONE RECEPTOR MODULATOR CLASS LATE-STAGE DRUG ANALYSIS AND FORECASTS 100
Overview 100
Pipeline summary 100
Definition of current comparator therapy 100
Lupron 100
Asoprisnil 101
Profile 101
Drug overview and clinical trial data 103
Patient potential 104
Marketing factors 104
Satisfaction of unmet needs 106
Forecasts to 2014 107
Comparison of key compounds in the SPRM class 109
External factors 109
Internal factors 110
Drug profile 110
Company 110
CHAPTER 7 HORMONALS/ANTI-HORMONALS LATE-STAGE ANALYSIS AND FORECASTS 113
Overview for hormonals 113
Pipeline summary 113
Definition of current comparator therapy 113
Lupron 113
Endometrion (dienogest) 114
Profile 114
Drug overview 117
Clinical trial data 117
Patient potential 123
Marketing factors 124
Satisfaction of unmet needs 126
Forecasts to 2014 127
Libra (deslorelin, estradiol and testosterone) 127
Profile 127
Drug overview 130
Clinical trial data 130
Patient potential 132
Marketing factors 132
Satisfaction of unmet needs 133
Forecasts to 2014 134
Comparison of key compounds in the hormonal/antihormonal class 134
External factors 134
Internal factors 135
Drug profile 135
Company 135
CHAPTER 8 OTHER DRUGS LATE-STAGE ANALYSIS AND FORECASTS 138
Overview for 'Other' class drugs 138
Pipeline summary 138
Definition of current comparator therapy 138
Lupron 138
FP1096 139
Profile 139
Clinical trial data 141
Patient potential 143
Marketing factors 143
Satisfaction of unmet needs 144
Forecasts to 2014 145
Comparison of key compounds in the 'other' class 146
External factors 146
Drug profile 146
Company 146
Other drugs in the 'other' class 148
Chronodyne (terbutaline) 148
CHAPTER 9 INNOVATIVE EARLY-STAGE PROJECTS 150
Key Phase I and preclinical compounds in endometriosis 150
GnRH antagonists 150
Teverelix 150
NBI-42902, NBI-56418 and other candidates 151
TAK-810 153
GnRH agonists 153
Leuprolide (inhaled) 153
Eligard 153
Antiprogestins 154
Progenta 155
Endometriosis market size estimate 155
Methodology 155
Key research impacts on endometriosis 159
Will aromatase inhibitors offer the market anything new? Femara well placed to be first to market 159
APPENDIX A 161
Contributing experts 161
Report methodology 161
Japanese market data 161
Regional launch dates for new products 161
Standard units 161
Pricing forecasts 162
Bibliography 162
APPENDIX B 166
Research and analysis methodologies 167
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