Commercial and Pipeline Insight: Infertility - Optimizing a market bounded by social opinion and physician preference

Commercial and Pipeline Insight: Infertility - Optimizing a market bounded by social opinion and physician preference

Introduction

The market for infertility drugs is a complex and dynamic arena shaped by numerous factors such as changing social attitudes, national legislation, and prescriber preferences. Brand strength and diverse portfolios have allowed Organon, Merck Serono and Ferring to secure a firm foothold in the market, worth over $1 billion in 2006, and represent tough competition.

Scope

ABOUT DATAMONITOR HEALTHCARE 2
About the Women's Health pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Contributing experts 4
Datamonitor insight into the infertility market 6
Key metrics 8
Datamonitor pipeline assessment summary 9
CHAPTER 2 DISEASE OVERVIEW 12
Definition of infertility 13
Unassisted reproduction 13
Etiology of infertility 14
The causes of female infertility 14
Polycystic ovary syndrome 15
Endometriosis 17
Uterine fibroids 18
The causes of male infertility 19
Correctable conditions in the male 20
Combined infertility 21
Unexplained infertility 22
CHAPTER 3 EPIDEMIOLOGY AND PATIENT BASED MARKET FORECASTS 23
Epidemiologically-derived infertility market size 24
Epidemiologic methodology of sizing the US and 5EU patient population 24
Female population eligible for infertility treatment (1) 25
Relationship status: marriage assumed necessary (2) 25
Prevalence of infertility (3) 26
Presentation rates (4) 27
Diagnosis rates of a specialist physician (5) 28
Treatment initiation (6) 29
Epidemiologic methodology of sizing the Japanese patient population 30
Patient derived infertility market forecasts 30
Patient derived forecast methodology 32
Trending the treatment seeking rate 32
Trending the marriage rate 32
Segmentation of the patient population by treatment cycles 33
Cost per treatment cycle 34
Market value 34
Epidemiological trends 35
The ageing population will prevent dramatic market growth 35
The prevalence of infertility by etiology 37
Almost 20% of couples seeking treatment require therapy for multiple-factor infertility 38
CHAPTER 4 TREATMENT OPTIONS AND TRENDS 40
Segmentation of infertility treatment 41
ART treatment options 41
Ovulation induction 41
Intrauterine insemination 42
In vitro fertilization 43
Intracytoplasmic sperm injection 44
Gamete intrafallopian transfer 44
Zygote intrafallopian transfer 44
Classification of infertility products 44
Follicle stimulating hormones-follitropins (FSH) 46
Luteinizing hormone (LH) 47
Human menopausal gonadotrophins-menotropins (hMG) 47
Human chorionic gonadotrophin (hCG) 48
Gonadotrophin releasing hormone (GnRH) analogs 49
Pharmaceutical treatment pathways 50
Over 193,000 treatment cycles occurred in the 5EU in 2001 52
Future treatment trends 52
IVF more frequently chosen as first-line therapy 53
GnRH agonists versus GnRH antagonists 54
The advantages of antagonists 55
Efficacy studies fail to identify superior analog 55
Physician choice will divide future market share equally 56
Volume reduction as mild stimulation protocols strive to reduce multiple births 57
Urinary and recombinant products must fulfill different niches 59
r-FSH versus menotropins 61
Unmet need in the infertility market 62
Education of non-specialist physicians will aid diagnosis and referral 63
Complicated treatment cycles detract from success rates 64
Patient-friendly delivery devices help to prevent discontinuation 64
Simplified treatment regimens ease patient stress levels 66
Neutrality in clinical trials to avoid bias 67
CHAPTER 5 MARKET DYNAMICS 69
Market sizing using prescription data 70
Dynamics of the current infertility market 71
Slow growth recoups market value to 2003 level 71
Gonadotrophins are the integral part of infertility treatment 72
GnRH antagonists gain on agonists in 2006 but still have some way to go 74
Regional sales are influenced by country-specific legislation 74
Follitropin products lead the market 77
Product use is not exclusive to infertility 79
Key companies involved in the infertility market 80
Three companies hold 84.6% share of the total infertility market 80
Change at the top means competition will be fierce 81
Smaller portfolios suit current market climate 82
Successful companies generate strong relationships with physicians 82
Organon capitalizes on Puregon to become 2006 market leader 83
Merck Serono loses share despite extensive portfolio 85
Innovation allows Ferring greatest growth 88
IBSA's geographical experience is a threat to 7MM players 90
SWOT analysis of the infertility market 91
Opportunities 92
Trend towards later parenthood will increase demand for fertility services 92
New embryological techniques expand treatable population 93
Infertility support websites can increase brand awareness among patients 96
Threats 99
Restrictive guidelines are unlikely to slacken in the near future 99
Influx of low-priced alternatives will increase price competition 100
CHAPTER 6 R&D PIPELINE OVERVIEW AND CLINICAL TRIAL DESIGN 104
Pipeline overview: limited pipeline dominated by existing market players 105
Infertility pipeline lacks direction and innovation 106
Development needs to diversify 107
Pergoveris is the initial threat to marketed products 108
Top three market players overwhelm pipeline 108
Merck Serono's pipeline structure optimizes timing of market entry 109
Organon's pipeline indicates long-term focus 109
Small companies should capitalize on outlicensing 109
Clinical trial design in infertility and subfertility research 110
Code of best practice 110
Analysis must stem from 'intention to treat' patient numbers 111
Controversial crossover trials may inflate results 112
First-cycle enrolment avoids carry-over effects 113
Sample size estimation to be derived from patient number 113
Lack of superiority is not the same as equivalence 114
Should singleton live birth rate replace live birth rate as primary outcome? 114
CHAPTER 7 FOLLITROPIN LATE-STAGE DRUG ANALYSIS & FORECASTS 116
Overview for the follitropin class 117
Comparative forecasts 117
Comparative Datamonitor drug assessment summary 118
Definition of current comparator therapy: Puregon 119
Puregon's key clinical trials 121
Marketing and patient factors 123
Org-36286 (extended-release corifollitropin alpha) 125
Drug overview 125
Datamonitor drug assessment summary 126
Forecasts to 2016 126
Marketing factors 128
Patient potential 128
Clinical trial data 130
Phase III 130
Phase II 131
CHAPTER 8 MENOTROPIN LATE-STAGE DRUG ANALYSIS & FORECASTS 133
Overview for the menotropin class 134
Comparative forecasts 134
Comparative Datamonitor drug assessment summary 135
Definition of current comparator therapy: Menopur 136
Menopur's key clinical trials 137
Marketing and patient factors 138
Pergoveris (follitropin alpha and lutropin alpha) 140
Drug overview 140
Datamonitor drug assessment summary 140
Forecasts to 2016 141
Marketing factors 143
Patient potential 144
Clinical trial data 145
Primary Phase II/III bridging study 145
Secondary Phase II/III bridging study 147
CHAPTER 9 GLOBAL MARKET ISSUES 149
Globalization of the infertility market 150
E7 markets are a useful guide to worldwide market growth 150
Despite growth, E7 markets will not rival 7MM in the short term 151
Inter-market differences: the impact of legislation 151
Reproductive tourism 155
A multitude of inter-related factors promote reproductive tourism 156
Case study: Observing patient migration from Italy 157
Responding to the impact of reproductive tourism 158
Pharma must strengthen portfolios in stable or recipient markets 158
Physician behavior is vital to maintain the respectability of reproductive travel 159
Reproductive tourism is the best solution for patients in the absence of ethical agreement 161
BIBLIOGRAPHY 163
Journal papers and articles 163
Websites 168
APPENDIX A 173
Forecasting methodology 173
Datamonitor forecast methodology 173
Epidemiological patient-based forecasts 173
IMS forecasts 175
Contributing experts 177
APPENDIX B 178
About Datamonitor 178
About Datamonitor Healthcare 178
Datamonitor Healthcare's therapy area capabilities 179
About the Disease analysis team 180
Disclaimer 181
List of Tables
Table 1: Infertility market top down forecast across the seven major markets, 2006-2016 8
Table 2: Top down forecast of key pipeline infertility products in 2016 ($000s) 8
Table 3: Infertility market bottom-up forecast based on patient numbers in the US, Japan and 5EU, 2006-2016 9
Table 4: Causes of female infertility 14
Table 5: Causes of male infertility 19
Table 6: Patient population of women receiving infertility treatment in the 7MM, 2006 24
Table 7: Infertility market value ($m) patient based forecasts, 2003-2009 31
Table 8: Infertility market value ($m) forecast derived from patient numbers, 2010-2016 32
Table 9: Patient numbers by female infertility etiology in the US and 5EU, 2006 39
Table 10: Classification of the infertility market according to Datamonitor's definition 45
Table 11: Branded follitropins available in the 7MM, 2006 47
Table 12: Branded menotropins available in the 7MM, 2006 48
Table 13: Branded chorionic gonadotrophins available in the 7MM, 2006 49
Table 14: Branded GnRH agonists available in the 7MM, 2006 50
Table 15: Branded GnRH antagonists available in the 7MM, 2006 50
Table 16: Treatment cycles in the 7MM, 2000 and 2001 52
Table 17: Studies investigating the efficacy of GnRH analogs 56
Table 18: ICD-10 codes used to define the infertility market 70
Table 19: Country-specific ART practices, 2007 75
Table 20: Organon's infertility franchise, 2007 83
Table 21: Merck Serono's infertility franchise, 2007 86
Table 22: Ferring's infertility franchise, 2006 88
Table 23: IBSA's infertility franchise, 2007 90
Table 24: Infertility patient websites, 2007 97
Table 25: Legislation governing ART in the 7MM, 2007 99
Table 26: Infertility market pipeline, 2007 105
Table 27: Key companies involved in the infertility pipeline, 2007 108
Table 28: Methodological considerations of infertility trials 111
Table 29: Key products in late-stage R&D pipeline for follitropins, 2007 117
Table 30: Puregon: key facts 121
Table 31: Key products in late-stage R&D pipeline for menotropins, 2007 134
Table 32: Menopur: key facts 137
Table 33: E7 infertility market sales, 2006 and CAGR, 2003-06 151
Table 34: E7 infertility markets: key facts, 2007 153
Table 35: Datamonitor drug assessment parameters 176
List of Figures
Figure 1: Datamonitor pipeline infertility drug assessment summary 10
Figure 2: Algorithm for the treatment of male infertility 20
Figure 3: Number of women aged between 20 and 45 years old in the seven major infertility markets, 2006-2021 36
Figure 4: Females patients willing and able to receive infertility treatment in the 7MM from 2006 to 2016 37
Figure 5: Causes of infertility for US couples undergoing ART using fresh, non-donor eggs or embryos, 2004 38
Figure 6: ART treatment options 41
Figure 7: Infertility treatment pathway in the seven major markets 51
Figure 8: Schematic overview of trends expected in infertility treatment, 2007-2016 53
Figure 9: Unmet need in the infertility market, 2007 62
Figure 10: Growth of the seven major infertility markets, 2003-06 71
Figure 11: Breakdown of the gonadotrophin class by molecule, 2006 73
Figure 12: Infertility market size by country, 2003-06 76
Figure 13: Sales performance of the top five infertility brands across the 7MM, 2005-06 78
Figure 14: Percentage breakdown of total brand sales by indication of the top five infertility products in the 7MM, 2006 80
Figure 15: Market share and growth of the top three companies in the infertility market, 2005-06 81
Figure 16: Organon's 7MM infertility franchise by brand, 2006 84
Figure 17: Merck Serono's 7MM infertility franchise by brand, 2006 87
Figure 18: Ferring's seven major market infertility franchise by brand, 2006 89
Figure 19: SWOT analysis of the infertility market across the seven major markets, 2007 92
Figure 20: Mother's age at first birth in France, Germany, Spain and Italy, 1985-2000 93
Figure 21: Ferring's fertility website 98
Figure 22: Breakdown of fertility market pipeline by development status, 2007 106
Figure 23: Datamonitor's comparative forecast of sales for the follitropins across the IMS-derived, seven major markets ($m), 2007-2016 117
Figure 24: Datamonitor's competitive positioning analysis for Puregon and Org-36286 in the IMS derived, seven major markets, 2007-2016 119
Figure 25: Historical sales for the follitropins, Puregon and Gonal-F, 2003-06 124
Figure 26: Datamonitor's competitive positioning analysis for Org-36286 in the IMS-derived, seven major markets, 2007-2016 126
Figure 27: Datamonitor's forecast of sales for Org-36286 across the seven major markets ($m), 2007-2016 127
Figure 28: Datamonitor's comparative forecast of sales for the menotropins across the IMS-derived, seven major markets ($m), 2007-2016 134
Figure 29: Datamonitor's competitive positioning analysis for Menopur and Pergoveris in the IMS-derived, seven major markets, 2007-2016 136
Figure 30: Historical sales for the top three menotropins Menopur, Menogon and Humegon, 2003-06 139
Figure 31: Datamonitor's competitive positioning analysis for Pergoveris in the IMS derived, seven major markets, 2007-2016 141
Figure 32: Datamonitor's forecast of sales for Pergoveris across the IMS derived, seven major markets ($m), 2007-2016 142
Figure 33: Market share and growth of the E7 infertility markets, 2005-06 152
Figure 34: Reproductive migration of Italian couples in 2003 and 2005 158