Stakeholder Insight: Infertility - Undifferentiated drugs force need to strengthen prescriber and payer relationship

Over 11.5 million women suffer from infertility in the seven major markets. Although prevalence rates are stable, the trend towards later parenthood is inducing an increasing demand for infertility treatments. As cost of therapy is the major barrier access, the raise in demand puts increased pressure on healthcare payers to reimburse these treatments across the seven major markets.

Report Highlights
Prescribers perceive available IVF drugs are largely undifferentiated from each other. This allows physicians to prescribe according to personal preference and convenience, which means companies need to build strong relationships with physicians to increase brand loyalty.

Companies with urinary products need to strongly compete on a lower cost profile by lobbing with IVF payers and need to guarantee supply reliability. In Japan, where physicians prescribe 56% of follicle stimulating hormone and 80% of human chorionic gonadotropins in their urinary forms there is a clear opportunity for urinary companies.

The low scoring of Pergoveris (follitropin-alpha and luveris-alpha, Merck Serono) and Org36286 (corifollitropin-alpha, Organon) by survey respondents suggests that there is limited commercial potential for straightforward reformulations of existing drugs. There is a greater need for oral formulations.
[Studien Infos ausblenden]

ABOUT DATAMONITOR HEALTHCARE 2
About the Genitourinary pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the Infertility market 3
Contributing experts 5
Related reports 5
CHAPTER 2 INTRODUCTION AND SCOPE 7
Coverage of the Stakeholder Insight Survey 7
Epidemiology and patient segmentation 9
Diagnosis, presentation and referral options 9
Treatment options and trends 9
Key prescribing influences and brand assessment 9
Improving treatment outcomes 9
Assumptions and caveats 10
Future trends 10
CHAPTER 3 COUNTRY TREATMENT TREES 11
Introduction to treatment trees 11
Assumptions and caveats 12
US 13
Japan 14
France 15
Germany 16
Italy 17
Spain 18
UK 19
CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION 20
Disease definition 21
Overview of conception 21
The causes of infertility 23
Female infertility 24
Hormonal imbalances 26
Polycystic ovaries syndrome 27
Endometriosis 29
Pelvic inflammation disease 30
Uterine fibroids 30
Male infertility 31
Sperm disorders 32
Obstructive azoospermia 33
Varicocele 33
Medication side effects 33
Hormonal imbalances 33
Joint infertility 33
Unexplained infertility 34
Infertility prevalence 34
There are over 11 million infertile women across the seven major markets 34
US 36
Japan 37
France 37
Germany 37
Italy 37
Spain 38
UK 38
Trends in epidemiology 38
Infertility prevalence rates have been stable over the years 38
Alternative infertility candidates expands market potential 39
Demand for infertility treatment is expected to grow although female prevalence is stable 40
CHAPTER 5 PRESENTATION, DIAGNOSIS, AND REFERRAL OPTIONS 43
Presentation 44
Diagnosis 45
Diagnostic tests 46
Male tests 46
Female tests: 46
Diagnostic unmet need 47
Over 50% of female infertility cases are diagnosed between the ages of 31 and 40 years 48
Female age of diagnosis affects treatment options 49
Over 30% of male infertility is diagnosed over 40 years of age 49
Referral patterns 50
US 51
Europe 52
On average, it takes a patient 11 months to be referred to an infertility specialist in the seven major markets 53
CHAPTER 6 TREATMENT OPTIONS AND TRENDS 55
Introduction 56
Treatment rates 56
Pharmacological versus non-pharmacological 56
In vitro fertilization treatment rates are low due to cost, stress, and poor success rates 57
Assisted reproduction techniques 60
Ovulation induction 61
Intrauterine insemination 62
Assisted hatching 63
Overview of in vitro fertilization 64
Long or downregulation protocol 66
Short or flare up protocol 66
Other protocols 67
Mixed 67
Mild stimulation 67
Natural 69
In vitro fertilization therapy stages 69
Ovarian stimulation 69
Egg retrieval 70
Embryo retransfer 70
Trends in in vitro fertilization 71
Long in vitro fertilization protocols are the most common across the seven major markets 71
On average a woman can receive three to four in vitro fertilization cycles per year 73
Cryopreservation 75
Cryopreservation will increase as the freezing techniques improve and become safer for the embryo 75
Overview of available drug classes 77
Follicle stimulating hormone 78
Human menopausal gonadotropins 83
Luteinizing hormone 84
Human chorionic gonadotropin 85
Gonadotropin releasing hormones 87
Controversies surrounding drug classes 92
Human menopausal gonadotropin versus follicle stimulating hormone - no evidence of significant difference in clinical outcomes 92
Recombinant versus urinary products - physicians choose recombinants based on perceived superior efficacy and safety 95
Treatment guidelines 97
National Institute for Health and Clinical Excellence 97
American Society for Reproductive Medicine. 97
Japan Association of Obstetricians and Gynecologists 98
European Society for Human Reproduction and Embryology 98
In vitro fertilization laws and regulations 98
Trends in pharmacological treatment 101
Human chorionic gonadotropins and gonadotropin releasing hormone agonists are the most widely used drug classes 101
US physicians prescribe fewer drug combinations than in other markets 102
Many different treatment regimens are prescribed 103
Drug regimens rarely change between first and second cycles 111
Monotherapies are seldom used in Japan and the five EU countries 112
Gonadotropin releasing hormone antagonists are not prescribed in the most common treatment regimens 112
Unlike other countries, in Germany no drug regimen is preferred to another 113
Future trends in assisted reproduction 113
In vitro maturation is limited by safety concerns 113
Current data show that in vitro maturation yields similar pregnancy rates as in vitro fertilization 114
In vitro maturation and fertility preservation 114
Is in vitro maturation the future? 115
Reproductive tourism 115
CHAPTER 7 PRESCRIBING INFLUENCES AND BRAND ASSESSMENT 117
Factors influencing physician decision making 118
The cost of drugs remains one of the most important drug attributes in most countries. 119
Physician perception of key brands 120
Total drug scores per drug per country 122
Interpreting a brand map 124
In vitro fertilization drugs are all very similar in terms of physician perception 124
Follicle stimulating hormones 125
Human menopausal gonadotropins 129
Physicians perception shows that no drug is clearly defined by any one attribute 131
Gonadotropin releasing hormone analogs 132
Pipeline drugs 136
CHAPTER 8 IMPROVING TREATMENT OUTCOMES 139
Treatment outcomes 140
Up to half of women receiving in vitro fertilization treatment achieve pregnancy 140
Age greatly affects in vitro fertilization outcomes 141
Lifestyle, such as smoking and stress, adversely impacts fertility 143
In vitro fertilization outcomes in the US and in the UK 143
The majority of patients will achieve pregnancy within completion of the third in vitro fertilization cycle 144
Lack of finances is not the only reason for interruption of in vitro fertilization treatment 146
Pregnancy then single live births are the main goals of in vitro fertilization 148
Embryo quality is key to in vitro fertilization success 150
Unmet needs 151
Reduction in patient payments will increase access and expand market 152
Price and reimbursement schemes limit access to in vitro fertilization 153
Development of novel drug targets for in vitro fertilization treatment 157
Improvement of drug administration route is the key successful factor for a new product entering the market 158
BIBLIOGRAPHY 159
Journal papers 159
Websites 166
Other 169
APPENDIX A - PHYSICIAN SAMPLE 170
Physician research methodology 170
Physician sample breakdown 170
US 170
Japan 171
France 171
Germany 172
Italy 172
Spain 173
UK 173
Contributing experts 174
APPENDIX B - SCREENER AND SURVEY QUESTIONNAIRE 175
Screener questionnaire 175
Survey questionnaire 175
Section 1 - Presentation and Diagnosis 175
Section 2 - Treatment Cycles: IVF/IVF/ICSI 177
Section 3 - Treatment Outcomes 182
Section 4 - Product Profiles 184
Section 5 - Demographics 185
APPENDIX C - ABOUT DATAMONITOR 187
About Datamonitor 187
About Datamonitor Healthcare 187
About the Genitourinary analysis team 188
Disclaimer 189
[Inhaltsverzeichnis ausblenden]

Table 1: Causes of female infertility, 2008 25
Table 2: World Health Organization classifications of polycystic ovarian syndrome 27
Table 3: Causes of male infertility 31
Table 4: Prevalence of female infertility in the seven major markets, 2008 35
Table 5: Summary of studies that determine the prevalence rate of female infertility in the seven major markets, 2008 36
Table 6: In vitro fertilization treatment rates and patient and cycle numbers across the seven major markets, 2008 58
Table 7: Number of clinics and in vitro fertilization cycles in the five EU countries, 1998-2004 59
Table 8: Number of infertility clinics per patient in the seven major markets, 2000 59
Table 9: Branded follicle stimulating hormones (FSH) available in the seven major markets, 2008 79
Table 10: Comparison of costs of recombinant versus urinary infertility products in the US, 2007 81
Table 11: Branded human menopausal gonadotropins (hMG) available in the seven major markets, 2008 83
Table 12: Branded human chorionic gonadotropins (hCG) available in the seven major markets, 2008 85
Table 13: Branded gonadotropin releasing hormones (GnRH) available in the seven major markets, 2008 88
Table 14: Summary of key studies comparing human menopausal gonadotropins (hMG) to recombinant follicle stimulating hormone (FSH) 94
Table 15: Country-specific in vitro fertilization (IVF) practices in the seven major markets, 2008 99
Table 16: Summary of infertility drug availability in the seven major markets, 2008 120
Table 17: Number and percentage of physicians who were able to rate each infertility drug, 2008 121
Table 18: Total score (out of 100) for each infertility drug in the seven major markets, 2008 122
Table 19: In vitro fertilization outcomes in the US for fresh non-donor cycles, 2005 143
Table 20: In vitro fertilization outcomes with and without intracytoplasmic injection for fresh non-donor cycles in the UK, 2006 144
Table 21: Summary of assisted reproduction techniques coverage in the seven major markets, 2008 153
Table 22: US physician sample breakdown, 2008 170
Table 23: Japan physician sample breakdown, 2008 171
Table 24: France physician sample breakdown, 2008 171
Table 25: Germany physician sample breakdown, 2008 172
Table 26: Italy physician sample breakdown, 2008 172
Table 27: Spain physician sample breakdown, 2008 173
Table 28: UK physician sample breakdown, 2008 173
Figure 1: Diagrammatic overview of the coverage of the Stakeholder Insight: Infertility survey, 2008 8
Figure 2: US infertility treatment tree, 2008 13
Figure 3: Japan infertility treatment tree, 2008 14
Figure 4: France infertility treatment tree, 2008 15
Figure 5: Germany infertility treatment tree, 2008 16
Figure 6: Italy infertility treatment tree, 2008 17
Figure 7: Spain infertility treatment tree, 2008 18
Figure 8: UK infertility treatment tree, 2008 19
Figure 9: Overview of the menstrual cycle 22
Figure 10: Regulation of follicle development by the hypothalamus-pituitary gland-ovary axis, 2008 23
Figure 11: The cause of infertility by gender across the seven major markets, 2008 24
Figure 12: Female infertility etiology breakdown in the seven major markets, 2008 25
Figure 13: Summary of possible treatments for female infertility ,2008 26
Figure 14: Male infertility etiology breakdown in the seven major markets, 2008 32
Figure 15: Percentage of women undergoing IVF who are single or in a same sex relationship in the seven major markets, 2008 39
Figure 16: Number of in vitro fertilization cycles in the five EU countries, 1998-2004 40
Figure 17: Number of in vitro fertilization clinics in the five EU countries, 1998-2004 41
Figure 18: Decline of fertility rates in the seven major markets, 1970-2002 42
Figure 19: Percentage of potentially infertile population presenting for treatment in the seven major markets, 2008 44
Figure 20: Infertility diagnosis rate in the seven major markets, 2008 45
Figure 21: Breakdown of age at diagnosis of female infertility in the seven major markets, 2008 48
Figure 22: Breakdown of age at male infertility diagnosis in the seven major markets, 2008 49
Figure 23: Consultation breakdown for infertility patients in the seven major markets, 2008 50
Figure 24: US referral pathway for infertility patients, 2008 51
Figure 25: Referral pathway in major five EU markets for infertility patients, 2008 52
Figure 26: Duration of referral pathways for infertility patients in the seven major markets, 2008 53
Figure 27: Breakdown of pharmacological and non pharmacological infertility treatment in the seven major markets, 2008 57
Figure 28: Treatment algorithm for infertility in the seven major markets, 2008 60
Figure 29: Assisted reproduction technique treatment options, 2008 61
Figure 30: Intrauterine insemination 62
Figure 31: Assisted hatching for in vitro fertilization treatment patients 64
Figure 32: In vitro fertilization (IVF) treatment pathway, 2008 65
Figure 33: Breakdown of in vitro fertilization (IVF) protocol types in the seven major markets, 2008 72
Figure 34: Comparison of in vitro fertilization (IVF) protocol types in the first and second treatment cycles in the total seven major markets, 2008 73
Figure 35: Average number of in vitro fertilization (IVF) cycles initiated per patient per year across the seven major markets, 2008 74
Figure 36: Overview of embryo transfer trends in in vitro fertilization (IVF) treatment across the seven major markets, 2008 77
Figure 37: Typical treatment procedure timeline during one in vitro fertilization cycle, 2008 78
Figure 38: Breakdown of urinary versus recombinant follicle stimulating hormone (FSH) use in the seven major markets, 2008 82
Figure 39: Breakdown of urinary versus recombinant human chorionic gonadotropin (hCG) use in the seven major markets, 2008 87
Figure 40: Breakdown of gonadotropin releasing hormone agonists and antagonists use across the seven major markets, 2008 90
Figure 41: Physician reasons for prescribing a gonadotropin releasing hormone (GnRH) antagonist rather than an agonist in the seven major markets, 2008 91
Figure 42: Reasons for prescribing a recombinant rather than a urinary product for in vitro fertilization (IVF) treatment in the seven major markets, 2008 95
Figure 43: Percentage of patients receiving drug classes used for in vitro fertilization (IVF) treatment in the seven major markets, 2008 102
Figure 44: Percentage of patients receiving drug classes used for in vitro fertilization (IVF) treatment by country, 2008 103
Figure 45: Percentage of patients receiving first and second treatment cycle regimens for in vitro fertilization (IVF) patients in the US, 2008 105
Figure 46: Percentage of patients receiving first and second treatment cycle regimens for in vitro fertilization (IVF) patients in Japan, 2008 106
Figure 47: Percentage of patients receiving first and second treatment cycle regimens for in vitro fertilization (IVF) patients in France, 2008 107
Figure 48: Percentage of patients receiving first and second treatment cycle regimens for in vitro fertilization (IVF) patients in Germany, 2008 108
Figure 49: Percentage of patients receiving first and second treatment cycle regimens for in vitro fertilization (IVF) patients in Italy, 2008 109
Figure 50: Percentage of patients receiving first and second treatment cycle regimens for in vitro fertilization (IVF) patients in Spain, 2008 110
Figure 51: Percentage of patients receiving first and second treatment cycle regimens for in vitro fertilization (IVF) patients in the UK, 2008 111
Figure 52: Number of points allocated to each infertility drug attribute to indicate its relative importance in the seven major markets, 2008 118
Figure 53: Number of points allocated to each infertility drug attribute, excluding efficacy and side effects, to indicate its relative importance in the seven major markets, 2008 119
Figure 54: Brand map of the scores of the individual products used in in vitro fertilization (IVF) in relation to each other, 2008 125
Figure 55: Number of points allocated to each follicle stimulating hormone (FSH) for all factors in the seven major markets, 2008 126
Figure 56: Percentage of patients receiving follicle stimulating hormones (FSH) split by brand in the seven major markets, 2008 127
Figure 57: Number of points allocated to each human menopausal gonadotropin (hMG) for all factors in the seven major markets, 2008 129
Figure 58: Percentage of patients receiving human menopausal gonadotropins (hMG) by brand in the seven major markets, 2008 130
Figure 59: Brand map of follicle stimulating hormones (FSH) and human menopausal gonadotropins (hMG), 2008 131
Figure 60: Number of points allocated to each follicle stimulating hormone (FSH) and human menopausal gonadotropin (hMG) for all factors in the seven major markets, 2008 132
Figure 61: Number of points allocated to each gonadotropin releasing hormone (GnRH) analog on all factors in the seven major markets, 2008 133
Figure 62: Percentage of patients receiving gonadotropin releasing hormone (GnRH) antagonists by brand in the seven major markets, 2008 134
Figure 63: Percentage of patients receiving gonadotropin releasing hormone (GnRH) agonists by brand in the seven major markets, 2008, 2008 135
Figure 64: Number of points allocated to Pergoveris in the seven major markets, 2008 136
Figure 65: Number of points allocated to Org-36286 in the seven major markets, 2008 138
Figure 66: In vitro fertilization (IVF) and in vitro fertilization/ intracytoplasmic injection (IVF/ICSI) treatment outcomes in the seven major markets, 2008 140
Figure 67: Change of first time mother's age in the seven major markets, 2006 142
Figure 68: Number of in vitro fertilization (IVF) cycles completed before achieving pregnancy in the seven major markets, 2008 145
Figure 69: Number of in vitro fertilization (IVF) treatment cycles completed before discontinuation for any reason in the seven major markets, 2008 146
Figure 70: Reasons for interruption in vitro fertilization (IVF) treatment in the seven major markets, 2008 147
Figure 71: Pregnancy outcomes following in vitro fertilization (IVF) treatment in the seven major markets, 2008 148
Figure 72: Unmet need in in vitro fertilization (IVF) treatment according to interviewed key opinion leaders, 2008 151
Figure 73: Reimbursement coverage of in vitro fertilization (IVF) or in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) in the seven major markets, 2008 154
[Tabellenverzeichnis ausblenden]