Hormonal Contraceptives - New directions in a competitive market
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Women's Health and Urology pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the hormonal contraceptive market - page 3
- CHAPTER 2 MARKET OVERVIEW - page 12
- Introduction - page 12
- Market definition for this report - page 13
- Identifying the target population - page 13
- After subtracting ineligible subsets of reproductively able women, the female target population is still substantial - page 13
- Absolute contraindications - page 14
- Asexuality - page 15
- Sterilization - page 15
- Homosexuality - page 15
- Other considerations - page 16
- Treatment rates are very low in Japan - page 17
- Male target population indicates the possible scope of the male hormonal contraceptive market - page 17
- Asexuality - page 19
- Sterilization - page 19
- Homosexuality - page 19
- Other considerations - page 19
- After subtracting ineligible subsets of reproductively able women, the female target population is still substantial - page 13
- Treatment Overview - page 22
- Oral contraceptives are joined by a variety of administration methods - page 22
- New variation in traditional dosing patterns - page 22
- Continuous exploration of steroidal compounds - page 23
- Side effects rarely suppress uptake - page 23
- Hormonal contraceptives are not without risk - page 24
- A shortened 'fertility recovery time' is a competitive advantage - page 24
- Unmet needs center around compliance - page 24
- Efficacy rates hampered by real world use - page 25
- Impact of side effects vary on a case by case basis - page 25
- VTE is the major safety issue - page 26
- Physician's seek product differentiation knowledge - page 27
- Market dynamics - page 28
- Regional analysis - page 29
- Sales in the US comprise over half of the sales in the seven major markets - page 29
- Spain is fastest growing European market - page 30
- Class analysis - page 31
- Low dose, monophasic contraceptives remain the most popular - page 31
- Analysis by delivery method - page 32
- Slow growth of OCs sees rise of VMPs and IUDs - page 32
- Brand analysis - page 33
- Three generics compete among market leaders - page 34
- Five brands dominate Japanese market - page 34
- Key players in the 5EU and US markets: Schering AG - page 35
- Schering's success: a broad portfolio - page 36
- Pipeline products maintain franchise strength - page 39
- Key players in the 5EU and US markets: Ortho McNeil (Johnson & Johnson) - page 39
- Similar strategy, different results - page 40
- Opportunities from the pipeline are limited - page 41
- Key players in the Japanese market: Wyeth - page 42
- Generic competition and product withdrawal in the Western markets force geographical expansion - page 42
- Additional indications and Japanese collaboration triumph - page 43
- Regional analysis - page 29
- CHAPTER 3 PIPELINE ANALYSIS - page 45
- Alternative administration methods represented in the pipeline - page 46
- Key opinion on the alternative delivery modes in the pipeline - page 46
- Oral contraceptives must be differentiated to have any future - page 46
- Safety fears should not allow transdermal delivery to be overlooked - page 47
- Injections continue to decline in popularity - page 47
- Implanon drives growth potential of subdermal methods - page 47
- Intrauterine devices have enormous potential - page 47
- Vaginal mechanical pessaries are well supported by the pipeline - page 48
- Key opinion on the alternative delivery modes in the pipeline - page 46
- Opinion divided over the health benefits of new estrogens - page 48
- Pipeline indicates the further development of progestogens - page 49
- Progestogen-only pills - page 50
- Nestorone may be an important new hormone in the contraceptive market - page 51
- Nestorone vaginal ring - page 51
- Alternative administration methods represented in the pipeline - page 46
- CHAPTER 4 CURRENT MARKET ISSUES - page 53
- Genericization of the market - page 53
- Three of the top 10 global selling products are generics - page 53
- Emergency contraception paves the way for over the counter (OTC) sales of hormonal contraceptives in the US - page 54
- OTC sales permit access to a new subset of the female population - page 55
- Who pays for contraception in the US? - page 55
- Analysis of cost and benefit to society - page 55
- FDA guidance for prescription-only to OTC switching - page 57
- Pharmaceutical companies' considerations - page 58
- Identifying potential prescription-only to OTC candidates - page 59
- Company with established brands in best position to be first to market - page 59
- OTC switching as a strategy following patent expiry - page 60
- Easy approval for brands with excellent safety records - page 60
- OTC sales provide opportunity for geographical expansion - page 60
- Key opinion leaders support the switch to OTC sales of hormonal contraceptives - page 60
- Male hormonal contraceptive (MHC) market - page 62
- The male hormonal contraceptive pipeline - page 62
- Non-hormonal Nofertil shows most promise - page 63
- How serious are Schering and Organon about the male hormonal contraceptive market? - page 63
- MENT products may offer a choice of administration methods - page 64
- NESGel-1 is far from launch - page 64
- Issues in the MHC market - page 64
- Gaining acceptability will be the biggest challenge - page 64
- Efficacy is not yet of a sufficient standard in male hormonal contraceptives - page 66
- Long- and short-term safety issues must be broadly explored - page 67
- Marketing must address key negative perceptions and stigma - page 67
- The male hormonal contraceptive pipeline - page 62
- Genericization of the market - page 53
- CHAPTER 5 LIFECYCLE MANAGEMENT STRATEGIES - page 69
- Geographical Expansion: The Japanese market - page 69
- Barriers to market growth include accessibility and price - page 69
- Perception of OCs as 'dangerous' promotes use of barrier methods and abortions - page 69
- Future growth of the Japanese market looks set to be slow - page 70
- Sales of Ange 28 highlight potential of additional indications - page 70
- Innovation will enliven the market - page 71
- Barriers to market growth include accessibility and price - page 69
- Innovative administration methods: NuvaRing - page 71
- SWOT analysis - page 72
- NuvaRing successfully tackles unmet needs - page 72
- Geographical expansion and off-label indication to boost sales - page 73
- VTE association and OC popularity present small hurdles - page 73
- SWOT analysis - page 72
- Innovative administration methods: Implanon - page 75
- SWOT analysis - page 75
- The adversity of side effects and looming genericization - page 75
- Popularity in the UK should be matched in the US generating strong uptake - page 76
- Organon: a future key player? - page 77
- SWOT analysis - page 75
- Innovative administration methods: Ortho Evra - page 77
- Facing safety issues - page 77
- Strategies for a bleak future - page 78
- Facing safety issues - page 77
- Alternative dosing regimens - page 78
- Implementing change - page 79
- Seasonale is reformulated to stave off generic competition - page 79
- Lybrel provides a new option in dosing - page 80
- Alternative dosing regimens will continue to influence the hormonal contraceptive market - page 81
- Implementing change - page 79
- Hormonal contraceptives seeking additional indications - page 81
- Acne vulgaris - page 83
- Market saturated with acne-indicated contraception - page 84
- Estrogen deficiency - page 84
- Mirena - page 85
- Tanaproget - page 85
- Trimegestone - page 86
- Moving forward with caution - page 86
- Premenstrual dysphoric disorder (PMDD) - page 87
- Yaz will enjoy first to market advantage for PMDD indicated hormonal contraceptives - page 87
- Lybrel may challenge in the long term - page 88
- Uterine fibroids - page 88
- An unexploited opportunity - page 88
- Neural tube defects - page 89
- Folic acid fortification of hormonal contraception - page 89
- Dysmenorrhea - page 90
- Oncology - page 91
- Acne vulgaris - page 83
- Geographical Expansion: The Japanese market - page 69
- BIBLIOGRAPHY - page 92
- References - page 92
- Websites - page 95
- APPENDIX - page 96
- Contributing experts - page 96
- About Datamonitor - page 97
- About Datamonitor Healthcare - page 97
- About the Women's Health and Urology analysis team - page 98
- Disclaimer - page 99
- List of Tables
- Table 1: Segmentation of the childbearing population by region (000s), 2005 - page 14
- Table 2: Segmentation of the reproductively able male population by region (000s), 2005 - page 18
- Table 3: Analysis of key brands in the 5EU and US hormonal contraceptive market, 2005-06 - page 28
- Table 4: Hormonal contraceptive pipeline, 2006 - page 45
- Table 5: A cost-benefit analysis of OTC sales of OCs - page 56
- Table 6: Male Hormonal Contraceptive Pipeline, 2006 - page 63
- Table 7: Hormonal contraceptives seeking additional indications, 2006 - page 83
- List of Figures
- Figure 1: Female population eligible for hormonal contraception for contraceptive purposes by region, 2006 - page 16
- Figure 2: Male population eligible for hormonal contraception by region, 2006 - page 21
- Figure 3: Total sales of the seven major hormonal contraceptive markets by region, 2001-05 - page 29
- Figure 4: Total sales of the 5EU hormonal contraceptive market by region, 2001-05 - page 30
- Figure 5: Sales of hormonal contraceptives by ATC class in the 5EU and US market, 2001-05 - page 31
- Figure 6: 5EU and US market growth and market share of hormonal contraceptives by administration method, 2004-05 - page 32
- Figure 7: The top 10 hormonal contraceptive products in the 5EU and US market, 2004-05 - page 34
- Figure 8: The Japanese hormonal contraceptive market, 2005 - page 35
- Figure 9: SWOT Analysis for NuvaRing, 2006 - page 72
- Figure 10: SWOT analysis for Implanon, 2006 - page 75
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