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Published by: Datamonitor
Published: Nov. 9, 2006
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Women's Health and Urology pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
- Datamonitor insight into the hormonal contraceptive market
- CHAPTER 2 MARKET OVERVIEW
- Introduction
- Market definition for this report
- Identifying the target population
- After subtracting ineligible subsets of reproductively able women, the female target population is still substantial
- Absolute contraindications
- Asexuality
- Sterilization
- Homosexuality
- Other considerations
- Treatment rates are very low in Japan
- Male target population indicates the possible scope of the male hormonal contraceptive market
- Asexuality
- Sterilization
- Homosexuality
- Other considerations
- Treatment Overview
- Oral contraceptives are joined by a variety of administration methods
- New variation in traditional dosing patterns
- Continuous exploration of steroidal compounds
- Side effects rarely suppress uptake
- Hormonal contraceptives are not without risk
- A shortened 'fertility recovery time' is a competitive advantage
- Unmet needs center around compliance
- Efficacy rates hampered by real world use
- Impact of side effects vary on a case by case basis
- VTE is the major safety issue
- Physician's seek product differentiation knowledge
- Market dynamics
- Regional analysis
- Sales in the US comprise over half of the sales in the seven major markets
- Spain is fastest growing European market
- Class analysis
- Low dose, monophasic contraceptives remain the most popular
- Analysis by delivery method
- Slow growth of OCs sees rise of VMPs and IUDs
- Brand analysis
- Three generics compete among market leaders
- Five brands dominate Japanese market
- Key players in the 5EU and US markets: Schering AG
- Schering's success: a broad portfolio
- Pipeline products maintain franchise strength
- Key players in the 5EU and US markets: Ortho McNeil (Johnson & Johnson)
- Similar strategy, different results
- Opportunities from the pipeline are limited
- Key players in the Japanese market: Wyeth
- Generic competition and product withdrawal in the Western markets force geographical expansion
- Additional indications and Japanese collaboration triumph
- CHAPTER 3 PIPELINE ANALYSIS
- Alternative administration methods represented in the pipeline
- Key opinion on the alternative delivery modes in the pipeline
- Oral contraceptives must be differentiated to have any future
- Safety fears should not allow transdermal delivery to be overlooked
- Injections continue to decline in popularity
- Implanon drives growth potential of subdermal methods
- Intrauterine devices have enormous potential
- Vaginal mechanical pessaries are well supported by the pipeline
- Opinion divided over the health benefits of new estrogens
- Pipeline indicates the further development of progestogens
- Progestogen-only pills
- Nestorone may be an important new hormone in the contraceptive market
- Nestorone vaginal ring
- CHAPTER 4 CURRENT MARKET ISSUES
- Genericization of the market
- Three of the top 10 global selling products are generics
- Emergency contraception paves the way for over the counter (OTC) sales of hormonal contraceptives in the US
- OTC sales permit access to a new subset of the female population
- Who pays for contraception in the US?
- Analysis of cost and benefit to society
- FDA guidance for prescription-only to OTC switching
- Pharmaceutical companies' considerations
- Identifying potential prescription-only to OTC candidates
- Company with established brands in best position to be first to market
- OTC switching as a strategy following patent expiry
- Easy approval for brands with excellent safety records
- OTC sales provide opportunity for geographical expansion
- Key opinion leaders support the switch to OTC sales of hormonal contraceptives
- Male hormonal contraceptive (MHC) market
- The male hormonal contraceptive pipeline
- Non-hormonal Nofertil shows most promise
- How serious are Schering and Organon about the male hormonal contraceptive market?
- MENT products may offer a choice of administration methods
- NESGel-1 is far from launch
- Issues in the MHC market
- Gaining acceptability will be the biggest challenge
- Efficacy is not yet of a sufficient standard in male hormonal contraceptives
- Long- and short-term safety issues must be broadly explored
- Marketing must address key negative perceptions and stigma
- CHAPTER 5 LIFECYCLE MANAGEMENT STRATEGIES
- Geographical Expansion: The Japanese market
- Barriers to market growth include accessibility and price
- Perception of OCs as 'dangerous' promotes use of barrier methods and abortions
- Future growth of the Japanese market looks set to be slow
- Sales of Ange 28 highlight potential of additional indications
- Innovation will enliven the market
- Innovative administration methods: NuvaRing
- SWOT analysis
- NuvaRing successfully tackles unmet needs
- Geographical expansion and off-label indication to boost sales
- VTE association and OC popularity present small hurdles
- Innovative administration methods: Implanon
- SWOT analysis
- The adversity of side effects and looming genericization
- Popularity in the UK should be matched in the US generating strong uptake
- Organon: a future key player?
- Innovative administration methods: Ortho Evra
- Facing safety issues
- Strategies for a bleak future
- Alternative dosing regimens
- Implementing change
- Seasonale is reformulated to stave off generic competition
- Lybrel provides a new option in dosing
- Alternative dosing regimens will continue to influence the hormonal contraceptive market
- Hormonal contraceptives seeking additional indications
- Acne vulgaris
- Market saturated with acne-indicated contraception
- Estrogen deficiency
- Mirena
- Tanaproget
- Trimegestone
- Moving forward with caution
- Premenstrual dysphoric disorder (PMDD)
- Yaz will enjoy first to market advantage for PMDD indicated hormonal contraceptives
- Lybrel may challenge in the long term
- Uterine fibroids
- An unexploited opportunity
- Neural tube defects
- Folic acid fortification of hormonal contraception
- Dysmenorrhea
- Oncology
- BIBLIOGRAPHY
- References
- Websites
- APPENDIX
- Contributing experts
- About Datamonitor
- About Datamonitor Healthcare
- About the Women's Health and Urology analysis team
- Disclaimer
- List of Tables
- Table 1: Segmentation of the childbearing population by region (000s), 2005
- Table 2: Segmentation of the reproductively able male population by region (000s), 2005
- Table 3: Analysis of key brands in the 5EU and US hormonal contraceptive market, 2005-06
- Table 4: Hormonal contraceptive pipeline, 2006
- Table 5: A cost-benefit analysis of OTC sales of OCs
- Table 6: Male Hormonal Contraceptive Pipeline, 2006
- Table 7: Hormonal contraceptives seeking additional indications, 2006
- List of Figures
- Figure 1: Female population eligible for hormonal contraception for contraceptive purposes by region, 2006
- Figure 2: Male population eligible for hormonal contraception by region, 2006
- Figure 3: Total sales of the seven major hormonal contraceptive markets by region, 2001-05
- Figure 4: Total sales of the 5EU hormonal contraceptive market by region, 2001-05
- Figure 5: Sales of hormonal contraceptives by ATC class in the 5EU and US market, 2001-05
- Figure 6: 5EU and US market growth and market share of hormonal contraceptives by administration method, 2004-05
- Figure 7: The top 10 hormonal contraceptive products in the 5EU and US market, 2004-05
- Figure 8: The Japanese hormonal contraceptive market, 2005
- Figure 9: SWOT Analysis for NuvaRing, 2006
- Figure 10: SWOT analysis for Implanon, 2006
AbstractIntroduction
The hormonal contraceptive market grew by 4.2% from 2004 to $5.0 billion in 2005. Market growth was driven in part by the strong uptake of Schering AG's Yasmin and Organon's NuvaRing which fulfill key strategies: additional indications and alternative delivery modes. Market growth is not expected to falter if companies employ these lifecycle strategies which promote uptake in a competitive market.
Scope of this report
- Identification of the key products and players in the seven major markets and their strategies for success
- Benchmarking lifestyle management strategies for hormonal contraceptives
- Assessment of the potential of the switch from prescription to over-the-counter opportunity
- Examination of the pipeline and future directions of the market, such as the elusive but potentially lucrative male hormonal contraception opportunity
Research and analysis highlights
Despite the slow growth of the Japanese market, opinion leaders believe it can be enlivened by the introduction of innovative delivery methods and by following the sales and marketing strategies successfully employed by Wyeth in Japan.
Should hormonal contraceptives become available over the counter, several companies are suitably placed to enter the new market, including those with two strong brands and those facing patent expiry on a key portfolio product.
Additional indications provide a key growth opportunity. The acne market is saturated with contraceptives and the Yasmin family is synonymous with premenstrual symptoms. However, estrogen deficiency and uterine fibroid indications are commercially attractive.
Key reasons to read this report
- Understand key opinion leaders views on topical issues in the hormonal contraceptive market
- Explore the avenues open to a company intending to optimize brand sales in a mature and competitive market
- Determine the strengths of and challenges to products with innovative delivery mechanisms, dosing regimens, and additional indications
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