Market Report Source

Overview

Introduction

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

*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

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.

Reasons to Purchase

*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

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