Schering AG, soon to be acquired by fellow German pharma company Bayer, dominates the global market for systemic oral contraceptives (ATC therapy class G3A) with its latest oral contraceptive Yasmin, and should boost its position in the future with the new low-dose version Yaz. Meanwhile Johnson & Johnson, has been adversely affected by safety/side-effect concerns about its Ortho-Evra contraceptive patch, which took off extremely well when first launched. Another company seeing success in this sector is Organon (part of the Dutch Akzo Nobel, group, but soon to be spun off into an independent company, Organon Biosciences). Its innovative product NuvaRing is also gaining market share, having overcome an initially slow market uptake.

New products drive strong growth
The G3A class has seen strong growth in recent years, with a number of major new product launches. Branded generic products have also entered the market, courtesy of Barr, and Watson, and this has disturbed the dominance of the former "Big Four Companies" in the sector (J&J, Schering, Akzo Nobel and Wyeth). Market leader Schering, however, has seen market share grow and grow.

*Systemic hormonal contraceptive market (G3A) 2001-2005

Source: IMS MIDAS Quantum

*Sales figures are largely measured through the retail and hospital pharmacies and in certain countries may not include other distribution channels such as clinics

In 2005, according to IMS, Schering AG was the number one corporation worldwide in the G3A class, with a 27.8% market share, followed by J&J with an 18.2% market share and generic manufacturer Barr with 12.2%. Akzo Nobel and Watson ranked fourth and fifth respectively. In 2005, sales in this class as a whole were reported by IMS to be up by 7.5% at $6.7 billion.

*Leading products in 2005

Source: IMS MIDAS Quantum

*Sales figures are largely measured through the retail and hospital pharmacies and in certain countries may not include other distribution channels such as clinics

Yasmin has been performing very well and the franchise will be boosted by the launch of the low-dose version Yaz (Yasminelle in Europe) in 2006. In the first quarter of 2006, according to Schering AG, sales of Yasmin rose by 34% to €180 million.

Ortho Evra faces safety concerns
In December 2005, the FDA announced that it required a warning on Ortho Evra's label stating that women who use the patch are exposed to around 60% more total oestrogen than if they were taking a typical OC. Generally, increased exposure to oestrogen may put women at greater risk of developing blood clots, although the FDA pointed out that it is not yet known if users of Ortho Evra are actually running a greater risk of this potential side-effect.

In September 2005, Organon announced that new data show that oestrogen exposure with its rival product NuvaRing is significantly lower than that achieved with Ortho Evra or with the oral contraceptive Microgynon. Later that year, Organon launched its first nationwide direct-to-consumer advertising campaign in the USA for NuvaRing.

In February 2006, J&J stated that it had received the first results from two separate ongoing epidemiologic studies designed to evaluate the risk of experiencing serious side-effects when using Ortho Evra. The objective of the first epidemiological study, which was conducted by the Boston Collaborative Drug Surveillance Program, was to evaluate the combined risk of heart attack and stroke in first-time users of Ortho Evra compared with first-time users of a norgestimate-containing OC with 35 micrograms of oestrogen. The other objective of the study was to separately evaluate the risk of heart attack, stroke and venous thromboembolic events (VTE) in the same women. The first published paper from this study, which specifically evaluates the risk of non-fatal VTE, was published on the website of the journal Contraception and concludes that "the risk of non-fatal VTE for the contraceptive patch is similar to the risk for OCs containing 35 micrograms of ethinylestradiol and norgestimate." J&J states that the evaluation of the other study objectives, including the risk of heart attack and stroke, is ongoing, but that available data did not show an increase in the risk of the combined endpoint of heart attack and stroke with the use of Ortho Evra.

In March 2006, a suit was filed against J&J in the USA on behalf of a 20-year old woman who died from a pulmonary thromboembolism after using Ortho Evra for 10 months.

Yaz launched, Implanon approved in the USA
Yaz, the lower-dose version of Yasmin, was launched in the USA in April 2006. In Europe, it will be called Yasminelle; it was approved in Europe via the MRP in May 2006 (and also launched in Switzerland and Argentina that month). Morgan Stanley analysts forecast that the Yasmin/Yaz/Yasminelle franchise will generate sales of €1.9 billion by 2012.

July 2006 saw FDA approval of another Organon hormonal contraceptive product, Implanon (etonogestrel implant). About the size of a matchstick, Implanon is the world's first and only single-rod implantable contraceptive, and is effective for up to three years. It was first launched in 1998 and is available in around 30 markets outside the USA. According to Organon, it is used by more than 2.5 million women world-wide. Organon USA will conduct a national programme to train healthcare providers on the insertion and removal procedures for Implanon. Only healthcare professionals trained through the Organon-sponsored programme will be able to prescribe Implanon. The programme is scheduled to begin in 2006 and as it progresses, the company states that Implanon will become more widely available during 2007.

This article was written by Susan Murray, Senior Editor of IMS Company Profiles.

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