70% revenue growth in systematic antifungal

According to a new report* from independent market analyst Datamonitor (DTML), the global systematic antifungal market will be worth almost $6bn by 2014.

Growth will primarily be driven by the novel echinocandin class, which the research firm expects to grow at a compound annual growth rate (CAGR) of 11.2% over the decade. Datamonitor warns that the increasing competitiveness of the systemic antifungals market necessitates a larger commitment of pre-launch resources, with a lengthening payback period.

Increased incidence and launch of novel, premium-priced antifungals fuels market growth

Invasive fungal infections primarily affect those whose immune system has been impaired by disease or treatment (the immuno- compromised). For example HIV and cancer patients, neonates, surgical patients and those undergoing solid organ transplants. According to Datamonitor, an estimated 9m patients across the seven major markets are considered 'at risk' from invasive fungal infections with approximately 1.2m actually affected in 2003.

The global systemic antifungal market has experienced strong growth since 1999, increasing in value from $2.1bn to $3.3bn in 2003. The introduction of the echinocandin class has been a key driver of this growth, and has boosted the value of the echinocandin sector by $312m in 2003. Datamonitor forecasts the systemic antifungal market to be worth $5.7bn by 2014, representing an overall growth of 73% over the period.

Echinocandins to account for 22% of total sales by 2014

Novel antifungals, such as Cancidas (caspofungin), experienced relatively slow initial uptake, as physicians have been reluctant to use it without detailed, peer reviewed data. However, 2003 sales were significantly stronger than 2002, demonstrating an acceptance of its role in antifungal therapy. Datamonitor expects the value of the echinocandin class to almost triple, from $429m in 2004 to $1.2bn in 2014. This class will account for 22% of the total systemic antifungal market compared with just 9% in 2003. While the azoles class will continue to dominate the antifungal market in 2014, their growth will but will be much lower by comparison (CAGR 4.3% compared with 11.2%, respectively).

Growing physician antifungal choices are leading to more selectivity in prescription choice. Consequently, the new azoles' product characteristics, such as oral bioavailability and ease of dosing, are becoming key factors in new product uptake. Likewise the novel azoles, for example Vfend (voriconazole) and posaconazole are expected to show rapid growth at the expense of older products such as Diflucan (fluconazole).

The launch of Vfend and Cancidas has created increased competition within a sector traditionally dominated by a limited number of products. As patent expiries and new product launches increase competition further, market penetration and product success will increasingly depend on effective positioning strategies and appropriate targeting of niche patient groups and pathogen types.

Pfizer, Merck & Co. and Fujisawa best positioned

Increasing competitiveness of the systemic anti-fungals market necessitates a larger commitment of pre-launch resources, with a lengthening payback period. Niche indications offer key opportunities for companies seeking to establish their products, while providing the potential for targeted co-promotion of antifungals with other products frequently used in at-risk groups. In addition, launch in less mature markets, such as Japan, has led to a much more rapid uptake than would be achieved in the EU or US. In Japan, antifungal treatment regimes are usually comprised of older, cheaper drugs, such as amphotericin B, nystatin, fluconazole and itraconazole. There is a significant unmet medical need for rapidly efficacious, low toxicity drugs, as demonstrated by the rapid uptake of Fungard (micafungin) following its launch in 2002. The product recorded $83m of sales in 2003, which is a considerable feat in light of Vfend recording $173m after launch in more markets.

Although Pfizer's sales will be negatively impacted by the loss of US patent protection for its leading antifungal, Diflucan, in July 2004, it is actively positioning Vfend as a successor, obtaining approvals for the treatment of Candida infections in addition to the original aspergillosis labeling. Pfizer is also well-positioned to take advantage of the potential offered by the Japanese market, with Vfend submitted for ap-proval in June 2003, and a strong sales and marketing network in place through the promotion of Diflucan. Similarly, Fujisawa, through its marketing of AmBisome in the US, should reap the benefits of co-promotion and possible combination therapy following the launch of micafungin in the US, expected in 2005. Although Merck currently markets only one antifungal product, Cancidas, the strong uptake expected over the next decade - as the product becomes firmly established in the treatment of severe and disseminated infections - will maintain the company's market share and antifungal sales revenue.

Laura Harris, antifungals analyst at Datamonitor comments: 'A limited number of antifungals have historically reduced the importance of product positioning than in other, more saturated therapy areas, such as antibacterials. However, as new antifungals have been successively launched, a concerted effort to highlight each product's benefits is necessary to ensure maximum product uptake. Targeted dissemination of data is essential to ensuring optimum uptake of a new antifungal product where post launch Phase IV trials go some way to appeasing the physician's reluctance to switch prescription through lack of data.'

Commercial Insight

*Commercial Insight: Antifungals - An Examination of the impact of key events in the systemic antifungal market, such as the patent expiries of leading products and the launch of several pipeline drugs, with recommendations for effective portfolio and lifecycle management. T +44 20 7675 7487 abourgeois@datamonitor.com