|Frost & Sullivan Market Insight||Published: 22 Jun 2000|
Mevalotin (pravastatin), the first Japanese statin product developed and introduced by Sankyo in 1989, largely contributed to prevailing hyperlipidemic therapy among doctors. Large-scale clinical studies using Mevalotin proved the product's superior efficacy in reducing cholesterol levels. More importantly, these studies verified a strong positive correlation with low-density lipoproteins (LDL) and incidences of primary and secondary ischemic heart diseases, thus contributed to reducing mortality of ischemic heart diseases. Mevalotin and Lipovas (simvastatin) introduced by Banyu in 1991 have penetrated the market and doctors have increased their drug usage frequencies on prescriptions. Consequently the Japanese antihyperlipidemic market whose value was only $350 million before 1989 grew to $2.2 billion in 1999. The market is projected to achieve $3.4 billion in 2006. Needless to say, statins monopolize the Japanese antihyperlipidemic market with 86 percent of revenue distribution. Amidst statins, Mevalotin is a market leader with market share of 52 percent and Lipovas follows this with 25 percent of market share in 1999.
Other classes of antihyperlipidemics include:
New Statin Products and Their Marketing Strategies
New statins following Mevalotin and Lipovas were introduced after 1998, nine years behind Mevalotin's introduction. Fluvastatin (Lochol) was launched in 1998 and Cerivastatin (Baycol and Certa) in 1999. Both new statins were introduced by co-marketing in order to offset the latecomers' disadvantages. The leading brands already established strong brand reputations and relationships with doctors. Furthermore, doctors are highly satisfied with Mevalotin and Lipovas for their safety and efficacy through their long usage experiences. New comers needed to convince doctors about their products' superiority and induce brand switches by visiting many doctors one by one. Novartis selected Tanabe as a partner for co-marketing of Lochol. Tanabe has strong relationships with cardiovascular doctors who are opinion leaders in the hyperlipidemic market. Bayer and Takeda introduced Cerivastatin, the fourth statin product, under different brand names in 1999, Baycol for Bayer and Certa for Takeda. Takeda has the strongest sales capability to both hospitals and general practitioners in Japan and currently defines lifestyle related diseases as their strategic business focus. With the strategy of strengthening sales capability, new comers increased their revenues, and conversely Mevalotin and Lipovas lost 2-3 percent of their market share in 1999. However, it is questionable how far new comers increase their revenues and how they can defend themselves from the entry of second-generation statins such as Lipitor, with their current sales strategies.
Future Market Entrants
Entrances of three new statins are projected for the period from 2000 through 2003. They are called second-generation statins due to their much stronger efficacy in reducing cholesterol levels than current products available in the market. Yamanouchi is introducing Lipitor in October 2000. The product was originally developed by Warner-Lambert. Yamanouchi plans to increase the number of medical representatives and put pressure to the statin products previously introduced. It is also very likely that Pfizer who currently acquired Warner-Lambert will join the sales of Lipitor in the Japanese market in the near future. Two more statins are in the pipeline. One is Itavastatin, which is under application and projected to enter the market in 2001. The product was co-developed by Nissan Chemical and Kowa, and will be marketed by Kowa and Sankyo. Sankyo plans to strengthen the company's market position by having dual statins in their product line. The other statin in the pipeline is Superstatin, which was licensed out from Shionogi to Astra Zeneca in 1998. The product is in the phase II clinical test and projected to be introduced in 2003. Those three products are regarded to have the same efficacy in reducing cholesterol levels. Between second-generation statins, Lipitor seems to have advantages due to its earlier introduction, established reputation outside Japan and strong sales capability. Itavastatin also hold the business opportunity as the product can utilize Sankyo's sales networks already established by Mevalotin. However, Sankyo is very likely to position Itavastatin as statin for severe conditional patients to avoid cannibalization with Mevalotin. This positioning might reduce the business chances of Itavastatin. Astra Zeneca is also very likely to resort to co-marketing with Japanese manufacturers.
Outlook of Future Antihyperlipidemic Market in Japan
Do Mevalotin and Lipovas continue losing their revenue to new statins? The answer is "no", if the current important attributes for brand selection by doctors continue. The answer is "yes", if other important attributes emerge and broaden doctors' selection. The current doctors' most important criteria when selecting statin brands are safety and efficacy. Mevalotin and Lipovas earned high satisfaction for both criteria and their efficacy and safety are proved not only by large-scale clinical studies but also by a long history of doctors' usage experiences. Second generation statins have proved that their efficacies exceed the first generation statins through several large-scale studies. However, the superior efficacies of second-generation statins might be targeted at a limited number of patients whose cholesterol levels cannot be lowered with current antihyperlipidemics. Therefore, Mevalotin and Lipovas may lose their market share though; they are very likely to retain their market positions as leading brands. However, new statins also hold the business opportunities if other important attributes can be added to current criterion of safety and efficacy. The ultimate purpose of hyperlipidemic therapy is to prevent the arteriosclerosis progression and to reduce incidences of the primary and secondary ischemic heart diseases. If any of the statins can prove their efficacies to prevent newly emerging risk factors for arteriosclerosis such as increase in lipoprotein (a) and remnants, as well as rupture of plaque associated with macrophages and oxidized LDL, those statins have business opportunities. If efficacy in preventing those risk factors will be newly added to doctors' criteria when selecting statin brands, this broadens doctors’ brand selection and provides new statins with business opportunities.
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