It is reported that the sales share of current anti-cancer drugs accounted for approximately 15% of the world pharmaceutical market, in the best-selling plant sources anti-cancer drugs, the “Paclitaxel” is undoubtedly the champion. Development and utilization of paclitaxel is gaining more and more attention.
Paclitaxel is a new plant anticancer drug. The mechanism of paclitaxel is different from other chemical synthesis anti-tumor agents or plants anticancer drugs. It is primarily in the way of inhibiting tumor cell’s important division manner – tubulin synthesis to make the tumor volume gradually reduced rather than directly kill cancer cells. The originally approved clinical use of paclitaxel was for the treatment of advanced ovarian cancer and non-small cell lung cancer. Since then, the medical community has been discovered many interesting new uses of paclitaxel, including in combination with anti-AIDS drugs to treat Kaposi’s sarcoma (a specific cancer of people with AIDS) as well as for colorectal cancer, bladder cancer, breast cancer and a series of thorny tumor diseases. Since the expansion of paclitaxel indications and side effects less than other anticancer drugs (chemotherapy), so that the products in the international market received many reputations and has become widely used first choice anti-cancer drug in clinical. Although the price is expensive, but its efficacy is outstanding, so that paclitaxel formulation on the market is always sold briskly.
The currently marketed paclitaxel by different sources of raw materials can be divided into two categories. The first category is processed by directly extract pharmaceutical raw materials from the Pacific yew bark, the second category is semi-synthetic paclitaxel that extracted “10 baccatin base” from the European ornamental twigs or leaves and other renewable resources, through semi-synthetic to be paclitaxel. The international market is still in use the two paclitaxel bulk drugs preparation methods that established ten years ago (ie, Yew tree bark extract method and twig extract half synthetic method). So far there has not been reported the third methods form of large-scale industrial production of paclitaxel. According to the latest statistics, in 2000 the total sales of the world market paclitaxel raw materials is $ 147 million, paclitaxel formulations market is about 1.3 billion -1.4 billion dollars, of which the United States consumes about 90-95% of the paclitaxel bulk drugs. In terms of volume, in 2000 the global paclitaxel bulk drugs production is about 370kg, and basically consumed the full year yield (no stock). Due to the international market demand for paclitaxel bulk drugs, by 2007, the sales of paclitaxel bulk drug was 1 time than in 2000, up to 700kg or more, total market sales reached about $ 200 million.
According to international pharmaceutical market analysts estimate, various countries demand for paclitaxel raw materials will increase rapidly in the next 5 years, increasing by 100%. The reason is that the effect of paclitaxel treated advanced cancer is significant, other chemotherapy drugs can not able to replace; second, the United States has begun produce yew leaven approved generic drug product, which means that paclitaxel in the United States is no longer an exclusive product. In addition, Italy, Germany pharmaceutical companies will launch their own generic drug paclitaxel formulations products during the year. As more and more generic paclitaxel products onto the market, the competition of each preparation factory competing against paclitaxel bulk drug will become increasingly fierce. There is no doubt that with the expansion of production, the demand for paclitaxel raw materials will continue to grow.
Most of the current paclitaxel production in China used for injections in their national markets, only a small number of raw materials for exporting to international markets. Authorities estimate that the total output of Chinese paclitaxel bulk drugs is about 40kg, accounted for 10% of international paclitaxel production.