Market Analysis of Ciprofloxacin and Intermediates in Recent Years
Year:2010 ISSUE:8
COLUMN:PHARMACEUTICALS AND BIOCHEMICALS
Click:342    DateTime:Nov.02,2010
Market Analysis of Ciprofloxacin and Intermediates in Recent Years    

Quinolones antibiotics are a family of relatively fast-developing antibiotics over the past decade and are cheaper than cephalosporin and macrolides antibiotics. Ciprofloxacin hydrochloride, levofloxacin and moxifloxacin are excellent representatives of quinolones that have been widely sold in the market. Because of their huge market capacity and large sales volumes, they have always ranked among the world's best-selling drugs.
   Currently, China, India, Germany (Bayer possesses the patents of ciprofloxacin hydrochloride and moxifloxacin), Japan and the United States (levofloxacin is patented to Daiichi Sankyo Co Ltd and sold in the U.S. market by Johnson & Johnson Services, Inc.) are major producers and consumers of fluoroquinolones antibiotics in the world. China has a certain production capacity of fluoroquinolones and occupies a market share of 30% in the international fluoroquinolones market. The global fluoroquinolones market is mainly dominated by ciprofloxacin and levofloxacin. Their sales value combines about 65% of the global fluoroquinolones sales value. The sales value of ciprofloxacin hydrochloride is only next to their sales value.
   Quinolone drugs have no patent protection in India, so any quinolone drugs with or without patents can be manufactured in India. However, ciprofloxacin hydrochloride and levofloxacin and their key intermediates consumed in India are all imported from China. So India has become China's largest export destination of ciprofloxacin active ingredient and key intermediates.
   More than 90% of China's ciprofloxacin active ingredient and key intermediates manufacturers are located in Zhejiang province. According to survey data, Zhejiang Chengda Pharmaceutical Co., Ltd. (Chengda Pharm) is China's largest manufacturer of ciprofloxacin active ingredient and key intermediates.
   There are two existing processes for the production of ciprofloxacin. One needs to use methyl cyclopropylcarboxylate amine (MCCA) or cyclopropane carboxylic acid (CPCA) as starting materials to produce ciprofloxacin. The other uses cyclopropylborate (CPB) as the starting raw material to produce ciprofloxacin. Chengda Pharm produces MCCA, CPCA and CPB, which are key intermediates for the production of ciprofloxacin active ingredient. The company supplies these intermediates to ciprofloxacin active ingredient producers using these two production processes. The company is also the only producer of CPB in China.
   At present, because only a few of China's active pharmaceutical ingredients have obtained international certification, China-made ciprofloxacin active and key intermediates are basically exported to non-standard markets like India and Southeast Asia and can be only sold at low prices. The price of ciprofloxacin active ingredient in the non-standard markets is generally US$25/kg. But after getting the FDA certification, it can reach US$40/kg.

China's sales amount of ciprofloxacin hydrochloride in 2006 - 2008
         (ton)
Manufacture                             2006    2007    2008
Zhejiang Guobang Pharmaceutical Co., Ltd.    600     650     600
Zhejiang Jingxin Pharmaceutical Co., Ltd.    360     400     380
Zhejiang Xinhua Pharmaceutical Co., Ltd.    200     300     270
Zhejiang Huayi Pharmaceutical Co., Ltd.     150     200     100
Others                                      50      -         -
Source: CNCIC

Major producers' sales volume of key intermediates of
   ciprofloxacin in 2007 – 2008
                   (ton)
Year                2007                2008
Company     MCCA    CPCA    CPB     MCCA    CPCA    CPB
Zhejiang Chengda Pharmaceutical Co., Ltd.
            134     117.6    78.9    214.5    92.4    69.4
Binhai Golden Hilen Medicine Chemistry Co., Ltd.
            90      60         -             -    100      -
Source: CNCIC