As the levo isomer of ofloxacin, levofloxacin belongs to the third-generation quinolone antibacterial agent; its antibacterial spectrum is same as ofloxacin, but its antibacterial action is 1 time stronger, and its toxicity is lower; it is clinically indicated for dozens of infectious diseases. The market performance of levofloxacin was eye-catching after marketing owing to its strong antibacterial action, good efficacy, and small side effects, etc., with the sales continuing to grow and the product rapidly becoming a star product on Chinese and foreign markets.
However, levofloxacin has shown weak growth and flat tendency on the Chinese pharmaceutical market in recent years. How its future performance will be is worth noting.
Glorious history
First developed and marketed in Japan by Daiichi Pharmaceutical in 1994, Levofloxacin was approved to be marketed in the U.S. in 1995. Levofloxacin enjoyed hot sales on the market with sales constantly rising after marketing owing to its strong antibacterial action and small adverse reactions, etc.: its global sales reached USD 550 million in 1998, USD 700 million in 1999, and USD 1.09 billion in 2000 ranking 37th on the list of global top 200 best-selling drugs. Also in 2000, levofloxacin surpassed ciprofloxacin for the first time, to top the global sales of quinolones; in 2010, it achieved the outstanding global sales of over USD 2 billion.
Topping the rankings for years
The levofloxacin API and tablet of Daiichi Pharmaceutical were approved to enter the Chinese market in 1995. The company later established a joint venture in Beijing, and had Daiichi Pharmaceutical Co., Ltd. provide API, and the joint venture Youerte Pharmaceutical Company sub-package and produce tablets, and sell the tablets on the Chinese market with trade name of Cravit in 1996. In 1998, levofloxacin entered the top 100 pharmaceutical products by sales in sample hospitals of major Chinese cities only after more than 1 year of marketing, ranking 98th; it quickly ascended to the 21st in 1999, 5th in 2000, and 3rd in 2001 ranking 1st among anti-infective drugs, and its sales in sample hospitals of major Chinese cities reached RMB 600 million in 2005. For over a decade thereafter, levofloxacin had been the leader of quinolone market in China. Many Chinese pharmaceutical enterprises joined levofloxacin production because of the optimism about the huge market space thereof. According to statistics, there are over 800 production approval numbers and over 300 manufacturers of levofloxacin in China.
Market stagflation in recent years
With the heavy use of levofloxacin in recent years, the resistance of bacteria has been growing, and the adverse reactions have increasingly showed. Some time ago the market of levofloxacin showed stagflation due to the strictest restriction order of antibiotics usage in the history of China plus the strong market competition of new antibacterial agents. Its market sales remained stable in 2014-2016, with size all reaching above RMB 800 million, however, it started to show negative growth. Levofloxacin had been the number one on the quinolone market in China over a decade, however, it was surpassed by moxifloxacin in 2016, to ranked second.
Analysis of future prospects
According to analysis, there are favorable and unfavorable factors for the future market development of levofloxacin in China, which will enter the momentum of steady growth.
Unfavorable factors mainly include: firstly, the restriction order of antibiotics usage will have long-term impacts. China now divides antibacterial drugs into restricted use level, unrestricted use level, and special use level, similar to the new standard of the World Health Organization, and there is a strict restriction on doctors’ right to prescribe those 3 levels of antibacterial drugs. The proportion of purchase quantity of antibacterial drugs in total purchase quantity of pharmaceutical products has been declining year by year in big and medium hospitals of major Chinese cities after y...
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