Cefaclor has become a widely accepted antibiotic due to its reasonable pricing and increasing clinical maturity. Over the past few years, its growth rate has been strong, encouraging manufacturers to continuously innovate with new formulations and specifications. However, rising costs of penicillin industrial salt have led to higher market prices for cefaclor.
According to data from leading medical publications like Scrip and Market.Letter, cefaclor was among the top 10 best-selling drugs globally for ten consecutive years from 1987 to 1997. It dominated both prescription and retail sales in the antimicrobial category. In 1993, global consumption reached over 400 tons, rising to 450 tons by 1996. Sales of its preparations remained between $1 billion and $1.1 billion annually.
The patent for cefaclor has now expired, allowing multiple manufacturers to enter the market. Major suppliers include Eli Lilly (USA), Shionogi (Japan), ACS Dobfar (France), and Ranbaxy (India). In China, about 11 domestic producers have received approvals, with Guangzhou Baiyunshan, Suzhou Zhonglian, and Zhejiang Ang Likang being key players. The first approval was granted to Shandong Xinhua-Kenfu Pharmaceutical in 2002, but no new companies registered after 2005.
While generic competition has driven down prices, it has also expanded the market. Cefaclor’s total sales are expected to continue growing in the future. Recently, the price of raw materials has surged to around 2450–2500 yuan/kg, intensifying competition in the raw material market.
China lacks a competitive edge in producing upstream intermediates like 7-ACCA, which is essential for cefaclor. Most raw materials are imported from India, which holds key production technologies. In 2006, China imported 42 tons of cefaclor and 43 tons of 7-ACCA, showing significant year-on-year growth.
The fluctuating price of penicillin industrial salt has impacted cefaclor prices. After a wave-like increase, cefaclor prices have risen, but with recent declines in penicillin salt, cefaclor prices may follow suit. With more players entering the market, competition will likely intensify.
In the hospital drug market, cefaclor has shown strong growth. Since its first development in China in 1994, it quickly gained popularity. By 2006, there were 45 manufacturers, including Shandong Zibo Xinda, Harbin Yuheng, and Guangzhou Baiyunshan. Cefaclor capsules and granules were included in national insurance lists, and sustained-release tablets were added later, boosting market growth.
Currently, the most common forms are 250 mg capsules and 125 mg granules. In the first half of 2008, capsule output reached 51.98 million units, and granules reached 56.664 million bags. Production is concentrated among a few major companies, with Shandong Zibo Xinda and Guangzhou Baiyunshan leading in granule production.
New dosage forms, such as 375 mg sustained-release tablets, have been developed by companies like Xinda Pharmaceutical and Zhejiang Ang Likang, further expanding the product range.
The cefaclor market is currently in a balanced phase, with top manufacturers maintaining stable positions. Original brands like Xijiao Lao remain popular in key hospitals, while domestic products compete fiercely, often at lower prices. Despite competition from foreign joint ventures, cefaclor continues to gain traction.
With its convenient oral administration, cefaclor is especially popular in pediatric medicine. Data shows a significant increase in prescriptions for cephalosporin antibiotics in pediatrics, particularly for respiratory and urinary tract infections. Quinolones are restricted for children due to safety concerns, and penicillins/macrolides face limitations due to side effects. This makes cefaclor a preferred choice in pediatric care.
After two price adjustments, cefaclor has become affordable for most patients. Its long-term clinical use has made it a mature and trusted option. These factors ensure a promising future for cefaclor, with substantial growth potential in the market.
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