Research Report on Industry of Oral Antibiotics for Children in China, 2011-2012

The prevalence rate of Chinese children aged 0-14 is 15%, and the proportion of sick children in total sick population is about 20%. About 85% of the diseases suffered by children are respiratory diseases and digestive system diseases.

Survey shows that in China, the proportion of children aged 0-4 who suffer from respiratory diseases and digestive system diseases in the age group suffering from them accounts for about 80% and 10% respectively, totaling up to 90%. The proportion of children aged 5-14 who suffer from respiratory and digestive system diseases is slightly lower than that of children group aged 0-4, but both totals up to 80%. China has about 250 million children aged 0-14. Although this figure is lower than ever before, medicines for children still enjoy a broad market, especially for anti-infective drugs which account for the largest proportion in clinical medicines (nearly 60%), among which the antibiotic medicines include injections and oral agents. The annual market scale of China's oral antibiotics for children exceeds CNY 2 billion.

In the future, the growth of the scale of antibiotics for children in China will mainly result from the increase in the proportion of oral agents and antibiotics specially designed for children. Seen from varieties, the development trend of oral antibiotics for children tends to be unanimous with drugs for adults on the one hand. For example, oral cephalosporins have been widely applied clinically in recent years, and these products will also be rapidly applied in drugs for children; on the other hand, drugs for children emphasize more on safety, such as few side effects of azithromycins and other macrolide drugs or allergic reactions of penicillins and cephalosporins, which is the reason for it to become oral antibiotics for children with the highest sales value.

Currently, there are several constraints in R & D and production of drugs for children:

1. The children's own physical characteristics result in a long development cycle of drugs for children, low profits, and many pharmaceutical companies' unwillingness to produce children's drugs.

2. In clinical studies, it is a major problem of R&D of drugs for children that data of some diseases suffered by children and corresponding dosages are deficient; while the clinical trials of newly researched and developed drugs entail the cooperation of volunteers, but it is generally difficult to find children examinees.

3. Due to multiple-batch and small-lot production and relatively complex technology, the production cost of drugs for children is high and targeted government encouragement policies are absent.

For these reasons, there are few pharmaceutical enterprises specializing in the production of drugs for children in China currently, and most drugs for children are produced by various manufacturers as by-products. Only Simcere Pharmaceutical and other few manufacturers have established well-known brands in the market of drugs for children. Seen from market shares, imported products and products of foreign-owned enterprises occupy a large share in the market of drugs for children in China.

China's anti-infective drugs for children are mainly composed of injections and oral agents, and the latter has the characteristics of convenient administration, good effect and insignificant toxicity and side effects. In recent years, as oral anti-infective drugs for children with strong antibacterial action and few adverse reactions which are suitable for children in taste, appearance and packaging come into the market continuously, the development of anti-infective drugs exclusive for children market is promoted to a large extent. With the normalization of the use of drugs for children in hospitals, and the choice of providing drugs for families, parents also like to choose oral antibiotics which have good taste and are convenient to take. Oral antibiotics for children will enjoy a tremendous growth room in the future.

It is predicted that the market scale of oral antibiotics for children will be close to CNY 3 billion in 2011 and about CNY 5 billion in 2015.

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