Analysis On The Bottleneck Of Development Of API Market

China as the world's largest producer and exporter of api active pharmaceutical ingredient , api active pharmaceutical ingredient in China's pharmaceutical trade accounted for nearly 40% of the proportion, accounting for the proportion of total exports closer to 50%, China's pharmaceutical industry has been due to the rapid development of raw materials and continued brilliant - maintained high growth for many years. But now, the api active pharmaceutical ingredient scenery is no longer, especially the bulk of the export of raw materials, excess capacity market downturn, exports into the most difficult period.

2013 January to July, China's import and export of api active pharmaceutical ingredient was 18.463 billion US dollars, an increase of 3.74%. Among them, the export volume of 14.096 billion US dollars, the export volume to maintain the growth rate of 8.91%, but due to export prices fell by 4.59% year on year, making exports grew by only 3.91%, while vitamins, antibiotics and anti-infective, respiratory system Raw materials were decreased by 10.43%, 1.6% and 29.21%.

It can be seen that the current export growth of bulk raw materials in China is more to "price change" in the form of performance, and the amount of winning is the current China in the global market base of raw materials drug firm foothold.

Characteristics of raw materials demand rigid

China's api active pharmaceutical ingredient has been dragged down by years of high energy consumption, heavy pollution and low added value. In fact, we have seen the international market dominance of these glittering data by expanding capacity, low labor costs and resources Consumption, etc. to achieve.

In recent years, in the artificial production costs and drug terminal prices this rise and fall in the context of environmental protection standards upgrade speed will undoubtedly affect the production and operation of enterprises. The appreciation of the renminbi also makes the price advantage of China's export of raw materials gradually lost, lower value-added bulk drugs and intermediates in the export pressure increased.

And the international regulatory trend will make the already struggling export enterprises worse, such as the EU issued 62 directive requirements, from July 2, 2013 onwards, all exports to Europe api active pharmaceutical ingredient (human active substances) must be issued by the exporting country regulatory authorities Of the written statement that the implementation of the new directive has been China's exports of drugs have a serious impact on the European market. In addition, the United States in October 2012 through the "generic drug application fee bill" (GDUFA) provides for the increase in foreign companies GMP check the frequency and charges, which means that the export of US pharmaceutical companies will add an additional cost , Exacerbated the burden on the enterprise.

Facing the decline of export of raw materials, the international situation is grim and many other challenges, China's api active pharmaceutical ingredient transformation and upgrading is particularly urgent. Between 2011 and 2016, the world will have sales of more than 250 billion US dollars of drugs face patent expiration. Brand drug protection of a large number of patent expiration, to promote the rapid development of generic drug market, and generic drug market driven by the strong growth of the demand for raw materials. Although the characteristics of China's specialty drug market share can not be compared with bulk drugs, but the growth rate is far beyond the latter. The first half of this year, China's specialty api active pharmaceutical ingredient exports 1.067 billion US dollars, an increase of 11.23%, some products such as atorvastatin and so even doubled. China's pharmaceutical companies such as the success of the transformation and upgrading of products, continue to achieve the value chain, the growth potential will be unlimited.