Overview and Prospect of API export

I overview of API export (I) overall operation according to statistics of the Ministry of industry and information technology, the total output value of China's API manufacturing industry in 2012 was 330.475 billion yuan, an increase of 16.59% year on year, accounting for 18.1% of the total output value of China's pharmaceutical industry In 2012, the global economic situation was in a downturn The contradiction between supply and demand in the API market was prominent The competitive price reduction in the process of domestic drug bidding and purchase also brought a certain impact to the industry According to the statistics of medical insurance chamber of Commerce, in 2012, the export volume of API in China was 22.695 billion US dollars, up 3.16% year on year; the export volume was 6062300 tons, up 3.04% year on year; the average unit price of export increased 0.11% year on year The export volume in 2012 increased slightly compared with the same period in 2011, indicating that the international market share of APIs in China has not changed greatly In the first quarter of 2013, China's API export volume was US $5.937 billion, up 3.91% year on year, and the export growth rate is still at a low level (II) international market distribution In 2012, China exported APIs to 180 countries and regions, with exports to Asia, Europe and North America of US $10.286 billion, US $6.411 billion and US $3.445 billion, respectively, accounting for 88.75% of the three markets The pattern of major export markets has not changed and shows a steady growth trend, with exports to the three markets increasing by 2.95%, 4.13% and 5% year on year respectively .47% From the perspective of export market, the top ten export markets of API in China in 2012 are India, the United States, Japan, South Korea, Germany, the Netherlands, Spain, Italy, Brazil and Belgium, accounting for 61.44% of the total As far as the international market is concerned, the economic recovery in Europe and the United States still presents great uncertainty, and it is difficult for market demand to recover to the original level and speed of development in a short period of time; the economic growth of emerging pharmaceutical markets such as Russia and South America slows down, and it is more difficult to expand; the trade risks in African, Western and Middle East markets are large, and enterprises are cautious; the labor forces in India and Southeast Asia are successful The market share of Chinese products will be squeezed due to the lower cost and faster currency depreciation (3) from the perspective of export enterprises, there were 9426 enterprises engaged in API export in 2012, 2 fewer than that in 2011, which reflected that the main body of API export tends to be stable In 2012, the top ten enterprises in API export volume accounted for 10.33% According to the export situation of provinces and cities, in 2012, China's API exports were still mainly concentrated in coastal areas In terms of export volume, the top five provinces and cities for API export are Zhejiang, Jiangsu, Shandong, Shanghai and Hebei, with the cumulative export volume accounting for 69.23% (IV) export products in 2012, China's chemical API export commodities were included in 252 customs codes, accounting for 65% of the year-on-year growth in export volume and 69% of the year-on-year growth in export volume, showing a good overall growth trend In terms of the average export unit price, 57% of API products showed a year-on-year growth in 2012, 43% of API products showed a year-on-year decline in the average export unit price, but about 38% of API products with price growth were below $10 / kg, still hovering in the lower price range From the perspective of export volume, in 2012, there were 101 varieties with export volume of API over US $50 million and 66 varieties with export volume over US $100 million Vitamin and antibiotic APIs are the largest suppliers in the international market, which has not changed in recent years 2 Industry competitiveness analysis: China is a big producer and exporter of APIs, with obvious advantages of full range, large scale, high quality and low price, which can not be replaced in a short time In the industry chain, China is highly complementary with developed countries in Europe and America, and has different emphasis with competitors such as India China's API exports to European and American markets account for more than 50% of China's total pharmaceutical exports, and the exports of vitamin C, penicillin industrial salt, vitamin E, saccharin sodium, paracetamol and other bulk products have accounted for more than half of the world trade volume, while other about 70 kinds of API products also account for a large proportion, which plays an important role in the international market Under the guidance of the 12th Five Year Plan for the pharmaceutical industry, China's pharmaceutical industry as a whole will continue to develop steadily Economic growth and policy guarantee will promote the rapid growth of pharmaceutical consumption, and will continue to be the endogenous driving force for the development of China's pharmaceutical industry Under the general trend of adjusting structure and promoting transformation, the concentration of API industry, technological innovation, quality and safety, and international competitiveness are all in one To some extent, the improvement of energy conservation and emission reduction has also achieved good results In the process of renewal of new GMP, the quality and value of pharmaceutical products will be improved as a whole, which has laid a good development environment for China's pharmaceutical foreign trade III challenges faced by the industry (I) data from the Ministry of industry and information technology of overcapacity shows that in 2012, the growth rate of the overall fixed asset investment in China's pharmaceutical industry increased significantly year on year, which exceeded the growth rate of the total industrial output value and total assets of the whole industry, showing a significant expansion trend In the new GMP transformation process, such rapid fixed asset investment is very easy to cause the problem of overcapacity in API manufacturing industry with relatively low technology content, and then reduce the overall profits of the industry, resulting in vicious competition, which is a common dilemma faced by many API enterprises at present (II) in 2012, with the increase of cost, the profit of API industry showed negative growth, which is rare in recent years The main reason for the decrease of profit is that the ability to digest environmental protection cost is not high, and the environmental protection standard has been raised too fast On the one hand, all costs are rising, on the other hand, terminal drug prices are falling, which brings great difficulties to API enterprises Unless the enterprises have strong bargaining power, there are not many such API products at present (3) RMB exchange rate restricting RMB exchange rate is still an important factor restricting the development of enterprises The increasing appreciation of RMB means the increasing export pressure of bulk APIs and intermediates with low added value The continuous appreciation of RMB exchange rate has seriously affected the export of enterprises The advantage of API export in price competition in China is gradually lost, which also forms a certain pressure on the operation of export enterprises (IV) international regulation is becoming increasingly strict In June 2011, the European Parliament and the European Commission issued a new decree 2011 / 62 / EU, which requires that all APIs (active substances for human use) exported to Europe must issue a written statement from the regulatory authorities of the exporting country from July 2, 2013 On February 22 and August 6, 2012, the official website of the US Food and Drug Administration (FDA) issued import warnings successively, saying that the quality supervision system of 33 Chinese heparin crude product manufacturers could not prevent product pollution, or did not meet the cGMP of the United States, suspected of producing problematic heparin products, and said that it would directly detain all types of heparin and related products exported by the above-mentioned enterprises to the United States After the warning was issued, it has a negative impact on the heparin industry and even the pharmaceutical export in China On the whole, the preparation and inspection procedures of API enterprises in China are becoming more and more complex, and the production conditions and quality standards to be met are endless IV work done by the chamber of Commerce (I) coordinate and promote the government to solve difficult problems in the pharmaceutical industry In response to the problem that some of the customs tariff numbers of pharmaceutical products that are strongly reflected by the enterprises are classified incorrectly and inspected by the customs, we have made special reports to the Ministry of Commerce, the General Administration of customs and other departments for many times, and held "Symposium on customs policies of pharmaceutical enterprises in Shanghai and Zhejiang area", "2012 National Training Conference on customs policies of pharmaceutical enterprises" and other activities in cooperation with the Customs Department of the General Administration of customs, and prepared to work with the customs this year To cooperate in compiling the manual of Customs Classification of pharmaceutical products, so as to regulate and guide the customs clearance and export of enterprises In view of the major obstacles caused by EU directive 62 to the export of API to EU, we have invited relevant departments and key enterprises to hold special meetings for many times, accompanied officials of the Ministry of Commerce and the drug administration to Europe for consultation, cooperated with relevant industry organizations, importers and Indian industry associations to put pressure on the European Commission, and cooperated with the Ministry of Commerce and the drug administration in WTO / TBT No 57 and 58 At the second regular meeting, serious concerns were raised about the new EU directives With the efforts of CFDA, EU drug regulatory authorities came to China in July 2012 to jointly hold a symposium and dialogue with CFDA to help Chinese enterprises understand the specific requirements of EU API Market Access Regulations and good production practices, and achieved good results (II) improve the professional service level and serve the enterprise wholeheartedly In 2012, CCPIT launched the construction of "operation and prediction and early warning information platform for pharmaceutical trade", taking more than 300 APIs, Chinese herbal medicines and medical devices as the pilot, integrated and optimized the existing data, information and report resources, absorbed some leading enterprises to establish a data direct report system, relying on the advantages of professional talents and information release system of the chamber of Commerce, and realized the goal of facing the government, industry and enterprises Pharmaceutical trade tracking analysis and market-oriented services We also rely on leading enterprises to set up overseas exhibition centers in the United States to provide substantive services for the brand promotion and marketing channel construction of Chinese plant extract enterprises in foreign countries China Pharmaceutical Enterprise Management Association and China Pharmaceutical Enterprise Management Association also jointly issued the "preparation internationalization pilot enterprise honor certificate" to enterprises that have passed the high-end certification in Europe and the United States, and encouraged enterprises to explore the high-end international market (III) give full play to the advantages of international contacts and build a trade and investment promotion platform In 2012, in cooperation with the visit of national leaders, CCPIT organized a high-level delegation of pharmaceutical investment and trade to the United States, Denmark and Iceland respectively to carry out business investigation and economic and trade promotion Through visiting the competent government departments, industrial organizations and key enterprises of the host country, CCPIT held business negotiation activities with many world-famous cross country pharmaceutical groups In 2012, CCPIT also signed a memorandum of cooperation with the Trade Commission of the Ministry of foreign affairs of Denmark, laying a foundation for deepening cooperation I will also establish a strategic partnership with Yale University At the same time, we also organized delegations to Japan, Indonesia, Malaysia, Thailand, India and other countries, organized the Russian pharmaceutical delegation of the Ministry of industry and information technology, and organized enterprises to Kenya and Tanzania to hold "African China pharmaceutical product promotion and exchange activities" In 2012, we also organized enterprises to participate in 39 professional exhibitions abroad, with 3518 exhibitors from 1553 enterprises participating in the exhibition, with an exhibition area of about 16000 square meters Through the above-mentioned different forms of visits, exchanges and exhibitions, we publicized the good image of Chinese medicine and promoted the counterpart exchanges between Chinese and foreign enterprises V the export of APIs will move forward in the challenge In 2013, the global economy will develop in a good way The expectations of major international organizations for China's economic growth in 2013 are generally better than that in 2012 With the implementation of national policies and measures to support foreign trade development, it will help enterprises to accelerate transformation and upgrading, further improve their comprehensive competitive advantage, and ease current difficulties In general, China's API export will move forward in 2013 In the face of challenges, we should actively deal with them First, we should continue to vigorously explore the international market, strive to expand the share, increase the efforts to explore the surrounding markets and emerging markets, and actively participate in regional economic and trade cooperation Second, we should effectively solve various difficulties faced by export enterprises, such as the problem of enterprises being inspected by the customs due to the adjustment of tariff classification of pharmaceutical products EU directive 62 should Third, seize the opportunity of a new round of global pharmaceutical industry transfer to Asia and improve China's commitment