Market size is around 5 billion

　　 my country's pharmaceutical excipients industry is highly fragmented. Up to now, there are many statistics on the scale and current situation of the domestic pharmaceutical excipients market, but they lack authority. How big is the entire market? In the absence of relevant statistics, can you give a rough figure through scientific and reasonable analysis and inference? Yu Zhanwen, secretary-general of the China Pharmaceutical Industry Research and Development Promotion Association, believes that pharmaceutical excipients are not as easy to manage as drugs and are not as easy to manage as medicines. However, some people in the industry who understand the development of the industry can follow their own practices. Experience, and through scientific analysis of relevant data, give a rough outline. To

"Throughout the decades of development of excipients, there are few companies that specialize in research and development of new materials for pharmaceutical excipients." Wang Ran, general manager of Tianjin Aileyi Pharmaceutical Materials Co., Ltd. pointed out that so far, only the beta cyclodextrin derived from Cydex Substances are excipients specially developed for medicinal use. Most of the varieties are prepared in other industries (such as fine chemicals, food, and cosmetics) and then transferred to pharmaceutical excipients. For example, some bulk pharmaceutical excipients such as starch, lactose, cellulose, etc. belong to this situation. At present, almost no domestic starch-producing enterprises apply for drug production approvals for medicinal purposes. Many pharmaceutical excipients only account for a small proportion of the manufacturer's output. If the requirements for pharmaceutical excipients are too high, some manufacturers may abandon the production of pharmaceutical excipients and switch to other industries. It is for this reason that the state does not currently require pharmaceutical excipient manufacturers to implement GMP certification, but only recommend certification. Therefore, it is difficult to make statistics on the market information of pharmaceutical excipients.

　　Wang Ran, who has been in the pharmaceutical industry for decades, emphasized that the prescriptions of preparations are fixed, and the production companies generally have little difference. According to conservative estimates, pharmaceutical excipients account for 5% to 10% of the cost of preparations. These preparations include chemical preparations, biological and biochemical products and proprietary Chinese medicines. As long as the output value of the above three is known, the cost of pharmaceutical excipients can be roughly calculated. output value. According to data released by the Ministry of Industry and Information Technology, the total industrial output value of the chemical pharmaceutical preparation industry in 2008 was 233.6 billion yuan, the bio-biochemical product manufacturing industry was 76.87 billion yuan, and the Chinese patent medicine manufacturing industry was 177.94 billion yuan. 488.41 billion yuan. According to the average profit rate of about 20% of the pharmaceutical industry, according to conservative calculations, the total output value of domestic pharmaceutical excipients in 2008 was about 5 billion yuan.

　　Another method is to calculate by bulk products, because bulk products account for a large proportion of the entire pharmaceutical excipients. For example, lactose, starch, mannitol, cellulose ethers, resins and hollow capsules in solid preparations, glycerides, PEG, etc. in ointments, sucrose, sodium chloride, etc. in liquid preparations, these bulk products have accumulated About 5 billion yuan. To

　　 In addition, it can also be calculated by the sales of pharmaceutical excipient companies. At present, there are about 50 relatively standardized pharmaceutical excipient manufacturers in China, with annual sales mostly ranging from 30 million to 80 million yuan, and total sales are about 2 billion to 4 billion yuan. In addition, there are more than 10 foreign-funded pharmaceutical excipient companies in China. According to a conservative estimate of annual sales of 40 million yuan each, the total sales are about 500 million yuan. The combined sales of these companies are about 4.5 billion yuan.

"There are statistics that the total output value of the domestic pharmaceutical excipients industry is about 100 million U.S. dollars. This figure is unreliable." Yu Zhanwen believes that based on scientific analysis and inference, the total output value should be 600 million to 700 million U.S. dollars. The growth rate is generally the same as the growth rate of the pharmaceutical industry. In 2008, the growth rate of the domestic pharmaceutical industry was about 25%, and the growth rate of the pharmaceutical excipients industry is probably the same.

　　Broad prospects for industry development

　　Relevant data show that the total global pharmaceutical excipient market in 2001 was about US$3 billion, of which Europe and the United States accounted for about 70%, Japan accounted for about 15%, and the annual growth rate was about 5%, showing an upward trend. With the widespread application of new excipients and the acceptance of foreign entrusted processing of domestic generic drugs, my country's pharmaceutical excipients industry is expected to develop rapidly in the future, and the varieties of traditional excipients will compete with new excipients. At the same time, the entire industry will also accelerate its integration, the degree of concentration will be greatly improved, and the investment boom in pharmaceutical excipients will continue to rise.

　　 There are many factors in the driving force of the excipients market. One of the primary reasons is the process of globalization. Wu Zhenghong, a professor at China Pharmaceutical University, pointed out that the expansion of pharmaceutical production to global manufacturing and sales, and the globalization process includes the reorganization of manufacturing sites, which will result in the concentration of regional or global products in a few factories. Each factory has its unique process and formulation, thus forming a sales center in the region. This requires similar reorganizations for manufacturers of auxiliary materials to meet customer needs and continue this business relationship. To

Haitong Wan, a professor at Zhejiang University of Traditional Chinese Medicine, believes that under the influence of the rapid development of bioengineering preparations, insoluble and insoluble pharmaceutical preparations, and new formulations of traditional Chinese medicine, the definition of pharmaceutical excipients has gradually changed. New antibodies or other new concept products It is included in the category of pharmaceutical excipients, and the development prospects of the pharmaceutical excipients industry are promising. "With the restructuring of the international pharmaceutical industry chain, the trend of part of the drug R&D and manufacturing process is gradually shifting to developing countries, and R&D outsourcing and pharmaceutical foundry businesses are facing development opportunities." Wang Ran said, because my country has a cost advantage , Sufficient professional and technical personnel, rich production experience, and huge market potential have become a key area for the transfer of the global pharmaceutical industry. With the expansion of the production scale of preparations, the market demand for pharmaceutical excipients is bound to increase. To

　　 Facing the bright prospect of pharmaceutical excipients, the development of industry standards has become an inevitable trend. Wang Ran believes that there are currently more than 500 types of pharmaceutical excipients in China, and only 26.9% of them meet the medicinal standards; there are 187 types of approved excipients, accounting for 32% of the excipients; companies with pharmaceutical production licenses Accounted for 19%, of which chemical companies accounted for 45%, food and other companies accounted for 36%. The concentration of the domestic pharmaceutical excipients industry is low, the industrial structure is unreasonable, and the enterprises are small, scattered, and chaotic. It is only a matter of time before the implementation of GMP certification for pharmaceutical excipient manufacturers. Taking into account the current industrial situation, relevant government departments are studying the implementation of the DMF (Drug Raw and Excipient Quality Master File Management) system. Some pharmaceutical excipient manufacturers with outdated production conditions will be Eliminated. To

Kong Zhenyu, executive vice chairman of the China Pharmaceutical Industry Research and Development Promotion Association, emphasized that the concentration of my country's pharmaceutical excipients industry will further increase in the future. A small number of domestic enterprises will occupy the main market due to brand, quality, technological innovation and standardized operation, and the number of small enterprises will Reduce; at the same time, foreign auxiliary materials companies will set up wholly-owned or joint venture production bases in China, and industry competition will develop from a low level to a high level. The scale of standardized enterprises will rapidly increase, forming a gradient of industrial scale, old varieties will gradually be refined, and new varieties will develop into slow and controlled release formulations and powder compression (canned) excipients.