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The development of pharmaceutical excipients is getting healthier

The development of pharmaceutical excipients is getting healthier

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Market size is about 5 billion
China's pharmaceutical excipients industry is highly fragmented. Up to now, there are many statistics on the scale and current status of the domestic pharmaceutical excipient market, but they lack authority. How large is the size of the entire market, and in the absence of relevant statistics, can it 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 the variety of pharmaceutical excipients is not as easy to manage as drugs, and the statistics of relevant market data are difficult to be precise, but some industry insiders who understand the development of the industry can follow their own business. Experience and give a rough outline by scientific analysis of relevant data.
“Over the decades of development of excipients, almost no enterprises have specially developed new materials for pharmaceutical excipients.” Wang Ran, general manager of Tianjin Ailei Pharmaceutical Materials Co., Ltd. pointed out that only cydex's beta-cyclodextrin derivative has been produced so far. The materials are specially developed for medicinal use. Most of the varieties are made in other industries (such as fine chemicals, food, cosmetics), and then transferred to pharmaceutical excipients. For example, some large-scale pharmaceutical excipients such as starch, lactose, and cellulose all fall into this category. At present, there are few companies producing starch in China that apply for pharmaceutical production approval for medicinal purposes. Many pharmaceutical excipients only account for a small proportion of producers' production. 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 precisely because of this consideration that the state does not currently require GMP certification for pharmaceutical excipients, but only for certification. Therefore, market information on pharmaceutical excipients is difficult to count.
Wang Ran, who has been in the pharmaceutical industry for decades, emphasizes that the prescriptions for 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 preparation products. These preparations include chemical preparations, biochemical products and proprietary Chinese medicines. As long as the output values ​​of the above three are known, the pharmaceutical excipients can be roughly deduced. output value. According to data released by the Ministry of Industry and Information Technology, in 2008, the chemical preparation industry realized a total industrial output value of 233.6 billion yuan, the biochemical and biochemical products manufacturing industry completed 76.87 billion yuan, and the proprietary Chinese medicine manufacturing industry reached 177.94 billion yuan. 488.41 billion yuan. According to the average profit rate of about 20% in 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 use bulk products to calculate, 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 in ointments, PEG, etc., sucrose, sodium chloride, etc. in liquid preparations, etc. About 5 billion yuan.
In addition, it can also be measured by the sales of pharmaceutical excipients. At present, there are about 50 relatively standardized pharmaceutical excipients in China, with annual sales of around 30 million to 80 million yuan and total sales of 2 billion to 4 billion yuan. In addition, there are more than 10 foreign-funded pharmaceutical excipients in China, with a conservative estimate of 40 million yuan in annual sales, and total sales of about 500 million yuan. The sales of these companies add up to about 4.5 billion yuan.
"There is statistics that the total output value of the domestic pharmaceutical excipients industry is about 100 million US dollars. This figure is not credible." Yu Zhanwen believes that according to scientific analysis and inference, the total output value should be 600 million to 700 million US dollars. The growth rate is generally the same as that of the pharmaceutical industry. In 2008, the growth rate of the domestic pharmaceutical industry was about 25%, and the growth rate of the pharmaceutical accessories industry was probably such a trend.
Broad prospects for industrial development
According to relevant data, in 2001, the global market for pharmaceutical excipients totaled about US$3 billion, of which about 70% were in Europe and America, and 15% in Japan, with an annual growth rate of around 5%, showing an upward trend. With the wide application of new excipients and the domestic commissioning of foreign generics, the future of China's pharmaceutical excipients industry is expected to develop rapidly, and the varieties of traditional excipients will be in line with new types of excipients. At the same time, the entire industry will also accelerate integration, the concentration will be greatly improved, and the medicinal accessories investment boom will continue to rise.
There are many factors in the driving force of the excipient market. One of the primary reasons is the globalization process. Wu Zhenghong, a professor at China Pharmaceutical University, pointed out that pharmaceutical production has expanded to global manufacturing and sales, and the globalization process involves the reorganization of manufacturing sites, which will result in regional or global product concentration in several factories. Each factory has its own unique processes and dosage forms to form a sales center in the area. For the excipient manufacturers, a similar restructuring must be carried out to meet the needs of the customer and to continue this business relationship.
Wan Haitong, a professor at Zhejiang University of Traditional Chinese Medicine, believes that the definition of pharmaceutical excipients is gradually changing due to the rapid development of bio-engineering preparations, insoluble and insoluble pharmaceutical preparations, new dosage forms of traditional Chinese medicines, and new antibodies or other new concept products. It has been included in the scope of pharmaceutical excipients, and the development prospects of the pharmaceutical excipient industry are promising. "With the reconstruction of the international pharmaceutical industry chain, the trend of some parts of drug development and manufacturing to the developing countries is gradually becoming obvious, and the research and development outsourcing and pharmaceutical foundry business are facing development opportunities." Wang Ran said that because of China's cost advantage With sufficient professional and technical personnel, rich production experience and huge market potential, it has become a key area for the global pharmaceutical industry to shift. With the expansion of the scale of preparation, the market demand for pharmaceutical excipients will increase.
Faced with the bright prospects of pharmaceutical excipients, the development of industry norms has become an inevitable trend. Wang Ran believes that there are currently more than 500 varieties of domestic pharmaceutical excipients, accounting for only 26.9% of the medicinal standards; 187 varieties with approval number, accounting for 32% of the varieties of excipients; enterprises with pharmaceutical production licenses 19%, of which chemical companies accounted for 45%, food and other companies accounted for 36%. The concentration of domestic pharmaceutical excipients is low, the industrial structure is unreasonable, and enterprises are small, scattered and chaotic. It is only a matter of time to implement GMP certification for pharmaceutical excipients. Considering the current status of the industry, relevant government departments are studying the implementation of DMF (main quality management of pharmaceutical raw materials), and some pharmaceutical excipients with backward production conditions will be Eliminated.
Kong Zhenyu, executive vice president of the China Pharmaceutical Industry Research and Development Promotion Association, stressed that the concentration of the pharmaceutical excipients industry in China will be further enhanced in the future. A small number of domestic enterprises will occupy the main market due to brand, quality, technological innovation and standard operation, and the number of small enterprises will At the same time, foreign excipients will set up wholly-owned or joint-venture production bases in China, and the competition in the industry will develop from a low level to a high level. The scale of the standardized enterprises will increase rapidly, forming a gradient of industrial scale, and the old varieties will gradually be refined. The new varieties will develop towards slow-release preparations and powder-pressed (canned) accessories.