Because the export of pharmaceutical intermediates is not restricted by importing countries like the export of drugs, the production of pharmaceutical intermediates in the world is transferred to developing countries, and the chemical raw materials and intermediates needed for pharmaceutical production in China are basically compatible, and only a small part needs to be imported. Moreover, due to China's abundant resources and low prices of raw materials, many pharmaceutical intermediates are exported in large quantities.
Looking at the whole industry, the pharmaceutical intermediate industry in China has six characteristics: first, most of the enterprises are private enterprises, with flexible operation and small investment scale, ranging from several million to/kloc-0.2 billion yuan; Second, the geographical distribution of enterprises is relatively concentrated, mainly centered on Taizhou, Zhejiang and Jintan, Jiangsu; Third, with the country's increasing attention to environmental protection, the pressure on enterprises to build environmental protection treatment facilities is increasing; Fourth, the product update speed is fast, and the profit rate will drop sharply after entering the market for 3-5 years, forcing enterprises to continuously develop new products or improve processes to obtain higher profits; Fifth, because the production profit of pharmaceutical intermediates is higher than that of general chemical products, and the production process is basically the same, more and more small chemical enterprises join the ranks of producing pharmaceutical intermediates, which leads to increasingly fierce disorderly competition in the industry; Sixth, compared with raw materials, the profit rate of producing intermediates is low, and the production process of raw materials and pharmaceutical intermediates is similar, so some enterprises not only produce intermediates, but also use their own advantages to start producing raw materials. Experts pointed out that it is an inevitable trend for the production of pharmaceutical intermediates to develop towards raw materials. However, due to the single use of raw materials, it is greatly influenced by pharmaceutical companies, and it often happens in China that there are no users after enterprises develop products. Therefore, production enterprises should establish long-term and stable supply relations with pharmaceutical enterprises to ensure the smooth sales of products.
1. Typical pharmaceutical intermediate market
1. 1. The demand for phenylacetic acid continues to grow.
After nearly 50 years of development, China's β -lactam antibiotics have formed a complete production system. At present, almost all β -lactam antibiotics can be produced in China (except the varieties within the patent period), and the cost is very low. The output of penicillin ranks first in the world and is exported to the international market in large quantities. Cephalosporins are basically self-sufficient and some of them can be exported.
At present, domestic intermediates matching with β -lactam antibiotics can be produced by themselves, and side-chain intermediates can be produced and exported in large quantities except for semi-synthetic antibiotic mother nuclei 7-ACA and 7-ADCA, which need to be partially imported.
Take phenylacetic acid as an example, the main supporting intermediate of β -lactam antibiotics. There are nearly 30 phenylacetic acid production enterprises in China, with an annual total production capacity of about 20,000 tons. But most enterprises are small in scale, with the largest annual output of 2,000 tons, and most others have an annual output of several hundred tons. In 2003, the domestic total demand of phenylacetic acid was about 6.5438+0.4 million tons, of which penicillin G accounted for 85%, other drugs accounted for 4%, spices accounted for 7%, and pesticides and other fields accounted for 4%. With the development of domestic perfume, medicine, pesticide and other industries, the demand for phenylacetic acid will further increase. In 2005, China's pharmaceutical industry consumed phenylacetic acid 1.4 million tons, pesticide industry consumed about 500 tons, and perfume industry consumed about 2000 tons. Together with consumption in other fields, the total consumption of phenylacetic acid in China reached 654.38+800,000 tons in 2005.
1.2. Pyridine-containing intermediates have become a hot spot.
At present, the main quinolones developed and put into mass production in China are norfloxacin, ciprofloxacin, ofloxacin, enoxacin, lomefloxacin and fleroxacin. Among them, norfloxacin, ciprofloxacin and ofloxacin have the largest output, accounting for about 98% of the total fluoroquinolones in China.
Quinolones are generally fluoroquinolones synthesized by fluorobenzene ring, and then condensed with piperazine (or methylpiperazine). China is one of the countries with the largest output of fluorine-containing drugs and intermediates in the world, and more than 80% of fluorine-containing intermediates are exported. On the whole, China's fluorobenzene intermediates developed earlier, and the current production capacity is generally surplus; The intermediate of trifluoromethyl benzene developed late and developed rapidly in recent years. For heterocyclic aromatic compounds, especially fluoropyridine, only a few domestic research units and manufacturers have the synthesis technology of fluoropyridine intermediates. Therefore, the fluoropyridine intermediate will become one of the main directions of domestic fluorine intermediate research and development in the next few years.
1.3. p-aminophenol has a big gap.
China has become the largest producer of antipyretic and analgesic drugs in the world, with the output of aspirin, paracetamol and metamizole all exceeding 1 10,000 tons, and the output of phenacetin, aminopyrine and antipyrine exceeding 654.38+10,000 tons. At present, the output of antipyretic and analgesic drugs in China is growing rapidly, and it is expected to increase at a rate of about 8% in the future. The production of antipyretic and analgesic intermediates is large and there are many manufacturers. With the growth of antipyretic and analgesic drugs, intermediates have also developed greatly.
Domestic consumption of paracetamol has increased rapidly, and exports have also shown a rapid growth momentum. P-aminophenol is an important intermediate for the synthesis of paracetamol, and it has developed rapidly in recent years. At present, the annual output of p-aminophenol in China is about 32,000 tons. In 2005, the domestic production of acetaminophen reached more than 50,000 tons, and the pharmaceutical industry consumed 45,000 tons of acetaminophen. Combined with its application in other fields, the total demand of p-aminophenol in 2005 was about 50,000 tons, with a large market gap and broad development and utilization prospects.
2. China medicine intermediate embodiment
In recent years, many large pharmaceutical companies in the United States and Europe have gradually transferred the production of pharmaceutical intermediates to developing countries or imported pharmaceutical intermediates with reliable quality from developing countries from the perspective of saving production costs and environmental protection requirements. All these have brought excellent business opportunities to pharmaceutical intermediate production enterprises in China. Due to the technical advantages accumulated for many years and the huge demand in the future pharmaceutical market, the development potential of China's pharmaceutical intermediate industry is huge. However, it is worth noting that with the country's increasing attention to environmental protection, the cost of environmental protection will be a difficult problem for intermediate production industries.
2. 1. Selection of dominant varieties
In China's pharmaceutical intermediate product chain, the intermediate products of middle and upstream basic APIs occupy a dominant position in the whole chain because of their wide application fields, which have developed rapidly and attracted much attention from the market.
However, the export of pharmaceutical intermediates in China is also under pressure from other countries, especially Indian. India's rapid rise in the pharmaceutical industry has now formed a competitive and healthy relationship with China. Facts have proved that in the main export areas of China's pharmaceutical intermediates, such as the European Union, North America, the Middle East and Southeast Asia, the Indian impact should not be underestimated.
Therefore, China pharmaceutical intermediate industry must adjust its export strategy. Choosing competitive intermediate varieties will be an effective breakthrough. In terms of specific varieties, sulfonamides, tetracyclines, analgin and other commodities are the early varieties in China. With the passage of time, China's pharmaceutical intermediates have developed rapidly, and our advantages can be seen from the share of some varieties in the world's main production and sales. For example, VC, penicillin, acetaminophen, paracetamol and citric acid account for more than 60% of the global share. Amoxicillin, ceftriaxone, ibuprofen and aspirin are all internationally influential products. In product classification, anti-infective drugs, vitamins, antipyretic and analgesic drugs, amino acids and so on. It is an export-oriented API series in China, accounting for more than 90% of the total export volume of all APIs, and the corresponding intermediates are also in great demand in China.
Relevant pharmaceutical intermediate manufacturers should pay attention to the fact that with the development of the situation, the research and production of pharmaceutical intermediates should also be adjusted. The change of disease spectrum will create a new field in the pharmaceutical market, and the corresponding pharmaceutical intermediates will also change, thus bringing new opportunities. It is predicted that the diseases with the highest incidence in 20 10 include mental illness, climacteric disease, erectile dysfunction, obesity, cardiovascular and cerebrovascular diseases, cancer, chronic sinusitis, migraine, diabetes, senile diseases and fatal infection. It is bound to usher in the growth of demand for related pharmaceutical intermediates.
2.2. The export structure should be upgraded.
Although China's pharmaceutical intermediate industry is facing a strong situation, we should also see that the profit of pharmaceutical intermediates is at the bottom of the tower, even lower than that of raw materials. In fact, China's pharmaceutical intermediate industry itself has its own shortcomings, such as low added value of products, lack of independent intellectual property products, poor establishment of export channels, insufficient information support, and insufficient utilization of information resources. Coupled with external factors such as rising prices of water and electricity, coal transportation, chemical raw materials, increasing environmental protection costs, and lowering the export tax rebate rate of some pharmaceutical commodities, its competitive advantage in the international market is gradually threatened.
Domestic pharmaceutical intermediate manufacturers lack experience in grasping the international market and systematic research on the pharmaceutical market, policies and trade rules of trading countries (regions), which makes the comprehensive quality of intermediate exports not high. Therefore, experts suggest that the export structure of domestic intermediates must be changed, the industry itself and the construction of production software need to be strengthened urgently, and efforts should be made to build a number of enterprises and products with cGMP, FDA, E/DMF, COS and other certifications.
2.3. Accelerate the formation of core competitiveness
Even for enterprises with relatively good profits, how to form their core competitiveness, establish their own brands and enhance their technological digestion and innovation capabilities should also be considered. In the long run, the domestic pharmaceutical intermediate industry must develop in this direction and accelerate the formation of core competitiveness.
At present, most domestic enterprises have lost interest in "staple food", and they all think that even if the market improves, their profit level will not be too high. Therefore, all kinds of so-called characteristic APIs will be highly sought after, and enterprises will spare no effort to switch production. However, it is worth reflecting that the demand for characteristic API is limited. Once the market supply surges and the price fluctuates greatly, the business risks undertaken by intermediate production enterprises will be enormous. Therefore, what enterprises should do is not blindly follow the trend and pursue short-term interests, but find core competitiveness to maintain the "evergreen" profits of enterprises.
However, although the main force of domestic intermediate production and export is large state-owned enterprises, and private and foreign-funded enterprises have also grown rapidly in recent years, on the whole, most intermediate production enterprises are small and medium-sized enterprises with limited strength and fierce competition in the industry, but they are in a disorderly state.
At present, some foreign pharmaceutical intermediate manufacturers have been actively implementing the development plan of entering China. Although the product positioning is different, it adds more pressure to domestic pharmaceutical intermediate enterprises, large and small.