Since the export of pharmaceutical intermediates is not like the export of drugs will be subject to all kinds of restrictions by the importing country, as well as the world's pharmaceutical intermediates production to developing countries to transfer, at present, China's pharmaceutical production of chemical raw materials and intermediates required by the basic can be matched, only a small portion of the need to import. And because of China's abundant resources, raw material prices are lower, there are many pharmaceutical intermediates have also realized a large number of exports.
Looking at the industry as a whole, China's pharmaceutical intermediates industry has six characteristics: First, most of the enterprises for the private sector, business flexibility, investment scale is not large, basically in the millions of dollars to one or two million dollars; Second, the enterprise geographic distribution of a more centralized, mainly in Taizhou, Zhejiang Province, and Jiangsu Province Jintan as the center; Third, with the country's increasing attention to environmental protection, the enterprise construction of environmental protection treatment facilities are increasing pressure; Fourth, the rapid pace of product renewal, generally 3-5 years after the market profit margins will fall dramatically, forcing enterprises to continue to develop new products or improve the process, in order to obtain higher profits; Fifth, due to the production of pharmaceutical intermediates higher than the general profits of chemical products, the production process is basically the same, there are more and more small-scale chemical enterprises to join the ranks of the production of pharmaceutical intermediates, resulting in the industry's increasingly fierce disordered competition; Sixth, compared with APIs, the production of intermediates, low profit margins, and APIs and pharmaceutical intermediates production process is similar, so part of the enterprise not only the production of intermediates, but also to take advantage of their own advantages to start the production of APIs. Experts pointed out that the production of pharmaceutical intermediates to the direction of the development of APIs is an inevitable trend. However, due to the single use of APIs, by the pharmaceutical companies have a great influence on the domestic enterprises often occur after the development of products but no users of the phenomenon. Therefore, the manufacturer should establish a long-term stable supply relationship with pharmaceutical companies in order to ensure smooth product sales.
1.Typical pharmaceutical intermediates market
1.1.Phenylacetic acid demand continues to increase
China's β-lactam antibiotics after nearly 50 years of development has formed a complete production system. At present, almost all β-lactam antibiotics (except for the patent period of varieties) can be produced in our country, and the cost is very low, penicillin production ranked first in the world, a large number of exports to supply the international market; cephalosporin antibiotics are basically able to self-sufficiency, but also strive for a part of the export.
At present, with β-lactam antibiotics supporting intermediates in China can produce all their own, in addition to semi-synthetic antibiotics, the mother nucleus of 7-ACA and 7-ADCA need to be part of the imports, all the intermediates of the side chain can be produced, and a large number of exports.
Taking phenylacetic acid, the main intermediate of β-lactam antibiotics, for example, there are nearly 30 phenylacetic acid manufacturers in China, with a total annual production capacity of about 20,000 tons. However, most of the enterprises are small in scale, the largest annual output of 2,000 tons, most of the other annual output of hundreds of tons. 2003 total domestic demand for phenylacetic acid is about 14,000 tons, the consumption structure of penicillin G accounted for 85%, other pharmaceuticals accounted for 4%, spices accounted for 7%, pesticides and other areas accounted for 4%. With the development of domestic spice, medicine, pesticide and other industries, the demand of phenylacetic acid will increase further. in 2005, China's pharmaceutical industry consumed 14,000 tons of phenylacetic acid, the pesticide industry consumed about 500 tons, and the spice industry consumed about 2,000 tons. Together with the consumption in other fields, the total consumption of phenylacetic acid in 2005 amounted to 18,000 tons.
1.2.Fluorinated Pyridine Intermediates Become Hot Spot
At present, the quinolone antimicrobials that have been developed and put into mass production in China mainly include Norfloxacin, Ciprofloxacin, Oxyfloxacin, Enrofloxacin, Lomefloxacin, Flerofloxacin, etc. Among them, Norfloxacin, Ciprofloxacin and Flerofloxacin are the most popular ones. Among them, Norfloxacin, Ciprofloxacin and Oxyfloxacin have the largest production volume, accounting for about 98% of the total domestic production of fluoroquinolone antibacterial drugs.
Quinolones are generally synthesized from fluorine-containing quinolines by fluorine-containing benzene ring and condensed with piperazine (or methyl piperazine). China is one of the world's largest producers of fluorine-containing drugs and intermediates, with more than 80% of fluorine-containing intermediates supplied for export. As a whole, the development of fluorobenzene intermediates in China is relatively early, and the production capacity is generally in excess; the development of trifluorotoluene intermediates is relatively late, and the development speed is relatively fast in recent years; for heterocyclic aromatic compounds, especially fluorinated pyridines, there are only some individual research units and manufacturers in China who have the synthesis technology of fluorinated pyridine intermediates, so the fluorinated pyridine intermediates will become one of the main directions for the research and development of the fluorine containing intermediates in China in the next few years. Therefore, fluorine-containing pyridine intermediates will become one of the main directions of domestic fluorine-containing intermediates in the next few years.
1.3.P-aminophenol gap
China has become the world's largest producer of antipyretic and analgesic drugs, aspirin, paracetamol, anacin and other varieties of production are more than 10,000 tons, and finasteride, aminopyralid, and antipyrine and other varieties of production of more than 1,000 tons. At present, China's production of antipyretic and analgesic drugs is growing rapidly, and is expected to grow at a rate of about 8% in the future. The production of intermediates for antipyretic and analgesic drugs supporting the production of large output, production enterprises. With the growth of antipyretic and analgesic drugs, its intermediates have also gained considerable development.
Domestic consumption of paracetamol is increasing rapidly, and exports are also showing rapid growth momentum. P-aminophenol is an important intermediate in the synthesis of paracetamol, has also grown rapidly in recent years. At present, China's annual output of p-aminophenol is about 32,000 tons, in 2005, the domestic production of paracetamol reached more than 50,000 tons, the pharmaceutical industry consumed 45,000 tons of p-aminophenol, plus applications in other fields, in 2005, the total demand for p-aminophenol is about 50,000 tons, a large gap in the market, the development and utilization of the prospect is broad.
2. China's pharmaceutical intermediates facing the situation
In recent years, the United States and Europe, many large pharmaceutical companies from the level of savings in production costs and environmental requirements, the production of pharmaceutical intermediates gradually transferred to developing countries, or more from developing countries to import quality and reliable pharmaceutical intermediates. This has brought excellent business opportunities to China's pharmaceutical intermediates manufacturers. Due to years of accumulated technological advantages and the huge demand of the future pharmaceutical market, China's pharmaceutical intermediates industry has a huge potential for development. However, it is worth noting that, with the country's increasing attention to environmental protection, environmental protection costs for the intermediates production industry will be a difficult problem that can not be ignored.
2.1.Selection of advantageous varieties
China's pharmaceutical intermediates product chain, in the middle and upper reaches of the basic API intermediates due to the wider application areas, occupies the advantageous position of the entire chain, so it has been the more rapid development, but also in the market in the spotlight.
However, China's pharmaceutical intermediates products exports have also suffered from the pressure of other countries, especially India. India's rapid rise in the pharmaceutical industry, and now with our country to form a competitive and *** raw relationship. Facts have proved that in China's pharmaceutical intermediates main export areas of the European Union, North America, the Middle East, Southeast Asia, etc., from India's impact should not be underestimated.
Thus, China's pharmaceutical intermediates industry must adjust the export strategy. Select competitive intermediate varieties or will be an effective breakthrough. Specific varieties, sulfonamides, tetracyclines, anandamide and other commodities are China's earlier to go out varieties. With the passage of time, China's pharmaceutical intermediates have developed rapidly, from the current part of the varieties accounted for the world's major share of production and sales can be seen in our advantage. Such as VC, penicillin, p-acetamidophenol, paracetamol, citric acid, etc. accounted for more than 60% of the global share, amoxicillin, ceftriaxone, ibuprofen, aspirin, etc. are in the global influence of the product categories. In the product classification, anti-infectives, vitamins, antipyretic and analgesic drugs, amino acids, etc. is China's export-oriented API series, accounting for more than 90% of the total exports of all APIs, and the corresponding intermediates domestic demand is also larger.
Related pharmaceutical intermediates manufacturers should note that: with the situation, pharmaceutical intermediates research and production should also be adjusted. Changes in the disease spectrum will create new areas of the pharmaceutical market, the corresponding pharmaceutical intermediates will also change, thus bringing new opportunities. It is predicted that the highest incidence of diseases in 2010 are mental illness, menopausal diseases, erectile dysfunction, obesity, cardiovascular and cerebrovascular diseases, cancer, chronic sinusitis, migraines, diabetes, geriatric diseases, fatal infections, etc., which will surely usher in an increase in demand for related drug intermediates.
2.2.Export structure to be upgraded
While China's pharmaceutical intermediates industry is facing a strong trend, but we should also see, in the pharmaceutical industry's pyramid-shaped value ranking, pharmaceutical intermediates profits at the bottom of the tower, even lower than the bulk of APIs. In fact, China's pharmaceutical intermediates industry itself exists, such as low value-added products, the lack of independent intellectual property rights products, the establishment of export channels is not smooth, insufficient information support, inadequate utilization of information resources, etc. "short board", coupled with the price of water, electricity, coal and chemical raw materials, environmental protection costs and part of the pharmaceutical commodities Export tax rebate rate downward and other external factors, the competitiveness of its advantages in the international market is gradually threatened.
Domestic pharmaceutical intermediates manufacturers lack experience in grasping the international market, the trading country (region) pharmaceutical market, policy, trade rules and lack of systematic research, so that the comprehensive quality of intermediates export is not high. Therefore, the experts proposed that the domestic intermediates must change the export structure, the industry itself and the construction of production software needs to be strengthened, and strive to create a number of cGMP, FDA, E/DMF, COS and other certified enterprises and products.
2.3.Accelerate the formation of core competitiveness
Even for relatively good profits for the enterprise, how to form core competitiveness, set up its own brand, enhance the ability to digest technology and innovation, should also be a matter of consideration. In the long run, the domestic pharmaceutical intermediates industry must develop in this direction to accelerate the formation of core competitiveness.
At present, the majority of domestic enterprises have lost interest in the "road goods", are that even if the market improves, the level of profitability will not be too high, so a variety of so-called characteristics of the API will be highly sought after, the enterprise spared no expense to invest in the full conversion. However, it is worth reflecting that the demand for specialty APIs is relatively limited, once the market supply surge, price volatility is great, the intermediate production enterprises to bear the business risk will be huge. Therefore, the enterprise to do, not to chase the short-term interests of blindly follow the trend, but to find to maintain the profits of the enterprise "evergreen" core competitiveness.
However, despite the domestic production and export of intermediates is the main force of large-scale state-owned enterprises, private, three-funded enterprises in recent years has also been rapid growth, but the overall point of view, most of the intermediates production enterprises for the small and medium-sized enterprises, the strength of the limited, the industry competition is fierce but in a state of disorder.
At present, some foreign pharmaceutical intermediates manufacturers have been actively implementing the development of China's entry into the program, despite the different positioning of the product, but this is the domestic large and small pharmaceutical intermediates for the pressure to add a heavy