At present, China's pharmaceutical industry as a whole shows an upward trend of full-line expansion, and has released great potential. At the same time, due to the slow recovery of the international market and the general rise of international trade protectionism, the resistance and difficulties faced by China's pharmaceutical foreign trade will be intensified. The author believes that the main difficulties and obstacles that must be overcome in the development of China's pharmaceutical industry are as follows:
The negative impact of the international financial crisis and related uncertainties still exists.
At present, the international financial crisis shows no signs of bottoming out. It is generally predicted that the global economic growth rate will be between 2% and 3% in 20 10. According to IMS statistics, the global pharmaceutical market will perform relatively well in 20 10, with a growth rate of 4%~6%, and the market scale will exceed 825 billion US dollars. By 20 13, the global pharmaceutical market will maintain a compound annual growth rate of 4%~7%, and the market scale is expected to exceed $975 billion.
Although the expectations of the pharmaceutical industry are better than those of other industries, the impact of the crisis cannot be underestimated. In order to reduce costs and improve production efficiency, major multinational pharmaceutical companies generally began to tighten their expenses, reorganize their internal institutions, adjust their research and development priorities, and suspend new projects. Affected by shrinking international market demand, stricter regulatory policies and other factors, China's pharmaceutical products export is still facing greater pressure in 20 10. Among them, the trade in proprietary Chinese medicines will continue to show a deficit. The export resistance of some related health care products and massage appliances used for rehabilitation physiotherapy is difficult to eliminate in a short time, and the situation is not optimistic. At the same time, Europe, America, India and some emerging economies will restrict pharmaceutical products made in China because of the financial crisis and for the sake of safeguarding the interests of their own enterprises, and more opinions in favor of trade protection have emerged. For example, paul krugman, a Nobel laureate in economics, said in an article published in The New York Times that "the export surplus caused by China's mercantilism has harmed the interests of the whole world, and this policy is predatory." The international climate determines that trade friction will be inevitable. At the same time, the United States and other countries will continue to put pressure on China on the issue of RMB appreciation, and will not rule out a new round of currency disputes. The overall trade environment facing China will be very complicated and severe.
The task of upgrading industrial structure is increasingly urgent.
In 2008, there were 5,949 enterprises with pharmaceutical sales income above 5 million yuan, with the cumulative sales income of 656 1 billion yuan, and the average sales of each enterprise was only 1. 1 billion yuan. The total sales revenue of the top 100 industrial enterprises is 246.9 billion yuan, and the overall concentration of the top 100 enterprises is 4 1%, while the total sales revenue of the top 10 pharmaceutical enterprises in the world accounts for 25% of the global pharmaceutical market, rising to 45% in 2008. The top ten pharmaceutical companies in the United States account for 90% of the sales in the United States. The top ten pharmaceutical companies in the world generally spend 15%~20% of their sales revenue in that year, while the proportion of pharmaceutical companies in China is less than 1%, and excellent companies rarely exceed 5%. Insufficient investment in R&D and weak innovation ability of enterprises have always been the key problems that have plagued the deep development of pharmaceutical industry in China. The proportion of R&D investment in most enterprises is at a very low level. At the same time, the domestic venture capital market has not yet been established, and the intermediate links of the whole technological innovation system are seriously broken. At present, the main body of pharmaceutical R&D in China is still scientific research institutes and institutions of higher learning, and most enterprises cannot become the main body of pharmaceutical R&D, which makes some key industrialization technologies have not been broken for a long time, which restricts the extension of the industry to downstream high-tech and high-value-added deep-processed products, and the product upgrading is slow, which can not keep up with and meet the market demand in time. Industry-University-Research's trade differentiation is serious. Although the concentration of China's pharmaceutical manufacturing industry has been greatly improved, there is still a big gap compared with developed countries. The present situation of many, small and scattered enterprises restricts the improvement of pharmaceutical innovation ability.
In addition, there is also a problem of low concentration in the field of commercial circulation. In 2009, there were 65,438+3,000 pharmaceutical wholesale enterprises in China, and the total commercial sales of pharmaceuticals nationwide was 469.9 billion yuan. The sales of the top three wholesale enterprises-Sinopharm Holdings, Shanghai Pharmaceuticals and Jiuzhoutong are about10 billion yuan, accounting for about 2 1% of the total market sales, and others are about 65,438. The sales of Cardinal, Mckesson and AmerisourceBurgen, the top three pharmaceutical wholesale enterprises in the United States, account for 90% of the total market sales, and the market share of the top ten pharmaceutical wholesale enterprises reaches 96%. Too many small enterprises in China's pharmaceutical business field lead to serious disorderly competition, generally low service capacity and unfair competition, especially the black-box operation tied to the interests of hospitals.
Large energy consumption, heavy pollution and waste of resources pose a threat to the sustainable development of the industry.
The pharmaceutical industry in China is one of the key industries of environmental protection. Most chemical raw materials have high energy consumption, serious environmental pollution and low added value, and the pressure of three wastes treatment and environmental protection is increasing. Behind the fact that China has become the world's largest producer of APIs, the sacrifice of resources and energy has become an inestimable cost. The annual output of penicillin industrial salt in China is 60,000 tons, accounting for 90% of the world's output; The annual output of vitamin C exceeds 300,000 tons, accounting for 60% of the world's output; The annual production capacity of citric acid has reached 700,000 tons, accounting for 65% of the world output. Even APIs that are not produced in many poor countries are still produced on a large scale in China. The industrial development environment has not improved because of the increase in output value, but has become more severe, and the harmonious relationship between man and nature has been challenged as never before. In addition, the laws and regulations related to the protection of traditional Chinese medicine resources are lagging behind, the production mode of traditional Chinese medicine planting is backward, the necessary organization is lacking, a certain scale is not formed, and the necessary market information guidance is lacking in the production and planting process, which leads to the disorderly development and utilization of traditional Chinese medicine. On the one hand, the over-exploitation of wild medicinal resources leads to the situation that some varieties are on the verge of extinction, and even face extinction; On the other hand, due to blind planting, it leads to a large backlog and a huge waste of resources. Many Chinese herbal medicines are exported at very low prices through primary products. For example, among the 500 commonly used Chinese herbal medicines, there are 1 12 species that must be protected, among which 10 species are endangered, 38 species are rare and 46 species are endangered. Some Chinese herbal medicines, such as licorice, ephedra, Bupleurum, cistanche deserticola, Saussurea involucrata, Rhodiola, Cordyceps sinensis, Fritillaria cirrhosa, etc. Due to over-exploitation or predatory development, it has shrunk year by year, which has begun to affect the clinical use of traditional Chinese medicine and the production of pharmaceutical companies.
There is a general lack of internationally certified products and experience in international market operation.
After China's entry into WTO, the market boundaries at home and abroad have become increasingly blurred, and Chinese and foreign enterprises have shown a multi-party game pattern. In the process of internationalization and integration, China pharmaceutical enterprises have three obvious shortcomings: First, they lack the ability to acquire the international market, especially the ability to standardize market access. Most of China's chemical raw material drugs have not obtained the international market access permit, and less than 20 pharmaceutical products have passed cGMP certification in developed countries such as the United States and Europe. Second, enterprises generally lack professionals with experience in international drug market operation, and their international marketing ability is weak. Most enterprises only make products, not markets, and have not really started their own brands abroad. Third, in the process of international communication, the improper handling of intellectual property issues often leads to embarrassing situations. Among them, the protection of pharmaceutical intellectual property rights has always been a weak link in the development of pharmaceutical enterprises in China, and it is also a frequent field of disputes with foreign enterprises. In the revised Patent Law implemented by 1 99365438+1October1,China implements patent protection for pharmaceutical compounds. At the same time, according to the Sino-US Memorandum of Intellectual Property Rights signed by China and the United States in 1992, retrospective administrative protection was given to medical inventions patented in more than 40 countries such as the United States, the European Union and Japan from the end of 1986 to the end of 1992, thus establishing an important legal system for the protection of medical intellectual property rights. After China's entry into WTO, the level of intellectual property protection in China has been obviously improved, but there is still a big gap with the requirements. Compared with the protection of patented pharmaceutical products abroad, there are very few pharmaceutical products with independent intellectual property rights in China. In China National Intellectual Property Administration's Patent Bulletin for Invention, there are very few patent applications for chemical drugs in China, most of which are patents for improvement of process or dosage form, while foreign applications account for more than 90%, most of which are new chemical synthetic drugs; The number of patent applications for traditional Chinese medicine is relatively large, but the general quality is not high, and even if authorized, its protection scope is very small; Although China accounts for nearly half of biopharmaceutical patent applications, the creativity and quality of inventions are far from those of foreign countries.
Generally speaking, the future development of China pharmaceutical industry is full of thorns and challenges, but the prospects will be brighter and brighter. It is believed that more pharmaceutical enterprises in China will proceed from their own reality, seize every opportunity as much as possible, actively forge ahead, and maximize their interests in the international market. At the same time, after adjustment and reorganization, China's domestic market is expected to achieve a good business order, release greater business opportunities and potential, and become a huge market particularly favored by international pharmaceutical enterprises. It won't be long before China becomes one of the world's pharmaceutical powers.