According to the statistics of the national renewal of the license of drug manufacturers in 2001, there are 5,146 API and pharmaceutical preparation manufacturers in China, including more than 1,700 "three-funded" enterprises (the world's top 20 multinational pharmaceutical companies have set up joint ventures in China). There are about 1,100 state-owned and state-controlled industrial enterprises. Calculated on the basis of output value, the shareholding economy in the industry as a whole has risen from 12% in the early part of the "Ninth Five-Year Plan" to 33.2% at present, "three-funded" economy from 15% to 18.8%, while the proportion of state-owned economy has dropped from 55% to 36.1%. The ownership structure of the pharmaceutical industry has been further adjusted, basically forming a pattern of public ownership as the mainstay, with a variety of ownership economies*** developing together. Among the more than 5,000 enterprises in the pharmaceutical industry, there are more than 200 biopharmaceutical enterprises, more than 1,100 enterprises producing traditional Chinese medicines and about 4,000 enterprises producing chemical drugs. By the end of 2001, the production of nearly 1,500 types of chemical raw materials, with a total output of 430,000 tons, ranking No. 2 in the world; the production of chemical preparations 34 dosage forms, more than 4,000 varieties; and China's traditional Chinese medicine, has gradually embarked on the road of scientific, standardized, and can produce, including drop pills, aerosols, injections, including the modern Chinese medicine dosage forms more than 40 kinds of total output of 370,000 tons, varieties of more than 8,000 varieties. The total output has reached 370,000 tons, with more than 8,000 varieties. In addition, China can produce more than 300 kinds of biological products such as vaccines, toxins, antisera, blood products, in-vivo and out-of-vivo diagnostic reagents, including 20 kinds of modern bioengineered medicines, and can produce about 900 million people/samples of prophylactic products. China can also produce more than 11,000 varieties of medical equipment, including X-ray tomography imaging devices, magnetic **** vibration device, specifications; can produce 8 categories of more than 1,200 specifications of pharmaceutical machinery products.
From the market behavior of China's pharmaceutical enterprises and brand development, due to the excessive development of enterprises, a large number of basic medicines, a serious surplus, the total supply of products over demand, and most of the famous drug brands for foreign brands, their market share is higher than the domestic brands. From the current domestic market share, "three-funded" enterprises accounted for 25% of the products, imported products accounted for 12%, 35% of the national products, while large hospitals in major cities purchased "three-funded" enterprises and imported drugs up to 60% to 70%. Visible, foreign-funded products have a great influence on China's pharmaceutical market. According to statistics, at present, in China's provincial Chinese medicine hospitals in the application of drugs, Chinese medicine tablets, pCms and western medicines, the ratio of 3:3:4, prefectural and municipal level of the ratio of 2:3:5, county-level ratio of 1.8:3:6.2. 2001. In China's drug coinage, the proportions of western medicines, proprietary Chinese medicines, other health products and biological products were roughly 60%, 25% and 15% respectively. The shares of domestic enterprises, "three-funded" enterprises and foreign enterprises in China's pharmaceutical market were 43.0%, 29.0% and 28.0% respectively in 1999. 29.0% and 28.0% in 1999, and 47.1%, 30.0% and 22.9% in 2000. In 2000 and 2001, the shares of "three-funded" enterprises, domestic enterprises and foreign enterprises in the hospital drug market were 30%, 23%, 47% and 43%, 35% and 22% respectively. According to statistics, in 2002, in China's pharmaceutical retail terminal market, hospital sales and pharmacy sales accounted for 80% and 20% respectively, hospital sales still dominate.
Problems in China's pharmaceutical industry
China's pharmaceutical industry since the reform and opening up, although there has been great development, but there are many problems.
China's pharmaceutical production enterprises exist "a small, two more than three low" phenomenon
"A small" refers to the majority of small-scale production enterprises. According to statistics, China's more than 5000 pharmaceutical production enterprises, almost 90% of small enterprises. 2001, the country's top 500 large-scale enterprises in the pharmaceutical industry only 25. According to China Pharmaceutical Business Association statistics, in 2001, annual sales of more than 5 billion yuan of pharmaceutical enterprises only 2, more than 2 billion yuan of 10, more than 1 billion yuan of 23, more than 100 million yuan of about 250, the number of less than 4% of the total number of pharmaceutical business enterprises.
"Two more" refers to the number of enterprises, product duplication. In our country more than 5000 pharmaceutical production enterprises, most of the enterprise brand-name products, varieties of similar phenomenon is common. Biopharmaceuticals, for example, only α-interferon has Shenzhen Kexing, Shenyang Sansheng, Anhui Anke, Tianjin Huarida more than 10 production, IL-2 has 9 production. Another example of Chinese medicine, cattle yellow detoxification tablets have more than 150 enterprises in the country. There are some new products, such as clarithromycin, erythromycin, azithromycin and levofloxacin, etc., duplication of production, blindly expanding the phenomenon is also very prominent, the production of more than 50 enterprises, so that the supply of these new products exceeds demand. And like vitamin C and other old products also appeared blindly expand the production scale of the problem, resulting in product prices fell again and again, and even on the verge of losses.
"Three low" refers to the majority of manufacturers of products with low technological content, low research and development of new drugs, management capacity and low economic efficiency. From the point of view of the research and development of new drugs, the development of a new drug, generally take about 10 years, in the Western developed countries need to spend about 500 million to 1 billion U.S. dollars, at least 200 million to 500 million yuan in China. However, China's funds dedicated to the development of new drugs only 10 million to 20 million yuan per year, plus pharmaceutical companies to invest in their own funds totaled less than 1% of the output value of the pharmaceutical industry, the development of new drugs is seriously underinvested, which directly leads to the development of new drug innovation and low level of preparation, innovative drugs are rare. China produces 97% of the chemical drugs are generic drugs, to 2001, China's independent development of internationally recognized innovative drugs only two: artemisinin and sodium dimercaptosuccinate. At present, China still mainly focuses on the introduction of generic versions. This situation has led to further deterioration of market competition, preventing enterprises from entering the track of benign development, thus limiting the development of China's pharmaceutical industry.
A part of the pharmaceutical industry enterprises failed to meet the GMP standards, seriously hindering China's drugs to enter the international market
China's implementation of GMP management has been nearly 20 years of history, although a certain degree of success, but there are still many problems, such as the enterprise workshop does not meet the requirements of the GMP, the professional knowledge of the production of technical personnel and production skills are not high, the production process and operating procedures of the Formulation and implementation of the production process and operating procedures are not scientific and strict enough, resulting in poor product quality, can not well protect people's lives, health and safety. According to statistics, as of January 2003, only 1,464 manufacturers have obtained 1,892 GMP certificates, and there are still about 4,000 pharmaceutical companies that must pass the GMP certification by June 30, 2004, or else they can only be eliminated. And the few enterprises that have already passed GMP certification. In the implementation of standards there are also certain violations, which not only restricts the improvement of drug quality, but also seriously impede the entry of China's drugs into the international market. Pharmaceutical enterprises should actively import ISO9000 quality management system, improve their own access to the market standards, in accordance with GMP norms, in order to make their products have a stronger competitiveness, in order to enter the international market to actively create conditions.
China's pharmaceutical intellectual property protection is not optimistic
China began in 1993, the implementation of 20 years of patent protection of drugs. It should be recognized that for decades China's pharmaceutical companies have been accustomed to copying drugs from other countries, the lack of incentive to innovate, the ability to create new drugs is not strong, and at the same time, due to the indifference of the concept of intellectual property rights protection, so that we would have fewer than a number of innovations, but also did not get a good protection, which makes us have to swallow their own seed of bitter fruit. For example, China's pharmaceutical scientists and technicians developed the new chemical drug artemisinin successfully in the 1970s after more than a decade of hard work. This drug is a major invention in the field of medicine in China, and it is also the only independently developed new chemical drug in the field of medicine in China that was recognized by the world before 1998, and it was awarded the Ministry of Health and the National Science and Technology Prize, and it has had a significant impact in the world. However, because China did not have the necessary conditions for intellectual property protection at that time, when the research paper on artemisinin was published, foreign enterprises immediately made structural modifications and applied for patents. Originally China's invention has become a foreign patent, China's annual export losses of 200 million to 300 million U.S. dollars for this alone. Another example, China's vitamin C two-step hair alcohol method of preparation technology is also an invention with the international advanced level of invention, but also due to intellectual property protection awareness is not strong, so that a foreign enterprise to buy this preparation technology with 5 million U.S. dollars in the knowledge that the technology did not apply for patents after picking up a bargain, only spent tens of dollars on the paper to buy back. A few years later, foreign production of vitamin C with this low-cost technology to the international market dumping, squeezing China's vitamin C export prices, causing great losses to our country, resulting in a number of domestic producers into difficulties. Therefore, how to use intellectual property rights agreements to stimulate, protect and develop China's pharmaceutical industry has become China's pharmaceutical enterprises an imminent task.
Single financing channels, industrial development funds are insufficient
Pharmaceutical industry compared with other industries, there are "four high": high investment, high yield, high risk, high technology-intensive, especially now some of the genetic engineering and other bioengineering pharmaceutical industry. At present, China's high-tech pharmaceutical industry, in addition to the source of funds invested by shareholders in the equity, mainly relying on bank loans, financing channels are narrow. Because the bank pays much attention to the safety and liquidity of funds, the risk of high-tech investment makes the bank cautious and cautious. As a result, the pharmaceutical enterprises financing ability is obviously not strong, a serious shortage of funds. Development of a serious lack of funds has become a pharmaceutical enterprise development and research of new drugs, updated equipment, open up markets a huge obstacle.
Pharmaceutical market competition is disordered, there are industry unethical
With the formation of the market economy, China's pharmaceutical market has seen some new changes. Pharmaceutical purchase and sale of various links of profit distribution is unreasonable, coupled with the same product by a number of manufacturers, forcing enterprises to have to take high pricing, high concessions promotional means. In recent years, hospitals from the drug sales enterprises to purchase concessions for about 18% of the price of medicines, while the concessions from the direct purchase of drugs manufacturers has reached more than 25%. The drug market environment continues to deteriorate, drug prices continue to climb, greatly harming the interests of the majority of patients. And enterprises are also forced by the pressure of the currency market, the main energy are used in the market competition, unable to take into account technological innovation. After entering the World Trade Organization, this kind of disorderly competition and the industry's unhealthy wind and then maintain, China's pharmaceutical enterprises will be very difficult to adapt to the international market.
In summary, China's pharmaceutical industry in the past 20 years has been a certain development, but there are many problems. In order to keep pace with the development of the world's pharmaceutical industry, the entire industry must expand the scale, shut down, stop some small pharmaceutical enterprises, to avoid duplication of construction, the state should be macro-control through the appropriate measures to change the pharmaceutical distribution enterprises, "more, small, scattered, chaotic, poor" situation, and further improve the relevant systems, the establishment of a sound modern enterprise suitable for China's national conditions. Sound modern enterprise management system suitable for China's national conditions, in order to promote the further development of China's pharmaceutical industry.
China's pharmaceutical market development trend
Pharmaceutical economic operation will continue to show steady growth
China's total value of the pharmaceutical industry in 1990-2001 each year, respectively, 392, 502, 634, 746, 862, 1060, 1251, 1400, 1630, 1946, 2332, 270 billion yuan The annual average increase of 19.5%; from 1990 to 2001, the annual total sales of drugs were 151.42, 176.67, 208.13, 231.34, 373.91, 464.04, 532.03, 607.29.776.87.922.90, 108.45, 126 billion yuan, with an average annual increase of 21.7%. In 2002, China's pharmaceutical industry totaled 330 billion yuan, an increase of 18.8%, higher than the national economic growth rate of more than 10 percentage points. Pharmaceutical industry "Tenth Five-Year" development goal is: the pharmaceutical industry gross output value of an average annual growth rate of 12% or so. Can maintain such a high rate of development, of course, there are reasons.
The natural growth of the population is the basic factor for the increase in demand for pharmaceutical products: in 2000, China's population was 1.295 billion, and by 2005, China's population will reach 1.33 billion, the net growth of the population will generate new demand for pharmaceutical products. Moreover, the data of the 5th national census in 2000 showed that the elderly (over 60 years old) population in China is close to 130 million, accounting for about 10% of the total population, and China has stepped into the ranks of the aging countries. In the future, the elderly population will grow at an annual rate of about 3%, and it is expected that the total number of elderly people in China will reach 160 million in 2005, accounting for 11.52% of the total population; it will increase to 280 million in 2025, accounting for 17% of the total population; and it will exceed 400 million in 2050, accounting for 27% of the total population, and will reach its peak. Currently, drug consumption among the elderly population already accounts for more than 50 percent of total drug consumption, and the aging of the population further promotes drug consumption.
People's living standards continue to improve, further promote the demand for medicines: China's 1990 ~ 2001 annual per capita level of medicines were 13, 15, 18, 20, 31, 38, 43, 50, 62, 74, 85, 99 yuan. At present, the level of drug consumption in China is still very low, while the per capita consumption of drugs in middle-developed countries has been between 40 and 50 dollars. However, from the above figures, it can be seen that with the sustained development of the national economy, people's living standards continue to improve, China's per capita level of drug use is also rising year by year. Through the further development of the vast rural market, China's drug market will also show more space for development.
New changes will take place in the structure of drug consumption
The structure of drugs is becoming more reasonable: the implementation of the new health insurance system and the introduction of the new "health care reform" program will have a significant impact on the restructuring of China's pharmaceuticals, modern biotechnology drugs, natural medicines, and marine medicines will likely challenge the status of conventional chemical drugs. Good efficacy and low price are two factors that patients must consider when using drugs. As a result, sales of high-city, low-priced drugs will continue to increase and take up a larger share of the market. The retail market is also expanding day by day. At present, the wholesale and retail structure of the national pharmaceutical market is gradually changing, the proportion of retail sales of pharmaceutical commodities has increased from 5% to more than 15% in the past, and in a few areas has risen to 20% to 30%. It is expected that this momentum with the reform of the medical system and the implementation of prescription drugs and non-prescription drug classification and management system will be further expanded.
Over-the-counter drugs will enter a phase of rapid development: the classification and management of drugs will bring changes in the structure of drug demand. China's non-prescription drug market sales are very considerable, in 1990 for 250 million U.S. dollars (equivalent to 1.91 billion yuan), rose to 1.01 billion U.S. dollars in 1994 (equivalent to 8.38 billion yuan), an increase of more than three times in four years. In 1996, China's non-prescription drug market sales rose to 1.3 billion U.S. dollars (equivalent to 10.79 billion yuan), has become the world's fastest-growing non-prescription drug market sales. According to statistics, in 2001, China's non-prescription drug market sales have exceeded 24 billion yuan, accounting for 20% of total drug sales. Although China's per capita consumption of non-prescription drugs is lower than the global per capita consumption of non-prescription drugs, but with the deepening of the reform of the medical system, people's awareness of self-medication continues to grow, as well as the further implementation of the drug classification and management system, China's market for non-prescription drugs has shown a strong momentum of development. Experts expect that by 2005, China's non-prescription drug sales are expected to reach 60 billion yuan, 2020 China will become one of the world's largest non-prescription drug sales market.
Pharmaceutical prices are becoming more reasonable
In the first few years, the phenomenon of high drug prices in China is more serious, but in the next few years this phenomenon will be basically reversed. By the country's efforts to increase the regulation of drug prices and the double impact of increased market competition, drug prices in recent years continue to go down. According to data from the National Bureau of Statistics, since 1997, the State Planning Commission has lowered the price of centrally managed drugs 10 times, reducing the price of more than 200 varieties of drugs. The rate of increase in the retail price index for Chinese and Western medicines dropped gradually from 8.8% in 1996 to 0.3% in 2000, and to -1.5% in 2001, the first time there was negative growth; in 2002, the price index for medicines was further reduced, to -2.7%, -3.4% and -3.7% in January to March, respectively. Drugs are elasticity of demand for commodities, the price drop, the demand will also have a substantial increase, but for the industry whether the sales volume growth can offset the price drop caused by the reduction in sales revenue will directly affect the pharmaceutical industry's economic efficiency. From the short-term effect, the effect of falling prices over the effect of demand growth, indeed, the performance of the pharmaceutical enterprises have a greater negative impact, some enterprises production is difficult to sustain, some enterprises have to apply for the Planning Commission to re-pricing. According to relevant sources, the State Planning Commission is consulting all parties on the issue of pharmaceutical prices, I believe that does not rule out the possibility of the introduction of a new policy, and the new policy will inevitably take into full account the negative effects of the last few price cuts, and ultimately make the price of medicines more reasonable, in the people's benefit at the same time, the interests of pharmaceutical companies can also be guaranteed.
The number of pharmaceutical enterprises will be greatly reduced, the scale of operation gradually expanded
China's pharmaceutical industry has long been more enterprises, small scale, high cost, low efficiency and other stubborn problems. After joining the World Trade Organization, market competition intensified, some enterprises will be merged, reorganization, some enterprises will have to withdraw from the market, China's pharmaceutical market "map" will be redistributed. The result of this survival of the fittest is that the number of pharmaceutical enterprises decreases year by year. In 2001, about 10% of the total number of pharmaceutical enterprises have been eliminated small-scale pharmaceutical factories, and in 2002, about 10% of the small-scale pharmaceutical factories can be eliminated. According to the prediction of relevant experts, after the Tenth Five-Year Plan, the number of pharmaceutical enterprises in China will be reduced by 25%-35%. The state's goal of enterprise organization structure for the development of the pharmaceutical industry in the Tenth Five-Year Plan is also adjusted as follows: on the basis of the existing large-scale enterprise groups, we will strive to cultivate 10 large-scale pharmaceutical enterprise groups with sales of more than 5 billion yuan through stock listing, merger, consolidation, reorganization, etc. The annual sales of these enterprises will account for more than 30% of the total sales of the national pharmaceutical industry enterprises, and the main products will have the ability to compete with the international multinational corporations; and we will also strive to develop the ability of the pharmaceutical industry to compete with the international multinational corporations. Cultivate 5 to 10 large pharmaceutical distribution groups with diversified operations for domestic and foreign markets and annual sales of more than 5 billion yuan; establish 40 large pharmaceutical distribution groups with annual sales of more than 2 billion yuan for the domestic market or domestic regional markets, and the sales of these enterprises account for more than 70% of the total sales of the pharmaceutical industry; establish 10 pharmaceutical retailing groups that are well-known both at home and abroad. 10 well-known pharmaceutical retail chain enterprises at home and abroad, each enterprise has more than 1,000 outlets; the establishment of a number of regional pharmaceutical retail chain enterprises, each enterprise has about 100 outlets. With the deepening of enterprise reform and industry restructuring, the next few years, a large number of listed companies as the main body of large companies, large groups will stand out, they are through the joint, mergers and acquisitions, restructuring to achieve extraordinary convergence of resources, asset value-added capital expansion, the formation of a strong strength, is expected to be invincible in the globalization of market competition.
Pharmaceutical market structure continues to diversify, multi-level direction
Pharmaceutical market economic structure diversification: calculated by the output value of the pharmaceutical industry in the shareholding economy in the industry's proportion has risen from the "Ninth Five-Year Plan" in the early 12% of the current 33.2%, "three-funded" economy from 15% to 18.8%, the state-owned economy from 55% down to 36.1%. The ownership structure of the pharmaceutical industry has been further adjusted, basically formed a public system as the main body, a variety of ownership of the economy *** with the development of the pattern. The shares of domestic enterprises, "three-funded" enterprises and foreign enterprises in China's pharmaceutical market were 43.0%, 29.0% and 28.0% respectively in 1999, and 47.1%, 30.0% and 22.9% respectively in 2000. The domestic pharmaceutical market is dominated by the State-owned pharmaceutical economy, with all types of collective and joint-stock economies, as well as the "three-funded" and "cooperative" economies, all developing at the same time. This diversified structure of the pharmaceutical economy, the active pharmaceutical market is very good.
3.5.2 The composition of the pharmaceutical market is multilevel: it includes an open market characterized by bidding, a semi-open market based on pharmaceutical contracts, a closed market based on the state plan, and a retail market characterized by free purchasing and selling, all of which are oriented to the pharmaceutical market and fully reflect the relationship between supply and demand and the law of value.
Diversification of demand for medicines: with the improvement of living standards, people are purchasing more and more medicines and health food. The buyers and sellers with financial support have special preference for high-grade drugs and new drugs, while the buyers and sellers at the middle and low levels still occupy most of the drug market share. In terms of the investment direction of funds, buyers and sellers have different input weights in the aspects of production, supply, marketing, research and use, constituting a new pattern of purchase and sale. For example, the country's sales of medicine in the last two years showed the following changes: the elderly, women, pediatrics, the amount of drugs rose, the amount of drugs for adults declined; new varieties of demand rose, the demand for old varieties declined; health care medicines, famous and excellent into the amount of drugs rose, the general medicinal herbs, into the amount of drugs declined; joint venture drugs rose, the use of imported drugs declined.
Pharmaceutical modern logistics development to further accelerate
In recent years, China's pharmaceutical industry gross profit has been declining. At present, the average gross profit margin of the domestic pharmaceutical wholesale industry is 12.6%, while the average cost rate of 12.5%. 2002 January to September, China's pharmaceutical commercial average net profit margin of only 0.59%. U.S. pharmaceutical wholesale industry, the average gross profit margin of 5%, the average cost rate of only 3% to 4%, the average commercial net profit margin of 1% to 2%. China is now engaged in pharmaceutical wholesale enterprises more than small, nearly 17,000 wholesale enterprises in sales of more than 1 billion yuan only 10, more than 5 billion yuan only 3-6. And China's 120,000 retail enterprises, the largest chain store annual turnover of only 500 million yuan. How can we face the onslaught of foreign investment if this situation of high logistics costs, low net profit margins and a large and small number of wholesale enterprises is maintained? It can be seen that the development of modern logistics has become China's pharmaceutical industry's top priority. Modern logistics is the product of the information age, with the deepening of the reform of the pharmaceutical distribution system, accelerate the development of modern logistics is an important means of coping with international competition. Fifth Plenary Session of the Fifteenth Central Committee of the Party pointed out: to vigorously develop modern logistics. This is a major issue from the strategic height of China's economic development, we should raise awareness and attach great importance to this work. The competition of commercial enterprises, the key in logistics, efficient logistics and distribution is the key to the success of commercial enterprises. The development of modern pharmaceutical logistics must be combined with China's national conditions, and the implementation of GSP and business process reorganization, pay attention to the advanced and applicability of equal importance to the introduction of modern logistics management technology as a support, it must be both software and hardware, rather than just building large warehouses. We need to learn from advanced foreign experience, combined with the actual rapid development of modern logistics, the implementation of large-scale, standardized, intensive operation, and strive to achieve the goal of "reducing costs and increasing efficiency.
Market competition will become more intense
With the development of global economic integration and China's accession to the World Trade Organization, the domestic pharmaceutical market has become an international competitive market is not in doubt. Domestic enterprises will face the challenge of large multinational enterprises and not only other domestic enterprises, if not to reform and accelerate the internationalization process will be eliminated in the competition. At this stage of the pharmaceutical market, the competition has just begun, because there are still a lot of restrictions on the entry of foreign capital, foreign goods into the tariff barriers. At this stage, foreign investment in the Chinese market can only be carried out in the form of joint ventures and cooperation, and there are restrictions on the proportion of investment, while similar foreign drugs entering the Chinese market have lost a certain degree of competitiveness due to high tariffs leading to high prices. In a few years, the above situation will change. Huge Chinese pharmaceutical market will attract large foreign companies to invest in large amounts of money, China will become the world's major APIs and preparations production base, import and export trade of drugs will grow dramatically, the phenomenon of price disparity of drugs will be gone, the pharmaceutical market competition will become more intense.