The business club reported on October 11th that the reporter learned from the "2010 Injection Industry Conference and High-Level Forum for Infusion Enterprises" that due to the implementation of the new medical reform and the "New Rural Cooperative" policy, sales volume of major infusions nationwide climbed sharply last year from 2006. The 61 million bottles/bag rose to 80.5 million bottles/bag. According to comprehensive estimates, in the past 10 years, the compound growth rate of the infusion industry nationwide was 17.2%. At the same time, the concentration of the infusion industry rose rapidly: In 2006, the output of the top 10 companies in the infusion industry accounted for approximately 23.37% of the country's total output, while the proportion of production capacity of the top 10 companies last year exceeded 50%. In addition, the product structure of large infusion products is also undergoing profound changes: the market share of glass bottle infusion products has dropped from 64.77% in 2007 to 43.72% in 2009, and the production capacity and sales volume of plastic bottles and soft bags have increased significantly. rising.
Wanyang Bath, the vice general manager of Sichuan Kelun Pharmaceutical Co., Ltd., the country's largest infusion manufacturing company, said that the sales volume of the large infusion market has been boosted by the medical consumption driven by the national medical reform policy, and the product structure adjustment is due to industrial upgrading and public Drug quality concerns. As we all know, this year is a challenging year for the infusion industry. The new version of GMP, which is widely concerned but has never been introduced, is said to be almost the same as the EU standard. Under the new standard, the infusion industry is facing the biggest adjustment. The industry believes that the infusion industry currently faces multiple challenges.
Market follows demand
At present, China's large infusion products are mainly divided into glass bottle packaging, plastic bottle packaging and soft bag packaging according to packaging materials. Before 2006, glass bottles accounted for nearly 70% of the market. In 2007, sales of glass bottles were 4.145 billion bottles, 1.4 billion plastic bottles and 855 million bags. By 2009, sales of glass bottles had fallen to 3.5 billion bottles, plastic bottles sales of 2.845 billion bottles, and soft bags of 1.66 billion bags. The market sales of glass bottles and plastic bottle products are already close.
Wanyang Bath indicated that the market share and production volume of glass bottle infusion continues to decline, which is the result of upgrading products. It is a natural choice for enterprises to continuously improve their efficiency and reduce costs after they have mastered the production techniques of plastic bottles and soft bag products.
In fact, the retreat of glass bottles and the rapid rise of plastic bottles and soft bags have deeper causes. From the point of view of the development of the international market, with the development of economy, the level of people's use of drugs has increased, and non-bottle-packed infusion products have rapidly replaced conventional glass bottle packaging products with their safety and environmental protection, especially in developed countries such as Europe and the United States. Non-glass bottle packaging infusion products already accounted for most of the market share. China's market has long been dominated by low-cost glass bottle packaging products, but with the rapid economic development, plastic bottles and soft bag products have also begun to be accepted by the market. Especially in the past two years, as the prices of raw materials such as soda ash and natural gas continue to rise, the average price increase for medical glass has exceeded 20%, and there have been incidents such as the bottle-smashing of glass bottles and out of stock in some regions. In this situation, many infusion companies started looking for new packaging replacement materials. Plastic bottles and soft bags, as relatively high-end packaging materials for infusion products, have great advantages in product pricing and entering the high-end market. Moreover, in recent years, through the process improvement and large-scale production, the cost of plastic bottles and soft bags has decreased year by year. At present, its price is similar to that of glass bottles, but its advantages of low energy consumption, low freight, and low risk are obvious. It is understood that in the disaster relief of the Wenchuan earthquake, all infusion products shipped to the disaster area are plastic bottle and soft bag packaging products.
Gu Weijun, secretary general of China Pharmaceutical Engineering Equipment Association, recently inspected the infusion industry in the country. He said that with the wide coverage of medical insurance and the continuous deepening of the “New Rural Cooperatives,†the primary market’s medical payment capacity has increased significantly. At present, in the most remote rural markets, patients also use plastic bottle and soft bag infusion products.
The industry is facing the "test"
The reporter learned from the State Food and Drug Administration that the revision of the new version of the GMP has now been completed and is waiting for the Ministry of Health to issue the program. It is expected to be officially launched before the end of November and formally implemented in January next year.
It is reported that the biggest change in the new version of GMP is in the field of sterile products, adjusting the cleanliness requirements of aseptic formulations, increasing the requirements for on-line monitoring, and refining the requirements for the culture medium; the purification level adopts EU standards and implements A, B, C, D four standards. Gu Weijun said that the cleanliness requirements currently enforced in China are different from the WHO standards and EU classification settings. Most large-volume injection companies and some freeze-dried powder injection companies need to be transformed.
At last year's China International Pharmaceutical (Industry) Exhibition and Technology Exchange Conference, reporters saw that many pharmaceutical machinery companies have carried out technological upgrading and transformation of pharmaceutical machinery in response to the needs of the new GMP and pharmaceutical companies. The reporter also learned from the pharmaceutical companies that as early as last year, many companies had started to update their equipment and moved closer to the new standard.
Zhang Yu, head of product development at Beijing Shuanghe Pharmaceutical Co., Ltd., said that in the new GMP compliance reform, companies will consider adjusting the product structure. However, when adjusting the structure, the most troublesome enterprise is how to adapt the packaging materials, processes and raw materials to the new product. standard.
It is understood that at present, the supply capacity of infusion packaging materials in China is still relatively weak, and there is no supporting infusion product packaging industry. The specifications and standardized production of packaging materials are still difficult to achieve. Some raw materials for packaging materials need to be imported. The problem of foreign suppliers of raw materials for packaging materials came out one after another. Chinese companies face the risk of raw material supply failure at any time.
“In the past few years, some companies have made a big fuss about packaging to reduce costs: the infusion bottle mouth and bottle cap have become smaller and smaller. Because there is no standard in the thickness of plastic bottles and the wall of the bottle is thinner and thinner, these have quality. Risk," said the person in charge of an infusion company in Shandong.
Ge Junyou, vice general manager of quality responsible for Sichuan Kelun, believes that the risk of infusion products comes mainly from two aspects. The first is standard materials. Although different packaging materials, assembly covers, and interface suppliers are all audited, it is difficult to guarantee product quality. Uniformity, which has a lot to do with the production process of packaging materials, sampling inspection has little significance. For this reason, Sichuan Kelun eliminated many suppliers of packaging materials from 2008 to 2009; the second is the use of circulation, “We found that the infusion products were handed to the dealers and the storage environment was not optimistic. In pharmaceutical factories and warehouses, we must strictly control the temperature, but it is difficult to ensure the proper temperature in the circulation, especially in rural small and medium-sized hospitals. The clinic, storage environment and use environment are all very poor. For the production enterprises, these links cannot be controlled and pose a great threat to the safety of medications.
Expecting input and output rationalization
At present, many infusion companies have adopted the new version of the GMP compliance reform as a chance to upgrade their products and adjust their structure. At the same time, huge investment in capital is inevitable. According to estimates, the industry investment for the new version of the GMP reform will reach 20 billion to 30 billion yuan. For the most influential infusion industries, the numbers of input and output and profit costs have become particularly sensitive. As we all know, the infusion industry has always been less profitable, and "a bottle of infusion solution cannot sell a bottle of mineral water" is not an exaggeration. Nowadays, the “only low price theory†of bidding and procurement in some provinces makes the infusion company's operation difficult.
Duan Wei, deputy general manager of Shijiazhuang Pharmaceutical Co., Ltd., said: “Large infusion prices have dropped dramatically. Like plastic bottles and infusions, before the first half of last year, the market price was basically two yuan or more per bottle. Now whether it is a successful bid to enter the hospital or enter a primary medical institution The price of many plastic bottle products is already the same as that of glass bottles. The prices of 500 ml and 250 ml doses are basically between 1.1 and 1.2 yuan, and there are many rebates. The 100 ml plastic bottle infusion price is maintained at around 1 yuan. The price is an important reason for the delisting of glass bottles. From our company's perspective, the purchase price of plastic bottles is about the same as a year ago, that is to say, it is a net profit to lose the price of plastic bottle infusion.
Look at soft bag packaging infusion, with the main domestic production companies continue to put into production soft bag production line, soft bag infusion prices are also falling. "Soft bag infusions rarely entered secondary and high-end hospitals by bidding at a price of 3 yuan per bag, and before last year, the price of soft bag infusions did not fall below 3 yuan. This is due to the The vicious competition, on the other hand, is due to frequent bids in local bidding, and for manufacturers, one side is the sharp increase in the cost of raw materials and labor, and the other is the continuous increase in investment in order to meet production standards, which really tests the affordability of the enterprise and society. Responsibility, Duan Wei said.
At present, there are 407 enterprises that have production licenses in the infusion industry in China, and about 35 of them have an annual output of 100 million bottles or more. Gu Weijun believes that China's infusion industry is still in the midst of overcapacity, unfair competition, and homogenization of products. Under the drive of the new medical reform, the infusion market demand will rise sharply, and further adjustment of the industry structure is imperative. In the process, there will be quite a number of companies exiting the market, and more and more companies with financing capabilities and financing channels will be bigger and stronger through mergers and acquisitions, so that the industry will quickly move to concentration. "The United States now has only 3 infusion companies, and Germany has only 5." Gu Weijun said.
According to Yu Mingde, president of the China Pharmaceutical Enterprise Management Association, the quality standard of infusion products is a general trend. In this process, companies will encounter some difficulties, but in the face of difficulties, they should also stick to their social responsibilities. At the same time, they should also see that the overall development trend of the industry is good.
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