(1) Technical barriers
Downstream customers of cellulose ether have higher requirements on the quality and stability of cellulose ether. Quality control technology is an important technical barrier in the cellulose ether industry. Manufacturers need to master the design matching performance of core equipment, key parameter control of production process, core production process, formulate operating standards, and after a long period of debugging and continuous technical improvement, they can produce stable and high-quality cellulose ether; Only after a long period of research investment can we accumulate enough experience in the application field. It is difficult for new enterprises entering the industry to master the core technology in a relatively short period of time. To master the large-scale production of pharmaceutical and food-grade cellulose ethers with stable quality (especially cellulose ethers for slow and controlled release), it also requires a certain amount of research and development investment or a period of experience accumulation. Therefore, there are certain technical barriers in this industry.
(2) Barriers to professional talents
In the field of production and application of cellulose ether, there are high requirements for the quality and technical level of professional technicians, operators and managers. The core technicians and operators remain relatively stable. It is difficult for most new entrants to obtain professional talents with R&D and core technologies in a relatively short period of time, and there are professional talent barriers.
(3) Qualification barriers
Cellulose ether enterprises need to obtain relevant qualifications to produce and sell pharmaceutical grade cellulose ether and food grade cellulose ether.
Among them, pharmaceutical grade cellulose ether is an important pharmaceutical excipient, and its quality directly affects the safety of drugs. In order to ensure drug safety, my country implements a licensing system for drug production. In order to strengthen the supervision of the pharmaceutical industry, the state has formulated a series of laws and regulations in terms of industry access, production and operation. According to the “Letter on Printing and Distributing the Requirements for the Registration and Application of Pharmaceutical Excipients” issued by the State Food and Drug Administration, the production license management of pharmaceutical excipients is implemented, and new pharmaceutical excipients and imported pharmaceutical excipients are subject to the approval of the National Bureau. There are already national standard pharmaceutical excipients Approved by the provincial bureau. The state’s supervision of pharmaceutical excipients is becoming increasingly strict, and various provinces and cities have formulated corresponding management measures in accordance with the “Administrative Measures for Pharmaceutical Excipients (Draft for Comment)” issued by the state. In the future, if enterprises cannot produce pharmaceutical excipients strictly in accordance with national standards, they may not be able to enter the market. Before choosing or replacing a certain type or brand of pharmaceutical grade cellulose ether, pharmaceutical manufacturers must pass the inspection and file with the competent authority before they can formally purchase and use it. There are certain barriers in the qualification approval of pharmaceutical manufacturers for suppliers. . Only after the enterprise obtains the “National Industrial Product Production License” issued by the Provincial Bureau of Quality and Technical Supervision can it be approved to produce cellulose ether as a food additive.
According to relevant regulations such as the “Related Regulations on Strengthening the Supervision and Management of Pharmaceutical Excipients” issued by the State Food and Drug Administration on August 1, 2012, enterprises must obtain the “Drug Production License” to produce HPMC plant capsules, and the varieties must obtain national food and drug supervision. registration license issued by the Bureau.
(4) Funding barriers
The production of cellulose ether has obvious scale effect. Manually operated small devices have low output, poor quality stability, and low production safety factor. The large-scale automatic control device is conducive to ensuring the stability of product quality and improving the safety of production. Large-scale complete sets of automation equipment require a large amount of funds. In order to improve product competitiveness, enterprises need to continue to invest in expanding production capacity and increasing R&D investment. New entrants must have strong financial strength in order to compete with existing companies and face certain financial barriers to enter the industry.
(5) Environmental barriers
The production process of cellulose ether will produce waste water and waste gas, and the environmental protection equipment for treating waste water and waste gas has a large investment, high technical requirements and high operating costs. At present, the domestic environmental protection policy is becoming increasingly strict, which puts forward strict requirements on the environmental protection technology and investment in the production of cellulose ether, which increases the production cost of enterprises and forms a relatively high environmental protection barrier. Cellulose ether production enterprises with backward environmental protection technology and serious pollution will face the situation of being eliminated. High-end customers have higher environmental protection requirements for cellulose ether manufacturers. It is becoming more and more difficult for enterprises that do not meet environmental protection standards to obtain the qualification to supply high-end customers.
Post time: Apr-10-2023