(1) Qualification barriers
Direct contact with the packaging materials and containers of drugs directly affects the effectiveness and safety of drugs, and China has implemented registration and approval management by the State Food and Drug Administration since 2004. Pharmaceutical packaging materials manufacturers must first carry out the transformation of the purification workshop, through the purification level testing of professional institutions by the Food and Drug Administration for on-site review, and select three batches of products for full inspection, all the tests are qualified and then organized by the China Institute for Food and Drug Control experts for technical review, and finally the State Food and Drug Administration for approval and issuance of the "Drug Packaging Materials and Containers Registration Certificate".
Each variety and each material structure of the direct contact drug packaging materials produced by the pharmaceutical packaging material manufacturer must obtain the "Registration Certificate for Pharmaceutical Packaging Materials and Containers" issued by the State Food and Drug Administration, especially since the implementation of the new version of GMP on March 1, 2011, the approval of the registration certificate for pharmaceutical packaging materials has become more stringent. The time period for newly established pharmaceutical packaging material manufacturers to obtain the qualification of "Registration Certificate for Pharmaceutical Packaging Materials and Containers" is long and difficult, and the acquisition of qualification forms an entry barrier for new entrants in the industry.
(2) Technical barriers
Pharmaceutical packaging industry is a multidisciplinary, knowledge-intensive, capital-intensive high-tech industry, the industry product development, design, production usually involves pharmacy, materials science, fine chemistry, packaging engineering, machinery manufacturing and other disciplines and technologies, into the industry needs to have a strong cross-industry technology integration ability, but also need to have a long-term technical experience accumulation, and the accumulation of proprietary technology and the cultivation of scientific research and development capabilities is a long-term process, the general enterprise in a short period of time can not be quickly formed.
Enterprises in the leading position in the industry, with a large number of pharmaceutical packaging material product registration certificates, pharmaceutical packaging material product technology patents, product design, production technology and production technology leading, therefore, the products they produce have significant advantages in variety, performance and customer satisfaction, which helps to maintain their core competitiveness and form barriers to enterprises entering the industry in the later stage.
(3) Financial barriers
The main production equipment of the domestic pharmaceutical packaging industry, such as solvent-free laminating machine, precision coating machine, high-precision printing machine, etc., is relatively expensive, and enterprises entering the industry need to have strong financial strength to produce products with industry-leading level.
The production process of pharmaceutical packaging materials mainly relies on packaging design, through the printing equipment will be all kinds of color, brilliant and colorful colors are completely transferred to the substrate, and then through the composite equipment to bond the substrate with different properties into a whole, and finally through slitting or bag-making equipment cutting (welding) into the appropriate use specifications of downstream customers, to achieve exquisite printing, fully functional pharmaceutical packaging material products, so having a set of sophisticated production equipment for the issuer, not only can broaden the production types of products, but also improve the production quality of products.
In the production process of the company's products, the improvement of equipment performance can flexibly switch to other products to meet customer needs. For example, the issuer's production line for pharmaceutical aluminum foil is a high-performance equipment integrating printing and coating, which can realize front and back printing, and realize forward and reverse automatic overprint patterns (with anti-counterfeiting function) for the requirements specified by customers. The improvement of equipment performance can improve the production quality of products. For example, the issuer is one of the earliest manufacturers in China to use solvent-free production equipment to produce high-barrier pharmaceutical packaging materials in the pharmaceutical packaging materials industry, and by replacing the traditional dry composite equipment with solvent-free composite equipment to produce pharmaceutical packaging materials, it not only reduces VOC emissions and energy consumption, but also eliminates the risk of excessive solvent residues in the final product and greatly improves product quality because no organic solvents are used in the whole process of compounding.
Therefore, the pharmaceutical packaging industry is a capital-intensive industry, and the scale of equipment investment in general project construction is relatively large, and new enterprises entering the industry need to rely on the accumulation of external resources, and the capital threshold has become an obstacle to entering the industry.
(4) Talent barriers
The pharmaceutical packaging industry involves a variety of disciplines and technologies, so having a group of high-level, multidisciplinary background compound professionals is the key factor to determine whether an enterprise has core competitiveness. Generally speaking, the growth cycle of core technical talents in the pharmaceutical packaging industry is long, and the cost of internal training is high. At the same time, enterprises have a greater degree of protection for this part of the talents, and often take various incentive measures to retain them, and it is difficult for new enterprises to enter the industry to attract the required technical personnel through open recruitment. The pharmaceutical packaging industry itself started late in China's market-oriented development, and the advanced equipment of training institutions such as universities is relatively lacking, and the scientific research conditions are limited, so it is difficult to train qualified high-end talents on a large scale in a short period of time.
In addition to core technical personnel, the pharmaceutical packaging industry has a greater demand for skilled workers. At this stage, there is a large gap between the supply and demand of such talents in China, and it is difficult for new enterprises to recruit a sufficient number of skilled workers.
(5) Marketing network barriers
The domestic sales network is mainly hired by enterprises in accordance with the sales area in the local area, and the cooperative sales with pharmaceutical packaging machinery enterprises is also a more common model.
When pharmaceutical companies select the varieties and suppliers of pharmaceutical packaging materials, they must first conduct a six-month drug stability test, and conduct on-site inspections on the supplier's production environment, production equipment, inspection equipment, and management system documents. Therefore, once entering the supplier list of pharmaceutical enterprises, it forms a barrier to new entrants; at the same time, after the pharmaceutical enterprises select a certain packaging machinery, the selection of pharmaceutical packaging materials supporting it is also affected by the recommendation of packaging machinery enterprises to a certain extent, packaging machinery enterprises in order to ensure the adaptability of packaging materials and packaging machinery, reduce debugging time, often choose familiar brand packaging materials manufacturers to match with them, and the cooperation with packaging machinery enterprises has also strengthened the market development ability of pharmaceutical packaging materials enterprises.
