The degree of marketization and competition in the indu […]
The degree of marketization and competition in the industry
Compared with foreign countries, China's pharmaceutical hollow capsule industry started late, the relevant management system and standards have yet to be improved, and there is room for further improvement in industrial concentration. Prior to 2012, China's relevant industry regulatory regulations did not require pharmaceutical hollow capsule enterprises to organize production in strict accordance with the "Code for the Quality Management of Pharmaceutical Excipients Production"; at the same time, the Chinese Pharmacopoeia (2005 edition) did not include pharmaceutical hollow capsules in the country. The drug standard system has led to the production and sales of hollow capsules according to the Chinese Pharmacopoeia (2000 edition) before the introduction of the Chinese Pharmacopoeia (2010 edition). At that time, a large number of non-standard small-scale enterprises participated in the market competition, and the resulting malicious low-price competition formed a certain impact on the pharmaceutical hollow capsule industry, and squeezed the development space of specialized pharmaceutical hollow capsule enterprises. The relevant provisions on strengthening the supervision and management of pharmaceutical excipients (Guo Food and Drug Administration  No. 212) stipulate that pharmaceutical excipients production enterprises should strictly implement the "Quality Management Standards for the Production of Pharmaceutical Excipients" and establish and improve the enterprise quality management system. With the gradual implementation of GMP of pharmaceutical excipients, the capsule production enterprises with low level of technological technology and backward production equipment will be gradually eliminated. Pharmaceutical hollow capsule production enterprises with advanced production equipment, process technology and diversified sales channels will occupy Market dominance. In the future, China's pharmaceutical hollow capsule industry will enter a stage of rapid integration, and competition will mainly be carried out between large domestic capsule manufacturers and manufacturers with foreign investment background. The advantages of foreign-funded enterprises in using technological equipment, production technology, enterprise management, and international sales channels will bring great pressure to domestic enterprises. At the same time, the development of new pharmaceutical hollow capsules will accelerate, which will also increase the degree of competition in the industry.
Major players in the industry and their market share
With the accelerated development of new pharmaceutical hollow capsules, related companies such as Er Kang Pharmaceutical participated in market competition through mergers and acquisitions in the upstream and downstream, and tried to rapidly promote the large-scale production of hydroxypropyl starch hollow capsules. According to the announcement of Erkang Pharmaceutical, about 1.939 billion yuan was raised through non-public issuance for the project of “100 billion starch capsule hollow capsules and 30 billion starch soft capsules per year”. The construction period is 2 years. After the birth, the industrial chain layout of starch plant capsules will be gradually improved.
The production and sales of medicinal hollow capsules in China must obtain the drug production license and the approval number of the pharmaceutical excipients. At the same time, it is necessary to further verify its functionality, safety and stability to meet the relevant national standards and drug filling characteristics. In the early stage of the promotion of hydroxypropyl starch hollow capsules, it may not be possible to change the consumption habits of end customers and special medication needs (such as some drugs suitable for enteric capsules) in a short period of time. In addition, the National Food and Drug Administration issued the The relevant provisions on the supervision and management of pharmaceutical excipients clarify that for the supplementary application for changing the types of pharmaceutical excipients, the State Food and Drug Administration requires corresponding research, submitting research materials and supplier audit results, and submitting them to the State Food and Drug Administration for approval. It can be used; for pharmaceutical manufacturers that only change the suppliers of pharmaceutical excipients without changing the types of pharmaceutical excipients, the State Food and Drug Administration requires pharmaceutical manufacturers to submit supplier audit data and file with the provincial food and drug regulatory authorities. Therefore, the hydroxypropyl starch hollow capsule is unlikely to form a substantial impact on the conventional medicinal hollow capsule in a short time.