As one of the important pharmaceutical excipients, phar […]
As one of the important pharmaceutical excipients, pharmaceutical companies have increasingly standardized and diversified the performance requirements of medicinal hollow capsules, which puts higher requirements on the overall technical level and research and development capabilities of the pharmaceutical hollow capsule industry. With the deepening of the industry standardization process, enterprises that use the “non-sterile production process” to produce medicinal hollow capsules under the GMP environment will occupy a favorable position in the market competition; at the same time, process innovation, variety innovation and matching with specific users The customized technical service is also gradually becoming the core competitiveness of the pharmaceutical hollow capsule enterprises entering the high-end market.
With the rapid development of pharmacy research, the research and development of oral slow-release and controlled-release dosage forms is one of the important directions for the development of pharmaceutical industry. For slow-release and controlled-release capsule products such as new enteric-coated hollow capsules and gastrointestinal composite hollow capsules. Demand is increasing. According to the data of China Medical Statistics Annual Report 2011, in 2011, the output of slow-release and controlled-release capsules in China has reached 2.81 billion. For new entrants, due to lack of technical accumulation and R&D talents, it is difficult to improve existing production technology and The level of equipment cannot meet the R&D and production capacity required to enter the high-end market.
As one of the medicinal excipients, the sales of medicinal hollow capsules have the characteristics of wide market, scattered industry and low sales of single customers. Therefore, the marketing target of medicinal hollow capsule enterprises is mainly concentrated in many downstream pharmaceutical preparation enterprises. And a part of health products companies.
In general, pharmaceutical preparation companies will sign quality agreements with pharmaceutical hollow capsule manufacturers, and conduct strict qualification examinations and on-site quality audits. If the medicinal hollow capsule used is changed, it is also necessary to study and evaluate the effect of the change on the stability and safety of the preparation. The "Regulations on Strengthening the Supervision and Administration of Pharmaceutical Excipients" further require that pharmaceutical production enterprises should establish quality records for all purchased pharmaceutical excipients and their suppliers, and report to the provincial supervision and management department for filing; at the same time, for the quality of the preparations that may affect the preparation. Changes need to be re-declared. Therefore, downstream customers have higher requirements for the quality of medicinal hollow capsules, but the relationship between supply and demand is relatively stable, and it is generally not easy to change suppliers.
The above-mentioned two aspects of the industry characteristics determine that the pharmaceutical hollow capsule production enterprises develop customers for a long time, and need to invest a large amount of manpower, material resources and technical support to establish a broad and stable customer relationship group. Therefore, the establishment of sales channels and brand reputation is a long-term accumulation process, but once the market preemption and brand advantage are established, it will form a major barrier to other competitors.
Driven by the continuous growth of China's pharmaceutical industry, the production capacity and market demand of the pharmaceutical hollow capsule industry have been continuously improved and maintained steady growth. Prior to the “Chromium Excessive Capsule” incident in 2012, due to the imperfect industrial supervision system, the pharmaceutical hollow capsule industry in the industry showed a differentiation phenomenon: non-standard enterprises rely on low-cost competition strategies to concentrate on production and sales in the low-end market, while standardized enterprises rely on quality management. Advantages and brand advantages compete in the mid- to high-end market. At the same time, under the effect of “bad money drives out good money”, the low-end market of medicinal hollow capsules continues to erode the demand of medium and high-end markets, and has formed a certain impact on standardized production enterprises. Therefore, there is a structural supply and demand contradiction in the pharmaceutical hollow capsule industry as a whole: on the one hand, the market supply of low-end medicinal hollow capsules is relatively sufficient, and the market competition is fierce. Under the cost pressure brought by low-price competition, enterprises can only control the cost of products by lowering the quality management standards, resulting in insufficient product quality, which will cause hidden dangers to the safety and stability of the drug production and circulation system. On the other hand, due to quality The establishment of the management system and the renovation of GMP plant facilities require a large amount of capital investment, and the supply of high-quality medicinal hollow capsules is insufficient. At the same time, as domestic medicinal hollow capsules are gradually recognized by foreign pharmaceutical companies, some domestic medicinal hollow capsules have entered the international market. , thereby further reducing the supply of domestic high-end pharmaceutical hollow capsule market. After the “Chromium Excessive Capsule” incident, the industry supervision has become stricter. The pharmaceutical manufacturers have continuously improved the quality requirements of medicinal hollow capsule products. The non-standard pharmaceutical hollow capsule production enterprises will be eliminated, resulting in the shortage of medicinal hollow capsules.