滕州Barriers to entry in the pharmaceutical intermediate industry

① Customer barriers

The pharmaceutical industry is monopolized by a few multinational pharmaceutical companies. Pharmaceutical oligarchs are very cautious in choosing outsourcing service providers, and the inspection period for new suppliers is generally longer. Pharmaceutical CMO enterprises need to meet the communication patterns of different customers and undergo long-term continuous assessment in order to gain the trust of downstream customers and become their core suppliers.

② Technical barriers

The ability to provide high-tech value-added services is the foundation of pharmaceutical outsourcing service enterprises. Pharmaceutical CMO enterprises need to break through the technical bottlenecks or blockages of the original route and provide optimized pharmaceutical process routes to effectively reduce drug production costs. Without long-term and high cost R&D investment and technological reserves, it is difficult for enterprises outside the industry to truly enter this industry.

③ Talent barriers

The technological innovation and industrial operation of pharmaceutical processes require a large number of excellent R&D, production management talents, and project execution personnel. It is difficult for CMO enterprises to establish a competitive R&D and production elite team in a short period of time by establishing behavior patterns that comply with cGMP standards.

 ④ Quality regulatory barriers

The quality supervision requirements of drug regulatory agencies such as the FDA are becoming increasingly strict, and products that have not passed the audit cannot enter the market of importing countries.

 ⑤ Environmental regulatory barriers

Pharmaceutical companies with outdated processes will bear high pollution control costs and regulatory pressure, and traditional pharmaceutical companies that mainly produce high pollution, high energy consumption, and low value-added products (such as penicillin and vitamins) will face accelerated elimination. Adhering to process innovation and developing green pharmaceutical technology has become the future development direction of the pharmaceutical CMO industry.