Demand for lyophilizer industry is booming, new test is coming soon

Although the first round of certification deadline has come to an end, new tests are coming. Continuously improved industry standards have spawned changes in the pharmaceutical machine industry. For pharmaceutical machinery companies, to meet the market test and meet new requirements, it is also an opportunity. challenge.

In this case, domestic pharmaceutical companies that have not passed the certification will face two options, stop production or renovate. If you choose to reform, then companies will invest a lot of money to update equipment, which will require higher standards for the production of pharmaceutical drugs for the production of sterile drugs.

The new GMP requirements for asepsis increase, and thus put forward higher requirements for the isolation and automation of pharmaceutical equipment. According to statistics, for the 1000-1200 stock lyophilization production lines in current domestic operations, more than 90% of domestic freeze-dried products of pharmaceutical companies still use manual feed and discharge materials. In the next few years, the market share of automatic discharge systems and aseptic isolation devices will increase. In other words, freeze-drying system equipment consisting of three major devices, freeze dryers, sterile isolation systems, and automatic access and discharge systems, will emerge in the future. A substantial increase.

According to relevant statistics of the China Pharmaceutical Equipment Industry Association, currently, 20% of China's chemical preparations are freeze-dried, and the proportion of freeze-dried drugs in biological products reaches 30%, and the proportion is still rising. The domestic manufacturers of freeze-dried drugs have grown from the six major biological products research institutes directly subordinate to the Ministry of Health at the beginning to provincial and municipal or regional biopharmaceutical plants and veterinary drug biological product factories. The rapid growth of the pharmaceutical industry will drive the rapid development of the freeze-drying system industry.

In addition, with the gradual shift of the production of APIs in developed countries in Europe and America to emerging market countries such as China and India, pharmaceutical companies in emerging markets need not only to expand the scale of freeze-dried production lines, but also to upgrade the technical level of lyophilization system equipment to meet the requirements of international GMP regulations. , Which also stimulated the demand for freeze-drying systems.

In the remaining two years prior to the second round of certification deadline on December 31, 2015, the remaining nearly 4,700 pharmaceutical companies across the country will also face a cruel "test of life and death". Relevant companies need to regain their strength and be prepared to fight hard.

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