Offense or Defense? The pharmaceutical industry market is about to change dramatically

　　In 2018, China's pharmaceutical industry will usher in a decisive year of consistency evaluation. Whether it is the aggressive attacking faction or the defensive faction that chooses to retreat in the big wave, I believe that all of them have already smelled the shake-up that the unstoppable consistency evaluation is going to bring.
　　Pioneer victory is expected
　　In fact, at present, a considerable part of the generic drug companies have begun its key varieties of consistency evaluation. Competitive pharmaceutical listed companies have long been on their own generic drug species to reorganize and layout, even if many varieties are not in the "289 directory", after all, the big companies play the game is more chips.
　　As of November 20, the General Administration has accepted the application of 30 varieties of unified, which contains 8 did not change the prescription process application and 22 change the prescription process application, CDE has accepted the first batch of varieties of the earliest approval results in December this year or next year in January can be out. Means, this batch of pharmaceutical enterprises will be the first to feel the benefits of the policy.
　　As we all know, consistency evaluation to the generic drug industry is a structural adjustment, will break the original market pattern and then remodeling. In short, it is the first to pass the final test of the enterprise will be eliminated and original research manufacturers previously occupied by the market space for redistribution.
　　For example, Jingxin Pharmaceuticals, which has strong momentum in consistency evaluation, has three varieties of products accepted by the CDE, namely, Rosuvastatin, Levetiracetam and Sertraline hydrochloride. And one of the Rosuvastatin belongs to the large varieties with wide market space, who can win the battle of card position in the consistency evaluation, who can seize the market high ground.
　　Therefore, including Zhengda Tianqing and Baiyunshan Pharmaceuticals, there are about 20 companies, including this variety of BE test for the record, but Jingxin Pharmaceuticals has seized the opportunity to submit to the CDE, there is a great opportunity to successfully pass the consistency evaluation. In this way, as the original manufacturer of AstraZeneca has about 68% of the market share, Jingxin Pharmaceuticals is expected to take advantage of the low price advantage to get a piece of the pie.
　　And strong R & D strength, rich variety of companies will benefit from the industry concentration in the long term. For example, the drug, from the reference preparation for the record number of view, he currently has the largest total, before the industry has pointed out that this will give Shanghai Pharmaceuticals to bring a curved road to overtake the opportunity.
　　In addition, like Xinlitai with clopidogrel and DZH with atorvastatin tablets, these varieties of consistency evaluation in the first opportunity, there is a great opportunity to take advantage of the policy dividend greatly exceeded other pharmaceutical companies.
　　Give up is not equal to death
　　Previously, there are voices in the industry pointed out that consistency evaluation will die a large number of drugs. This sentence is a few points of truth, but not all. We have to make it clear that giving up is just another option, not equal to death.
　　With the rules of the game of consistency evaluation gradually clear, the industry is more deeply aware of the high cost of time and money spent is not just talk.
　　On the one hand, it will take about 2 years to complete the consistency evaluation, and the process also needs to bear the delay caused by additional risk issues, which has high requirements for technical test and time planning.
　　On the other hand, the price of BE test for consistency evaluation is rapidly increasing at present, and the average level has reached 2~3 million dollars. Together with the cost required for the preliminary pharmacological evaluation, the cost required to complete the consistency evaluation of a single generic drug will exceed 5 million.
　　The cost of generic drug consistency evaluation is too high, it will take a very long time to recover, from the perspective of input-output ratio, there will be a large portion of pharmaceutical companies choose to give up due to economic issues.
　　More importantly, some statistics point out that the "289 catalog" in the number of individual varieties of pharmaceutical enterprises with less than 10 approvals accounted for only 43%. In other words, many varieties of the track have a large number of competitors.
　　In the face of such fierce competition, selective abandonment of some varieties, combined with the company's strategic development needs to select the varieties that contribute more to the enterprise consistency evaluation is a wise approach.
　　According to the State Drug Administration in August released "on the enterprise to carry out 289 catalog of generic drugs quality and efficacy consistency evaluation of the basic information" shows that the ranking of the top varieties of a number of enterprises to give up the consistency evaluation.
　　Among them, the number of enterprises holding the largest number of document number of compound sulfamethoxazole tablets, the number of enterprises to give up the evaluation reached 391. And closely followed by norfloxacin capsules, metronidazole tablets, berberine hydrochloride discs and vitamin B6 tablets, the number of enterprises abandoning the corresponding varieties were 234, 212, 232 and 187 respectively.
　　At present, there are still some enterprises that are not sure whether to give up each variety, and I believe that with the passage of time, there will be more enterprises to see the situation and make a choice, and then this number will rise.
　　Content source: Pharmaceutical local station (yiyaoguanchajia)
　　Author: Chuanbai