Consistency evaluation and national centralized procurement policy have become the difference between life and death for most small and medium-sized pharmaceutical companies, and most small and medium-sized enterprises cannot afford such a huge price reduction space. In the future, drug competition will mainly be the competition of R&D capability, product technology, cost control and product echelon. With the continuous expansion of the variety of centralized mining, the market will be more and more concentrated in the head enterprises.
Injection will enter the price war as soon as next year.
China securities journal learned that two documents, Technical Requirements for Consistency Evaluation of Quality and Efficacy of Chemical Injection Generic Drugs and Requirements for Application Materials for Consistency Evaluation of Quality and Efficacy of Listed Chemical Injection Generic Drugs, are about to be completed, and the official documents may be released at the end of this year, when the consistency evaluation of injections will be officially launched, and some varieties are expected to take the lead in completing the evaluation before the end of next year.
The staff of the Food and Drug Administration told china securities journal that the consistency evaluation is a reshuffle of generic drugs in China, which will comprehensively improve the quality of generic drugs in China and ensure the consistency with the quality and efficacy of the original research products. Judging from the contents of the above two consultation documents, the technical requirements of injection conformity evaluation have gradually been in line with international standards, which will put forward higher requirements for R&D and injection production in China. This move also means that once the three companies have reviewed each variety, the medical insurance bureau can bring it into the scope of centralized national procurement and significantly reduce the price.
According to Minenet's data, in 2065438+2008, the consumption scale of chemical injections in the domestic market (national public medical institutions and retail pharmacies) reached 626.404 billion yuan.
According to drug statistics, by the end of September this year, there were 434 acceptance numbers, involving 120 varieties. In terms of the number of applications, leading enterprises in the industries such as Kelun Pharmaceutical, Qilu Pharmaceutical, China Bio-Pharmaceutical, Changjiang, Haosen Pharmaceutical and Hengrui Pharma are in the forefront. At present, only azithromycin for injection has passed the consistency evaluation according to the supplementary application, and the other nine varieties for injection that have passed the evaluation are approved for production according to the new registration classification of chemicals (deemed to have passed the consistency evaluation).
The staff of Food and Drug Administration told china securities journal that compared with oral tablets, the consistency evaluation of injections has shorter cycle, lower technical difficulty and lower cost (about three or four million yuan), so most enterprises have the ability to pass the consistency evaluation. Once a variety has been evaluated by three companies, it will face a price war when it is collected nationwide.
A high-quality faucet will control dust.
"4+7" quantity procurement emphasizes "quantity-price linkage", and takes 60%-70% market share as a bargaining chip to achieve the purpose of exchanging quantity for price. Once the enterprise wins the bid, it will quickly occupy the market, and the price of winning the market is to minimize the price; Once unsuccessful, it means losing the market and facing the risk of bankruptcy.
Therefore, the competition between price and market becomes the key game of quantity procurement. In this game, on the one hand, countless small and medium-sized pharmaceutical companies are at a disadvantage because of "price", and their ability to reduce costs and upgrade pharmaceutical production processes is limited, and they do not have enough economic strength to give prices below cost; On the other hand, based on the "quantity" reason, even if the price is slightly better, it will win 60%-70% of the market share in a procurement cycle, and it cannot be guaranteed that low-priced and low-quality drugs will not be produced to achieve income balance.
Insiders of the Medical Insurance Bureau told china securities journal that under the drug procurement policy, the competition among pharmaceutical companies is largely cost competition, including production cost, procurement cost and labor cost. At the same time, it has changed the mode of drug circulation, cut off the interest chain of drug circulation, and the role of medical representatives as sales staff of pharmaceutical companies will decline.
However, there are also some sub-sectors that are less affected and the impact is almost zero. First, pharmaceutical companies with strong R&D capabilities, such as Hengrui Pharma and Fosun Pharma; Second, biopharmaceutical enterprises, such as Changchun Gaoxin, zhifei Bio, etc., can't bring the quantity into the procurement catalogue because there are no generic drugs such as hormone drugs and vaccines. Third, private medical institutions such as pharmacies and clinics are the main sales channels rather than public hospitals, such as Sunflower Pharmaceutical, Revision Pharmaceutical and Tongrentang. Fourth, pharmaceutical companies with less product competition, such as Huahai Pharmaceutical, the competitor of Paroxetine and lisinopril, and Yang Zijiang Pharmaceutical, the competitor of Enalapril Maleate Tablets.
Industry mergers and acquisitions will be greatly accelerated.
Purchasing with quantity will inevitably lead to the reshuffle of the domestic pharmaceutical industry, and those small and medium-sized enterprises with low specialization, small production scale and high operating costs will be the hardest hit. In the future, large enterprises will merge with small enterprises, and the development of the industry will tend to be intensive and large-scale. According to the analysis of many people in the industry, after consistency evaluation and national centralized procurement are further developed, the industry will have three major development trends at present.
First of all, the market of each variety will be divided by a few enterprises, and the industry concentration will be greatly improved. According to the deployment of the Food and Drug Administration, all generic drugs must be evaluated for consistency in the future, and it is stipulated that "more than three enterprises of the same variety have passed the consistency evaluation, and varieties that have not passed the consistency evaluation will no longer be selected in centralized procurement". At present, 3 1 provinces and cities in China have implemented this policy. It can be predicted that with the development of consistency evaluation and national centralized procurement, the top three enterprises that have passed the re-evaluation will carve up a certain market, while the remaining enterprises with this variety will face elimination.
Secondly, it will ensure the quality and efficacy of generic drugs and gradually replace the original drugs. The technical requirements for consistency evaluation of generic drugs strictly refer to European and American drug regulatory laws to ensure that the quality and efficacy of generic drugs passing consistency evaluation are equivalent to those of the original drugs. On this basis, policies such as "products that pass the conformity evaluation are given the same treatment as the original drug in terms of bidding, procurement and medical insurance payment" and "drug patent link and test data protection" have created a good external environment for generic drugs to replace the original drug. Under many favorable conditions, domestic generic drugs will gradually replace the original research drugs, which is expected to break the monopoly of the original research products.
Finally, influenced by policy-driven or product quality improvement, more local enterprises will enter overseas markets. Influenced by the policy of "supporting drugs produced by enterprises in China and approved by the European Union, the United States or Japan to be listed in China", some enterprises with certain R&D capabilities will use this policy to obtain certification and approval overseas, and then declare conformity evaluation to the Food and Drug Administration to speed up the approval process. In addition, domestic generic drugs that pass the consistency evaluation are expected to achieve mutual substitution with the original research products in clinical treatment, which greatly improves the international competitiveness of generic drugs in China. It is expected that more local enterprises will try to explore overseas markets to increase product sales. Therefore, whether it is objectively improving product quality or subjectively speeding up the examination and approval process with the help of overseas declaration, more enterprises will enter overseas markets.
(Article Source: china securities journal)
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