Guess after 4 + 7: who is the most hit? Who is eager to transform?

After 4 + 7, China's patent expired chemical drug market seems to have suddenly changed Before 4 + 7, even the original research products whose patents have expired can often maintain a relatively high price level and occupy more than 50% of the market share; while the generic manufacturers, if the number of competing producers is not large, can also maintain a relatively good price and maintain a market share of 20% - 30%, all the way to "win by the big money" And even though there are many manufacturers of generic drugs, these drugs usually enter the low-cost drug catalog, and the natural sales flow is also good As long as the bid is won, it is still possible to make money After all, when there is no conformity assessment, quality control is just a matter of muddling along After 4 + 7, it is clear that the good days of not only outdated original drugs, but also generic drugs will come to an end The bottom line of price reduction: it turns out that the price of generic drugs in China has not been linked with that in Europe, America and Japan After this "4 + 7" quotation, the industry suddenly found out that the market price of generic drugs in Europe, America and Japan was so low There is no doubt that the price is one of the important factors to promote the enterprise to carry out the consistency evaluation The products through the consistency evaluation can be purchased online and compete with the same quality level of the original research Moreover, three products through the consistency evaluation can drive the products that fail to pass the consistency evaluation out of the purchase market of medical institutions This means that the number of generic pharmaceutical manufacturers in the market is reduced, and the price still has room to rise, so enterprises have the power to layout large-scale products in the market and carry out consistency evaluation As of April 21, 2019, no statistics has been made for declaration by new registration classification According to Xianda data v3.5, 34 enterprises have applied for conformity assessment of amlodipine besylate tablets, 27 enterprises have applied for conformity assessment of metformin hydrochloride tablets, 26 enterprises have applied for conformity assessment of Amoxicillin Capsules and 20 enterprises have applied for conformity assessment of ranitidine hydrochloride capsules All of the above products are consistent It is very likely to enter the price war when evaluating the overheated products, among which amlodipine is a product in the "4 + 7" catalogue, and the price selected is only 0.15 yuan However, low price is likely to reduce the enthusiasm of enterprises for investment consistency evaluation Before "4 + 7", the main products that Chinese pharmaceutical companies made money were traditional Chinese medicine injections and exclusive dosage form improvers with Chinese characteristics The product competition strategy was to sell drugs with gold under the background of high prices The product price determines the profit space and sales volume As long as there is no major defect in the safety of the product, the higher the price, the better the product will sell In recent years, China's pharmaceutical enterprises have been forced to transform due to the reform of auxiliary drug policy, chemical drug registration reform, drug "zero plus" and drug proportion Domestic production enterprises all expect to succeed in transformation through consistency evaluation The policy of "4 + 7" is only one winner and the lowest price winner The final winner of more than three competitors' products is surprisingly low Apart from the production cost and the original auxiliary package cost, the product winner's price basically has no promotion and marketing expenses For enterprises accustomed to the high price marketing mode, the "high price" mode of generic drugs is only the first to be imitated The products with relatively few relative families may be products with relatively difficult technology, such as slow and controlled-release tablets, inhalants, and even biological similar drugs similar to the concept of "generic drugs", but there is also a trend of overheated investment The exclusive patent new drug is also a product type that is likely to maintain the "high price" mode, so domestic enterprises are eyeing the new drug again Supply and demand determine the price There are 3000 enterprises in China and at least 200 enterprises are eager to transform No matter which direction of development, as long as there are 10 domestic enterprises willing to layout, they will face price war in the future The reason why "low price" will become a difficult problem in the transformation of domestic pharmaceutical enterprises is that the vast majority of domestic pharmaceutical enterprises have never experienced the price war of "4 + 7" to determine the life and death, and even do not know how to survive after the low price of products, and how to change the transformation from production to marketing mode 02 international generic layout: doomed to be frustrated? Also hit by low prices are international enterprises In order to encourage domestic enterprises to export and upgrade their internationalization, the consistency evaluation policy introduced "drugs produced and listed in the same production line in China and approved for listing in the EU, the United States and Japan are deemed to pass the consistency evaluation" Compared with the price of domestic generic drugs, the market price of foreign generic drugs can not make money for all products For example, in the United States, many media have commented that the golden age of American generic drugs has come to an end The golden age of American generic drugs was the first ten years after the implementation of drug price competition and patent period compensation act in 1984 Because the prescription rate of generic drugs is not very high and the market scale is not large, the pharmaceutical giants basically do not lay out generic drugs The generic drug market is mainly occupied by small and medium-sized pharmaceutical enterprises in North America Due to the small number of approvals, the price of generic drugs at that time was relatively high, the profits were considerable, and the market growth was very fast After 2000, in order to reduce medical expenses, FDA accelerated the review and approval of generic drugs In 2001, the prescription rate of generic drugs in the United States exceeded 50% for the first time, and the competition of generic drugs began to turn white hot From 2000 to 2017, the number of andas approved by FDA increased from 294 to 924, with a total of 9450 approved In 2018, FDA launched gdufa II In the 2018 FDA generic approval report released in 2019, it was mentioned that FDA approved or temporarily approved 1021 new drug simplified applications (andas) in 2018, 14% of which were complex generic drugs, 10% of which were first generic drugs, 18% of which were complex generic drugs With the increase of Anda number, the price of generic drugs has declined year by year The average price of generic drugs in the United States is only 15% of the original research drugs, and some products even fall below 10% of the original research drugs In the United States, 90.3% of generic drugs (no brand and brand) are prescribed, and only 23% of the total drug market in the United States is sold All in all, the U.S generic market has entered a growth bottleneck period, and it is unlikely to continue to maintain high-speed growth The main expectation of internationalization of domestic enterprises' layout is to compete for the domestic generic market by accelerating the approved consistency evaluation through double reporting policy, or to compete for the market by introducing imported generic drugs However, the price of "4 + 7" is basically the same as that of American generic drugs, which will frustrate the enthusiasm of domestic enterprises in the internationalization of generic drugs In addition, there are also differences in the approval time and progress of applying for conformity assessment by different means for double cross products The same is true for double cross products The speed of supplementary application for conformity assessment for oral drugs is faster than that of new registration classification, which often needs clinical trials; the speed of application for new registration classification for injection is faster than that of supplementary application for conformity assessment, which is the latter No product has been approved The explosion of chemical plants in Jiangsu and Shandong in recent months has also increased the pressure on domestic enterprises Environmental impact assessment has made the domestic API industry unable to adapt, and the mystery of where the API enterprises can actually produce remains unresolved The explosion and shutdown rectification of chemical plants means that the supply of intermediates in upstream enterprises of API will also have problems The filing process of imported APIs has not been straightened out Under the scarcity of domestic API supply, the competition of domestic pharmaceutical industry will not be the more detailed division of labor and more competitive, but the enterprises that master the scarce resources in the upstream will win in the price war, which is why the enterprises integrated with API are more likely to gain a favorable position in the "4 + 7" competition 03 generic marketing model transformation? The advantages of "4 + 7" for the selected enterprises include: ensuring that the selected products of "4 + 7" enter the hospital preferentially by various administrative means, preferentially using (included in the doctor's assessment index), preferentially replacing the dosage form products corresponding to the same medication route of the common name products, monitoring the growth of the dosage of the competitive products to ensure the dosage of the selected products, collecting money in advance, etc The products that have not been selected are relatively less friendly The products that have not been selected and have passed the consistency evaluation will not be purchased in the pilot cities As long as they don't win the election, they basically lose the market of medical institutions This will force the unsuccessful products to be sold in the drug retail channel Referring to the U.S generic retail mode, the U.S drug sales and wholesalers mainly pay through medical insurance, and calculate the retail price through PBMs Then American drug sales and wholesalers push down the purchase price All the difference is the profit of American drug sales and wholesalers The U.S drug sales and wholesalers have formed a "four giant" oligopoly, and the U.S drug sales and wholesalers are in a bargaining advantage Since there is only one manufacturer of new drugs / brand drugs without bargaining space, and there are many generic drug manufacturers, the drug sales and wholesalers in the United States can purchase from different manufacturers, and the more suppliers, the greater bargaining space for drug sales and wholesalers in the United States, the profit will be inclined to drug sales and wholesalers in the United States, and the profit space for generic drug manufacturers is strict Be weakened again In the retail channel of drugs, the first thing to solve is the buyer's purchase behavior China does not implement the separation of pharmaceutical industry as the United States does The scale of medical institutions accounts for nearly 70% of the pharmaceutical market In the short term, it is still difficult to form medical separation in the domestic drug market After "zero plus", the drug retail channel has been in the problem of drug price hanging upside down - the price of the same drug in the drug retail channel is higher than the price of the hospital, the hospital drugs usually have medical insurance reimbursement, and the drug buyer will be more inclined to purchase drugs in the hospital The "4 + 7" selection price will further aggravate the "upside down" problem in drug retail industry Although the first batch of "4 + 7" products is not many, the products passing the consistency evaluation are likely to be listed in the subsequent batches of "4 + 7" The hot products of consistency evaluation are mainly products with large market scale such as chronic diseases, which will affect the drug structure of drug retail In 2018, the drugs with a large share in the retail market are mainly cardiovascular drugs (including antihypertensive drugs), hypoglycemic drugs, anti-tumor drugs and immunomodulatory drugs, with a market scale of more than 200 billion yuan In addition to hypoglycemic drugs, other categories of the above products have entered the first batch of "4 + 7" catalog products "4 + 7" will promote drug retailers to pay more attention to traditional Chinese medicine oral drugs with similar indications, as well as the anti allergy drugs, male erectile dysfunction and contraceptives that are not covered by medical insurance and free from "4 + 7" problems Some provinces and cities even require that the drug retail channel must be equipped with "4 + 7" medium-sized products and "the same product and the same price" sales even cause the objection of the drug retail channel For example, the sales price of the pharmacy under the pilot scheme of prescription outflow in Fuzhou should not exceed the low price between the online price of the sunshine purchasing platform or the maximum sales price of the sunshine purchasing platform, and the drug retail chain (including its stores) should not The drugs listed in the outflow prescription of the dispensing hospital shall be changed without authorization, and the patients shall not be able to pick up the drugs in the store due to the insufficient drug reserve This will lead to the disorder of the original price system of retail drugstores and enter the situation of negative gross profit management It is true that "4 + 7 volume purchase" has a positive effect on alleviating "expensive medical treatment" However, this policy will limit