87 original drugs delisting countdown! How can generic drugs seize the market through consistency evaluation?

The industry shuffle period brought by consistency evaluation is coming According to the report of Tianfeng Securities Research Institute, as of December 6, a total of 63 batches were in the CDE consistency evaluation sequence, and another 24 products applied for listing through the general generic drug application way, and after listing, they were deemed to have passed the consistency evaluation It is expected that 87 products in the first batch will be certified for conformity assessment of generic drugs With the publication of bidding, medical insurance payment and other supporting measures, generic drugs have formed a rolling attack on the original drugs by virtue of the policy advantages from consistency evaluation The market share of original research drugs corresponding to 87 varieties will continue to decrease, and the situation faced by original research drug companies will become very clear: price reduction or exit The competition of generic drugs will break through the mature markets in the United States and Japan With the expiration of original research patents and the listing of generic drugs, the market share of original research drugs will plummet However, under the old bidding system in China, domestic generic drugs could not reach the same level in terms of quality, and they mostly relied on their own sales ability to compete with each other in a low-quality and vicious way The original research drugs occupied most of the market share for a long time and the price was high According to the analysis of Guojin securities, under the old bidding system, the bidding group is divided according to the quality level, the original research drug is divided into groups and is independent, and the pricing system is stable The domestic generic drugs generally compete with them by changing the dosage form and acid radical, or win the bid at a reduced price and compete at a low price In addition, the original bidding adopts the elimination bidding mode, the medical institutions can't choose the production enterprises, the newly listed generic drugs can't realize the large quantity through bidding, and the absence of medical insurance in the pricing system and a series of other disadvantages make the generic drugs in China unable to realize the import substitution For example, in 2007, amlodipine generic drugs were listed in the United States, and by 2014, the market share of the original drug "luohuoxi" was only 0.5%; in China, due to the absence of drug patents before China's accession to the WTO, amlodipine generic drugs were listed in 2000, but luohuoxi still accounts for more than 40% of the market share The second tier of generic drugs, such as China Resources Secco and Yangzi jianghaini, are less than half of the original research in terms of market share and price There are more than 60 enterprises whose price system has collapsed The bid winning price is less than 1 yuan Each enterprise has a small market share In addition, rosuvastatin was listed on the market in 2008 The original research product "Keding" still accounts for 50% of the market share In the U.S market, when the generic drugs were listed in 2016, the sales amount of the original research decreased by 32%; when the capecitabine generic drugs were listed in the U.S., the sales amount of the original research decreased by 48.6% globally Consistency evaluation will improve the quality threshold of generic drugs in China, give them the opportunity to compete directly with the original drugs, and reshape the competition pattern The self payment standard of medical insurance will gradually become clear with the implementation of consistency evaluation The drug pricing model will be reshaped, and the original "bidding + administrative pricing" will be transformed into the redistribution of benefits under the medical insurance payment standard After the consistency evaluation, the influence of brand on the prescription will be weakened, the sensitivity of patients to the out of pocket part will be the main choice factor, and the domestic drugs will gradually increase the market share depending on the price advantage On the hospital side, in the short term, under the mechanism of "the payment standard and purchase price difference belong to the hospital", the enterprises willing to accept the second price negotiation are expected to obtain higher market share, and the profit space of generic drugs is larger; in the medium and long term, with the implementation of payment by disease, under the background of drug proportion and total cost control, the drugs will become the cost end, and under the same quality, the hospitals are more willing to use the price Domestic generic drugs with lower quality On the doctor side, the medical separation system will increase the cost of diagnosis and treatment, encourage doctors' interests to be sunny according to the common name prescription, and weaken the preference for brand in the process of doctors' prescription At the same time, the interests of doctors often give way to the interests of hospitals, which will promote the substitution of domestic research At that time, with the acceleration of the three medical linkage, generic drugs will continue to erode the market share of the original research drugs, the long-term stable price system of the original research drugs will be broken, and active price reduction will become the general trend Through the consistency evaluation, the generic drugs are directly connected with the original research drugs, opening the war situation The current reform trend is obviously conducive to accelerating this process 2 are these original research products out of the market? According to the report of Guojin securities, 75.5% of oral preparations in China have import substitution opportunities (that is, there are both original research drugs and generic drugs in the Chinese market) From 2011 to 2015, the proportion of generic drug sales did not exceed 50%, but the steady improvement proved that it has the ability of import substitution Among them, clopidogrel of xinlitai and acarbose of Huadong medicine have proved the feasibility of import substitution Clopidogrel with a market scale of more than 15 billion yuan is currently occupied by Sanofi, xinlitai and Lepu medical By virtue of its excellent sales ability, xinlitai obtained nearly 40% market share in 2015, while Lepu Medical Co., Ltd seized nearly 10% market share in three years through its advantages of higher cost performance and collaborative network of stent in cardiology Xinlitai's application for conformity assessment was accepted by CDE in October 2017, and Lepu medical's be test is in progress Acarbose's sales in China's oral hypoglycemic drug market are increasing with the precise positioning of its products In 2016, the market size was about 7.6 billion yuan In this process, relying on the advantages of industrial and commercial integration, Huadong pharmaceutical has achieved a market share increase of 10% in three years At present, the market competition pattern of acabotang is 72% for Bayer, 25% for Huadong pharmaceutical and 3% for LVYE pharmaceutical The be test of East China medicine is in progress In 2016, voglibose's market scale was about 1.3 billion yuan, and its main manufacturers were foreign-funded enterprises, Takeda pharmaceutical In 2016, it still accounted for 56% (about 700 million), while the domestic manufacturers, chenpai pharmaceutical and Chenxin pharmaceutical, accounted for about 40% Beijing New Pharmaceutical Co., Ltd has filed the reference preparation of voglibose tablets in July 2016, but as of September 10, 2017, Chenxin Pharmaceutical Co., Ltd and chenpai Pharmaceutical Co., Ltd., which have a large market share, have not been filed yet, and Beijing New Pharmaceutical Co., Ltd is expected to take the lead in the conformity evaluation of generic drugs In 2016, the market size of metformin in China was about 4 billion There are many manufacturers of metformin, but at present, most of the shares are still occupied by foreign-funded enterprises Squibb, with a market share of 82% in 2016 According to the data of drug clinical trial registration and information publicity platform, as of October 16, 2017, yuekang Pharmaceutical Co., Ltd and Boya biology Co., Ltd have completed the be test in January 2017 and August 2017 respectively, and a number of enterprises such as Sihuan Pharmaceutical Co., Ltd., Zhengda Tianqing Pharmaceutical Co., Ltd and Deyuan Pharmaceutical Co., Ltd are conducting the be test How to squeeze the raw drug market? It is not far from the first batch of generic drug conformity evaluation, according to relevant enterprises, the first batch will be released around New Year's day At the policy level, the bidding rules issued by Gansu Province show that its bidding will adopt the same way as innovative drugs, and adopt the form of joint negotiation between provinces and cities In a practical sense, through consistency evaluation, it means that the national level will endorse the consistency of its quality and efficacy with the original research Compared with the original research, the products through the consistency evaluation of generic drugs have the characteristics of "high cost performance", that is, the quality and efficacy are consistent with the original research, and the price is much lower There is no doubt that the consistency evaluation of generic drugs is a good thing for both the industry and the society as a whole, which can be said to be beneficial to the country and the people Moreover, in the current era of continuous pressure on medical insurance funds, the widespread use of generic drugs is the general trend In this regard, the enterprises that are about to pass the consistency of generic drugs should lay out ahead of time, take advantage of the consistency evaluation of generic drugs to seize the market How to snatch? First of all, from the policy level, both the industry and the enterprises should call on the provinces to support the enterprises that pass the conformity evaluation of generic drugs in the bidding process, so as to better guide the enterprises to carry out the conformity evaluation of generic drugs Secondly, from the perspective of communication, enterprises need to make great efforts in doctors and patients to form the concept that the products evaluated by the consistency of generic drugs are more cost-effective than the original drugs As far as enterprise operation is concerned, relevant departments of enterprise market should formulate corresponding communication themes for doctors and patients, and carry out consistency evaluation of generic drugs promotion Because although the industry of generic drug consistency evaluation is saying every day, as we all know, doctors and patients may not know it, so enterprises should make full efforts to spread these two groups and educate them through different channels Third, from the perspective of market, generic drugs with high cost performance and consistent evaluation should be the first choice for bidding in all regions, forcing the price reduction of original research drugs, completely changing the past global patent expiration of original research drugs, and the market share of developed countries has been occupied by generic drugs, but still occupying the main market share in China It is necessary for enterprises to promote the industry to form a correct atmosphere of market rules Under the premise of the consistency evaluation of generic drugs, it should be the general trend for generic drugs to replace the original research drugs In the future, it can be seen that with the listing of generic drugs, high price original research drugs must be reduced or lost in China Market scale top 20 oral solid preparations progress of generic consistency evaluation