Diabetes market changes! 2018 domestic competitors vs foreign leaders, who will win?

With more than 100 million diabetics in the Chinese market, China's diabetes drug market is bound to be a battleground In this market, there are not only acarbose with annual sales of more than 10 billion, but also insulin glargine with single product sales of more than 8 billion yuan More importantly, the new products will be launched one after another to further accelerate the change of diagnosis and treatment methods and market pattern 2017 is the year when new diabetes drugs came into the market in China The newly approved drugs include exenatide microspheres for injection of GLP-1 receptor agonist amylin, lisinotide injection of Sanofi, gligligliptin and metformin tablets (I) and (II) of compound gligligligligliglingham, sustained-release tablets (I), (II) and (III), SGLT 2 Engliptin tablets of the inhibitor bolingyingehan, kagliptin tablets of Johnson and Johnson, daggliptin tablets of AstraZeneca, and deguin of the long-acting insulin Novo Nordisk In the visible time, the newly launched drugs in 2017 will change the current competitive situation and market pattern of Chinese diabetes drugs According to the drugs recommended by the American Diabetes Association (ADA) medical diagnosis and treatment standards for diabetes 2018, except for bromocriptine (rapid release), pranlinide, abirotide, dulaglutide and inhaled insulin which are not listed in China, other products have been listed in China 1 pay attention! Background: in 2017, the Ministry of human resources and social security officially released the 2017 version of the national basic medical insurance, industrial injury insurance and maternity insurance drug catalog, and then the Ministry of human resources and social security issued the notice on including 36 drugs into the category B scope of the national basic medical insurance, industrial injury insurance and maternity insurance drug catalog The main changes are as follows: 1 DPP-4 inhibitors, a major class of antidiabetic drugs, have been newly included in the new drug catalog, but only for second-line drugs 2 Medium effective insulin and its analogues, premixed insulin and its analogues, animal derived long-acting insulin and protamine zinc insulin are newly classified 3 Glimepiride and acarbose were upgraded from class B to class A 4 Add gliclazide II and miglitol 5 Quinazoline diketone drugs remove the restriction of "patients who are not suitable for insulin drugs and have no effect on other oral hypoglycemic drugs" Hyperglycemia removes the limitation of "limiting severe hypoglycemia and children" 6 "Ultra short acting human insulin analogue" was changed to "short acting insulin analogue", and the restriction clause was changed from "limited to type 1 diabetes mellitus with recurrent hypoglycemia and fragile diabetes mellitus" to type 1 diabetes mellitus; other type 2 diabetes mellitus patients with short acting insulin and oral medicine are difficult to control 7 Nateglinide and repaglinide were moved to "other hypoglycemic drugs" instead of being classified as sulfonylureas 8 The GLP-1 receptor agonist, lilalutide, was included in the category B scope of the national directory of basic medical insurance, work injury insurance and maternity insurance drugs (2017 version) (hereinafter referred to as the drug directory) with the medical insurance negotiation price of 410 yuan (3ml: 18mg / piece, prefilled injection pen), and the restriction condition was "limit the patients with BMI ≥ 25 whose oral hypoglycemic drugs such as metformin or insulin control effect is not good, and It needs to be prescribed by a specialist of a medical institution at or above level 2 " Data source: ADA and Yaohai roam in China's hospital sample terminal market In 2017, the hospital terminal data was 5.9 billion yuan, only 4% higher than that in 2016 The low growth rate is expected to be in line with the start of graded medical treatment for chronic diseases in 2017 Diabetes is one of the diseases of graded medical treatment Acarbose is the largest market in the generic name of oral hypoglycemic drugs In 2017, the market sales of sample hospitals reached 10.83 billion yuan, up 6.7% from 2017 Metformin ranks the second in the market scale of oral antidiabetic drugs with a sales volume of 5.68 billion yuan in 2017, up 5.4% from 2017 The top two products are the first-line recommended drugs, which shows the influence of domestic diabetes drug guidelines Insulin glargine is the largest insulin The market sales of sample hospitals in 2017 was 8.14 billion yuan The sales volume of DPP-4 inhibitor new medical insurance company siggliptin, saggliptin, liggliptin and agliptin all achieved a growth rate of more than 30% However, due to the small sales base in 2016, no product has exceeded 2 billion yuan in the sample hospital market In 2017, the sales volume of sigletin was 1.16 billion yuan, that of sagletin was 690 million yuan, that of vigletin was 400 million yuan, and that of ligletin was 190 million yuan The market size of sample hospitals in 2017 reached 520 million yuan The sales volume of exenatide, which is in charge of marketing by Sansheng pharmaceutical, was 32.56 million yuan in 2017 The sales volume of GLP-1 receptor agonist new drug independently developed by Renhui biology in 2017 was 230000 yuan Data source: PDB database 2 domestic competitors vs foreign enterprise leaders diabetes drug market is the leading market of foreign enterprises in China The top five enterprises in sales volume are all foreign-funded or joint ventures Novo Nordisk ranked first in 2017 In 2017, the sales volume of sample hospitals in the field of diabetes was 1.42 billion yuan, up 2% from 2016 Novo Nordisk (Novo Nordisk) sells the best product, aspartic insulin (premixed), with a sales volume of 450 million yuan in 2017 The second place was Sanofi sample hospital sales of 870 million yuan, up 3% from 2016 Sanofi's best product is insulin glargine, with a market scale of 620 million yuan in 2017 Bayer ranks third with one acarbose product In 2017, the market scale of sample hospitals reached 720 million yuan, with an increase rate of 3% The dominant diabetes market of foreign enterprises is also reflected in the market of generic products with expired patents, such as acarbose, metformin, glimepiride, repaglinide, gliclazide and voglibose The expired original drugs occupy more than 50% of the market share on the basis of better quality In the case of acarbose, Bayer has 66% of the market Hangzhou, China, the United States and East China account for 29% of the market share, while Sichuan green leaf only accounts for 5% At present, none of the diabetes drugs listed in China has been approved for conformity evaluation The 289 products in the catalogue that have completed the consistency evaluation before the end of 2018 include metformin hydrochloride tablets, Acarbose Tablets and capsules, glibenclamide tablets, glipizide tablets and capsules, and glimepiride tablets As shown in the table, except for acarbose capsules, glibenclamide tablets and glipizide capsules, other diabetes products in the 289 catalog have been applied for conformity assessment by enterprises Glibenclamide tablets of Foshan derico Pharmaceutical Co., Ltd., metformin hydrochloride tablets and sustained-release tablets of Ouyi Pharmaceutical Co., Ltd of Shiyao group, metformin hydrochloride sustained-release tablets of Qingdao Baiyang Pharmaceutical Co., Ltd., Shanghai xuantai Haimen Pharmaceutical Co., Ltd and Zhejiang Haizheng xuantai Pharmaceutical Co., Ltd have been applied for production on the basis of China US double news, and have obtained priority review 。
In terms of the first generic drugs, Jiangsu Haosen Pharmaceutical Group Co., Ltd obtained the priority review of wiggletti tablets Jiangsu aosaikang and Zhengda Tianqing have all entered the self-examination catalogue In terms of domestic new diabetes drugs, Shenzhen xinlitai Pharmaceutical Co., Ltd has obtained the clinical priority review of the new ddp-4 inhibitor fugliptin benzoate tablets In 2017, Hengrui pharmaceutical launched the phase III clinical trial of SGLT 2 inhibitor henggliptin The GLP-1 receptor agonist polyethylene glycol loseptide injection independently developed by Jiangsu Haosen has applied for production and entered the major special priority review In terms of imported new drugs, the clinical application of Dula Glycopeptide Injection of Eli Lilly Asia has obtained priority review Table: data source of products for application consistency evaluation of diabetes drugs: drug hailou 3 changes the future elements Considering that diabetes drug market is a chronic disease requiring long-term medication, entering the medical insurance catalog can stimulate the growth of drug market more, and the market pattern of diabetes drugs can be more affected if the newly listed non-medical insurance drugs do not enter the medical insurance drugs in a short period of time In 2018, the main focus of the diabetes drug market is: 1 Whether the new products entering the medical insurance can maintain high-speed growth, and how much impact on the drugs already on the market 2 in 2018, which diabetes drugs have been approved for consistency evaluation, and whether the approved products can change the current situation that expired original research drugs account for half of the total How soon can the newly approved diabetes drugs enter the dynamic adjustment catalogue of medical insurance.