Breaking through the iron curtain of giants, how can local pharmaceutical companies "snatch back" the diabetes market?

Drastic changes in lifestyle and aging population over the past decade have accelerated the spread of diabetes According to statistics, there were 425 million diabetics in 2017 The incidence rate is as high as 8.8% (20 to 79 years) Among all countries, China has the heaviest burden of diabetes, with the number of patients (114 million) accounting for nearly 27% of the world's total, ranking first in the number of global diabetes patients In 2017, the global diabetes market reached US $77.5 billion, and it is predicted that this number will further increase to US $202.4 billion in 2022 According to the prediction of China industry information network, the total market size of China in 2022 will be close to 43.7 billion US dollars Therefore, it is necessary for China to occupy a place in the diabetes drug market At present, the competition of diabetes market is very fierce Traditional insulin is still the largest market share, accounting for about half of the market The rest were divided by DPP-4 inhibitor (dipeptidyl peptidase 4 inhibitor) (21%), GLP-1 receptor (glucagon like peptide-1) agonist (17%) and SGLT2 inhibitor (sodium glucose cotransporter 2) (6%) According to the data of prospective industry research institute, at present, the global diabetes market is dominated by four giants - Novo Nordisk, Lilly, Sanofi and Merck Their combined market share is about 72% Novo and Nord are innovative biopharmaceutical companies focused on diabetes and obesity drugs It has the widest range of diabetes products and its diabetes business accounts for 81% of the company's total revenue in 2017 Of all types of drugs, insulin is the largest category, accounting for about 70% of the total, followed by GLP-1, accounting for 26% Lilly, another diabetes giant, came second last year Its main product is recombinant insulin, which is currently the highest sales volume in this field In second place was their blockbuster, truccity, a long-acting GLP-1 receptor agonist injected once a week Last year, this has become one of the main driving forces for Lilly's growth Sanofi Sanofi's leading position in the diabetes market is mainly from its insulin product Lantus (insulin glargine injection) Sales began to decline rapidly as Lilly launched its Lantus imitation To maintain its market position, Sanofi has developed a new Lantus formula, toujeo In 2017, toujeo generated a total of $951 million in revenue Merck's diabetes product line is relatively simple Its main products are metformin and sigletin, among which sigletin is the first DPP-4 inhibitor in the world Since its birth, this star DPP-4 inhibitor product has brought huge revenue to Merck In the third year of listing, its annual revenue has exceeded 1 billion US dollars However, in the face of expiring patents and new GLP-1 drugs, sales of cigliptin began to decline in 2017 In contrast to the global market, insulin and oral antidiabetic drugs occupy the majority of China's diabetes market So far, due to the influence of medical insurance and medication habits, new drugs have not been favored But in recent years, the situation is also changing, especially with the acceleration of drug import approval process, expiration of imported drug patents, and medical insurance reform, a new wave of diabetes drugs will gradually appear and further change the market structure of China With the issuance of the national basic medical insurance, work injury insurance and maternity insurance drug catalogue (2017 version), 36 kinds of diabetes drugs have been listed In general, there are several new bright spots: recombinant human insulin (short-term effect, premixed), glimepiride and acarbose have been increased from class B to class A; insulin analogues (short-term effect, premixed), gliclazide II, migliol, migrainet calcium and DPP-4 inhibitors (agliptin, gliptin, shagliptin, wiggliptin and siggliptin) have been newly included in class B of medical insurance; The use limits of pioglitazone and rosiglitazone were removed; the use limits of long-acting insulin analogues were changed; the ultra short acting insulin analogues and α - lipoic acid were removed from the medical insurance catalogue These changes will greatly affect the structure of China's diabetes market, because the success of any drug in the domestic market, entering the medical insurance catalog is undoubtedly a very important step, which will stimulate market demand and obtain greater market share But foreign pharmaceutical companies still dominate the Chinese diabetes market Last year, the top five diabetes market share were Novo Nordisk, Sanofi, Bayer, BMS and Lilly Among them, Novo Nordisk accounts for more than 25% of the total market share The competitiveness of domestic pharmaceutical industry is relatively weak So far, only glimepiride tablets (Yousu) and metformin tablets of Guangzhou Hairui Pharmaceutical Co., Ltd of Yangtze River Pharmaceutical Group have passed the consistency evaluation, and acarbose, the oral hypoglycemic drug with the largest market share, has not yet taken action [1] Although more than 60% of drugs have not started conformity assessment, this stagnation will change as the new health insurance policy is pushed forward At present, the domestic market of DPP-4 inhibitors has been occupied by imported crude drugs, and the domestic pharmaceutical companies are still struggling to find a breakthrough However, major international pharmaceutical companies have focused on upgrading their products and actively developed long-term DPP-4 inhibitors Therefore, the gap between domestic and international pharmaceutical enterprises is very obvious In the competition of DPP-4 inhibitors, regolitine of Hengrui pharmaceutical has been in the leading position in China Despite the withdrawal of class 1.1 new drug application from CFDA in 2016, a series of phase 3 and multiple phase 1 clinical trials of regolitine have not stopped Compared with other competitors, it is expected to become the first approved self-developed DPP-4 inhibitor in China In addition, dbpr108 of Shiyao group, egletin of LVYE pharmaceutical and egletin of xuanzhu pharmaceutical are all in phase I clinical trials GLP-1 GLP-1 agonist has the characteristics of strong hypoglycemic effect, weight loss, low risk of hypoglycemia and possible cardiovascular benefits Many Chinese pharmaceutical companies have high hopes for this business As a rising star in the pharmaceutical industry, Jiangsu Haosen put forward the application for listing peg loxenatide on December 6, 2017 It is a class 1 Chemical developed by Jiangsu Haosen It is a long-acting GLP-1 receptor agonist and is intended to be used in single drug or combined with metformin to treat type 2 diabetes The product only needs to be injected once a week At present, the GLP-1 receptor agonists approved for marketing in China are all short-acting preparations, which are exenatide (twice a day), lilalutide (once a day), benalutide (three times a day), lisnertide (once a day) Rosenatide of hausen is the first long-acting GLP-1 receptor agonist applying for marketing in China, with huge advantages Other notable references in GLP-1 include Hangzhou Hongyun Huaning Biomedical Engineering Co., Ltd (Gmax biopharm) and Huadong Pharmaceutical Co., Ltd Competition in this area will become more intense in the future The main domestic enterprises of insulin industry in China are Ganli pharmaceutical, Haizheng pharmaceutical, Yichang Changjiang pharmaceutical, Wanbang pharmaceutical, etc Ganli pharmaceutical, Jiangsu Wanbang and Zhuhai Federation are carrying out consistency evaluation In terms of product categories, most domestic companies focus on human insulin and its long-term formula However, some enterprises have begun to research and develop insulin lysine, insulin glargine, insulin asparagus and various premixes Gradually, more and more drug companies are joining in the fierce competition of diabetes Sglt-2 sglt-2 is a new type of diabetes treatment target, and also a hot spot in the field of diabetes research The mechanism of action is to specifically inhibit the reabsorption of glucose by the kidney, and excrete the excess glucose from the urine As a rising star in the global diabetes market, many international pharmaceutical companies are stepping up their efforts in this area, but only a few Chinese pharmaceutical companies are involved In June last year, Hengrui took the lead in carrying out the phase III test on its independently developed henggelinet Jiaglijing of xuanzhu medicine, rongglijing of dongyangguang medicine and tagglijing of Tianjin Pharmaceutical Research Institute are all in phase I clinical trials From the current situation of new drug research and development in China, it is not difficult to see that Hengrui has taken the lead in the research and development of oral diabetes drugs in China Once a series of drugs are successfully listed, they can also compete with international pharmaceutical companies with price and policy advantages [1] Https://baijiahao.baidu.com/s? Id = 1615051591335203708 & Wfr = Spider & for = PC [2] there are many data collection and snowballs, Medicine intelligence network and medicine magic cube are not marked one by one.