Big market ignored! Understand the gold digging opportunities of enterprises in the heavy drug area of urinary system

According to Chinese urological disease diagnosis and treatment guidelines 2014 edition, urological diseases are divided into: tumors mainly include: renal cell carcinoma, bladder cancer, prostate cancer, testicular cancer and penile cancer; stones; prostatic hyperplasia and voiding dysfunction are mainly divided into: benign anterior adenohyperplasia, neurogenic bladder and overactive bladder; finally Is the urinary system of some infections Because tumor drug is a special field of drug use, calculus is mainly treated by surgery, urinary tract infection is a routine anti infection drug program, so the urinary system drugs discussed in this paper are mainly focused on the third kind of drugs, that is, prostate hyperplasia and urinary dysfunction When Chinese people talk about urinary system medicine, they always think of the overwhelming men's Hospital of Putian department They started in this field and made huge profits in this field Advertising bombing and false propaganda make the drug use in this field out of the scope of rational science However, from the epidemiological perspective, BPH, overactive bladder and urinary incontinence are not only high incidence rate, but also seriously affect the quality of life According to the epidemiological data published in 2011, the prevalence of overactive bladder in China was 6%, of which 6% were women, 5.9% were male and the incidence rate was higher in people over 40 years of age Although the disease is small, there are also heavy drugs However, from the current situation of R & D application, domestic pharmaceutical companies are really indifferent to this market 1 [clinical demand] incidence rate TOP 3 disease benign prostatic hyperplasia benign prostatic hyperplasia (BPH) is a common progressive disease, which can significantly affect the quality of life of middle-aged and elderly men Clinical treatment of BPH includes drug treatment and surgical treatment For the majority of patients who do not reach the surgical indications, drug therapy is the main treatment At present, the cause of BPH is not clear, the vast majority of the views are that there are two necessary conditions for the occurrence of BPH - aging and functional testis At present, the mechanism of BPH is not clear, which may be caused by the balance of proliferation and apoptosis of epithelial and stromal cells BPH is characterized by hyperplasia of interstitial and glandular components of prostate in histology, enlargement of prostate in anatomy, obstruction of bladder outlet in urodynamics and symptoms of lower urinary tract At present, the drug treatment of BPH mainly includes α receptor blocker, 5 α reductase blocker (5ari), M receptor blocker and plant preparation Neurogenic bladder neurogenic bladder is the lower urinary tract dysfunction caused by the disorder of nerve control mechanism, which can be diagnosed only on the premise of neuropathy All diseases that may affect the neuroregulation of urinary storage and / or micturition may cause bladder and / or urinary tract dysfunction There is no reliable statistical data for the correlation between the clinical manifestations of neurogenic bladder and the location and degree of nerve injury Physical therapy is mainly used, and the effect of single drug treatment is limited Only combined treatment can achieve the maximum effect At present, the drugs in this field mainly include: M receptor blocker, α receptor blocker, α receptor agonist, desmopressin, etc Overactivity of bladder is a kind of syndrome which is composed of urgency of urination, frequency of urination and urgency of incontinence Often accompanied by frequent urination and nocturia symptoms, with or without urgent urinary incontinence, no urinary tract infection or other clear pathological changes At present, M receptor blockers are commonly used in the treatment, mainly tolterodine and solinacin (click the picture to enlarge) 2 ["heavy bomb"] the varieties for layout consistency evaluation according to the relevant data of punctuation medicine information, in 2013, the market of prostate disease medicine in China was about 4.127 billion yuan, while the compound annual growth rate from 2009 to 2013 was 15.06% It can be inferred that in 2016, the market of prostate disease drugs was about 6 billion yuan, of which the sales of chemical drugs accounted for about 45%, and the proportion of Chinese patent drugs accounted for about 55% The sales volume is larger: finasteride, tamsulosin, doxazosin, propranolol and terazosin Finasteride and tamsulosin account for more than 70% of the total prostate drug market, which is a typical oligopoly market Finasteride consistency evaluation investment opportunity big finasteride tablet (trade name: baoliezhi), developed and produced by mosadon, was approved by FDA in 1992 for BPH treatment, and approved to be listed in China in 1994 In the domestic market, 31 finasteride generic tablets and 9 capsules have been approved for marketing These generic drugs were approved in this stage from 2003 to 2005 After 2005, according to Xianda data v3.2, no other manufacturers applied for the product At present, 33 manufacturers are selling the product in the market According to the sales data, mosadong's finasteride still accounts for more than 90% of the domestic market, 33 domestic manufacturers compete for the remaining 10% of the share, and the highest share of domestic manufacturers accounts for about 1% of the whole finasteride market, which shows the serious mismatch between the number of sales manufacturers and the sales market Although the product is not included in the 289 list of conformity assessment, it has been on the market for more than 20 years in China and is still under the full control of the original research institute If an enterprise has relevant strategic vision and prepares the conformity assessment in advance, it may shake the current situation of the market in the future Tamsulosin is expected to compete with the original drug Tamsulosin (also known as tamsulosin) was developed by Yamauchi pharmaceutical company of Japan (the company later became part of Astaire) In July 1992, it was approved to be listed by the FDA, and the trade name was "hannal" The patent in the United States expired in 2009 Therefore, in 2010, generic drugs were approved to be listed in the United States In March 2004, the administrative protection period of Halle in China ended After that, domestic tamsulosin APIs and sustained-release capsules were approved for production In 2002, Zhejiang hailisheng Pharmaceutical Co., Ltd obtained the production approval document with the trade name of "qisuo" Subsequently, Jiangsu Hengrui Pharmaceutical Co., Ltd., Kunming Jida Pharmaceutical Co., Ltd., Zhejiang Kangenbei Pharmaceutical Co., Ltd and Shandong lunanbeite Pharmaceutical Co., Ltd produced APIs and sustained-release preparations In addition to the approved production of the five enterprises, Fujian golden age, Beijing South Korea and the United States, and Shenzhen Wanhe are still applying for the imitation of the product According to the relevant IMS data, Astaire's Harold occupies about 60% of the market share of the whole tansolosin market, followed by Kunming Jida and Zhejiang hynixon, with about 15% of the market share From the perspective of the bid price, the price of domestic drugs is about 70% of the original research Tansorosin belongs to the 289 list of consistency evaluation If the domestic manufacturers pass the consistency evaluation, through the reduction of prices and the support related to policies, they can compete with the original research The future market of doxazosin is more considerable Doxazosin was developed by Pfizer and was approved by FDA to be listed in the United States in 2005 At present, in China, 10 manufacturers of doxazosin tablets have obtained production approval, while only Pfizer and Hefei cube pharmaceutical have obtained relevant marketing approval According to IMS related data, in addition to the original research, there are only 8 domestic manufacturers in the production of this variety Pfizer occupies 95% of the market share, and Hefei cube, which is completely consistent with the original research formulation, ranks the first in China, accounting for about 4% of the market share After 2010, there are still six manufacturers applying for the imitation of the product, among which Beijing Honglin pharmaceutical and Sinopharm group Guorui pharmaceutical apply for the slow-release dosage form, while other manufacturers still apply for the ordinary dosage form Doxazosin is not on the list of consistency evaluation, but for Hefei cube, if it can pass the consistency evaluation, the future market will be more considerable Solinax, the first imitator of solinax, is developed by Yamauchi company of Japan and listed by three companies in the world, anstar, GlaxoSmithKline and TIWA The product was first launched in Europe in 2004 and entered the United States in 2005 It has become the fastest growing drug in the U.S market In China, solina was approved to be listed by Estelle in 2009, with a sales record of 8 years At present, none of solina has been approved to be listed in China The imitators of this product are all applying for imitations from 2014 to 2015, with a total of 10 manufacturers, which should be in the be stage at present The first one approved in the future can be called the real first imitation 3 [project approval thinking] today's short board is tomorrow's opportunity 1 The market is not small, and there are few people who pay attention to it Compared with the hot research fields such as anti-tumor and hepatitis C, the research and development of new drugs for urinary system diseases is not good in China According to Xianda data v3.2, at present, there is only one class 1.1 new drug application in this field in China, that is, fudanafei tablet of Shandong xuanzhu Pharmaceutical Technology Co., Ltd., and there is no relevant new drug application for drugs with the same mechanism of action, only relevant imitation From the perspective of market data and relevant epidemiological data, the scale of urinary medicine market is not small, but from the perspective of application data, domestic enterprises pay little attention to this field In addition to the imitation of heavyweight drugs, the related studies are stagnant There is no company in China that specializes in the development of urinary tract medicine like Estelle If there are companies in China that want to make efforts in this field, they can pay attention to the product line and development track of Estelle 2 The original research is unique: it is a good opportunity for consistency evaluation At present, the urinary market is still controlled by the original research drug If the relevant imitation enterprises seize the opportunity of consistency evaluation, it may break the original research's unique situation in the future It can be seen from the market data that, although the products of several best-selling drugs in the market have entered China for decades, the original research still has a very strong control over the market It is speculated that this situation should be related to the marketing configuration of the enterprise However, the consistency evaluation of generic drugs is actually better than that of high-quality generic manufacturers If the consistency evaluation can be arranged earlier and the academic promotion is reasonable, further market expansion in the future should not be too difficult 3 Market chaos: standardized market can bring huge space to face high R & D cost and capital cost, and crude Chinese patent medicine and health care products seriously disrupt the market in this field As we all know, pharmaceutical companies one day