The domestic prostatic research drug Tamsulosin market is maturing

With the continuous investment in drug research and development in major pharmaceutical companies around the world, new drugs for the treatment of benign prostatic hyperplasia are constantly replenishing the market. Despite the large variety of therapeutic drugs, the medical market is dominated by α1-adrenoreceptor inhibitors, 5α-reductase inhibitors, androgen receptor antagonists, and botanical drugs.

Steady growth
In the market for more than 50 drugs for the treatment of benign prostatic hyperplasia, the α1-adrenergic receptor inhibitors tamsulosin, terazosin, alfuzosin and doxazosin are in the forefront, and 5α-reductase inhibition The agent and the androgen receptor antagonists finasteride, eric androzine, dutasteride and the like occupy the main market. Although plant drugs have more varieties and fewer side effects, they can only occupy about 20% of the shares because they are slower than chemical drugs.

According to a recent foreign medical market research report, global sales of prescription drugs for benign prostatic hyperplasia have fluctuated between 4 billion and 5 billion US dollars. In 2006, 6 of the top 500 drugs sold worldwide were Benign prostatic hyperplasia drugs, the market totaled 4.291 billion US dollars, an increase of only 5.02% over the previous year. Due to the sales of products, only increased to 4.306 billion US dollars in 2007, α1-adrenergic receptor inhibitors accounted for 4 points. Three markets, of which tamsulosin has occupied half of the river market against the benign prostatic hyperplasia market.

According to the data provided by the Information and Drug Administration of the State Food and Drug Administration (SFDA), in 2007, the urinary system medication in the sample hospitals of 16 cities in China was 494 million yuan, an increase of 17.87% over the previous year, of which about half of the prostate drugs were used. In 2007, anti-prostate hyperplasia drugs increased by 10.71% compared with the previous year, and the drug varieties showed a highly concentrated situation. The top 6 varieties of sample hospital sales were finasteride, tamsulosin, and more. Sarazosin, ubiquitin, terazosin and eprilate, these six major varieties account for more than 90% of the prostate drug use, of which the first place is finasteride, accounting for 42%, while the third generation is long The α1-adrenergic inhibitor tamsulosin ranked second, accounting for 21.73%. It is estimated that the total amount of prostate drugs in the country is about 2 billion yuan, and the overall growth is slow.

The original research drug is growing well
Tamsulosin is a third-generation superselective long-acting alpha1-adrenergic inhibitor, also known as tamsulosin. The drug was successfully developed by Japan's Yamauchi Pharmaceutical Co., Ltd., and was approved by the FDA in July 1992. The trade name is "Harnal". After the integration of global business in Japan's Yamauchi Pharmaceutical and Fujisawa Pharmaceuticals, it is now a product of Astellas. After the listing of Tamsulosin, Germany's Boehringer Ingelheim and Abbott USA jointly developed a global market. In 1997, it was approved by the US FDA and listed under the trade name "Alna/Flomax".

In 2003, global sales of the three companies' products were $2.640 billion, more than double the number at the beginning of the century. Sales in Yamauchi, Boehringer Ingelheim and Abbott were 9.20, 9.96 and $724 million, respectively. With the promotion of the products, the market of Tamsulosin is maturing. In 2007, Boehringer Ingelheim's Flomax sales were 1.281 billion US dollars, an increase of 10.62% over the previous year; Anstel's Harle sales were 1.126 billion US dollars, an increase of 3.78% over the previous year. In the past four years, the average growth rate of Tamsulosin was about 6%.

From the performance of Tamsulosin of Boehringer Ingelheim and Abbott, both varieties showed a wave of development, and after the Zui reached a steady growth in the global market. In 2007, tamsulosin occupied half of the antiprostatic hyperplasia drugs. It is expected that Tamsulosin will continue to dominate in the next few years.

National products are maturing
Tamsulosin is a high-priced drug in the prostate drug market in China. In 1996, Tamsulosin Sustained-release Capsules in Shenyang Mountain were listed and distributed in China and obtained administrative protection in China. Tamsulosin Sustained-release Capsules developed rapidly in similar products, and its competitive momentum is strong in the domestic market. The share of the company has risen steadily and has entered the national essential medicines catalogue.

In March 2004, Harle’s administrative protection period ended in China. After that, the domestic tamsulosin bulk drug and its sustained release capsule were successively approved for production. In 2002, Zhejiang Hailisheng Pharmaceutical Co., Ltd. obtained the production approval, and the trade name was “Qisuo”. Subsequently, Jiangsu Hengrui Medicine, Kunming Jida Pharmaceutical, Zhejiang Kangenbei Pharmaceutical, Shandong Lunan Beite Pharmaceutical Co., Ltd. produced 5 raw materials and their sustained release preparations. In 2008, they issued the raw materials for Wushang Cihang Pharmaceutical in Hengshui City, Hebei Province. Production approval.

According to statistics from 16 national sample hospitals in China, the amount of Tamsulosin used in medicine has reached 36.72 million yuan in 2005, an increase of 23.37% in 2006. In 2007, the state adjusted the price of tamsulosin to slow down the increase in drug use. The amount of drug used was only 6% higher than the previous year, but it still ranked second in anti-prostate hyperplasia drugs, and the sales amount reached 48 million yuan. The share occupied exceeds 20%.

According to statistics from the China Pharmaceutical Business Association, the wholesale market of Tamsulosin has exceeded 100 million yuan. From the proportion of Tamsulosin in the domestic market in recent years, the share of domestically produced drugs is growing year by year, forcing the possession of imported drugs. The rate has been declining. Harle has dropped from 95% in 2005 to 92% in 2006 and 90% in 2007. Statistics from the first quarter of this year show that Harle’s share is 88%.

Among the domestically-made medicines, Zhejiang Qi Lisheng’s “Qi Suo”, Yunnan Kunming Jida Pharmaceutical’s “Jumbo Bent”, Hangzhou Kang Enbei’s “Bei Tan” and Jiangsu Hengrui Medicine’s Tansuo Luoxin occupied 4 12% share. Under the factors of equal quality and equivalent efficacy and relatively low price, the market share of domestic tamsulosin sustained-release preparations has increased steadily.

Prostatitis and benign prostatic hyperplasia are conditions in which men have a higher incidence. In recent years, the incidence of prostate diseases in China has increased year by year. At present, there are 30 million benign prostatic hyperplasia patients in the urban population, which is a very large market for elderly male patients. Under the favorable factors of the gradual improvement of the medical level and the continuous emergence of new drugs, the market for benign prostatic hyperplasia drugs is still expanding.

Prostatic hyperplasia
(Reporter Chen Guodong) Recently, the fourth session of benign prostatic hyperplasia health education activities, experts of the Chinese Medical Association pointed out that the incidence of benign prostatic hyperplasia has increased year by year, has become a major disease affecting the health of the elderly.

In order to improve the health awareness of older men, improve the quality of life of the elderly, to promote, promote, popularize, and knowledge of benign prostatic hyperplasia (BPH) diseases. The Chinese Medical Association Urology Branch and Anstelai have long-term cooperation, and a large-scale benign prostatic hyperplasia health education activity is held in 17 cities nationwide. The activity will be used by urologists to educate older men about benign prostatic hyperplasia in areas designated by the Institute of Urology.

Benign prostatic hyperplasia is a common disease in men and middle-aged men, and about half of men over the age of 50 develop clinical symptoms. As the age increases, the incidence increases gradually. During the period of 60 to 79 years old, the incidence rate is greater than 60%; men over 80 years old have an 80% chance of suffering from this disease. The hyperplastic prostate squeezes the urethra, causing a series of symptoms of urinary dysfunction, such as urinary urgency, weak urine flow, urinary incontinence and other dysuria. These symptoms seriously affect the quality of life of patients. If left untreated, it will cause many serious complications and even endanger the lives of patients.


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