Polypeptide drugs are important prevention, diagnosis, monitoring and treatment drugs in the 21st century. They are a kind of compounds made of several amino acids linked by peptide bonds, widely exist in organisms and play an important role in biological activities in various cells.

In the field of medicine, peptide drugs are mainly used to treat cancer, cardiovascular disease, immune metabolic diseases, blood diseases, infectious diseases, and also have significant effects on pain relief, memory loss, and mental disorders.

"Troika" drives the market: rare diseases, tumors and diabetes

The international large varieties of polypeptides have expired one after another, which has stimulated the outbreak of demand for polypeptides. At present, the global peptide drug market has exceeded 20 billion US dollars, with a small overall scale, but maintained a long-term high-speed growth. In recent years, the number of approved and clinical peptide drugs has increased, and at the same time, a number of heavyweight patents have expired. In the future, a large number of new peptide drugs and generic drugs will be listed, which will promote the further growth of the global peptide market. In particular, protein drugs are gradually accepted by doctors and patients, and polypeptides as therapeutic drugs have attracted more and more attention of pharmaceutical giants.

Chronic disease treatment is the core market of peptide drugs, accounting for more than 75% of the global peptide drug market. Rare diseases, tumors and diabetes are the "troika" driving the peptide market. It is reported that 2014-2019 is the peak period of patent expiration for peptide heavyweight drugs, such as galatiride, exenatide and lilalutide, etc., and generic pharmaceutical companies will be approved one after another. The expiration of peptide drug patents will undoubtedly bring opportunities to many domestic generic pharmaceutical manufacturers.

According to the data of global best-selling drugs, according to the sales trend from 1997 to 2014, the compound growth rate is, while the global peptide drug market is growing faster than the overall drug market. At present, the world's best-selling peptide drugs mainly include: galatiride, lilaluptide, octreotide, leuprorelin, tripatide, goserelin, exenatide and bivalirudin.

In 2014, the sales of gratiray, lilaluptide, octreotide, leuprorelin, tripatide, goserelin, exenatide and bivalutin were US $billion, US $billion, US $billion, respectively. Among them, there are many large varieties of gratiride acetate with sales of more than 4 billion US dollars, as well as exenatide and lilaluptide, which have a significant growth trend at present.

Gratire was developed and launched by TIWA company in 1996, and the product was approved and launched in the United States in 1996 for the treatment of multiple sclerosis. In the western countries with high incidence of multiple sclerosis, the efficacy and tolerance of grantirole have been confirmed. In 2013 and 2014, the global sales of gratire exceeded 4 billion US dollars. It is a heavyweight peptide product, and also the fist product of TIWA pharmaceutical company. However, the considerable revenue of gratire also faces the challenge of generic pharmaceutical companies, and TIWA pharmaceutical company's exclusive marketing right for the drug is extended to 2014.

Local pharmaceutical companies have the opportunity, and the annual compound growth rate of peptide market isAt present, the expansion of the global peptide drug market and the mass listing of generic drugs have also brought growth impetus to the peptide Market in China. At present, China's peptide drug market is dominated by immune products, and the proportion of tumor and diabetes products is not high, so the market is not mature, still in the stage of rapid growth, with unlimited potential in the future.

The growth of peptide Market in China is much faster than that in the world. The annual compound growth rate is. With the increasing incidence of cardiovascular and cerebrovascular diseases, tumors, endocrine nutrition, metabolism and immune diseases, the growing demand for drugs will rapidly expand the overall scale of peptide drug market in China.

At present, the polypeptide drugs in the domestic market are mainly driven by large varieties. In recent years, with the continuous entry of imported polypeptide drugs into the Chinese market, in 2014, the main imported products of sample hospitals were octreotide sales of billion yuan, goserelin sales of billion yuan, leuprorelin sales of billion yuan, lilalutide sales of 1971 million yuan, exenatide sales of 19.4 million yuan, and cilalutide sales of 19.7 million yuan The sales volume of trarick is 14.92 million yuan, bivalluding is 9.48 million yuan, tripatide is 5.08 million yuan, and etibatide is 270000 yuan. In recent 3-5 years, the newly marketed products of lilalutide, exenatide, bivalirudin and tripatide all showed a high growth rate.
The top 5 importers are goserelin of AstraZeneca, octreotide of Novartis, leuprorelin of Takeda, leuprorelin of Sandoz, and lilaluptide of Novo Nordisk. The top 4 importers are leuprorelin of Beijing Bonte pharmaceutical, leuprorelin of Shanghai Lizhu pharmaceutical and Jilin Octreotide (lierning) from Changchun Yixin Pharmaceutical Co., Ltd. and octreotide (shengodin) from Shanghai first biochemical pharmaceutical Co., Ltd.

At present, the domestic peptide drugs are still in the initial stage compared with the imported products. In the future, with the expiration of the peptide patent drugs, the market growth will be more considerable.

Domestic R & D is catching up, and pharmaceutical companies will emerge in the future

According to the data of sample hospitals in 22 cities in China, in recent years, the newly listed peptide products are favorable for larupin, bivalirudin, tripartide and etibatide, among which the 3 products of larupin, bivalirudin and tripartide have increased rapidly and at an obvious speed.

Lilaluptide is the original research product of Novo Nordisk. It was approved by EU in 2009, FDA in 2010, and entered China in 2011. In 2013, the global sales of lilaluptide was 4%,At present, the good market promotion is the lilalutide of Novo Nordisk, which entered China in 2011. The drug is injected once a day. The therapeutic effect of this product is better than that of exenatide. At present, the sales of this product in China are more than that of exenatide. It can be seen that lilalutide has greater advantages than the competitive products.

According to the data of 22 sample hospitals in China, in 2014, the sales volume of lilaluptide sample hospital was RMB 1971 million, up year on year. At present, only one import company of Novo Nordisk company is selling in China. At present, the domestic enterprises that are applying are Hangzhou Jiuyuan gene engineering and Shenzhen Hanyu pharmaceutical; the import companies are Novo Nordisk compound preparation degu insulin / lilalutide injection. It's worth noting that in 2015, Novo Nordisk's lilalutide was approved by the FDA and will enter the weight-loss drug market in the United States under the trade name of "saxenda". In the next few years, Novo Nordisk's lilalutide will continue to enjoy market monopoly.

Bevaludine is the original research product of medicine company, trade name "Angiomax", which is a synthetic anticoagulant peptide drug, approved to be listed in the United States in 2000. This product is mainly used to prevent ischemic complications before and after angioplasty and interventional treatment of unstable angina pectoris. It is mainly used as an emergency medicine for myocardial infarction. In the United States, the patent of this product expired on September 23, 2010, and the patent in Europe will expire in 2015. In the future, the market scale of bevaludine will continue to expand with the expiration of the patent.

According to the data of 22 sample hospitals in China, in 2014, the sales volume of bevaludine's domestic sample medicine was 8.48 million yuan, an increase of 11% year-on-year. Only Shenzhen xinlitai Pharmaceutical Co., Ltd. was the exclusive one in China, with the trade name of "teganin". Bevaludine mainly competed for part of the market share of low molecular weight heparin sodium. At present, there are 12 enterprises applying in China, including Haosen pharmaceutical, Shenzhen Wanle pharmaceutical, Changzhou No.4 pharmaceutical, etc.

Tripatide is the original research product of Lilly company, with the trade name of "forteor". It was first approved for use in postmenopausal women with osteoporosis, male osteoporosis patients with primary or hypogonadism, and then new indications were added again - for the treatment of osteoporosis with high risk of fracture related to persistent, systemic glucocorticoid treatment. In 2011, the global sales volume of futeo reached US $billion, and in 2014, it reached US $billion, with a rapid market growth rate.

According to the data of 22 sample hospitals in China, in 2014, the sales volume of domestic sample medicine of tripatide was 5.08 million yuan, a year-on-year increase. Only Lilly, an import company, was selling the product exclusively in China. According to the domestic market situation, the market share base of the product was relatively low due to its late listing. Since 2011, the market share of tripatide has been increasing year by year. At present, the enterprises that are applying in China are: Shenzhen Hanyu Pharmaceutical Co., Ltd. and Shanghai United cell bioengineering Co., Ltd.
Etibatide is the original research product of MSD company. Its trade name is "Integrilin". It was first listed in the United States in July 1998. This product is mainly used in the treatment of acute coronary syndrome or in the support of percutaneous coronary intervention.

According to the data of 22 sample hospitals in China, in 2014, the sales volume of etibatide in China was 270000 yuan. Only one company of Jiangsu Haosen Pharmaceutical Co., Ltd. is selling in China, and there is no imported product. Judging from the domestic market situation, the market share base of the product is relatively low due to its late listing.

It is worth noting that in December 2014, etibatide of Hanyu Pharmaceutical Co., Ltd. was approved to be listed. So far, two domestic enterprises have been approved to be listed. At present, Hainan Shuangcheng Pharmaceutical Co., Ltd. is also the company that is applying for listing in China.

At present, the market of polypeptide drugs in China is still dominated by foreign brands and occupies a large share. The peptide drugs made in China are all the ones that have passed the patent protection period or have not applied for patent in China.

Most peptide drugs in developed countries are still in patent protection period. The patent protection period of these drugs will expire in the next 5-10 years, which will usher in new market opportunities for peptide generic drugs. With the rapid rise of peptide pharmaceutical enterprises in China, more and more domestic pharmaceutical enterprises will emerge in the future.

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Chengdu Shengnuo Biotechnology Co., Ltd. has "Chengdu polypeptide drug engineering technology research center" in Chengdu, mainly engaged in polypeptide, polypeptide drug and beauty peptide research. Our zero defect has passed the FDA certification, and now it has become the first-class professional peptide drug and product development, technology transfer, technical service and peptide drug industry in the scale production and export of China's parks.