Analysis of the global best-selling drug Top50 and domestic competitors in 2014

Source: Medical Economics Report October 23, 2015 according to the statistics of evaluatepharm, the total sales volume of the top 50 best selling drugs in the world in 2014 reached US $215718 million, accounting for 27.62% of the total market volume of prescription drugs and OTC drugs in the world, which has increased compared with 2013, and the proportion has remained above 27% in 2010-2014 Among them, the top ten accounted for 10.77% of the total drug market, which was lower than 10% since 2012, 9.71% and above 10% in the past years It can be seen that the top 50 global best-selling drugs have a huge impact on the world drug market pattern Influenced by many factors, the market leading position of traditional heavyweight drugs is weakening, and the contribution rate of best-selling drugs to global sales is declining The 50th drug in the list is zytiga, with sales of $2.237 billion in 2014, which is also the threshold of the top 50 best sellers in 2014 Since the threshold fell to $1.981 billion in 2011, it has returned to the benchmark of $2 billion in 2014 The top 10 best selling drugs ranked in 2014, with a total sales volume of 84.167 billion US dollars, accounting for 39.14% of the top 50, up from 2013 The ranking of the top ten drugs in 2014 was severely shaken by the addition of sovaldi Suvaldi (sofosbuvir), Gilead's new anti HCV drug, was approved for marketing in the United States at the end of 2013, and then approved for clinical use in the European Union in January 2014 This is the world's first pure oral anti HCV drug Its global sales reached US $10.283 billion in 2014, ranking second in the list, with a growth rate of 7275% compared with 2013 Since 2012, Sumerian has been ranked the top for three consecutive years, with sales of US $12.89 billion in 2014 Thanks to the seventh indication and price increase approved by FDA recently, Sumerian's global sales in 2014 increased by 17% over the previous year Because of its large sales base, xiumeile's absolute increase in 2014 compared with 2013 was as high as $1876 million, which is equivalent to the sales of a heavy product The birth of sovaldi made other drugs on the list move backward one by one, among which Seretide, GSK's asthma treatment drug, dropped more, from the 4th to the 72014th, with global sales down 15% year-on-year The decline of sales of seretide is mainly due to the pressure of generic competition and clinical substitutes Mylan has launched the first imitation product of seretide in the UK market for adult asthma patients In the field of asthma and COPD treatment, competition from alternative products such as AstraZeneca's symbiort and mosadong's Singulair also poses a great threat to Seretide, which leads to its market share being gradually swallowed up II The development of biomedical technology has made more breakthroughs in the treatment of diseases In recent years, the growth of biomedical industry has been leading the development of the industry After Lipitor, the best-selling drug was Semel, which became the first biological drug with annual sales of more than 10 billion dollars In 2014, there were 22 biotech drugs among the top 50 drugs in the world, creating a market value of 105.824 billion US dollars, accounting for 49.05% of the sales, accounting for half of the total Among the top 10, there are 7 biotech drugs, accounting for 71.84% of the total sales Biotech drugs have occupied a leading position, among which Enbrel and Lantus are biotech recombinant products, while Humira, REMICADE, rituxan, Avastin and Herceptin are all monoclonal antibodies However, most of these biopharmaceuticals will lose their exclusive market position due to the loss of patent protection in 2020, and will face fierce competition from biological analogues According to the sales forecast in 2020, the market share of other Biopharmaceutics has declined, except that Sumeria has barely kept the market stable Sanofi's arrival fell by 9% because in 2015, basic insulin will face competition from Lilly bio similar drugs in Europe By 2020, the sales volume of lektron will decrease by 5% In 2013, the EU approved remsima from celltrion in South Korea and infactra from hospitara in Illinois, which are two imitated versions of infliximab This is the world's first bio imitated monoclonal antibody, which has a great impact in the industry This also means that the products of Johnson & Johnson and MSD will be directly exposed to the competition of biological similar drugs 3 In terms of the top 50 best-selling drugs in 2014, Johnson & Johnson has the largest number of products in the top 50 best-selling drugs Amgen and Pfizer were shortlisted for 5 varieties respectively, followed by Novartis, Roche and Merck with 4 each, Sanofi, AstraZeneca and Gilead with 3 each (IV) the distribution of the treatment fields of the best-selling drugs from the treatment categories of the top 50 best-selling drugs in 2014, the best-selling drugs quickly cut into the cancer field with the highest prevalence from the traditional high cholesterol and high blood pressure fields; Cancer, arthritis, diabetes, respiratory system are the areas with high incidence rate This is also consistent with the best selling drug treatment category The only exception is bacterial infection Although the incidence rate is not low, antibiotics are not on the list Among the top 50 best selling drugs in the world in 2014, the total sales volume of cancer treatment drugs reached US $41.477 billion, becoming the best-selling drug category Next is the arthritis medicine, the diabetes medicine, the respiratory system medicine, the blood system medicine Adalimumab was approved to treat rheumatoid arthritis in China as early as 2010 It was officially listed in China at the beginning of August 2010 In 2013, CFDA approved it to relieve the related symptoms and symptoms of patients with active ankylosing spondylitis (as) According to the data of sample hospitals of Nanfang Institute, in 2014, the sales scale of adamumumab in sample hospitals of 16 cities in China reached 20.51 million yuan, a year-on-year increase of 9% Adalimumab is only imported in China, and xiumeile is in a monopoly position In 2015, two enterprises applied for adalimumab injection and two kinds of biological products for treatment, which are in the stage of clinical trial application With the scale of bioengineering industry in China and the mature technology of antibody drugs, it is believed that the emergence of adalimumab products in China will not be too far away 2 in October 2012, the Enbrel patent expired, but Amgen won a new patent, which can extend the Enbrel patent protection to 2028 The patent (European standard) for the composition of the Enbrel bionic drug will expire in 2015 Cipla of India has announced the launch of Enbrel's first bio generic drug in 2013, which will be produced by CP Guojian Pharmaceutical Co., Ltd in Shanghai, China Samsung bioepis has also developed and produced Enbrel's biological analogues to open up the European market According to the data of sample hospitals in 2014, the sales volume of etanercept reached 20.4 million yuan, a year-on-year increase of 24% At present, China's enri generic drugs include CITIC Guojian's "yisaipu" and SAIJIN's "qiangke" The two drugs were approved in 2005 and 2011 respectively Ambarox (recombinant human tumor necrosis factor receptor type II antibody fusion protein for injection) of Haizheng Pharmaceutical Co., Ltd has completed the on-site inspection of product registration in early 2015, and has now entered the stage of three in one comprehensive evaluation There are also other manufacturers in China that have applied for the biosimilars of etanercept Rosuvastatin "Keding" is the antilipidemic drug of AstraZeneca, which has entered the Chinese market since 2007 "Determinable" patent will expire on January 8, 2016 In China, the incidence rate of cardiovascular diseases has been increasing significantly in recent years Rosuvastatin calcium is promising in China Because of the patent protection scope that can not be covered by China, no matter whether rosuvastatin calcium raw material or preparation is patent protected, there is no patent protection problem As of October 20, 2015, there were 25 CFDA approved approval documents for rosuvastatin calcium products, involving 11 local enterprises such as Zhejiang Jingxin Pharmaceutical Co., Ltd and Lunan Beite Pharmaceutical Co., Ltd., among which 6 obtained production approval documents for APIs, 5 obtained production approval documents for preparations, including capsules and tablets From 2014 to October 2015, there were 47 applications involving rosuvastatin According to the statistical analysis of the punctuation information sample hospital database, the domestic sales of rosuvastatin increased by 37% year on year in 2014 From the perspective of the sample hospital market, AstraZeneca's original research drug "Keding" accounts for 76.51% of the market share, followed by Shandong lunanbeite, which accounts for 10.05% of the market share, and its proportion with manufacturers is less than 10% 4 aripiprazole is a new atypical antipsychotic developed by Otsuka Pharmaceutical Co., Ltd in Japan Its patent protection in Europe has expired In April 2015, its patent in the United States expired The imitations of TIWA and Apotex pharmaceutical hit the market In 2006, aripiprazole of Otsuka pharmaceutical entered the Chinese market and was listed under the trade name of "anlufan" In 2014, the annual sales volume of aripiprazole drug market in sample hospitals was about 66.48 million yuan, an increase of 16% year on year Chengdu Kanghong's generic "bosiqing" sample hospital market accounted for 34.73%, while Shanghai's "OPEC" of Chinese and Western pharmaceutical industry accounted for 11.85% On the whole, the domestic and the original drugs are equally divided 5 zytiga of abirateron acetate (ZEKE) Johnson & Johnson has been dominating the market since it came into the market in 2011, but xtandi, a new generation of prostate cancer oral drug jointly developed by astallas and mediation, has the unique advantages of single drug use The industry forecasts that xtandi will subvert zytiga's dominant position in the two major markets in Europe and the United States In May 2015, CFDA approved the production and sales of zytiga of Xi'an Janssen Pharmaceutical in China The patent of abirateron acetate, the active ingredient of zytiga, expires on February 18, 2014 with the patent No of us 5604213 From 2014 to 2015, a total of 10 domestic enterprises applied for the APIs and tablets of abiolone acetate, all of which are class 3.1 drugs, which are in the clinical stage of new drug application Domestic generic drugs of abiolone are in the near future.