AIDS global market is about to break 30 billion US dollars, and domestic enterprises are scrambling for food

The highlight of this year's event is December 1, which coincides with the 30th World AIDS Day The theme of this year's publicity is "sharing the responsibility of AIDS prevention, sharing the right to health, and building a healthy China" As we all know, HIV is the main cause of AIDS People used to talk about AIDS, but anti HIV drugs have gradually changed AIDS from a dreadful super terminal disease to a controllable chronic disease According to statistics, the global sales volume of anti HIV drugs in 2016 was US $23.023 billion, with a compound growth rate of 8.4% in 2011-2016, significantly higher than the average growth rate of about 3.5% in the global drug market With price constraints, patent invalidation, impact of generic drugs and other factors, the HIV treatment market will enter a relatively stable growth period in the future, and the market value is expected to increase to $32 billion by 2022 According to the statistics of CDE, as of November 29, 42 product specifications have reported to CFDA for supplementary application for conformity assessment of generic drugs, including tenofovir dipivoxil fumarate produced by Chengdu Beite Tenofovir fumarate dipivoxil belongs to nucleotide reverse transcriptase inhibitors (NRTIs), and is a drug for the treatment of AIDS and chronic hepatitis B the original manufacturer is Gilead   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> International" cocktail therapy "is the mainstream At present, there are six kinds of AIDS drugs that have been officially approved for marketing, including NRTIs, NNRTIs, PIs, instis, fusion inhibitors and receptor antagonists In addition, there are different kinds of composite drugs Because HIV is easy to mutate and attack the human immune system, a single drug can not control the proliferation of the virus in the human body The way to treat AIDS is generally to mix several drugs with different mechanisms (i.e "cocktail therapy") Juluca, the new anti AIDS drug just approved by FDA on November 21, is a two in one AIDS compound drug composed of indis and NNRTIs, and also the first dual drug therapy approved by FDA to treat this indication It can be seen that the combination of drugs has become the focus of research and development of anti HIV drugs, and small molecule compound preparations will occupy a dominant position in the future anti HIV drug market According to the top 10 anti HIV drugs sold in 2016 (Table 1), combined drugs accounted for 5 places, and ranked top, with a total sales of US $9.711 billion, accounting for 51.3% of the top 10 drugs Table 1: Top 10 products of global anti HIV drug sales in 2016 Source: none = "shifumousedownstyle ('shifu bus_ ')" style = "margin: 1em Auto; padding: 0px; max width: 100%; color: rgb (62, 62, 62); font family:" hiragino sans GB "," Microsoft YaHei ", Arial, sans serif; font size: 16px; line height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> genvoya is expected to be the top in the world According to table 1, in 2016, the sales of the top ten HIV drugs in the world exceeded US $1 billion, of which the sales of Gilead's compound drug truvada was the highest, reaching US $356.6 million In addition, the compound drugs in the top 10 products include Atripla, truvada and stribild, genvoya, enriti, and trimeq of GSK / Pfizer; the single drugs include darunavir of Johnson & Johnson, latiravir of mosadong, dotiravir of GSK, and tenofovir dipivoxil of Gilead From this group of data, it is not difficult to see that Gilead is the leader in the anti HIV drug market!     According to the latest financial report data, in the first half of 2017, the highest sales volume of anti HIV drugs was genvoya of Gilead, which was 1.626 billion yuan, a year-on-year increase of 230% In 2017, the annual sales volume is expected to reach about 3.5 billion dollars, becoming the new best-selling anti HIV drugs; truvada's sales volume decreased by 17% to 1.526 billion dollars, ranking the second; the fast-growing drugs are trimeq and tivicay, both of which increased year-on-year More than 55% Genvoya was approved by the US FDA in 2015 It is the latest approved drug of Gilead anti HIV cocktail therapy pipeline It is a four in one compound drug It is composed of the antiviral drugs elvitegravir, emtricitabine, cobicistat and tenofovir Alafenamide (TAF) is suitable for HIV-1 patients who have never taken anti HIV drugs or whose virus has been inhibited   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; Border bottom color: rgb (0, 0, 0); box sizing: border box! Im portant; word wrap: break word! Im portant; "> the domestic anti AIDS market is to be expanded China has implemented the system of fixed-point production and centralized procurement of anti HIV drugs, which is incorporated into the national drug storage, unified distribution and allocation, and distributed level by level through the national disease prevention and control network Therefore, the domestic anti AIDS drug market is mainly composed of two parts, one is hospital use, the other is government procurement Due to the small number of patients receiving treatment in the hospital, government procurement occupies the main market share China's HIV drug market is relatively small According to data, the global HIV drug sales in 2016 was US $23.023 billion, while the domestic anti HIV drug market was only RMB 2-3 billion, which is a huge gap with the European and American markets Table 2: in addition to the existing anti HIV drugs in China, it is reported that there are at least 90 new anti HIV drugs approved by the U.S FDA, while there are only 20 kinds of anti HIV drugs approved for marketing in China, among which the commonly used first-line anti HIV drugs are zidovudine, lamivudine, stavudine, nevirapine and eferene, and the second-line drugs are mainly krizhi and tenofovir   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; Border bottom color: rgb (0, 0, 0); box sizing: border box! Im portant; word wrap: break word! Im portant; "> in recent years, more and more drug companies have joined the competition Zidovudine tablets and capsules produced by Northeast Pharmaceutical are listed on the market It is the first domestic anti AIDS drug approved by China Subsequently, the drug regulatory department approved domestic De hydroxyinosine and stavudine, which marked the start of the domestic anti AIDS drug market On November 30, 2016, tenofovir dipivoxil fumarate tablets declared by Chengdu Beite Pharmaceutical Co., Ltd obtained the approval for new drug production, becoming the first manufacturer in China to obtain the qualification for imitative creation of this variety At the end of this year, the patent of tenofovir dipivoxil fumarate (trade name: Werder) is about to expire, and more manufacturers of tenofovir are expected to appear in the domestic market Table 3: priority review of tenofovir fumarate in 2017 data source: CFDA drug review center another priority review of new imported anti AIDS drugs is worthy of attention, is the dutiabalamib tablets of GlaxoSmithKline, which was approved by CFDA on July 26   As the R & D cost of anti AIDS drugs is relatively high, most of the intellectual property rights of effective anti AIDS drugs are in the hands of foreign companies (including Merck, GlaxoSmithKline, Roche, Abbott and other international pharmaceutical giants) Therefore, only by developing anti AIDS drugs with intellectual property rights in China, can the drug price be rapidly reduced, so that domestic drug manufacturers have Market competitiveness.