Development status and trend of global anti-tumor antibody drugs

1、 Development status of anti-tumor antibody drugs As one of the most widely used clinical treatment fields of anti-tumor drugs, anti-tumor drugs have been listed from the first anti-tumor drug rituximab (Roche) in 1997 As of November 2018, 35 anti-tumor antibody drugs have been approved (excluding delisted drugs), accounting for 42.86% of all anti-tumor drugs Distribution (%) of different disease areas of listed antibody drugs data source: FDA / EMA official website, sorted out by Huoshi Creation Research Institute (data acquisition up to November 2018) Among the approved listed antibody drugs, anti-tumor is the largest market area of antibody drugs, accounting for half of the whole antibody drug market In recent years, with the research and development of new antibody drugs and the continuous expansion of indications of antibody drugs on the market in the field of cancer, the overall growth rate of anti-tumor antibody drug market is obvious, and the overall market in 2017 reached US $42.806 billion Data source of global anti-tumor antibody drug market (US $100 million) in the past five years: annual report of the company's official website, sorted out by flint Research Institute (data as of 2017), the top five hot targets account for nearly 90% of the market share, and heavyweight drugs emerge repeatedly There are more than 20 targets of anti-tumor antibody drugs on the market From the analysis of target market of drugs on the market, the antibody drugs of PD-1 / PD-L1, HER2, CD20, VEGF / VEGFR and EGFR, the five hot targets of anti-tumor antibody, occupy 89% of the market share In recent years, immunosuppressive checkpoint inhibitors targeting PD-1 / PD-L1 and ctal-4 have attracted much attention Among them, PD-1 / PD-L1 is one of the hottest research directions in the field of tumor drugs A total of 6 drugs have been approved for listing, with a market of 9.678 billion US dollars in 2017 Data sources of antibody drugs and market share of each target: in the annual report of each company, the top five anti-tumor antibody drugs sorted out by huoshichuang Research Institute (data obtained up to 2017) are rituximab, trastuzumab, bevacizumab, navacizumab and paimmumab respectively, with a global market of more than $3 billion in 2017 Top 1 billion US dollars of anti-tumor antibody drug market listed: IMS / annual reports of major pharmaceutical companies, sorted out by huoshichuang Research Institute (data as of 2017) 1.3 global antibody drug market is highly concentrated, Roche ranks first with a number of anti-tumor antibodies According to the market data of antibody drugs that have been listed and the sales volume shown in the annual reports of each company, there are 9 enterprises with a global market of more than 4 billion US dollars and 4 enterprises with a global market of 10 billion level, which are Roche, Aberdeen, Johnson & Johnson and Amgen respectively The antibody drugs of 9 pharmaceutical giants account for 85% of the market share Competition pattern of antibody drug enterprises in 2017 (proportion:%) data source: annual report of each enterprise, sorted by Huoshi Creation Research Institute, data as of 2017 Roche is the most listed antibody drug company in the world There are 10 antibody drugs on sale, and Herceptin, Avastin, and rituxan, which are used to treat various cancers such as colon cancer and lymphoma, are all stable In 2017, the total sales volume of antibody drugs on the market reached US $32.3 billion, accounting for anti-cancer The market share of body medicine is 26% 2、 The development trend of anti-tumor antibody drugs 2.1 the target research and development of anti-tumor antibody drugs has entered the stage of flowering According to the data statistics of flint database, among all the antibody drugs entering the clinical stage, the indications include about 470 new anti-tumor drugs, involving more than 180 targets, accounting for half of all the antibody drugs under research (826) Among them, the antibody targeting at PD-1 / PD-L1 is still a hot spot in tumor immunotherapy In addition to several kinds of popular target drugs on the market, the hot targets in research are also concentrated in HGF, OX-40, CD40, ADP, havcr2 and other new targets Target of anti-tumor antibody drugs in clinical research and number of drugs in research (more than 2) data source: sorted by flint Creation Research Institute, data statistics as of November 2.2, 2018, the new generation of anti-tumor immune checkpoint antibody has become a development hotspot In addition to PD-L1 and CTLA-4, Tim-3 (T cell immunoglobulin mucin molecule-3), tigit (T cell immunoglobulin domain and protein of immune receptor tyrosine inhibitory motif) and other immunosuppressive molecules have been found, as well as dozens of new targets with immunostimulatory effects, including ICOS (induced T cell costimulatory molecule), OX40 (CD134, Among them, CD27, CD40, OX40, GITR, ICOS, etc have entered the clinical research stage, and many companies have established their own layout Hope to bring new dawn for tumor immunotherapy 2.3 the combination of immunocheckpoint inhibitors is becoming the development direction of anti-tumor therapy With the rise of immunotherapy, the combination of immunocheckpoint inhibitors or targeted drugs, chemotherapy drugs and other drugs are emerging in an endless stream At present, FDA has approved the combination therapy of two immune checkpoints: opdivo + yervoy of BMS, keytruda of Merck and pemetrexed + carboplatin Compared with any single drug treatment, the combination treatment showed excellent therapeutic effect on Orr and PFS Data sources of combination therapy approved by FDA: FDA, Flint Creation Research Institute At present, although only two PD-1 related combined trials have been approved by FDA, according to a review of PD-1 and PD-L1 clinical trials published by CRI in nature in 2018, there are many related trials in 2018, up to 1716, involving 240 different targets Other common combination therapies include chemotherapy (283 items), radiotherapy (114 items), radiotherapy and chemotherapy (58 items) and targeted therapy At present, CTLA-4, VEGFA, CD20, LAG-3 and CSF-1R are the most popular targets In 2018, the clinical trial landscape for PD1 / PDL1 immune checkpoint inhibitors 2.4 is a new technology antibody drug, which set off a new upsurge of tumor treatment research and development At present, with the maturity of connectivity technology and the introduction of ADC drugs, ADC has gradually become a new and effective means of tumor treatment With the success of Roche kadcyla, in recent years, there has been an upsurge in the research and development of antibody coupled drugs (ADC) around the world Hot targets include HER2, EGFR, CD19 and CD19 At present, more than 10 ADC drugs have entered the late clinical stage At present, some data sources of antibody coupled drugs in the late clinical stage: cortellis database, and Huoshi Creation Research Institute collated (as of October 2018) According to a new report released by Research & markets, a global well-known market research company, it is estimated that 7-10 new ADC drugs will be listed in the next 10 years, and the ADC market size will reach 10 billion US dollars in 2024 Three Summary, with the continuous rise of cancer incidence rate, anti-tumor drugs have become the largest market segment in pharmaceutical industry, and there are many kinds of drugs Antibody drug is one of the fourth generation tumor treatment methods after surgery, radiotherapy and chemotherapy, and it is also the focus of innovation and research At present, the main market of anti-tumor drugs in the world is targeted drug monoclonal antibody In the future, with the continuous development and in-depth development of new technologies and antibody drugs, many new targets, new antibodies and antibody drug combination programs will be continuously developed and put into use In the future, antibody drugs with anti-tumor drugs as the core still have great development potential.