Market forecast of monoclonal antibody

Source: biosurvey 2013-12-13 in the past few years, monoclonal antibody drugs have become the largest annual sales in the world's biopharmaceutical field, and in the next few years, monoclonal antibody drugs will also be the main force in this field The rapid development of monoclonal antibodies and the successive expiration of many "blockbuster" class patent drugs, such as Johnson & Johnson's anti-tumor necrosis factor (TNF) - α monoclonal antibody REMICADE in the United States and Europe in 2018 and 2014 respectively, Roche's rituxan and Herceptin, a monoclonal antibody against HER-2 receptor, were patented in Europe in 2014 and 2015, respectively, while in the United States they were all until 2018 The considerable profit space and huge potential market make the monoclonal antibody generic drugs become the competitive territory of many pharmaceutical companies The monoclonal antibody industry is about to blow out "In 2004, we were talking about antibodies By 2012, we were all making antibodies." An antibody drug entrepreneur returning from overseas recently said at the second antibody summit held in Beijing An authoritative person in the research, development and industrialization of antibody drugs in China pointed out that antibody drugs not only have a huge market and demand, but also will be a sunrise industry in the next few years As the heavy bomb drug patent is about to expire, and new technologies continue to emerge, the therapeutic monoclonal antibody generic pharmaceutical industry, which previously deterred most manufacturers, now seems to be easy to obtain So now the whole world wants to enter this field Even SamSung group, which is a semiconductor company, has begun to make antibody drugs According to Li Jing of the National Engineering Research Center for antibody drugs, the global antibody drug market has grown from 310 million US dollars in 1997 to about 44 billion US dollars in 2009, an increase of more than 100 times, with a compound growth rate of 51.13% in the past 13 years; The share of antibody drugs in the global biopharmaceutical industry has also expanded from 10.5% in 2000 to 56.41% in 2009, becoming the largest sub industry in the biopharmaceutical industry Industry insiders predict that by 2014, the top six best-selling drugs in the world will be biotechnology drugs, and seven of the top ten best-selling drugs in the world will be biotechnology drugs, six of which are recombinant antibody drugs Therapeutic monoclonal antibody drugs are in the leading position in modern pharmaceutical industry At present, the global annual sales of multiple antibody drugs can reach 5-6 billion US dollars, or even 7-8 billion US dollars if it is good The sales revenue of one drug in 2016 is expected to exceed 10 billion US dollars Such an attractive market prospect naturally makes many enterprises palpitate At present, Haizheng pharmaceutical, Fosun Pharmaceutical, Tongyi pharmaceutical, Hualan biology, Watson biology and other listed companies are all entering the field of antibody drugs, and non listed pharmaceutical companies such as Shiyao group and Shenwei pharmaceutical are also involved Innovation or imitation although China's financial strength is much stronger than before, there is still a considerable gap from the international level in the development of truly innovative drugs Only from the perspective of capital investment, China's R & D investment in biomedicine in all five years of the 12th Five Year Plan is not as much as that of Roche in Switzerland Moreover, under the current mode of new drug research and development, the cost of developing new drugs is higher and higher, but the success rate is lower and lower In the long run, the development of bio innovative drugs supported by the state is indeed very important to China, but its success rate is not high at the current stage of industry development, mainly due to the insufficient investment of the state and enterprises, as well as the insufficient accumulation of time and industry technical capacity According to the general industry rules, it will take 15-17 years for bio innovative drugs to be developed and put into production, 10-12 years for bioletter products (improvement of original bio products), and 5-7 years for bio generic drugs From the perspective of the investment and patience of the government and investors, it is unlikely to succeed in the development of antibody innovative drugs at present Generally, the success rate of developing bio innovative drugs is up to 10%, while that of developing bio generic drugs is up to 90% The biggest challenge of developing generic drugs is market competition, while the biggest challenge of developing innovative drugs is the success rate of drug-forming in the development process In view of this, at present, the most practical and feasible way for Chinese enterprises is to focus on the development and industrialization of antibody generic drugs, and to simultaneously layout the development of bioletter products, and then gradually transition to the original innovative drug development A pharmaceutical investor also said that from the perspective of industrial development strategy, China's McAb industry is similar to the Internet, and it is more appropriate to follow the strategy Industry analysts stressed that compared with chemical generics, bio generics, especially monoclonal antibodies and other high-end bio generics have higher technology and investment threshold, and they have higher requirements for enterprise experience, technical strength and investment strength, so the profit margin is also higher than that of general chemical generics Therefore, although China's antibody industry is facing a rare development opportunity, its market situation also presents the situation of "thousands of troops cross the single wooden bridge" As we all know, the structure of McAbs is far more complex than that of small molecule drugs, so the path of their generic production and approval process is also more rugged The main difficulties are post transcriptional modification, three-dimensional structure and protein aggregation, which are also the common problems faced by the research and production of bio generic drugs All of these can lead to changes in immunogenicity and antibody targeting, resulting in a decrease in therapeutic activity However, global pharmaceutical companies are still enthusiastic about the research and development of monoclonal antibody generic drugs In the past year, research in this field has been in full swing Rituxan, the first target of biosimilars developers, has been developed and produced by Sandoz, TIWA pharmaceutical in Israel and Samsung in South Korea In June last year, South Korean celltrion company, the world's second largest single clone antibody manufacturer, announced the clinical trial results of its REMICADE generic ct-p13 to the European anti rheumatism Alliance (EULAR) The results showed that ct-p13 had the same efficacy and good tolerance as the original REMICADE This result is expected to make celltrion become the world's first McAb generic company that can really be listed in the regulatory market Reditux, a replica of rituximab manufactured by Dr Reddy's company, has been sold in India in 2007 However, the regulations on generic drugs in India are inconsistent with the approval standards of the international market, so it has not been approved for listing in Europe and America so it is not considered as a real generic drug