1, the status quo of the development of monoclonal antibody industry in China
The monoclonal antibody drug market in China has just started, but it has developed rapidly. It has been realized from basic research to industrialization. Our country's first listed monoclonal antibody for the Wuhan Institute of biological products produced T lymphocyte CD3 antigen monoclonal antibody, which was approved by the SFDA in 1999, and used for organ transplant rejection treatment. At present, our country to obtain production approval of the monoclonal antibody products has reached 9, the ongoing clinical trials of 23 monoclonal antibody.
Medical terminal sales data show that the domestic monoclonal antibody market developed rapidly in recent years, the current size of more than 1 billion yuan, and annual growth rate of more than 50%, higher than the growth rate of the international monoclonal antibody market. (data source: Huatai Securities Research Report)
At present, China's monoclonal antibody market is still in the monoclonal antibody as the main body, but the market share of domestic monoclonal antibody is gradually improving. Since the antibody drug was approved in our country until 2008, more than 99% of the market share in China has been occupied by imported products. Until Baitai biological teshin students after the listing, only to break the foreign monoclonal antibody to occupy the absolute market share situation, the market share of domestic McAb gradually enhanced.
2, China's monoclonal antibody industry facing opportunities
2.1 national policies to support the monoclonal antibody industry
In 2006 the national long-term science and technology development plan (2006-2020) "the biological technology as a high-tech industry in the future to catch up. And the target discovery technology and gene operation technology are classified as cutting-edge technology in biotechnology, both of which are the key technologies in the development of monoclonal antibody drugs. In 2009, the State Council promulgated a number of policies to promote the development of the biological industry, and put forward to actively research and development on the treatment of common diseases and major diseases have significant efficacy of biotechnology drugs. In 2010, the State Council identified the biological industry as one of the seven strategic emerging industries in the country.
November 2011 issued the "Twelfth Five" biological technology development plan "is made clear that the establishment of antibody of massive and rapid reaction in the production of the new technology, construction and optimization technology of the humanized antibody; for new and recurrent major infectious diseases and multiple infectious disease development of new vaccines and antibody drug; for malignant tumor, cardiovascular and cerebrovascular diseases, metabolic diseases, autoimmune diseases major non infectious diseases developed therapeutic vaccines and antibody drug. "The state plans to invest in major new drug research and development, the creation of special funds of about 40 billion, than the" five eleven "during more than doubled.
2.2 domestic monoclonal antibody drug market demand is huge
Since the monoclonal antibody market started late in our country, the current clinical drug use is still dominated by chemical drugs, the monoclonal antibody market share is low, and has a higher development potential than the international market. IMS data show that in 2007 the global monoclonal antibody drug has accounted for 34.4% of the whole biological pharmaceutical market, while China is only 1.7%, far below the global average.
Southern Medicine Economic Research Institute data show that in 2009 China's Hospital oncology drug market reached 40 billion 500 million yuan, an increase of 28.57% compared to 2008. "2011 Chinese trend anti - tumor market forecast report" predicts that by 2020, there will be 550 Chinese million new cancer cases. This will further promote the development of the cancer drug market. But the anti-cancer drug market in our country, monoclonal antibody drug use is relatively low in proportion, accounted for all of the anti-cancer drug market in 4.8% of the share, and the monoclonal antibody in anticancer drug market has topped the list, occupy 34% of the market share. In view of the monoclonal antibody (McAb) than traditional chemotherapy drugs has obvious clinical advantage, Huachuang securities research predicted the mAb cancer drug market in 2015 is expected to reach 325 to 650 billion yuan.
In addition to cancer treatment, the second major areas of application of monoclonal antibody drug is the autoimmune disease. Rheumatoid disease has been one of the high incidence of disease in China, in 2009 the size of China's rheumatoid drug market reached a billion yuan, an increase of 41.87%. In Europe and America, the proportion of monoclonal antibody drugs has reached about 50%, while the domestic drug is still dominated by chemical drugs. Among them, the first twenty of all drugs for chemical drugs, accounted for 70% of the market share. Huachuang securities research analyzed that our country rheumatoid antibody drugs is expected to maintain more than 40% of the speed of rapid growth, such as 1% of patients received treatment of words, the theory of market capacity of up to 52.5-63 billion yuan.
In addition, monoclonal antibody drugs in the field of organ transplantation, infectious diseases, cardiovascular disease, and other areas have a certain degree of application. With the above monoclonal antibody drugs in cancer, autoimmune diseases combined with the application of the field of its market demand is very huge, and at present our country monoclonal antibody drug sales only about one billion yuan, the market can be described as a blue ocean.
2.3 China's per capita income level gradually increased
Currently monoclonal antibody drugs in our country use rate is low, in addition to monoclonal antibody market started late in China, doctors drug habits and other factors and an important constraint is monoclonal antibody based drug cost is higher, inhibit the release of domestic demand. With the improvement of people's living standard and the increase of per capita income, this situation will be alleviated.
2011 China's per capita net income of rural residents of 6977 yuan, year-on-year growth of 17.9%, after deducting price factors, the actual growth of 11.4%; urban residents per capita disposable income of 21810 yuan, than last year grew 14.1%, after deducting price factors, a real increase of 8.4%. In the past ten years, China's per capita income of residents is shown in figure four. Among them, the rural per capita net income of rural residents, urban per capita disposable income of urban residents.
With the increase of the income level of residents and the ability to pay, there will be more and more patients will be selected