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Rapid development of biopharmaceutical industry
According to the latest statistics from IMS Health, the world’s leading pharmaceutical market consulting and research company, the annual sales of genetically modified biotech drugs in 2004 have exceeded US$40 billion. From 1998 to 2003, the annual growth rate of global biotechnology drug sales was between 15% and 33%, much higher than the traditional pharmaceutical industry with an annual growth rate of 7% to 10%. Four major factors accelerating industrial development In recent years, the biopharmaceutical industry has been able to grow at such a high rate, mainly due to four factors: First, biotechnology has made considerable progress; Second, more and more biotech drugs have been approved for listing, and its The growth rate is much higher than traditional chemical drugs; Third, biotechnology drugs have less toxic side effects and exact therapeutic effects; Fourth, the high added value of biotechnology drugs. Unbalanced regional development Despite its rapid development, the development of the biopharmaceutical industry in the world is extremely uneven. In the final analysis, the level of development of a country’s biotech drugs ultimately depends on the country’s scientific and technological strength and the people’s living standards. In 1993, the biopharmaceutical industry in North America (mainly the United States), the European Union, and Japan was almost three-fold, accounting for between two billion to three billion U.S. dollars in a total market share of 8.4 billion U.S. dollars. However, after 10 years of development, the United States has left other countries and regions far behind. As of the end of 2002, sales of biotech medicines in the United States accounted for 58% of the global market, and this proportion has also expanded. The EU’s market share has reached 22% after five years of development. The development of biopharmaceuticals in Japan has lagged or even stagnated. In the past 10 years, the sales of biotechnology drugs have been hovering between 2 billion and 3 billion U.S. dollars. The types and production scale of biological products are far behind that of the United States. In particular, rapid development of antibody drugs, Japan's R & D capabilities are also very limited, until 2001, only one therapeutic antibody (OK-T3) listed. However, in the last two years, Japan has realized that in the field of biopharmaceuticals, governments and companies are investing more in biopharmaceuticals. From 2001 to 2003, five therapeutic monoclonal antibodies were approved. They are Herceptin and Rituxan respectively. , Simulect, Remicade, and Synagis. Biopharmaceuticals are basically in their infancy in other countries and regions. "Blockbuster" products continue to emerge. The above table lists the 10 newest biotech drugs with annual sales from June 2003 to June 2004. Nine of these 10 varieties are "blockbusters" with annual sales of more than one billion U.S. dollars, of which the top six drugs in 2004 will have annual sales of more than 2 billion U.S. dollars. Of these 10 drugs, erythropoietin (EPO) still dominates, and there are three products that are EPO products. However, from the perspective of growth, the growth rate of EPO sales has slowed down. From 2002 to 2003 The annual growth rate is only 4% to 7%. The most robust growth is in antibody products. There are four types of antibody drugs entering the top ten, namely Remicade and Enbrel for rheumatoid arthritis, Rituxan for non-Hodgkin’s lymphoma and Herceptin for breast cancer treatment. Their annual growth rate has reached 40% to 70%, which is the main force driving the rapid growth of biopharmaceuticals. Due to outstanding clinical performance and huge market demand, it will continue to maintain a strong momentum of development in the coming years. Due to the high specific affinity of antibody molecules and target antigens, antibody drugs show strong specificity, good curative effect, and low toxic and side effects in the treatment process, which has become a hot research field for pharmaceutical companies. At present, the FDA has approved 17 therapeutic antibodies, two receptor-Fc fusion protein antibody drugs, and therapeutic antibodies have become the largest variety and the largest amount of sales of biotechnology drugs. These drugs show very good therapeutic effects in the treatment of tumors, rheumatoid arthritis and Crohns disease, anti-organ transplant rejection, prevention of viral infection, and anti-platelet aggregation. It is estimated that there will be 17 kinds of antibody drugs listed in 2008, and its sales will exceed 20 billion U.S. dollars, accounting for 1/3 of the entire biopharmaceutical industry. Global annual sales of recombinant insulin products have exceeded US$5 billion, making it the third-largest category of biotechnology drugs other than antibody drugs and EPO. Among the top 50 biotech drugs in the annual sales from June 2003 to June 2004, 11 were genetically modified insulin products. The insulin mutant products Humalog, Lantus and others have become the two highest sales of insulin products because of their excellent performance. Cytokine drugs still have some room for growth, but the market is already near saturation. For example, NEUPOGEN (G-CSF) has seen negative growth. Although PEGylated G-CSF has seized its market, overall, interferon, Colony-stimulating factors, EPO, and other cytokine products have been on the market for more than 10 years. The market is very mature. Therefore, its growth momentum is relatively stable. The annual growth rate is generally around 5% to 10%. It is worth mentioning that sales are located in the top 10 biotech drugs and 8 products are expressed in mammalian cells. The large-scale cultivation of animal cells has become the most critical industrialization technology in biopharmaceuticals. With the exception of EPO-a, which has a very small dose, the Top 10 biotech drugs expressed by the remaining six animal cells are not capable of producing in the country. The gap between China's biopharmaceutical level and Europe and the United States has been increasing.
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