The pharmaceutical industry is an important part of the national economy and is closely related to the people's vital interests such as life, health and quality of life. Since the reform and opening up, China's pharmaceutical industry has maintained a rapid growth rate. From 1978 to 2010, the average annual growth rate of the output value of the pharmaceutical industry reached more than 15%, the scale has continued to expand, and the quality and efficiency of economic operations have continued to improve. my country has become the world's largest producer of pharmaceutical preparations.
The combination of biotechnology achievements and scientific principles and methods such as microbiology, chemistry, biochemistry, and pharmacy has formed one of the important sub-industries of the pharmaceutical industry.
The "China Biopharmaceutical Industry Technology R&D and New Product Launch Analysis Report" shows that the country has increased its support for biotechnology innovation and bioindustry development, allowing my country's biopharmaceutical industry to maintain a rapid development momentum. Data show that from 2003 to 2010, the compound annual growth rate of sales revenue of China's biopharmaceutical industry reached 21.52%. In 2010, the industry's production and sales exceeded 100 billion yuan, with a year-on-year growth rate of more than 40%.
It is believed that in the next ten years, a number of gene therapy programs and drugs will enter the application stage. China's biopharmaceutical R&D and industrialization capabilities will also be greatly improved, forming a new drug landscape with three pillars: chemical drugs, traditional Chinese medicine, and biological drugs. Our country will obtain 200 new biological drug certificates, develop nearly 200 biological drugs, and nearly 400 biological drugs enter the clinical trial stage for major diseases such as cancer, heart disease, hypertension, diabetes, and neurological diseases. The rapid development of China's biopharmaceuticals The time has come.
In 2011, biopharmaceutical sales reached US$160 billion, accounting for 19% of the global pharmaceutical market. It is expected that by 2020, biopharmaceuticals will account for more than one-third of global pharmaceutical sales. The total annual output value of my country's pharmaceutical manufacturing industry has exceeded 1.2 trillion yuan, and the average annual export growth rate has remained stable at 25%-30%. Among them, chemical raw materials are an important industry that represents the international competitiveness of my country's pharmaceutical industry. Its annual output value accounts for nearly half of the country's total pharmaceutical output value, and its export proportion exceeds 60%. The global biosimilar market will grow from US$2.43 million in 2010 to US$3.7 billion in 2015, which is equivalent to a loss of US$51 billion in sales for 30 brand-name drugs. In 2015, the annual sales of biosimilar drugs in my country will increase from 274.8 billion yuan in 2011 to 447.8 billion yuan, with an average annual compound growth rate of about 15%, and will always account for 62% of the country's total biopharmaceutical sales. about. During the period 2012-2016, patented drug sales are expected to continue to grow at a growth rate of over 25%. As the patents of some blockbuster biological drugs are about to expire, drugs worth US$150 billion will lose patent protection from 2010 to 2017, which will drive the generic drug market to grow from US$123.85 billion in 2010 to US$231 billion in 2017. The biopharmaceutical camp is huge and developing rapidly. Half of the world's pharmaceuticals are biosynthesized. Especially when synthesizing drugs with complex molecular structures, it is not only simpler than chemical synthesis, but also has higher economic benefits.
A series of breakthrough applications of various biopharmaceutical analysis systems and microbial transformations developed over half a century in drug development have created huge medical value and economic benefits for the pharmaceutical industry. The characteristic of microbial pharmaceutical industry production is to use certain microorganisms in a "pure state", that is, not only the "seed" must be excellent, but also only one kind. If other strains come in, they will be miscellaneous bacteria. For fixed products, there must be the most suitable "food" - culture medium for its growth according to the process. The components of the culture medium cannot be changed at will. If a strain is in the same fermentation medium, if a certain component is missing or added, the fermentation finished product will be completely different. For example, Streptomyces aureus can produce chlortetracycline in a medium containing chlorine, and tetracycline can be produced in the absence of chloride or by adding substances that inhibit the formation of chloride in the medium. When drug-producing bacteria are put into fermentation tanks for production, they must be expanded and prepared from seeds. Transfer the stored bacterial strains from the slope to the shake flask for culture. The grown seeds in the shake flask are put into a seed tank with a large culture capacity. After they grow well, they can be put into the fermentation tank for culture. Different fermentation scales also have different fermentation tanks, such as 10 tons, 30 tons, 50 tons, 100 tons, and even larger tanks. This is like the different sizes of pots we use when cooking.