Analysis of biopharmaceutical industry chain
Analysis of biopharmaceutical industry chain
Compared with the traditional chemical pharmaceutical process, biopharmaceutical uses modern biotechnology means such as genetic engineering, genetic engineering, cell engineering, and enzyme engineering. The production process is complex, involving the construction of genetically engineered cells or strains, the industrial amplification of high-density and high expression fermentation process, the separation and purification of recombinant proteins and other key technical links. It has higher requirements for equipment, instruments and technical personnel, The production process needs to be closely monitored.
In addition, biological drugs are mostly polypeptides, proteins and other macromolecular drugs. The structure and properties of biological analogues cannot be completely equivalent to the original drugs. The research and development cost of biological analogues is much higher than that of chemical generic drugs. Drug manufacturers need to verify the effectiveness and safety of drugs from the clinical research stage. Therefore, the biopharmaceutical industry has high capital and technical barriers.
China is in a period of rapid growth in the development and manufacturing of biomedical products. In addition, the field of chemical medicine and traditional Chinese medicine in China is also developing rapidly. In order to cope with infectious diseases, cancer, heart disease, hypertension, diabetes, nervous system diseases and respiratory diseases, China's pharmaceutical industry still needs to maintain rapid growth. It is undeniable that in recent years, China has been paying more attention to biomedicine and increasing the number of universities and research centers in this field.
However, under the influence of the current regulatory policies, the speed of innovative biological drugs entering the Chinese market is very slow, which creates obstacles for patients to obtain safe and effective innovative biological drugs in time. Moreover, the current medical insurance policy has very limited reimbursement for biological drugs, which restricts patients from getting help from biological drugs in time, such as monoclonal antibody biological drugs commonly used in the field of cancer and other diseases. China is still at the initial stage in the field of biomedicine and needs to make further efforts in key areas. With the rapid economic growth, the Chinese market has a huge demand for agricultural biotechnology and bioenergy technologies.
In recent years, the domestic biological drugs mainly include hepatitis B vaccine, interferon, IL2, GCSF, recombinant streptokinase, recombinant epidermal growth factor and recombinant human insulin. More than ten polypeptide drugs such as TPA (tissue fibrinogen activator) and IL3 are undergoing phase I and II clinical trials. The development of monoclonal antibody has entered clinical practice, and the treatment of hemophilia type B has achieved preliminary results. More than 40 genetic drugs such as recombinant chymosin are being developed. domestic α The market share of interferon has exceeded that of imported products, which is the first in China γ Interferon has the ability to transfer technology to foreign countries, and a new generation of interferon is under development. According to the prediction of relevant departments, in the future, the annual growth rate of biotechnological drugs in China will not be less than 25%, and the annual total output value will exceed 2 billion yuan. The development prospect is very broad.