Abstract:In recent years, the genetic engineering drug industry has benefited from the rapid progress of gene editing technology (such as CRISPR/Cas9) and delivery system technology (such as viral vectors and non-viral vectors), which has made its therapeutic potential in the field of genetic and non-genetic diseases increasingly apparent. By the end of 2023, six gene therapy drugs in mainland China have successfully obtained market access, marking that the domestic gene therapy market is entering a new period of rapid development. According to statistics, by 2023, the scale of the mainland gene therapy market has exceeded 2 billion yuan.
1. Definitions and Classification
Genetically engineered drugs refer to special drugs developed by genetic engineering technology that can prevent and treat certain diseases, but the content is very small and difficult to be prepared by traditional methods. According to the different principles of action, genetic engineering drugs can be roughly divided into two categories: recombinant protein drugs and nucleic acid drugs. Among them, recombinant protein drugs can be subdivided into cytokine drugs (such as interferon, colony factor, interleukin, coagulation factors, etc.), protein hormone drugs (such as growth hormone, insulin, follicle-stimulating hormone, thyroid-stimulating hormone, etc.), thrombolytic drugs (such as tissue plasmin activators, streptokinase, Nucleic acid drugs refer to drugs that play a role at the nucleic acid level (DNA and RNA) to treat or prevent diseases by correcting mutant genes and regaining their proper functions, which can be subdivided into DNA drugs, antisense RNA drugs, RNAi drugs, ribozymes and other categories.
Second, industry policies
1. Competent authorities and regulatory system
The competent authority of the genetic engineering drug industry is the State Drug Administration, which conducts administrative and technical supervision over the whole process of research, production, circulation and use of drugs in mainland China, and the drug regulatory departments of the people's governments of all provinces, autonomous regions and municipalities directly under the Central Government are responsible for the drug supervision and administration within their respective administrative regions. The state implements the drug production license system, the drug manufacturing good manufacturing practice (GMP) system, the drug business quality management practice (GSP) system, the new drug certificate and drug approval number system, the national drug standard system, the drug pricing system, etc. to supervise and manage the industry.
2. Industry-related policies
In recent years, the mainland government attaches great importance to the development of the biomedical industry, and lists genetic engineering drugs as one of the key areas for the development of the national pharmaceutical industry. At the same time, policies such as the "14th Five-Year Plan" for National Drug Safety and Promoting High-quality Development, and the Opinions on Several Special Measures to Relax Market Access for Shenzhen's Construction of a Pilot Demonstration Zone of Socialism with Chinese Characteristics also propose to strengthen the supervision of the domestic pharmaceutical market and continue to help the orderly, standardized and healthy development of the mainland genetic engineering drug industry.
3. Industry barriers
1. Market access barriers
Mainland genetic engineering drug production and trading enterprises must obtain the "Drug Production License" and "Drug Business License" issued by the State Food and Drug Administration/State Food and Drug Administration in order to carry out production and business activities, and at the same time, drug production must strictly implement the "Drug Administration Law" and GMP, GSP and other regulatory requirements. This series of systems has ensured the orderly development of the genetic engineering drug industry in mainland China, and has also formed a strict market access mechanism in the genetic engineering drug industry. In addition, the state has also introduced a series of management measures and measures in terms of drug bidding and centralized drug procurement, which have raised the regulatory access barriers to the genetic engineering drug industry to a certain extent.
2. Financial barriers
The genetic engineering drug industry is a high-input industry, and its new product development has the characteristics of high capital investment, long project research and development and approval cycle, and high risk. In addition, there are many special equipment required for the production of genetic engineering drugs, some important instruments and equipment are expensive, product sales channels are complex, there are many links, capital turnover is slow, and the investment in market development and product promotion is large. As a result, new entrants to the industry often take a long time to start up and face high financial pressure.
3. Technical barriers
First of all, independent research and development capability is one of the most important core competitiveness of the genetic engineering drug industry, which plays a decisive role in the development of genetic engineering drug manufacturers. Therefore, the genetic engineering drug industry has very high requirements for the technical development capabilities of related enterprises, and enterprises not only need to have a professional team of technical personnel and a strict and high-quality production environment, but also need to have strong technical experience accumulation, and the industry has high technical barriers.
Fourth, the industrial chain
1. Analysis of the industry chain
The upstream of the genetic engineering drug industry chain includes suppliers of raw materials and equipment for the production of cell culture media, gene sequencing instruments, special reagents, and chemical consumables. These products and genetic engineering technologies are the basis of genetic research and drug development, which directly affect the R&D and production of the middle and lower reaches of the industrial chain, and have high technical barriers.
The middle of the industrial chain is the R&D and production of genetically engineered drugs. This link involves multiple steps such as gene sequencing, gene editing, cell culture, drug screening and clinical trials, which is the core part of the gene medicine industry, and enterprises need to have strong R&D strength, rich clinical trial experience and strict production quality management system.
The downstream of the industrial chain is mainly the sales and channels of gene drugs, including hospitals, pharmacies, third-party testing institutions, etc. These institutions are an important link for gene drugs to eventually reach patients, and their sales and service capabilities directly affect the marketing and application of gene drugs. At the same time, government regulators, academic research institutions, and medical insurance companies also play an important role in the entire industry chain, and they have an important impact on the development of the industry in the formulation and implementation of policies such as approval, pricing, and reimbursement of genetic drugs.
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