Forecast and analysis of market size and entry barriers of China's pharmaceutical intermediates industry
Pharmaceutical intermediates are a kind of fine chemical products in the production process from pharmaceutical chemical raw materials to raw materials or drugs. The synthesis of chemical drugs depends on high-quality pharmaceutical intermediates. This kind of chemical product does not require a pharmaceutical production license and can be produced in an ordinary chemical plant. As long as it reaches a certain level, it can be used for the synthesis of pharmaceuticals.
Market size
From 2017 to 2019, China's pharmaceutical intermediate market has been showing a trend of negative growth. However, due to the impact of the outbreak, the global pharmaceutical market is rising rapidly. It is expected that the scale of China's pharmaceutical intermediate market is expected to grow to 231 billion yuan in 2022.
Barriers to entry
1. Industry entry barriers
Drug safety is related to the national economy and people's livelihood. The state has formulated a series of laws and regulations on the access, production, operation, and sales of the pharmaceutical industry to strengthen the regulation and supervision of the pharmaceutical industry. According to the "Measures for the Supervision and Administration of Drug Production" (Order No. 28 of the State Administration for Market Supervision and Administration), the establishment of a drug manufacturing enterprise must be approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality where the enterprise is located and issued a "Drug Production License". Drugs cannot be produced without the "Drug Production License"; the drugs produced must meet the drug standards such as the "Pharmaceutical Code of the People's Republic of China". ; Pharmaceutical production enterprises must meet the requirements for technical personnel, plant facilities, rules and regulations as stipulated in the Pharmaceutical Administration Law of the People's Republic of China and continue to comply with them. In addition, the globalization of the pharmaceutical industry is relatively high, especially the chemical raw material drug manufacturing industry has formed a stable division of labor system in the global collaboration. At present, my country has become one of the world's largest producers of chemical raw material drugs. If domestic companies want to enter the European and American markets, they must meet local regulatory requirements. Regulatory requirements in various regions have raised the barriers to entry into the industry, especially for new entrants, whether it is to meet domestic or foreign regulatory requirements, it will take a long time.
2. Technical barriers
The pharmaceutical manufacturing industry is a technology-intensive industry. R&D capabilities are the core competitiveness of pharmaceutical manufacturing companies. The pharmaceutical manufacturing industry is a technology-intensive industry. R&D capabilities are the core competitiveness of pharmaceutical manufacturing companies and play a decisive role in the development of the company. The pharmaceutical manufacturing industry has the characteristics of cross-professional application, multi-technology integration, and rapid technology update, which are embodied in technology development capabilities, chemical synthesis capabilities, core catalyst selection, process control, etc., and constantly develop new products and optimize existing processes. It is the key to the survival and development of pharmaceutical manufacturing enterprises, and it is the driving force for the continuous progress and development of the entire pharmaceutical manufacturing industry. If chemical raw material pharmaceutical companies want to maintain their advantages in the global market competition and achieve sustainable development, they must have strong technical strength and rich experience reserves. For new entrants, it is generally difficult to master relevant R&D technologies and production processes in a short period of time, and it is difficult to compete with outstanding companies in the industry in terms of product quality and cost control. Therefore, the industry has high technical and process barriers. . Outstanding companies compete, so this industry has high technical and technological barriers.
3. Environmental protection barriers
Since the manufacturing of APIs and pharmaceutical intermediates is a heavy-polluting industry, the requirements for environmental protection are higher than those of general industries. Since the manufacturing of APIs and pharmaceutical intermediates is a heavy-polluting industry, the requirements for environmental protection are higher than those of general industries. As the public's awareness of environmental protection increases and the country's requirements for environmental protection continue to increase, the design of the production process of related enterprises and the investment in the treatment and discharge of pollutants will continue to increase significantly. Therefore, companies that do not have environmental technology advantages, scale advantages, and cost advantages will be gradually eliminated, and new entrants with insufficient strength will also be rejected by environmental barriers. Entering enterprises will also be turned away by environmental protection barriers.
For more information, please refer to the "Research Report on the Market Prospects and Investment Opportunities of China's Pharmaceutical Intermediates Industry" issued by the China Commercial Industry Research Institute. At the same time, China Commercial Industry Research Institute also provides industrial big data, industrial intelligence, industrial research reports, industrial planning, and industrial parks. Planning, the 14th Five-Year Plan, industry investment and other services.
2026-10-29
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