Development trend and characteristics of pharmaceutical intermediate industry, opportunities and challenges facing scale

1. Development trend of pharmaceutical intermediate industry

The development of fine chemical industry is one of the solid foundations of our construction of manufacturing power, but also an important path to realize the energy saving and emission reduction target put forward by the country and develop low carbon economy. The production process of fine chemical industry is complex, and the production raw materials and products involve dangerous chemicals, so the safety and environmental protection risks are high. In addition, enterprises are facing many pressures, such as the global economic downturn, rising domestic labor costs and intensifying market competition. Pharmaceutical intermediates include antimicrobial drug intermediates, antipyretic and analgesic drug intermediates, cardiovascular drug intermediates and anticancer drug intermediates, among which antimicrobial drug intermediates can be divided into quinolones, β-lactam, aminoglycosides, tetracycline, amide alcohols, macrolides, etc., according to the chemical structure of antibacterial drugs synthesized by further reaction and antibacterial mechanism.

1) The pharmaceutical industry continues to shift to Asia

The pharmaceutical industry in developed countries in Europe and the United States started earlier, but with the continuous development of global productivity and the deepening of international division of labor, pharmaceutical enterprises in developed countries in Europe and the United States focus on the research and development of innovative drugs and market development, so that the pharmaceutical intermediate industry is speeding up the transfer to Asian countries including China and India. Taking our country as an example, by means of mature petrochemical industry chain and rich basic resources, all kinds of main raw materials needed for the production of medical intermediates can be obtained at home, which improves production efficiency and reduces transport cost; At the same time, relying on the perfect domestic industrial system, so that domestic enterprises in the production equipment, construction and other aspects of cost and quality have a competitive advantage, accelerate the production of products; In addition, Chinese enterprises and research institutes have accumulated many years of technology in the field of medicine and fine chemical industry, forming a core competitive intellectual property system, training a large number of first-class R & D personnel and industrial workers, to ensure that the production line of pharmaceutical intermediates can run smoothly and the production process can be improved continuously.

Therefore, under the general trend of deepening international division of labor system, the center of gravity of pharmaceutical intermediate industry is expected to further transfer from Europe and America to Asia, and the scale of Chinese pharmaceutical intermediate industry will be further expanded, forming an Asian-led industrial pattern, which not only meets the needs of the development of Chinese pharmaceutical industry, It can also provide key pharmaceutical intermediates for global manufacturers of apis, generics and innovative drugs, and promote the development of the world pharmaceutical industry.

(2) The added value of the product and the complexity of the process are constantly increasing

The synthesis of medicine depends on high quality medical intermediates. With the technological innovation and industrial upgrading of pharmaceutical industry, higher requirements will be put forward for pharmaceutical intermediates. Although the development prospect of Chinese medicine intermediates is broad, there is still a certain gap between the development of Chinese medicine intermediates industry and the needs of the pharmaceutical industry at present, some products have higher technical level requirements, domestic production can not be organized, basically dependent on imports, there are some products although the output can meet the requirements of the domestic medicine industry, but the cost is high, the quality is not good, It has affected the competitiveness of pharmaceutical products, and still needs to improve the production process.

In order to meet the continuous development of the pharmaceutical industry, Chinese pharmaceutical intermediates industry will develop from the original traditional mode of low level repetition, lack of innovation and extensive production to the direction of innovation and upgrading, high quality and high level. With the advancement of research and development and the accumulation of independent intellectual property rights, the added value and process complexity of pharmaceutical intermediates will continue to increase. Become a strong guarantee for the development of pharmaceutical industry.

(3) Energy conservation and environmental protection requirements are becoming stricter

In recent years, the state has vigorously advocated the green and low-carbon development of the whole pharmaceutical industry chain, improved the level of green manufacturing, implemented carbon emission reduction actions in the pharmaceutical industry, and built a green industrial system. At the same time, the state has implemented strict environmental supervision and rectification of the chemical industry, put forward strict requirements for the industry's energy saving and environmental protection technology, eliminated a number of small enterprises and cottage factories with weak technology and poor product quality, and promoted the industry to develop towards environmental protection and standardization.

With the increasingly strict requirements of energy conservation and environmental protection, coupled with the pharmaceutical intermediate manufacturing process is complex, more reaction links, so the industry manufacturers need to vigorously develop green advanced technology, with environmental protection treatment facilities in line with the standards and low consumption and energy saving production equipment, in order to implement the consumption reduction target responsibility.

(4) The degree of automation continues to improve

In order to meet the needs of drug production with a wide variety and complex structure, pharmaceutical intermediates are usually complex in variety and more reaction steps. In the past, most production enterprises continue to use the traditional production process, but the application of new technology is still less. The production process is mostly manual operation, and automation has not been widely used, leading to poor product quality, low production efficiency, and difficult to guarantee the safety.

With the continuous improvement of the supporting system of safety production, the continuous rise of labor costs, and the increasingly strict requirements of the pharmaceutical industry on the quality of intermediates, the automation degree of the production process of pharmaceutical intermediates is getting higher and higher, which requires manufacturers to design automatic control schemes for the production characteristics of pharmaceutical intermediates, and select automatic control instruments. Continuously improve the degree of automation in the production industry.

2. Characteristics of pharmaceutical intermediate industry

Pharmaceutical intermediates are fine chemical products from chemical raw materials to raw materials or drugs. They are usually special chemicals with high technology density and high added value. Because of the variety of medicine, chemical structure is complex, so the demand for intermediate variety is more. Different from large-scale chemical production process, the production process of pharmaceutical intermediates is usually characterized by miniaturization, batch batch and multi-function. Some pharmaceutical intermediates production enterprises have developed relatively large-scale, automatic, continuous and modular production processes by combining the experience of large-scale chemical production. The upstream industry of pharmaceutical intermediates is the basic chemical raw materials, and the downstream industry is the chemical raw materials and chemical pharmaceutical preparations.

Pharmaceutical intermediate industry is an important link in the pharmaceutical industry chain. With the increasing of product added value and process complexity of Chinese pharmaceutical intermediate, it is becoming a strong guarantee for the development of pharmaceutical industry. Pharmaceutical intermediates include antimicrobial drug intermediates, antipyretic and analgesic drug intermediates, cardiovascular drug intermediates and anticancer drug intermediates, among which antimicrobial drug intermediates can be divided into quinolones, β-lactam, aminoglycosides, tetracycline, amide alcohols, macrolides, etc., according to the chemical structure of antibacterial drugs synthesized by further reaction and antibacterial mechanism.

After years of rapid development of Chinese pharmaceutical intermediates industry, Chinese pharmaceutical production needs have been basically satisfied by the production of Chinese pharmaceutical intermediates, but there are still a small number of high-end intermediates with complex synthesis technology that need to be met by import. Currently, China benefits from its obvious competitive advantages in talent, patent protection, infrastructure and cost structure, and has become one of the major R&D and production bases of pharmaceutical intermediates in the world. It not only provides a large number of high-quality pharmaceutical intermediates for generic drug manufacturers, but also increasingly becomes the preferred strategic cooperation destination for pharmaceutical enterprises. It provides key pharmaceutical intermediates to a large number of manufacturers of apis, generics and innovative drugs.

3. Opportunities facing the pharmaceutical intermediate industry

(1) The scale of industry demand continues to expand, and the product application field continues to extend

The pharmaceutical industry is a strategic industry related to the national economy and people's livelihood, economic development and national security, and is an important foundation for a healthy China. Chinese medicine industry is in the booming stage, antibacterial drugs are an important component of medicine industry. With the growth of the global population and the acceleration of the aging process, the demand for antibacterial drugs shows a steady rising trend, which drives the continuous expansion of the industry demand scale.

(2) Supported by national industrial policies, the industry develops in a standardized and orderly way

In recent years, the state attaches great importance to the sustainable and stable development of the industry, It has issued a number of industry development plans and industrial policy guidelines, including the 14th Five-Year Plan for National Economic and Social Development and the Outline of Long-term Goals for 2035, the 14th Five-Year Plan for Pharmaceutical Industry Development, the 14th Five-Year Plan for National Pesticide Industry Development, and the Implementation Plan for Promoting High-quality Development of the API Industry. It has effectively promoted the adjustment and optimization of the industrial structure, supported and standardized enterprises, eliminated backward production capacity, increased industrial concentration, and improved the competitive environment, guided the standardized and orderly development of the industry, enhanced the core competitiveness of leading enterprises, realized the scientific and sustainable development of the industry, and created a good policy environment for the long-term and stable development of the pharmaceutical intermediate industry.

(3) Development opportunities brought by global pharmaceutical intermediate industry transfer

Under the general trend of high operating costs and increasingly saturated labor supply in developed countries and increasingly mature industrial chains in developing countries and regions, the global intermediate industry is speeding up its transfer to Asian countries including China and India. With the rapid development of the Chinese market, there are also sufficient professional and technical personnel, rich basic resources, complete petrochemical industry chain and other advantages. Under the general trend of the deepening international division of labor system, the scale of relevant industries in China will be further expanded to form an Asian-led industrial pattern, which not only meets the needs of China's industrial development, but also can provide key intermediate products for the global market. Bring further development opportunity for pharmaceutical intermediate industry.

(4) The introduction of relevant policies of "purchasing with quantity" in medical reform

Procurement with quantity, that is, through the general idea of national organization, alliance procurement and platform operation, the way of "procurement with quantity, in exchange for price" effectively reduces the purchase price of preparations. In November 2018, the fifth session of the Commission for Deepening Overall Reform deliberated and adopted the Pilot Plan for State Organized Centralized Drug Procurement, which clarified the general idea of "state organized, alliance procurement and platform operation" in volume procurement.

Quantity purchase policy aims to explore reasonable pricing of clinical drugs and dilute the influence of academic promotion on the premise of ensuring the consistency of drug quality and quantity, so as to effectively reduce the price of clinical drugs while ensuring the economic benefits of the bid-winning enterprise. First of all, antibacterial drugs, as one of the main drugs used in Chinese public hospitals, have been widely used for a long time and exist in the medical insurance catalog for a long time. Quantity procurement policy will not have a significant adverse effect on the quantity of antibacterial drugs used. Secondly, the price of terminal drugs has been greatly reduced to reduce the sales expenses of pharmaceutical manufacturers. Finally, in order to ensure the supply of raw materials that meet the standards of scale and quality, downstream pharmaceutical and API manufacturers will choose intermediate enterprises with stable production capacity and quality as long-term partners, so as to enhance the position of high-quality upstream intermediate enterprises in the industrial chain and maintain certain bargaining power. Therefore, the introduction of the relevant policy of "purchasing with quantity" in the medical reform helps to promote the close cooperation between pharmaceutical intermediates manufacturers with standardized management and downstream pharmaceutical and API manufacturers, which brings opportunities for the development of pharmaceutical intermediates industry.

4. Challenges facing the industry

(1) The influence of national policies to regulate the use of antibiotics

With the introduction of a series of policies to regulate the use of antibiotics, such as the Measures for the Management of Clinical Application of Antibiotics and the Action Plan for Reducing the Use of Veterinary Antibiotics (2021-2025), the use of antibiotics is subject to stricter supervision and management. On the other hand, the introduction of relevant policies also helps to promote the scientific, rational and standardized use of antibacterial drugs, prolong the life cycle of antibacterial drugs, and is conducive to the long-term and steady development of the industry.

(2) increasingly strict requirements for energy conservation and environmental protection

In recent years, the state has successively issued the "14th Five-Year Plan for Pharmaceutical Industry Development", "14th Five-Year Plan for National Pesticide Industry Development", "Comprehensive Directory of Environmental Protection (2021 edition)", "Guidelines for Promoting the Green Development of the API Industry" and other sound policies to promote energy conservation and low-carbon development of the industry and improve the level of green manufacturing. On the one hand, a large number of enterprises with backward technology and weak technology are gradually eliminated. On the other hand, it also promotes the further improvement of industrial concentration, and the allocation of market resources to the industry leader enterprises with strong comprehensive strength and leading energy conservation and environmental protection technology.

(3) The financial strength of some enterprises in the pharmaceutical intermediate industry is weak

The development and technological progress of the pharmaceutical intermediate industry need a large amount of investment in research and development, whether it is new technology, new product development and transformation, all need financial support, but in addition to a few large enterprises, enterprises in the industry are mostly small and medium-sized enterprises, there is a certain shortage in financial strength, and its main source of funds for their own business accumulation and bank loans, There are certain deficiencies in the scale and source channels of funds, which limit the technological innovation of enterprises in the industry.