The growth space of my country's pharmaceutical excipients industry is expected to exceed 200 billion yuan

Pharmaceutical Network, July 7th.
Pharmaceutical excipients are the general term for ingredients in pharmaceutical preparations other than the main drug.
They come from a wide range of sources and have a wide variety of categories
.
From the perspective of the composition of pharmaceutical preparations, pharmaceutical excipients usually account for more than 80%
.
Although pharmaceutical excipients are not the core components that affect the efficacy of drugs, they have important functions such as excipients, acting as carriers, improving drug stability, solubilization, solubilization, and slow and controlled release, which affect the quality, safety and effectiveness of the preparations.
Important ingredients
.

Industry large space
of pharmaceutical excipients industry started relatively late, according to the National Bureau of Statistics bio- pharmaceutical industry revenue data, 4% to the value of materials related to estimates, at present, China's pharmaceutical excipients market size of 63.
2 billion yuan, compared to In mature overseas markets, there is still room for growth of more than 200 billion yuan
.
In terms of the proportion of output value, the output value of foreign pharmaceutical excipients accounts for 10% to 20% of the output value of the entire pharmaceutical preparation industry, and this proportion is 3% to 5% in the domestic market
.
At present, China's pharmaceutical excipients production company about 470, divided into accessories specializing in the production companies, chemical companies and food manufacturers
.
Among them, the number of professional pharmaceutical excipient companies is not high, and most companies are small in scale, single in production, and few companies with sales of more than 100 million yuan
.
Overall, the concentration of the domestic pharmaceutical excipients industry needs to be improved
.
In addition, there are more than 540 types of pharmaceutical excipients in China, and the standards of excipients included in the Pharmacopoeia of the People's Republic of China have increased from 132 in the 2010 edition to 335 in the 2020 edition
.
The number of medicinal excipients in use in the United States and Europe is about 1500 and 3000 respectively, and the standards of medicinal excipients included are about 750 and 1500 respectively
.
It can be seen that, in terms of the number of excipients and the number of standards, my country's pharmaceutical excipients have a large room for development.

.

　　Quality reflects bargaining power
.
There are many upstream raw material suppliers in the pharmaceutical excipient industry chain, which can be divided into two categories.
The first category is chemical companies, which provide basic chemical raw materials; the second category is agricultural and forestry companies, which provide agricultural and forestry raw materials
.
Nowadays, there are more than 300 basic chemical raw material companies in China, mainly distributed in resource-rich regions such as the central and western regions.
The overall situation is overcapacity, and the bargaining power of midstream pharmaceutical excipient manufacturers is weak
.
With the advancement of urbanization and the decrease in the number of farmers, China's agriculture and forestry industry is showing a trend of agglomeration and development of leading enterprises, which is conducive to the large-scale procurement of midstream pharmaceutical excipient manufacturers
.
In this context, midstream companies can not only reduce procurement costs, but also have a stable upstream supply chain
.
The production enterprises in the middle reaches of the pharmaceutical excipients industry chain are divided into two types: crude low-end pharmaceutical excipients production enterprises and fine high-end pharmaceutical excipients production enterprises
.
The former are mostly chemical companies or food processing companies, with simple raw material processing technology, serious homogenization competition, and low technical barriers; the latter are mainly pharmaceutical companies engaged in the production of pharmaceutical excipients with a high level of technology.
This type of company has passed Improve the production process to realize the research and development and production of high-end pharmaceutical excipients, which has obvious advantages in the industry competition
.
The downstream of the pharmaceutical excipients industry chain is mainly pharmaceutical companies
.
From the perspective of cost structure, although the amount of pharmaceutical excipients accounts for 80% of the drugs, the cost accounts for a relatively small amount, not exceeding 7%, and the price fluctuations of pharmaceutical excipients have little effect on drug prices
.
From the perspective of bargaining power, the pharmaceutical field is the most important sales direction of pharmaceutical excipients.
Midstream pharmaceutical excipient manufacturers rely on downstream pharmaceutical companies to a high degree, and pharmaceutical excipient manufacturers have weaker overall bargaining power
.
With the implementation of generic drug quality and efficacy consistency evaluation and related review and approval policies, downstream pharmaceutical companies have gradually increased the quality requirements of pharmaceutical excipients, and the bargaining power of large enterprises specializing in the production of pharmaceutical excipients will increase
.

　　High-quality enterprise development is full of confidence
In August 2016, the National Food and Drug Administration issued the " Announcement on Matters Concerning the Related Review and Approval of Pharmaceutical Packaging Materials and Pharmaceutical Excipients ", clearly stipulating that pharmaceutical excipients will no longer be approved separately, but will be reviewed together when applying for registration of related drugs.
Approval is to associate isolated and dispersed pharmaceutical excipients with preparations and manage them on a single platform, which means that the quality of pharmaceutical excipients largely determines the results of preparation approval
.
In addition, according to the announcement, preparation companies are responsible for the use of pharmaceutical excipients
.
Therefore, preparation companies will give priority to cooperation with suppliers who can provide medicinal excipients with good quality and safe safety.
Enterprises with low quality and irregular production will be eliminated one after another, which will greatly promote medicinal excipient products.
With the improvement of the quality level, the concentration of the pharmaceutical excipients industry is expected to further increase, and the industry's competitive landscape is facing reshaping
.
The core of the consistency evaluation of the quality and curative effect of generic drugs is the prescription and technology of the pharmaceutical preparations.
Although the pharmaceutical excipients, which are an important part of the pharmaceutical preparations, have no physiological activity, they will cause compatibility contraindications when they interact with the drug.
Quality will directly affect the quality, stability and efficacy of preparations.
Therefore, the screening of pharmaceutical excipients is an important research content for the evaluation of the quality and efficacy of generic drugs
.
This puts forward higher requirements on the quality of excipients, which is good for the development of high-quality pharmaceutical excipients enterprises
.
In the context of the newly revised "Drug Administration Law", China's supervision of pharmaceutical excipients is gradually in line with international standards
.
From the perspective of the subdivision rules of the related review and approval system, the relevant domestic policies are closer to the U.
S.
DMF policy, and more emphasis is placed on treating drugs as an organic whole consisting of APIs, pharmaceutical packaging materials, and excipients, while the regulatory system for excipients is relatively more advanced.
In order to approach the filing system and emphasize the main responsibility of preparation enterprises, the pharmaceutical excipient industry has ushered in new opportunities for development
.
(Author's unit: Firestone Creation)