Does the 3 exclusive "absolute leaders" of TOP10 varieties of children's medicines exist?

According to data from the National Food and Drug Administration on August 11, the State Food and Drug Administration has passed priority review and approval for the market since this year.
More suitable dosage forms have filled the gap of some domestic children's therapeutic drugs
.
Earlier, China’s children’s drug market has always been in the status quo of “four less and two more”.
As national policies continue to increase, children’s drug R&D and review have received more dividends, and more and more new children’s drugs have been approved for marketing.
, The market will also usher in a major reshuffle
.
At the 2021 Mis Conference held on July 21-25, Minet.
com senior researcher Tan Xiaojing gave a special report on "Analysis of China's Children's Medicine Market Status and Future Development Trends", and talked about the past, present and future of the children's medicine market
.

The predicament of “four less and two more” needs to be overcome.
The policy will increase market welcome opportunities.

Children’s medicines refer to special medicines used by minors under 14 years of age.
Children are not reduced adults.
As a special medication group, they have their own unique physiological characteristics.
Therefore, the treatment plan should be determined according to the characteristics and specific conditions of the children in different periods
.
Tan Xiaojing, a senior researcher at Minai.
com, said when talking about the current supply and demand of children's medicine in China, the predicament of "four less and two more" needs to be overcome
.
The first "fewer" is less variety
.
According to incomplete statistics, children's medicines only account for about 5% of all medicines
.
The second "less" is less dosage form
.
Children's medicines in China are mainly powders, granules, tablets, and oral solutions, but there is a lack of dosage forms suitable for children, such as scored tablets, inhalants, chewables, and patches
.
The third "fewer" is less specifications
.
Children of different ages and different weights have different dosages of physiologic drugs, but there is a phenomenon of "medicine reliance on medication and dosage reliance on guessing" in children's medication
.
The fourth "less" is that there are fewer special drugs
.
Children's medicines in my country are mainly general medicines such as respiratory system, digestive system, and anti-infective medicines, while special medicines such as tumor diseases, cardiovascular diseases, and nervous system diseases are scarce.

.
As for the "two-to-many" clinical use of drugs, there are many irrational use of drugs and many adverse reactions .
There are also interlocking causal relationships here
.
Due to the insufficient variety and variety of children’s special drugs available , doctors have adopted methods such as halving adult drugs when prescribing drugs, which makes the problem of clinical use of children’s drugs exceeding the instructions.
The phenomenon of rational use of drugs is frequent, and the incidence of adverse reactions in children in the process of drug use is also on the rise
.
China's policies and regulations for children's medicines started late compared to the United States, the European Union and other countries, and the difficulty in advancing pediatric clinical trials has undoubtedly increased the difficulty of the development of children's medicines
.
The research and development cost of children's medicine is high, the research and development cycle is long, and the sales pricing mechanism in the terminal market has no obvious advantages, which causes many companies to be unwilling to engage in the research and development and production of children's medicine
.
In order to get rid of this embarrassing situation, in recent years, the national level has successively issued a number of policies to encourage and support the development of the children’s drug market from R&D, approval, production, and sales.
Approval has accelerated the marketing process of children's drugs
.

　
Source: CDE, based on "product name + manufacturer", excluding APIs
.
According to data from Meinnet.
com, among the 1,270 currently announced drugs included in the priority review and approval list, 108 are children’s drugs (based on product + manufacturer), 104 are chemical drugs, and 4 are proprietary Chinese medicines; from the therapeutic field Look, nervous system drugs, systemic anti-infective drugs, anti-tumor and immunomodulators are ranked in the top three
.
Of these children’s drugs that have been included in the priority review and approval, 37 have been approved for marketing, of which 17 have been on the market, and have shown rapid growth in the three major terminals and six major markets, achieving rapid post-marketing Increasing the amount has alleviated the shortage of clinical children's medicines in my country to a certain extent, and at the same time has given relevant companies a "strengthening shot".

.
According to statistics from the National Health Commission, the two-week prevalence and consultation rates of children aged 0-14 have increased.
The increase in prevalence and consultation rates has led to an increase in the market demand for children's medicines
.
In addition, from 2014 to 2020, the child population in China will continue to grow.
The earlier full liberalization of the "three-child policy" will also help promote the rebound of the population, and the children's drug market will usher in new development opportunities
.
Promote the protection of children's medicines.
From 2016 to 2019, government departments formulated three batches of the " List of Encouraging R&D and Application of Children's Drugs ", with a total of 105 varieties, which is conducive to guiding the research and development of children's drugs and guiding enterprises to rationally organize production
.

The market size has dropped to 70 billion, and the concentration of TOP10 manufacturers is not high
.
According to the data from Minet.
com, the compound growth rate of China's children's drug market sales from 2016 to 2019 is more than 10%.
In 2019, it has exceeded 87.
2 billion yuan.
It will be affected by the epidemic in 2020.
, Sales fell for the first time, but still close to 70 billion yuan
.
In addition, from the perspective of market share, the children's drug market accounts for less than 5% of China's drug terminal market, and the market space is still huge
.

　　China's children's medicine market sales (100 million yuan) Source: Mynet database, calculated based on product market retail prices
.
In terms of categories, the sales of children's chemical drugs in China from 2016 to 2020 accounted for more than 60% of the market, and continued to rise.
Among them, the market share of nutritional supplements and anti-infective drugs was more than 20%
.
In the children's Chinese patent medicine market, medicines for respiratory diseases account for more than 60% of the market, followed by medicines for digestive system which account for nearly 30% of the market
.
In terms of dosage form, powders and granules are easy to take and are the mainstream pharmaceutical forms in the children's medicine market
.
There are few types of special dosage forms for children and low status, among which dripping pills and aerosols have increased
.
In the children's chemical drug market, non-exclusive products account for nearly 80% of the market, and the homogenization of the chemical drug market is fierce
.
In the children's Chinese patent medicine market, the market share of exclusive products is close to 50%, and the competitive landscape in the Chinese patent medicine market is relatively relaxed
.
It can be seen that the market share of exclusive products is on the rise in both the chemical medicine and Chinese patent medicine markets
.
Table 1: Data source of the top 10 children's medicines in 2020: The total sales of the TOP10 children's medicines in 2020 in the Meinenet database exceed 20 billion yuan, all of which are over 1 billion large varieties, but from the perspective of market share, they are relatively scattered and there is no absolute Leadership variety
.
Among them, there are 8 chemical drugs, only Dongyang Sunshine’s Oseltamivir Phosphate Granules are exclusive varieties, and the 2 Chinese patent medicine finalists are exclusive varieties
.
Table 2: Data of TOP10 manufacturers of children's drugs in 2020 Source: Mynet database.
TOP10 manufacturers have a combined sales of more than 20 billion in 2020, and Changchun Jinsai Pharmaceutical ranks first with more than 4 billion
.
However, in terms of market share, the highest manufacturers account for less than 7%, and the TOP10 total is also below 30%, showing that the market concentration is not high and there is no absolute leading company
.
From the perspective of product structure, apart from Sunflower Pharmaceutical's relatively rich product line in the children's medicine market, the product lines of other manufacturers are relatively simple
.

　Overcoming the four major problems, the future of the children's medicine market can be expected
, Tan Xiaojing, a senior researcher at Minet.
com, said that the current children's medicine market has fierce competition for the homogeneity of chemical medicines, and the proportion of Chinese patent medicines is not high, and the concentration of leading companies is not high, and most of the products are single , Such a situation is a combination of danger and opportunity
.
Companies only need to find the right target, deepen their efforts, and with the inclination of policies, the dividends of the children's medicine market will really be in their hands
.
First, enrich the product portfolio
.
Pediatrics involves a wide spectrum of diseases and has general medicine properties.
Enriched product portfolio can form product synergies.
It is also conducive to building brand image, enhancing patients' dependence on brands, reducing academic promotion costs, and ultimately achieving scale effects
.
Second, specification development
.
Children of different ages and even different weights have different dosages.
At present, more than 90% of children's medicines in China have only one specification, which is not conducive to clinical use
.
The development of multiple specifications of the same species can be used for children of different ages and weights, increasing the convenience and safety of children's medication, and at the same time helping manufacturers to establish differentiated advantages
.
Third, the dosage form is improved
.
At present, common dosage forms are mainly used in the children's medicine market in China, and there is a lack of new dosage forms on the market abroad
.
For products with clear clinical value, significant efficacy and high safety, it is possible to improve the development of special preparations or products suitable for children, such as scoring agents, Aerosols, patches, etc.
, make children's medication choices more abundant, which is conducive to terminal sales
.
Fourth, explore the field of treatment
.
The children's medicine market in China is mainly based on respiratory diseases, anti-infective drugs, and digestive system drugs.
Most of these drugs are general drugs, and many varieties have been approved by manufacturers.
The homogeneity is serious and lacks selling points
.
However, there is a shortage of drugs in the fields of nervous system, tumor, and cardiovascular diseases, and the market demand is gradually increasing.
In addition, national policies are encouraging the development of specialty drugs.
Therefore, the development in the field of specialty drug treatment can avoid homogenization competition
.

　　Data source: Mi Neiwang database