With the rapid growth of the children's drug market, the research and development of specialty drugs is facing challenges

According to the seventh census, the population of 0-14 years old in China is 253.
38 million, accounting for 17.
95%.
Compared with 2010, the proportion has increased by 1.
35 percentage points
.
Among them, the proportion of China's children's population has rebounded significantly
.
It is worth noting that the industry believes that with the advent of the three-child policy, the proportion of children in China in the future may have a high probability of ushering in a new round of growth
.
This will also bring a new round of room for growth to the children's medicine market
.
It is estimated that in 2021, the size of China's children's drug market may exceed 200 billion yuan, and it will continue to maintain an average annual growth rate of more than double digits
.
However, the industry has also pointed out that although the current market demand for children's medicines in China is increasing, the contrast is that the supply of children's medicines in China is lagging
.
According to data from the National Medical Products Administration (NMPA), among the more than 6,000 domestic pharmaceutical factories, there are more than 30 companies that have a children’s drug production department, and the number of companies that specialize in children’s drugs is even more pitiful, with only more than 10 Among the conventional drugs, there are more than 3,600 prescription drugs for adults, and only more than 60 kinds of drugs for children
.
In addition, under the background of few companies specializing in the production of children's medicines, the research and development products of children's medicines are also very single, and they mainly focus on antibiotics, cold medicines, analgesics and antipyretics
.
For the above problems, the analysis believes that it is mainly due to the lack of children's clinical trials that make research and development very difficult, the high ethical requirements of children's drug clinical trials need to take into account the characteristics and affordability of the children's population, and the recruitment of research subjects is difficult
.
Under the influence of these factors, the difficulty in the development of specialty drugs has clearly become a major challenge for the continued growth of the children's drug market
.
In order to change this situation, the state and related pharmaceutical companies have begun to take actions one after another
.
For example, since this year, in order to better meet the needs of children’s clinical medications, in April and May, the Center for Drug Appraisal has successively issued the "Guiding Principles for Clinical Trials of Modified New Drugs for Children's Chemicals (Draft for Comment)" and "Chemicals and Treatments".
The two major guiding principles of the "Technical Guiding Principles (Draft for Solicitation of Comments)" written with the information related to children's medication in the instructions of biological products are publicly solicited to further strengthen the technical guidance of children's medication
.
On September 29, the State Food and Drug Administration issued an announcement requesting the instructions of five anti-tumor drugs that are already on the market to supplement children's medication information
.
In addition, at the end of September, the state also issued the "China Children's Development Program (2021-2030)" to encourage the development and production of children's drugs, and accelerate the approval of children's drug applications
.
It also proposed to "explore and formulate a national children's essential medicine list, and timely update the children's banned drugs list"
.
Benefiting from favorable policies, more and more pharmaceutical companies have begun to accelerate and increase their deployment in the children's drug market
.
According to statistics, more than 10 children's medicines have been approved for marketing since 2021
.
In addition, there are currently more than 40 new pediatric drugs in China at the stage of clinical approval and above
.
In terms of dosage form, new drugs under development are mainly in the form of granules, oral liquids, sprays and other suitable for children
.
The industry believes that with the liberalization of China's "three-child" policy, the potential of the new population will continue to be released, and children's drug companies will also have more development opportunities
.
However, opportunities often coexist with challenges.
As the children's medicine market will usher in an explosion in the future, the industry thresholds and bottlenecks will also become not to be underestimated
.
For R&D companies, in addition to accelerating innovation, they also need to maintain good communication with drug review departments and medical institutions, and work in the same direction to speed up the development of children's drugs
.