Analysis of the current situation and trend of children's drug market in recent years

1.1. Number of children and frequency of illness:
According to the authoritative data of the 2015 China Statistical Yearbook released by the National Bureau of Statistics, as of 2014, China's newborn birth rate was 12.37 per 1,000 births, the natural population growth rate was 5.21 per 1,000, and by 2014 china's existing children (aged 1-14) were 226 million, accounting for 165 per cent of the population.
with the development of the economy, the improvement of people's living standards, as well as family planning reform, the implementation of the two-child policy, the birth rate has been increasing in recent years. The birth rate and total population are expected to continue to rise in the future, with 17.8-19.5 million new births each year.
China's birth rate has increased in recent years, while the two-week prevalence rate is high, according to 2008 IMS statistics, China's two-week prevalence rate of pediatrics reached 251.1 per 1,000, 0-4 years old children with a higher prevalence rate than 5-12 years old children. The increase in the number of newborns and the increase in the two-week prevalence rate further contributed to the increase in the number of paediatric clinics.
although China's birth rate and total population show a steady growth trend, but the proportion of the population aged 0-14 years has decreased year by year, while the proportion of 15-64 years old population has become an upward trend. The dependency ratio for the child population has steadily declined (i.e. the number of children to be burdened by 100 working-age people: child-agedependencyrate, CDR). This trend will lead to an increase in the ability of single-child patients to spend more on health care.
A comprehensive analysis based on the above data can be found: 1) With the adjustment of the national fertility policy, China's birth rate in recent years and in the future shows a steady upward trend, it can be predicted that the social demand for medical and health services for the paediatric population, pediatric outpatients, paediatric drug use will be steadily increased. 2) On the other hand, it is worth noting that in recent years, the proportion of the population aged 0-14 years has been on a continuous downward trend, while the proportion of the population aged 15-64 years has been on the rise. The dependency ratio for the child population has steadily declined (i.e. the number of children to be burdened by 100 working-age people). child-agedependencyrate,CDR。 This trend will lead to an increase in the ability of child patients to spend more on health care. That is, each child receives more attention and money in health care. Each family unit can reduce overall expenditure as a result of the reduction in the number of children in the family, but families with fewer children are more able to consume than larger families with more children and invest more in their children's financial resources. The above population base data show that children's health care services in terms of both "quantity" and "quality" have a huge market space and growth trend.1.2. The current situation of supply in the field of children's medicine
The market for paediatric drug use is heating up, but the market demand is far from being satisfied. Data from recent years show that there are two significant differences in the field of pediatric drug use. The first is the gap between outpatient volume and market share. According to authoritative statistics, in 2015, the number of pediatric emergency departments reached 2-500 million, accounting for 9.6% of the total number of emergency departments in the country. Sick children account for 19.25 per cent of the total number of sick people in our country. However, sales of children's medicines account for only 3% of China's total pharmaceutical market, even in the domestic first-tier metropolis, children's drug sales accounted for only 4.1%. A large number of child patients are using adult drugs that do not indicate the amount of children's usage and have not been systematically studied in pediatric clinical studies!
the other hand, the growth rate of the demand for pediatric-specific drugs and the difference in the number of products. In 2014, drug sales for children's usage were 56 billion yuan, reaching 68.8 billion yuan for the whole of 2015, up 19% year-on-year and higher than the average growth rate in the pharmaceutical industry. Through the CFDA "domestic drugs" database query found that as of June 2016, China shared 162.673 million drug codes, of which, according to incomplete statistics, pediatric drugs have about 3000 numbers, accounting for only 1.8% of the total number of numbers. Of the more than 6,000 pharmaceutical companies, only 30 are specialized manufacturers of children's medicines. In 2015, 2,690 drugs were approved, while only 19, or 0.7%, were approved for children.1.3. Problems in the field of children's drug use:
In the context of strong demand and serious shortage of supply, there are many practical problems with children's drug use. Mainly concentrated in clinical drug use and new drug development two aspects. 1) First of all, from the demand side of clinical drug use, children's drug use has high adverse reactions, drug abuse, children's use of adult drugs and other issues;1.3.1 Demand side dilemma for clinical drug use 1.3.1.1 High adverse reactions:
A joint survey conducted by the State Administration of Food and Drug Administration and related departments on the safe use of drugs for children shows that China The rate of unreasonable drug use in children is as high as 12%-32%, and the rate of adverse drug use reactions (ADRs) in children is about 12.9%, nearly twice that of adults, of which 24.4% are newborns and nearly 4 times that of adults.1.3.1.2 Drug Abuse and Overuse
At present, the inappropriate use and overuse of paediatric drugs in China is more common. Adverse reactions such as improper use of antibiotics occur from time to time. Some pediatricians use antibiotics blindly or frequently without clear signs, leading to drug resistance.
abuse of anti-heat analgesants. Infants and young children are susceptible to respiratory diseases, causing varying degrees of fever symptoms, such as not taking into account the cause, simple treatment of anti-heat analgesics, sometimes leading to sudden rise in the body temperature of children. In addition, the abuse of such drugs can cause adverse reactions such as liver damage and stomach bleeding.
glucosin abuse. Some primary care physicians often use glucoticoids for deheated treatment and also use antimicrobials in large doses. The abuse of glucoticoids can lead to a variety of adverse reactions, including stunting in children, osteoporosis, electrolyte disorders, hypoproteinemia and decreased immune function, and can also lead to metabolic disorders, leading to a variety of infectious diseases. Studies have shown that the abuse of glucoticoids is one of the major causes of aseptic necrosis of fecal bones.
generally lack of public awareness of adverse reactions to midgrass drugs. Many parents think that Chinese herbal medicine is pure natural, low adverse reactions of drugs, than Western medicine is safe, some studies have shown that this is a mistake may lead to 39.48 percent of chinese herbal adverse reactions, serious may lead to drug hepatitis, nephritis.1.3.1.3 Children use adult medicine
Due to the lack of appropriate child drug dosage forms, health care workers and parents often use unsafe alternatives to separate adult dosage form tablets and mash them or take capsules of drugs dissolved in water for children to take. Currently, more than half of the drugs used in children are untested and authorized for use. Children are usually given adult medications, while some adult drugs have no data on the safety of children's medications at all. Through the CFDA "domestic drugs" database query found that as of June 2016, China shared 162.673 million drug codes, of which, according to incomplete statistics, pediatric drugs have about 3000 numbers, accounting for only 1.8% of the total number of numbers. According to the data provided by the collaborative hospital of the Hospital Prescription Analysis Cooperation Project, the survey of the first 300 pediatric common drug instructions with drug frequency of more than 0.1% in more than 70 sample hospitals in six major cities in China found that only about 35% of the drugs had information on children's drug use.1.3.2 Supply-side dilemmas in the development and production of children's medicines 1.3.2.1 Lack of clinical trials for children
Clinical trials of children's drugs are inherently ethically demanding, and the design of the trial program needs to take into account the characteristics and affordability of the child population. The difficulty of recruiting the subjects and the relatively high rate of shedding in the research process require clinical researchers to have a high level of management, as well as knowledge and experience in children's medicine, pharmacy, nursing, ethics, psychology and so on. In addition, as of June 2016, the "List of Drug Clinical Trial Institutions" listed on the CFDA website shows a total of 822 clinical research unit certificates, but only a few dozen of them qualified for pediatric trials, and the professional distribution is uneven. Therefore, in the design of research and development pipeline, drug candidate evaluation, should take into account the difficulty of clinical research, risk, capital and time costs and other factors. This problem will be analyzed in subsequent studies.1.3.2.2 children's dose is scarce
compared with advanced countries abroad, China's children's dosage forms are fewer types, the design is not reasonable enough. Children-specific dosage forms are mainly considered from three aspects. 1) Consider the dose suitable for the characteristics of the child. For a long time a variety of commonly used drugs lack of children-specific doses, when used in a rough way manually split, on the one hand destroyed the characteristics of the drug itself, on the other hand, can not be accurate dosage; Simple, but the accurate top, effectiveness and compliance of low-child children will play a great role in the consideration of dosage forms suitable for children, such as the rapid development of oral disintegratives, oral mucosas, throat sprays, nasal sprays, mixed suspension drops, advanced orthodontic technology, etc. will help the pediatric community to improve the quality and compliance of the drug.1.3.2.3 Special drugs concentrated
due to the relatively high incidence of children in the respiratory tract, intestines, china's market for such drugs are more concentrated, some small disease drugs even exist in short supply. The regulatory authorities issued the "first to encourage research and development to declare the list of children's drugs" obviously have structural considerations. The main attack on major diseases, hugging group heating is a business strategy. In line with the intention of national structural adjustment, to provide the market with high value-added scarce products, and to seek the national high policy tilt is also a strategic choice.1.3.2.4 production costs are high
children's dosage is small, coupled with the current market share of some enterprises is relatively dispersed, resulting in the production of products in small quantities, multi-lot problems. At present, some domestic enterprises in the respiratory and digestive categories are more concentrated, these categories are more seasonal. In high season, there is a shortage of real-time production capacity, frequent variety switching phenomenon, and in the off-season there is a contradiction between overcapacity and insufficient operating rate. This has created significant obstacles to increased productivity and reduced production costs. In the follow-up study, we will see the intention of product restructuring in national policy, which is not only the need for regulatory authorities to ensure the safety of the supply of small varieties, but also for enterprises may also be the inspiration to optimize the production capacity structure.1.3.3 Subtation
Comprehensive information, we can see that the children's drug market has broad prospects for development, both in terms of "quantity" (increase in birth rate) and in terms of "quality" (decrease in dependency ratio, increase in affordability). At the same time, we also clearly see that the market demand is greater than supply, there is an imbalance between pediatric visits and sales of children-specific drugs, as well as the rapid increase in consumer demand and the decline in the number of professional enterprises and products. There are many factors that cause this situation: among them, the problem of clinical drug use concept, the problem of national policy orientation, and the consideration of pipeline strategy of children's drug research and development.2.1. Policy Combing
In recent years, with the increase of the birth rate of newborns in China and the increasing demand for medical and health services for children, the state regulatory authorities at all levels have issued a number of relevant policy documents aimed at regulating and promoting the medical and health services of children in China. Children's medication, as an important part of children's health care services, has been the focus of policy. According to incomplete statistics, from May 2014 to June 2016, state regulatory authorities issued as many as 13 policy documents directly related to children's drug use. From the policy-oriented documents issued by multiple DNS to the landing documents involving circulation, clinical, registration and other sub-links, the idea of reform of children's drug policy has begun to emerge. (Dandelion WeChat Group)