"At present, special medical food can be bought in hospitals and online according to the regulations; the formula of special medical diseases can only be bought through hospitals and pharmacies, in which the pharmacies have their own smooth access for drug intake and delivery, but the path of the whole special medical category into the hospital is still being explored, because the hospital has no charge code for this category, so patients can only buy it in pharmacies." Recently, at the health science and nutrition industry forum, Gu Xinxin, President of Nestle Health Science Greater China, said in an interview with the reporter of the 21st Century Business Herald that although special medical food is a blue ocean, the last kilometer into the hospital is still impassable.
Special medical food, i.e. formula food for special medical purposes, refers to a kind of formula food specially processed and prepared to meet the special needs of people with limited eating, digestive tract absorption disorder, metabolic disorder or specific disease status for nutrients or meals. Before 2015, special medical foods in the Chinese market were regarded as enteral nutrition preparations and used as drugs. Only after the promulgation of the new food safety law in 2015, special medical foods were classified as special foods.
In this regard, Shi Hanping, director of gastrointestinal surgery, director of clinical nutrition department and director of National Key Laboratory of market supervision of Beijing Shijitan Hospital, suggested that in order to make special medical food play a greater role in the treatment, prevention and rehabilitation of diseases, we should first improve the understanding of nutrition and carry out popular science publicity and education, so that more patients and medical personnel can understand the clinical efficacy of special medical food and improve the treatment effect Improve the quality of life and save the value of medical expenses, the society can promote the academic value of special medical food, and the government management department can give more policy preference to the special medical food industry.
huge market
The world's first special medical food was born in 1957 for the dietary treatment of phenylketonuria. At that time, it was approved by the U.S. Food and Drug Administration (FDA) as an "orphan drug". After that, with the introduction of a series of relevant regulations, medical food in the United States was gradually on the right track and began to enter a stage of rapid development.
From 2016 to 2021, the scale of China's special medical food market has gradually expanded, and the growth rate is much higher than that of the global special medical food market, with an average annual growth rate of more than 30%. In addition, China's market share of special medical food in the global market is further increasing. In 2016, this proportion was only 3.9%; In 2020, the proportion has climbed to 9.5%. In 2020, the global market scale of special medical food was 81.48 billion yuan. The market scale of special medical food in China is 7.72 billion yuan.
At present, the State Administration of market supervision has released that there are more than 80 special medical foods that have been registered. Nestle and Abbott, two foreign-funded enterprises, occupy the first echelon. They have 11 and 8 special medical foods respectively, while Shengyuan group, China's first manufacturer of maternal and infant nutritional food listed on Nasdaq, ranks third with five products approved.
In the follow-up, many enterprises also made progress. For example, Chongqing Pharscin Pharmaceutical Co.Ltd(002907) ( Chongqing Pharscin Pharmaceutical Co.Ltd(002907) . SZ) said on the investor interaction platform on April 25 that the two special medical foods developed by the company are currently in the pilot stage, and the relevant formulas have been sold in the market as nutritional foods.
In fact, these special medical formulas are not simple formulas. They all need precise nutrition. Gu Xinxin told the 21st Century Business Herald that the total nutrition formula of special medicine should at least 28-30 vitamins, minerals, proteins, fats and carbohydrates, and the proportion should meet the requirements of the dietary guidelines for Chinese residents.
"It is OK for ordinary elderly people to take ordinary full nutrition special medical formula, but if they have diabetes, they should choose those with low glycemic index, and those with kidney disease should adjust the amount and composition of protein. There are also cancer patients, in fact, many advanced cancer patients, especially, will have many nutritional problems." Gu Xinxin pointed out.
According to the literature, in 2019, China had 260 million hospitalizations and 69 million operations, of which 40% - 50% of hospitalized patients were malnourished. At the same time, there are about 4.5 million cancer patients in China, and the malnutrition of cancer patients is as high as 80%;
In addition, in 2019, there were 254 million people aged 60 and over and 176 million people aged 65 and over in China. About 29% of the elderly were malnourished, and the risk of malnutrition among the elderly over 65 was more than 40% higher than that of the people under 65.
Shihanping said that every year, on the basis of 15 diseases such as coronary heart disease, colorectal cancer, breast cancer, measles and head and neck tumors, 400000 people in China die directly from malnutrition. Other studies have shown that the risk of death of cancer patients is reduced by 30% on the basis of routine treatment and nutritional treatment. "Compared with expensive anti-tumor therapy, nutritional therapy can not only significantly improve the survival time and quality of life of patients, but also reduce the cost of treatment, but its popularity in China is limited."
According to the survey on the nutritional status of patients with common malignant tumors in China, the incidence of malnutrition in hospitalized patients with malignant tumors in China is as high as 80%, and the incidence of moderate and severe malnutrition is as high as 58%. Among them, 26.1% of patients were severely malnourished, and only 19.6% of patients had no malnutrition.
Wang Guiqi, director of the endoscopy department of the Cancer Hospital of the Chinese Academy of Medical Sciences, also pointed out that the treatment of malnutrition requires means and weapons, just as surgeons need scalpels for surgery. The effective weapon to treat malnutrition is special medical food, and calls on everyone to make good use of special medical food to ensure their own health.
In addition, as one of the key protective diseases listed by the World Health Organization in the 21st century, the incidence of allergic diseases among infants and young children in China has also shown an upward trend in recent years. According to the survey conducted by the maternal and child health care center of China Center for Disease Control and prevention in 33 cities nationwide, the proportion of parents of children aged 0-2 in China who reported that their babies had or were suffering from allergic diseases was as high as 40.9%, and the incidence rate of milk protein allergy in infants was 0.83%-3.5%. The clinical manifestations of milk protein allergy are diverse. In severe cases, there will be food refusal, diarrhea, vomiting or reflux, resulting in growth and development disorders.
When discussing the current situation and Prospect of infant allergy prevention and treatment, the above experts said: "Parents have a wrong understanding of children's allergies, which leads to children's allergies in supplementary food, milk and other supplementary nutrition. However, in recent years, parents' awareness of anti allergy has improved and began to turn from simply avoiding allergens to seeking the help of special medical products to ensure the comprehensive and diversified nutrition of infants and children in the process of growth and development. In addition, the field of Pediatrics has never stopped exploring the prevention and treatment of allergy problems, and HMO's The addition opens up new ideas for the prevention and treatment of infant allergy ".
admission difficulty and cognition to be strengthened
With the formal implementation of the administrative measures for the registration of formula food for special medical purposes, special medical food has got rid of the embarrassing situation of wandering between drugs and food and obtained its official status. According to different clinical needs and applicable populations, the general principles of formula food for special medical purposes (GB 299222013) divides formula food for special medical purposes into three categories, namely, fully nutritious formula food, specific fully nutritious formula food and non fully nutritious formula food.
However, in Gu Xinxin's view, solving the problem of identity is a big step for special medical food, but there are still many problems to be solved.
At the same time, Gu Xinxin also told the 21st Century Business Herald that the difficulty of entering the hospital is another major problem to be solved in the last kilometer of special medical food.
According to reports, general total nutrition can be bought in hospitals and online; The special prescription of disease can only pass through hospitals and pharmacies. The access of pharmacies is very smooth, but hospitals only allow drugs to enter. In the process of purchasing and implementing hospital charges, the hospital has no way to charge because there is no charge category and charge bar code related to special medicine in the hospital system.
It is worth noting that, in addition to the above problems, the current market awareness of special medical food still needs to be strengthened. An insider pointed out that at present, the market is full of some health products that publicize various functions, which also has a great impact on the formal special medical food, because the publicity of special medical food needs to be in strict accordance with the provisions of relevant national departments, and the relevant functions and effects cannot be mentioned. "Special medical food policy supervision is strict, but there are still many cognitive problems."
AI media consulting analysts pointed out that China adopts a registration system for special medical food, and the policy supervision is very strict. Special medical food enterprises are required to have independent production lines, and have high requirements on production capacity, R & D capacity and inspection capacity. In addition, special medical food takes about 2-3 years from R & D to production line construction and then to smooth approval, which leads to policy barriers in the industry Both financial and technical barriers are relatively high.
In addition, according to the survey data of AI media consulting, more than 50% of consumers believe that low social awareness is the main factor limiting the special medical industry, followed by the lack of guidance from professional nutritionists, accounting for 48.8%. AI media consulting analysts believe that with the improvement of residents' income level, the public's demand for nutrition and health increases, but the lack of popular science and nutrition education are important factors hindering the development of special medical food. Therefore, accelerating the popularization of special medical food in clinic and the public will be an urgent problem to be solved by all parties in the industry.
Shi Hanping suggested that in order to make special medical food play a greater role in the treatment, prevention and rehabilitation of diseases, we should first improve the understanding of nutrition, carry out science popularization and education, and let more patients and medical personnel understand the clinical efficacy of special medical food.