This special medical food has been approved! China's special medical food market is less than 1% of the world, and this sea is "special" blue!

On August 3, 2018, the State Administration of Market Supervision and Administration approved the registration of one enterprise with a total of one formula food for special medical purposes. Now published as follows. As a professional event in the health and nutrition industry, China Health and Nutrition Expo will continue to pay attention to key industry information such as health food, health food, and special medical formula food (special medical food).



In recent years, the field of formula foods for special medical purposes (referred to as special medical foods) has just started and has great potential, and has been regarded as another blue ocean in the field of health. What is a special medical food? What is the difference between it and health care products? What are the enterprises in the layout? Why is it the drugstore to be developed gold? Xiaobian will tell you.


Special medical food-the forerunner of nutritional therapy


Special medical food is widely used, which can be embedded in the nutritional supplement and balanced nutrition of various diseases, and is different from the general nutritional supplement. According to the characteristics of the disease, it is a comprehensive and balanced supplement of nutrition, which belongs to the category of nutritional treatment, and does not increase the extra burden on the body.


Food for Special Medical Purpose (FSMP), referred to as special medical food, refers to the formula food specially processed to meet the special needs of people such as restricted eating, digestion and absorption disorders, metabolic disorders or specific disease states for nutrients or diet. Its production standard is higher than that of health care products and lower than or equal to that of drugs.


According to different clinical needs and applicable people, the General principles of Formula Food for Special Medical purposes (GB29922-2013) divides these products into three categories, namely, full nutrition formula food, specific full nutrition formula food (diabetes, respiratory disease, kidney disease, tumor and other full nutrition formula food) and non-full nutrition formula food (whey protein, peptide powder, etc.).


Special medical food VS health food


"Special medical foods and health products have similar functions," said Gu Xinxin, general manager of Nestle Health Sciences Greater China. "However, special medical foods must be used under the guidance of clinicians or clinical nutritionists".


Gu Xinxin introduced that in China, the incidence of malnutrition in cancer patients is about 70-80%. For these patients, ordinary foods cannot meet their clinical needs, and special medical foods are developed for their nutritional needs. Experts believe that nutritional intervention plays an important role in the recovery of diseases. Special medical food can reduce the hospitalization time of patients, reduce the readmission rate, and reduce the infection of patients during hospitalization.


Special medical food event


On July 1, 2016, the "Administrative Measures for the Registration of Formula Foods for Special Medical Purposes" (hereinafter referred to as the "Measures") was formally implemented, filling the gaps in the relevant regulations of special medical foods in my country. It has also become the perfection and supplement of another major category of pharmacies, and has become a new category that is significantly separated from the current health products and ordinary foods.


In April 2017, the State Food and Drug Administration (CFDA) established the Special Food Registration Management Department to open a new chapter in the registration management of health food, special medical purpose formula food (FSMP) and infant formula food.


In November 2017, the State Food and Drug Administration recently issued the "Announcement on Adjusting the Transition Period of Registration and Administration of Formula Foods for Special Medical Purposes" (2017 No. 139). The announcement made it clear that the transition period for the registration and management of special medical food was also extended from January 1, 2018 to January 1, 2019.


In May 2018, Zhang Mao, director of the reorganized State Administration for Market Regulation, said in an interview that he would strive to achieve full coverage of infant formula products for special medical purposes under 1 year old by December 31 this year. At present, only 6 special medical foods have been approved. But during the transition period, there are many excellent products in circulation with food font size.


With the introduction of the policy, it will further regulate the special medical food market, and at the same time promote the capital operation of the special medical food field. More international brands will enter China, and the Chinese special medical food field will enter the brand Warring States period.


Market space of special medical food


Special medical food in Europe and the United States and other developed countries, has more than 20 years of development history, forming a complete industrial system. According to statistics from the China Nutrition and Health Food Association, the global annual consumption of special medical foods ranges from 56 billion yuan to 64 billion yuan, and the market size is increasing at an annual rate of 6%. Among them, the annual consumption in Europe and the United States is about 400-50 billion yuan, Japan and South Korea reach 150-22 billion yuan, while China's current market size only accounts for 1% of the world, about 0.6 billion yuan, which is far from meeting the market demand.


On the other hand, according to agency statistics, the demand for special medical food in my country (2011 to 2017) rose from 6500 tons to 36600 tons, an increase of more than 4.63 times; the output of special medical food also rose from 2000 tons to 24700 tons, an increase of nearly 11.4 times.


Which companies have been laid out?


According to statistics, more than 90% of the domestic special medical food market share is monopolized by multinational (joint venture) companies, including Nuditia, Huarui Pharmaceutical, Abbott Pharmaceutical, Nestle, etc.


It is reported that there are more than 30 enterprises involved in the field of special medical food in China, but only a few enterprises can do the research and development of product characteristics, and there is still a big gap between the products and foreign enterprises in terms of tonality, taste and taste.


At present, in addition to Nestle, Mead Johnson, Beinmei and other large dairy enterprises, Stone Pharmaceutical Group, Hengjin Pharmaceutical and other pharmaceutical enterprises have also begun to layout the market.


Nestlé's new factory in Taizhou has been completed. According to the plan, this factory will produce liquid special medical food products for Nestle Health Sciences, with an investment of more than 1 billion yuan in the first phase of the project. Nestle said the Taizhou plant is one of its most modern and technologically advanced plants in the country.


Other multinational dairy companies are also trying to seize the domestic specialty medical market. On April 22, Mead Johnson announced the introduction of a 75-year-old special medical product Anmin Jian LGG from the United States, further in the field of special medical food. Mead Johnson revealed that the product is actively preparing to apply for formula registration. Not long ago, Danone Group's special food professional enterprise Nudisia and China Women's Foundation jointly promoted its phenylketonuria formula product Periflex from the perspective of public welfare.


In addition, Jianhe Group, Shengyuan International and Beinmei have also submitted applications for registration of their own special powder formula. Among them, Beinmei's lactose-free formula for infant formula for special medical purposes has become the only approved special medical product in China. For the major dairy enterprises, their own special medical and infant food has seized the market share in the first time.


In addition, pharmaceutical companies with strong research and development strength and GMP have also begun to lay out the field of special medicine.


At the end of 2017, New Novo Pharmaceuticals Co., Ltd., a subsidiary of CSPC, submitted an IPO application to the CSRC to be listed on the GEM. According to its prospectus, the company will invest 0.46 billion yuan to be used in the construction of health food and special medical food production projects. After the completion of the project, the relevant production capacity will be greatly improved-including the new "production capacity of 50 million bags of special medical formula food powder and 50 million bottles of special medical formula food nutrient solution".


In November 2017, Jilin Hengjin Pharmaceutical Group invested 0.15 billion yuan to establish a traditional Chinese medicine and special medical food processing and production project in Hubei. He said that he would take advantage of the existing industrial foundation of Jilin Hengjin Pharmaceutical, take the big health and medical industry as a breakthrough, and strive to enter the domestic capital market within three years.


"Two Children" and "Chronic Disease" = Pharmacy Optimization


With the liberalization of the "second child" policy and the increase in the number of newborns, the sales of commonly used drugs in pediatrics will rise to a certain extent, which is due to the rigid demand of "disease". In this area, we will increase the variety of special medical food in pediatrics to solve its pain points such as anorexia, disease consumption, disease nutrition supplement and so on.


With the aging of the population and the improvement of living standards, the "stalls" of people with chronic diseases will increase, and there are many growth opportunities that can be tapped in this market. The chronic diseases of the elderly are characterized by reduced eating, weight loss, metabolic disorder caused by diseases, etc., while special medical foods are targeted to solve the nutritional problems of limited eating, digestive and absorptive disorders, metabolic disorders or specific disease states.


At this stage, the pharmacy volume category (all kinds of drugs, rigid demand) has been completed, non-brand high-wool product system has also been completed. Varieties that have not yet fully met the demand are the preferred categories for drugstore category construction, and are also the direction for drugstores to cultivate new kinetic energy.


Special medical food is not only a variety that has not yet met the demand, but also a variety that cultivates new kinetic energy and new growth points. Specific service mode, according to the advantages of their pharmacies, special medical food is grafted into the daily operation of pharmacies. In the next 5 years, special medical food is a new category growth point for pharmacies, which will have a far-reaching impact on pharmacies in the future, and it is worth the advance layout of pharmacies.


The professional special medical food trading platform is coming.


In the face of such a vast blue ocean, China Health and Nutrition Expo has specially set up a special medical formula (FSMP) exhibition area, inviting domestic and foreign enterprises engaged in the research and development, production and sales of special medical formula, infant special medical formula, enteral nutrition support equipment and equipment to participate in the exhibition, gather industry forces, jointly publicize and promote the knowledge and concept of special medical formula, and expand its influence, together to expand and strengthen the whole industry of special medical use formula food.


Prescription Food for Special Medical Purposes (FSMP)
Guangzhou China Import and Export Commodities Fair Exhibition Hall
You are cordially invited to join!


Display content
Formula food for special medical purposes
Infant Formula for Special Medical Purposes
Enteral nutrition support equipment


Audience composition
Pharmaceutical distributors and agents with vast hospital resources
More than 45% of the country's chain pharmacies purchase


Article reference source: General Administration of Market Supervision and Administration, China Pharmacy, Special Medical Food Research and Development Frontier Dynamics, Pharmaceutical Geography, Pharmaceutical Merger and Acquisition Circle, NetEase Finance and Economics, China Science Popularization Network.