December 14, 2021 Longchang Chemical

First acquaintance with hyaluronic acid

Hyaluronic acid is the common name of hyaluronic acid. It is a non-sulfur linear mucopolysaccharide composed of disaccharide units D-glucuronic acid and N-acetylglucosamine. It is widely distributed in the connective tissue, epithelial tissue and nerves of the human body. Within the organization. In 1934, hyaluronic acid was separated from bovine vitreous by Karl Meyer and John Palmer of Columbia University.

In the current medical cosmetology industry, hyaluronic acid is widely used as a cosmetic filler. It is usually injected into the dermis to play the role of moisturizing, lubricating and shaping. In the field of micro plastic surgery, it can be used as rhinoplasty, chin filling, lip augmentation and Fillers such as anti-wrinkle, or as injection products for moisturizing water-light injections, occupy a major share of the medical aesthetics filler market.

Hyaluronic acid was first approved by the FDA in 2003 to be used for skin wrinkle treatment. Later, because of its water-retaining and water-locking functions, it has gradually been used for medical skin replenishment such as water-light acupuncture.

According to different molecular weights, hyaluronic acid can be divided into three categories: macromolecules, medium molecules and small molecules. Molecular weight is an important parameter. The functional application fields of hyaluronic acid of different molecular weights are different.

The world’s main source of hyaluronic acid raw materials

In 2018, my country’s sales of hyaluronic acid raw materials reached 430 tons, accounting for 86% of global sales, and the market size of raw materials reached 3.07 billion. From the perspective of product structure, domestic hyaluronic acid raw materials are mainly concentrated in low-value-added cosmetics and food grades, and high-value-added pharmaceutical-grade raw materials account for a low proportion.

In terms of sales volume, currently the TOP 5 manufacturers of hyaluronic acid raw materials in the world are all Chinese companies. According to the market share, they are Huaxi Biological (36%), Focus Biological (12%), Fufeng Biological (10%) , Dongchen Biological (8%) and Anhua Biological (7%).

The raw materials and end products of hyaluronic acid used in the medical beauty industry are required to be pharmaceutical-grade hyaluronic acid. The raw material manufacturer needs to obtain the qualification for the production of pharmaceutical-grade hyaluronic acid raw materials, and has technical indicators such as the purity of the raw material products, protein impurities, and heavy metal content. With higher requirements, pharmaceutical-grade raw materials only account for 2.3% of the total sales of domestic hyaluronic acid raw materials, which is far below the world average. The domestic production companies involved in this field are mainly Huaxi Biology and Zhongshan Biology.

Imported products dominate the domestic medical aesthetics filled hyaluronic acid market

The medical-grade hyaluronic acid terminal products in the medical beauty industry are mainly injection cosmetic filling products, and the added value of the products is high. The finished products need to be approved by NMPA Class III medical devices. In 2018, the market size of my country’s medical aesthetics filled hyaluronic acid reached 3.7 billion yuan, with a compound annual growth rate of more than 17%, becoming the main driving force for the growth of the domestic pharmaceutical-grade hyaluronic acid market.

At present, there are 27 injection products of hyaluronic acid for injection approved by NMPA certification in China, which belong to 14 companies, including 6 imported and 8 domestic companies. In comparison, the brand advantage of imported products is obvious, most of the products are priced higher than domestic products; the concentration of domestic imported products is between 20mg/ml~24mg/ml, and the concentration of domestic products is mostly 16mg/ml~ 20mg/ml In the meantime, most products can last for half a year to a year, and it usually takes half a year or a year to refill to maintain the plastic effect.

From the perspective of sales amount, the market size of the hyaluronic acid medical aesthetic terminal market in 2018 was 3.7 billion yuan. Korean companies and European and American companies accounted for the top two domestic market shares, and the combined market share of the two was 74.7%. Dominates the domestic medical aesthetics filled hyaluronic acid market. Representative companies are South Korean companies LG (25.50%), Humedix (13.20%), American Allergan (19.4%), and Swedish Q-Med (12.20%); local companies account for 23.4% The total market share of the company ranks third, and the main companies are Haohai Biological (18.4%), Amic (12.5%) and Huaxi Biological (11.5%).

The core differences of different brand products

The half-life of unmodified natural hyaluronic acid in the skin, eyes, joints and other parts ranges from about 1 to 21 days. This feature limits the application of hyaluronic acid in the medical aesthetics industry. Changing the characteristics of hyaluronic acid through the use of cross-linking agents and different cross-linking technologies can improve the filling and shaping ability of hyaluronic acid and the endurance time in the body to varying degrees.

However, this kind of cross-linking technology has a high threshold. While improving the performance of hyaluronic acid, it is also necessary to consider the safety of the product. In particular, the importance of safety far exceeds the improvement of product performance. According to reports, cross-linking agents that are not combined with hyaluronic acid can bind to DNA when they are free in the body, and are highly toxic and carcinogenic. In the actual production process, the residual amount of cross-linking agent needs to be controlled within a safe range. Inside. Therefore, cross-linking technology is the core difference between products of different brands and the focus of patent layout.

At present, the cross-linking agents used in FDA-certified hyaluronic acid filled products include BDDE (butanol glycidyl ether) and DVS (divinyl sulfone). BDDE is recommended and commonly used in the domestic medical aesthetics industry for cross-linking.

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