In recent years, with the rapid development of biomaterials science, agarose, as a natural polysaccharide, has shown unique application value in the field of tissue engineering scaffold construction and cosmetic filling materials. Its adjustable molecular structure, excellent gel properties, and controllable degradation properties make it an important alternative to traditional synthetic materials. In this paper, the chemical composition, gel formation mechanism, and degradation kinetics of agarose are systematically sorted out, and its competitive advantages in clinical application are revealed through comparative analysis with mainstream filling materials. At the same time, combined with the latest market trends, the development prospects of this material in the field of medical aesthetics and regenerative medicine are prospected.

1. Overview of
agarose Agarose, also known as agar, is a chain neutral polysaccharide proposed from red algae, which does not contain or contains a small amount of sulfate salts, and is the main component of agar. It has high gel strength at low concentrations, is a nearly transparent gel matrix, and is stable against microorganisms, so it has a wide range of uses in the fields of biochemical and medical research. Agarose can not only be used biochemically as a support for gel electrophoresis and a carrier of affinity chromatography, but also medically used for the study of viral bacterophiles, bacteria, clinical testing, biochemical analysis, proteins, nucleic acids, antigens, antibodies, and the separation, purification and preparation of drugs of polysaccharides.

1. Chemical composition and molecular configuration
Agarose is a natural polysaccharide extracted from red algae, the main components of which are D-galactose and 3,6-dehydrated-L-galactose, linked by α-(1→3) and β-(1→4) glycosidic bonds. This particular disaccharide repeat unit imparts an alternating distribution of the rigid backbone and flexible regions of the molecular chain, presenting a typical spiral conformation in X-ray diffraction analysis. The molecular weight range is usually between 80,000-120,000 Da, and its purity index is based on sulfate content as the core parameter, and the sulfate residue of high-quality products can be controlled below 0.2%.

2. Gel formation mechanism
At 90~100°C, the hydrogen bonds between the agarose structural units are broken, and the agarose is dispersed into water in the form of random curls to form a clarified solution. When the temperature drops to 30~40°C, the agarose molecular chains are intertwined with each other through hydrogen bonds, forming a tightly arranged double helix structure to form a gel. The gel has a water content of up to 99% and strong water absorption capacity, making it suitable for maintaining a moist tissue environment. The driver of gel formation is hydrogen bonding, which connects the hydroxyl and oxygen atoms of the agarose molecule. This process does not involve covalent bonding, explaining the reversibility of the gel.

3. Degradation Pathway
• Agarose can be degraded by enzymatic hydrolysis, relying on agaroses such as α-agarosese and β-agarosese to break down its glycosidic bonds.
• The degradation of agarose in organisms is mainly cleared by macrophages and metabolized intracellularly through the pentose cycle.

4. Comparison
with Existing Filling Materials Agarose is similar to HA in terms of water absorption and shaping, making it suitable for applications such as facial fillers, but its biocompatibility and natural origin may offer additional advantages over other materials. The non-hydrophilic properties reduce the risk of swelling, providing a "what you see is what you get" effect.

Characteristics	Agarose fillers	Hyaluronic acid filler	Polylactic acid fillers	Hydroxyapatite filler
Efficacy (change in WSRS, 3 months).	-1.1	-1.1	Incremental improvement without direct data	Immediately visible, no direct data
Duration	3-18 months concentration correlation).	6-18 months	1-2 years or more	1-2 years
Shaping power	Forms a tough gel that can be injected and is suitable for areas that require support	Highly fluid, easy to inject and shape, widely used for facial fine lines and wrinkle filling	Used in suspension form with medium shaping power	It is usually in granular or solid form and has poor shaping power
Swelling rate	Low (non-hydrophilic)	High (15-20%)	low	low
Applicable parts	Facial filling, tissue engineering	Facial fillers, joint lubrication	Facial volume recovery	Orthopedic/Dental Prosthetics, Facial Fillers

5. Clinical study
• A study involving 700 patients showed that agarose gel had high safety and efficacy in facial enhancement, with 82% of patients scoring 1 or 2 (excellent or significantly improved) on the Global Aesthetic Improvement Scale (GAIS) and 85% of patients having a satisfaction score of 8 or above.
• Another comparative study found that 2.5% agarose gel was comparable to NASHA-L (a hyaluronic acid filler) in correcting nasolabial folds, with similar WSRS and GAIS scores, and a return to baseline began after 7-8 months.

2. Market Size and Competitive Landscape
The dermal fillers market is expected to reach $14.8 billion by 2032 at a growth rate of 10.5%, driven by an increasing aging population and growing demand for non-invasive aesthetic procedures (Dermal Filler Market Trends | Industry Forecast Report, 2032)。 Hyaluronic acid fillers currently dominate, but agarose is emerging as an alternative option due to its biodegradability and natural origin.

Key Market Players:
1.Advanced Aesthetic Technologies, Inc. (AAT).
Company Profile: AAT is a fast-growing multinational company headquartered in Boston, USA, focusing on biotechnology research and development in the field of aesthetic medicine. Product Layout: Its flagship product, the Algeness® series, has been developed over 15 years of scientific and clinical research, aiming to provide high-quality and safe filler solutions for doctors and aesthetic patients. Algeness®VL is a product in this series, which has obtained EU CE certification and is available in more than 40 countries and regions around the world.

2. Lanzhou Biotechnology Development Co., Ltd. Company Profile: Lanzhou Biotechnology Development Co.
, Ltd. is affiliated to China National Pharmaceutical Group and is an important platform of Sinopharm in the medical aesthetics sector, mainly engaged in the production and sales of biological products and medical toxic drugs (including botulinum toxin type A), as well as medical devices, cosmetics and other fields. Product layout: On January 20, 2025, its agent "Algeness®VL Agarose Facial Injection Filler" officially obtained the registration license for imported Class III medical devices issued by the State Medical Products Administration. This is the first agarose-based injection filler material in China, which is mainly used for injection on the surface of the periosteum of the nasolabial folds of the face to correct moderate to severe nasolabial folds.

3. Shanghai Petal Biotechnology Co., Ltd

Company Profile: Shanghai Petal Biotechnology Co., Ltd. is a joint venture company established in 2023 by Liaoning Dema, Wuhan Xiruiyan and Bellong Biotech. With agarose as the core, Petal Biotech is committed to its innovative R&D and application expansion in many fields, including medical products, biomanufacturing tools, cosmetics and food. Product layout: Its first injectable agarose filler AG15 has successfully completed R&D output and entered the clinical registration stage. AG15 contains 1.5% injectable agarose, which can be used for the treatment of moderate to severe wrinkles in multiple parts of the face, neck, hands, etc., and has the advantages of high biocompatibility, long-lasting, non-embolism, no cross-linking, softness, and non-water absorption.

3. Product technology and industry dynamics
Product Overview:
1. Algeness ® series
Algeness is developed by Advanced Aesthetic Technologies and distributed in the UK by Wigmore Medical. It entered the UK market in 2015 and is the first product of its kind on the market. On January 20, 2025, Lanzhou Biotechnology Development Co., Ltd.'s agent product, Algeness®VL, obtained the registration license for importing Class III medical devices (National Machinery Injection 20253130037) from the State Medical Products Administration, which is the first officially approved agarose-based injection filling material in China.
Algeness contains 1.5 to 3.5% agarose, a polysaccharide polymer derived from red algae, 96 to 98.5% sterile saline and 0.5% non-cross-linked hyaluronic acid (HA). In the product range, it is used for injections of fine lines and wrinkles, for lip contouring, as well as for medium and deep reshaping of the face. The effect lasts up to 12 months.
Product Type:
• Algeness HD (1.4 mL subcutaneously) consists of 1.5% low-density agarose and 98.5% sterile saline, primarily used to treat wrinkles, marionette lines, and wrinkles, as well as lip augmentation, lip contouring, and treatment of wrinkles near the mouth (corners of the mouth). Treatment lasts from 4 to 8 months.
• Algeness VL (Subcutaneous 1.4 mL) consists of 2.5% low-density arose, 97% sterile saline, and 0.5% non-cross-linked hyaluronic acid for medium to deep volumizing treatments to treat cheeks, chin, jawline. It can also be used as an alternative to rhinoplasty or non-surgical rhinoplasty. Injectable treatments last 8 to 12 months.
• Algeness DF (Deep Volumizing 1.4ml) with 3.5% low-density arose, 96.1% sterile saline, and 0.4% non-cross-linked hyaluronic acid is a deep volumizing product that is ideal for the chin, cheeks, deep volumizing fillers, and nasolabial folds. Treatment can last 8 to 12 months, and in some cases longer

Product Advantages:
Naturally degradable: It has natural degradable properties and can gradually degrade in the body after injection, avoiding the long-term risks that may arise from permanent fillers

Non-absorbent: Unlike traditional hyaluronic acid fillers, Algeness®VL is non-absorbent, which allows doctors and consumers to have more direct control over the results and avoid volume changes caused by water absorption.

Low embolism risk: Agarose gel has good dispersibility in the body, and even if it accidentally enters the blood vessel, the risk of embolism is extremely low, further improving the safety of injection operations.

Long-term and stability: Due to the lack of enzymes that degrade agarose in the body, Algeness®VL has a longer degradation time and long-lasting effects, usually lasting 8-12 months.

Adjustable texture for a wide range of applications: The hardness and concentration of Algeness®VL can be adjusted according to needs, making it suitable for a variety of filling needs, from shallow to deep, such as fine lines, lips, nasolabial folds, chin, etc.

Mild Post-Injection Reaction: After injection with Algeness®VL, the swelling is usually mild, the effect is immediate, and it is well tolerated by patients.

Registration certificate information

Registration certificate number	The national equipment is injected into the 20253130037
Name of the registrant	Jimei Sheng Co., Ltd. GHIMAS S.p.A
Residence of the registrant	Via Cimarosa, 85 40033 Casalecchio di Reno   ( BO ) Italia
Production address	Via Cimarosa, 85 40033 Casalecchio di Reno   ( BO ) Italia
Agent Name	Lanzhou Biotechnology Development Co., Ltd
Agent address	No. 888, Yanchang Road, Yanchang Road Street, Chengguan District, Lanzhou City, Gansu Province
Product Name	Agarose Facial Injection Filler ALGENESS VL
Manage categories	Category 3
Model specifications	Model: Algeness VL, Specification: 1.4ml/bottle
Structure and composition/main components	The product consists of a syringe with a pre-filled filler, an empty syringe connected by a connector, an end cap, and an injection needle. The filler is composed of agarose, non-crosslinked sodium hyaluronate, sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate and water for injection, of which agarose is extracted from seaweed and the labeled concentration is 25mg/mL, and sodium hyaluronate is prepared by microbial fermentation with a labeled concentration of 5.75mg/mL. The 27G x 3/4" needle is made of 304 stainless steel and is available in quantities of 4. The syringe containing the gel, the empty syringe connected by a connector, the end cap is sterilized by gamma rays, and the syringe is sterilized with ethylene oxide. The product is for single use and the product is valid for 11 months.
Scope of application/intended use	This product is suitable for superficial injection of periosteum in the nasolabial folds of the face to correct moderate to severe nasolabial fold wrinkles.
Product storage conditions and expiration date
Annex	Product technical requirements
Other content	/
Note:	/
Approval department	State Medical Products Administration
Date of approval	2025-01-20
Effective date	2025-01-20
Expiration date	2030-01-19
Changes
Note

2. Anroumei (Aga-FILL).

Aga-FILL (Agarose Gel AG15 for injection) is a new generation of medical aesthetic injection product independently developed by Petal Biotech, and is the first self-developed agarose filler for injection in China.

AG15 contains 1.5% injectable agarose, which can be used to treat moderate to severe wrinkles on various areas such as the face, neck, and hands. AG15 has the advantages of high biocompatibility, long-lasting, non-embolism, no cross-linking, softness, and non-water absorption, avoiding some technical shortcomings of traditional fillers. Currently, AG15 has entered the clinical stage and is expected to obtain registration in 2026.

Product advantages

High biocompatibility: As a natural polymer material, agarose can form a stable gel structure without crosslinking agents, effectively avoiding potential safety hazards caused by crosslinker residues.

Long-lasting: The effect can last for more than 12 months.

No embolization, no cross-linking: It has a low embolization risk, further improving the safety of injection operations.

Soft and non-absorbent: Agarose gel has good shaping ability and instant results, which can meet doctors' needs for precise injections and personalized shaping.

4. Global regulatory developments

European Union

In the European Union, dermal fillers are classified as Class III medical devices under the Medical Device Regulation (MDR, EU 2017/745) and are subject to certification by a notified body. In 2012, Algeness was CE marked for sale in Italy, initially for therapeutic use and recently expanded to aesthetic use, in compliance with the requirements of Annex XVI. This makes it legally available for sale and use in EU member states.

China

On December 23, 2024, the "Agarose Gel for Injection" submitted by Shanghai Beirong Biogenetic Engineering Co., Ltd. was defined as a Class III medical device by relevant departments, with a classification code of 13-09-02.1.

According to the Regulations on the Supervision and Administration of Medical Devices, the Classification Rules for Medical Devices, the Classification Rules for In Vitro Diagnostic Reagents, the Classification Catalogue of Medical Devices, the Catalogue of Class I Medical Devices, the Classification Catalogue of In Vitro Diagnostic Reagents, and the Guidelines for Classification and Definition issued by the State Medical Products Administration, agarose gel for injection is defined as three types of medical devices, mainly for the following reasons:

Ø Implanted in the human body: Agarose gel for injection is used for the treatment of moderate to severe wrinkles in multiple parts of the face, neck, hands, etc., and is a medical device implanted into the human body.

Ø High risk level: The product needs to pass rigorous clinical verification to ensure its safety and efficacy. Class III medical devices usually carry high risks and require strict review and approval by the national drug administration.

Biocompatibility and Safety: Agarose gels for injection offer advantages such as high biocompatibility, no crosslinkers, low risk of embolism, enzymatic hydrolysis, flexible filling, and long-lasting properties, which make them require strict control during use to ensure safety and efficacy.

January 20, 2025Algeness®VL "Agarose Facial Injection Filler" represented by Lanzhou Biotechnology Development Co., Ltd. has obtained the registration license of the National Medical Products Administration of China to import Class III medical devices, and the registration certificate number is 20253130037 National Machinery. This is the first officially approved agarose-based injection filling material in China.

United States

Currently, FDA-approved filler materials do not include agarose-based products. Advanced Aesthetic Technologies is advancing clinical trials for Algeness®VL and is preparing to submit a marketing application to the U.S. FDA.

Japan and South Korea

Although agarose products have not yet become popular in the Japanese and Korean markets, medical professionals have begun to pay attention to and evaluate such products. South Korea's Koru Pharma Company obtained a patent for a new filler technology based on agarose and hyaluronic acid in March 2025. In the field of Japanese medical aesthetics, agarose fillers have also begun to attract attention. Japanese doctors refer to Algeness as an "agar filler" (agar filler), indicating that medical professionals in Japan have begun to come into contact with and use this product. Some Japanese doctors said that after understanding the properties of agarose fillers, they plan to try it first on their own faces, and then gradually introduce it into clinical practice. Especially when it comes to rhinoplasty applications, agarose fillers may perform better. In view of its mature hyaluronic acid filler product system, the competition in the Japanese and Korean markets will be more fierce in the future.

5. Market challenges and future prospects

Technical Focus: Research focuses on optimizing the physicochemical properties of agarose, such as gel strength and uniformity, to enhance clinical efficacy, especially in the application of facial injectable gels.

Market level: Establishing an ISO standard system for medical-grade agarose has become a top priority. There are still batch differences in key indicators such as gel strength and endotoxin content of existing products, which restricts their application in Class III medical devices.

Regulatory Approvals: Approvals are not yet available in key markets like the United States, making the approval process complex and time-consuming. For example, Algeness plans to submit it to the FDA for approval in 2025, but it has not yet passed.

Competitive pressure: In the field of beauty fillers, agarose competitors and main substitutes are short-lasting mainstream filler hyaluronic acid products. The two have similar effects, and agarose is expected to solve problems such as steaming, embolization and crosslinker residues. However, the market for hyaluronic acid (HA) fillers is mature, and agarose needs to prove its unique advantages. Studies have shown that its safety and effects are similar to HA, but market acceptance still needs to be improved.

6. Conclusion

As a representative of the third generation of medical aesthetic filling materials, agarose is reshaping the technological landscape in the field of soft tissue filling with its unique molecular properties and engineering transformation potential. Its advantages are not only reflected in the breakthrough of basic physical and chemical properties, but also in the multi-dimensional balance of biosafety, functional durability and clinical operation convenience. However, as a new type of medical aesthetic product, the market awareness and acceptance of agarose still need time to cultivate, and the quality management system and risk control mechanism need to be further improved.

References:

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7. Data from the State Food and Drug Administration