Collagen Registration Certificates Increase But Remain Insufficient, Industry Still in Growth Phase: CITIC Securities

Stock News
Dec 30, 2025

CITIC Securities released a research report stating that from a demand perspective, consumers have strong awareness and robust demand for collagen. From a supply perspective, registration certificates for both natural collagen and recombinant collagen are on a trend of increasing. In the short term, the total number of registration certificates is within a reasonable range, but the number of products actually launched and scaled up is limited, with overall prices remaining high. Supply has not yet fully met consumer demand, indicating the industry is still in a growth phase where certificate holders can find suitable market positions. In the medium term, as the number of certificates increases, brands with strong product differentiation will become competitive, with differentiation highly dependent on materials and the underlying technology and processes. In the long run, competitive differences stemming from the products themselves will likely narrow among brands. In a flourishing and diverse market landscape, the comprehensive strength of "product + channel + marketing" is expected to play a more significant role.

Head Leopard Research Institute estimates that, calculated at ex-factory prices, the size of China's medical aesthetics injectable market will be approximately 26.8 billion yuan in 2024, representing a year-on-year increase of 26.4%. This market is projected to expand to 65.3 billion yuan by 2028, with a Compound Annual Growth Rate (CAGR) of +24.9% during this period. Furthermore, collagen-based products within this market are forecasted to achieve a CAGR of +50.7% from 2024 to 2028. Based on company announcements, the structure of the medical aesthetics channel, and standard business models, it is estimated that the combined ex-factory revenue of the top two leaders in collagen-based medical aesthetics injectables will be around 1.5 billion yuan in 2024, corresponding to an end-market scale of approximately 5.4 billion yuan. The total end-market scale for genuine products is estimated to be between 6 and 7 billion yuan. Overall, collagen-based medical aesthetics injectable products are priced relatively high, and current consumer demand is not yet fully satisfied.

As more registration certificates are granted and products are launched into the market, it is anticipated that a product ladder will form with high-end (>10,000 yuan per dose), mid-range (4,000-6,000 yuan per dose), and low-price (500-2,000 yuan per dose) tiers. This will cater to the needs of various consumers and significantly increase the penetration rate of medical aesthetics procedures. Simultaneously, it will boost the proportion of collagen-based injectables within the broader category of medical aesthetics biomaterials.

In the natural collagen segment, four new registration certificates were approved in 2025. New products are innovating across multiple dimensions such as materials, indications, and concentration, leading to differentiated pricing. The industry is entering a phase of scaled expansion. According to the NMPA website, the natural collagen sector currently has 10 registration certificates approved for 7 companies, with 4 new additions since early 2025: two from Keruikang Biology, one from Aibairui Biology, and one from Chongshan Biology. Analysis of existing certificates shows: 1) By material source: 4 certificates (approx. 40%) are for products derived from porcine skin; 5 (50%) from bovine skin; and 1 (10%) from bovine Achilles tendon. 2) By application site: 6 certificates (60%) target nasolabial fold correction; 3 (30%) the forehead; currently only 1 certificate each exists for the cheek and nose areas. 3) By type: Products are predominantly Type I collagen, with 8 certificates (80%); 2 certificates (20%) are for Type I+III combinations. 4) By cross-linking: 7 certificates (70%) are for non-cross-linked products; 3 (30%) are for cross-linked products. 5) By specification: Volumes are concentrated at 0.5ml and 1.0ml, with the largest single dose being 2.5ml from Keruikang Biology. 6) Pricing is wide-ranging: Different specifications and products are priced from 2,000 yuan to nearly 20,000 yuan.

Industry leaders are actively expanding into the natural collagen field through mergers, acquisitions, and agency agreements. Previously approved products have been constrained in scaling up due to factors like production capacity, processes, channels, and marketing capabilities. New products approved since 2025 are expected to break through limitations related to material sources, formulations, processes, and concentrations, potentially driving rapid volume growth for natural collagen.

Currently, the number of approved and commercially available recombinant collagen products is limited, allowing newly approved brands to secure favorable market positions. While there are many projects in development and under application, homogeneity is a significant issue; only products with strong differentiation are likely to succeed in the future. Long-term success will belong to companies with strong comprehensive capabilities in "product + channel + marketing," coupled with appropriately diversified and synergistic business operations. According to the NMPA website, as of December 2025, China has approved 5 Class III medical device certificates for recombinant collagen medical aesthetics injectables (Giant Biogene: 1, Jinbo Bio: 3, Chuangjian Medical: 1). By type, Jinbo Bio's 3 certificates and Chuangjian Medical's 1 certificate are for Type III collagen, while Giant Biogene's first certificate is for Type I collagen. Based on incomplete information from company announcements, the NMPA website, and sources like the Medactive WeChat public account, it is believed that a low single-digit number of new products (including from Giant Biogene, Chuangjian Medical, Taiyuan Biology, Juyuan Biology, etc.) might receive approval in 2026.

Regarding projects under application and in development, currently known initiatives are primarily focused on Type III collagen, utilizing lyophilized, solution, and gel formulations, indicating high similarity. However, looking ahead, it is anticipated that companies will intensify R&D efforts in areas such as different collagen types (e.g., Type XVII, Type VII), amino acid sequences (full-length vs. fragment), spatial structures (triple helix or multi-helix), and composite use with other biomaterials. Consequently, the current focus should be on early beneficiaries of certificate approvals and market launches. Future attention should shift more towards product differentiation and innovation, while the long-term view requires assessing companies' comprehensive strength across product, marketing, and channels.

Risk factors include stricter approval policies for collagen products and failure to meet industrialization expectations; rapid increase in supply of collagen medical aesthetics products leading to intensified competition and lower-than-expected profitability across the industry chain; potential negative publicity affecting collagen medical aesthetics products and industry development; economic weakness dampening discretionary consumption like medical aesthetics; and technological advancements leading to new biomaterials diverting or replacing existing collagen materials.

Investment strategy: Technologies and processes for both natural and recombinant collagen are continuously advancing, with application scenarios constantly expanding. The gradual increase in approved collagen products will lead to richer indications, a more complete pricing ladder, and an expansion of the consumer base alongside higher penetration rates. Currently, although the number of registration certificates for both natural and recombinant collagen products is increasing, the market is far from saturated. Companies have opportunities to benefit from the growing industry pie and can find their niche within the medical aesthetics market. Recommendations include: 1) Companies with recombinant collagen lyophilized fiber certificates expected to launch in the first half of 2026, and with recombinant collagen solutions and gels potentially approved in 2026, potentially forming a second growth curve. 2) Companies that have entered the natural collagen field through acquisitions, with related Class III medical device R&D and clinical trials progressing steadily, poised to become new forces in the existing biomaterials portfolio upon future approval. 3) Companies with strong pharmaceutical R&D and regulatory review experience, simultaneously developing natural and recombinant collagen through both agency agreements and in-house research.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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