Recombinant Collagen Expect to See Booming Development in China
- Chaileedo Press
- May 25, 2023
- 3 min read
Updated: Jun 5, 2023
China NMPA released two announcements on the valuation principles of recombinant collagen to regulate the development of recombinant collagen biomaterials.
Recently, the National Medical Products Administration's Medical Device Technical Review Center announced the Guidance Principles for the Registration Review of Recombinant Collagen Wound Dressings and the Evaluation Guidance Principles for Recombinant Humanized Collagen Raw Materials (hereinafter referred to as the Evaluation Principles) for two medical device product registration review guidance principles to further standardize the management of recombinant collagen wound dressings and other medical devices.
"A unified evaluation method and standard for recombinant humanized collagen has finally been established, and the market's standardized development is imminent," said a cosmetics industry insider.
In recent years, recombinant collagen, as a new type of biomaterial made from synthetic biology technology, has attracted the attention of the cosmetics industry, capital markets, and consumers due to its good application scenarios in medical aesthetics and medical devices.
According to CHAILEEDO Intelligence data, the market size of China's recombinant collagen in 2022 was 18.5 billion yuan ($2.62 billion), an increase of 71.3% year-on-year. It is estimated that by 2027, the market size of recombinant collagen will reach 108.3 billion yuan ($15.32 billion). By product, functional skincare products accounted for 43% of the recombinant collagen market in 2022, and medical dressings accounted for 44%. It is expected that the recombinant collagen functional skincare products will overtake medical dressings in 2023 to reach 14.25 billion yuan.
With the market's rapid growth, the number of companies entering the recombinant collagen market has increased, and issues such as chaotic product naming and false efficacy claims have emerged. Many practitioners have publicly called on relevant departments to intervene as soon as possible, continuously update industry standards, and better regulate the development of the recombinant collagen industry.
Specifically, the Evaluation Principles point out that companies can use different analysis methods to fully identify the molecular weight, isoelectric point, amino acid sequence, and various post-translational modifications (such as deamidation, oxidation, glycosylation/glycation modification, proline hydroxylation, etc.) of the material, and conduct appropriate testing, providing corresponding test reports to confirm that the final product has the claimed raw material conformation, aggregation state, degradation state, and higher-order structure of collagen protein.
The head of R&D at a leading recombinant collagen company told CHAILEEDO that the main challenge for companies in the research and development of recombinant humanized collagen is to form the correct "triple helix" structure. CHAILEEDO learned that the triple helix structure of recombinant collagen is technically difficult to mass-produce at present. Some companies claim that their products have a triple helix structure but cannot provide a theoretical basis and proof, posing a risk of false advertising.
In addition, the Evaluation Principles also point out that when evaluating the biological function of recombinant humanized collagen, companies can evaluate the biological function of recombinant humanized collagen by assessing cell-collagen protein interactions and testing cell proliferation, differentiation, adhesion, migration, or translocation.
When recombinant humanized collagen is used as a raw material for the preparation of medical device products, the Evaluation Principles state that companies need to assess risks such as sensitization, skin irritation, and material-mediated pyrogenicity; if storage is involved in the production process of recombinant humanized collagen intermediates, corresponding stability studies should be conducted. In the research, sensitive characteristics that can reflect quality changes, such as content, integrity, purity, microbiological safety, and biological properties, should be studied.
In general, in addition to identifying methods and testing methods for different structures of recombinant humanized collagen, the Evaluation Principles also propose corresponding testing methods for purity determination, content detection, impurities/contaminants and additives, and thermal stability of the raw materials. Companies are required to choose suitable indicators based on different intended uses and application sites, different production processes, expected effects, and the final state of the medical device.
As can be seen, from the naming of recombinant collagen biomaterials and the establishment of industry standards to the evaluation guidance principles for recombinant humanized collagen and the registration review guidance principles for recombinant collagen wound dressings, the national level supervision of the recombinant collagen market is moving from comprehensive standardization to refined management. This is also an essential path for an emerging field to transition from explosive growth to high-quality, standardized development.
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