Aminolevulinic Acid

Photodynamic therapy is an important minimally invasive treatment for proliferative diseases such as skin cancer and condyloma acuminatum at present. As a second-generation photosensitizer prodrug, aminolevulinic acid is an endogenous porphyrin synthesis precursor, which has no photosensitivity itself. After entering lesion cells, it can be metabolized into protoporphyrin IX with strong photosensitive activity through the heme synthesis pathway. After being irradiated by light of a specific wavelength, it generates reactive oxygen species, which selectively kill lesion cells with minimal damage to surrounding normal tissues. At present, it is mainly used clinically in the photodynamic therapy of condyloma acuminatum, basal cell carcinoma and actinic keratosis, and can also be used as an adjuvant for the local treatment of moderate to severe acne. Its applicable population covers patients of all ages with no history of porphyrin allergy who meet the indications, and it is one of the core medications for photodynamic therapy in dermatology.

The global market size related to aminolevulinic acid was approximately USD 320 million in 2023, and the compound annual growth rate is expected to remain at 7.8% from 2024 to 2030. The growth drivers mainly come from the rising prevalence of skin cancer and the continuous expansion of indications for photodynamic therapy. In terms of the domestic market, the sales of aminolevulinic acid preparations at the terminal of public medical institutions exceeded RMB 1.2 billion in 2023. At present, the original research product occupies nearly 90% of the market share, and only 3 domestic enterprises have been approved for generic preparations, leading to a large supply gap of APIs. With the popularization of photodynamic therapy in primary medical institutions, there is sufficient space for generic drug substitution in the future.

The original research enterprise of aminolevulinic acid is PharmaLight Biologics, a Danish company, with the original brand name "Levulan". Its core compound patent expired in major global markets in 2016. The main dosage form approved for the original research product is topical powder, with a specification of 354 mg per bottle. It has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *Collection of Chemical Drug Catalogs* in China. As of now, a total of 2 domestic enterprises have obtained CDE registration numbers (status A) for aminolevulinic acid APIs, and 3 domestic generic topical aminolevulinic acid hydrochloride powders have been approved for marketing. The original research product has not yet been approved for import in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for aminolevulinic acid APIs. Most products are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of different scenarios such as API research and development, quality research, and consistency evaluation.