First, the growth of new structural types of products is promising.
According to the statistics in 2023, CAR-T, ADC, RNAi and other new structural types of products are growing rapidly, among which CAR-T products are growing at 60%-177%, antibody-coupled drugs (ADC) are growing at 14%-163%, and RNAi therapy enterprise Alnylam's RNAi therapeutic products are growing at 14%-45%. The growth of cell gene therapy is better, and it will be a faster growth track.
Second, cell gene therapy (CGT) research and development boom.
2019 is the starting point for the rapid development of China's CGT industry, CAR-T products, oncolytic virus products, AAV products and other cell gene therapy clinical trials continue to increase, according to statistics, China's GCT market size is expected to reach 17.9 billion yuan in 2025.
Following NMPA's approval of the first domestic CAR-T product Yidakai in 2021, and the first Class 1 new drug CAR-T product Benoda, in 2022, Reindeer Medical/Cinda Bio, Keji Pharmaceutical and Legendary Bio respectively submitted the listing application for the independently developed BCMA CAR-T products ikirencel, Zewerki Olencel and Sidagio Olencel. In 2023, three multiple myeloma CAR-T products are approved by the FDA, and if sales can reach expectations after commercialization, it is expected to stimulate more capital and participants to enter, which may further enhance the upsurge of CGT product development.
Third, the new trend of biomedical technology will reshape the industrial development pattern.
In 2023, some new trends in technology development may have a significant impact on the future direction of biomedical industry research: CRISPR-Cas gene editing technology; Enzymatic DNA synthesis; Drug delivery systems; Microecological therapy; mRNA drugs; Antibody-coupled drugs (ADCs); Xenotransplantation; CAR-NK cell therapy; Phage therapy; Bispecific antibodies.
Fourth, synthetic biology is blooming.
Synthetic biology has epoch-making significance, reflected in the subvert the cost plus advantage of the chemical industry from the bottom, the production of some products can reflect the absolute cost advantage, and the production process is fully in line with the "carbon neutral" requirements, in 2024, the target of synthetic biology will be more abundant, and there will be more synthetic biology companies listed.
Fifth, API enterprises are ready to meet the dividend of "volume procurement".
Although China is the largest API production and exporter, the overall product level needs to be improved, API enterprises to expand to CDMO/CMO, grab the early layout of imitation API, and API enterprises have production cost advantages to meet the dividend of "volume procurement", which will help rapid volume expansion in 2024.
Sixth, the localization of upstream life sciences has entered a new stage of industry development.
The upstream industry chain of life sciences has a large demand for biologics, raw material consumables and test equipment, etc. Since 2019, under the dual promotion of their own technological development and the development opportunities brought by the external environment, the revenue of the head companies in various segments has grown rapidly.
Under the environment of emphasizing autonomy and control and domestic substitution and the promotion of biopharmaceutical Localization Federation (BLA), biopharmaceutical localization substitution companies are expected to continue the rapid development trend in 2024.