Domestic bioprocessing technologies to watch
As the biopharmaceutical market expands, small-scale technologies that are essential to the production process are gaining attention. In particular, some of the technologies are world-class by domestic companies.
Bio small parts are materials, parts, and equipment utilized in the R&D, production, and service stages of the bio industry. According to a report by the KDB Future Strategy Institute's Industrial Technology Research Center, the demand for biopharmaceuticals has led to a sharp increase in production scale, and the small parts industry, which is essential to the production process, is also growing.
The global market size of cell culture media and reagents is expected to expand from $5.032 billion in 2019 to $7.447 billion in 2024. Single-use bags are expected to grow from $1.869 billion in 2020 to $6.529 billion in 2028.
However, five global companies control more than 75% of the total market. Domestic bio companies import more than 90% of raw materials. Only 16% of equipment is localized. Merck Group of the U.S. is considered the No. 1 company with a share of about 25%, while Cytiva of the U.S. has grown to become the world's No. 2 bioprocessing company through strategic alliances and mergers and acquisitions (M&A), and Danaher of the U.S. acquired Pal Corporation in 2015 to become the world's No. 3 bioprocessing company.
Germany's Sartorius is also ranked fourth with a 9.9% share of the bio small parts market, thanks to its strategy of expanding its business through high-quality products. US-based Thermofisher has gained competitiveness through M&A and continuous new product launches, while Japan's Asahikasei has secured a monopoly on virus filters used in bioprocessing.
Domestic biosorption companies are less well-known and lack government support, but some boast world-class technology.
Excellera Pharmaceuticals, founded in 2015, has received support from government agencies such as the Ministry of Trade, Industry and Energy, the Ministry of SMEs and Startups, and the Korea Health Industry Promotion Agency since its inception, and developed the world's first serum-free chemotaxis culture medium, CellCor, in just over three years.
The medium is categorized into the first generation of bovine fetal serum, the second generation of serum-free medium, and the third generation of chemical composition medium. Fetal bovine serum is a medium made from bovine fetal blood and is most commonly used by pharmaceutical and biotechnology companies. However, it is limited by viral infections, homogenization, and ethical issues.
Serum-free media use human platelets and animal-derived extracts to improve safety compared to fetal serum media, but they have the disadvantage of large-scale supply issues and difficulty in tracing raw materials.
On the other hand, chemical composition media, which are considered the next generation of media, utilize recombinant proteins, which are highly safe, available in large quantities, and homogeneous. In a comparison of serum-free media, Selker showed that the time for cells to double in number was much shorter than 20-30 hours in Selker, indicating superior proliferation. The shorter proliferation time is considered a major advantage as it reduces research costs. Currently, Excelsior Pharmaceuticals is pursuing listing on the KOSDAQ market and has recently passed the technology assessment.
Microdigital (305090) succeeded in localizing the first and only disposable cell culture machine in Korea. The company, which is the country's No. 1 bioscience company, launched its disposable cell culture device Cellbig in 2020.
The product is the world's first bioreactor using the free rocking method (Rocking + Orbital), which maximizes the advantages while excluding the disadvantages of existing competitors.
Cell culture machines such as Thermofisher, Cytiva, and Sartorius have limited mixing systems. On the other hand, Cellvic realizes a free mixing system that moves left, right, up, down, and diagonally, and can produce a large capacity of 1000L. In addition, there is no impeller in the incubator (bag), which realizes the optimal environment for cell growth. The price is also highly competitive at 70% of global products.
However, despite securing global technology, domestic companies have a high preference for foreign-made equipment. Therefore, there is a need for policy support from the government to utilize domestic products.
The industry is suggesting that the government should support R&D expenses for domestic product development and provide direct support to incentivize companies that use domestic products.