Refer Report
Leading global contract development and manufacturing (CDMO) companies, including Samsung BioLogics, have begun to ‘solidify the three-tier system’ by rapidly increasing their production capacity. This is to widen the gap with latecomers, but there are concerns that the issue of ‘excessive facilities’ may arise if only antibody drug factories are expanded in the mid to long term.
Widening the gap with latecomers such as China’s Wuxi
According to the pharmaceutical and bio industry on the 29th, Samsung BioLogics plans to break ground to build the 6th factory in Songdo, Incheon in the second half of next year. Samsung BioLogics’ production capacity, which is 604,000L as of today, is expected to increase to 784,000L when the 5th factory is completed next year and to 964,000L four years later.
Switzerland’s Lonza and Japan’s Fujifilm, which are considered among the top three CDMOs along with Samsung BioLogics, are also rapidly expanding their production capacity. Lonza, which ranked first in CDMO sales last year, plans to increase its production capacity from 320,000 liters as of today to at least 790,000 liters in four years, and Fujifilm plans to increase its production capacity from 140,000 liters to 750,000 liters in the same period. As of today, China’s Wuxi Biologics, which has a production capacity of 260,000 liters, is finding it difficult to immediately increase its size due to the enactment of the U.S. Biosecurity Act, and Germany’s Boehringer Ingelheim, which has a production capacity of 500,000 liters, has no plans to further expand its capacity. The industry predicts that ultimately the three companies will establish a three-strong system based on production capacity.
Expansion to target the 460兆 antibody market
The reason for the expansion is that the global biopharmaceutical market itself is growing. This is because it is believed that demand will not decrease as new drugs with high added value, such as anticancer drugs and dementia treatments, continue to be released to the market as biopharmaceuticals. Among various treatment approaches (modalities), the drug market with the largest market size is the antibody therapy field, where Samsung BioLogics, Lonza, and Fujifilm are competitively increasing their size.
According to the Korea Biotechnology Association, the antibody treatment market size in 2029 is expected to be $355 billion (approximately 467.53 trillion won). It is nearly 10 times the size of cell and gene therapy (CGT, approximately $45 billion) and antibody drug conjugates (ADC, approximately $30 billion), which have not yet blossomed into markets.
An official from the CDMO industry said, “Economies of scale are a factor that determines competitiveness in antibody drugs,” and added, “This is a strategy to widen the gap with latecomers such as India through bold expansion.”
What will happen when the era of ‘customized treatment’ comes?
The problem is that the era of antibody drugs is coming to an end and the market for next-generation drugs such as CGT is blooming in earnest. According to the Korea Biotechnology Association, the growth rate of CGT over the next six years is expected to be 41.6% and antibody therapy is expected to be 8%. Unlike antibody drugs, drugs such as CGT do not require large-scale production facilities. Because it is a ‘customized treatment’ that extracts cells from the patient’s body and then reintroduces them into the body, it requires a completely different process from existing antibody drugs.
Lonza entered the CGT CDMO market early and dominated the market. It is known that the CGT produced by Lonza includes Gilead Sciences’ chimeric antigen receptor T cell (CAR-T) treatment drug ‘Yescarta’. Fujifilm also plans to invest 6 trillion won by 2028 to produce new genetic drugs based on messenger ribonucleic acid (mRNA). Samsung BioLogics is pursuing a strategy to expand the production range of existing antibody treatments with antibody-drug conjugates and bispecific antibodies. An industry insider said, “The market trend led by antibody drugs will not change in the short term.”
Reporter Nam Jeong-min peux@hankyung.com
Source: korean