CDMO, which requires a high level of quality control, has a strong focus on performance. The projects tend to concentrate on companies which accept a large number of contracts. It is said that the top 10 companies are responsible for approximately half of all biopharmaceutical manufacturing. Major global CDMOs are focusing on increasing their manufacturing capacity to meet growing demand. We have summarized their business trends.
Major CDMO companies in the world
The world’s largest bio CDMO is Lonza, a Swiss company with sales of 6.2 billion Swiss francs in 2022. It supports a wide range of modalities, from small molecules to antibodies, cell/gene therapy, and exosomes. Lonza has recently strengthened the field of antibody-drug conjugates (ADCs) through acquisitions. Bio CDMO sales account for approximately 60% of total sales.
China’s Wuxi Biologics ranks second in global market share. The company operates as a “CRDMO” (CDMO + CRO) and takes on large-scale projects. South Korea’s Samsung Biologics is another company that continues to grow rapidly. Production capacity has expanded from 362,000 liters in 2018 to 420,000 liters in 2022, and further expansion is underway. Germany’s Boehringer Ingelheim has the world’s top-class production capacity for animal cell culture tanks (antibodies, etc.). In 2022, our CDMO business generated sales of 1 billion euros.
Antibodies, protein preparations, and mRNA
The two largest Japanese bio CDMO companies are Fujifilm Holdings (HD) and AGC. Fujifilm and AGC both have sales of over 100 billion JPY (650M USD). Both companies have expanded their scale through acquisitions, with recent sales of CDMO-related businesses exceeding 100 billion JPY. In 2019, they acquired the US Biogen factory and acquired large culture tanks. In April 2022, Fujirilm acquired the US company Atara, making a full-fledged entry into cell therapy including CAR-T cell therapy.
The company’s strength lies in the cultivation of animal cells, such as antibodies, and in addition to the high-productivity technology, it has established continuous production technology for active pharmaceutical ingredients, from cultivation to purification. Fujifilm is also proceeding with the construction of a domestic base in Toyama with the aim of starting operations in 2026. As a result, global production capacity is expected to reach approximately 660,000 liters in 2026.
AGC operates businesses in both synthetic pharmaceuticals and biopharmaceuticals. For animal cell culture, they introduced single-use bags (SUBs), and now they have the second-largest production capacity globally. In 2020, AGC acquired AstraZeneca factory and acquired large culture tanks. They expanded their business to gene therapy in 2021 and to mRNA drugs in 2023.
Regeneration, cell therapy, and gene therapy
Takara Bio operates covers a wide range of modalities with a focus on gene therapy drugs. In the field of regenerative medicine, Takara is upgrading the facilities by the introduction of large bioreactors and cell processing rooms which enable large-scale manufacturing for commercial products. Nikon has a strategic business alliance with Lonza in cell production for regenerative medicine.
Middle molecules
Chemical manufacturers with chemical synthesis technology lead the middle molecule business. Nitto Denko has the world’s largest nucleic acid drug manufacturing base. Actually, they are the world’s top share in nucleic acid drug substance manufacturing. Otsuka Chemical, a subsidiary of Otsuka Holdings, manufactures active pharmaceutical ingredients and intermediates for a wide range of pharmaceutical products, from small molecules to medium molecules and antibodies.
Summary
CDMO businesses have been developing with the latest biotechnology as well as global pharmaceutical companies. Let’s see how the business will develop for the next 5 years.
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