Nippon Shokubai Plans to Expand Its GMP-Compliant Nucleic Acid Drug API Manufacturing Capacity Tenfold
- Research and Development
NIPPON SHOKUBAI CO., LTD. (Headquarters: Osaka, Japan, President: Kazuhiro Noda) announced to expand its GMP*1)-compliant manufacturing capacity for nucleic acid drug active pharmaceutical ingredients (APIs) tenfold, in response to the rapidly growing global demand in the nucleic acid drug market.
Nucleic acid drugs are generally defined as “chemically synthesized drugs with oligonucleotides as active ingredients that exert their effects without being translated into proteins.”*2) As a new modality following small molecule and antibody drugs, they are expected to be applied in areas such as rare diseases, neurological disorders, and cancers—fields where conventional treatments have been limited.
The global market for nucleic acid drugs is projected to exceed 1,400 billion yen by 2030*3). In line with this, the global CDMO*4) market for nucleic acid drugs is expected to grow at an average annual rate of 14% from 2021 to 2030, reaching 200 billion yen by 2030*3). Against this backdrop of market expansion, pharmaceutical companies in Japan and abroad have expressed strong expectations for the enhancement of our GMP-compliant manufacturing facilities.
This capacity expansion will involve the installation of a large-scale production line with ten times the capacity (several kilograms per batch) of our existing line. The new facility is scheduled to begin operation in 2027. With this, we will become one of Japan’s largest CDMOs, capable of manufacturing nucleic acid drug APIs for common diseases that require large-scale supply. We will strengthen our manufacturing system to meet a wide range of needs, from non-clinical stages to large-scale commercial production.
GMP-compliant manufacturing facility in Suita, Osaka
where the large-scale production line will be installed
Leveraging our long-standing expertise in organic synthesis and rigorous quality control systems, we manufacture oligonucleotides and peptides, which are medium-sized molecule APIs. Our GMP-compliant facilities, among the most advanced in Japan, have been audited and visited by multiple pharmaceutical companies, all of whom have given high evaluations, establishing our strong reputation in the industry.
We will continue to provide flexible contract manufacturing services that meet diverse needs and contribute to a sustainable society by ensuring a stable supply of medium-sized molecule APIs that support human health and life.
*1) GMP: Good Manufacturing Practice – standards for manufacturing and quality control of pharmaceuticals.
*2) Source: National Institute of Health Sciences. (n.d.). Division of Molecular Target and Gene Therapy Products, Section 2. Retrieved June 17, 2025, from https://www.nihs.go.jp/mtgt/section2.html
*3) Source: TPC Marketing Research Corp., “2023 Global Nucleic Acid Drug CDMO Market”
*4) CDMO: Contract Development and Manufacturing Organization