Nippon Shokubai Plans to Expand Its GMP-compliant Nucleic Acid Drug API Manufacturing Capacity Tenfold

OSAKA, Japan, June 24, 2025 /PRNewswire/ -- NIPPON SHOKUBAI CO., LTD. headquartered in Osaka, Japan, has announced a plan to expand its GMP (*1)-compliant manufacturing capacity for nucleic acid drug "active pharmaceutical ingredients" (APIs) tenfold in response to rapidly growing global demand in the nucleic acid drug market.

Logo: https://kyodonewsprwire.jp/img/202506180762-O1-70uPn32K 

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 the backdrop of market expansion, pharmaceutical companies in Japan and abroad have expressed strong expectations for the enhancement of Nippon Shokubai's GMP-compliant manufacturing facilities.

The capacity expansion will involve the installation of a large-scale production line with ten times the capacity (several kilograms per batch) of the company's existing line. The new facility is scheduled to begin operation in 2027, making it one of Japan's largest CDMOs, capable of manufacturing nucleic acid drug APIs for common diseases that require large-scale supply. The company will strengthen its manufacturing system to meet a wide range of needs, from non-clinical stages to large-scale commercial production.

GMP-compliant manufacturing facility in Osaka: https://cdn.kyodonewsprwire.jp/prwfile/release/M104641/202506180762/_prw_PI2fl_024c9kQ0.png 

Leveraging Nippon Shokubai's long-standing expertise in organic synthesis and rigorous quality control systems, the company manufactures oligonucleotides and peptides, which are medium-sized molecule APIs. Its GMP-compliant facilities, among the most advanced in Japan, have been audited and visited by multiple pharmaceutical companies, all of which have given high evaluations, establishing Nippon Shokubai's strong reputation in the industry. The company 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

About NIPPON SHOKUBAI CO., LTD.: https://kyodonewsprwire.jp/attach/202506180762-O1-3r7974vt.pdf 

For more information: https://www.shokubai.co.jp/en

SOURCE NIPPON SHOKUBAI CO., LTD.