Samsung Biologics, one of the world’s largest contract development and manufacturing organizations, has been experiencing impressive growth in recent years. Coming off a year of record revenues, and with the biopharmaceutical market expected to continue to grow, the CDMO has set ambitious targets for its growth strategy in 2023. CEO John Rim further outlined these targets at an address at the J.P. Morgan Healthcare Conference in January.
“We are formalizing a plan and will pursue both organic and inorganic strategies to further grow Samsung Biologics,” said Rim.
This means that the CDMO will pursue growth through acquisitions and internal development of its technology and resources. It’s a strategy that Samsung Biologics employed in 2022 as well, when Rim described the company’s multidimensional growth plan of expanding manufacturing capacity, building a more diverse portfolio, and extending its global footprint.
In 2022, this involved constructing new facilities, developing end-to-end mRNA vaccine production capabilities, and investing in the full acquisition of Samsung Bioepis, a biosimilars company that Samsung Biologics founded as a joint venture with Biogen in 2012.
2023 will see similar plans, said Rim. He discussed the CDMO’s potential entry into antibody-drug conjugates and gene therapies, plans to begin full operations at its Plant 4 facility with new manufacturing contracts, and to invest in the construction of a second Bio Campus at its headquarters in Songdo, South Korea.
Organic Growth
“Samsung has had phenomenal organic growth, such as investing in Bio Campus 2, continuing to build new plants, operating our CDO business, expanding our sales offices, [and] advancing new technologies,” said Rim at the conference.
The initial investment in Bio Campus 2 involved purchasing 357,366 square meters (about 88.3 acres) of land in the Incheon Free Economic Zone of South Korea for 426 billion KRW ($323 million) . The plot of land is 30% larger than the CDMO’s first Bio Campus.
According to Rim, Samsung Biologics will invest $6 billion in constructing Bio Campus 2. The new facility will include at least four new manufacturing plants and an open innovation center designed to “nurture promising companies related to next-generation medicines.”
“The company will decide on building a fifth plant within this year after the fourth plant becomes fully operational,” added Rim.
Samsung Biologics’ fourth plant started partial operations in October 2022, within 23 months of breaking ground, an unprecedented rate for such a large facility. It will house the most manufacturing capacity of any biomanufacturing facility in the world at 240,000 liters and will be fully functional in 2023. Rim noted that it already has CMO contracts for multiple products from clients worldwide.
He added that the CDMO “currently has CMO contracts with 12 of the top 20 global pharmaceutical companies” and “is discussing CMO contracts for 34 medicines with 26 biopharmaceutical companies around the world.”
In addition to building on its industry-leading capacity, Samsung Biologics is actively diversifying its portfolio and adding new technologies. In 2022, it completed construction of an end-to-end mRNA vaccine production facility, which gives it the ability to complete all steps of the mRNA vaccine process, from designing the mRNA sequence, synthesizing the mRNA, formulating the vaccine using enzymes and coating it with lipid nanoparticles, and transferring it to the final drug product with an aseptic fill/finish process.
Samsung Biologics demonstrated these end-to-end capabilities when it completed the first commercial-scale run of production for another mRNA vaccine candidate. The CDMO produced 650 grams of mRNA at a titer of 12 grams per liter and completed the run only seven months after initial technology transfer.
Acquisitions and Investing in R&D
In 2022, Samsung Biologics fully acquired Samsung Bioepis. The company already has several approved biosimilars for immunology and oncology applications, and in August 2022, it added Hadlima, a biosimilar based on the autoimmune and inflammatory disease drug Humira.
Biosimilars are designed to have similar efficacy, safety, and quality to a reference biologic while offering a more affordable option for patients. Hadlima, like its reference drug Humira, is used to treat diseases such as rheumatoid arthritis, psoriasis, and Crohn’s disease.
Humira is currently the world’s top-selling drug, generating $21.2 billion in sales in 2022, but AbbVie, the company that produces it, expects Humira’s market share to decline by at least 37% in 2023 due to competition from biosimilars such as Hadlima.
Rim noted the opportunity to gain some of this market share, explaining that “from a portfolio perspective, we have the broadest biosimilar portfolio with 10 products. The biggest opportunity for us this year will be the launch of the Humira biosimilar, which will happen in July.”
Samsung Biologics may also pursue investments in antibody-drug conjugates, a type of targeted cancer therapy that combines an antibody, a cytotoxic drug, and a linker molecule to selectively deliver the drug to cancer cells. The CDMO is also looking into cell and gene therapy, according to Rim.
These investments follow Samsung Biologics’ 2022 investments in U.S.-based Jaguar Gene Therapy and Senda Biosciences, a company with a molecular profiling and analytics platform that programs nanoparticles and information-bearing molecules such as mRNA.
“The company plans to expand its portfolio in line with market changes and prepare a foundation for sustainable growth,” Rim said.
