mRNA Vaccine Production Predicted to Drive CDMO Market Growth as Samsung Biologics Expands Capabilities

mRNA

The market for contract development and manufacturing organizations (CDMOs), which provide outsourced drug development and manufacturing services for biopharmaceutical companies, is showing continuous growth, according to a recent report. The report, authored by medical market research firm Medi-Tech, predicts the market for CDMOs is expected to grow at a compound annual growth rate of 15% over the next three years, reaching $35 billion by 2025. According to the report, increased demand for mRNA vaccine production will play a significant role in this growth.

mRNA vaccine production drove growth in the CDMO market following the onset of the COVID-19 pandemic. Biopharma companies turned to CDMOs to satisfy massive demand for COVID-19 vaccines, the first ever mRNA vaccines to reach the market. Samsung Biologics, a leading CDMO listed as a “key player” in the report, helped meet this demand, providing fill/finish services for Moderna’s COVID-19 vaccine. Now, as demand for mRNA vaccine production is predicted to continue to drive growth in the industry, Samsung Biologics is expanding its mRNA capabilities along with expansion in other areas driving industry growth.

CDMO Market Growth Drivers

The report identifies several drivers for growth in the CDMO market, each of which aligns with Samsung Biologics’ capabilities.

First, the report emphasizes the potential growth of CDMOs that focus on biologics, noting that “the outsourcing ratio in biologics manufacturing is much less compared to that for small molecules, providing ample opportunity for growth.”

Since its founding in 2011, Samsung Biologics has focused on biologics development and manufacturing, capitalizing on this opportunity for growth. As biopharma companies consider CDMOs to meet increased demand for biologics development and manufacturing, they’re turning to Samsung Biologics because of its established track record in the biologics space and its industry-leading capacity.

As the report explains, “companies are looking for CDMOs that can provide significant regulatory leadership and expertise in all stages from early-stage discovery to commercialization.” 

The cause of the increased demand for biologics is innovation in technologies like mRNA vaccines, as well as other technologies such as viral vector and cell and gene therapy. According to the report, demand for these newer technologies exceeds supply, and even larger biopharma companies may lack capabilities in these areas, leading to more outsourcing to CDMOs such as Samsung Biologics.

In addition, the CDMO market is trending towards companies such as Samsung Biologics that can offer a one-stop-shop model in biologics development and manufacturing.

The report explains that, “due to the complexities intrinsic to biologics development, biopharma companies look for a full-service CDMO handling all services, from cell line development through fill/finish and packaging.”

Establishing these end-to-end services has been a priority for Samsung Biologics, as the company has developed tight integration between its drug substance (DS) manufacturing and aseptic fill/finishing operations at its facilities in Songdo, South Korea. This integration involves a dedicated Manufacturing Sciences and Technologies (MSAT) Laboratory specializing in drug product (DP) processing and measures risk mitigation and process optimization.

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Samsung Biologics Expands mRNA Vaccine Production Capabilities

Expanding its end-to-end capabilities in mRNA vaccine production is a central component of what Samsung Biologics CEO John Rim calls the company’s “multidimensional growth plan.”

Building on its success in fill/finish manufacturing for Moderna’s mRNA vaccine, Samsung Biologics added an mRNA drug substance manufacturing facility to its current site in Songdo. The CDMO now offers true end-to-end mRNA vaccine production, including bulk drug substance, aseptic fill/finish, labeling and packaging, and cold chain storage. Providing these services at a single facility, Samsung Biologics can fulfill demand for mRNA vaccine production on faster timelines.

In addition to expanded mRNA vaccine production capabilities, Samsung Biologics is working toward developing expanded capabilities in other growing areas of innovation in biologics, as CEO John Rim explained in a March 2022 letter to shareholders.

“As the demand for next-generation medicines such as cell and gene therapy is expected to increase steeply, Samsung Biologics is planning to expand its business portfolio to encompass viral vector and plasmid DNA, in addition to mRNA,” said Rim.

A “Growth Engine” of the CDMO Industry

As Samsung Biologics’ expansion in mRNA and other areas tracks with the needs of the biopharma industry, it’s no coincidence that the CDMO has experienced exponential growth in recent years. Samsung Biologics reported a revenue increase of 35% in 2021, and the company’s growth shows no sign of slowing down. It reported record-high first-quarter revenue of 511.3 billion Korean won (KRW) in 2022, up 96% year over year from KRW 260.8 billion in the first quarter of 2021. Samsung Biologics also reported a 141% year-over-year increase in net profit in the first quarter of 2022.  

Samsung Biologics is investing its increased revenue in continuing to expand its facilities and portfolio, with the goal of developing innovative biologic medicines that save patients’ lives. In addition to expanding mRNA vaccine production and diversifying its portfolio in areas such as biosimilars, Samsung Biologics is constructing its fourth plant in Songdo. When the plant is completed, Samsung Biologics will offer 620,000 liters of capacity at its Songdo facilities, the largest capacity in any single location worldwide. The company is also in the process of acquiring land for the construction of a Bio Campus II in Songdo. The campus will house large-scale antibody manufacturing facilities and an open innovation center to foster biotech startups.

Finally, Samsung Biologics is actively pursuing overseas growth, exploring the potential of U.S. and European operations to meet growing demand in those locations.

Rim summarized the company’s growth strategy at the 40th Annual J.P. Morgan Health Care Conference in January 2022: “Through proactive investment in increasing our manufacturing capacity, enhancing portfolio diversification, and expanding facilities overseas, Samsung Biologics will be able to accelerate the buildup of its core success drivers as the next growth engine of the industry.”

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