As the contract development and manufacturing organization (CDMO) industry kicks off a new year, a recent report has projected the CDMO market to increase at a compound annual growth rate of 10.3%.
The report, which projected activity from 2022 to 2030, expects the market to grow from roughly $13.17 billion in 2021 to $31.84 billion in 2030, a total increase of over 141% in a nine-year period. This growth continues a trend of increasing demand for CDMO partnerships in both drug substance and drug product services, and Samsung Biologics, an industry leader, has expanded its capabilities in both areas to meet this demand.
2022 saw Samsung Biologics begin partial operations at a new manufacturing plant, its fourth and the largest of its kind in the world. It also launched a new end-to-end mRNA vaccine production facility with drug substance and drug product capabilities. And the CDMO has recently further invested in biosimilars, cost-effective drugs designed to replicate the effects of similar biologics, acquiring full ownership of biosimilars firm Samsung Bioepis in March.
Samsung Biologics is looking to build on this growth in 2023. Plant 4 is scheduled to be fully operational this year, and the company continues to pursue portfolio diversification in mRNA and biosimilars. It will also ramp up the use of new platforms launched in 2022 to streamline drug screening and the development of bispecific antibodies.
“Not only have we delivered on our commitments by commencing [good manufacturing practice] operations of Plant 4 within just 23 months from the start of its construction, we have also developed and launched our next-generation biotechnologies — S-DUAL™ and DEVELOPICK™ — which will help streamline and accelerate the antibody development process to save time and cost for our clients,” explained Samsung Biologics president and CEO John Rim in a recent statement.
CDMO Market Growth in Drug Substance Services
According to the report, drug substance services accounted for the largest portion of CDMO revenues in 2021 at over 50%, and this percentage is projected to remain relatively stable in subsequent years.
Drug substance manufacturing services refer to the process of developing the active ingredient in a drug, including cell culture and purification. This can be distinguished from drug product services, which involve transferring this substance into the final product, such as a vial or capsule, that will be delivered to patients.
For Samsung Biologics, the main driver of drug substance revenue has historically been its monoclonal antibody business. Since its establishment in 2011, the CDMO has quickly established industry-leading capacity to manufacture monoclonal antibodies, with three plants already operating at near full capacity prior to the construction of Plant 4.
When Plant 4 becomes fully operational at a 240,000-liter capacity in 2023, Samsung Biologics will provide the most manufacturing capacity at any single location in the world, with a total of 604,000 liters at its Songdo, South Korea, headquarters.
In addition to continuing to expand its monoclonal antibody business, Samsung Biologics ventured into new drug substance territory in 2022, adding mRNA drug substance capabilities to its existing mRNA drug product services. The result is a one-stop-shop approach to mRNA vaccine production that’s designed to optimize the potential of mRNA therapeutics to be developed quickly at a variety of scales.
The new mRNA suite, which includes plasmid DNA linearization and transcription, mRNA purification, and lipid nanoparticle encapsulation of mRNA molecules, went online in April 2022 and completed its first manufacturing run in late July 2022. Its first project, a commercial-scale run of mRNA vaccines for GreenLight Biosciences, produced 650 grams of mRNA and was completed just seven months after the initial technology transfer.
For Rim, this speaks to the potential of an end-to-end mRNA suite, which can both speed up production times and reduce the risk of contamination from transport.
“This demonstrates a major achievement in our continuing goal to offer one-stop, end-to-end mRNA production from drug substance to aseptic fill/finish to commercial release, all from a single site, as we strive across our biomanufacturing network to fight the pandemic,” said Rim in a press release announcing the completion of the partnership’s first production run.
Thus far, mRNA vaccines have only been approved for COVID-19 applications, but mRNA researchers are working on several other promising areas, including personalized cancer vaccines and vaccines for infectious diseases ranging from HIV to influenza. As this new technology develops, Samsung Biologics has positioned itself as a potential CDMO partner for mRNA vaccine production in a variety of areas and at a variety of scales with its new drug substance capabilities.
CDMO Market Growth in Drug Product Services
While drug substance services are expected to continue to account for a significant portion of CDMO revenues, the report indicates that there is room for growth in drug product services as well.
“The drug product category will grow faster in the market in the years to come,” it states. “This can be ascribed to CDMOs’ platform strength and low technical and IP-related concerns, which is why the pharmaceutical sector is progressively embracing drug product outsourcing.”
In a recent interview, Rim echoed these sentiments, noting that more and more pharmaceutical companies are recognizing that partnering with a CDMO for drug product services enables the partner to focus on strengths in research and development while relying on a robust manufacturing infrastructure.
“In the past, pharma companies looked at [contract manufacturing organizations] partnerships and dual sourcing primarily as a risk mitigation exercise,” he said. “However, pharma is now realizing that its core competencies are in [research and development] rather than in building and maintaining manufacturing facilities, leading to a greater degree of outsourcing. I foresee that trend continuing, particularly in an environment of constrained supply chains post-COVID.”
The COVID-19 pandemic highlighted the issues that can arise amid supply chain disruptions in the pharmaceutical industry, and outsourcing processes such as fill/finish, packaging, and labeling can help mitigate the risk of a lack of material availability or technical adaptability affecting a company’s production schedule.
As Samsung Biologics continues to expand its capacity and capabilities, it will look to lead the way in CDMO growth in both drug substance and drug product services in 2023 and subsequent years.