The market for mRNA vaccine production, estimated at $42.6 billion in 2021, is expected to grow to approximately $128 billion by 2030 at a compound annual growth rate of roughly 13%, according to a new report from Precedence Research.
As the mRNA market grows, leading players in the biopharmaceutical industry are determining how to strategically approach this innovative area of research and development. For Samsung Biologics, one of the world’s largest contract development and manufacturing organizations (CDMOs), the answer was to develop an end-to-end mRNA vaccine production suite that can handle both the synthesis of mRNA and the transfer into a final drug product at a single facility.
“Few manufacturers/CDMOs are adequately equipped or capable of carrying out all manufacturing steps, leading to logistical, monetary, and time line difficulties. Frequent handling of mRNA across multiple locations increases contamination and degradation risks,” wrote Samsung Biologics’ Huisub Lim, lead scientist of mRNA manufacturing, and Pierre Catignol, executive vice president and head of manufacturing, in an article on the evolution of the mRNA market. “When the entire work stream is coordinated by one partner from a single location, transitions across development and production tasks run smoothly, maximizing efficiency and mitigating potential risks.”
Thus far, the only approved mRNA vaccines for human use have been for COVID-19, but for Samsung Biologics, equipping its facilities with these end-to-end capabilities is a bet on the viability of mRNA vaccine production for therapeutics beyond COVID-19 applications.
“The use of mRNA vaccines highlighted their massive potential, and subsequently led to it becoming the technology of choice for COVID-19 vaccine developers. However, its popularity is not limited to only the COVID-19 market,” explained Lim in a roundtable on trends in the biopharmaceutical industry. “Its flexibility and effectiveness have made it an attractive option for the treatment and prevention of many other diseases, ranging from cancers to HIV. As of July 2021, there were more than 70 mRNA therapeutics in clinical pipelines globally and many more assets in early development.”
mRNA Vaccine Production Market Drivers
Demand for COVID-19 vaccines is expected to continue to contribute to the growth of the mRNA vaccine production market as new variants arise and booster vaccines are advanced. However, the share of the market accounted for by COVID-19 vaccines is expected to shift, with researchers predicting that mRNA vaccines will be developed for applications such as personalized cancer therapeutics and heart disease treatments, as well as preventive vaccinations for infectious diseases such as HIV and Zika.
In addition to developments in mRNA vaccine research, the market’s growth is expected to be driven by government investment in mRNA, as well as investment from biopharmaceutical companies such as Samsung Biologics.
In terms of geographic demand, the Precedence Research report noted that North America accounted for 35% of market share, followed by Europe at 28.7% and Asia Pacific at 22.7%.
Samsung Biologics’ End-to-End Capabilities
Samsung Biologics first became involved with mRNA vaccine production as a provider of drug product services for Moderna’s COVID-19 vaccine in 2021. The CDMO provided aseptic fill/finishing for the vaccines, as well as packaging and labeling at its facilities in Songdo, South Korea.
With the addition of drug substance capabilities, Samsung Biologics is now able to produce the active mRNA drug substance along with providing these drug product services. The process involves using enzymes to linearize circular strands of plasmid DNA (pDNA), which can then be encoded into mRNA. The mRNA is encapsulated in lipid nanoparticles and stored at precise cold temperatures to ensure stability.
The first use of this technology for Samsung Biologics was a commercial-scale manufacturing run of a COVID-19 vaccine for GreenLight Biosciences. The project moved from lab bench to commercialization in just seven months, producing 650 grams of mRNA at a titer of 12 grams per liter.
“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 John Rim, CEO and president of Samsung Biologics.
While Samsung Biologics and other companies in the industry such as Moderna and Pfizer have been focused on applying mRNA technology to combat the pandemic, projects such as Samsung Biologics’ partnership with GreenLight provide evidence of the potential of mRNA vaccine production for other applications to be quickly and effectively scaled for commercial production.
“One of the greatest challenges when producing quality pharmaceuticals is advancing from a small lab to large-scale commercial production,” said GreenLight CEO Andrey Zarur. “We are grateful for the help and support of Samsung in demonstrating that our small mRNA process can scale in a linear fashion to the industrial scale that will be needed to help satisfy the vaccine needs of humanity.”
The advantage of mRNA vaccine production over traditional methods lies in its easy adaptability and quick scalability. Traditional vaccines require manufacturers to grow a virus in living cells, which can be time-consuming, costly, and difficult to adapt to mutating viruses. By contrast, mRNA vaccines are produced using an in vitro (cell-free) process in which information on the mRNA needed can be encoded, edited, and quickly shared electronically.
This easy editability has made mRNA vaccines ideal for fighting a virus with several variants such as COVID-19, but it also makes mRNA a tantalizing technology to use in personalized vaccines, particularly as an alternative to chemotherapy when treating cancer. MRNA vaccines work by instructing the body to develop proteins that fight the targeted infection. When used to fight cancer, the mRNA could instruct the body to target cancer cells.
mRNA Market Outlook
Scientists and executives at Samsung Biologics are optimistic about the growth potential of the mRNA market, and their newly developed capabilities position them to be a significant player in this growing market.
“As part of the company’s sustainable growth plan, we are continuing with our advancements in business portfolio, venturing into offering multimodal products including cell and gene therapies and next-gen vaccines utilizing mRNA, pDNA, and viral vectors, all at a single site,” said the CDMO in an article explaining its mRNA capabilities. “Continuing from our partnership signing with Moderna and GreenLight Biosciences to manufacture COVID-19 vaccines, our teams of experts will forge ahead together with our efforts to proactively grow into a manufacturing hub for vaccines to help save lives of people worldwide.”