A new report forecasts that the market for mRNA vaccine production will reach $22.6 billion by 2031. The report highlights the role of mRNA vaccine applications beyond COVID-19. Expectations for the growth of new applications for mRNA vaccines come as Samsung Biologics, a leading contract development and manufacturing organization (CDMO), is expanding its mRNA vaccine production capabilities.
Samsung Biologics, listed by the report as one of the key CDMOs operating in the mRNA vaccine market, began offering mRNA services in 2021, providing fill/finish services for Moderna’s COVID-19 mRNA vaccine. Now, Samsung Biologics is investing in a larger role for mRNA in its increasingly diverse portfolio, adding mRNA drug substance services to its drug product capabilities at its facilities in Songdo, South Korea.
Following the successful start of its mRNA vaccine fill/finish manufacturing last year, Samsung Biologics has added an mRNA drug substance manufacturing facility, offering a true end-to-end manufacturing service for mRNA vaccines and therapeutics. The facility will begin manufacturing the mRNA vaccine candidate of GreenLight Biosciences.
mRNA COVID-19 Vaccines
The COVID-19 vaccines produced in 2021 were the first mRNA vaccines approved for human use, but for decades, researchers have understood the potential value of mRNA vaccines. Traditional vaccine development requires slowly growing a virus in mammalian cells or chicken eggs. By contrast, mRNA vaccines can be produced and altered quickly via a cell-free process that involves synthesizing proteins based on electronically generated sequences.
However, researchers struggled to develop a delivery system for mRNA molecules. Now, with the introduction of effective delivery systems that coat mRNA in lipid nanoparticles, mRNA vaccines have become more viable, as evidenced by the large-scale production of mRNA COVID-19 vaccines on accelerated timescales.
As an industry-leading CDMO, Samsung Biologics played an important role in mRNA vaccine production for Moderna’s COVID-19 vaccines. While the CDMO didn’t produce the active substance in the vaccines, its fill/finish services ensured a safe, effective end product.
“Samsung Biologics was the first in Korea to perform fill/finish manufacturing of Moderna’s COVID-19 mRNA vaccine and obtain approval from the Korean Ministry of Food and Drug Safety (MFDS),” said Samsung Biologics CEO John Rim. “Samsung Biologics will continue to dedicate itself to providing a reliable supply of COVID-19 vaccines and treatments and contribute to the ending of the prolonged COVID-19 global pandemic.”
Forecasts for mRNA Vaccine Production
According to the report, high demand for COVID-19 vaccines led to exponential growth in the mRNA vaccine market in 2021. However, as more individuals have been vaccinated against COVID-19 and demand decreases, the market for mRNA vaccines is forecasted to rely more on other applications. Potential applications include malaria, influenza, hemorrhagic fever, genital herpes, Lyme disease, and cancer to name a few.
The report notes: “The rising number of clinical trials for cancer therapies, the growing burden of infectious diseases, and novel innovations by pharmaceutical CDMO companies are likely to support the growth of mRNA manufacturing and synthesis services market in the forecast period.”
Geographically, the Asia Pacific area accounts for the largest portion of the mRNA vaccine market at 33.4% in 2021. According to the report, the region will continue to account for a large portion of the market, driven by increasing awareness about mRNA vaccines and government investment in mRNA R&D. With its position as a global leader with a strong presence in South Korea’s growing biotech hub, Samsung Biologics is well positioned to meet demand in the Asia Pacific sector.
In addition, Samsung Biologics is pursuing overseas expansion plans in other regions predicted to drive the growth of the mRNA vaccine market, such as North America.
Samsung Biologics’ Expanded mRNA Capabilities
Building a diverse portfolio is a pillar of Samsung Biologics’ growth strategy, along with increasing its industry-leading capacity and expanding its global footprint. In investing in expanded mRNA vaccine production capabilities, Samsung Biologics is diversifying its portfolio by offering one-stop-shop services in an area of rapid innovation.
James Park, executive vice president and chief business officer at Samsung Biologics, explained the company’s expanded capabilities in a recent interview with FiercePharma.
“We are building our capability end-to-end from an mRNA perspective. We have a strong quality control organization and the analytical capabilities for release testing of the mRNA vaccines,” said Park. “And also, we are building the capability for drug substance.”
Samsung Biologics will continue to offer the fill/finish services it provided for Moderna’s mRNA vaccine production while adding drug substance capabilities. This means the company can also produce the active substance for mRNA vaccines at its facilities in Songdo rather than rely on receiving shipments. The result will be a robust, efficient mRNA vaccine production process.
mRNA and a Decade of Growth
In an address celebrating Samsung Biologics’ first decade of operations in April 2021, Rim outlined the company’s plans for the next decade.
“Ten years ago, we had the vision to enrich people’s lives through technology and innovation. Now heading into the next decade, we see a clear path before us. Our 2030 vision is to become a global top-tier biopharma company, with the mission to make high-quality, safe treatments more accessible to patients around the world,” said Rim.
As its expanded mRNA capabilities coincide with forecasts of increasing innovation in mRNA technology for the next 10 years, Samsung Biologics is building toward realizing this vision.
“The work we do today with cutting-edge innovation and technology impacts a better tomorrow for humanity,” said Rim. “We are driven to discover, develop, and manufacture breakthrough solutions to save lives, and are only just getting started.”