mRNA vaccine production

CDMO Samsung Biologics Expands mRNA Vaccine Production as Experts Forecast Growth in the mRNA Technology Market

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With the development, approval, and widespread use of COVID-19 mRNA vaccines, mRNA technology achieved a significant breakthrough in 2020 and 2021. Now, as biopharma companies pursue mRNA vaccine production for a wide variety of applications, experts are assessing the potential for this innovative technology to play a key role in the evolution of the industry. While COVID-19 catalyzed accelerated development of mRNA vaccines, the technology appears to be here to stay beyond the pandemic.

Recognizing this trend, Samsung Biologics, a leading contract development and manufacturing organization (CDMO), is expanding its mRNA capabilities. The CDMO played a significant role in mRNA vaccine production during the pandemic, providing fill/finish manufacturing services for Moderna’s COVID-19 mRNA vaccine, and it’s now expanding its capabilities to offer drug substance manufacturing for end-to-end mRNA vaccine production in Songdo, South Korea.

COVID-19 may have initiated an mRNA revolution, but the applications of mRNA vaccines extend far beyond COVID-19, as outlined in a recent Nature report on the evolution of the mRNA vaccine market. With its focus on end-to-end mRNA capabilities, Samsung Biologics is situated at the cutting edge of this innovative and fast-growing segment of the biopharma industry.

Evolving mRNA Market Trends

According to the report, the combined market capitalization of the five publicly listed companies focusing on mRNA platforms was approximately $15 billion in 2019, and by August 2021, that capitalization was more than $300 billion.

There is no doubt demand for mRNA vaccines to combat COVID-19 played a central role in this 2,000% growth. However, the data suggests continued investment in mRNA vaccine production is an indicator of optimism for the technology’s other applications.

To attain a more wide-ranging assessment of the market, the report analyzed 180 mRNA pipeline assets from 31 companies as of July 2021, separating assets into three categories based on the underlying mechanism of action: prophylactic vaccines, therapeutic vaccines, and therapeutics. Among others, the report highlighted the following two trends in mRNA vaccine production:

1.)   Prophylactic vaccines dominate the mRNA market.

Prophylactic vaccines are preventive vaccines designed to build up immunity in a patient rather than treat an existing condition. The report expects these vaccines will dominate mRNA vaccine production for the next 15 years, as they display a higher probability of success. As of July 2021, 77% of companies analyzed had at least one prophylactic vaccine in their pipeline.

While short-term mRNA prophylactic vaccine revenue is expected to come from COVID-19 vaccines, the report estimates the average peak global sales per pipeline asset for non-COVID prophylactic mRNA vaccines to be $800 million globally, with a total risk-adjusted market size of $7 billion–$10 billion by 2035.

2.)   Therapeutic mRNA vaccines have potential as cancer treatments.

Therapeutic mRNA vaccines are used to treat existing conditions and the most promising application for this technology is in immuno-oncology, targeting either single antigens or multiple antigens in cancer patients.

The report found that 19 of 26 current mRNA therapeutic vaccines in development target multiple antigens. This includes personalized cancer vaccines (PCVs), where mRNA has advantages over peptide-based vaccines. The total market for PCVs is estimated to be $7 billion–$10 billion in 2035.

Samsung Biologics’ Expanded mRNA Vaccine Production Capabilities

Amid this innovation in mRNA technology and growth in the mRNA market, Samsung Biologics has committed to a focus on mRNA production as it expands its facilities and portfolio.

“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. And also, we are building the capability for drug substance,” said James Park, chief business officer at Samsung Biologics, in a recent interview with FiercePharma.

After successfully partnering with Moderna to manufacture mRNA vaccines during the pandemic, Samsung Biologics is adding drug substance manufacturing to round out end-to-end mRNA vaccine production capabilities. This will enable the CDMO to handle all aspects of production, from bulk drug substance to aseptic fill/finish and cold storage, at a single facility.

In a letter to shareholders at the 11th Annual General Shareholders Meeting (AGM), CEO John Rim explained that Samsung Biologics plans to develop a new mRNA drug substance manufacturing facility, which is expected to be ready for current Good Manufacturing Practice operations within the first half of 2022. The facility is scheduled to begin manufacturing GreenLight Biosciences’ COVID-19 mRNA vaccine candidate.

But Samsung is not only focused on COVID-19 applications as it expands its mRNA vaccine production capabilities.

“The use of mRNA technologies in the production of vaccines in response to COVID-19 has demonstrated the effectiveness and potential of the technology,” said James Choi, Samsung Biologics’ executive vice president and chief information and marketing officer, in a recent interview with the European Pharmaceutical Review. “The capability for mRNA to be easily edited not only makes it the ideal tool to combat viruses that can quickly mutate, but also gives it the potential to be used in the treatment of countless other diseases.”

Outlook

Ultimately, while the market for mRNA vaccine production has seen an unprecedented boost due to the COVID-19 pandemic, the technology’s potential for fast production and editing has many in the biopharma industry optimistic about its future as an effective option for treating a variety of diseases.

The Nature report concluded that though mRNA vaccine production may decline as the need for COVID-19 vaccines decreases, the market is expected to grow in the long term with the introduction of new prophylactic and therapeutic vaccines, reaching a value of $23 billion by 2028.

With its expansion of mRNA vaccine production capabilities, Samsung Biologics is well positioned to play a leading role as the mRNA market grows.

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