Messenger RNA (mRNA)’s role in the creation and delivery of COVID-19 vaccines has seen pharmaceutical and life sciences organisations massively ramp up their mRNA research, development, and production capabilities. Interestingly, scientists from the University of Pennsylvania, Katalin Karikó (also a former SVP at BioNTech) and Drew Weissman, jointly received the 2023 Nobel Prize in medicine for their efforts in the mRNA space, which were instrumental in the development of COVID-19 vaccines.
But now that demand for COVID-19 vaccines is slowing, what’s next for mRNA? And what can pharmaceutical companies do to make the most of the research and production capacity that’s now available to them?
Finding mRNA’s next big use cases
The international race to develop viable COVID-19 vaccines hugely advanced our collective understanding of mRNA, and what it can be used to accomplish. Now, major pharmaceutical companies are reallocating resources to explore and develop new mRNA-based vaccines and therapies.
For example, Moderna is using mRNAs to develop new vaccines for flu, RSV (Respiratory Syncytial Virus), HIV, Lyme disease, and the Zika virus, as well as therapeutics for oncology, immuno-oncology, and cystic fibrosis. BioNTech is developing mRNA therapeutics for advanced R/R melanomas and metastatic non-small cell lung carcinomas. Sanofi is developing mRNA vaccines for influenza and RSV, and mRNA therapies for oncology, while Ionis is using mRNAs to create therapies and treatments for Alexander Disease.
That’s just a small snapshot of the mRNA innovation that’s happening across the pharmaceutical industry today. At large, the single greatest opportunity and growth appears to be in the prophylactic vaccine space, which collectively accounts for 42% of the total mRNA pipeline today. While many of these vaccines and therapeutics still have a way to go, we’re moving towards a diverse market landscape that has the potential to disrupt existing vaccine and therapy portfolios.
mRNA market outlook
The drop-off in demand for COVID-19 vaccines has resulted in a reasonably poor short-term outlook for the mRNA market. Producers (including bio-pharmaceutical companies and CMOs manufacturing raw materials, drug substances, and drug products) are set to have excess production capacity available, and overall sales are set to fall. However, the long-term market outlook is very different.
The mRNA vaccines and therapeutics market is expected to exceed USD 68 billion by 2030, with a CAGR of around 8.8% between 2023 and 2030. As leaders transform their mRNA development pipelines into market-ready therapeutics, the face of the market will shift massively.
Evidence of that impending shift can already be observed. In Q2 2023 alone, advanced molecular therapy companies penned 117 new deals. In a very short space of time, we’ve seen Moderna invest in several facilities in Australia, Canada, Kenya, and the UK, as well as its most recent investment in a new manufacturing plant in the US. In addition, Applied DNA has recently acquired Spindle Biotech, Merck acquired mRNA CDMO AmpTec, and Sanofi acquired both Translate Bio and Tidal Therapeutics.
Seizing the mRNA opportunity
With production capabilities widely available at the right cost, and producers looking to form partnerships with companies that can help them start producing new vaccines and therapies, now is the right time for pharmaceutical firms to seize the mRNA opportunity. For pharmaceutical and life sciences companies that want to make the most of today’s mRNA market opportunity, we recommend exploring a few different paths forward including pursuing partnerships and acquisitions, building partnerships with Contract Development and Manufacturing Organisations (CDMOs), and keeping a pulse on the mRNA market.
Larger companies can take this opportunity to acquire smaller biotech organisations with specialized mRNA product lines, given the significant growth potential of the market and a limited two-year window before target companies experience substantial expansion. For teams unable to pursue direct acquisitions, co-development partnerships should be considered, facilitating R&D collaborations between organisations with complementary needs and skills, enabling the swift development of vaccines and therapies, and ensuring market entry before major growth takes hold. Additionally, with COVID-19 vaccine production slowing, CDMOs equipped for mRNA production are eager to establish production partnerships with pharmaceutical and life sciences entities in the coming years, capitalizing on available capacity to cost-effectively produce mRNA vaccines and therapies while maximizing margins.
Finally, staying vigilant about mRNA market dynamics, including ongoing clinical trials, is advisable, as the rapidly evolving landscape continually presents new investment opportunities and approaches. Vigilance in monitoring the market will position your organisation to seize emerging opportunities effectively.
Be wary of market challenges
As teams take steps to explore future use cases of mRNA, it’s important that they don’t overlook some of the persistent challenges that hinder growth in the pharmaceutical market.
First and foremost, governance and regulatory compliance need to stay at the top of their agendas. New products must go through rigorous tests, checks, and regulatory processes before they can be brought to market, and those steps must remain a priority throughout accelerated research and development processes.
It’s also important to note that the vaccines and therapies that will drive mRNA growth over the next decade are still at a nascent stage. They can cost a significant amount to produce, and teams will need to keep a close eye on their production processes to ensure that they stay efficient. That way the final prices of their therapies can stay competitive.
And as always, it’s essential that the organisations investing in mRNA development and production keep a close eye on market and supply chain conditions. While supply of the lipid nanoparticles required to produce mRNA therapies, and the availability of the ultra-cold logistics required to ship and store them, are both adequate today, that picture could quickly change as the market grows.
Latika Mahajan
Latika Mahajan is Assistant Manager, Life Sciences for The Smart Cube.
