1.1.1 Development of mRNA technology for use in therapeutic and vaccine applications has been underway for decades. That investment, coupled with extensive government funding and support and cooperation among all members of the biopharma industry value chain, made it possible to bring the two successful mRNA vaccines against the SARS-nCoV-2 virus to the market in record time during the COVID-19 pandemic. By February 2024, an estimated 13.5 billion vaccine doses had been administered globally, representing vaccination of 70.6% of the world’s population.[1] As of May 2023, the Centers for Disease Control and Prevention (CDC) reported that over 599 million people had been dosed with the two leading mRNA vaccines, Spikevax (Moderna) and Comirnaty (Pfizer/BioNTech).[2] Although the pandemic has receded, the lasting impact of COVID-19 on mRNA technology will likely be its rapidly expanded acceptance by regulators and payers alike.
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1.2.1 The mRNA market comprises two primary product categories: therapeutics and vaccines. mRNA vaccines work by delivering a genetic blueprint that instructs cells to produce an antigen, typically a viral protein, which then triggers an immune response. This approach has been widely validated by the COVID-19 pandemic, where mRNA vaccines from Moderna and Pfizer/BioNTech demonstrated both rapid development timelines and high efficacy. Products in development are now targeting a broad array of virus-borne diseases (influenza, Zika, dengue, rabies, HIV, hepatitis, and Venezuelan equine encephalitis, among others), as well as bacterial infections, such as Staphylococcus and tuberculosis.
1.2.2 In contrast, mRNA therapeutics involve delivering genetic instructions that encode for functional proteins intended to replace or supplement those missing or malfunctioning in a patient’s body. Therapeutic vaccines against many types of cancer often include personalized treatments based on the tumor characteristics of individual patients. Therapies are being actively explored across oncology, rare diseases, and metabolic and autoimmune conditions, among other indications.[7] Development is underway for drug products functioning via protein or gene replacement or as delivery agents for gene-editing tools, including CRISPR components and human retrovirus-like proteins that can implement controlled edits.[3][4][5][6] Products in development that are indicated for rare and genetic conditions are often touted as potential curative treatments, and not just therapeutics.
1.2.3 The mRNA market can be segmented by application, technology type, and end user. Application-wise, it is broadly divided into vaccines and therapeutics, each with distinct development pipelines and market dynamics. From a technology perspective, conventional mRNA remains dominant, but next-generation formats are gaining traction. saRNA offers lower dosage requirements by enabling replication within cells, while circRNA provides improved stability and extended protein expression.[8] These advancements are expanding the functional range of mRNA beyond traditional applications.
1.2.4 End users of mRNA-based products and services span pharmaceutical and biotechnology companies, academic and research institutions, and governmental organizations. While large pharma has played a leading role in pandemic-era vaccine development and now increasingly in oncology and personalized immunotherapy, smaller biotechs are often the source of innovation in RNA modalities and platform technologies. Academic centers and government programs remain essential for foundational research, early-stage development, and pandemic preparedness initiatives. Together, these stakeholders shape a complex but rapidly converging market ecosystem.
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1.3.1 The large number of candidates progressing through the clinic has created significant demand for good manufacturing practice (GMP)–compliant mRNA drug/vaccine substance and product. This increase has led to capacity shortages that are anticipated to become problematic as more therapies enter the clinic.[4]
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1.4.1 Naked mRNA cannot be administered directly into a patient because the vast majority would be degraded in the bloodstream before it reached the target cells. Several different delivery vehicles have been developed, and more are under investigation for this purpose.
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1.5.1 Most readers in Q1/Q2 2024 are well aware that 2023 was a rough year for biotech funding. Before we discuss the 2024–2025 funding outlook, it is instructive to review how we got here. The following discussion is a compilation of analyst reports from 2020–2023 from Silicon Valley Bank and PitchBook.
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1.6.1 The route of administration is known to impact the expression of proteins from mRNA therapeutics and influence the immune responses from mRNA vaccines. Intramuscular (IM) delivery is common for vaccines, but antigen-specific immunity can also be achieved when mRNA vaccines are delivered via other routes of administration, many of which are being explored, including intravenous (IV), hypodermic, intradermal (ID), intraperitoneal (IP), subcutaneous (SC), intranasal (IN), intranodal, and intrasplenic.[22] Each route of administration has its own specific advantages, and each is employed depending on the requirements of the product. As mentioned earlier, oral delivery formulations are in development but have not yet demonstrated technical efficacy. See the in-depth discussion on the topic by our team on Pharma’s Almanac.[21]
1.6.2 Systemic administration is also a possibility, as is the combination of different routes to boost responses. Because mucosal immunity is necessary to prevent the spread of infectious diseases, developers are particularly looking to find methods of administering mRNA vaccines against such pathogens that target the mucosal system.
1.6.3 Differences that have been observed based on delivery method include the subclass of immunoglobulin G (IgG) produced, the specifics of the cytokine response, the overall level of response, the subclass of immune cells activated, the overall response level of innate versus acquired immunity, and the level of memory T cell response. It is fair to assume that the route of administration will influence the efficacy and type of response for non-vaccine therapeutics as well. As one may expect, the route of administration is also an important consideration for reducing potential side effects.
1.6.4 Most of the effort to modulate tissue targeting is focused on modifying LNP formulations through the use of different ionizable lipids (with different hydrocarbon tail lengths, for instance), different lipopolyplexes, and technologies focused on conjugating the LNP with specific ligands, such as antibodies.
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1.7.1 As we saw with other advanced therapies, the analytical requirements to release a drug product can be murky with new modalities. Although there are some established guidances for DNA products, gene-editing therapies, and chimeric antigen receptor (CAR)-T–type ex vivo gene therapies, none yet exist for release and characterization of mRNA therapies. As a result, developers are performing more tests that they will likely need (and more than were performed on COVID-19 mRNA vaccines) to ensure that their drug meets regulatory approval. With little data available, the FDA is taking a “levelheaded approach” to development of a guidance. The question of potency assays for multivariant vaccines and rare diseases has proved especially difficult for some developers to navigate.
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