U.S. mRNA Therapeutics Market Size to Worth USD 12.18 Bn by 2033

According to latest study, the U.S. mRNA therapeutics market size was worth around USD 5.10 billion in 2023 and is predicted to grow around USD 12.18 billion by 2033 with a compound annual growth rate (CAGR) of roughly 9.1% between 2024 and 2033.

The mRNA therapy sector has emerged as a significant growth factor in the pharmaceutical industry, driven by its remarkable advantages in vaccine development.

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U.S. mRNA Therapeutics Market Overview

The U.S. mRNA therapeutics market is experiencing rapid growth driven by the safe, programmable, flexible, and cost-effective design and production capabilities inherent in mRNA therapy. Currently, mRNA therapy is predominantly applied in three major directions: immunotherapy, protein replacement therapy, and regenerative medicine therapy. Tumor immunotherapy and infectious vaccines are the most mature and popular among immunotherapies, while the mRNA pipeline is expanding to target genetic diseases such as infectious diseases, oncological diseases, and rare diseases.

While the rational design and optimization of epitopes or antigen-specific sequences require careful consideration, recent advancements have spurred a paradigm shift. Vaccines are now not only employed for disease prevention but also for treatment, broadening the market scope. The development of innovative RNA platform technologies like circRNA and saRNA and enhanced delivery methods promises to propel mRNA therapy into new frontiers, including in vivo cell programming. Moreover, the knowledge gained from mRNA therapy's development is poised to benefit the broader RNA drug landscape, including long non-coding RNA therapeutics, further catalysing growth in the U.S. mRNA therapeutics market.

  • In June 2022, Evonik invested US$220 million in partnership with the U.S. Government to construct a new lipid production facility for mRNA-based therapies in the U.S.

Key Takeaways

  • By type, the prophylactic vaccines segment held the largest share of 52.4% in 2023.
  • By application, the oncology segment led the market, with a revenue share of 57.28% in 2023. The segment is observed to sustain the growth rate during the forecast period. 
  • By end-use, the hospital and clinics segment held the largest share of 59.92% of the market in 2023. The segment is expected to sustain its position throughout the forecast period.

mRNA Therapeutics Market Size in the Global 2024 to 2033

The global mRNA therapeutics market size is calculated at USD 14.27 billion for 2024 and is expected to reach around USD 58.90 billion by 2033, growing at a CAGR of 17.06% from 2024 to 2033. North America dominated the market with over 40.75% share in 2023.

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Market Dynamics


Advanced delivery systems

As mRNA products function upstream of protein synthesis from the post-transcriptional, pre-translational stage of a gene, they represent a dramatic change in pharmacological regulation. When it comes to mRNA medications, there are several benefits over traditional small molecule and antibody therapies. These include a straightforward design, shortened development cycles, high target specificity, wide therapeutic application, and extended effectiveness. mRNA medicines, which are widely used to treat viral infections, cancers, and genetic illnesses, are on the verge of becoming the third main class of pharmaceuticals. The development of delivery system technology, which is critical for safeguarding RNA structure, improving targeting accuracy, lowering dose needs, and minimizing harmful side effects, is essential to their success, thereby driving the growth of the U.S. mRNA therapeutics market.


Regulatory and manufacturing hurdles constrain.

The expansion of mRNA therapeutics encounters formidable challenges distinct from vaccine development, chiefly stemming from disparate manufacturing and regulatory requirements. The varied applications, classifications, and manufacturing protocols inherent to mRNA therapeutics complicate the streamlining of regulatory approval processes. Strict control over immunostimulatory by-products like double-stranded RNA is imperative during manufacturing to ensure sustained immunotolerance for long-term treatments. The absence of a standardized production pipeline and limited scalability in manufacturing, driven by the high costs associated with current good manufacturing practice (cGMP)-grade reagents required for in vitro transcription (IVT), constrains the growth potential of the U.S. mRNA therapeutics market.


Accelerated adoption of mRNA therapeutics

The emergence of mRNA as a versatile solution for combating future pandemics and various infectious diseases like rabies, Zika, and cytomegalovirus infection, coupled with ongoing clinical advancements in cystic fibrosis and cancer treatments, presents a significant opportunity for the U.S. mRNA therapeutics market. The rapid development and authorization of mRNA vaccines for SARS-CoV-2 during the COVID-19 pandemic underscored the technology's potential and efficacy. Robust regulatory norms and industry standards are necessary to guarantee the efficacy, safety, and quality of novel mRNA-based therapeutics. These are constantly changing. Global cooperation between developers, producers, regulatory bodies, and national control laboratories may be enhanced by establishing a standard methodology for evaluating mRNA quality. This would enable the production of safe and effective mRNA products more quickly. This evolving landscape creates a fertile ground for growth and innovation within the U.S. mRNA therapeutics market.

mRNA as therapeutic vaccines for cancer immunotherapy

With the constant improvement of vaccines, a paradigm shift has recently taken place in using vaccines not only for disease prevention but also for disease treatment. Studies regarding therapeutic vaccines mainly focus on cancers, not only due to the inherent characteristics of cancer, but also because of the recent explosion and successes in the field of cancer immunotherapy, including immune checkpoint blockade (ICB), chimeric antigen receptor T cells (CAR-T) mediated therapy, and cancer-specific antigens. The key idea for cancer therapeutic vaccines is to use cancer-specific antigens to train the human immune system, which in turn kills cancer cells with high specificity. As mRNA has increased immunogenicity compared to DNA vaccines, the capability to encode multiple antigens or whole antigens with many epitopes, and the ability of rapid manufacturing, it seems to have great potential as therapeutic vaccines, especially as cancer vaccines to initiate and amplify the anticancer immune response.

It has been reported in early 2000 that intranodal injection of naked mRNA encoding tumor antigen can inhibit cancer growth in a mouse model. In 2008, patient-derived autologous mRNA was first applied as a vaccine to treat patients bearing melanoma. The naked self-adjuvanted mRNA has later been applied as the mRNA vaccine for the first time in phase I/II clinical trials by intradermal injection in prostate cancer patients. However, the success of the mRNA cancer vaccine has yet to be achieved because of some key challenges in cancer complexity and mRNA technology.

Unlike preventative vaccines for infectious diseases, therapeutic cancer vaccines must also induce a strong cytotoxic cellular response to eradicate cancerous cells. Therefore, the selection of proper antigens capable of inducing tumor-specific immune responses becomes an essential task in the design of therapeutic mRNA vaccines. Tumor-associated antigens (TAA) and tumor-specific antigens (TSA) are reasonable candidates for cancer vaccine development. Typical TAAs are overexpressed antigens (like HER-2 in 30% of breast cancer) and differentiation-specific antigens (like PSA in Prostate cancer). However, as TAAs are also expressed in normal tissues, sometimes they have central tolerance due to the clonal deletion of autoreactive lymph cells during ontogenesis, leading to the consequence that the self-antigens cannot activate an appropriate immune response. Therefore, cancer cells may evade immunosurveillance and resist immunotherapy. A combination of multiple therapeutic mRNAs may help to overcome this obstacle. At present, there are several mRNA vaccines in clinical trials using multiple TAAs as immunologic stimulants Compared with TAAs, TSAs (especially neoantigens) can bypass central tolerance with high immunogenicity, because they generate the accumulation of aberrant proteins that are absent in normal tissues. However, tumor neoantigens are highly heterogeneous, suggesting that cancer immunotherapy using mRNA vaccines may be highly personalized. Several clinical trials have been launched recently to further evaluate the antitumor efficacy of personal mRNA vaccines.

U.S. mRNA Therapeutics Market Recent Developments

  • In September 2023, Moderna broadened the realm of mRNA Medicine with encouraging clinical results spanning cancer, rare diseases, and infectious diseases.
  • In September 2023, the FDA took action on updated mRNA COVID-19 vaccines to enhance protection against currently circulating variants.
  • In January 2022, Pfizer entered into an agreement with Acuitas Therapeutics for the Lipid Nanoparticle Delivery System for use in mRNA vaccines and therapeutics.

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By Type Insights

In the U.S. mRNA therapeutics market, the prophylactic vaccines segment held dominance in 2023. Over the next 15 years, mRNA is anticipated to emerge as the primary platform for prophylactic vaccines, given its significant representation within the vaccine pipeline and projected high success rates. Prophylactic vaccines, a cornerstone of global health success stories, save millions of lives annually through routine vaccination efforts. The advent of mRNA vaccines paves the way for safety-optimized prophylactic vaccination strategies, particularly against allergic diseases. Future research is essential to understand long-term effects and the comparison between vaccine-induced and natural immune responses, which is crucial for translating this knowledge into clinical practice.

By Application Insights

Based on application, the oncology segment dominated the U.S. mRNA therapeutics market in 2023 and is estimated to dominate during the forecast period. This dominance is attributed to mRNA-based cancer therapeutics, encompassing a range of innovative approaches such as mRNA cancer vaccines, cytokine-encoding mRNA, chimeric antigen receptors, tumor suppressors, and combination therapies. Leveraging mRNA to express multiple neoantigen peptides or tumor-associated antigens facilitates systemic dendritic cell targeting and establishes neoantigen-specific T cell immunity, overcoming T cell immune tolerance. Despite encountering greater challenges on the path to clinical adoption compared to mRNA vaccines for cancer, significant technological advancements have elevated mRNA to a new class of drugs with promising implications for vaccine development and diverse medical indications.

By End-use Insights

In the U.S. mRNA therapeutics market, the hospital and clinics segment dominated the market in 2023 and is estimated to hold the position throughout the forecast period. Hospitals and clinics are equipped with all the necessary equipment, products, healthcare resources, and everything needed to develop and test mRNA therapeutics. It is easy to monitor and take necessary actions quickly, especially in emergency situations. Healthcare professionals from different disciplines and nurses are available to provide patient-centered and multidisciplinary care, promoting the segment's growth.

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U.S mRNA Therapeutics Market Top Key Companies:

  • GSK plc.
  • BioNTech SE
  • CureVac N.V.
  • Sangamo Therapeutics, Inc.
  • Translate Bio, Inc.
  • Moderna, Inc.
  • Argos Therapeutics Inc.
  • Arcturus Therapeutics
  • AstraZeneca plc.
  • Pfizer Inc.
  • CRISPR Therapeutics AG

U.S mRNA Therapeutics Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S mRNA Therapeutics market.

By Type

  • Therapeutic Vaccines
  • Prophylactic Vaccines

By Application

  • Oncology
  • Rare Genetic Diseases
  • Infectious Diseases
  • Others

By End-use

  • Research Organizations
  • Hospitals & Clinics
  • Others

Frequently Asked Questions

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  • We have a global reach, with expertise spanning across continents, including North America, Europe, Asia-Pacific, Latin America, and the Middle East. We leverage a combination of primary and secondary research methodologies to offer country-level analysis.
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  • We conduct cross-sectional analysis by examining data from different individuals at a single point in time to identify patterns and trends across diverse segments of the market.
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