mRNA Vaccines and Therapeutics Market

Market Overview

The global mRNA vaccines and therapeutics market size was worth USD 36.54 billion in 2022 and is estimated to reach an expected value of USD 58.92 billion by 2031, growing at a CAGR of 13.3% during the forecast period (2023 – 2031).

mRNA-based therapeutics and vaccines permit the combination of desirable immunological properties. These are manufactured in the laboratory using mammalian cells and injected into the target to activate virus-detecting immune sensors and produce viral antigen proteins within the cells. This strengthens the immune system by enhancing B- and T-cell responses. Since the effective implementation of vaccination strategy is now the most viable method to prevent citizens from SARS-CoV-2 infection, pharmaceutical companies across the globe are in a race against time to develop messenger ribonucleic acid (mRNA) based COVID-19 vaccines, which are highly safe, productive, and reliable in terms of clinical outcome.

Additionally, as COVID-19 tightened its hold on the world due to the emergency of new SARS-CoV-2 mutant strains, regulatory authorities across the globe are significantly expediting their approval processes by issuing emergency use and conditional marketing authorizations to the pharmaceutical companies, thereby increasing the scope of the global market.

Highlights

• The non-COVID-19 mRNA vaccines dominate the application segment.
• Nucleoside-modified mRNA dominates the mRNA type segment
• North America is the most significant shareholder in the global market

Market Dynamics

Market Drivers

Growing Cases of COVID-19 Globally

COVID-19 is caused by the SARS-CoV-2 virus, which originated in Wuhan, China, in December 2019. The SARS-CoV-2 virus exhibits easy access and communication, directly or indirectly, through human-to-human transmission. The infection rate is massive because of the highly contagious nature of the virus, translating into a higher number of COVID-19 cases worldwide. Further, the high infection rate of this viral infection has resulted in a pandemic, which has emerged as one of the massive humanitarian challenges in recent times. With a steep rise in COVID-19 patients, a vital requirement exists for efficacious vaccines by refueling vaccine innovation. Due to the advantages being offered by the mRNA-based COVID-19 vaccines coupled with the growing cases of COVID-19 worldwide, the demand for these vaccines has massively increased in the last couple of months, which is expected to bolster the growth of the underlying global market in the forthcoming years.

Favorable Regulatory Environment

With the demand for mRNA-based COVID-19 vaccines getting outpaced due to massively increasing COVID-19 cases worldwide, the regulatory authorities worldwide have loosened restrictions on the regulations of these vaccines. Regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are offering emergency use authorizations (EMAs) and conditional marketing authorizations (CMAs), respectively, to the company’s manufacturing mRNA-based COVID-19 vaccines to ensure a constant supply for continuing vaccination strategies.

For instance, in February 2021, the FDA issued a new guidance policy, "Emergency Use Authorization for Vaccines to Prevent COVID-19", describing guidance to offer sponsors of requests for EMA for COVID-19 vaccines with necessary recommendations about the data and information required to support the issuance of EUA under the section 564 of the FD&C Act for the duration of a public health emergency. The FDA is actively involved in issuing EUA to potential mRNA-based COVID-19 vaccines, making it easier for domestic and international companies to launch their respective products after conducting robust clinical verifications to contain the spread of COVID-19.

Market Restraint

High Price Associated with mRNA-Based COVID-19 Vaccines

These vaccines have attracted significant attention from healthcare experts and governments because the mRNA-based COVID-19 vaccines allow the body's molecular process to create its own medicine against the infection, ensuring great efficacy and safety. Although mRNA-based vaccinations are now a crucial component of prosperous economies' effective vaccination programs, underdeveloped nations still face financial difficulties because of the high price of these vaccines. For instance, the estimated average cost of the mRNA-1273 vaccine of Modena, Inc. typically ranges between USD 11-USD 13 per dose.

Similarly, the average cost of BioNTech and Pfizer's BNT162b2 (COMIRNATY) ranges between USD 8 to USD 10 per dose. Since these vaccines are given in two doses per patient, the consolidated cost becomes very high, which is not affordable for citizens in emerging countries. This makes mRNA-based vaccines highly expensive for the governments of emerging economies to purchase in high volumes, creating a lack of accessibility of these highly productive vaccines, further restricting the growth of the underlying global market.

Market Opportunities

Growing Emphasis on Research and Development for Non-COVID-19 Applications

The underlying molecular mechanisms associated with the manifestation and progression of cancer, rare diseases, and immunological diseases have been extensively studied to discover novel therapies. The emergence of mRNA-based vaccines and therapies is becoming a promising platform for the development of novel treatments on account of various underlying advantages, which include efficiency in expressing tumor antigens in the antigen-presenting cells (APCs), initiation of an adaptive immune response, and facilitation of APC activation, among others. Extensive research is being conducted on mRNA-based vaccines and therapies for cancer immunotherapy and rare disease treatments. Research institutes and industry players are investigating research on the structural modifications in mRNA and its formulation methods to develop promising drugs based on mRNA.

Additionally, companies operating in the mRNA vaccines and therapeutics ecosystem are incorporating industry-academia collaboration to assess and develop novel candidates who could help physicians to treat cancer subtypes and rare, life-threatening diseases. Further, companies focused on developing mRNA-based therapies incorporate synergies with other pharmaceutical companies to develop novel therapies for non-COVID-19 applications. These advancements in the development of mRNA-based therapies for non-COVID-19 applications are expected to offer lucrative opportunities to legacy and emerging companies to expand their portfolio for treating life-threatening disorders, which is anticipated to provide massive growth in the forthcoming years.

Regional Analysis

North America Dominates the Global Market

Based on region, the global market is analyzed across North America, Europe, Asia-Pacific (APAC), Latin America, and Rest-of-the-World (RoW).

North America is the highest revenue contributor and is estimated to exhibit a CAGR of 8.12% during the forecast period. The North America region majorly comprises the U.S. and Canada. Due to various prominent factors, the U.S. dominated the global mRNA vaccines and therapeutics market (by COVID-19 vaccines). These include significantly growing fund infusions for mRNA vaccine development, high rise in the pipeline products, presence of established and emerging pharmaceutical companies, presence of ultracold manufacturing and supply chains, and increasing awareness about mRNA-based COVID-19 vaccines, among others. In North America, several established mRNA vaccine manufacturers and developers focus on bringing advanced products to the market to support the country's immunization strategies. Large and small market players invest heavily in research and development and increase their manufacturing capacities by incorporating business synergies and funding activities to capture market share. For instance, in June 2020, Moderna, Inc. collaborated with Catalent, Inc. for large-scale, commercial fill-finish manufacturing of the company's novel mRNA-based COVID-19 vaccine candidate, mRNA-1273, at Catalent's biologics facility in Indiana U.S. Moreover, in January 2020, Moderna, Inc. received a funding award from the Coalition for Epidemic Preparedness Innovations (CEPI) for developing an mRNA-based COVID-19 vaccine for SARS-CoV-2 infection. Also, market players such as Translate Bio and Arcturus Therapeutics Holdings Inc. are anticipated to boost the market's growth in the North American region.

Europe is anticipated to grow at a CAGR of 2.1% during the forecast period. Due to several prominent factors, the Europe mRNA vaccines and therapeutics market (by non-COVID-19 vaccines) is expected to grow significantly during the forecast period, 2026-2031. These factors include rising research and development expenditure related to mRNA vaccines and therapeutic advancements, rising fund infusions for the development of mRNA vaccines and therapeutics for cancer and rare diseases, increasing government initiatives targeting the adoption of precision medicine, and the presence of legacy and emerging market players, among others. Private and government organizations are playing an important role by offering funding to companies to expedite the development of mRNA vaccines and therapeutic candidates present in clinical trials. For instance, in December 2019, BioNTech SE received a fund infusion of USD 58.7 million from the European Investment Bank to support the research and development, manufacturing, and market access for its most advanced treatments based on mRNA technology.

Asia-Pacific is the third largest region. The Asia-Pacific mRNA vaccines and therapeutics market (by COVID-19 vaccines) are expected to increase as mRNA-based COVID-19 vaccines are expected to launch in 2021. Several APAC countries, including Japan and Australia, are working continuously to enhance the adoption of mRNA-based COVID-19 by entering into supply agreements with the manufacturers. Countries like China and South Korea are expected to launch mRNA-based COVID-19 vaccines in the second quarter of 2021, subject to regulatory approvals from the healthcare authorities. Therefore, with the successful launch of mRNA-based COVID-19 vaccines in the APAC countries, the market's competitiveness is anticipated to increase, which is further expected to offer lucrative opportunities to the manufacturers. However, the high Price associated with mRNA-based COVID-19 vaccines coupled with the lack of ultracold manufacturing facilities and supply chains in the developing countries of APAC may become a prominent restraining factor for the market.

Segmental Analysis

The global market has been segmented based on applications, mRNA type, and region.

By application, the global market is divided into COVID-19 mRNA vaccines (commercialized vaccines, pipeline vaccines) and non-COVID-19 mRNA vaccines (oncology, infectious diseases, other diseases). 

The non-COVID-19 mRNA vaccines segment dominates the market and is anticipated to grow at a CAGR of 8.6% during the forecast period. RNA-based vaccines and therapies are a new class of treatment modality that effectively combines the potential of mRNA to encode a particular protein having high safety and efficacy. This new treatment modality potentially involves exploiting the body's immune system to identify and kill cancerous cells. Recent research in immuno-oncology has shown that antitumor responses can be successfully achieved by activating antigen-specific T-cells for different cancer types. It is worth mentioning here that cancer patients may or may not respond to these therapies. To resolve this potential medical unmet need, academic research institutes and companies are actively conducting in-depth studies to harness the potential of mRNA-based treatment modalities to establish precision medicine in the field of oncology to deliver tailored medication to one patient at a time. Moreover, the administration of mRNA-based treatment modalities can direct the patient's cells to select specific neoepitopes, which may help the immune system to effectively recognize and distinguish cancerous cells from normal healthy cells, thereby selectively destroying them.

By mRNA type, the global  market is divided into COVID-19 (Nucleoside-Modified mRNA (modRNA), Unmodified mRNA, Self-Amplifying mRNA), Non-COVID-19 (Nucleoside-Modified mRNA (modRNA), Unmodified mRNA, Self-Amplifying mRNA). 

The COVID-19 (by mRNA type) segment dominates the market and is anticipated to grow at a CAGR of 4.3% during the forecast period. The growth of this segment is majorly accredited to the increasing research on nucleoside-modified mRNA (modRNA), the growing adoption of modRNA by the pharmaceutical companies for the development of COVID-19 vaccines, and the recent approval of modRNA -based COVID-19 vaccines by the regulatory authorities, among others. Market juggernauts in the global markets such as Moderna, Inc. and BioNTech SE/Pfizer Inc. have recently developed and commercialized modRNA-based COVID-19 vaccines, which are safe and highly effective. Due to the growing demand for these vaccines worldwide for establishing robust vaccination strategies, the requirement of modRNA is expected to increase in the forthcoming years massively.

Recent Developments

• January 2023 - Arcturus Therapeutics Holdings Inc., a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, announced that the Clinical Trial Application (CTA) for ARCT-032, an inhaled investigational mRNA medicine to treat cystic fibrosis (CF), received approval to proceed into a Phase 1 First-in-Human study in New Zealand.
• January 2023 - CSL Limited announced that its subsidiary, CSL Seqirus, finalized its global collaboration and license agreement with Arcturus Therapeutics Holdings Inc ("Arcturus Therapeutics"; NASDAQ: ARCT). The agreement grants access to Arcturus Therapeutics' late-stage self-amplifying mRNA (sa-mRNA) vaccine platform technology, which recently reported results from a large COVID-19 Phase III vaccine efficacy study, meeting its primary and secondary endpoints of prevention of infection and severe disease with a favorable safety and tolerability profile.