MRNA Vaccine & Therapeutics Raw Material Market

Global mRNA Vaccine & Therapeutics Raw Material Market was Worth of USD 11,635.3 Million in 2021 and it is Expected to Reach USD 1041.8 Million at the End of 2024 with CAGR of -55.26%. 

mRNA Vaccine & Therapeutics Raw Material Market Scope -

mRNA has been in clinical trail from a decade, and it is being used in various research and development projects. But due to various factors like less proven facts, fear of getting misused as bioweapon and others has forced mRNA to remain behind the curtain. So, till now mRNA has been used only for R&D purposes and numerous companies has invested millions of dollars on various products which are under clinical trials. In result, no mRNA product has been commercialized in global vaccine & therapeutics market.

But sudden panicking situation created by coronavirus outbreak has called for every kind of technology we can use against Covid-19. Even if mRNA had never been used against any disease but scientist did had years of research on RNA technologies including mRNA which is why scientists were able to start testing practices against Covid-19 so quickly. Owing to significant advantages associated with mRNA vaccine like short production time, low production cost and long immune response time has shown great potential and importance in uncertain times like COVID. Skyrocketing demand and advantages attributed to mRNA vaccine has created new opportunity in global vaccine market which is mRNA vaccine & therapeutics market.

As mRNA vaccine production don’t rely on growing cells it becomes much simpler process as compared to other vaccine production process. Also, the number of doses produced in cell-based production facilities with 2,000 L bioreactor volumes can be produced in mRNA facility with only 30 to 50 L bioreactors. This significantly reduces the production cost so the capital cost to open new production facility and becomes easier to scale in short term. mRNA can be easily modified which will give manufacturers the capability to address new disease mutations. Along with aforementioned advantages it is expected that technology platforms set for COVID vaccines can be useful for manufacturing mRNA vaccines for other diseases. For instance, Moderna has developed a booster mRNA vaccine targeted against the other COVID variant B.1.351, which is undergoing clinical trials. Aforementioned upsides of mRNA-based vaccines are set to create high demand for mRNA vaccine & therapeutics raw materials during the forecast period (2021-2024).

mRNA has been never created on large scale due to which there were no dedicated production plants for mRNA-based products nor for raw materials and sudden spike in demand have created various challenges across the supply chain for mRNA-based vaccine manufacturers, raw material suppliers, logistic players & etc. But to tackle this challenge numerous companies has shifted their cashflow towards mRNA production. Investments are utilized for various agreements, partnerships, and facility expansions by leading companies like Pfizer, BioNtech, and Moderna. To address the various challenges related to mRNA production they had taken major steps in respect to raw material, storage, logistics, fill-and-finish, etc. For instance, Pfizer has partnered with Croda which will supply Pfizer lipid-based excipients. Unlike, Pfizer, Moderna, a biotech firm do not have any in house production capability due to which it has made contract with Lonza to produce mRNA active for Moderna’s mRNA-1273 vaccine. Apart from aforementioned leading company’s numbers of mid and small-scale companies are trying to leverage from skyrocketing growth of mRNA vaccine & therapeutics market. For instance, Providence Therapeutics has focused towards creating mRNA-based vaccine for Canada and underserved Markets. It has partnered with Northern RNA which will provide Cap Analogs, Plasmid DNA, and other essential raw materials required to produce mRNA. mRNA-based vaccine has attracted numerous companies which are likely to produce their own mRNA-based vaccines in year 2021. For instance, Gennova Biopharmaceuticals Ltd, an Indian company is set to offer its own mRNA-based vaccine, HGCO19. This vaccine is under clinical phases, and it is likely to enter in market in 2021. Furthermore, GreenLight is also developing its own mRNA vaccine and claims to have better technology as compared to traditional technology. GreenLight has said that its mRNA production will cost only fraction of cost which is required for IVT (In vitro synthesis).

United States is set to dominate the global mRNA vaccine & therapeutics market accounting near half of the global demand in 2021. United States is set to maintain its dominance in the market owing to presence of large mRNA vaccine production facilities. Leading companies like Pfizer and Moderna have well established production facilities for mRNA vaccine & therapeutics in United States which will assist this region to maintain its dominance throughout the forecast period. United States is followed by Europe which is set to account near other half of the global mRNA vaccine & therapeutics raw material demand.

Analyst Comment, “Large number of investments, and directed strategies towards mRNA market will result in promising growth for mRNA vaccine & therapeutics raw material market creating USD 11,635.3 Million in 2021”.

mRNA Vaccine & Therapeutics Raw Material Market Key Players -

• Jena Bioscience GmbH
• Thermo Fisher Scientific Inc.
• SBS Genetech
• Lucigen
• Sigma Aldrich
• Others

mRNA Vaccine & Therapeutics Raw Material Market Segmentation -

By Product Type

• Capping Agents
• Nucleotides
• Plasmid DNA
• Others

mRNA Vaccine & Therapeutics Raw Material Market Trends -

Vaccines prevent millions of diseases and save countless lives each year. And, for the most emerging viral vaccines, the main obstacle is not the effectiveness of traditional methods but the need for rapid development and large-scale deployment. Finally, traditional vaccines cannot pertain to non-communicable diseases, such as cancer. Therefore, there is an urgent need to develop a more powerful and versatile vaccine platform. Moreover, nucleic acid therapies have emerged as a promising alternative to traditional vaccine methods. Additionally, the mRNA vaccine represents a promising alternative to traditional vaccine methods because of its high efficiency, rapid growth potential and low cost of production, and safe administration. However, their application has been limited until recently due to instability and inefficiency in the in vivo delivery of mRNA. Recent technological advances have now largely overcome these problems, and several mRNA vaccine platforms against infectious diseases and many types of cancer have demonstrated encouraging results in both animal models and humans.

However, over the last decade, major technological innovations and research investments have made mRNA a promising therapeutic tool in the field of vaccine development and protein replacement therapy. The use of mRNA raw material has many beneficial properties on subunits, killed and lives reduced viruses as well as DNA-based vaccines raw materials. There are many types of raw materials-based vaccines available in the market today, including protein-based, protein-based technology, viral vector technology, and reverse vaccinology technique, emerging and reemerging pathogens. According to many scientists as well as manufacturers, mRNA raw material-based vaccine is highly effective and low cost. As a result, all scientists and manufacturers are currently focusing on mRNA raw material-based vaccine production.

Many countries have now approved mRNA-based vaccines, so the future is bright. According to a scientific journal, Covid-19 actually opened up a new range of vaccines. This moment is very crucial and driving factor for mRNA raw material-based vaccine in development history is important. First, it is a new technology. mRNA vaccines are faster, easier and cheaper to make than traditional vaccines. These benefits are useful to everyday people and this success leads to vaccines. Many vaccines are currently being developed using mRNA raw material. Some vaccines have already been tested for the 1^st phase, while others are still being tested. Vaccines made using mRNA raw material will be widely available in the market in the near future. The following are some of the important properties of mRNA raw material-based vaccine which distinguishes mRNA raw material-based vaccine from other raw material-based vaccines as well as versatility and increasing the trend for mRNA vaccine and therapeutics and thus supplementing the demand for mRNA vaccine and therapeutics raw materials:

• Security: As mRNA is a non-integrating platform, non-infectious, there is no potential risk of infection or underlying mutagenesis. In addition, mRNA is degraded by normal cellular processes and its Vivo half-life can be controlled using various modification and distribution methods. The underlying immunogenicity of mRNA can be low modulated to further enhance the safety profile.
• Efficacy: Various modifications make mRNA more stable and highly translatable. Efficiency can be achieved in vivo delivery by rapid absorption and expression in the cytoplasm, by mRNA formation in carrier molecules. mRNA is the least genetic vector; therefore, anti-vector immunity is avoided, and the mRNA vaccine may be given more frequently.
• Product: mRNA-based vaccines have the potential for fast, inexpensive, and scalable production, mainly due to the high yield of in vitro transcription reactions. The mRNA vaccine field is developing rapidly; a large chunk of preclinical data has been collected over the last several years and many human clinical trials have been initiated. The mRNA vaccine has the potential to address a number of challenges in the development of both infectious disease and cancer vaccines.

Growing trend of the mRNA vaccines and therapeutics against the various diseases is creating more scope for the mRNA vaccines and therapeutics raw materials market. For example: -

A) Increasing Production of Covid-19 vaccine: - As the Covid-19 pandemic spreads rapidly all over the world, thus the development and production of vaccine to get acquired immunity against Covid-19 is necessary. There are more than one hundred vaccines under development worldwide. Among them, the new-type mRNA nucleic acid vaccine has the advantages of short R&D period, relative safety, long immune response time, short production period, and there is no risk of integration into host DNA. In this response to sudden infectious diseases, the development of mRNA vaccines has shown great potential and importance which is increasing the demand for mRNA vaccine raw materials.

B) Growing trends of mRNA Vaccine and Therapeutics the Vaccines Against Infectious Diseases: - The development of preventive or curative vaccines against infectious pathogens is one of the most effective means of preventing an epidemic. However, traditional vaccine raw material has largely failed to develop effective vaccines against challenging viruses such as HIV-1, herpes simplex virus and respiratory syncytial virus (RSV). In addition, the slow pace of commercial vaccine development and approval is insufficient to respond to the rapid emergence of acute viral diseases, as evidenced by the 2014-2016 outbreaks of Ebola and Zika viruses. Therefore, the development of a more powerful and versatile vaccine raw material is important. Preclinical studies hope that mRNA vaccines will complement many aspects of the ideal clinical vaccine: they show favorable safety profiles in animals, are versatile and fast to design for emerging infectious diseases and are capable of scalable good manufacturing practice (GMP). Production (already underway by several companies). Unlike protein vaccination, many variants of mRNA vaccines respond to strong CD8⁺T cell responses, perhaps due to the efficient presentation of endogenous antigens produced on MHC class I molecules, in addition to potent CD4⁺T cell responses. In addition, unlike mRNA vaccines has been shown to produce potent neutral antibody responses in animals with only one or two low-dose vaccinations. As a result, mRNA vaccines have developed protective immunity against a wide variety of infectious agents in animal models, leading to strong optimism. However, in 2018 published results of two clinical trials of mRNA vaccines for infectious diseases were somewhat moderate, leading to more cautious expectations about the prognostic translation of clinical success. Furthermore, two major types of RNA vaccines have been used against infectious pathogens: autoimmune or replicated RNA vaccines and non-replicating mRNA vaccines. Non-replicating mRNA vaccines can be identified by their distribution method: X-vivo loading of DC or direct in vivo injection into various physical sites. As a result, mRNA raw material-based vaccines are more beneficial against infectious diseases as compared to other vaccine raw materials. Therefore, the use of mRNA raw material is likely to be ubiquitous in the near future.

As per an article published on Springer Nature Limited; a rapidly growing number of preclinical studies in this area have recently been published and many have entered human clinical trials as mentioned in below table:

• TABLE 1 Clinical trials with mRNA vaccines against infectious diseases

Sponsoring Institution	Vaccine type (Route of Administration)	Targets	Trial Numbers (Phase)	Status
Argos Therapeutics	DC EP with autologous viral Ag and CD40L mRNAs (i.d.)	HIV-1	NCT00672191 (II)	Completed
CureVac AG	RNActive viral Ag mRNA (i.m., i.d.)	Rabies virus	NCT01069809 (II)	Completed; results NA
Erasmus Medical Center	DC loaded with viral Ag mRNA with TriMix (i.nod.)		NCT02042248 (I)	Completed; results NA
Fundacio Clinic per la Recerca Biomedica	Viral Ag mRNA with TriMix (NA)	HIV-1	NCT02241135 (I)	Active
Massachusetts General Hospital	DC loaded with viral Ag mRNA (i.d.)	HIV-1	NCT02888756 (II)	Recruiting
McGill University Health Centre	DC EP with autologous viral Ag and CD40L mRNAs (i.d.)	HIV-1	NCT02413645 (I)	Active
Moderna Therapeutics	Nucleoside-modified viral Ag mRNA (i.m.)	HIV-1	NCT00833781 (II)	Completed

 C) Growing trends of mRNA Vaccine and Therapeutics Raw Materials in the Vaccines Against Cancer: -

Clinical trials with mRNA vaccines against cancer: - The mRNA-based cancer vaccine has been recently and extensively reviewed. Cancer vaccines and other immunotherapy show promising alternative strategies for malignant treatments. Cancer vaccines can be formulated to target tumor-related antigens that are expressed primarily in cancer cells. For example, growth-related factors, or antigens specific to cells that are malignant due to physiological mutations. These neoantigens, or their neopitopses, have been deployed in humans as mRNA vaccine targets. Most cancer vaccines are therapeutic rather than prophylactic and seek to stimulate cell-mediated responses, such as those in CTL, which are able to clear or reduce tumor load. According to the world cancer research fund international study, in 2020, it is estimated that around 18,094,734 million cases of cancer were diagnosed.

The first evidence-based study that not only proposed the concept of RNA cancer vaccines, but also published evidence of the viability of this approach two decades ago. Since then, numerous preclinical and clinical studies have demonstrated the viability of mRNA vaccines to fight cancer. That’s why demand for raw material used in vaccines is increasing. As per an article published by Springer Nature Limited, Clinical trials with mRNA vaccines against cancer are given below:

• TABLE 2 Clinical trials with mRNA vaccines against cancer

Sponsoring Institution	Vaccine Type (Route of Administration)	Targets	Trial Numbers (phase)	Status
Herlev Hospital	DC loaded with TAA mRNA (i.d.)	Breast cancer, melanoma Prostate cancer	NCT00978913 (I) NCT01446731 (II)	Completed Completed
Asterias Biotherapeutics	DC loaded with TAA mRNA (NA)	AML	NCT00510133 (II)	Completed
BioNTech RNA Pharmaceuticals GmbH	Naked TAA or neo‑Ag mRNA (i.nod.)	Melanoma	NCT01684241 (I) NCT02035956 (I)	Completed; results NA Ongoing
CureVac AG	RNActive TAA mRNA (i.d.)	Non-small-cell lung cancer	NCT00923312 (I/II) NCT01915524 (I)	Completed Terminated
CureVac AG	RNActive TAA mRNA (i.d.)	Prostate cancer	NCT02140138 (II) NCT00831467 (I/II) NCT01817738 (I/II)	Terminated Completed Terminated
Oslo University Hospital	DC loaded with autologous tumour or TAA mRNA (i.d. or NA)	Melanoma	NCT00961844 (I/II) NCT01278940 (I/II)	Terminated Completed216

 D) Increased Government Initiatives: There are no specific guidelines from the FDA or the European Medicines Agency (EMA) for mRNA vaccine products. However, the increasing number of clinical trials conducted under EMA and FDA monitoring indicates that regulators have adopted methods proposed by various organizations to show that products are safe and acceptable for testing in humans. Because mRNA falls into a wide range of genetic immunogenic vaccines, many of the guidelines defined for DNA vaccines and gene therapy vectors can be applied to mRNA with some adaptations to reflect the unique characteristics of mRNA. A detailed review of EMA regulations for RNA vaccines by Hinz and colleagues highlights the different regulatory pathways prescribed for therapeutic applications against prophylactic infectious diseases. Regardless of the specific classification in the existing guidelines, some themes may be followed in what is mentioned in these guidance documents and what has been reported for recently published clinical studies. In particular, a recent report on the mRNA vaccine against influenza virus highlights preclinical and clinical data showing bioavailability and survival in rats, disease protection and immunity in related animal models (ferrets), local reactions and toxicity in humans. As mRNA products become more prominent in the vaccine field, specific guidelines are likely to be developed that will clarify the need for production and evaluation of new mRNA vaccines.

By Regional & Country Analysis:

• North America

• U.S.
• Canada

• Europe

• U.K.
• France
• Germany
• Italy

• Asia Pacific

• China
• Japan
• India
• Southeast Asia

• Latin America

• Brazil
• Mexico

• Middle East and Africa

• GCC
• Africa
• Rest of Middle East and Africa

Report Analysis	Details
Historical data	2018 - 2021
Forecast Period	2022 - 2028
Market Size in 2021:	USD 11,635.3 Million
Base year considered	2021
Forecast Period CAGR %:	-55.26%
Market Size Expected in 2024:	USD 1041.8 Million
Tables, Charts & Figures:	175
Pages	200
mRNA Vaccine & Therapeutics Raw Material Key Players	Jena Bioscience GmbH, Thermo Fisher Scientific Inc., SBS Genetech, Lucigen, Sigma Aldrich, Others
Segments Covered	By Product Type
Regional Analysis	North America, U.S., Mexico, Canada, Europe, UK, France, Germany, Italy, Asia Pacific, China, Japan, India, Southeast Asia, South America, Brazil, Argentina, Columbia, The Middle East and Africa, GCC, Africa, Rest of the Middle East and Africa