Market Insight-Global mRNA Vaccines - Therapeutics Market Overview 2022
The Global mRNA Vaccines & Therapeuticsm Market Was Valued at USD 39.60 Billion in 2021 and Is Expected to Reach USD 11.898 Billion by the end of 2028, growing at a CAGR of -19.38% between 2022 and 2028.– Bossonresearch.com
The global mRNA Vaccines & Therapeuticsm market was valued at USD 39596.95 million in 2021 and is expected to reach USD 11868.26 million by the end of 2028, growing at a CAGR of -19.38% between 2022 and 2028. The COVID-19 pandemic and the advantages of mRNA therapeutics, along with related technological advancements, are the core drivers driving the mRNA Vaccines & Therapeutics market.The COVID-19 pandemic has favorably impacted the growth of the global market owing to an increase in the number of COVID-19 patients globally and substantial external financing for the production of mRNA-based COVID-19 vaccines. Furthermore, when new strains of the SARS-COVID-19 virus appeared in many countries around the world, the demand for mRNA vaccines rose sharply due to their effective protection against these strains. Hence, the use of these mRNA-based products is expected to increase during the COVID-19 pandemic and lead to market growth.
Figure Global MRNA Vaccines & Therapeutics Market Size
Source: Bossonresearch.com, 2022
Driving Factors
COVID-19 Pandemic
The COVID-19 pandemic has favorably impacted the growth of the global market owing to an increase in the number of COVID-19 patients globally and substantial external financing for the production of mRNA-based COVID-19 vaccines. Furthermore, when new strains of the SARS-COVID-19 virus appeared in many countries around the world, the demand for mRNA vaccines rose sharply due to their effective protection against these strains. Hence, the use of these mRNA-based products is expected to increase during the COVID-19 pandemic and lead to market growth.
The advantages of mRNA therapy and the advancement of related technologies
Compared with traditional vaccines, mRNA vaccines have the advantages of high efficacy and low production costs. Compared with traditional vaccines (attenuated, inactivated, recombinant subunit and other vaccines), mRNA vaccines have a simple production process, do not require cell culture or animal-derived substrates, and have fast synthesis and low cost. In terms of mechanism of action, compared with traditional inactivated vaccines, traditional vaccines directly inject antigenic proteins into the human body to cause an immune response. Due to its mature technology and R&D and production experience, the adverse reaction rate is low. mRNA is the injection of mRNA encoding viral antigens into the body, and the corresponding antigens are produced by the body's own cells, thereby activating specific immunity. The process of presenting antigens with inactivated vaccines is one-time, and no new antigens will be added thereafter. The process of antigen presentation of mRNA vaccines is short-lived and sustainable, and the protection efficiency is relatively higher. However, compared with DNA vaccines, which are also nucleic acid vaccines, mRNA vaccines do not need to enter the nucleus to function, there is no risk of integration into the host genome, and they are transiently expressed, and the half-life can be adjusted by modification. Messenger RNA has become even more of a promising therapeutic tool due to recent technological advances, such as improved stability, translation, and delivery techniques. In fact, mRNA vaccines paved the way for a new field of pharmacology and emerged as a prominent therapeutic category. These mRNA vaccines support the next generation of vaccination, ushering in a new era of vaccine development. For example, in March 2020, Moderna, Inc. and the National Institute of Allergy and Infectious Diseases jointly developed mRNA-1273 (NIAID). It has shown 94.1% effectiveness in preventing symptoms of COVID-19 and received Emergency Use Authorization from the U.S. Food and Drug Administration (US FDA) in December 2020 for widespread immunization of people.
Benefits for the treatment of various diseases
mRNA therapeutics are a rapidly growing class of medicines for multiple diseases that will transform accepted standards of service and advance customized medicine. In theory, mRNA has the potential to synthesize any protein, so mRNA can also be used as a protein supplement or replacement therapy to treat a variety of other diseases. Overall, mRNA technology has the potential to be a competitive way to help across a wide range of applications, especially as further progress is made in the timely delivery and stability of mRNA. With the advent of several mRNA-based technologies, the development of these therapies has increased to target myriad disease indications. Hence, the demand for mRNA-based products is expected to grow in the coming years. This market growth is driven by the prevalence of chronic diseases such as cancer, heart disease, respiratory system, CKD and rare diseases such as propionic acidemia, methylmalonic acidemia, glycogen disease, phenylketonuria, metabolic and immune disorders driven by rising rates. For example, global spending on oncology drugs reached $164 billion in 2020 and is expected to grow to $269 billion in 2025, according to IQVIA. Furthermore, the popularity of mRNA vaccines, development of personalized cancer treatments; robust new product pipeline has increased the demand for mRNA vaccines and therapeutics, thereby propelling industry growth over the forecast period.
Potential application areas and strategies for mRNA technology:
Source: Qin S et al. mRNA-based therapeutics: powerful and versatile tools to combat disease. Signal Transduct Target Ther. 2022 May 21;7(1):166.
Increase in investment amount and R&D efforts
Increasing investment by operating companies in the production of advanced and effective therapeutics and vaccines is likely to support industry growth throughout the projected time frame. There has been a further surge in activity in this area following the approval of the first mRNA vaccine, Comirnaty®, under an Emergency Use Authorization (EUA) in 2020. Since then, two other mRNA-based medicines under the EUA, namely (in chronological order of approval year) Spikevax® (December 2020) and GEMCOVAC-19™ (June 2022), have received regulatory approval. Additionally, more than 1,000 mRNA therapeutics are being evaluated at various stages of clinical trials to treat multiple disease indications. This demonstrates the remarkable scientific advancement and therapeutic promise of these breakthrough drug candidates. For example, in April 2021, Arcturus Therapeutics, a U.S.-based mRNA therapy developer, formed a joint venture with Axcelead, Inc., a Japanese company, and is building a production facility in Minamisoma, Fukushima Prefecture. These investments are likely to complement industry growth in the coming years. Increased mergers and alliances and increased R&D efforts by pharmaceutical companies to improve various preventive vaccinations have further impacted the market growth. For example, in June 2022, Pfizer and Valneva announced the completion of an equity investment for the development and commercialization of a preventive vaccine for infectious diseases. In addition, the lack of precision cancer treatments is forcing governments and some key players to invest extensively in research and development.
Policy supports for the latest generation of mRNA vaccine technologies
As the latest generation of vaccine technology, mRNA has verified its great potential in the prevention and control of infectious diseases and its strategic significance to public safety in the new crown epidemic. The platform that independently masters mRNA vaccine research and development technology is in line with policy orientation, and national policies actively encourage domestic companies to develop mRNA vaccines. The research and development of the new crown mRNA vaccine has become an important starting point for the mRNA technology platform, and will drive the overall development of the mRNA industry chain, which will simultaneously improve the technological accumulation and industrial development of companies from various countries in the field of CGT. Watson/Aibo's new crown mRNA vaccine ARCoV Phase III clinical enrollment has been completed in February 2022, pending unblinding. Fosun Pharma introduced BioNTech's mRNA new crown vaccine BNT162b2, which was approved for emergency use in Hong Kong in January 2021. The sales in 2021 will exceed 1 billion yuan. Phase II clinical data shows that the neutralizing antibody GMT increased by about 60 times after 1 month of vaccination, and Safe and well tolerated. On January 28, 2022, Watson Bio and Blue Magpie signed the "New Crown Variant mRNA Vaccine Technology Development and Commercialization Cooperation Agreement", and the two parties will jointly develop the new crown variant monovalent or multivalent mRNA vaccine. On June 27, 2022, St. Regis Bio's world's first freeze-dried mRNA vaccine of the new crown Omicron strain entered the clinical stage.
Key Development Trends
The market for mRNA therapeutics and mRNA vaccines will continue to grow
Currently, more than 35 companies are evaluating more than 195 mRNA therapeutics and mRNA vaccines in various stages of development for countless disease indications. In addition, some promising leads, especially those showing enhanced efficacy, are expected to be launched commercially over the next decade. Furthermore, the mRNA drug development pipeline is likely to grow further given the active participation of large pharma and new entrants. It is also worth highlighting that nearly 150 collaboration agreements have been signed between industry/academic stakeholders to advance the development of its proprietary pipeline drug candidates. The overall mRNA therapeutics and mRNA vaccines market is expected to continue to grow, driven by growing interest from various stakeholders and encouraging clinical study results.
Below are: Clinical trials of RNA medicines and RNA-transfected cell therapies for (A) disease condition, (B) the modality used for the indicated condition, and (C) the number of clinical trials featuring RNA interventions using ASOs, siRNA, mRNA, saRNA, and mRNA-transfected cell interventions year-by-year.
Source: Current Status and Future Perspectives on MRNA Drug Manufacturing
Rapid progress in mRNA preventive vaccines and tumor vaccines
mRNA preventive vaccines are progressing the fastest. A number of mRNA vaccines for non-COVID-19 infectious diseases have entered the clinical stage, including BioNTech's influenza vaccine and CureVac's two rabies vaccines in phase I clinical trials. Moderna's pediatric RSV vaccine and pediatric hMPV/PIV3 vaccine are in Phase I clinical trials, Zika virus vaccine is in Phase II clinical trials, and adult RSV vaccine, an influenza vaccine, and CMV vaccine are in Phase III clinical trials. According to research by Market Watch, the global preventive vaccine market is expected to grow from $40.8 billion in 2019 to $50.3 billion in 2025 (excluding benefits from new crown vaccines). It is estimated that 20% of vaccines adopt the mRNA technology route, and the mRNA vaccine (excluding the new crown vaccine) will reach a market size of 10.1 billion US dollars by 2025. Tumor vaccines have the fastest clinical progress in addition to prophylactic vaccine mRNA technology. According to the paper published in Nature (Xie, W., Chen, B. and Wong, J., 2021. Evolution of the market for mRNA technology. Nature Reviews Drug Discovery, 20(10), pp.735-736), enter Most of the therapeutic vaccines in clinical trials are tumor vaccines. We counted the marketed products and pipelines that have entered the clinical stage of the world's three major mRNA companies Moderna, BioNTech and CureVac. Among them, there are 7 tumor vaccine projects, and 4 projects that have entered clinical phase II or above at the same time. Other application areas In total, only 10 entered the clinic. By disease type, melanoma has the largest portion of trials in cancer. Relatively speaking, there are still few mature varieties, and the industry is in a stage of rapid development. It is expected to take the opportunity of the epidemic to accelerate the clinical progress. Tumor vaccines will be a niche space for mRNA products. The huge commercial potential depends primarily on the size of the patient population and clear advantages over other therapeutic approaches targeting multiple tumor-associated antigens. mRNA tumor vaccines can express proteins inside cells, eliminating the step of antigen uptake, which may be beneficial to the activation of the immune system; mRNA tumor vaccines are very easy to achieve personalized treatment, Moderna can achieve personalized treatment from design to clinical use within 60 days tumor vaccine.
mRNA vaccines are expected to continue their leadership in the booster market
The Omicron strain may lead to the pan-influenza of the new crown epidemic, and the sequential inoculation of the mRNA vaccine booster is effective in maintaining the lead. The current research data show that the immune response induced by sequential vaccination is significantly higher than that of the same vaccine, so the better clinical effect is mixed vaccination. Selecting vaccines of other technical routes for booster immunization may break the protective immune response bottleneck of inactivated vaccines. Therefore, the booster vaccination of mRNA, adenovirus vector and recombinant protein is expected to further improve the protection rate of the vaccine to the population. With the advantages of fast development speed and high efficiency, mRNA vaccines are expected to continue to maintain a leading position in the booster market.
Protein replacement and supplementation therapy has a wide range of applications and a broad market space
One of the most common applications of mRNA is for therapeutic antibodies and functional proteins. Most studies are still in the early stages of clinical use, using mRNA to express specific functional proteins to complement missing proteins and to replace foreign proteins (such as therapeutic antibodies) that activate or inhibit cellular pathways. The main advantages of mRNA replacement therapy are:
In the case of repeated administration, many pathological defects can be treated by transient expression of therapeutic proteins.
Direct delivery of genetic information encoding protein drugs, and in situ expression using individual cells as reactors can speed up the drug-making process.
We predict that for proteins with a broad therapeutic window for which pharmacokinetic and pharmacodynamic understanding has been established in humans, proteins expressed in readily accessible organs, and those that are completely inactive in the corresponding patient population In other words, the barriers to development are smaller. Therefore, the most promising drugs to be replaced are mainly recombinant protein drugs such as monoclonal antibodies, cytokines, hematopoietic factors, interferons, interleukins, and recombinant enzymes. Therefore, mRNA therapy is expected to replace part of the protein drug market. According to Research And Markets data, the global protein drug market reached US$93 billion in 2017 and is expected to expand to US$220 billion in 2025, with a compound annual growth rate of 11.2%. Among them, monoclonal antibodies are the largest category. The global monoclonal antibody market will reach US$106.9 billion in 2020, and the market size is expected to grow to US$179.6 billion by 2025, with a compound annual growth rate of 11.9%. Others mainly include recombinant protein drugs such as cytokines, hematopoietic factors, interferons, interleukins, and recombinant enzymes. mRNA has its own unique advantages and is expected to partially replace the protein drug market.
Areas of application such as regenerative therapy remain to be discovered
The application of mRNA technology in other fields remains to be explored, including allergy immunotherapy, regenerative medicine therapy (gene editing + regulation of cell fate), medical aesthetics, etc. Over the past decade, genome editing has emerged as a potential alternative to gene therapy. The precise knock-in or knock-out of defective genes using engineered mRNAs makes gene editing technology promising for the treatment of inherited diseases. BioNTech and Moderna have yet to deploy other fields, but CureVac and CRISPR Therapeutics have partnered to develop the Cas9 gene editing system, which is currently in preclinical research. Regenerative therapy is expected to reach a market size of $17.9 billion by 2025, according to Markets and Markets.
Global MRNA Vaccines & Therapeutics Market: Competitive Landscape
On basis of geography, the mRNA Vaccines & Therapeuticsm market is segmented into North America, Europe, Japan, China, etc. Europe will dominate the market with a share of over 68.38% in 2021. Availability of substantial research funding, high frequency of RNA-based drugs, and clinical trials drive the European market.
Currently, the main players in the mRNA Vaccines & Therapeuticsm Market include BioNTech, Moderna Therapeutics, Translate Bio, eTheRNA, Tiba Biotechnology. Among them, BioNTech and Moderna Therapeutics have become the absolute leaders of the mRNA Vaccines & Therapeuticsm Market, accounting for 53.18% in 2021 respectively and 44.64% market share.
Key players in the MRNA Vaccines & Therapeutics Market include:
BioNTech
Moderna Therapeutics
Translate Bio
eTheRNA
Tiba Biotechnology
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