Market Segment by Type (mRNA Prophylactic Vaccines, Therapeutics Vaccines, mRNA Therapeutics), Market Segment by Vector (Self-amplifying, Non-amplifying mRNA), Market Segment by Vector Platforms (naked mRNA, Cell-Specific, Carrier Mediated), Market Segment by Carrier Mediated (Viral, Non-viral), Market Segment by Non-viral (Polymer-based Vectors, Lipid Nanoparticles, Peptide-based Vectors), Market Segment by Route of Delivery (Intradermal, Subcutaneous, Intramuscular, Intravenous, Intranodal), Market Segment by Applications (Cell Therapy, Gene Editing, Protein Replacement, Cancer Immunotherapy, Infectious Diseases), Market Segment by End-Users (Hospitals & Clinics, Research Organizations), plus COVID-19 Impact Analysis and Recovery Pattern Analysis (“V”-shaped, “W”-shaped, “U”-shaped, “L”-shaped), Profiles of Leading Companies, Region and Country.
The global mRNA Vaccines & Therapeutics market was valued at US$58,452.6 million in 2021 and is projected to grow at a CAGR of -7.89% during the forecast period 2022-2032.
Technology Advances Driving the Market Growth
The mRNA technology is one of the biggest scientific breakthroughs of recent times and it is expected to play a pivotal role in developing a support system for other technology platforms such as CART-T cell therapies or CRISPR-Cas gene-editing therapies. mRNA technology will usher various digital platforms to develop new products and services. The technology will create an ecosystem with many companies venturing into the development of the drugs and vaccines and support these pharmaceutical companies, new digital firms, and platform delivery companies are expected to frogspawn the market growth.
These support systems are expected to bring more innovation and disruptive changes in the way drugs and vaccines are manufactured thereby passing on the benefits to a patient population with rare, autoimmune diseases including cancers. The biggest technological challenge for mRNA drug delivery is the innate lack of mRNA stability and to overcome this companies such as Moderna and BioNTech have built their proprietary platforms. These platforms are expected to advance in the way mRNA-based medicine would be delivered, making them less toxic and improving patients ‘ability than the existing ones. Globally, R&D companies have established their internal platforms, with a focus on the treatment of infectious diseases and oncology treatment therapies, for instance, RNActive of CureVac and the nucleoside modified mRNA-LNP platform from Moderna.
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How has COVID-19 had a Significant Positive Impact on the mRNA Vaccines & Therapeutics Market?
COVID-19 turned out to be a game-changer opportunity for mRNA vaccines and therapeutics market players. The pandemic helped the research fraternity to launch the mRNA vaccine under emergency approval and its outcomes were positive. The promising results of “Comirnaty” have prompted the application of mRNA in personalized cancer vaccine treatment and rare and autoimmune diseases. Currently, there are more than 20 clinical trials for oncology and various clinical trials are in the drug discovery phase.COVID-19 pandemic brought multiple stakeholders together on one platform thereby bolstering the global infrastructure for vaccine development. Companies involved in LNP platforms have garnered interest from big pharmaceutical companies and have led to a large number of collaborations. Despite the enormous success, there are still certain challenges and bottlenecks in the supply chain and effective storage and transport of these vaccines.
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What are the Current Market Drivers?
Significant Research Funding to boost the market growth
COVID-19 triggered a rapid need for vaccine development with funds pouring from all government organizations. Moderna which launched “Spikevax” and received U.S. FDA approval on January 31, 2022, had already bagged US$1 billion in aid from the U.S. Government during its R&D program. Additional worth US$1.5 billion was signed between Moderna and NIH for the supply of 100 million mRNA vaccine doses post the success in the late stage of clinical trials. In total, Moderna seized a fund of US$2.48 billion in R&D and supply from the federal government for its mRNA vaccine research program. In Europe, Germany invested 300 million Euros (US$368 million) to CureVac. The German Government participated in this funding owing to the potential mRNA technology for the development of new vaccines and therapeutics, including COVID-19. Funding was witnessed from Non-Government Organizations for therapeutic treatments for instance, Bill & Melinda Foundation has funded one of the research programs of BioNTech for its Tuberculosis clinical trial named BTN164.
Recently in February 2022, the Biden government reignited its cancer moonshot project with emphasis on reducing cancer deaths to half by 2047. The focus of this new project would be preventive cancer vaccines such as Human Papilloma Virus (HPV) using mRNA technology. Funding for these projects would be made as a part of the Advanced Research Projects for Health (ARPA-H). The funding committee has approved US$2.4 billion to US$3 billion to launch ARPA-H.
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Where are the Market Opportunities?
mRNA Cancer Vaccines
With significant technological advancements in the past decade cancer vaccines have touted attention from the industry players. Moreover, recent FDA approvals of six checkpoint inhibitor drugs and two chimeric antigen receptors (CAR-) T-cells immunotherapies, cancer vaccines are being weighed as potential treatment therapies. Commercially available preventive vaccines include the human papillomavirus (HPV) and another for the hepatitis-B virus which leads to liver cancer. There has been growing interest in both prophylactic as well as therapeutic mRNA vaccines, post the success of mRNA COVID-19 vaccines. Moreover, due to its structural advantage and magnitude of protein expression, mRNA vaccines are being preferred over DNA vaccines by research and the scientific fraternity now. In addition to this, successful delivery platforms such as lipid nanoparticles, polymers and peptides have been beneficial for the uptake of mRNA technology. Besides, these advantages its in-vitro transcription mode is been widely applied to the production of mRNA. The IVT method is free from isolation and does not need the purification of biological samples. Presently, non-replicating mRNAs have been considered suitable for cancer treatment however self-amplifying mRNAs are inching their space in this treatment therapy.
Analytics, Machine Learning, and Cloud Data Warehousing
To stay competitive and simplify the development, manufacturing and distribution for testing clinical trials of newly developed drugs and vaccines, mRNA manufacturers are working in collaboration with IT-firms and cloud service providers. Cloud-based services such as computing of data, data storage, and security have become a cornerstone for successful launch of drugs in the market. The cloud based service providers provide end to end support including substantial risk involved in development of drug or uncertainties pertaining to commercial success of the drug. For instance, in August 2020, Moderna, declared AWS (Amazon Web Services) as its preferred cloud service provider. Moderna will deploy AWS services for its regular analytical and machine learning workloads. In December 2021, Pfizer also announced its collaboration with AWS. Amazon Web Services will support Pfizer to accelerate its drug development processes and clinical manufacturing through rapid innovation and application of its cloud based solutions. We anticipate more biotech firms in mRNA manufacturing sector to avail these services for optimization of internal R&D processes and clinical trials.
The major players operating in the mRNA Vaccines & Therapeutics market are AstraZeneca PLC, Moderna, CureVac N.V., BioNTech SE, Pfizer Inc., GSK PLC, Arcturus Therapeutics Holding Inc., Translate Bio (now a Sanofi Company), Sanofi, eTheRNA and Stemirna Therapeutics. Companies operating in this market have adopted various strategies including investment in R&D, collaborations, M&A, partnerships, regional business expansion, and new platform offerings among other strategies to expand their global reach.
On 16th February 2022, BioNTech announced expansion of its manufacturing facility in Africa. This will be the first modular mRNA manufacturing facility to supply and promote mRNA vaccines in the African region
On 3rd February 2022, Merck and eTheRNA inked a research agreement, with this agreement Merck will get an access to mRNA technologies of eTheRNA. This partnership will explore the application of eTheRNA’s proprietary LNP delivery platform for treatment of various diseases chose by Merck
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