M-RNA SYNTHESIS SERVICE MARKET ANALYSIS

Global m-RNA synthesis service market is estimated to be valued at US$ 6,438.6 Million in 2023 and is expected to exhibit a CAGR of 5.57% during the forecast period (2023-2030). Increasing launch of services for m-RNA synthesis is expected to drive the market growth over forecast period. Moreover increasing prevalence of chronic and infectious diseases is expected to drive the market growth.

Analysts’ Views on Global m-RNA Synthesis Service Market:

Global m-RNA synthesis service market's growth is expected to propel over the forecast period, owing to rising government initiatives and efforts for the development of mRNA therapeutics, especially during the emergence of the COVID-19 pandemic. For instance, in August 2022, the Australian Government, Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and the Victorian Government entered into a partnership to establish an mRNA vaccine manufacturing facility at Monash University in Melbourne, Australia. This facility aims to produce up to 100 million vaccine doses each year that will help in protecting Australian’s against future pandemics and will reduce Australian people’s dependence on imported mRNA vaccines.

Figure 1. Global m-RNA Synthesis Service Market Share (%), By Application, 2023

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Global m-RNA Synthesis Service Market- Driver

Increasing Facility Expansion by Market Players

Major companies operating in the global m-RNA synthesis service market are focused on organic growth strategies such as facility expansions, and this is expected to drive growth of the global m-RNA synthesis service market over the forecast period. For instance, in March 2021, Maravai LifeSciences, a global provider of life science reagents and services to researchers and biotech entrepreneurs, expanded its contract development and manufacturing organization (CDMO) capabilities at TriLink BioTechnologies, a division of Maravai LifeSciences, with the launch of its plasmid DNA (pDNA) manufacturing services. TriLink's new plasmid services will provide customers the convenience of a single-source messenger RNA (mRNA) solution, manufactured with Current Good Manufacturing Practice (cGMP) capabilities, from plasmid synthesis through final release testing

Increasing Prevalence of chronic and infectious diseases

 Increasing prevalence of chronic and infectious diseases such as cancer, cytomegalovirus (CMV), HIV (human immunodeficiency virus), hepatitis, among others is expected to drive the market growth over the forecast period. For instance, according to the data provided by Breastcancer.org, in March 2022, an estimated 287,850 new cases of invasive breast cancer are expected to be diagnosed in women, in the U.S., along with 51,400 new cases of non-invasive (in situ) breast cancer in 2022. Moreover, according to the Centers for Disease Control and Prevention, one out of every 200 babies is born with congenital cytomegalovirus (CMV) infection and around one out of five babies, in the U.S., is born with congenital CMV infection that will have long-term health problems such as  mononucleosis or hepatitis (liver problem).

Figure 2. Global m-RNA Synthesis Service Market Share (%), By Region, 2023

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Global m-RNA Synthesis Service Market- Regional Analysis

Among regions, North America is expected to dominate the market over the forecast period, due to North Americas’ 39.5% market share and increasing government initiatives for advancements in mRNA vaccine technology in the region that will enhance the synthesis services for mRNA. For instance, in October 2022, government of Canada announced funding for advancements in mRNA vaccine technology at the University of British Columbia. The Honorable Harjit S. Sajjan, Minister of International Development and Minister responsible for the Pacific Economic Development Agency of Canada (PacifiCan), announced the funding of US$ 11.1 million, through PacifiCan, for the University of British Columbia (UBC) in order to undertake two new projects to enhance the delivery and efficacy of mRNA vaccines.

Europe region is expected to have a lucrative growth over the forecast period, due to European Commission approval for mRNA in the region. For instance, in November 2022, Pfizer Inc., a pharmaceutical and Biotechnology Company, in collaboration with BioNTech SE, a Germany based biotechnology company announced that the European Commission (EC) had granted a conditional marketing authorization (CMA) for COMIRNATY, an mRNA based vaccine. This approval will increase the demand for mRNA synthesis and services in Europe.

Global m-RNA Synthesis Service Market– Impact of Coronavirus (COVID-19) Pandemic

Coronavirus disease 2019 (COVID-19) is a highly contagious infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), according to World Health Organization (WHO) till January 03, 2022, 651,918,402 people are affected worldwide.

Global mRNA synthesis service market is witnessing growth, due to increasing demand for development of new vaccines in order to control the spread of the coronavirus disease. According to data from the Centers for Disease Control and Prevention (CDC), updated on December 12, 2022, the use of mRNA vaccines is safe and effective, and its safety has been rigorously tested to aid the fight against COVID-19 pandemic. Moreover, CDC recommends COVID-19 vaccines for everyone who is 6 months and older and booster dose for everyone who is 5 years and older, if eligible. Therefore, COVID-19 has shown a significant positive impact on the global mRNA synthesis service market.

Global m-RNA Synthesis Service Market Segmentation:

The global m-RNA synthesis service market report is segmented into application, scale of operation, end user and region.

Based on Application, the market is segmented into Therapeutic Development, Vaccine Production, Drug Discovery, and Others. Out of which, Vaccine Production segment is expected to dominate the m-RNA synthesis service market  during the forecast period, due to increasing  research and development activities, clinical trials, and production of m-RNA vaccines.

Based on Scale of Operation, the market is segmented into Research and Commercial. Out of which, Research segment is expected to dominate the market over the forecast period, due to increasing launch of mRNA services for research applications.

Based on End User, the m-RNA synthesis service market is segmented into Biopharmaceutical Companies, Contract research organizations (CROs), and Others. Biopharmaceutical Companies segment is expected to dominate the market over the forecast period, due to increasing number of clinical trials for the development of mRNA vaccines by biopharmaceutical companies.

Based on Region, global m-RNA synthesis service market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to dominate the market over the forecast period, due to increasing number of product approvals from regulatory authorities in U.S.

Among all segmentation, application segment has highest potential, due to increasing clinical trials of m-RNA based vaccines to prevent diseases such as COVID-19, HIV, and others. For instance, in May 2022, The Center for Family Health Research (CFHR) in Kigali, Rwanda (Africa), and The Aurum Institute in Tembisa, South Africa, announced the initiation of first participant screening for a Phase I clinical trial of an mRNA HIV vaccine antigen (mRNA-1644).

Global m-RNA Synthesis Service Market- Cross Sectional Analysis:

In application segment, vaccine production segment is dominant in North America region, due to increasing number of innovations for the manufacturing of mRNA vaccines. For instance, in August 2021, Aldevron, a U.S.- based company of GMP bio manufacturer and a service provider of plasmid DNA, mRNA, and proteins, and Ginkgo Bioworks, Inc., a biotech company, announced a manufacturing breakthrough for vaccinia capping enzyme used in the manufacturing of mRNA vaccines. This breakthrough shows improvements in the manufacturing yield of vaccinia capping enzyme (VCE), a component that is required in production of mRNA therapies and vaccines. This breakthrough will increase the demand for mRNA synthesis and services in the region.

In end user, Biopharmaceutical companies held as a dominant segment in Europe region, due to increasing facility expansions by biopharmaceutical companies in the region. For instance, For instance, in June 2021, Sanofi, a pharmaceutical company, announced the launch of vaccines mRNA Center of Excellence. The mRNA Center will accelerate the development and delivery of next-generation vaccines across Marcy l’Etoile, France.

Global m-RNA Synthesis Service Market: Key Developments

Increasing number of discoveries in m-RNA manufacturing is expected to drive the market growth over forecast period. In August 2022, New England Biolabs, a company producing and supplying recombinant and native enzyme reagents for life science research, announced the release of Faustovirus Capping Enzyme (FCE), an mRNA capping solution that combines high activity and a broad temperature range to support mRNA therapeutic manufacturing needs.    

Market players are focused on manufacturing vaccines, which will increase the demand of m–RNA synthesis over the forecast period. For instance, in May 2022, EUROAPI, a company developing, producing, and marketing active pharmaceutical ingredients, expanded its collaboration with Sanofi, a multinational pharmaceutical and healthcare company, in order to support Sanofi’s mRNA vaccine platform with development of lipid nanoparticles. In this collaboration, EUROAPI will develop and optimize innovative chemical synthesis routes and will manufacture GMP (Good Manufacturing Practices) batches for various second-generation cationic lipids through its Contract Development and Manufacturing Organization (CDMO) activity.

Global m-RNA Synthesis Service Market: Restraint

Technical and Logistics challenges

Technical and logistics challenges during the synthesis and storage of mRNA therapeutics is expected to hamper the market growth. mRNA vaccines are  unstable at high temperatures that makes packaging and distribution difficult. Long-term storage and delivery of vaccines is important, as governments seeks to vaccinate rural and remote communities. The vaccines have important workflow requirements including storage at very low and consistent temperatures. As a result, manufacturers must have access to reliable cold chain storage, which can be expensive to install, if it is not already in place. Moreover, other challenges associated with mRNAs include intrinsic instability, extremely large size, charge, and high chances of enzymatic degradation.

Therefore, improved vectors or drug delivery systems may help in increasing the wider application of mRNA-based therapeutics and can tackle these restraints.

Global m-RNA Synthesis Service Market: Key Players

Major players operating in the global m-RNA synthesis service market include Maravai LifeSciences, Azenta US, Inc., Creative Biolabs, Becton, Dickinson And Company, Creative Biogene, Kaneka Corporation, Danaher, eTheRNA, Biomay AG, ApexBio Technology, RiboPro, F. Hoffmann-La Roche Ltd, System Biosciences, LLC., Aurigene Pharmaceutical Services Ltd., OZ Biosciences, Aldevron and GenScript.

Definition: m-RNA synthesis  is a processes by which m-RNA molecules are generated and are prepared for clinical applications such as vaccine development. However, in eukaryotic cells, these two processes happens independently of each other in both space and time: m-RNAs are created in the nucleus and proteins are afterwards produced in the cytoplasm. M-RNA vaccines instruct human cells to produce a proteinor even just a portion of a proteinthat incites an immunological response in human bodies by using an mRNA made in a laboratory.