MRNA SYNTHESIS AND MANUFACTURING MARKET: OVERVIEW
As per Roots Analysis, the mRNA synthesis and manufacturing market is estimated to grow from USD 1.15 billion in the current year to USD 1.35 billion by 2035, at a CAGR of 20% between 2028 and 2035.
mRNA Synthesis and Manufacturing Market
The market sizing and opportunity analysis has been segmented across the following parameters:
Type of Product
- Active Pharmaceutical Ingredients
- Finished Dose Formulations
Scale of Operation
- Preclinical and Clinical Scale
- Commercial Scale
Synthesis and Manufacturing Activity
- Contract Manufacturing
- In-house Manufacturing
Indication Type
- COVID Indications
- Non-COVID Indications
Therapeutic Area
- Infectious Diseases
- Oncological Disorders
- Other Disorders
Application Area
- mRNA Vaccines
- mRNA Therapeutics
Geographical Regions
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East and North Africa
MRNA SYNTHESIS AND MANUFACTURING MARKET: GROWTH AND TRENDS
Ribonucleic acid (RNA) is a molecule found in all living cells that translates genetic information into different proteins to carry out various cellular functions. Importantly, RNA can exist in various forms, such as messenger RNA (mRNA), transfer RNA (tRNA), and ribosomal RNA (rRNA). Amongst these, mRNA has become a crucial therapeutic approach in modern healthcare industry.
mRNA is a single-stranded RNA molecule that carries the genetic information found in DNA to synthesize proteins. The genetic information found on mRNA is translated into amino acids, which are then processed into a functional product (proteins). Significantly, following the COVID-19 pandemic, the production of mRNA vaccines and therapeutics has attracted notable focus as they have developed into a next-generation class of drugs for treating the COVID-19 infection. Additionally, mRNA therapies are being assessed for the management of different oncological, infectious, and genetic conditions. This versatility and scalability of mRNA therapeutics have further contributed to their adoption, positioning them as a cornerstone of personalized mRNA medicine production and vaccine development. Moreover, these therapies are expected to possess enhanced safety profiles for patients due to the low risk of insertional mutagenesis.
Due to this success, the need for mRNA synthesis and production has risen significantly, leading mRNA therapeutic /vaccine developers to actively investigate alternatives to meet the current demand. In this regard, outsourcing became a profitable choice for companies involved in mRNA therapeutic / vaccine development, providing effective and scalable solutions for mRNA therapeutics and vaccine development. Given the current trends and anticipated opportunities in the mRNA synthesis and manufacturing sector, we anticipate that this field is poised for single-digit market growth in the near future.
mRNA SYNTHESIS AND MANUFACTURING MARKET: KEY INSIGHTS
The report delves into the current state of the mRNA synthesis and manufacturing market and identifies potential growth opportunities within industry. Some key findings from the report include:
1. The current market landscape features the presence of close to 55 providers that claim to offer customized services for mRNA synthesis across the world; 60% of these are headquartered in North America.
2. Majority (~95%) of the mRNA custom synthesis service providers offer 5' modifications of mRNA, primarily because it enhances mRNA stability, translation efficiency and reduces chances of immunogenicity.
3. Stakeholders are actively upgrading their existing capabilities in order to enhance their respective portfolios and gain a competitive edge over other players active in the mRNA custom synthesis domain.
4. Owing to the rising demand for mRNA vaccines coupled with advancements in mRNA synthesis and manufacturing technologies, ~45 companies are actively offering mRNA contract manufacturing services.
5. Around 60% of the companies are offering mRNA contract manufacturing services for both drug substances and drug products; ~90% players offer mRNA contract manufacturing services at clinical scale.
6. mRNA contract manufacturing service providers are proactively enhancing and diversifying their mRNA manufacturing capabilities to strengthen their service portfolios and establish a competitive market foothold.
7. Presently, close to 115 kits are available in the market for mRNA synthesis; these kits are designed to cater to a wide range of applications, including molecular biology, protein production and vaccine development.
8. mRNA synthesis kits comprise of a variety of components, catering to the specific needs of clients; notably, T7 polymerase emerged as the most preferred type of enzyme being offered in more than 95% mRNA synthesis kits.
9. Presently, close to 115 kits are available in the market for mRNA synthesis; these kits are designed to cater to a wide range of applications, including molecular biology, protein production and vaccine development.
10. mRNA synthesis kits comprise of a variety of components, catering to the specific needs of clients; notably, T7 polymerase emerged as the most preferred type of enzyme being offered in more than 95% mRNA synthesis kits.
11. The rising interest in this market is reflected from the diverse partnerships established among various stakeholders in the recent past; in fact, close to 50% of the deals were inked in the last three years.
12. Various mRNA-based therapeutic / vaccine developers across the world are anticipated to forge strategic alliances with mRNA synthesis and manufacturing service providers to further augment their drug portfolio.
13. Majority (~30%) of the big pharma activities in this domain have been led by Sanofi; of these, most of the initiatives (50%) were instances of partnerships and collaborations inked with various stakeholders active in this domain.
14. Currently, majority of the mRNA synthesis and manufacturing market share is captured by North America; this can be attributed to the advanced healthcare infrastructure, enabling players to conduct extensive research.
15. The infectious diseases sub-segment is estimated to capture most of the overall market share in the current year, owing to the effectiveness of mRNA therapeutics and vaccines in the treatment of such diseases.
16. North America is expected to capture a significant market share of the overall mRNA synthesis and manufacturing market; this trend is unlikely to change in the future.
17. Driven by the rapid success of mRNA-based vaccines and therapeutics developed by prominent players in the US, the mRNA synthesis and manufacturing market is expected to grow at CAGR of 6.5%.
mRNA SYNTHESIS AND MANUFACTURING MARKET: KEY SEGMENTS
Active Pharmaceutical Ingredients Holds the Largest mRNA Synthesis and Manufacturing Market Share
Our estimates suggest that in the current year, the active pharmaceutical ingredients sub-segment is likely to capture majority (>60%) of the mRNA synthesis and manufacturing market share. This can be attributed to the fact that active pharmaceutical ingredients are a fundamental component of any therapeutic / vaccine, that impact the overall efficacy and safety of the product.
Commercial Scale Captures the Largest mRNA Synthesis and Manufacturing Market Share
In the current year, commercial scale sub-segment captures the highest market share (>85%), owing to the commercialization of a large number of mRNA-based therapeutics and vaccines. Further, the market for preclinical and clinical scale is likely to witness a moderate increase during the forecast period. Significant research and development in this field are driving growth in the preclinical and clinical areas, resulting in a rise in the development of mRNA-based products. Additionally, the firms are concentrating on expanding mRNA production facilities to enhance operations at different scales.
Contract Manufacturing is Anticipated to Dominate the mRNA Synthesis and Manufacturing Market
In the current year, the contract manufacturing sub-segment occupies the highest market share (~60%). This dominance is primarily driven by the complexity of mRNA production, which demands specialized expertise and often relies on third-party service providers. Further, the market is likely to witness a substantial increase in the share of in-house manufacturing sub-segment, growing at a CAGR of 7.5% during the forecast period.
Non-COVID-Indications is Likely to Grow at a Notable CAGR During the Forecast Period
The COVID indication sub-segment occupies the highest market share (95%) in the current year. This can be attributed to the fact that mRNA-based products can instruct cells to produce specific pathogen proteins, which in turn trigger a strong and targeted immune response without exposing the individual to the actual pathogen. Further, the market is likely to witness a substantial increase in the share of non-COVID indications, growing at a CAGR of 37.5% during the forecast period.
Focus on Infectious Disease mRNA Therapies
In the current year, the infectious diseases sub-segment occupies the highest market share (~95%), given the fact that mRNA therapeutics and vaccines demonstrated tremendous success in combating the COVID-19 pandemic. Further, the oncology segment is likely to witness significant market growth owing to the increasing prevalence of cancer and the need to develop novel therapeutic options to treat oncological disorders efficiently.
mRNA Vaccines Holds the Largest mRNA Synthesis and Manufacturing Market Share
In the current year, the market is solely driven by mRNA vaccines sub-segment as per mRNA synthesis and manufacturing market forecast, given their proven clinical success, broad preventive applications and flexible nature. Further, the market is likely to witness a substantial increase in the share of mRNA therapeutics, growing at a CAGR of 61.1% during the forecast period. This is because of their rapidly expanding therapeutic applications for therapeutic areas such as oncological, genetic, autoimmune and cardiovascular disorders, thus generating a strong clinical momentum for mRNA therapeutics.
North America to Propel in the mRNA Synthesis and Manufacturing Sector in the Coming Years
North America is likely to capture majority share (>40%) of the market. In addition, the market in North America is expected to grow at a CAGR of 6.6%, during the forecast period. This is because of the advanced healthcare infrastructure in North America, enabling several players in the industry to conduct extensive research and develop novel mRNA modalities for a wide array of therapeutic indications.
Primary Research Overview
Discussions with multiple stakeholders in this domain influenced the opinions and insights presented in this study. The market report includes detailed transcripts of interviews conducted with the following individuals:
- Chief Executive Officer, Mid-sized Organization, Belgium
- Chief Commercial Officer, Mid-sized Organization, France
- Business Development Manager, Mid-sized Organization, Spain
- Team Leader, Large Organization, South Korea
In addition, the market report includes transcripts of the following other third-party discussions:
- Scientist in Nucleic Acid Therapeutics, Very Large Organization, United States
- Senior Product Manager, Very Large Organization, United States
- NEB RNA Research Senior Scientist, Large Organization, United States
- Professor and Director of the BASE facility and, Associate Professor and Deputy Director of the BASE facility, Vert Large Organization, Australia
Example Players in the mRNA Synthesis and Manufacturing Market
- Aldevron
- APExBIO
- Aurigene Pharmaceutical Services
- BioCell
- Biomay
- BioNTech
- Biorbyt
- CELLSCRIPT
- Creative Biogene
- Curia
- Eurogentec
- GenScript
- eJena Bioscience
- Lonza
- Merck
- Porton Advanced
- Revolution Biotechnology
- Samsung Biologics
- ST Pharm
- Thermo Fisher Scientific
- TriLink BioTechnologies
- Vernal Biosciences
- WuXi Biologics
- YXgene
mRNA SYNTHESIS AND MANUFACTURING MARKET: RESEARCH COVERAGE
- Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the mRNA synthesis and manufacturing market, focusing on key market segments, including [A] type of product, [B] scale of operation, [C] synthesis and manufacturing activity, [D] indication type, [E] therapeutic area, [F] application area and [G] geographical regions.
- Market Landscape 1: A detailed assessment of companies offering mRNA custom synthesis services, based on several relevant parameters, including [A] year of establishment, [B] company size, [C] location of the headquarters, [D] type of service offered, [E] type of starting material, [F] structural modification, [G] type of purification method, [H] scale of operation, [I] application area and [J] GMP compliance.
- Company Competitiveness Analysis: A competitiveness analysis of mRNA custom synthesis service providers, based on [A] supplier strength, and [A] service strength
- Market Landscape 2: A comprehensive assessment of the mRNA contract manufacturing service providers, based on [A] year of establishment, [B] company size, [C] location of the headquarters, [D] location of manufacturing facilities, [E] type of product, [F] type of additional services offered, [G] scale of operation, [H] GMP compliance.
- Company Competitiveness Analysis: In-depth company competitiveness analysis of mRNA contract manufacturing service providers based on [A] supplier strength and [B] service strength.
- Market Landscape 3: A detailed assessment of the current market landscape of mRNA synthesis kits based on several relevant parameters, such as [A] kit, [B] type of enzyme, [C] type of enzyme mix used, [D] type of mRNA component modified, [E] number of reactions, [F] yield per reaction, [G] reaction run-time and shelf life, [H] year of establishment, [I] company size, [J] location of the headquarters and [K] most active players.
- Product Competitive Analysis: An insightful analysis of mRNA synthesis kits, based on [A] developer strength and [B] product portfolio strength.
- Company Profiles: In-depth profiles of prominent players across North America, Europe and Asia-Pacific, focusing on [A] year of establishment, [B] location of headquarters, [C] B-mRNA synthesis service portfolio, [D] recent developments and [E] an informed future outlook.
- Partnerships and Collaborations: A detailed analysis of the partnerships inked between stakeholders engaged in this industry, based on several parameters, such as [A] year of partnership, [A] type of partnership, [B] type of product, [C] type of partner and [D] most active players.
- Likely Partner Analysis: a comprehensive analysis of mRNA-based therapeutics / vaccines developers that are likely to partner with mRNA contract manufacturing service providers.
- Big Pharma Initiatives: A review of the various mRNA-focused initiatives undertaken by big players, highlighting trends across various parameters, such as [A] number of initiatives, [A] year of initiative, [A] type of partnership, [B] type of expansion, [C] region of expansion, [D] type of pharmaceutical and [E] therapeutic area.
- Market Impact Analysis: An in-depth analysis of the factors that can impact the growth of the mRNA synthesis and manufacturing market. It also features identification and market analysis of [A] key drivers, [B] potential restraints, [C] emerging opportunities, and [D] existing challenges.
KEY QUESTIONS ANSWERED IN THIS REPORT
- How many companies are currently engaged in this market?
- Which are the leading companies in this market?
- What is the current global capacity of developers?
- What factors are likely to influence the evolution of this market?
- What is the current and future market size?
- What is the CAGR of this market?
- How is the current and future market opportunity likely to be distributed across key market segments?
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