Given the current technical and operational challenges associated with the manufacturing of mRNA-based products, innovators in the biopharmaceutical industry are increasingly relying on the mRNA synthesis and contract manufacturing service providers.
Roots Analysis has announced the addition of “mRNA Synthesis and Manufacturing Services Market (2nd Edition), 2022–2035” report to its list of offerings.
Owing to the recent success and growing pipeline of mRNA-based products in the market, mRNA, as a therapeutic agent, has gained significant traction from the medical community. However, due to challenges, such as high capital requirement, stringent regulations and lack of technical expertise, outsourcing has become a preferred business model and CMOs are upgrading their existing capabilities and service portfolios to meet the increased demand for mRNA-based products.
Key Market Insights
Presently, 30+ companies claim to offer custom synthesis services for mRNA, globally.
Majority of the service providers are mid-sized players (44%), followed by small (35%), large (12%) and very large players (9%). Additionally, more than 25% of the stakeholders were established post 2010. It is also worth mentioning that over 50% of the total players are based in North America, specifically in the US.
More than 40 companies, across the globe, claim to provide contract manufacturing and fill / finish services for mRNA vaccines / therapeutics.
Of the aforementioned players, nearly 85% of the contract manufacturing service providers are based in North America and Europe. Notably, more than 50% of the total players engaged in this space offer services for drug substance (APIs) manufacturing.
Currently, more than 95 mRNA synthesis kits are available in the market.
Close to 70% of the mRNA synthesis kits contain capping enzymes; of these, 96% use T7 RNA polymerase enzyme mix for the synthesis of modified mRNAs. It is worth highlighting that majority (54%) of the kit developers are small players.
More than 170 clinical trials have been registered for the evaluation of mRNA-based therapeutics / vaccines, worldwide.
The clinical research activity, in terms of number of trials registered, is reported to have increased at a steady CAGR of 44%, during the period 2017-2022. Of the total number of trials registered, close to 22% have already been completed, while 46% of the studies are actively recruiting participants.
Partnership activity within this domain has grown at a CAGR of 60%, between 2019 and 2022.
Nearly 34% of the deals were inked in 2021. Majority of the instances captured in the report were manufacturing agreements, representing 22% of the total partnerships. Further, most of the intercontinental deals have been inked by players based in North America.
North America and Europe are anticipated to capture close to 65% of the global market share, by 2035.
The market in Asia Pacific is likely to grow at the highest CAGR during the period 2022-2035. In terms of type of product, drug substance (APIs) is expected to occupy a larger share (70%) of the overall mRNA synthesis and manufacturing service market in 2035.
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Key Questions Answered
- What are the factors driving mRNA synthesis and manufacturing market?
- How many players are providing services for custom synthesis of mRNAs?
- How many players are offering mRNA contract manufacturing services for commercial purposes?
- How many kits are available in the market for the synthesis of mRNA?
- Which geographical segment has the highest growth rate in mRNA synthesis and manufacturing market?
- Which segment, in terms of type of product, accounts for the largest mRNA synthesis and manufacturing market share?
- What is the partnership and collaboration trends in mRNA synthesis and manufacturing domain?
- Who are the key players in mRNA synthesis and manufacturing market?
The financial opportunity within the mRNA synthesis and manufacturing service market has been analysed across the following segments:
- Type of Product
- Drug substances (APIs)
- Drug products (FDFs)
- Application Area
- mRNA-based vaccines
- mRNA-based therapeutics
- Therapeutic Area
- Infectious diseases
- Oncological disorders
- Other diseases
- Key Geographical Regions
- North America
- Latin America
- Middle East and North Africa
- Rest of the World
The research also includes detailed profiles of the key players (listed below) engaged in mRNA synthesis and manufacturing domain; each profile features a brief overview of the company, details related to its service portfolio (for mRNA synthesis and contract manufacturing service providers) / product portfolio (mRNA synthesis kit providers), recent developments and an informed future outlook.
- Jena Biosciences
- New England Biolabs
- Thermo Fisher Scientific
- TriLink BioTechnologies
For additional details, please visit
https://www.rootsanalysis.com/reports/mrna-synthesis-and-manufacturing-market.html or email [email protected]
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About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights.
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