mRNA Synthesis and Manufacturing Market by Type of Product (Drug Substances (APIs) and Drug Products (FDFs)), Application Area (mRNA-based Vaccines and mRNA-based Therapeutics), Therapeutic Area (Infectious Diseases, Oncological Disorders and Other Disord

mRNA Synthesis and Manufacturing Market by Type of Product (Drug Substances (APIs) and Drug Products (FDFs)), Application Area (mRNA-based Vaccines and mRNA-based Therapeutics), Therapeutic Area (Infectious Diseases, Oncological Disorders and Other Disorders) and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, Till 2035

MRNA SYNTHESIS AND MANUFACTURING MARKET: OVERVIEW

As per Roots Analysis, the global mRNA synthesis and manufacturing market is estimated to be worth USD 1.06 billion in the current year.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Product

Drug Substances (APIs)

Drug Products (FDFs)

Application Area

mRNA-based Vaccines

mRNA-based Therapeutics

Therapeutic Area

Infectious Diseases

Oncological Disorders

Other Disorders

Key Geographical Regions

North America

Europe

Asia-Pacific

Rest of the World

MRNA SYNTHESIS AND MANUFACTURING MARKET: GROWTH AND TRENDS

In recent years, mRNA technology has revolutionized the pharmaceutical industry to prevent and treat a wide array of diseases and disorders. The success of COVID-19 vaccines has paved the path for mRNA vaccines and therapeutics. It is worth highlighting that, in the past few years, more than 170 clinical trials related to mRNA-based therapeutics / vaccines have been registered. Multiple preclinical and clinical reports demonstrating the efficacy of these platforms have been published in the last two years. As a result, there is an evident increase in the demand for mRNA manufacturing capacity. However, the synthesis and manufacturing process of mRNA-based therapeutics / vaccines is complex and associated with several challenges. Production of such drug products requires skilled labor, stringent manufacturing protocols and specialized expertise. Due to such operational and technical challenges associated with the production of RNA-based products, innovators in the biopharmaceutical industry are increasingly relying on contract service providers. In the foreseen future, as more of such RNA-based leads mature and move into the clinic and / or get commercialized, we anticipate the mRNA synthesis and manufacturing services market to witness healthy growth.

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 the industry. Some key findings from the report include:

1. The current market landscape features the presence of more than 35 companies that claim to offer services for custom synthesis of mRNA, across the world.

2. Various players offer different types of services for mRNA synthesis, based on the requirements of their clients; majority of the players prefer to use plasmid DNA as a starting material to synthesize mRNA.

3. Over 40 companies currently claim to offer contract manufacturing services for drug substance (mRNA) as well as drug product (mRNA-based vaccines and therapeutics), across various scales of operation.

4. Several firms (encompassing startups as well as well-established companies), with varying resources, have been actively involved in this domain; the majority of these firms have manufacturing facilities in Europe.

5. Presently, more than 95 kits (comprising of different components) are available in the market for the synthesis of customized mRNAs; notably, the majority of these have enzymes for cap modification of the mRNA.

6. mRNA synthesis kits carry out various reactions depending on the number of reagents in the kit; in addition, around 30% of the kits yield over 60 µg of mRNA per reaction.

7. In pursuit of building a competitive edge, stakeholders are actively upgrading their existing capabilities to enhance their respective service offerings and comply with the evolving industry benchmarks.

8. In order to meet the rising demand, drug developers are steadily relying on CMOs for the production of mRNA; this approach not only offers a set of streamlined processes but also greater flexibility.

9. To cater to the rising demand for mRNA synthesis kits, companies are actively undertaking initiatives to integrate advanced features in their respective mRNA synthesis kit portfolios.

10. Both industry and non-industry players have forged strategic partnerships in the mRNA synthesis and manufacturing domain; notably, majority of the deals in this domain were manufacturing agreements.

11. 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.

12. Several big pharma players have undertaken a variety of initiatives (partnerships, acquisitions, funding and expansion) for enhancing their mRNA-related portfolio and its therapeutic applicability.

13. Identifying the driving factors (that fuel advancement) as well as barriers (that slow down research progress) helps improve strategic planning and results in efficient operations in mRNA synthesis and manufacturing domain.

14. The opportunity within the mRNA synthesis and manufacturing market is likely to be well distributed across different types of product, application area, therapeutic area and key geographical regions.

MRNA SYNTHESIS AND MANUFACTURING MARKET: KEY SEGMENTS

Drug Substances (APIs) are Likely to Dominate the mRNA Synthesis and Manufacturing Market During the Forecast Period

Based on type of product, the market is segmented into drug substances (APIs) and drug products (FDFs). It is worth highlighting that majority of the current mRNA synthesis and manufacturing market is captured by bulk drug substances (APIs) and this trend is likely to remain the same in near future.

mRNA Therapeutics is the Fastest Growing Segment in the mRNA Synthesis and Manufacturing Market During the Forecast Period

Based on application area, the market is segmented into mRNA-based vaccines and mRNA-based therapeutics. It is worth highlighting that that majority of the current mRNA synthesis and manufacturing market is captured by mRNA vaccines.

Infectious Diseases Segment Accounts for the Largest Share for the mRNA Synthesis and Manufacturing Market

Based on therapeutic area, the market is segmented into infectious diseases, oncological disorders and other disorders. While infectious diseases account for a relatively higher market share, it is worth highlighting that oncological disorders segment is expected to witness substantial market growth in the coming years.

North America Holds the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. It is worth highlighting that currently, North America captures majority of the mRNA synthesis and manufacturing market, and this trend is unlikely to change in the near future.

Example Players in the mRNA Synthesis and Manufacturing Market

Aldevron

Aurigene Pharmaceutical Services

Biomay

Curia

eTheRNA

Eurogentec

Genscript

Merck KGaA

TriLink BioTechnologies

Vernal Biosciences

WuXi Biologics

APExBIO

CELLSCRIPT

Enzynomics

Jena Bioscience

New England Biolabs

Thermo Fisher Scientific

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

Chief Executive Officer, eTheRNA

Chief Commercial Officer, tebubio

Business Development Manager, Canvax

Team Leader, GC Pharma

MRNA SYNTHESIS AND MANUFACTURING MARKET: RESEARCH COVERAGE

The report features an in-depth analysis of the mRNA synthesis and manufacturing market, focusing on key market segments, including type of product, application area, therapeutic area and key geographical regions.

The report analyzes various factors such as drivers, restraints, opportunities, and challenges affecting the market growth.

A comprehensive evaluation of mRNA custom synthesis service providers, considering various parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters (North America, Europe and Asia Pacific), type of services offered (mRNA modification, mRNA purification, scale-up, process development and fill / finish), starting material (plasmid DNA, mRNA sequence and PCR fragments), structural modification (5’ modification, 3’ modification, ribonucleotide base modification and others), type of purification method (chromatography, electrophoresis, desalting / precipitation and others), application area (vaccine production, therapeutic production and others) and scale of operation (preclinical / research, clinical and commercial). Further, the chapter also features information on the length of the mRNA manufactured and mRNA production capacity of the stakeholders.

A comprehensive competitive analysis of mRNA custom synthesis service providers (across key geographical regions), examining factors such as supplier strength and service strength.

Thorough analysis of mRNA contract manufacturing service providers, detailing year of establishment, company size (in terms of number of employees), location of headquarters (North America, Europe and Asia Pacific), location of manufacturing facilities, type of additional services offered (formulation development, analytical testing, process development, mRNA purification, fill / finish, scale-up, regulatory support and others) type of product manufactured (drug substances (APIs) and drug products (FDFs)) and scale of operation (preclinical / research, clinical and commercial).

A comprehensive competitive analysis of mRNA contract manufacturing service providers (across key geographical regions), examining factors such as supplier strength and service portfolio strength.

A detailed assessment of the current market landscape of mRNA synthesis kits based on several relevant parameters, such as kit components (enzyme mix, reagents, buffer and others), type of enzyme (capping enzyme and tailing enzyme), type of enzyme mix used (T7 polymerase, SP6 polymerase and T3 polymerase), mRNA component modified (cap, base and tail), number of reactions (5 reactions, 10 reactions, 15 reactions, 16 reactions, 20 reactions, 25 reactions, 48 reactions and 50 reactions), yield per reaction (less than 31µg, 31-60 µg, 61-90 µg and more than 90 µg), reaction run time (less than 61 minutes, 61-120 minutes and more than 120 minutes) and kit price (less than USD 500, USD 501-USD 700, USD 701-USD 900 USD, USD 901-USD 1,200 and more than 1,200 USD). In addition, the chapter provides a detailed analysis of mRNA synthesis kit providers, along with information on their year of establishment, company size (in terms of employees count), location of headquarters and most active players (in terms of number of mRNA synthesis kits offered).

An insightful analysis of mRNA synthesis kits, based on supplier strength and product strength.

In-depth profiles of key industry players in mRNA manufacturing market, focusing on company overviews, service portfolio, recent developments and an informed future outlook.

Detailed profiles of the key mRNA synthesis kit providers, focusing on company overviews and mRNA synthesis kits portfolio.

An analysis of partnerships established in this sector, since 2019, on the basis of several parameters, such as year of partnership, type of product, type of partner and most active players (in terms of the number of partnerships signed). It also provides for the regional distribution of the companies involved in these agreements.

A detailed evaluation of over 35 mRNA-based therapeutics / vaccines developers that are most likely to collaborate with mRNA contract manufacturing service providers. This analysis considers various relevant parameters, including developer strength (in terms of company’s experience), company size, (in terms of number of employees), pipeline strength (based on the number of mRNA-based drugs in pipeline), highest phase of development, therapeutic area, route of administration and type of candidate being developed.

Assessment of the various mRNA-focused initiatives undertaken by big pharma players, based on several relevant parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative and therapeutic area.

KEY QUESTIONS ANSWERED IN THIS REPORT

How many companies are currently engaged in this market?

Which are the leading companies in this market?

What kind of partnership models are commonly adopted by industry stakeholders?

What are the factors that are likely to influence the evolution of this market?

What is 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?

REASONS TO BUY THIS REPORT

The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.

Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.

The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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