Global GMP-Grade IVT Enzymes for Therapeutic RNA Market Size is valued at USD 361.9 Mn in 2024 and is predicted to reach USD 923.0 Mn by the year 2034 at a 10.4% CAGR during the forecast period for 2025-2034.
GMP-grade IVT (In Vitro Transcription) enzymes are essential for producing therapeutic RNA including mRNA used in vaccines, gene therapies, and other RNA-based treatments. Manufactured under strict Good Manufacturing Practice (GMP) standards, these high-purity enzymes ensure consistent, high-quality RNA synthesis suitable for research, preclinical, and clinical applications.
RNA is transcribed from a DNA template containing a T7 promoter, enabling high-yield production commonly used in large-scale manufacturing of mRNA vaccines (such as COVID-19 vaccines), gene-editing tools like CRISPR, and protein replacement therapies. Key GMP-grade IVT enzymes include T7 RNA polymerase, poly(A) polymerase, and capping enzymes such as Vaccinia Capping Enzyme, all of which contribute to generating stable, translation-ready mRNA. Beyond vaccines, these enzymes also support regenerative medicine by enabling the creation of mRNA that drives tissue repair and cellular reprogramming.
Enzymes that enable high-yield, scalable IVT (In Vitro Transcription) processes for producing mRNA at gram-to-kilogram scales are vital to the GMP drug substance manufacturing (commercial) segment. This demand was clearly demonstrated during the COVID-19 pandemic, when billions of vaccine doses required large-scale mRNA synthesis. Among these, GMP-grade T7 RNA polymerase plays a central role engineered for superior activity and stability, it allows manufacturers to consistently meet industrial-scale requirements. Expanded GMP production infrastructure and the growing capabilities of contract manufacturing organizations (CMOs) have further increased the availability of these RNA polymerases, driving the expansion of commercial mRNA production. As the mRNA therapeutics market continues to grow, demand for GMP-grade IVT enzymes rises correspondingly, with RNA polymerases maintaining the largest market share due to their pivotal role in transcription. Continuous advancements in enzyme engineering are now enhancing yield, purity, and cost efficiency, solidifying their importance in large-scale mRNA drug substance manufacturing.
Some of the Major Key Players in the GMP-Grade IVT Enzymes for Therapeutic RNA Market is:
· New England Biolabs (NEB)
· Thermo Fisher Scientific
· Roche CustomBiotech
· Merck KGaA (MilliporeSigma)
· Aldevron (Danaher/Cytiva)
· TriLink BioTechnologies (Maravai)
· Kactus Bio
· Yeasen Biotech
· Takara Bio
· Canvax Biotech
· LGC Biosearch Technologies
· Novoprotein
· Jena Bioscience
· Baseclick GmbH
· Tinzyme
· Promega Corporation
· Kaneka Eurogentec
· BOC Sciences
· Creative Biogene
· HONGENE
The GMP-grade IVT enzymes for the therapeutic RNA market are segmented into enzyme type (IVT workflow), RNA modality, application/use stage, and end user. Based on the enzyme type, the market is segmented into RNA polymerases, capping enzymes, tailing enzymes - poly(A) polymerase, template generation enzymes, cleanup/yield/protection, and circular RNA enzymes. Based on the RNA modality, the market is divided into mRNA, saRNA/replicons, circRNA, gRNAs/crRNAs (CRISPR), and other therapeutic RNAs. Based on the application/use stage, the market is divided into GMP drug substance manufacturing, GMP clinical supply & process development (phase I–III), diagnostics/IVD, and translational research with GMP continuity. Based on the end-user, the market is divided into biopharma/biotech sponsors (in-house manufacturing), CDMOs/CMOs, diagnostics companies, and academic/government translational centers.
mRNA is being widely explored for applications such as protein replacement therapies and cancer immunotherapies, including personalized neoantigen vaccines. To ensure safety, purity, and consistency, all mRNA therapeutics intended for human use must be produced under rigorous Good Manufacturing Practice (GMP) standards, following guidelines like ICH Q7 and ISO 13485. GMP-grade IVT enzymes such as T7 RNA polymerase, RNase inhibitors, and capping enzymes serve as critical raw materials that meet these regulatory requirements. As more mRNA candidates advance into clinical development, the demand for GMP-grade enzymes has surged; however, limited availability of high-quality raw materials and the high cost of key enzymes like T7 RNA polymerase and DNase I have created supply challenges. The inherent flexibility of the mRNA platform allowing rapid sequence modifications without altering the core production process makes it ideal for fast-response vaccines and personalized therapies, further amplifying the demand for GMP-grade IVT enzymes to ensure reliable, high-quality mRNA synthesis across diverse therapeutic areas.
RNA polymerases are key enzymes in the synthesis of mRNA used for a range of applications, including CRISPR/Cas9 systems that encode Cas proteins and protein replacement therapies targeting conditions such as hemophilia and cystic fibrosis. The expanding pipeline of RNA-based therapeutics is driving strong demand for high-quality, GMP-grade RNA polymerases to ensure a consistent supply for both clinical and commercial-scale production. Within the therapeutic RNA ecosystem, the RNA polymerase segment plays a crucial role in overcoming supply chain bottlenecks by providing reliable, high-purity enzymes. Ongoing advances in RNA polymerase engineering aimed at improving transcription efficiency and minimizing unwanted double-stranded RNA byproducts are further strengthening supplier competitiveness. Meanwhile, emerging technologies such as microfluidics and continuous IVT systems are enhancing the scalability and productivity of RNA synthesis, fueling the growing demand for GMP-grade RNA polymerases to support next-generation RNA therapies.
North America dominates the market for GMP-grade IVT enzymes for therapeutic RNA due to significant investments from private investors and pharmaceutical companies that are speeding up the development of mRNA technology, as well as significant financing from government agencies like the NIH and BARDA. This financial assistance directly supports the need for high-quality GMP-grade enzymes essential for both clinical and commercial-scale RNA synthesis. In May 2024, U.S.-based Aldevron joined forces with Acuitas Therapeutics to enhance mRNA services through lipid nanoparticle (LNP) encapsulation, further solidifying this leadership. The partnership combines state-of-the-art LNP formulation with GMP-grade RNA polymerases, such as Aldevron's Codex® HiCap T7 RNA Polymerase, to create an integrated solution that expedites the manufacturing of mRNA therapeutics and further solidifies North America's leadership in providing end-to-end mRNA platforms.
· In April 2024, TriLink BioTechnologies (TriLink), a Maravai LifeSciences company declared its new cGMP mRNA production facility's grand opening. Using TriLink's strong mRNA production capabilities, the 32,000-square-foot facility was built especially for mRNA manufacture to assist late-phase drug researchers from Phase 2 to commercialization. As developers swarm to capitalize on the promising technique for an expanding range of applications, the milestone opening is anticipated to contribute to the advancement of mRNA-based therapy. The facility, which is situated in San Diego's Sorrento Valley, has separate Grade C cleanroom suites for the production of mRNA, a capacity increase from 1g to >100g per batch, extensive in-house analytical capabilities, and laboratory space for on-site quality control testing.
· In Mar 2023, Creative Biogene was committed to improving the newest medical technologies, such as vaccines, gene editing, cell treatments, and immunotechnology. In order to support research in the areas of preclinical drug discovery, industrial synthetic application, biomedical development, and fundamental life sciences research, Creative Biogene delivers knowledge to deliver products of the highest quality consistently on time. To further research and project development across multiple domains, Creative Biogene has announced the launch of its GMP-grade mRNA synthesis services.
|
Specifications |
|
|
Market Size Value In 2024 |
USD 361.9 Mn |
|
Revenue Forecast In 2034 |
USD 923.0 Mn |
|
Growth Rate CAGR |
CAGR of 10.4% from 2025 to 2034 |
|
Quantitative Units |
Representation of revenue in US$ Mn and CAGR from 2025 to 2034 |
|
Historic Year |
2021 to 2024 |
|
Forecast Year |
2025-2034 |
|
Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
|
Segments Covered |
By Enzyme Type (IVT Workflow), RNA Modality, Application / Use Stage, End User |
|
Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
|
Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; The UK; France; Italy; Spain; China; Japan; India; South Korea; Southeast Asia; South Korea; South East Asia |
|
Competitive Landscape |
New England Biolabs (NEB), Thermo Fisher Scientific, Roche CustomBiotech, Merck KGaA (MilliporeSigma), Aldevron (Danaher/Cytiva), TriLink BioTechnologies (Maravai), Kactus Bio, Yeasen Biotech, Takara Bio, Canvax Biotech, LGC Biosearch Technologies, Novoprotein, Jena Bioscience, Baseclick GmbH, Tinzyme, Promega Corporation, Kaneka Eurogentec, BOC Sciences, Creative Biogene, HONGENE |
|
Customization Scope |
Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
|
Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global GMP-Grade IVT Enzymes for Therapeutic RNA Market Snapshot
Chapter 4. Global GMP-Grade IVT Enzymes for Therapeutic RNA Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Porter's Five Forces Analysis
4.7. Incremental Opportunity Analysis (US$ MN), 2024-2034
4.8. Competitive Landscape & Market Share Analysis, By Key Player (2023)
4.9. Use/impact of AI on GMP-Grade IVT Enzymes for Therapeutic RNA Market Industry Trends
4.10. Global GMP-Grade IVT Enzymes for Therapeutic RNA Market Penetration & Growth Prospect Mapping (US$ Mn), 2021-2034
Chapter 5. GMP-Grade IVT Enzymes for Therapeutic RNA Market Segmentation 1: By Enzyme Type (IVT Workflow), Estimates & Trend Analysis
5.1. Market Share by Enzyme Type (IVT Workflow), 2024 & 2034
5.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Enzyme Type (IVT Workflow):
5.2.1. RNA Polymerases
5.2.1.1. T7 RNA Polymerase (dominant)
5.2.1.2. SP6 RNA Polymerase
5.2.1.3. T3 RNA Polymerase
5.2.2. Capping Enzymes
5.2.2.1. Vaccinia Capping Enzyme (Cap-0)
5.2.2.2. mRNA Cap 2′-O-Methyltransferase (Cap-1)
5.2.2.3. Alternative Viral Capping Enzymes (Faustovirus,etc)
5.2.3. Tailing Enzymes - Poly(A) Polymerase
5.2.4. Template Generation Enzymes
5.2.4.1. Restriction Endonucleases
5.2.4.2. High-fidelity DNA Polymerases
5.2.5. Cleanup / Yield / Protection
5.2.5.1. DNase I / dsDNase (RNase-free)
5.2.5.2. Inorganic pyrophosphatase
5.2.5.3. RNase inhibitor
5.2.6. Circular RNA Enzymes
5.2.6.1. T4 RNA Ligase I/II
5.2.6.2. RNase R
Chapter 6. GMP-Grade IVT Enzymes for Therapeutic RNA Market Segmentation 2: By RNA Modality, Estimates & Trend Analysis
6.1. Market Share by RNA Modality, 2024 & 2034
6.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following RNA Modality:
6.2.1. mRNA
6.2.2. saRNA/replicons
6.2.3. circRNA
6.2.4. gRNAs/crRNAs (CRISPR)
6.2.5. Other therapeutic RNAs (lncRNA/antisense where IVT is used)
Chapter 7. GMP-Grade IVT Enzymes for Therapeutic RNA Market Segmentation 3: By Application / Use Stage, Estimates & Trend Analysis
7.1. Market Share by Application / Use Stage, 2024 & 2034
7.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Application / Use Stage:
7.2.1. GMP Drug Substance Manufacturing (commercial)
7.2.2. GMP Clinical Supply & Process Development (Phase I–III)
7.2.3. Diagnostics/IVD (GMP-qualified enzymes used in regulated kits)
7.2.4. Translational Research with GMP continuity (pilot/tech-transfer lots)
Chapter 8. GMP-Grade IVT Enzymes for Therapeutic RNA Market Segmentation 4: By End User, Estimates & Trend Analysis
8.1. Market Share by End User, 2024 & 2034
8.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following End User:
8.2.1. Biopharma/Biotech sponsors
8.2.2. CDMOs/CMOs
8.2.3. Diagnostics companies
8.2.4. Academic/Government Translational Centers
Chapter 9. GMP-Grade IVT Enzymes for Therapeutic RNA Market Segmentation 5: Regional Estimates & Trend Analysis
9.1. Global GMP-Grade IVT Enzymes for Therapeutic RNA Market, Regional Snapshot 2024 & 2034
9.2. North America
9.2.1. North America GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
9.2.1.1. US
9.2.1.2. Canada
9.2.2. North America GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Enzyme Type (IVT Workflow), 2021-2034
9.2.3. North America GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by RNA Modality, 2021-2034
9.2.4. North America GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Application / Use Stage, 2021-2034
9.2.5. North America GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
9.3. Europe
9.3.1. Europe GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
9.3.1.1. Germany
9.3.1.2. U.K.
9.3.1.3. France
9.3.1.4. Italy
9.3.1.5. Spain
9.3.1.6. Rest of Europe
9.3.2. Europe GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Enzyme Type (IVT Workflow), 2021-2034
9.3.3. Europe GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by RNA Modality, 2021-2034
9.3.4. Europe GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Application / Use Stage, 2021-2034
9.3.5. Europe GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
9.4. Asia Pacific
9.4.1. Asia Pacific GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
9.4.1.1. India
9.4.1.2. China
9.4.1.3. Japan
9.4.1.4. Australia
9.4.1.5. South Korea
9.4.1.6. Hong Kong
9.4.1.7. Southeast Asia
9.4.1.8. Rest of Asia Pacific
9.4.2. Asia Pacific GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Enzyme Type (IVT Workflow), 2021-2034
9.4.3. Asia Pacific GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by RNA Modality, 2021-2034
9.4.4. Asia Pacific GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Application / Use Stage, 2021-2034
9.4.5. Asia Pacific GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
9.5. Latin America
9.5.1. Latin America GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
9.5.1.1. Brazil
9.5.1.2. Mexico
9.5.1.3. Rest of Latin America
9.5.2. Latin America GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Enzyme Type (IVT Workflow), 2021-2034
9.5.3. Latin America GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by RNA Modality, 2021-2034
9.5.4. Latin America GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Application / Use Stage, 2021-2034
9.5.5. Latin America GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
9.6. Middle East & Africa
9.6.1. Middle East & Africa Wind Turbine Rotor Blade Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
9.6.1.1. GCC Countries
9.6.1.2. Israel
9.6.1.3. South Africa
9.6.1.4. Rest of Middle East and Africa
9.6.2. Middle East & Africa GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Enzyme Type (IVT Workflow), 2021-2034
9.6.3. Middle East & Africa GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by RNA Modality, 2021-2034
9.6.4. Middle East & Africa GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by Application / Use Stage, 2021-2034
9.6.5. Middle East & Africa GMP-Grade IVT Enzymes for Therapeutic RNA Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
Chapter 10. Competitive Landscape
10.1. Major Mergers and Acquisitions/Strategic Alliances
10.2. Company Profiles
10.2.1. New England Biolabs (NEB)
10.2.1.1. Business Overview
10.2.1.2. Key Enzyme Type (IVT Workflow)/Service Overview
10.2.1.3. Financial Performance
10.2.1.4. Geographical Presence
10.2.1.5. Recent Developments with Business Strategy
10.2.2. Thermo Fisher Scientific
10.2.3. Roche CustomBiotech
10.2.4. Merck KGaA (MilliporeSigma)
10.2.5. Aldevron (Danaher/Cytiva)
10.2.6. TriLink BioTechnologies (Maravai)
10.2.7. Kactus Bio
10.2.8. Yeasen Biotech
10.2.9. Takara Bio
10.2.10. Canvax Biotech
10.2.11. LGC Biosearch Technologies
10.2.12. Novoprotein
10.2.13. Jena Bioscience
10.2.14. Baseclick GmbH
10.2.15. Tinzyme
10.2.16. Promega Corporation
10.2.17. Kaneka Eurogentec
10.2.18. BOC Sciences
10.2.19. Creative Biogene
10.2.20. HONGENE
Global GMP-Grade IVT Enzymes for Therapeutic RNA Market- By Enzyme Type (IVT Workflow)
· RNA Polymerases
o T7 RNA Polymerase (dominant)
o SP6 RNA Polymerase
o T3 RNA Polymerase
· Capping Enzymes
o Vaccinia Capping Enzyme (Cap-0)
o mRNA Cap 2′-O-Methyltransferase (Cap-1)
o Alternative Viral Capping Enzymes (Faustovirus,etc)
· Tailing Enzymes - Poly(A) Polymerase
· Template Generation Enzymes
o Restriction Endonucleases
o High-fidelity DNA Polymerases
· Cleanup / Yield / Protection
o DNase I / dsDNase (RNase-free)
o Inorganic pyrophosphatase
o RNase inhibitor
· Circular RNA Enzymes
o T4 RNA Ligase I/II
o RNase R
Global GMP-Grade IVT Enzymes for Therapeutic RNA Market – By RNA Modality
· mRNA
· saRNA/replicons
· circRNA
· gRNAs/crRNAs (CRISPR)
· Other therapeutic RNAs (lncRNA/antisense where IVT is used)
Global GMP-Grade IVT Enzymes for Therapeutic RNA Market – By Application / Use Stage
· GMP Drug Substance Manufacturing (Commercial)
· GMP Clinical Supply & Process Development (Phase I–III)
· Diagnostics/IVD (GMP-Qualified Enzymes Used in Regulated Kits)
· Translational Research with GMP continuity (Pilot/Tech-transfer Lots)
Global GMP-Grade IVT Enzymes for Therapeutic RNA Market- By End User
· Biopharma/Biotech sponsors (In-house Manufacturing)
· CDMOs/CMOs
· Diagnostics companies
· Academic/Government Translational Centers
Global GMP-Grade IVT Enzymes for Therapeutic RNA Market – By Region
North America-
· The US
· Canada
Europe-
· Germany
· The UK
· France
· Italy
· Spain
· Rest of Europe
Asia-Pacific-
· China
· Japan
· India
· South Korea
· Southeast Asia
· Rest of Asia Pacific
Latin America-
· Brazil
· Mexico
· Rest of Latin America
Middle East & Africa-
· GCC Countries
· South Africa
· Rest of the Middle East and Africa
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
To know more about the research methodology used for this study, kindly contact us/click here.
