mRNA Therapeutics – Thematic Intelligence

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mRNA Therapeutics Market Overview

Ribonucleic acid (RNA) therapeutics utilize exogenously delivered RNA to instruct the production of proteins within a cell, disrupt the ordinary production of proteins, or act as a targeting ligand, depending on the type of RNA employed. RNA is used for different regulatory and messenger functions within the cell, including both protein downregulation and protein upregulation.

There are currently no mRNA-based therapeutics that are not vaccines in any of the seven major pharmaceutical markets. There are five mRNA therapies in clinical trial development across various indications: three are in clinical trials for rare genetic diseases and two for different types of cancers. Specialized designations for gene therapies can be assigned to gene therapy products. In the US, this is regenerative medicine advanced therapy (RMAT). In the EU, it is advanced therapy medicinal products (ATMP). The 7MM have set up programs to expedite gene therapy approvals, especially when they address an unmet need or are targeting orphan indications.

Report Pages 57
Regions Covered Global
Key Trends Industry Trends, and Regulatory Trends
Value chain mRNA, Antisense mRNA, RNAi, and RNA Aptamers
Major Players Moderna, Ultragenyx, BioNTech, and Omega Therapeutics
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mRNA Therapeutics – Market Analysis

OTX-2002 would be the first programmable epigenetic medicine, making it a strong driver of sales during this forecast period. Additionally, the clinical trial readouts provide strong evidence for its use as a monotherapy as well as a therapy to be integrated with existing treatment options. mRNA-3705 is anticipated to reach the second-highest amount in sales during 2028, followed by mRNA-3927.

mRNA Therapy Market Analysis and Forecast, 2023-2028

mRNA Therapy Market Analysis and Forecast

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mRNA Therapeutics – Key Trends

The key trends associated with the mRNA therapeutics theme can be segmented into regulatory trends and industry trends.

Industry Trends: The mRNA therapeutics field is expanding, but high cost and production scalability are issues. It is difficult to achieve high quality and highly pure mRNA via scalable manufacturing. Robust analytical methods are needed to establish safety, potency, and purity of mRNA therapeutics in large-scale manufacturing.

Current delivery systems are lacking due to the degradation of mRNA. mRNA is susceptible to degradation by ribonucleases. This further limits the therapeutic application of mRNA. mRNA therapeutics delivery needs to be customized to specific tissues focusing on optimal size, surface charge, and lipid composition.

Regulatory Trends: The 21st Century Cures Act streamlines the regulatory process for the discovery and delivery of regenerative medicines, including gene therapies. As of 2016, gene therapies are eligible for the RMAT designation, including all the benefits of the fast track and breakthrough therapy programs, as well as more collaboration with the FDA to dictate endpoints that may support accelerated approval.

In order to speed up regulatory processes for advanced medicinal therapies, the EU implemented the priority medicines (PRIME) pathway in 2016. Through tailored interactions with the EMA, regulatory processes can be more rapidly deployed and completed to ensure there are no gaps in marketing authorization applications.

mRNA Therapeutics – Value Chain

The mRNA therapeutics value chain can be segmented into four categories: mRNA, Antisense mRNA, RNAi, and RNA aptamers. mRNA therapy involves producing a protein/peptide via the protein synthesis machine processed in the transfected cell in vitro or in vivo.

mRNA Therapeutics Value Chain

mRNA Therapeutics Value Chain

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Drug Development Scorecard

GlobalData’s Drug Development Thematic Scorecard provides a comprehensive outlook for players in the drug development sector over the next two to four years, based on 10 of the major themes set to transform the landscape, including genomics. It includes 55 companies from across the industry, including biopharmaceutical companies, biosimilar and generic manufacturers, contract development and manufacturing organizations, and contract research organizations.

Drug Development Thematic Scorecard

Drug Development Thematic Scorecard

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mRNA Therapeutics – Competitive Landscape

Moderna, Ultragenyx, BioNTech, and Omega Therapeutics are some of the major players in the mRNA therapeutics theme.

Market Report Overview

Report Pages 57
Regions Covered Global
Key Trends Industry Trends, and Regulatory Trends
Value chain mRNA, Antisense mRNA, RNAi, and RNA Aptamers
Major Players Moderna, Ultragenyx, BioNTech, and Omega Therapeutics

 

Scope:

  • Overview of mRNA therapeutics (excluding vaccines) in development including regulatory and market access details, product & company profiles.
  • Quotes from US-, 5EU-, and Japan-based key opinion leaders and researchers.
  • Key topics covered for mRNA therapeutics in the seven major markets (7MM) include trends, value chain, market analysis, opportunities, challenges and unmet needs, and high-value deals.
  • Pipeline analysis: Comprehensive data split across different phases and indications, emerging novel trends under development, and analysis of the most promising pipeline drugs.
  • Analysis of the key dynamics of the mRNA therapeutics market. Insightful review of the key industry drivers and challenges. Deals and R&D strategies are covered to highlight business opportunities.

Scope

  • Overview of mRNA therapeutics (excluding vaccines) in development including regulatory and market access details, product & company profiles.
  • Quotes from US-, 5EU-, and Japan-based key opinion leaders and researchers.
  • Key topics covered for mRNA therapeutics in the seven major markets (7MM) include trends, value chain, market analysis, opportunities, challenges and unmet needs, and high-value deals.
  • Pipeline analysis: Comprehensive data split across different phases and indications, emerging novel trends under development, and analysis of the most promising pipeline drugs.
  • Analysis of the key dynamics of the mRNA therapeutics market. Insightful review of the key industry drivers and challenges. Deals and R&D strategies are covered to highlight business opportunities.

Reasons to Buy

  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current deals and technologies to identify companies with the highest potential.
  • Develop business strategies by understanding the trends shaping and driving the mRNA therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the mRNA therapeutics market in the future.
  • Design your development strategy through a review of potential novel targets or combinations across indications.
  • Understand the challenges and strategies impacting the development of mRNA therapeutics agents in preclinical studies and clinical trials.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Moderna
Ultragenyx
BioNTech
Omega Therapeutics

Table of Contents

1.1. Preface

1.1.1. Table of Contents

1.1.2. Abbreviations

1.1.3. Related Reports

1.2. Executive Summary

1.2.1. Key Findings

1.3. Introduction

1.3.1. What are RNA Therapeutics?

1.3.2. What are mRNA Therapeutics?

1.3.3. History of mRNA Therapeutics Development in the 7MM

1.3.4. Key Influencer Twitter Chat Related to mRNA Therapeutics

1.4. Trends

1.4.1. Industry Trends – The mRNA Therapeutics Field is Expanding, but High Cost and Production Scalability are Issues

1.4.2. Industry Trends – Current Delivery Systems are Lacking Due to Degradation of mRNA

1.4.3. Industry Trends – mRNA Therapeutics Have Major Potential for Broad Application but Must Overcome Eliciting Immune Responses

1.4.4. Regulatory Trends – Regulatory Trends in the US

1.4.5. Regulatory Trends – Regulatory Trends in the EU

1.4.6. Regulatory Trends – Regulatory Trends in Japan

1.5. Value Chain

1.5.1. RNA Therapy Value Chain

1.5.2. mRNA Therapeutics: Rare Genetic Disorders

1.5.3. mRNA Therapeutics: mRNA-Based Cancer Immunotherapies

1.5.4. mRNA Therapy in Clinical Trials

1.6. Pipeline Products

1.6.1. mRNA Therapy Pipeline Candidates in the 7MM

1.6.2. mRNA Therapy Candidates, 7MM: Overview

1.6.3. mRNA Therapy Candidates, 7MM: BNT-141

1.6.4. mRNA Therapy Candidates, 7MM: LUNAR-GSD3/UX053

1.6.5. mRNA Therapy Candidates, 7MM: mRNA-3705 & mRNA-3927

1.6.6. mRNA Therapy Candidates, 7MM: OTX-2002

1.7. Market Analysis and Deals

1.7.1. mRNA Therapy Market Analysis and Forecast

1.7.2. Top 10 Transaction Deals by Size in the mRNA Therapy Space, 2012-2022

1.7.3. Latest Transaction Deals in the mRNA Therapy Space

1.7.4. Mergers and Acquisitions that Include mRNA Therapy Assets, 2020-2022

1.7.5. Mergers and Acquisitions that Include mRNA Therapy Assets, 2015-2019

1.8. Regulatory and Market Access

1.8.1. Regulatory – US

1.8.2. Market Access – US

1.8.3. Regulatory – EU

1.8.4. Market Access – EU

1.8.5. Regulation of Gene Therapy in the US and Europe

1.8.6. Examples of Mexico-Approved Biologics (Innovator, Vaccines, etc.)

1.8.7. Regulatory and Market Access – Japan

1.8.8. Comparison of Early Access Schemes in the US, EU, and Japan

1.9. Opportunities, Challenges, and Unmet Needs

1.9.1. mRNA Therapies: Opportunities

1.9.2. mRNA Therapies: Challenges

1.9.3. mRNA Therapies: Additional KOL Perspectives

1.9.4. Clinical Unmet Needs in mRNA Therapy – Gap Analysis

1.9.5. Commercial Unmet Needs in mRNA Therapy – Gap Analysis

1.9.6. Unmet Needs – KOL Perspective

1.10. Companies

1.10.1. Drug Development Scorecard – Genomics

1.10.2. Future Players Based on Pipeline Strength: Moderna

1.10.3. Future Players Based on Pipeline Strength: Ultragenyx

1.10.4. Future Players Based on Pipeline Strength: BioNTech

1.10.5. Future Players Based on Pipeline Strength: Omega Therapeutics

1.11. Appendix

1.11.1. Bibliography

1.11.2. Primary Research

1.11.3. Key Themes Impacting the Pharmaceutical Industry

1.11.4. Our Thematic Research Methodology

1.11.5. About the Authors

1.11.6. Contact Us

1.11.7. Disclaimer

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