The field of mRNA therapeutics is in the early stages of clinical trial development.
The mRNA therapeutics landscape is promising with high projected sales in the coming years.
There are no current regulatory guidelines that dictate the approval and development process for mRNA therapeutics. They are instead regulated as gene therapies.
mRNA therapeutics must overcome barriers with delivery in order to be successful.
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; all five mRNA therapies are in Phase I/II development.
The mRNA therapeutics market is forecast to reach over $2 billion by 2028 globally.
OTX-2002 is projected to contribute most significantly to that revenue, generating $1.6 billion during 2028.
The mRNA therapeutics landscape is promising with high projected sales in the coming years.
There are no current regulatory guidelines that dictate the approval and development process for mRNA therapeutics. They are instead regulated as gene therapies.
mRNA therapeutics must overcome barriers with delivery in order to be successful.
Key Highlights
There are currently no mRNA-based therapeutics that are not vaccines in any of the seven major pharmaceutical markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan).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; all five mRNA therapies are in Phase I/II development.
The mRNA therapeutics market is forecast to reach over $2 billion by 2028 globally.
OTX-2002 is projected to contribute most significantly to that revenue, generating $1.6 billion during 2028.
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
Table of Contents
1. Table of Contents1.1. 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. Thematic Research Methodology
1.11.5. About the Authors
1.11.6. Contact the Publisher
1.11.7. Disclaimer
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Moderna
- Ultragenyx
- BioNTech
- Omega Therapeutics
