mRNA: Therapeutics and Global Markets

Table of Contents

Chapter 1 Introduction

Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Intended Audience
Methodology and Information Sources
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports

Chapter 2 Summary and Highlights

Chapter 3 Target Diseases and Disorders

Overview of Common Diseases and Disorders for mRNA Therapeutics

• Cancer
• Infectious Diseases
• Cardiovascular Disease
• Lifestyle Disorders
• Respiratory Disorders
• Musculoskeletal Disorders
• Gastrointestinal Disorders
• Urology Disorders
• Nephrology Disorders
• Immune Disorders
• Neurological Disorders
• Rare Diseases
• Other Disorders

Tobacco Smoking and Associated Diseases
Infectious Diseases: COVID-19 Pandemic Set the Stage for mRNA Therapeutics
Chronic Diseases: Expanding Horizon for mRNA Therapeutics
Rare Diseases: Large Unmet Need is Fueling mRNA Therapeutics
Aging, Gender and Onset of Diseases

• Global Demographics
• U.S. Demographics
• European Demographics
• Japanese Demographics

Current Challenges and Future Directions

Chapter 4 RNA Therapeutics

RNA Therapeutics Overview
Evolution of RNA Therapeutics

• History of RNA Therapeutics
• Development of RNA Therapeutics and Types

DNA vs. RNA Therapeutics
Clinical Need for RNA Therapeutics

• Increasing Disease Population and Economic Burden
• Limitations of Traditional Therapeutics
• Therapeutic Limitations of Biologics
• Poor Management of Chronic Diseases
• Limited Treatment for Rare Diseases

RNA Therapeutics

• Antisense Oligonucleotide (ASO) as Therapeutics
• Small Interfering RNA (siRNA) as Therapeutics
• miRNA as Therapeutics
• Aptamers as Therapeutics
• mRNA as Therapeutics

Manufacturing RNA-Based Biopharmaceuticals

• Chromatographic Purification Steps

Delivery of RNA Therapeutics

• Polymer Conjugation/Chemical Modification
• Encapsulation
• Lipid-Based Nanoparticles
• Polymer Nanomaterials
• Silica Nanoparticles
• Carbon and Gold Nanomaterials
• GalNAc

Institution and Hospital-Based RNA Therapeutics
Regulatory Influence on the Market for RNA Therapeutics
Market Situation for RNA Therapeutics

• Well-Developed Markets
• Developing Markets
• Underdeveloped Markets

Therapeutics and Cost Burden
Unmet Need
Current Challenges and Future Developments

Chapter 5 mRNA Vaccines

Vaccines: Overview
Vaccine-Based Disease Prevention
Evolution of mRNA as Vaccine
Clinical Need for mRNA Vaccines
mRNA Vaccines and Types by Application

• Prophylactic/Protective Vaccines
• Therapeutic Vaccines

mRNA Vaccine Product Segments

• Non-amplifying mRNA Vaccines
• Self-amplifying mRNA Vaccines

Immunogenicity and mRNA Vaccines

• Optimizing Injection Routes
• Co-encapsulation of Other Stimulatory Molecules

Formulation and Delivery of mRNA Vaccine
Approaches for Enhancing mRNA Stability
Advantages of mRNA Vaccines
Traditional Vaccine vs. mRNA Vaccines
Marketed/Commercial mRNA Vaccines

• Moderna
• BioNTech

mRNA Vaccine Pipeline and New Developments

• mRNA Vaccine Pipeline by Company
• mRNA Vaccines: New Developments

mRNA Vaccines and Future Pandemics
Unmet Need
Current Challenges and Future Outlook

Chapter 6 mRNA Drugs and Therapies

Overview of Drugs and Therapeutics
Therapeutic-Based Disease Treatment
Evolution of mRNA: Beyond Vaccines
Clinical Need for mRNA Therapeutics Beyond Vaccines
mRNA Vaccines vs. mRNA Therapeutics
mRNA Therapeutics and Types

• mRNA as Gene and Protein Replacement Therapy
• mRNA-Enhanced Cell Therapies
• mRNA-Enhanced Immunotherapies (Monoclonal Antibody)

Advantages mRNA Drugs and Therapies
Delivery of mRNA Therapeutics
mRNA Therapeutics Pipeline and New Developments

• mRNA Drugs for Protein Therapy Targeting Metabolic and Rare Diseases
• Pipeline for mRNA-Therapeutics by Company
• Pipeline for mRNA-Enhanced Cell Therapies
• mRNA Therapeutics and New Developments
• Widespread Concerns over the mRNA Medicinal Industry
• Issues with Personalized Medicine

Unmet Need for mRNA Therapeutics
Current Challenges and Future Outlook

Chapter 7 Market Size and Growth Analysis

Overview
Market Size and Growth Analysis by Region
Market Size and Growth Analysis by Product Segment

• mRNA Vaccines vs. Traditional Vaccines
• mRNA Drugs and Therapies

Market Size and Growth Analysis by Therapeutic Treatment Type
Market Size and Growth Analysis by Disease Type
Market Growth Drivers and Restraints

• Market Growth Drivers
• Market Restraints

Regulatory Impact on the Market for mRNA Therapeutics
SWOT Analysis of the Market for mRNA Therapeutics

Chapter 8 Competitive Landscape in the Market for mRNA Therapeutics

Disease Prevention and Treatment with mRNA Therapeutics

Chapter 9 Strategies in the Market for mRNA Therapeutics

Consolidation in the Pharmaceutical Market
Mergers and Acquisitions in the Biopharmaceutical Market
Recent Strategic Moves in mRNA Therapeutics

• Key M&A and In-licensing Deals
• Key Strategic Partnerships
• Key Venture Financing Deals

Future Strategic Landscape

Chapter 10 Regulatory Structure for Biopharmaceuticals

Regulatory Background
Regulatory Systems for Biopharmaceuticals by Region

• United States
• Europe
• Japan

Regulatory Systems for Medical Devices by Region

• United States
• European Union
• Japan

Regulations for mRNA Therapeutics

• Current Regulatory Issues for mRNA Therapeutics
• Moderna Vaccine Regulation in the U.K.

Key Regulatory Updates, 2020

• Pharmaceuticals
• Medical Devices

Chapter 11 Pricing and Reimbursement: Pharmaceuticals and Biologics

Pricing and Reimbursement Background
Pricing and Reimbursement of Pharmaceuticals and Biologics by Region

• United States
• Private Health Insurance
• Chronic Diseases and Cost Burden on Medicare
• Rise of Infectious Diseases and Pricing & Reimbursement for Vaccines in the US.
• Europe
• Japan

Pricing and Reimbursement Challenges for Pharmaceuticals

• Patented Medicines Price
• Prices of Older Drugs

Pricing and Reimbursement for Medical Devices by Region

• United States
• Europe
• Japan
• Other Parts of Asia-Pacific

Chapter 12 Conclusions on the Outlook for mRNA Therapeutics

Major Developments Influencing the Market

• Digital Transformation and Technological Developments
• Increasing R&D Spend and Shift Towards Modern Therapeutics and Technologies
• Collaborations for Advanced Therapeutics
• Market Consolidation for Strategic Growth and to Retain Market Leadership
• Demographic and Economic Trends
• Changing Structure of the Pharma and Healthcare Industry
• Lifestyle Medicine
• Patient-Centric Programs
• Prevalence of Self-Care
• Burden on Public Health System

Long-Term Outlook

Chapter 13 Company Profiles

ACCURNA INC.
AMGEN INC.
ARCTURUS THERAPEUTICS INC.
ARGOS THERAPEUTICS INC.
ARROWHEAD PHARMACEUTICALS
ATHERSYS
BIOCAD
BIONTECH
BOEHRINGER INGELHEIM
CANSINOBIO
CARTESIAN THERAPEUTICS INC.
CHIMERON BIO
CRISPR THERAPEUTICS INC.
CUREVAC
DAIICHI SANKYO
ELI LILLY AND CO.
ELIXIRGEN THERAPEUTICS INC.
ETHERNA IMMUNOTHERAPIES
ETHRIS GMBH
GENENTECH (SUBSIDIARY OF ROCHE)
GLAXOSMITHKLINE PLC
GREENLIGHT BIOSCIENCES INC.
HDT BIO CORP.
IN-CELL-ART
INTELLIA THERAPEUTICS
IONIS PHARMACEUTICALS INC.
JOHNSON & JOHNSON
KERNAL BIOLOGICS INC.
MAXCYTE INC.
MERCK KGAA
MERCURNA
MODERNA THERAPEUTICS
NOVARTIS
NUTCRACKER THERAPEUTICS
PFIZER
PHION THERAPEUTICS
POSEIDA THERAPEUTICS INC.
QUARK PHARMACEUTICALS
RECODE THERAPEUTICS
REGULUS THERAPEUTICS
RNAIMMUNE INC.
ROCHE
SANGAMO THERAPEUTICS INC.
SANOFI
SAREPTA THERAPEUTICS
SHANGHAI BENDAO GENE TECHNOLOGY CO., LTD.
STEMIRNA THERAPEUTICS LTD.
STRAND THERAPEUTICS
TIBA BIOTECHNOLOGY LLC
TRANSLATE BIO
VERTEX PHARMACEUTICAL
Chapter 14 Appendix A: List of Acronyms
Chapter 15 Appendix B: Professional Organizations
American Heart Association (AHA)
The Bill and Melinda Gates Foundation (BMGF)
Canada's International Development Research Centre (IDRC)
Center for Devices and Radiological Health (CDRH)
Center for Drug Evaluation and Research (CDER)
Centers for Medicare and Medicaid Services (CMS)
The Coalition for Epidemic Preparedness Innovations (CEPI)
Hormone Foundation
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
National Center for Biotechnology Information (NCBI)
National Institute of Aging (NIA)
Network for Excellence in Health Innovation (NEHI)
Pharmaceuticals and Medical Devices Agency (PMDA)
U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)
U.S. Food and Drug Administration (FDA)
U.S. National Institutes of Health (NIH)
World Cancer Research Fund International
World Health Organization (WHO)

List of Tables

Summary Table : Global Market for mRNA Therapeutics, by Country/Region, Through 2026
Table 1 : Global Prevalence of Breast Cancer Cases, by Country/Region, Through 2025
Table 2 : Global Epidemiology of Colorectal Cancer, by Region, Through 2030
Table 3 : Global Cancer-Related Deaths, by Cancer Type, Through 2030
Table 4 : Share of Global Cancer-Related Deaths, by Cancer Type, 2015
Table 5 : Case Fatality Rate, Global Viral Outbreaks, 2020
Table 6 : Global Incidence Share of Hypertension, by Patient Group Type, 2020
Table 7 : Global Prevalence of Angina Pectoris and Stroke (Survivors), Through 2030
Table 8 : Global Prevalence of Congestive Heart Failure and Stroke, Through 2030
Table 9 : Structural Heart Disease Management Through Medication
Table 10 : BMI Categories Based on Increasing Health Risks
Table 11 : Trends in Obesity Composition of the Global Population, Through 2025
Table 12 : Obesity and Severe Obesity vs. General Population in the U.S., Through 2025
Table 13 : Global Share of Diabetes, by Type
Table 14 : Global Prevalence of Diabetes, by Type, Through 2040
Table 15 : Global Symptomatic Prevalence of Key Musculoskeletal Disorders, Through 2025
Table 16 : Global Deaths, by Musculoskeletal Disorder, Through 2030
Table 17 : Global Deaths from Digestive Diseases, by Region, Through 2025
Table 18 : Global Mortality Share, by Chronic Disease Type, 2019
Table 19 : Global Shares of DALYs, by Chronic Disease Type, 2019
Table 20 : Estimated World Population and Annual Growth, by Age Group, Through 2030
Table 21 : Total Global Population, by Select Country/Region, Through 2030
Table 22 : U.S. Population Estimates and Projections, by Age Group, Through 2030
Table 23 : Estimates of Anticipated U.S. Life Expectancy at Birth, by Gender, Through 2020
Table 24 : European Population Estimates and Projections, by Age Group, Through 2030
Table 25 : Japanese Population Estimates and Projections, by Age Group, Through 2030
Table 26 : Traditional Vaccines vs. mRNA Vaccines
Table 27 : Marketed/Commercial mRNA Vaccines, by Company
Table 28 : Clinical Development of mRNA Vaccine, BioNTech
Table 29 : Clinical Development of mRNA Vaccine, Moderna
Table 30 : Clinical Development of mRNA Vaccine, CureVac
Table 31 : Clinical Development of mRNA Vaccine, Translate Bio
Table 32 : Clinical Development of mRNA Vaccine, Arcturus Therapeutics
Table 33 : Clinical Development of mRNA Vaccine, eTheRNA
Table 34 : mRNA Vaccine Development Pipeline, by Others
Table 35 : Clinical Development of mRNA Vaccines, by Research Institution
Table 36 : mRNA Drugs for Protein Therapy, Metabolic and Rare Diseases, by Company
Table 37 : mRNA Therapeutics, Non-viral Delivery for mRNA-Based Protein Therapy and Gene Editing, by Company
Table 38 : Clinical Development of mRNA Therapeutics, Moderna
Table 39 : Clinical Development of mRNA Therapeutics, Translate Bio
Table 40 : Clinical Development of mRNA Therapeutics, BioNTech
Table 41 : Clinical Development of mRNA Therapeutics, CureVac
Table 42 : Clinical Development of mRNA Therapeutics, Arcturus Therapeutics
Table 43 : Clinical Development of mRNA Therapeutics, Argos Therapeutics
Table 44 : Clinical Development of mRNA Therapeutics, Mercurna
Table 45 : Clinical Development of mRNA Therapeutics, Kernal Biologics
Table 46 : Clinical Development of mRNA Therapeutics, Shanghai Bendao Gene Technology
Table 47 : Global Market for mRNA Therapeutics, by Country/Region, Through 2026
Table 48 : Global Market for mRNA Therapeutics, by Product Segment, Through 2026
Table 49 : Global Market Shares of COVID-19 Vaccines, by Type, 2021
Table 50 : Global Market Shares of mRNA Vaccines vs. Traditional Vaccines, 2021
Table 51 : Global Market Shares of mRNA Therapeutics, by Therapeutic Treatment Type, 2026
Table 52 : Global Market for mRNA Therapeutics, by Disease Type, Through 2026
Table 53 : SWOT Analysis of the Market for mRNA Therapeutics
Table 54 : Global Market for mRNA Therapeutics, by Company, 2021
Table 55 : Intellectual Property Landscape for mRNA Therapeutics, by Company, 2021
Table 56 : Key Strategic M&A and In-Licensing Deals in the Market for mRNA Therapeutics, by Company, 2019 and 2020
Table 57 : Key Strategic Partnerships in the Market for mRNA Therapeutics, by Company, 2019-2020
Table 58 : Key Strategic Venture Financing Deals, mRNA Therapeutics, by Company, 2020
Table 59 : Countries that Authorized Moderna’s Vaccine for COVID-19
Table 60 : Standard Vaccine Pricing Process in the U.S.
Table 61 : COVID-19 Vaccine Price Range in the U.S., by Federal Government Purchase
Table 62 : Trends in Per Capita Real Gross Domestic Product Growth, by Region, 2016-2019
Table 63 : List of Acronyms Used in the Market for mRNA Therapeutics

List of Figures

Summary Figure : Global Market for mRNA Therapeutics, by Country/Region, 2020-2026
Figure 1 : Global Prevalence of Breast Cancer Cases, by Region/Country, 2015-2025
Figure 2 : Global Epidemiology of Colorectal Cancer, by Region, 2000-2030
Figure 3 : Global Cancer Related Deaths, by Cancer Type, 2000-2030
Figure 4 : Share of Global Cancer-Related Deaths, by Cancer Type, 2015
Figure 5 : Case Fatality Rate Share, Global Viral Outbreaks, 2020
Figure 6 : Global Incidence Share of Hypertension, by Patient Group Type, 2020
Figure 7 : Global Prevalence of Angina Pectoris and Stroke (Survivors), 2004-2030
Figure 8 : Global Prevalence of Congestive Heart Failure and Stroke, 2004-2030
Figure 9 : Trends in Obesity Composition of the Global Population, 2012-2025
Figure 10 : Obesity and Severe Obesity vs. General Population in the U.S., 2018 and 2025
Figure 11 : Global Share of Diabetes, by Type
Figure 12 : Global Prevalence of Diabetes, by Type, 2018 and 2040
Figure 13 : Global Symptomatic Prevalence of Key Musculoskeletal Disorders, 2012-2025
Figure 14 : Global Deaths, by Musculoskeletal Disorder, 2000-2030
Figure 15 : Global Deaths from Digestive Diseases, by Region, 2015-2025
Figure 16 : Global Mortality Share, by Chronic Disease Type, 2019
Figure 17 : Global Shares of DALYs, by Chronic Disease Type, 2019
Figure 18 : Estimated World Population and Annual Growth, by Age Group, 2000-2030
Figure 19 : Total Global Population, by Select Country/Region, 2000-2030
Figure 20 : U.S. Population Estimates and Projections, by Age Group, 2000-2030
Figure 21 : Estimates of Anticipated U.S. Life Expectancy at Birth, by Gender, 2005-2020
Figure 22 : European Population Estimates and Projections, by Age Group, 2000-2030
Figure 23 : Japanese Population Estimates and Projections, by Age Group, 2000-2030
Figure 24 : Global Market for mRNA Therapeutics, by Country/Region, 2020-2026
Figure 25 : Global Market for mRNA Therapeutics, by Product Segment, 2020-2026
Figure 26 : Global Market Shares of mRNA Drugs and Therapies, by Product Type, 2026
Figure 27 : Global Market for mRNA Therapeutics, by Disease Type, 2020-2026
Figure 28 : Global Market Shares of mRNA Therapeutics, by Leading Company, 2021
Figure 29 : Trends in Per Capita Real Gross Domestic Product Growth, by Region, 2016-2019

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