mRNA Vaccine and Therapeutics Market By Product (Prophylactic Vaccines, Therapeutic Vaccines, Therapeutic Drugs, and Others), Disease Type (Acute Hepatic Porphyria, Primary Hyperoxaluria Type 1, Hereditary Transthyretin-mediated Amyloidosis Genetic, Atherosclerotic Cardiovascular Disease, Others), Treatment Type (Monoclonal Antibody, Gene Therapy, Cell Therapy, and Others), Route of Delivery (Intradermal, Subcutaneous, Intramuscular, Intravenous, and Intranodal), Application (Rare Genetic Diseases, Oncology, Respiratory Diseases, Infectious Diseases, and Others), End-use (Hospitals & Clinics, Research Laboratories & Organizations, and Others), and Region - Market Perspective, Market Intelligence, Comprehensive Analysis, Historical Data, and Forecast for 2023 – 2032

Market Perspective

The global mRNA Vaccine and Therapeutics Market was valued at USD 2.2 billion in 2022 and is anticipated to surpass a valuation of USD 13.5 billion by 2032 at a CAGR of around 18.8% between 2023 and 2032.

In recent years, mRNA-based therapies have gained significant attention for their potential in treating chronic diseases, and RNA vaccines have emerged as a promising approach to vaccine development. Compared to DNA vaccines, RNA vaccines offer advantages in production, distribution, and safety, and have shown promise in human clinical trials, driving demand for mRNA vaccines and drugs.

The field of mRNA therapy and mRNA vaccines has seen steady growth, with substantial investments and technological innovations leading to the development of a range of drugs targeting various diseases. In particular, mRNA-based vaccines in oncology clinical trials have seen a dramatic increase and excluding COVID-19 trials in cancer patients, the number of mRNA vaccine patient trials in 2021 is expected to be second only to cancer.

As mRNA vaccines and drugs continue to demonstrate their immunological properties and offer the potential for personalized medicine, they are ushering in a new era of vaccines and changing the standard of care for many diseases. Produced in laboratories using mammalian cells, mRNA technology allows for rapid improvement and optimization of drug development, with virtually unlimited combinations of by-products.

Key Insights

• Based on the product, the prophylactic vaccines segment held the largest market share
• Based on disease type, the hereditary transthyretin-mediated amyloidosis genetic segment generated the highest revenue
• By treatment type, the monoclonal antibody segment dominated the market share
• By route of delivery, the subcutaneous segment is the most dominating segment
• By application, the infectious diseases segment is expected to dominate the market share over the forecast period
• By end-user, the hospital & clinics segment dominated the market over the projected timeframe
• Based on region, North America registered the dominating market share

Soaring Demand for New Vaccines and Therapeutics Drives the Market Growth

The demand for new vaccines and therapeutics has experienced significant growth in recent years, driven by the development of mRNA therapy and mRNA vaccines. This growth is attributed to the substantial preclinical data collected and the initiation of several human clinical trials, as well as the advent of various mRNA-based technologies that target a wide range of diseases.

Industry players have shown significant interest in cancer vaccines, particularly due to the significant technical progress in this area. Recent FDA approvals for several therapies, including six checkpoint inhibitor drugs and two chimeric antigen receptor (AUTO) T-cell immunotherapies and cancer vaccines, have been promising. Additionally, commercially available preventive vaccines such as the HPV and hepatitis B virus vaccines have been crucial in preventing the onset of liver cancer.

The success of mRNA COVID-19 vaccines has also led to increased interest in prophylactic and therapeutic mRNA vaccines. Compared to DNA vaccines, mRNA vaccines are preferred by the scientific and research community due to their structural advantage and breadth of protein expression. The uptake of mRNA technology has been aided by successful delivery platforms such as lipid nanoparticles, polymers, and peptides. Furthermore, the in vitro transcription method has been widely used in mRNA production, further driving the mRNA vaccine and therapeutics market growth.

Growing Research on mRNA Vaccines Propels the Market Growth

The market for mRNA vaccines has experienced significant growth due to the increased focus of pharmaceutical and healthcare companies on understanding the structure of mRNA and its potential in treating various medical conditions. This has resulted in a proliferation of research activities and studies aimed at developing mRNA-based vaccines to fight against several diseases. To contribute to market growth, pharmaceutical giants have adopted strategic measures such as collaborations, joint ventures, acquisitions, and mergers. Several drug makers have also focused their efforts on developing vaccines against Covid-19 and have expanded their research activities on mRNA vaccines.

In response to the growing demand for mRNA vaccines, market vendors are constructing new facilities to accelerate research activities and drive market growth. These efforts are expected to lead to further advancements in mRNA vaccine development and a wider range of treatment options for various medical conditions.

High Cost Associated with mRNA-based Vaccines and Therapeutics Hampers the Market Growth

Despite the several benefits, the delivery of mRNA-based vaccines presents potential logistical challenges with associated costs that hinder the adoption in emerging economies. In addition, the lack of adequate infrastructure in stable extreme cold temperatures in developing countries continued to lead to bans on mRNA-based COVID-19 vaccines. mRNA-based vaccines are fragile and can be easily denatured and destabilized unless there is a controlled, shallow supply chain from vaccine preparation to vaccination.

Although mRNA-based vaccines have become an integral part of developing robust vaccination strategies in developed economies, developing countries face financial challenges related to the high cost of these vaccines, which restricts the market growth.

Recent Developments

In September 2022: Benchling launched a complete set of functions for designing, modeling, and studying natural and chemically modified RNA in a single solution. The new RNA solution is the first purpose-built offering on the market to help R&D organizations accelerate the delivery of drug candidates.

In August 2022: Merck and Orna Therapeutics entered a collaborative agreement to discover, develop and commercialize several programs, including vaccines and therapies in infectious diseases and oncology. This comprehensive strategic collaboration combines Merck’s significant expertise in nucleic acid biology, clinical development, and manufacturing with Orna’s compelling circular RNA technology to explore the potential to develop a new generation of potential vaccines and therapies.

In June 2021: Sanofi invested about USD 423.35 million per year in the first center of excellence for mRNA vaccines. The center aims to accelerate developing and delivering next-generation vaccines with dedicated R & D, digital and chemical, manufacturing, and control (CMC) teams across multiple locations.

Segmentation Analysis

Based on product, the market is segmented into prophylactic vaccines, therapeutic vaccines, and therapeutic drugs. Preventive vaccines are the most dominating segment and are majorly used to prevent diseases such as vaccination against polio, rabies, human papillomavirus (HPV), influenza (flu), and hepatitis B. The dermis is an attractive site for injection and especially for vaccination because the dermis is highly vascular and contains many immune cells, including many dendritic cells.

Based on disease type, the market is classified as hereditary transthyretin-mediated amyloidosis genetic, acute hepatic porphyria, primary hyperoxaluria type 1, and atherosclerotic cardiovascular. The hereditary transthyretin-mediated amyloidosis genetic segment held the highest share owing to the rising demand for treating ATTR amyloidosis and the increasing need for treating fatal diseases.

Based on application, the market is categorized into rare genetic diseases, oncology, respiratory diseases, and infectious diseases. The infectious diseases segment is expected to dominate the market owing to the increased patient population and awareness of infectious diseases. The segmental growth is further supported by the increasing use of mRNA-based vaccines and the presence of many potential candidates in clinical trials for various infectious diseases.

Based on end-use, the market is segmented into hospitals & clinics, research laboratories & organizations, and others. The hospitals and clinics segment captured the dominating position in the market driven by the increasing number of patients visiting hospitals and clinics. The widespread use of vaccines and medicines in treating chronic diseases drives the mRNA vaccine and therapeutics market share.

North America Leads the Global mRNA and Therapeutics Market Due to Favorable Research Environment

North America is the most dominating region in the global mRNA vaccine and therapeutics market owing to the increasing availability of research funding, expansion of federal programs for RNA-based drugs, and the growing number of clinical trials. The spread of digital technology in the United States, the prevalence of chronic obstructive pulmonary disease (COPD) and respiratory diseases, the well-established healthcare infrastructure, and the presence of significant market competitors in the region are some factors influencing the expansion of the regional market. The proliferating need to develop transformative medicines, increasing fund infusions, a favorable regulatory environment, and a significant focus on precision medicine is further supporting the market growth.

Over the past few years, technological innovations and research investments have made mRNA a promising therapeutic tool in vaccine development and protein replacement therapy. The number of infectious diseases has increased rapidly across the region, which increased the need for research and development in the pharmaceutical industry. RNA vaccines are being studied to produce vaccines for several diseases. Clinical trials with mRNA vaccines against influenza, cytomegalovirus, HIV-1, rabies, and Zika virus have been ongoing, fostering market growth.

Europe is the Fastest Growing mRNA Vaccine and Therapeutics Market Owing to the Increasing Number of Patients

The European mRNA vaccines and therapeutics market has been experiencing rapid growth due to several factors. One of the main drivers is the increasing number of patients with rare genetic diseases in the region, coupled with a growing awareness of these conditions. This has prompted major players in the pharmaceutical industry to focus on developing transformative therapies using mRNA technology.

The success of mRNA COVID-19 vaccines has also led to increased interest in prophylactic and therapeutic mRNA vaccines in the region. Compared to DNA vaccines, mRNA vaccines are preferred by the scientific and research community due to their structural advantage and breadth of protein expression. Additionally, the use of successful delivery platforms such as lipid nanoparticles, polymers, and peptides in mRNA technology has further stimulated market growth.

Competitive Landscape

• Moderna, Inc.
• Pfizer Inc.
• Benchling
• Orna Therapeutics
• Merck KGaA
• Sanofi
• BioNTech SE
• Daiichi Sankyo Co., Ltd
• GSK plc
• Sangamo Therapeutics
• AstraZeneca

The global mRNA vaccine and therapeutics market are segmented as follows:

By Product

• Prophylactic Vaccines
• Therapeutic Vaccines
• Therapeutic Drugs
• Others

By Disease Type

• Acute Hepatic Porphyria
• Primary Hyperoxaluria Type 1
• Hereditary Transthyretin-mediated Amyloidosis Genetic
• Atherosclerotic Cardiovascular Disease
• Others

By Treatment Type

• Monoclonal Antibody
• Gene Therapy
• Cell Therapy
• Others

By Route of Delivery

• Intradermal
• Subcutaneous
• Intramuscular
• Intravenous
• Intranodal

By Application

• Rare Genetic Diseases
• Oncology
• Respiratory Diseases
• Infectious Diseases
• Others

By End-use

• Hospitals & Clinics
• Research Laboratories & Organizations
• Others

By Region

• North America
  • The U.S.
  • Canada
  • Mexico
• Europe
  • France
  • The UK
  • Spain
  • Germany
  • Italy
  • Nordic countries
    • Denmark
    • Finland
    • Iceland
    • Sweden
    • Norway
  • Benelux Reunion
    • Belgium
    • The Netherlands
    • Luxembourg
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • New Zealand
  • Australia
  • South Korea
  • Southeast Asia
    • Indonesia
    • Thailand
    • Malaysia
    • Singapore
    • Rest of Southeast Asia
  • Rest of Asia Pacific
• The Middle East & Africa
  • Saudi Arabia
  • UAE
  • Egypt
  • Kuwait
  • South Africa
  • Rest of the Middle East & Africa
• Latin America
  • Brazil
  • Argentina
  • Rest of Latin America