mRNA Therapeutics Contract Development & Manufacturing Organization Market (By Application; By Indication; By End-use) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

mRNA Therapeutics Contract Development & Manufacturing Organization Market Size and Growth

The global mRNA therapeutics contract development & manufacturing organization market size was valued at USD 4.17 billion in 2023 and is anticipated to reach around USD 12.18 billion by 2033, growing at a CAGR of 11.31% from 2024 to 2033.

Key Pointers

• North America led the market with the largest market share of 38% in 2023.
• Asia Pacific region is estimated to expand the fastest CAGR of 10.85% from 2024 to 2033.
• By Application, the viral vaccines stand out as the leading segment, accounting for 100% of global revenue in 2023.
• By Indication, the infectious diseases generated the maximum market share of 100% in 2023.
• By Indication, the metabolic & genetic segment is anticipated to grow at the noteworthy CAGR of 11.66% from 2024 to 2033.
• By End-Use, the biotech companies captured the maximum market share in 2023.
• By End-Use, the government & research institutes segment is expected to grow at the fastest CAGR of 11.55% from 2024 to 2033

mRNA Therapeutics Contract Development & Manufacturing Organization Market Overview

The field of mRNA therapeutics has witnessed a surge in interest and investment due to its potential to revolutionize the treatment of various diseases, including cancer, infectious diseases, and genetic disorders. As a result, the market for mRNA therapeutics Contract Development & Manufacturing Organizations (CDMOs) has experienced significant growth and evolution.

The mRNA therapeutics CDMO market comprises companies that specialize in providing contract services for the development, manufacturing, and production of mRNA-based therapeutics. These CDMOs offer a range of services, including mRNA synthesis, formulation development, process optimization, analytical testing, and regulatory support.

mRNA Therapeutics Contract Development & Manufacturing Organization Market Growth Factors

The growth of the mRNA therapeutics contract development & manufacturing organization (CDMO) market is propelled by several key factors. Firstly, the burgeoning interest and investment in mRNA therapeutics due to their potential to revolutionize disease treatment drive demand for CDMO services. Additionally, the increasing outsourcing trend among pharmaceutical and biotechnology companies seeking specialized expertise and infrastructure for mRNA therapeutic development and production contributes significantly to market expansion. Moreover, the expanding pipeline of mRNA-based drugs in clinical development stages necessitates reliable CDMO partners for scaling up production and ensuring regulatory compliance.

U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Size 2024 to 2033

The U.S. mRNA therapeutics contract development & manufacturing organization market size was surpassed at USD 1.1 billion in 2023 and is expected to hit around USD 3.23 billion by 2033, growing at a CAGR of 11.37% from 2024 to 2033.

The U.S. held the largest share of the mRNA therapeutics contract development & manufacturing organization market in 2023. With numerous pharmaceutical and life sciences companies based in the country, the U.S. accounts for the highest share of the North American regional market.

North America dominated the mRNA therapeutics contract development & manufacturing organization market, contributing 38% of global revenue in 2023. Market growth in North America is propelled by established CDMOs, expanding clinical trials, and the rising prevalence of infectious diseases, respiratory diseases, and cardiovascular & cerebrovascular diseases. For instance, in February 2024, Arcturus Therapeutics and CSL unveiled the results of a Phase 3 study follow-up on the ARCT-154 booster dose, marking the first sa-mRNA COVID-19 vaccine globally approved, offering administration at one-sixth the dose of Comirnaty (5 μg vs. 30 μg).

The mRNA therapeutics contract development & manufacturing organization market in the Asia Pacific region is projected to achieve a compound annual growth rate (CAGR) of 10.85% from 2024 to 2033. This growth is attributed to several key factors, including escalating investments in research and development (R&D), the surging prevalence of diseases amenable to mRNA therapies, and advancements in technology.

mRNA Therapeutics Contract Development & Manufacturing Organization Market Trends:

• Increasing Outsourcing: Pharmaceutical and biotechnology companies are increasingly outsourcing their mRNA therapeutic development and manufacturing activities to specialized CDMOs. This trend is driven by the need for access to expertise, infrastructure, and flexible manufacturing capacity without the need for significant upfront investment.
• Growing Pipeline of mRNA Therapeutics: The expanding pipeline of mRNA-based drugs in various stages of clinical development is fueling demand for CDMO services. As more mRNA therapeutics advance through preclinical and clinical trials, there is a corresponding need for reliable partners to support scale-up production and ensure compliance with regulatory requirements.
• Diversification of Service Offerings: CDMOs are expanding their service offerings to meet the evolving needs of clients. In addition to traditional mRNA synthesis and manufacturing services, CDMOs are providing value-added services such as analytical testing, regulatory support, and specialized formulation development to differentiate themselves in the market.
• Regulatory Environment: The regulatory landscape governing mRNA therapeutics is evolving, with regulators working to establish clear guidelines and standards for manufacturing and clinical development. CDMOs are closely monitoring these regulatory developments and adapting their processes and capabilities to ensure compliance and facilitate market access for their clients.

mRNA Therapeutics Contract Development & Manufacturing Organization Market Restraints:

• Manufacturing Complexities: Manufacturing mRNA therapeutics involves complex processes and technologies, including mRNA synthesis, formulation development, and purification. Scaling up production while maintaining product quality and consistency presents technical challenges for CDMOs, which may impact efficiency and timelines.
• Intellectual Property Issues: The mRNA therapeutics landscape is characterized by intense competition and intellectual property disputes, which can create uncertainties for CDMOs and their clients. Intellectual property issues related to mRNA sequences, delivery systems, and manufacturing processes may restrict market access and limit innovation.
• High Development Costs: Developing mRNA therapeutics requires substantial investment in research, development, and manufacturing infrastructure. The high upfront costs associated with technology development, clinical trials, and regulatory compliance pose financial barriers for both CDMOs and their clients, potentially slowing market growth.
• Supply Chain Risks: The global supply chain for mRNA therapeutics is vulnerable to disruptions, including raw material shortages, manufacturing delays, and logistics challenges. These supply chain risks can impact CDMOs' ability to deliver products on time and meet client expectations, potentially affecting market competitiveness.

Application Insights

Within the application segment, the market divides into viral vaccines, protein replacement therapies, and cancer immunotherapies. Viral vaccines stand out as the leading segment, accounting for 100% of global revenue in 2023. This dominance stems from established technology, the broad applicability of viral vaccines, and the introduction of various mRNA-based vaccines to combat the spread of the COVID-19 virus. Notably, Moderna unveiled mRNA-1345, an investigational respiratory syncytial virus vaccine, in January 2023. Moreover, ongoing Phase 3 trials investigating the coadministration of flu vaccine and COVID-19 (mRNA-1083) for older adults are fully enrolled, with data expected in 2024.

Concurrently, the cancer immunotherapies segment is poised to register the fastest CAGR over the forecast period, fueled by increasing cancer prevalence and investments in novel therapies to counter this trend. mRNA-based approaches in cancer immunotherapies exhibit substantial promise and garner significant attention in oncology circles. mRNA cancer vaccines, particularly, offer potent and adaptable immunotherapeutic potential, owing to their robust immunogenicity that elicits strong cell-mediated and humoral immune responses.

Indication Insights

The market's indication segment comprises infectious diseases, metabolic & genetic diseases, and cardiovascular & cerebrovascular diseases. Infectious diseases dominate, commanding a revenue share of 100% in 2023. The ascendancy of this segment is propelled by rising adoption of mRNA-based vaccines, a multitude of candidates entering clinical trials for various infectious diseases, and the advent of the COVID-19 pandemic. Given the longstanding global health challenge posed by infectious diseases, mRNA therapies emerge as promising solutions. The market for mRNA therapeutics in infectious diseases represents a dynamic and rapidly expanding segment with distinctive advantages and growth prospects. The burgeoning incidence of respiratory ailments underscores the imperative for swift and adaptable vaccine development.

Meanwhile, the metabolic & genetic segment is poised to exhibit a rapid CAGR of 11.66% over the forecast period, driven by the increasing number of products under development for these applications. Notably, in February 2023, Moderna forged an agreement with Life Edit Therapeutics to address genetic diseases using mRNA-based gene editing, combining Moderna’s mRNA platform with Life Edit’s specialized gene editing capabilities, including the precise technique of base editing.

End-Use Insights

End-uses segment the market into biotech companies, pharmaceutical companies, and government & academic research institutes. Biotech companies emerge as the dominant segment in 2023, propelled by the urgent need for therapeutics amidst the COVID-19 pandemic and the growing trend of outsourcing end-to-end services. This trend is particularly notable among small- and mid-sized biotechnology firms lacking mRNA development expertise. Strategic collaborations with CDMOs have enabled biotech companies to generate lucrative revenues. For instance, PackGene Biotech Inc. and Kudo Biotechnology forged a strategic partnership in September 2023 to offer high-quality mRNA manufacturing services for drug and vaccine development.

The government & research institutes segment is projected to witness the fastest CAGR of 11.55% from 2024 to 2033. This growth is fueled by increased government investment in novel therapies for chronic diseases and heightened healthcare interest following the pandemic's challenges. For example, in March 2023, the U.S. government allocated USD 31.9 billion for mRNA vaccine research and procurement. This investment aims to bolster mRNA COVID-19 vaccine development, production, and procurement from the National Institutes of Health to the Department of Defense, enhancing overall support for mRNA vaccine production.

MRNA Therapeutics Contract Development & Manufacturing Organization Market Key Companies

• Danaher (Aldevron)
• Biomay AG
• Bio-Synthesis, Inc.
• eTheRNA
• Kaneka Eurogentec S.A.
• TriLink BioTechnologies
• ApexBio Technology
• BioNTech SE
• Biocina
• Lonza
• Recipharm AB
• Novo Holdings (Catalent, Inc.)
• Samsung Biologics

MRNA Therapeutics Contract Development & Manufacturing Organization Market Segmentation:

By Application

• Viral Vaccines
• Protein Replacement Therapies
• Cancer Immunotherapies

By Indication

• Infectious Diseases
• Metabolic & Genetic Diseases
• Cardiovascular & Cerebrovascular Diseases

By End-use

• Biotech Companies
• Pharmaceutical Companies
• Government & Academic Research Institutes

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)