mRNA Therapeutics Contract Development & Manufacturing Organization Market Size, Share & Trends Analysis Report By Application, By Indication, By End-use, By Region, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The global mRNA therapeutics contract development & manufacturing organization market size was estimated at USD 4.14 billion in 2023 and is projected to grow at a CAGR of 11.28% from 2024 to 2030. Growth in the market can be attributed to the increasing burden of infectious diseases & cancer cases, rising mRNA vaccine development, shifting clinical requirements, and digitalization that have revolutionized vaccine development & other therapeutic applications. In addition, mRNA therapeutics manufacturing is driven by growing investments and an increasing number of CDMOs. Furthermore, Research & Development (R&D) activities and preclinical studies have augmented the market demand.

The COVID-19 pandemic positively impacted the market expansion by creating an urgent need for vaccines and a high amount of funding for developing and manufacturing mRNA-based COVID-19 vaccines. In addition, as mRNA vaccines offer a strong defense against new strains of the SARS-COVID-19 virus, demand is still high post-pandemic. The biopharmaceutical companies partnered with the CDMO during the mRNA COVID-19 vaccine (mRNA-1273). Such partnerships are likely to have supported the market during the pandemic. mRNA technologies have emerged as a unique and effective strategy to generate new medications that have the potential to change existing therapies or target difficult-to-treat indications, such as respiratory, cardiac, metabolic, and autoimmune illnesses, as well as cancer.

 Advances in mRNA technology and cellular delivery methods, with their low cost, ease of manufacture, and capacity to target previously unknown pathways, have endless potential to revolutionize medicine. These factors of mRNA are increasing the demand for mRNA CDMO services, thereby promoting market growth. The pharmaceutical and biotech industries are key end-users for CDMOs as they offer potential capabilities and cost savings over in-house manufacturing. Due to their inability to effectively produce and develop treatments, small- and mid-sized CDMOs contract out their development and manufacturing needs. This element is anticipated to boost market expansion.

Market Concentration & Characteristics

The market growth stage is stable and is expected to accelerate over the estimated period. The market is characterized by technologies, regulatory considerations, and globalization & outsourcing of product processes to influence advantages and specialized capabilities.

The mRNA therapeutics CDMO innovations are continuously evolving to meet the industry’s demands due to the increased burden of infectious & rare diseases. Several advancements have shaped the market, enhancing drug development, manufacturing processes, and productivity

Compliance with stringent regulatory requirements, particularly in the pharmaceutical industry, is critical. CDMOs in this market emphasize robust quality assurance practices and adherence to regulatory standards, thereby witnessing lucrative growth opportunities

Players in the market leverage strategies, such as collaborations, partnerships, and acquisitions, to promote the reach of their offerings and increase their product capabilities globally

Increasing R&D activities, rising number of mergers & acquisitions, and growing disease burden can influence market dynamics positively

The local presence of several established pharmaceuticals, the rising burden of infectious & rare diseases, and the growing demand for CDMOs fuel market growth. Other factors contributing to market growth are the rising success rate of RNA-based vaccines, regulatory approvals, and demand for personalized medicines

Application Insights

On the basis of application segment, the market is segregated into viral vaccines, protein replacement therapies, and cancer immunotherapies. The viral vaccines segment led the market, accounting for 100% of global revenue in 2023. The demand in the segment can be attributed to established technology, the wide applicability of viral vaccines, and the launch of various mRNA-based vaccines to control the spread of the COVID-19 virus. For instance, in January 2023, Moderna announced mRNA-1345, an investigational respiratory syncytial virus vaccine. Phase 3 trial involves studying the coadministration of flu vaccine and COVID-19 (mRNA-1083) for older adults and is fully enrolled.

This phase 3 study data is expected in 2024. Furthermore, expanding the mRNA vaccine pipeline is expected to drive market growth in the coming decade. The development of mRNA vaccines to treat various infectious diseases is also increasing. Companies have begun including vaccinations for various diseases, such as influenza, Zika, and Cytomegalovirus (CMV), in their pipelines along with COVID-19. This trend indicates the versatility of mRNA vaccines. Such factors are anticipated to drive market growth. The cancer immunotherapies segment is anticipated to grow at the fastest CAGR over the forecast period.

The growth is attributed to the increasing cancer prevalence and investments to develop novel therapies to combat this growing prevalence. Cancer immunotherapies, including mRNA-based approaches, are showing significant promise and attracting considerable attention in oncology. mRNA cancer vaccines represent a potent and adaptable approach to immunotherapy. The primary advantage of mRNA cancer immunotherapies is their potent immunogenicity, which triggers strong cell-mediated and humoral immune responses, thus contributing to market growth.

Indication Insights

On the basis of indication segment, the market is segregated into infectious diseases, metabolic & genetic diseases, and cardiovascular & cerebrovascular diseases. The infectious diseases segment dominated the market in 2023, accounting for a revenue share of 100.00%. The increasing adoption of mRNA-based vaccines, a high number of candidates entering clinical trials for various infectious diseases, and the COVID-19 outbreak in late 2019 have led to the dominance of this segment. Moreover, the prevalence of infectious diseases has long been a global health problem, and mRNA therapies have emerged as promising tools in combating these diseases.

mRNA therapeutics promises growth regarding infectious diseases, and the market represents a dynamic & fast-growing segment with unique advantages and growth potential. The growing incidence of respiratory diseases has highlighted the need for rapid and flexible vaccine development. For instance, in February 2024, ReCode Therapeutics mentioned that the first volunteer had been dosed in a Phase 1 clinical study of RCT2100. It is an inhaled investigational therapy based on mRNA for cystic fibrosis that is focused on 10-13% of patients with nonsense mutations who do not experience any side effects with approved CFTR modulators.

The metabolic & genetic segment is anticipated to grow at a rapid CAGR of 11.65% over the forecast period. This segment includes cancer and other genetic diseases. The segment growth is attributed to the subsequent number of products under development for these applications. For instance, in February 2023, Moderna entered into an agreement with Life Edit Therapeutics to address genetic diseases using mRNA-based gene editing. This partnership combines Moderna’s mRNA platform with Life Edit’s specialized gene editing capabilities, including an emerging and precise gene editing technique called base editing.

End-use Insights

On the basis of the end-uses, the market is segregated into biotech companies, pharmaceutical companies, and government & academic research institutes. The biotech companies segment dominated the market in 2023 due to the growing need for therapeutics for COVID-19 and increasing trend of outsourcing end-to-end services, especially among small- and mid-sized biotechnology companies that lack expertise in mRNA development. Moreover, strategic initiatives, such as partnerships and collaborations, with CDMO have helped biotech companies to generate profitable revenues. For instance, in September 2023, PackGene Biotech Inc. and Kudo Biotechnology formed a strategic partnership to offer high-quality mRNA manufacturing services for drug and vaccine development.

This collaboration encompasses comprehensive support for mRNA development, gene-to-mRNA conversion, Lipid Nanoparticle (LNP) formulation development, encapsulation, and production of finished drug products. The government & research institutes segment is expected to grow at the fastest CAGR of 11.55% from 2024 to 2030. The segment growth is due to rising investment by government bodies to develop novel therapies for chronic diseases and an elevated interest in healthcare post the major challenges faced due to the pandemic. For instance, in March 2023, the U.S. government invested USD 31.9 billion in research and procurement of mRNA vaccines. The investment will support the development, production & purchasing of mRNA-based COVID-19 vaccines through the National Institutes of Health to the Department of Defense. It aimed to enhance overall support for mRNA COVID-19 vaccine production.

Regional Insights

The North America mRNA therapeutics contract development & manufacturing organization marketaccounted for the largest share of 37.00% of the global revenue in 2023. The market growth is driven by established CDMOs, increasing clinical trials, and a growing prevalence of infectious diseases, respiratory diseases, and cardiovascular & cerebrovascular diseases in North America. For instance, in February 2024, Arcturus Therapeutics and CSL announced the results of a follow-up on the ARCT-154 booster dose Phase 3 study. It was the first sa-mRNA COVID-19 vaccine approved globally and can be administered at one-sixth the dose of Comirnaty (5 μg vs 30 μg).

U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Trends

The mRNA therapeutics contract development & manufacturing organization market in the U.S. held the largest share in 2023. The country accounts for the highest share of the North America regional market, as many pharmaceutical and life sciences companies are present in this country. Growing interest in clinical trials and the benefits of live biotherapeutics in treating rare diseases drive the development of new & novel drugs. Moreover, a well-established regulatory framework provides new opportunities for companies to develop and manufacture products with wide applications & target populations and improved knowledge of the importance of mRNA in terms of therapeutics.

Europe mRNA Therapeutics Contract Development & Manufacturing Organization Market Trends

The Europe mRNA therapeutics contract development & manufacturing organization market is expected to grow significantly. Due to the COVID-19 pandemic, vaccine developers entered into strategic agreements with contract development and manufacturing service providers to meet the urgent global demand for mRNA-based vaccines, which led to significant growth in the outsourcing industry. Moreover, manufacturing mRNA therapeutics is complex, cost-intensive, and requires skilled professionals. Thus, several small- to medium-sized companies rely on CDMO to produce mRNA-synthesized products to innovate new mRNA therapeutics.

The mRNA therapeutics contract development & manufacturing organization market in Germany held the largest share in 2023 owing to a substantial number of providers offering mRNA therapeutics and initiatives undertaken to expand the scope of these tools. For instance, in February 2023, BioNTech announced that it would invest USD 43 million to establish an mRNA manufacturing facility in Germany. Therefore, the market is expected to be driven by rising investments in mRNA technology.

The UK mRNA therapeutics contract development & manufacturing organization market is anticipated to grow over the forecast period. Increasing government initiatives to support mRNA therapeutics development and accelerate clinical trials for mRNA immune therapies drive market growth. For instance, in January 2023, BioNTech announced a strategic collaboration with the UK government to deliver personalized mRNA cancer immunotherapies to around 10,000 patients by 2030. This multiyear partnership focuses on three key strategic pillars: cancer immunotherapies, vaccines for infectious diseases, and expanding BioNTech's presence in the UK.

Asia Pacific mRNA Therapeutics Contract Development & Manufacturing Organization Market Trends

The mRNA therapeutics contract development & manufacturing organization market in Asia Pacific is expected to grow at a CAGR of 10.83% from 2024 to 2030. Key factors contributing to this growth are increasing R&D investments, the rising prevalence of diseases that can be targeted by mRNA therapies, and advancements in technology.

The China mRNA therapeutics contract development & manufacturing organization market is expected to grow over the forecast period. Significant investments in expanding and upgrading manufacturing infrastructure for mRNA therapies in China are expected to drive market growth in the near future.

The mRNA therapeutics contract development & manufacturing organization market in Japan held the largest share in 2023 due to growing initiatives to set up drug discovery infrastructure in Japan, rising investments by private & public sectors, and strategic initiatives, such as mergers & acquisitions, by key companies. For instance, in August 2022, Ricoh Company Ltd. announced the establishment of a Ricoh Biomedical Startup Fund to support mRNA drug R&D in Japan.

The India mRNA therapeutics contract development & manufacturing organization market is anticipated to grow at the fastest CAGR over the forecast period. This growth can be attributed to the availability of a large pool of skilled scientists, researchers, and professionals in biotechnology & pharmaceuticals.

Key mRNA Therapeutics Contract Development & Manufacturing Organization Company Insights

The major players operating across the market focus on adopting in-organic strategic initiatives, such as mergers, partnerships, acquisitions, etc. The prominent strategies companies adopt are service launches, mergers & acquisitions/joint ventures, mergers, partnership & agreements, expansions, and others to increase market presence & revenue and gain a competitive edge.

Recent Developments

• In January 2024, Oxford Nanopore Technologies Plc and Lonza announced a collaboration for cGMP validation and to commercialize a novel test to determine quality attributes of mRNA products by sequencing both the DNA template & mRNA

• In December 2023, BioNTech SE launched its new mRNA vaccine manufacturing capacity in Africa. The new facility was important for establishing a vaccine ecosystem in Africa and future pandemic preparedness

• In October 2023, Biomay AG announced a facility extension, which enabled the expansion of its GMP facilities to provide mRNA manufacturing & aseptic filling services

• In June 2023, Catalent announced the expansion of its OneBio Suite, across various biologic modalities, such as antibody & recombinant proteins, cell & gene therapies, and mRNA

mRNA Therapeutics Contract Development & Manufacturing Organization Market Report Scope

Global mRNA Therapeutics Contract Development & Manufacturing Organization Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global mRNA therapeutics contract development & manufacturing organization market report based on application, indication, end-use, and region:

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Viral Vaccines

  • Protein Replacement Therapies

  • Cancer Immunotherapies

• Indication Outlook (Revenue, USD Million, 2018 - 2030)

  • Infectious Diseases

  • Metabolic & Genetic Diseases

  • Cardiovascular & Cerebrovascular Diseases

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Biotech Companies

  • Pharmaceutical Companies

  • Government & Academic Research Institutes

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Indonesia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait