Messenger RNA (mRNA) vaccines and therapeutics have emerged as a transformative force in the pharmaceutical landscape, with the remarkable success of mRNA-based COVID-19 vaccines propelling this technology into the global spotlight.
The mRNA CDMO market plays a vital role in supporting the translation of cutting-edge mRNA research into viable, market-ready therapies. These specialised contract manufacturers provide essential services to biopharmaceutical companies, startups, and research institutions, enabling them to leverage the power of mRNA technology without having to build their own large-scale production capabilities from scratch.
This report offers insight into the key drivers fuelling the expansion of the mRNA CDMO market, the specific manufacturing challenges, growth drivers, key market players and choosing the right CDMO partner.
While recent news of US funding cuts to mRNA vaccine programs will make an impact, the global mRNA synthesis and manufacturing market is estimated to be worth $ 0.49 billion in 2025 and is likely to grow to $ 0.58 billion by 2035. This follows a sharp drop between 2024 and 2025, due to a reduced demand for COVID-19 vaccines. This data underscores the substantial opportunities for CDMOs specialising in the production and manufacturing of mRNA-based products.
Source- Roots Analysis
mRNA Technology for Disease Treatment
mRNA vaccines and therapeutics represent a novel approach to treating diseases by instructing the body’s own cells to produce therapeutic proteins. This innovative technology harnesses the natural process of protein synthesis within cells to generate specific proteins that can have a therapeutic effect, rather than relying on the direct administration of the proteins themselves.
The transformative potential of mRNA vaccines and treatments spans a wide range of previously untreatable diseases. Rapid advances in biotechnology and molecular medicine now enable the production of nearly any functional protein or peptide in the human body by introducing mRNA as a vaccine or therapeutic agent. This represents a leap forward in precision medicine, with exciting potential for preventing and treating various genetic and hard-to-treat diseases. Additionally, in vitro transcribed mRNA allows for programmable protein production that is faster, more efficient, flexible, and cost-effective compared to traditional methods.
These benefits position mRNA vaccines as the fastest responders in large-scale infectious outbreaks, as seen in the COVID-19 pandemic. Researchers have long aimed to improve the stability, immunogenicity, translation efficiency, and delivery systems for mRNA, and significant strides in molecular biology, RNA technology, vaccinology, and nanotechnology are bringing these goals closer to realization. This review provides a comprehensive overview of mRNA-based therapeutics, covering their principles, production, applications, and challenges. It underscores the importance of mRNA optimization and advanced delivery systems, addressing both the hurdles and opportunities in developing mRNA into a versatile tool for combating genetic disorders, infectious diseases, cancer, and other complex health challenges.
Source- Nature
How mRNA Vaccines and Therapeutics Work
The core principle behind mRNA vaccines and therapeutics is the use of synthetic mRNA molecules to provide the genetic instructions for the production of desired proteins within the target cells. Unlike traditional small-molecule drugs or protein-based therapies, mRNA therapeutics do not directly introduce the therapeutic protein into the body. Instead, they deliver the mRNA, which then acts as a template for cells to produce the relevant protein.
This process begins with the synthetic design of an mRNA molecule that encodes the genetic sequence for the target protein. The mRNA is then packaged and delivered to the target cells, often using specialised delivery mechanisms such as lipid nanoparticles (LNPs) or viral vectors. Once inside the cells, the mRNA is translated by the cellular machinery, leading to the production and secretion of the therapeutic protein. This approach allows the body’s own cells to become the “factories” for generating the desired proteins, offering an efficient and targeted therapeutic solution.
The 5 mRNA Production Steps
The simplicity, scalability, and speed of mRNA production makes it a promising platform for drug and vaccine development. Unlike traditional vaccine development methods, which may take years, mRNA vaccines can be developed in a matter of months.
Step 1: mRNA Template Design – The process begins with designing a plasmid DNA (pDNA) template that includes an RNA polymerase promoter and a specific mRNA sequence. This template is then amplified using expression systems like E. coli bacteria and linearized for better integration. To ensure the desired immune response, accuracy is crucial at this stage. Protecting the sequence from impurities helps maintain its stability and effectiveness in gene expression and translation.
Step 2: In vitro Transcription (IVT) – After the DNA template is prepared, the linear plasmid DNA is transcribed into mRNA using IVT. Unlike in vivo transcription, this method does not use animal-derived materials. RNA synthesis is achieved through an enzymatic reaction involving RNA polymerase and nucleotides. Post-transcription, the mRNA is capped to prevent degradation, enhancing its stability and translation efficiency. This step ensures the mRNA remains intact and functional.
Step 3: mRNA Purification – Once transcription is complete, the DNA template must be removed to isolate the mRNA. Various chromatography and filtration techniques, including tangential flow filtration (TFF), are used to purify the mRNA. This step is essential to separate the mRNA from the DNA template and eliminate any impurities that could interfere with the production process, ensuring a high-quality mRNA product.
Step 4: mRNA Characterization – Throughout production, efficient analytical tools are vital to ensure the mRNA remains unaltered and safe for use. mRNA molecules are sensitive to environmental stressors such as heat, light, and ribonucleases, which can lead to degradation and reduced efficacy. Techniques like mass spectrometry, RNase mapping, and RNA-sequence mapping are used to assess quality and minimize risks of degradation. Ensuring mRNA integrity is crucial as the technology sees increased interest, notably for mRNA vaccines.
Step 5: Formulation and Stability Optimization – The final step in mRNA production involves enhancing mRNA stability and preparing it for delivery. Due to its low stability, mRNA products require frozen storage and protective measures during manufacturing. LNPs are often used to deliver the mRNA safely to immune cells and stabilize the formulation. After formulation, the product is sterilized, aseptically filled, and packaged for storage or transport, ensuring it remains effective until it reaches the end user.
Source- Single Use Report
Therapeutic Applications of mRNA Technology
The adaptability of mRNA technology has broadened its use across various therapeutic areas, including:
- Vaccines for Infectious Diseases: The success of mRNA COVID-19 vaccines by Pfizer-BioNTech and Moderna highlights mRNA’s potential to swiftly develop effective vaccines for emerging diseases
- Cancer Immunotherapies: mRNA can encode tumour-associated antigens or activate the immune system to target cancer cells, creating new possibilities in cancer treatment
- Rare Genetic Disorder Treatments: mRNA therapies offer potential for correcting genetic mutations in rare diseases, bringing hope to patients with previously limited options
- Autoimmune Disease Therapies: By modulating immune responses, mRNA holds promise for treating autoimmune conditions like multiple sclerosis and rheumatoid arthritis
- Cardiovascular Disease Treatments: Researchers are exploring mRNA-based approaches to target genes linked to heart diseases, aiming to develop new cardiovascular therapies
- Neurological Disorder Therapies: mRNA is also being studied for treating neurological disorders such as Alzheimer’s and Parkinson’s disease
Pipeline and Product Development Trends
The mRNA vaccines and therapeutics market has seen significant progress, largely fuelled by the ground breaking success of mRNA COVID-19 vaccines from Pfizer-BioNTech and Moderna. These achievements have showcased the potential of mRNA technology and driven substantial investment and research momentum.
Beyond COVID-19 vaccines, the mRNA therapeutics pipeline has grown rapidly, with a variety of candidate therapies now in clinical development across multiple therapeutic areas. Key examples include:
- Approved COVID-19 vaccines from Pfizer-BioNTech and Moderna
- Numerous mRNA vaccines and therapies in clinical trials for cancer, genetic disorders, infectious diseases, and other indications
These developments and pipeline candidates highlight the fast-changing mRNA vaccine and therapeutics landscape—and the increasing role of CDMOs in turning cutting-edge research into viable, market-ready treatments.
Drivers of the mRNA Technology CDMO Market
- Growing Investment in R&D
- Success of COVID-19 mRNA vaccines has boosted investor confidence, leading to substantial funding for mRNA technology
- Expanding mRNA therapeutics pipeline with candidates for various diseases attracts more investment
- Partnerships between biopharmaceutical companies and CDMOs accelerate mRNA development with significant financial backing
- Government funding worldwide supports mRNA research and development efforts, benefiting the CDMO ecosystem
- Expanding Therapeutic Applications
- mRNA technology is expanding beyond vaccines to treat cancer, genetic disorders, autoimmune diseases, cardiovascular, and neurological conditions
- The adaptability of mRNA makes it attractive for addressing diverse medical needs
- CDMOs are essential in scaling mRNA synthesis, formulation, and manufacturing, enabling companies to adopt mRNA without building in-house facilities
These drivers foster a supportive environment for mRNA CDMOs, fueling market growth and establishing them as key players in advancing mRNA-based therapies.
Challenges in the mRNA Technology CDMO Market
Despite rapid growth, the mRNA therapeutics CDMO market faces key challenges:
- Regulatory Hurdles
CDMOs must navigate evolving regulations across regions, adapt to new standards, and ensure compliance to avoid delays in product development. - Scalability
Scaling up production, especially during emergencies, requires advanced facilities and skilled management to maintain product quality and meet demand without sacrificing speed or safety. - Supply Chain Vulnerabilities
CDMOs must mitigate supply chain risks by securing diverse sources for raw materials and addressing skilled labour shortages to ensure consistent mRNA production. - Intellectual Property
Complex IP rights and licensing requirements increase costs and create challenges in collaborating with patent holders while remaining competitive. - Cost and Pricing Pressures
Balancing affordability with high production costs is critical. CDMOs need efficient, sustainable models to manage costs while meeting healthcare pricing demands.
Overcoming these challenges calls for strategic planning, innovation, and robust partnerships across the mRNA ecosystem.
“The mRNA therapeutics market is fast expanding, driven by the rise of complex diseases and the expanding role of mRNA technologies and applications in oncology. The speed at which the COVID-19 vaccines moved through clinical trials and successful regulatory approval has positively influenced how risk is viewed in the industry,” comments Maria Colombo, PhD, Director, R&D – Nucleic Acid Services, Sean Essex, Global SME (mRNA/LNP), and Enrico Steiner, Director, Site Leader, mRNA, Pharma Services, Thermo Fisher Scientific.
As a consequence, there are other novel and breakthrough mRNA therapies moving swiftly from clinical trials toward commercial approval – areas such as therapeutic protein replacement and therapeutic antibody production and in vivo and ex vivo genome-editing. Examples include treatment for sickle cell anaemia, vaccines for infectious diseases like malaria, HIV, Rabies, Mpox, and other diseases/conditions, where there is a significant unmet need. Pressure on the pharmaceutical and biotech industries to deliver potentially ground breaking mRNA drugs in a timely manner for patients has significantly increased the demand for mRNA CDMO services.
To be successful, CDMOs themselves have had to rapidly evolve with the dynamic landscape of mRNA vaccines and therapeutics. The advent of AI presents significant opportunities and challenges for mRNA therapeutic CDMOs. Embracing new technologies such as continuous manufacturing, real-time monitoring, and analytics is essential to streamline and optimize development and manufacturing processes, thereby reducing program timelines. Additionally, there is a need to build flexibility in production capabilities to accommodate a range of manufacturing scales, from personalized therapies to large-scale commercial batches.
Adapting to new modalities beyond mRNA, such as self-amplifying RNA (saRNA) and circular RNA (cirRNA), and expanding service offerings for both manufacturing and robust analytical characterization methods is critical. These advancements must be achieved while maintaining compliance with stringent regulatory requirements. To combat these challenges and stay ahead of the curve, CDMOs are increasing their investment in innovation (R&D); for example, strengthening versatile LNP assets via development of proprietary lipids or partnerships to access proprietary lipid libraries. Also, a rising number of mergers and acquisitions/strategic partnerships point toward the CDMOs’ goals of offering the best “end-to-end” services for their biopharma sponsors.
Key Considerations When Choosing an mRNA CDMO Partner
As the mRNA therapeutics market grows, selecting the right contract development and manufacturing organization (CDMO) partner is critical for biopharma companies. Here are the key factors to consider:
- Strategic Partnerships
Effective CDMOs establish strategic, collaborative partnerships that enhance both expertise and resource-sharing, moving beyond transactional relationships. Look for CDMOs with unique capabilities that address traditional gaps, adding value and fostering growth. - High-Quality Standards
Quality is paramount. Leading CDMOs draw on COVID-19 vaccine experience to meet rigorous quality standards and maintain product integrity, prioritizing quality over speed. - Supply and Demand Responsiveness
In a dynamic market, CDMOs must be agile in managing supply-demand shifts and have proactive capacity planning. A deep understanding of client needs ensures reliability and efficiency. - Localized Supply
CDMOs with regional production capabilities support supply chain resilience and address geopolitical factors, enhancing security in product availability. - Broad Service Offerings
Comprehensive services—from raw materials to final product distribution—streamline processes and ensure high-quality, coordinated production, meeting diverse partner needs.
By focusing on these areas, biopharma companies can identify CDMOs equipped to drive the success of their mRNA therapies and bring transformative treatments to patients faster.
Key Takeaways
- The global mRNA CDMO market is valued at $1.06 billion in 2024 and projected to reach $0.58 billion by 2035, indicating strong growth potential despite pricing pressures.
- The success of mRNA COVID-19 vaccines has driven widespread investment and confidence in mRNA vaccines and therapeutics.
- mRNA therapeutics enable cells to produce therapeutic proteins, offering a new approach to treating infectious diseases, cancer, genetic disorders, and more.
- CDMOs play a critical role in enabling biotech companies to access mRNA manufacturing without building internal infrastructure.
- The production of mRNA involves five key steps: template design, IVT, purification, characterization, and formulation.
- mRNA vaccines are faster to develop than traditional vaccines, with simplified and scalable production processes.
- Applications of mRNA therapeutics extend to infectious disease vaccines, cancer immunotherapies, rare genetic diseases, autoimmune conditions, cardiovascular, and neurological disorders.
- The mRNA pipeline has expanded significantly post-COVID, with numerous candidates in clinical development.
- Key drivers for CDMO market growth include increased R&D investment, public-private partnerships, and government funding.
- Major challenges include navigating evolving regulations, ensuring scalable and flexible production, managing supply chain risks, IP complexities, and maintaining cost-efficiency.
- Biopharma companies should evaluate CDMOs based on strategic alignment, quality standards, responsiveness, regional capabilities, and comprehensive service offerings.
Frequently Asked Questions (FAQ)
What are mRNA therapeutics?
mRNA therapeutics use synthetic mRNA to instruct cells to produce specific proteins for therapeutic purposes—offering a fast, targeted, and versatile alternative to traditional drugs.
Why is the mRNA CDMO market important?
CDMOs enable biotech companies to bring mRNA therapies to market without building their own manufacturing infrastructure—accelerating innovation and reducing time-to-market.
What diseases can mRNA therapies treat?
mRNA is being used for:
- Infectious diseases (e.g., COVID-19)
- Cancer immunotherapies
- Rare genetic disorders
- Autoimmune and cardiovascular diseases
- Neurological conditions
What makes mRNA production faster than traditional methods?
Its simplicity and modularity allow mRNA vaccines and therapies to be developed and scaled within months versus years for traditional vaccines.
What are the steps in mRNA production?
- Template Design
- In vitro Transcription (IVT)
- mRNA Purification
- Characterization
- Formulation & Stability Optimization
What should companies look for in an mRNA CDMO partner?
Key factors:
- Proven quality and compliance
- Scalability and flexibility
- Strategic collaboration
- Regional production capabilities
- Comprehensive service offerings
What are the main challenges for CDMOs in this space?
- Navigating evolving regulations
- Scaling during public health crises
- Ensuring supply chain resilience
- Managing IP rights and licensing
- Balancing cost vs. pricing pressure
Recent mRNA CDMO Announcements:
- Kaneka Eurogentec’s New GMP mRNA Facility Now Ready for Vaccine and Gene Therapy Production (July 2025)
- TriLink and Quantoom Partner to Accelerate (sa)mRNA Drug Production (June 2025)
- TriLink BioTechnologies and IVI Partner to Advance mRNA Vaccine Development (May 2025)
- Wacker Biotech and RNAV8 Bio Partner to Advance mRNA Therapeutics (April 2025)
- Ethris and Lonza Collaborate on Room-Temperature mRNA Vaccine for Nasal Delivery (April 2025)
- uBriGene Biosciences Submits DMF for iPSC Reprogramming mRNA-LNP Kit (March 2025)
