mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Application (Viral Vaccines, Protein Replacement Therapies, Cancer Immunotherapies), By Indication ( Infectious Diseases, Metabolic & Genetic Diseases, Cardiovascular & Cerebrovascular Diseases), By End user (Biotechnology & Pharmaceutical Co

Market Overview

Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market

Key Market Drivers

Growing Investment in Research and Development is Driving the Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market

The surge in investment in R&D within the mRNA therapeutics sector has been a driving force behind the growth of the mRNA CDMO market. Several factors contribute to this increased investment

Expanding Therapeutic Applications is Driving the Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market

One of the primary factors propelling the mRNA therapeutics CDMO market's growth is the increasing number of therapeutic applications. Initially, mRNA technology gained prominence for its potential in developing vaccines, as seen in the rapid development of COVID-19 vaccines by Pfizer-BioNTech and Moderna. However, its utility extends far beyond vaccines.

mRNA therapeutics are being explored for cancer treatment, with the ability to trigger an immune response against cancer cells or directly target them with specific therapies.

As research continues to uncover new therapeutic opportunities, the demand for mRNA therapeutics CDMOs is expected to surge, as these organizations play a pivotal role in translating research into market-ready therapies.

CDMOs can synthesize mRNA molecules tailored to specific therapeutic targets, ensuring precise and effective treatments.

Key Market Challenges

Regulatory Hurdles

One of the most significant challenges in the mRNA therapeutics CDMO market is navigating complex regulatory landscapes. mRNA-based therapies represent a new frontier in medicine, and regulatory agencies worldwide are continually updating and adapting their guidelines. Manufacturers must ensure that their production processes and facilities meet stringent regulatory standards, which can vary from one region to another. Achieving regulatory compliance is a resource-intensive and time-consuming task that can delay product development and market entry.

Scalability Issues

Scalability is another major challenge faced by CDMOs in the mRNA therapeutics market. The production of mRNA vaccines and therapies requires state-of-the-art manufacturing facilities and equipment. Scaling up production capacity quickly to meet high demand, as seen during the COVID-19 pandemic, can be a logistical nightmare. Furthermore, mRNA therapies often involve complex and delicate processes that must be carefully controlled to maintain product quality and efficacy during scale-up.

Supply Chain Vulnerabilities

The global supply chain is vulnerable to various disruptions, including geopolitical tensions, natural disasters, and unexpected events like the COVID-19 pandemic. These disruptions can lead to shortages of critical raw materials, equipment, and skilled personnel needed for mRNA production. CDMOs must develop resilient supply chains, diversify sourcing options, and establish contingency plans to mitigate these risks.

Intellectual Property and Licensing

The mRNA therapeutics market is characterized by a complex web of intellectual property rights and licensing agreements. Many key technologies and patents are held by different companies and institutions, making it challenging for CDMOs to navigate the landscape. Negotiating licensing agreements, royalty payments, and compliance with various patents can add significant complexity and costs to mRNA therapy development.

Cost and Pricing Pressures

Developing and manufacturing mRNA therapies can be costly, especially in the early stages when technologies are still being optimized. Pricing pressures, both from healthcare systems and patient advocacy groups, can limit the profitability of mRNA CDMOs. Balancing the need for affordable treatments with the costs of research, development, and manufacturing poses a constant challenge.

Competitive Landscape

The rapid growth of the mRNA therapeutics market has attracted numerous players, increasing competition among CDMOs. Smaller CDMOs may struggle to compete with larger, more established firms that have greater resources and expertise. Differentiating services and establishing a reputation for quality and reliability are vital for success in this highly competitive industry.

Technological Innovation

The mRNA therapeutics field is continuously evolving, with new discoveries and technologies emerging at a rapid pace. CDMOs must invest in research and development to stay at the forefront of innovation. Staying updated with the latest advancements is crucial, as outdated technologies can quickly become obsolete, impacting the competitiveness of a CDMO.

Key Market Trends

Technological Advancements

The field of medicine and pharmaceuticals is constantly evolving, and one of the most exciting advancements in recent years has been the development of mRNA therapeutics. These groundbreaking therapies have shown immense potential in treating various diseases, from cancer to infectious diseases. As the demand for mRNA therapeutics continues to grow, so does the need for contract development and manufacturing organizations (CDMOs) specialized in this field

The rapid expansion of technological advancements in mRNA therapeutics has been a driving force behind the growth of the CDMO market.

Segmental Insights

Application Insights

Based on the category of Application, Viral Vaccines emerged as the dominant player in the global market for mRNA Therapeutics Contract Development & Manufacturing (CDMO) in 2022.

End User Insights

The Biotechnology & Pharmaceutical Companies segment is projected to experience rapid growth during the forecast period.

Regional Insights

North America emerged as the dominant player in the global mRNA Therapeutics Contract Development & Manufacturing (CDMO) market in 2022, holding the largest market share in terms of value. One of the primary reasons for North America's dominance in the mRNA therapeutics CDMO market is its thriving biotechnology ecosystem. The region boasts a rich network of biotech companies, academic institutions, research centers, and startups. These entities collaborate to advance mRNA technology, develop innovative therapies, and provide comprehensive CDMO services. Key cities like Boston, San Francisco, and San Diego have become global hubs for biotech innovation, housing numerous companies at the forefront of mRNA research and development. The presence of world-class talent, research infrastructure, and capital investment has allowed North America to push the boundaries of mRNA therapeutics.

Recent Developments

• InJune 2023, Kincell Bio, a forward-thinking Contract Development andManufacturing Organization (CDMO), recently emerged from its previouslyundisclosed status, securing $36 million in fresh capital. The launch fundingfor Kincell was spearheaded by Kineticos Ventures.
• InJune 2023, Vernal Biosciences, a pioneering Contract Development andManufacturing Organization (CDMO) specializing in mRNA and lipid nanoparticle(LNP) technologies, has successfully concluded a funding round of $20 million.The funding was spearheaded by Ampersand Capital Partners and Charles RiverLabs, with active participation from Dynamk Capital and the Vermont Center forEmerging Technologies.
• InApril 2023, BioCina, a prominent contract development and manufacturingorganization (CDMO), is delighted to declare its reception of a $5.0 millionAUD grant from the Federal Government's Medical Research Future Fund (MRFF)Grants scheme. This grant is intended to finance collaborative efforts withindustry partners aimed at the advancement of cutting-edge technologies for theproduction of highly precise mRNA vaccines.

Key Market Players

• Danaher corporation (Aldevron)
• Recipharm AB
• Biomay AG
• SamsungBiologics
• Lonza Group AG
• Catalent , Inc
• Bio-IndicationInc
• KanekaEurogentec S.A
• TriLinkBioTechnologies
• BioNTech SE