Nucleic Acid Therapeutics Contract Development And Manufacturing Organization Market

Nucleic Acid Therapeutics Contract Development And Manufacturing Organization Market Analysis

The Nucleic Acid Therapeutics Contract Development And Manufacturing Organization Market size is estimated at USD 4.92 billion in 2025, and is expected to reach USD 8.91 billion by 2030, at a CAGR of 12.6% during the forecast period (2025-2030).

The market is growing, propelled by the increasing investment in developing nucleic acid therapeutics, complexities in manufacturing nucleic acid therapeutics, and the growing number of collaborations and partnerships with the market players. Complexities in manufacturing nucleic acid therapeutics, which require expertise in manufacturing like CDMO, are expected to drive market growth during the projected period. Manufacturing nucleic acid therapeutics presents unique challenges due to the intricate nature of these molecules and the need for precise, high-quality production. There are some complexities in nucleic acid therapeutic manufacturing, and CDMOs play a crucial role. Nucleic acid therapeutics, such as mRNA and antisense oligonucleotides, require precise synthesis of specific sequences.

CDMOs have specialized expertise and equipment for accurate and efficient synthesis. In addition, developing effective delivery systems, including lipid nanoparticles and viral vectors, is essential for ensuring the therapeutic reaches target cells. CDMOs have expertise in formulating and producing these carriers. Due to such complexities associated with the manufacturing of nucleic acid therapeutics, there is a need for CDMO expertise, thereby boosting the market growth between 2024 and 2029.

The increasing investment by the CDMO for expanding the CDMO facilities and services for nucleic acid therapeutics will likely boost the market from 2024 to 2029. For instance, Agilent Technologies Inc. announced that it will invest around USD 725 million to expand its manufacturing capacity for therapeutic nucleic acid. This investment is a testament to the high demand for therapeutic oligos and the exceptional quality and service of therapeutic oligo contract development and manufacturing organizations (CDMO). Additionally, in July 2023, Biovian announced a significant investment of over EUR 50 million (USD 52.7 million) to expand its manufacturing facility for viral vectors in Turku, Finland. Such high investment by the CDMO companies to develop the manufacturing facilities and services offering robust growth prospects are expected to propel the market during the projected period.

Additionally, rising partnerships and collaboration by the market players are expected to contribute to the market growth between 2024 and 2030. For instance, in January 2023, Charles River Laboratories International Inc. and Rznomics Inc. announced a viral vector contract development and manufacturing organization (CDMO) partnership. Rznomics will leverage Charles River’s viral vector CDMO experience to initiate clinical development of its RNA-based anticancer gene therapy in liver cancer patients. Similarly, in October 2022 and April 2022, BACHEM collaborated with Eli Lilly and Company to innovate and produce active pharmaceutical components derived from oligonucleotides, an emerging class of intricate nucleic acid treatments.

Hence, several complexities in manufacturing nucleic acid therapeutics, high investment costs, and market players' strategic collaboration are expected to boost the market between 2024 and 2029. Nevertheless, strict regulatory guidelines and insufficient expertise in nucleic acid therapeutics are expected to restrain the market.

Nucleic Acid Therapeutics Contract Development And Manufacturing Organization Market Trends

The mRNA Therapy Segment is Expected to Witness Significant Growth Between 2024 and 2029

The field of mRNA-based therapeutics has witnessed a surge in attention and investment, driven by its promise to address a wide range of diseases, including infectious diseases, cancer, and genetic disorders. mRNA therapies can be tailored for various applications, from prophylactic vaccines to personalized cancer treatments. Personalized mRNA therapeutics are very complex for manufacturing and development, and they require specialized knowledge and expertise and are likely to need CDMO services. CDMO effectively manages the unique process requirements and complex manufacturing process of mRNA production, and it is essential to perform all aspects of the process in one location. This results in increased efficiency, reduced cost, and improved quality of mRNA drug substances and mRNA–lipid nanoparticle (LNP) drug products.

Significant investments from both public and private sectors are being directed toward mRNA research and development, leading to increased demand for specialized CDMO services. For instance, in July 2023, Vernal Biosciences, a CDMO, announced the completion of a USD 20 million funding round, led by Ampersand Capital Partners and Charles River Labs with participation from Dynamk Capital and the Vermont Center for Emerging Technologies to expand mRNA and LNP manufacturing. Such investment helps the CDMO players to expand their service portfolio, contributing to market growth.

Additionally, partnerships between CDMOs and pharmaceutical companies are becoming increasingly prevalent, allowing for the combined expertise and resources to accelerate the development of mRNA therapeutics. For instance, in February 2022, Moderna and Thermo Fisher entered into a 15-year strategic collaboration agreement for the dedicated, large-scale manufacturing of Spikevax, Moderna’s COVID-19 vaccine, in the United States. The agreement also applies to other investigational mRNA therapeutic candidates in Moderna’s pipeline. Similarly, in August 2023, AstraZeneca signed a new mRNA manufacturing deal with China’s CanSino Biologics, a CDMO company. Under the deal, CanSino will use its mRNA manufacturing platform to support AZ on the R&D of mRNA vaccines.

Hence, complexities in manufacturing mRNA therapeutics, increasing investment, and strategic collaboration are expected to boost the segment growth between 2024 and 2029.

North America is Expected to Hold a Significant Market Share Between 2024 and 2029

North America has witnessed an increase in CDMO investment in the production of nucleic acid therapeutics. Furthermore, the presence of several established companies and startups and the FDA approvals resulted in this region holding the maximum share in the global nucleic acid therapeutics CDMO market.

The increasing investment in the development of CDMO services is expected to contribute to the market growth between 2024 and 2029. For instance, in August 2022, IMM, a partner of VGXI, announced that it received a USD 12 million grant from the National Institutes of Health (NIH) to support the Phase 1 clinical trial of a DNA vaccine aimed at preventing Alzheimer's disease. The vaccine will be manufactured using VGXI's expertise in contract manufacturing DNA plasmids for human clinical trials, produced by GMP standards. Such investment and funding support the taking advantage of CDMO services, which are anticipated to boost market growth.

Moreover, strategic activities by the market players, such as facilities and services expansion, are expected to boost the market from 2024 to 2029. For instance, in May 2023, uBriGene, a cell & gene therapy contract development and manufacturing organization (CDMO), expanded into the United States market with the acquisition of a state-of-the-art GMP manufacturing facility from NASDAQ-listed company Mustang Bio Inc. Similarly, in November 2022, Charles River Laboratories International Inc. announced the expansion of its cell therapy contract development and manufacturing (CDMO) facility in Memphis, Tennessee.

Additionally, strategic collaboration by the market players is expected to contribute to the market growth from 2024 to 2029. For instance, in February 2023, Charles River Laboratories International Inc. and Purespring Therapeutics announced a plasmid DNA contract development and manufacturing organization (CDMO) collaboration. Under the terms of an agreement, the Plasmid CDMO alliance supports the first gene therapy platform targeting kidney diseases.

Hence, increasing investment and strategic collaboration are expected to boost the market in North America between 2024 and 2029.

Nucleic Acid Therapeutics Contract Development And Manufacturing Organization Industry Overview

The nucleic acid therapeutics contract development and manufacturing organization market is moderately competitive. Players are engaged in various strategic activities like expanding services, forming collaborations and partnerships, and carrying out mergers and acquisitions. Some of the key players in the nucleic acid therapeutics CDMO market are Agilent Technologies, Inc., AGC Biologics, Asymchem Inc., BACHEM, and BioCina.

Nucleic Acid Therapeutics Contract Development And Manufacturing Organization Market Leaders

Nucleic Acid Therapeutics Contract Development And Manufacturing Organization Market News

• In March 2024, AGS Biologics, a CDMO, received FDA clearance for its Milan site to commence commercial manufacturing of Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel), a gene therapy for metachromatic leukodystrophy (MLD).
• In January 2024, VGXI Inc., a CDMO focused on developing and producing nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, entered into a collaborative partnership with Resilience. In this agreement, VGXI has acted as a trusted plasmid DNA manufacturer, supporting Resilience's advanced therapy manufacturing endeavors.