According to The Insight Partners' research, the South & Central America DNA Plasmid Manufacturing Market was valued at US$ 17.5 Million in 2024 and is expected to reach US$ 48.8 Million by 2031, registering a CAGR of 15.8% from 2025 to 2031.
Expansion of contract development and manufacturing organizations (CDMOs) and integration of digital technologies in plasmid DNA manufacturing are among the critical factors attributed to the South & Central America DNA plasmid manufacturing market expansion.
The growing complexity of gene therapies and increasing regulatory demands have led to a significant rise in outsourcing plasmid DNA production to specialized Contract Development and Manufacturing Organizations (CDMOs). These CDMOs offer scalable, GMP-compliant manufacturing capabilities, enabling biopharmaceutical companies to accelerate time-to-market and avoid the high capital costs of building in-house facilities. Two leading CDMOs in this field are Aldevron, a Danaher company known for its high-quality plasmid DNA used in gene and cell therapies and mRNA vaccines, and VGXI, a subsidiary of GeneOne Life Science, recognized for its proprietary Helixfermentation technology and end-to-end-plasmid-DNA-service. Both have made significant investments to expand production capacity and meet the growing global demand for plasmid-based therapeutics.
In April 2025, ProBio-a global CDMO-announced the launch of its GMP plasmid DNA manufacturing service at its Hopewell facility. This new service enables the production of clinical-grade plasmid DNA from cell bank to batch release in three months, significantly faster than standard industry timelines. The offering provides reliable and accelerated access to high-quality plasmid DNA aimed at supporting gene and cell therapy developers. ProBio ensures that every batch-ranging from small-scale (50-200 mg) to gram-level quantities-meets client specifications with complete transparency and no hidden fees.
In June 2024, Bionova Scientific, a full-service biologics CDMO and part of the Asahi Kasei Group, announced a US$100 million investment to expand into plasmid DNA (pDNA) manufacturing. This investment aims to build a 100,000-square-foot development and production facility in The Woodlands, Texas, near Houston. Set to become operational in the first quarter of 2025, the facility will initially offer pDNA development services along with the production of research-grade and high-quality pDNA, with GMP manufacturing capabilities expected to come online in early 2026. Therefore, the expansion of CDMOs is expected to offer lucrative opportunities to the DNA plasmid manufacturing market in the coming years.
On the contrary, high manufacturing costs hamper the growth of the South & Central America DNA plasmid manufacturing market.
South & Central America DNA Plasmid Manufacturing Market Segmentation Analysis:
- By Product Type, the South & Central America DNA Plasmid Manufacturing Market is segmented into GMP Grade and R&D Grade. The GMP Grade segment is projected to expand at 16.0% CAGR during 2025 - 2031.
- By Application, the South & Central America DNA Plasmid Manufacturing Market is segmented into Cell and Gene Therapy, DNA Vaccines, Immunotherapy, and Others. The Cell and Gene Therapy segment is projected to expand at 16.3% CAGR during 2025 - 2031.
- By End User, the South & Central America DNA Plasmid Manufacturing Market is segmented into Pharmaceutical and Biotechnology Companies, CROs and CDMOs, and Others. The Pharmaceutical and Biotechnology Companies segment is projected to expand at 15.5% CAGR during 2025 - 2031.
By country, the South & Central America DNA Plasmid Manufacturing Market is categorized into Brazil, Argentina, and the Rest of South & Central America. Brazil is projected to expand at 16.2% CAGR during 2025 - 2031.
Key players operating in the DNA Plasmid Manufacturing Market are Charles River Laboratories International Inc, Catalent Inc, WuXi Biologics Inc, Sartorius AG, GenScript Biotech Corporation, Takara Bio Inc, AGC Biologics AS, Thermo Fisher Scientific Inc., SK Pharmteco Inc., Creative Biogene, among others.
- In February 2023, GenScript ProBio, a leading global Contract Development and Manufacturing Organization (CDMO), and RVAC Medicines Pte. Ltd., a biotechnology company focusing on the development and commercialization of messenger RNA (mRNA) therapeutics and vaccines, announced an agreement to establish a strategic partnership for the manufacturing of GMP-grade plasmid DNA (pDNA) for its mRNA COVID-19 vaccine candidate, RVM-V001, along with collaboration for future therapeutic pipelines.
- In January 2024, Charles River Laboratories International, Inc. (NYSE: CRL) announced the launch of its off-the-shelf Rep/Cap plasmid offering, designed to streamline adeno-associated virus (AAV)-based gene therapy programs.
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