In terms of revenue, the worldwide plasmid DNA manufacturing market was valued at USD 2.18 billion in 2024 and is representing a healthy CAGR of 17.92% during the forecast period The North America market reached USD 960 million in 2024. The market sizing and forecasts are revenue-based (USD Million/Billion), with 2024 as the base year..
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Market Overview and Industry Potential
Plasmid DNA manufacturing is a versatile technique to produce DNA constructs that are helpful in various research fields like molecular medicine, molecular biology, gene expression, gene editing, agriculture, protein production, etc. Research grade plasmid or plasmid manufactured under good manufacturing practices (GMP plasmid) is used in biopharmaceutical production and preclinical studies. These plasmids or plasmid DNA are manufactured by implementing standard guidelines to ensure compliance with regulatory, quality, and safety standards. The requirements for research-grade plasmids in preclinical studies and GMP-grade plasmids for production and quality testing purposes drive the growth of the plasmid DNA manufacturing market.
Furthermore, research-grade or catalog plasmids are highly preferred by CDMOs for laboratories and manufacturers, and for outsourcing and collaborations. In biopharmaceutical industries, plasmid DNA is used as a starting material for producing vaccines, immunotherapy products, viral vectors, and cell banks. It is also used in replication and scientists prefer the most suitable organism known as E. coli to produce a large quantity of plasmid DNA quickly and efficiently. The choice of different plasmid DNA production processes such as fermentation, cell harvesting, clarification, etc. boosts a large-scale industrial production of plasmid DNA.
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Role of Artificial Intelligence in the Plasmid DNA Manufacturing Market
Artificial intelligence-based computational modeling and machine-based intelligence can perform extremely complex analytical tasks by using a digital computer or a computer-controlled robot. Artificial intelligence helps to develop new approaches for the production of various viral and non-viral gene delivery vectors and highly efficient non-viral systems with low cellular toxicity.
AI can improve the functioning of CRISPR/Cas systems, and develop mRNA vaccine carriers. AI can develop viral mimicry templates for non-viral delivery systems. AI can improve cellular targeting limitations and AI-based development of novel vectors or micro/nanobots is possible.
Major Trends in the Plasmid DNA Manufacturing Market
Expansion of Cell and Gene Therapy Capacity:
With the growing demand for plasmid DNA manufacturing, development, and testing services, leading companies like Charles River Laboratories extended their cell and gene therapy (CGT) capacity to streamline complex supply chains. In April 2024, Charles River Laboratories presented its comprehensive advanced therapies solution named “Concept to Cure” in front of its clients which covers services related to viral vectors, plasmids, and cell therapy products.
In March 2024, Charles River Laboratories announced the extension of the collaboration between research-grade plasmid manufacturing and the Yong Loo Lin School of Medicine (NUS Medicine) of the National University of Singapore. This collaboration is associated with this leading medical education institution which comprises the world-known medical research field of stem cell biology and therapy. Additionally, this collaborative initiative presents a high-quality (HQ) plasmid DNA contract development and manufacturing (CDMO) agreement. The high-quality plasmid DNA utilizes the eXpDNA universal plasmid manufacturing platform and serves as a phase-appropriate solution. The high-quality plasmid manufacturing combines the principal features of good manufacturing practice (GMP) manufacturing. The HQ and GMP-compliant plasmid DNA serve as the principal starting materials for engineered stem cell cancer therapy.
Gene Therapy Studies to treat rare diseases having no cure:
Bardet-Biedl Syndrome (BBS) is a condition with limited treatment options and no cure for which Charles River Laboratories supports the development of gene therapies. The expert team of this company manufactured the HQ gene of interest (GOI) plasmid for Axovia Therapeutics. Axovia Therapeutics utilizes the expertise of Charles River Laboratories to produce plasmid DNA and accomplish its goals of developing potentially transformative therapies for ciliopathies.
Research reported that 1 in 1,000 people are identified to be affected by ciliopathies and over 20 are identified currently. These conditions can cause blindness, kidney disease, heart disease, deafness, chronic respiratory infections, obesity, infertility, diabetes, etc. Moreover, AXV101 is the lead program of Axovia Therapeutics which showcases adeno-associated virus (AAV9) -based gene therapy targeting retinal dystrophy associated with BBS. In preclinical studies, this gene therapy modified the identified disease and assisted patients in getting rid of vision loss by preventing retinal degeneration, BBS-induced weight gain, and obesity.
Plasmid DNA Manufacturing Market Report Coverage:
|
Report Coverage |
Details |
|
Base Year |
2024 |
|
Historic Period |
2020 to 2023 |
|
Forecast Period |
2025 to 2034 |
|
CAGR from 2025 to 2034 |
17.92% |
|
Market Size in 2024 |
USD 2.18 Billion |
|
Market Size in 2025 |
USD 2.64 Billion |
|
Market Size by 2034 |
USD 11.33 Billion |
|
Leading Region |
North America |
|
Fastest Growing Region |
Asia Pacific |
|
Segments Covered |
Product Type, Application Type, Disease Type, Regional Outlook |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
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Regional Analysis of Plasmid DNA Manufacturing Market:
U.S. Plasmid DNA Manufacturing Market Size 2025 to 2034
The U.S. plasmid DNA manufacturing market size surpassed USD 670 million in 2024 and is expected to reach around USD 3,630 million by 2034, registering a double digit CAGR of 18.41% between 2025 and 2034.
North America dominated the plasmid DNA manufacturing market in 2024 due to several biopharmaceutical industries in this region. Furthermore, the high disposable income, growing consumer awareness regarding gene therapies, and improved healthcare infrastructure significantly boost the regional market’s growth. The increased adoption of gene therapies for treating various diseases further drives the market’s growth. The increasing efforts in research and development for plasmid DNA manufacturing also drive the overall growth of the North American region in this market. The presence of well-established research institutes and government organizations contributes to well-planned and organized research activities and scientific discoveries in this region.
The establishment of the well-renowned Recombinant DNA Advisory Committee by the National Institute of Health offers monitoring services related to scientific, legal, and ethical issues. The adoption of Recombinant DNA technologies in healthcare and scientific research further propels the regional market’s growth. The review of human gene transfer research is performed by the Recombinant DNA Advisory Committee of NIH which plays a significant role in this market’s growth.
• In October 2024, VGXI Inc., a subsidiary of GeneOne Life Science Inc., and Cryoport Inc., a global leader in supply chain solutions for the life sciences announced their strategic partnership through which they will provide biostorage and bioservices for plasmid DNA products manufactured at VGXI Inc. in Texas. They will also provide supply chain solutions to further advance the next-generation therapies.
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Asia Pacific is expected to be the fastest-growing region in the plasmid DNA manufacturing market during the forecast period due to the growing investments in healthcare sectors by the leading industries. The companies make efforts to enable scientists to conduct R&D on plasmid DNA and related technologies. The expanding technological advancements like the developments of cell culture systems, good manufacturing practices (GMP), expression systems, etc. are contributing to a market’s growth remarkably. The tremendous opportunities, improved healthcare infrastructure, economic development, and favorable government initiatives accelerate the market’s growth in this region.
The presence of several manufacturers in the biotechnology and pharmaceutical sectors also boosts the regional market’s growth. The less expensive operating and manufacturing units for research conduct further propel regional growth. Japan is leading in regenerative medicine research and cell therapy research. Japan is also leading in the development and marketing of stem cell research which also contributes to the growth of this country and the Asia Pacific region.
• In January 2025, AGC Biologics announced its development and manufacturing services agreement with Adaptimmune, a company dedicated to redefining solid tumor cancer treatment with cell therapy. AGC Biologics also reported the commercial manufacturing of lentiviral vectors for Adaptimmune's Lete-Cel product.
Plasmid DNA Manufacturing Market Segments Analysis:
Product Analysis
The viral vector segment dominated the global plasmid DNA manufacturing market in 2023 due to the emerging applications of adeno-associated viral vectors in most cell-based gene therapies globally. The integration of viral vectors into large transgenes drives this segmental growth. The use of viral vectors, plasmid vectors, etc. in recombinant DNA technology for the production of recombinant proteins accelerates the growth of the viral vector segment.
The ease of biopharmaceutical production at high titers boosts the revenue share for viral vectors in the plasmid DNA manufacturing market. The supply of viral vectors or plasmid vectors in different forms with ideal properties is increasing throughout R&D divisions to develop recombinant protein products. Scientists prefer the choice of ideal vectors to achieve promising results through their research experiments which drives the growth of the viral vector segment remarkably.
The plasmid DNA segment is expected to be the fastest-growing in the plasmid DNA manufacturing market during the forecast period due to the rise in clinical developments, and the growth of cell and gene therapy and DNA vaccinations. The ongoing approvals for newly marketed therapies created a huge demand for research-grade and GMP-grade plasmid DNA. The promising quality of plasmids used in biomanufacturing surges the demand for plasmid DNA in the market. The ideal properties, adaptability to experimental conditions, ease of availability and accessibility, etc. are the major driving forces behind the adoption of plasmid DNA in molecular biology research projects. Advancements in molecular biology, molecular genetics, recombinant DNA technology, CRISPR/Cas 9 gene editing, etc. are driven by promising research outcomes through the use of plasmid DNA in these research areas.
Application Analysis
The gene therapy segment dominated the plasmid DNA manufacturing market in 2024 due to its wide applications in the treatment of several genetic disorders and inherited disorders. Furthermore, continuous technological advancements in developing reliable and safe treatments for various diseases boost this segmental growth in the market. The rising prevalence of genetic disorders such as sickle cell disease, thalassemia, hemophilia, cystic fibrosis, etc. leads to the emerging need for R&D of advanced gene therapies. The potential features of gene therapies in the replacement of faulty genes with healthy genes, insertion of new genes into affected cells, restoration of functions, and correctness of DNA present in cells drive this segmental growth significantly.
The DNA vaccines segment is expected to be the fastest-growing in the plasmid DNA manufacturing market during the forecast period due to the high incidence of chronic diseases and emerging pandemic or epidemic cases. The increasing R&D activities to develop novel therapies and vaccines drive this segmental growth noticeably. The growth is also attributed to the high demand for plasmid DNA manufacturing solutions for research purposes. The collaborations between biotechnology and pharmaceutical companies aim to develop potential DNA vaccines, mRNA vaccines, vaccine candidates, etc. to save the global population from severe health-related conditions.
Disease Analysis
The infectious disease segment dominated the plasmid DNA manufacturing market in 2024 due to the rising incidence of several infectious diseases caused by microbes and other infectious agents. The emerging need for novel medical treatments namely antifungal, antibiotic, antiviral, antiseptic, antiparasitic, etc. drives this segmental growth in the market prominently. The growing awareness for early-stage diagnosis, detection, and treatment of infectious diseases boosts the segmental growth in healthcare. Advancements in medical devices and therapies including CT scans, imaging tests, MRI, plasma therapy, etc. drive the importance of plasmid DNA manufacturing. The use of plasmid DNA in the treatment of several infectious diseases boosts segmental growth. The potential therapies and medications provide strong immunity through vaccine antigens and prevent pathogen infections.
The cancer segment is anticipated to be the fastest-growing in the plasmid DNA manufacturing market over the forecast period due to the increased use of vectors in the development of potential cancer treatments and therapies. The expansion of production facilities for vaccines and cancer medications, and technological progress surge the demand for plasmid DNA manufacturing in the market. A large number of cancer cases in the global population and the responsible factors drive the growth of the cancer segment. The global cancer research by scientists to save the young as well as elderly population accelerates this segmental growth.
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Competitive Landscape and Major Breakthroughs in the Plasmid DNA Manufacturing Market
The plasmid DNA manufacturing market continues to evolve rapidly and showcases significant advancements through innovations in 2023 and 2024, with a dynamic competitive landscape. Major players such as VGXI Inc., Akron Biotech, Cobra Biologics & Pharmaceutical Services, Aldevron, Plasmidfactory GmbH, Vigene Biosciences, Luminous Biosciences, Nature Technology Corporation, Delphi Genetics, JAFRAL Ltd., etc. hold a prominent position in the plasmid DNA manufacturing market. These companies exhibit promising resources and technical expertise to conduct preclinical research studies, R&D projects, etc. in diverse research areas and provide deep insights into diagnostic and therapeutic approaches. The companies also reach the overall financial growth in the market through outsourcing, acquisitions, financing, and state-of-the-art facilities.
What is Going Around the Globe?
• In June 2024, ProBio Inc., a New Jersey-based CDMO announced the expansion of its plasmid DNA and viral vector manufacturing capabilities with the start of its new state-of-the-art facility in Hopewell, New Jersey.
• In October 2024, VGXI Inc. and Cryoport Inc. announced their strategic partnership to support biopharmaceutical companies in the development of cell and gene therapies and m-RNA-based treatments.
Segments Covered in the Report:
By Product
• Viral Vectors
• Plasmid DNA
• Non-Viral
• Electroporation
• Lipid/Polymer
• Nanoparticles
• Others
By Application
• Gene Therapy
• DNA Vaccines
• Immunotherapy
• Others
By Disease
• Infectious Disease
• Genetic Disorder
• Cancer
By Geography
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)
Thanks for reading you can also get individual chapter-wise sections or region-wise report versions such as North America, Europe, or Asia Pacific.
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