According to recent study by Nova one advisor, the U.S. plasmid DNA manufacturing market size was USD 711.90 million in 2023, calculated at USD 863.11 million in 2024 and is expected to reach around USD 4,885.15 million by 2033, expanding at a CAGR of 21.24% from 2024 to 2033.
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The increasing importance of plasmid DNA in gene medicines and DNA vaccines, entering clinical trials and pharmaceutical markets, is driving significant growth in the U.S. plasmid DNA manufacturing market.
The U.S. plasmid DNA manufacturing market is experiencing rapid growth, driven by increasing demand from the nucleic acid vaccine and cell and gene therapy industries. Plasmid DNA produced using E. coli fermentation methods in large stainless steel bioreactors, faces challenges such as slow and expensive processes, limited capacity, and batch failures. This has led to a situation where demand significantly surpasses available capacity, making plasmid DNA manufacture a bottleneck in the genetic medicine revolution. While plasmid DNA was initially utilized in academia and laboratory settings, its role has expanded into the pharmaceutical industry, particularly in the production of therapeutic proteins. With the emergence of the cell and gene therapy industry, demand for plasmid DNA has transformed in terms of scale and quality, necessitating swift and effective responses from DNA manufacturers to meet market demands effectively.
- In January 2023, KromaTiD announced the launch of its Plasmid DNA Manufacturing Service.
- In January 2022, PLASMITEC, WACKER introduced its Plasmid DNA Production Platform.
U.S. Plasmid DNA Manufacturing Market Key Takeaways
- The cell & gene therapy segment held the largest market share of 55.43% in 2023.
- The DNA vaccines segment is expected to witness the fastest CAGR from 2024 to 2033.
- The cancer segment held the largest market share of 42.09% in 2023.
- The genetic disorder segment is expected to register a considerable CAGR from 2024 to 2033.
- The clinical therapeutics segment held the largest market share of 55.32% in 2023.
- The pre-clinical segment is expected to witness the fastest CAGR from 2024 to 2033.
- The GMP grade segment held the largest market share of 85.92% in 2023
- The R&D grade segment is expected to witness the fastest CAGR from 2024 to 2033.
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Plasmid DNA Manufacturing Market Size and Companies
The global Plasmid DNA Manufacturing market size was valued at USD 2.54 billion in 2024 and is anticipated to reach around USD 14.15 billion by 2033, growing at a CAGR of 21.02% from 2024 to 2033. North America held the largest market share of 42.22% of the global market in 2023.
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Market Dynamics
Driver
Rising Demand for DNA Vaccines and Gene Therapies
The increasing prominence of plasmid DNA (pDNA) as the foundation for promising DNA vaccines and gene therapies targeting various infectious, acquired, and genetic diseases, including HIV-AIDS, Ebola, Malaria, and cancer, among others, is propelling the growth of the U.S. plasmid DNA manufacturing market. DNA vaccines offer numerous advantages over conventional vaccines, such as enhanced stability, non-infectious nature, precise immune response targeting, and long-term efficacy. Particularly in developing countries where access to conventional vaccines is limited, the demand for new and improved vaccines is escalating.
However, the injection of pDNA typically elicits a weak immune response, necessitating large quantities of DNA vaccine for effective immunization. There is a growing imperative to increase product yield to mitigate manufacturing costs, thereby fueling the expansion of the U.S. plasmid DNA manufacturing market.
Restraint
Regulatory Compliance and Scalability Challenges
Manufacturing plasmid DNA at a commercial scale presents several challenges, hindering the growth of the U.S. plasmid DNA manufacturing market. Ensuring consistent quality and yield, while adhering to regulatory standards and cGMP practices, poses significant hurdles for pDNA manufacturing companies and Contract Development and Manufacturing Organizations (CDMOs). Scalability remains a key concern, as the transition from laboratory-scale processes to commercial production must be seamless and efficient. Sterility and controlled environments are paramount for high-quality results, necessitating careful consideration from the outset of process development. Addressing these challenges is crucial for designing efficient, reliable, and scalable processes, ultimately facilitating the growth of the U.S. plasmid DNA manufacturing market.
Opportunity
Increasing Importance of Plasmid DNA in Clinical Research
The growing significance of plasmid DNA (pDNA) in clinical research presents a promising opportunity for the U.S. manufacturing market. Serving as a crucial component for the production of viral vectors, mRNA, and vaccine therapies, pDNA is integral to novel therapeutic modalities, driving heightened demand and the need for enhanced production strategies. Its expanding role in gene therapy and genetic vaccination applications underscores the necessity for good manufacturing practice (GMP)-grade pDNA, mandated for direct gene transfer into humans and genetically modified cell-based therapies like chimeric antigen receptor (CAR) T cells. The acceptance of High-Quality Grade plasmid DNA as a starting material for GMP production of mRNA or viral vectors by regulatory agencies further amplifies opportunities in the U.S. plasmid DNA manufacturing market.
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U.S. Plasmid DNA Manufacturing Market Concentration & Characteristics
The plasmid DNA manufacturing industry is highly competitive and fragmented due to the presence of established & mid-tier companies and startups. It is expected to witness lucrative growth owing to rising demand for high-throughput gene analysis techniques and increased adoption of cell & gene therapies. Companies are planning strategies such as expansion through acquisitions and partnerships, investment in R&D to maintain competitiveness in life sciences and healthcare industry, product launches, and emphasis on customer service, and support.
The introduction of groundbreaking technologies, such as genetic engineering in biotechnology, has accelerated the pace of genomic research, which is expected to drive the demand for the manufacturing of plasmid DNA for cell- & gene-based therapies. For instance, in January 2023, Charles River Laboratories International, Inc. announced the launch of eXpDNA plasmid platform to expedite DNA programs.
Competition in the market is high due to the presence of well-established players, medium-sized companies, and startups. The market entities are undertaking diverse strategies, such as mergers & partnerships, to strengthen their market presence For instance, in January 2022, Aldevron acquired Nature Technology Corporation (NTC), a producer of novel and exclusive plasmid constructions & production methods utilized in the field of cell & gene therapy.
Several regulatory authorities have published relevant guidelines in U.S in this regard. For instance, the U.S. FDA has published its Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications. Under these guidelines, DNA vaccines are classified as biological products in section 351 of the PHS ACT which are regulated by FDA’s Center for Biologics Evaluation and Research. Furthermore, U.S. has a mix of both public and private health insurance. The public financing system includes federal & state governments, which provide reimbursement through Medicare and Medicaid programs.
Report Highlights
By Application Insights
The cell & gene therapy segment held the largest market share of 55.43% in 2023 , the U.S. plasmid DNA manufacturing market, with plasmid DNA (pDNA) playing a pivotal role as the essential starting point for producing viral vectors in gene therapies, gene-modified cell therapies, and mRNA vaccines and therapies. Plasmid DNA serves as the active pharmaceutical ingredient (API) for non-viral gene therapy and acts as the template for mRNA production in mRNA vaccine and therapy workflows through linearization and enzymatic in vitro transcription (IVT) reactions. mRNA produced from pDNA templates can induce the production of viral proteins to trigger immune responses in mRNA vaccines, or facilitate cellular production of proteins to replace defective or missing ones, highlighting the diverse applications and critical importance of plasmid DNA in advancing cell and gene therapies.
The DNA vaccines segment is poised to experience the fastest compound annual growth rate (CAGR) in the forecast period, driven by the critical role of plasmid DNA as a key starting material for manufacturing mRNA-based vaccines and therapies, as well as cell therapies. Plasmid DNA serves as an essential component in viral vector therapies, where circular DNA molecules are utilized as therapeutic transgenes, coding for viral capsids or serving as the vaccine itself. DNA vaccines, already approved for use in animals and developed against viruses like SARS-CoV-2, are gaining prominence. Plasmid DNA serves as the foundational material for mRNA vaccines, underscoring its versatility and significance in advancing innovative vaccine and therapy solutions.
By Disease Insights
The cancer segment held the largest market share of 42.09% in 2023, driven by the versatile applications of plasmid DNA in treating various diseases, including infections and cancer. In cancers where the immune system is compromised, DNA vaccination has shown promise in stimulating immune responses against cancer cells. Plasmids designed for cancer gene therapy can regulate the expression of proteins with diverse functions, including enzymes, toxins, and cytotoxic or proapoptotic proteins, effectively targeting and eliminating cancer cells. These innovative DNA strategies are anticipated to gain regulatory approval for cancer treatment in the near future, underscoring the significant potential of plasmid DNA in advancing therapeutic interventions against cancer.
The genetic disorder segment is forecasted to demonstrate significant growth in the coming years, propelled by the utilization of plasmids as crucial tools for cloning, transferring, and manipulating genes. Plasmids, employed as vectors in experimental settings, enable researchers to insert DNA fragments or genes, generating recombinant plasmids. Through transformation processes, these recombinant plasmids can be introduced into bacteria. This fundamental approach offers immense potential for understanding and potentially addressing genetic disorders by facilitating gene manipulation and exploration, driving advancements in genetic disorder research and treatment modalities.
By Development Phase Insights
The clinical therapeutics segment held the largest market share of 55.32% in 2023, driven by the utilization of research-grade or GMP plasmid in biopharmaceutical production and preclinical studies. Plasmid DNA produced in adherence to stringent guidelines and quality standards is essential for ensuring compliance with both quality and safety standards. With diverse applications and functions, plasmid DNA serves as a versatile tool for research, preclinical, and clinical requirements, playing a pivotal role in the clinical development of advanced therapies and products intended for commercial distribution. Its significance in various development phases underscores its integral contribution to advancing therapeutic interventions and achieving regulatory milestones in the biopharmaceutical industry.
The pre-clinical segment is anticipated to experience the fastest compound annual growth rate (CAGR) in the forecast period, driven by the utilization of pre-clinical plasmid DNA in safety and toxicology studies involving large animal models. Pre-clinical plasmid manufacturing ensures scalability to meet clinical demand as projects progress, while maintaining representative quality standards. These pre-clinical products are characterized by high purity and low endotoxin levels, specifically designed to support the pre-clinical development of advanced therapeutic modalities. Their importance lies in providing reliable and standardized materials for early-stage research and development, facilitating the transition of promising candidates towards clinical evaluation.
By Grade Insights
The GMP grade segment held the largest market share of 86.00% in 2023 .the U.S. plasmid DNA manufacturing market, driven by the widespread use of GMP-like plasmid DNA in pre-clinical studies, particularly in animal testing of drug safety and metabolism. This grade of plasmid DNA is produced with key features of GMP guidelines, ensuring a comparable production process and similar quality attributes. Production occurs in segregated production suites with strict document control and traceability measures in place. GMP-like grade serves as a cost-effective and efficient alternative to final GMP products, offering a faster timeline for development. It can be produced under specific conditions such as antibiotic-free, animal component-free, and RNase-free fermentation and purification, with a certificate of analysis (COA) provided upon product release and a TSE/BSE statement available upon request.
The R&D grade segment is projected to exhibit the highest compound annual growth rate (CAGR) in the forecast period. Research-grade plasmid DNA is tailored for basic research and drug discovery studies, manufactured under standard laboratory conditions with rigorous quality control measures to ensure high quality suitable for various downstream research applications. Research-grade (RG) offerings include custom manufacturing and stocked products tailored for diverse research and pre-clinical applications, providing quality, competitive pricing, and swift turnaround times to expedite the progression of research phases efficiently.
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U.S. Plasmid DNA Manufacturing Market Recent Developments
- In January 2024, Charles River Laboratories International, Inc. announced the launch of a Rep/Cap plasmid that will be available off the shelf for enhancing adeno-associated virus-based gene therapy programs
- In August 2023, Charles River Laboratories International, Inc. announced a collaboration with Fondazione Telethon for high-quality plasmid manufacturing for the production of GMP-compliant HQ plasmid DNA batches
- In January 2023, KromaTiD announced the launch of a plasmid DNA manufacturing service that is integral for novel vaccines and gene therapeutics development
- In April 2022, Akron Biotech opened a new cGMP plasmid DNA manufacturing facility in Florida. With this new facility, the company planned to address the evolving demand for gene therapies & vaccines.
U.S. Plasmid DNA Manufacturing Market Top Key Companies:
- Charles River Laboratories
- VGXI, Inc.
- Danaher (Aldevron)
- Kaneka Corp.
- Nature Technology
- Cell and Gene Therapy Catapult
- Eurofins Genomics
- Lonza
- Luminous BioSciences, LLC
- Akron Biotech
U.S. Plasmid DNA Manufacturing Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Plasmid DNA Manufacturing market.
By Grade
- R&D Grade
- GMP Grade
By Development Phase
- Pre-Clinical Therapeutics
- Clinical Therapeutics
- Marketed Therapeutics
By Application
- DNA Vaccines
- Cell & Gene Therapy
- Immunotherapy
- Others
By Disease
- Infectious Disease
- Cancer
- Genetic Disorder
- Others
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