According to the report, the U.S. viral vector and plasmid DNA manufacturing market size was estimated at USD 2.45 billion in 2023 and is projected to hit around USD 15.30 billion by 2033, growing at a CAGR of 20.1%during the forecast period from 2024 to 2033.
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The viral vector, a pioneering gene modification platform, is revolutionizing gene therapy and genetically modified cell therapies by potentially curing previously terminal diseases. As viral vector-based therapies expand beyond ultra-rare conditions to address common diseases with larger patient populations, the U.S. market for viral vector and plasmid DNA manufacturing is experiencing significant growth. This expansion is driven by the increased demand for innovative treatments that harness the power of genetic engineering to provide effective solutions for a broader range of health conditions.
U.S. viral vector and plasmid DNA manufacturing market cause rapid growth. A viral vector is a virus that is deployed as a carrier to deliver genetic material into cells. In the process of making a viral vector, manufacturers disable its dangerous pathogenic features while taking advantage of its natural ability to penetrate cellular material. Plasmid DNA is a new generation biotechnology product (gene medicines and DNA vaccines) that is just beginning to enter the marketplace. Plasmid DNA vectors may find application as preventive or therapeutic DNA vaccines for viral, bacterial, or parasitic diseases or for other indications such as cancer, or gene therapy products. The U.S. viral vector and plasmid DNA manufacturing market is experiencing rapid growth, driven by the expanding application of viral vectors and plasmid DNA in gene therapies and DNA vaccines.
Viral vectors, viruses modified to deliver genetic material into cells, are engineered to disable pathogenic features while leveraging their natural cellular penetration abilities. Plasmid DNA, an emerging biotechnology product, is beginning to enter the market, offering potential applications as preventive or therapeutic DNA vaccines for various diseases, including cancer and gene therapy products. Production methods for viral vectors include transfection with plasmids, stable packaging or producer cell lines, and infection using virus stocks.
Challenges such as large virus particle handling during chromatography and sensitivity of enveloped viruses to processing conditions necessitate innovative manufacturing solutions. ProBio Inc., a New Jersey-based CDMO, has announced the expansion of its plasmid DNA and viral vector manufacturing capabilities with a new state-of-the-art facility in Hopewell, New Jersey.
· This facility will serve as the North American operations hub, enhancing ProBio’s capacity to support the production of transformative cell and gene therapies. The clinical gene therapy field has advanced rapidly, with over 2,200 clinical trials initiated since 1989, approximately 65% of which are in the USA. This growth highlights the increasing demand for scalable, flexible, and innovative manufacturing solutions in the gene therapy market.
· In November 2023, Battelle, Andelyn Biosciences, and AmplifyBio were awarded task orders by the National Institute of Neurological Disorders and Stroke (NINDS) for plasmid and suspension AAV vector manufacturing and IND-enabling studies.
U.S. Viral Vector And Plasmid DNA Manufacturing Market Key Takeaways
- Based on vector type, the adeno-associated virus (AAV) segment dominated the market with the largest revenue share of 19.22% in 2023
- The lentivirus segment is projected to grow at the fastest CAGR of 20.2% during the forecast period.
- Based on workflow, the downstream processing segment dominated the market with the largest revenue share of 53.13% in 2023.
- The upstream processing segment is expected to grow at a CAGR of 19.1% over the forecast period.
- Based on the application, the vaccinology segment accounted for the largest revenue share of 22.11% in 2023.
- The cell therapy segment is expected to grow at the fastest CAGR over the forecast period.
- Based on end-use, the research institutes segment dominated the market with the largest revenue share of 58.19% in 2023.
- The pharmaceutical & biotechnology companies segment is expected to grow at a CAGR of 20.4% over the forecast period.
- Based on diseases, the cancer segment dominated the market with the largest revenue share of 38.17% in 2023.
- The genetic disorders are expected to grow rapidly during the forecast period.
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Global Viral Vector & Plasmid DNA Manufacturing Market Size & Share Factors Analysis By 2033
The global viral vector and plasmid DNA manufacturing market size was USD 6.19 billion in 2023, calculated at USD 7.45 billion in 2024, and is expected to reach around USD 39.30 billion by 2033, expanding at a CAGR of 20.3% from 2024 to 2033. North America dominated the market and accounted for 49.11% share in 2023.
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Market Dynamics
Driver
Advances in Molecular Biology
The expansion of the U.S. viral vector and plasmid DNA manufacturing market is driven by the critical roles these tools play in biotechnology and research. Plasmid DNA manufacturing is pivotal for producing DNA constructs used in genetic manipulation across fields like molecular biology, medicine, and agriculture. Key applications include gene expression, gene editing, and protein production, crucial for biopharmaceutical production and preclinical studies. Viral vectors have become indispensable in molecular biology, facilitating advances in genetic engineering and molecular research. These tools’ origins and potential implications underscores their growing significance, shaping the viral vector and plasmid DNA manufacturing market.
· In May 2024, Andelyn Biosciences was selected as the viral vector manufacturing partner for the California Institute for Regenerative Medicine (CIRM) Accelerating Medicines Partnership (AMP) Bespoke Gene Therapy Consortium (BGTC).
Restraint
Capital Infrastructure Investment Limits
The U.S. viral vector and plasmid DNA manufacturing market faces challenges in scaling due to the industry’s newness and diverse manufacturing platforms. While suspension-capable viral vector platforms benefit from scalable processes akin to monoclonal antibody manufacturing, manufacturers with adherent platforms encounter scalability limitations reminiscent of early biotech challenges. This dilemma complicates decisions for viral vector innovators regarding when and how to invest in capital infrastructure. Uncertainty surrounding infrastructure investment stifles market growth, as manufacturers navigate the balance between innovation and scalable production capabilities.
Opportunities
Integration of Biodegradable Scaffolds and Gene-Activated Matrices
The future demands in cell and gene therapy highlight continuous bioprocessing as a pivotal concept to explore and develop further. Plasmid DNA incorporating therapeutic genes within biodegradable scaffolds, known as gene-activated matrices (GAMs), offer promising applications. GAMs are designed for implantation in targeted areas, facilitating gradual delivery of therapeutic DNA to surrounding cells, thereby enhancing efficiency in bone formation and potentially addressing ectopic or defective sites. This innovation presents a significant opportunity for the U.S. viral vector and plasmid DNA manufacturing market, fostering growth through expanded applications in advanced therapies and regenerative medicine.
Report Highlights
By Vector Type Insights
Based on vector type, the adeno-associated virus (AAV) segment dominated the market with the largest revenue share of 19.22% in 2023. AAV is a non-enveloped virus engineered to deliver DNA to target cells, gaining significant traction in clinical-stage experimental therapeutic strategies. Its ability to generate recombinant AAV particles that lack viral genes while containing DNA sequences for various therapeutic applications has established it as one of the safest and most effective gene therapy vehicles. As a result, AAV is one of the most actively researched vectors in the gene therapy field, driving its prominence and market leadership.
The lentivirus segment is poised for substantial growth at a significant CAGR over the forecast period. Lentiviruses, a subclass of retroviruses, are notable for their ability to achieve permanent gene integration, thereby affecting non-dividing cells and terminally differentiated cells such as neurons, macrophages, and hematopoietic stem cells. These viruses are increasingly utilized for delivering therapeutic drugs to the tumor microenvironment, exemplified by the use of Interferon (IFN) under the control of the Tie-2 promoter to transduce hematopoietic stem/progenitor cells (HSPC).
By Workflow Insights
Based on workflow, the downstream processing segment dominated the market with the largest revenue share of 53.13% in 2023, focusing on separating the viral vector from impurities generated during upstream processing and preparing the virus for formulation and patient administration. This process, critical for ensuring product safety and potency, must meet stringent regulatory standards for impurities and contaminants. The workflow for plasmid DNA downstream process development includes clarification, tangential flow filtration (TFF), chromatography, and sterile filtration unit operations. Primary downstream purification begins with cell harvesting, lysis, and clarification. During cell harvest, cells are concentrated, and the fermentation broth is removed through centrifugation or microfiltration tangential flow filtration (MF-TFF).
The upstream processing segment is anticipated to experience significant CAGR growth over the forecast period, encompassing critical stages that form the foundation for successful viral vector production. This workflow begins with cell line development, where optimal host cells are selected and engineered for viral production. Upstream viral production initiates with generating cells that express the necessary components to create functional viral particles. The production of high-titer virus, crucial from R&D to commercial manufacturing, relies on effective methods that mitigate the risk of adventitious agents and ensure scalability throughout product development.
By Application Insights
Based on the application, the vaccinology segment accounted for the largest revenue share of 22.11% in 2023. Vaccines significantly reduce the risk of disease by leveraging the body’s natural defenses to build protection. They have prevented countless cases of disease and disability, saving millions of lives. Vaccine-preventable diseases can incur substantial costs due to doctor visits, hospitalizations, and premature deaths. Outbreak responses at national, state, and local levels demand considerable time, money, and manpower. Timely vaccinations in the U.S. result in savings of billions of dollars.
The cell therapy segment is projected to grow at the fastest CAGR over the forecast period. Stem cell therapy, also known as regenerative medicine, enhances the repair response of diseased, dysfunctional, or injured tissue using stem cells or their derivatives. This approach represents the next chapter in organ transplantation, utilizing cells instead of donor organs, which are in limited supply. In this process, researchers grow stem cells in a lab and manipulate them to specialize into specific cell types, such as heart muscle cells, blood cells, or nerve cells.
By End-use Insights
Based on end-use, the research institutes segment dominated the market with the largest revenue share of 58.19% in 2023. This segment provides services in viral vector design, gene silencing, and protein expression, encompassing viral vector construction, amplification, purification, and titration. Additional services include viral vector cloning, mutagenesis, and plasmid DNA preparation. The recent advances in gene therapy are promising, but it is crucial for scientists, institutional biosafety committees, and biosafety officers to maintain public trust in this technology’s clinical trial use. This requires proactive engagement with the public through ongoing forums and discussions.
The pharmaceutical and biotechnology companies segment is expected to grow at a significant CAGR over the forecast period. These companies have expanded to include the production of plasmid DNA (pDNA), a crucial building block for cell and gene therapy-based vaccines. Plasmids are indispensable molecular tools in life science research and are central to the biotechnology industry, facilitating the production of pharmaceutical proteins, antibodies, vaccines, industrial enzymes, and molecular diagnostics. The contributions of plasmids to biology and their substantial impact on biotechnology and scientific discovery have been immense.
By Disease Insights
Based on diseases, the cancer segment dominated the market with the largest revenue share of 38.17% in 2023. Oncolytic vectors play a pivotal role in this domain by replicating within targeted tumor cells to induce their lysis and can also be engineered to deliver foreign genes that produce antitumor immune factors or cytotoxic proteins, thereby enhancing therapeutic efficacy. Plasmid DNA technologies are also being developed for treating various diseases, including infections and cancer. In many cancers, the immune system’s function is compromised, enabling cancer cells to proliferate unchecked. DNA vaccination has shown promise in stimulating the immune response to combat cancer cells effectively.
Genetic disorders are projected to experience significant CAGR growth during the forecast period. Vectors serve as essential carriers designed to deliver therapeutic genetic material, such as functional genes, directly into cells. Plasmids are utilized in gene therapy for transferring genes that can express proteins lacking in cells, aiming to address genetic deficiencies. Certain gene therapy approaches involve precisely inserting therapeutic genes into predetermined chromosomal sites within the human genome, advancing the potential treatment of genetic disorders.
Recent Developments
· In June 2024, ProBio expanded plasmid and viral vector production in New Jersey to accelerate cell and gene therapies.
· In October 2022, Ray Therapeutics and Forge Biologics expanded their viral vector cGMP partnership to include plasmid DNA manufacturing.
· In February 2023, the Center for Breakthrough Medicines launched Precision Plasmids Manufacturing to expedite advanced therapies into clinical use.
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Key U.S. Viral Vector And Plasmid DNA Manufacturing Company Insights
Thermo Fisher Scientific, Inc., Catalent Inc., and Waisman Biomanufacturing are some of the key players operating in the market.
Thermo Fisher Scientific, Inc. manufactures and provides laboratory reagents, equipment, analytical instruments, consumables, & diagnostic products. The company operates through numerous brands, such as Thermo Scientific, Applied Biosystems, Fisher Scientific, Invitrogen, and Unity Lab Services. It operates in four reportable segments: analytical instruments, life sciences solutions, specialty diagnostics, and laboratory products & services.
Catalent, Inc. serves various pharmaceutical companies through its innovative manufacturing services. The company operates across five continents with 30 facilities that are located in different parts of the world. Its services include the manufacturing and packing of a wide variety of injectable, oral, and respiratory dosage forms. The company develops and delivers more than 70 billion doses for over 7,000 products.
U.S. Viral Vector And Plasmid DNA Manufacturing Market Top Key Companies:
- Thermo Fisher Scientific, Inc.
- Catalent Inc.
- Waisman Biomanufacturing
- Genezen
- Revvity (SIRION Biotech)
- Virovek Incorporation
- Charles River Laboratories (Cobra Biologics)
- RegenxBio, Inc.
U.S. Viral Vector And 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. Viral Vector And Plasmid DNA Manufacturing market.
By Vector Type
- Adenovirus
- Retrovirus
- Adeno-Associated Virus (AAV)
- Lentivirus
- Plasmids
- Others
By Workflow
- Upstream Manufacturing
- Vector Amplification & Expansion
- Vector Recovery/Harvesting
- Downstream Manufacturing
- Purification
- Fill Finish
By Application
- Antisense & RNAi Therapy
- Gene Therapy
- Cell Therapy
- Vaccinology
- Research Applications
By End-use
- Pharmaceutical and Biopharmaceutical Companies
- Research Institutes
By Disease
- Cancer
- Genetic Disorders
- Infectious Diseases
- Others
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