U.S. Viral Vector And Plasmid DNA Manufacturing Market Size | Companies
U.S. Viral Vector And Plasmid DNA Manufacturing Market Size and Growth
The U.S. viral vector and plasmid DNA manufacturing market size was valued at USD 2.45 billion in 2023 and is expected to be worth around USD 15.30 billion by 2033, with a registered CAGR of 20.1% during forecast period 2024 to 2033.
U.S. Viral Vector And Plasmid DNA Manufacturing Market Key Takeaways
U.S. Viral Vector And Plasmid DNA Manufacturing Market Growth
This can be attributed to the growing engagement of companies in research and product development in gene & cell therapy coupled with a substantial number of contract development organizations in the U.S. In addition, homegrown firms are expanding their manufacturing facilities in the country.
The U.S. viral vector and plasmid DNA manufacturing market accounted for a 42.0% share of the global market in 2023. The increasing number of government investments and the growing prevalence of targeted diseases fuel the market. In 2020, the Spinal Muscular Atrophy Foundation stated that approximately 10,000 to 25,000 adults and children in the U.S. were affected by spinal muscular atrophy, making it a relatively common disease among rare diseases.
Due to many contract manufacturers and research organizations, the cell & gene therapy manufacturing market space is highly competitive. In addition, the entry of new players and expanding facilities by existing players have intensified the competition in the U.S. market. Thermo Fisher Scientific, Inc. and Lonza are major players in this market. These companies have undertaken various strategies to strengthen their market presence. For instance, in July 2021, Thermo Fisher Scientific Inc. in Carlsbad, California, announced the addition of a new current GMP viral vectors and plasmid DNA manufacturing facility, allowing the company to meet the growing demand for vital mRNA-based vaccines and plasmid DNA-based therapies.
U.S. Viral Vector And Plasmid DNA Manufacturing Market Report Scope
| Report Attribute | Details |
| Market Size in 2024 | USD 2.94 Billion |
| Market Size by 2033 | USD 15.30 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 20.1% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Vector type, workflow, application, end-use, disease |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | Thermo Fisher Scientific, Inc.; Catalent Inc.; Waisman Biomanufacturing; Genezen; Revvity (SIRION Biotech); BioMarin; Virovek Incorporation; Charles River Laboratories (Cobra Biologics); RegenxBio, Inc. |
U.S. Viral Vector And Plasmid DNA Manufacturing Market 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. Recovery of vectors and clarification process using robust technologies boost revenue generation through this segment. Centrifugation or Tangential-Flow Filtration (TFF) followed by an alkaline or heat lysis method is majorly employed to recover pDNA from biomass. In addition, filtration techniques using depth filters are used to carry out the harvesting process for vector manufacturing. The most widely adopted method for harvesting lentivectors involves ultracentrifugation at 50,000 g/2h. At this ultra-high speed, current rotors generally exhibit a small volume capacity.
The lentivirus segment is projected to grow at the fastest CAGR of 20.2% during the forecast period. Lentiviral vectors are most frequently produced through transient transfection of adherent human-derived HEK293 cell lines in bovine serum-containing media using Polyethylenimine (PEI) transfection reagent. Although adherent systems-based small-scale lentivirus manufacturing is not expensive, it is difficult for companies to conduct high-throughput screening experiments. Owing to this, bioprocessing technology is being used to produce lentiviruses in quantities ranging from a few to hundreds of liters. This, in turn, is aiding in revenue generation for this segment.
U.S. Viral Vector And Plasmid DNA Manufacturing Market By Workflow Insights
Based on workflow, the downstream processing segment dominated the market with the largest revenue share of 53.13% in 2023. Downstream processes involve several purification methods that consist of multiple steps and are distinguished into three stages: capture, intermediate purification, and polishing. Chromatography and ultrafiltration techniques are employed for intermediate purification and final polishing steps. Chromatography techniques using ion exchange and affinity methods are the most preferred techniques employed in the industry. Nevertheless, these methods pose certain challenges, for example, these techniques require other purification methods for product purification, which results in loss of yield.
The upstream processing segment is expected to grow at a CAGR of 19.1% over the forecast period. The initial processing stage, known as upstream processing, involves introducing cells to the virus, growing these cells, and then extracting the virus from them. The growth in innovative product development, such as the ambr 15 microbioreactor system for high throughput upstream process development, is anticipated to boost this particular area.
U.S. Viral Vector And Plasmid DNA Manufacturing Market By Application Insights
Based on the application, the vaccinology segment accounted for the largest revenue share of 22.11% in 2023. The high demand for vaccines in several health conditions and cancer is anticipated to drive market growth over the forecast period.
The cell therapy segment is expected to grow at the fastest CAGR over the forecast period. Cell therapy-based medicines are increasingly being adopted owing to the advent of next-generation transfer vectors. These vectors are proven to be safe and efficacious. Patient samples are generally expanded, extracted, and further transduced by using gene therapy vectors. These modified transduced cells are then re-implanted into patients for therapeutic applications.
U.S. Viral Vector And Plasmid DNA Manufacturing Market 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 owing to the high demand for vectors for conducting research and the increasing involvement of scientific communities in gene and cell therapy research.
The pharmaceutical & biotechnology companies segment is expected to grow at a CAGR of 20.4% over the forecast period. With increasing investments in the field of cell and gene therapy, several biopharmaceutical companies are shifting their focus toward these advanced therapies. This has resulted in more research studies being conducted by companies to evaluate the potential of gene and cell therapies. Biotechnology and pharmaceutical companies are actively engaged in development of advanced therapies for several life-threatening diseases. Abeona Therapeutics is actively assessing AAV9-based gene therapies for CLN1 and CLN3 diseases. Similarly, a U.S.-based company-StrideBio-offers AAV-mediated gene therapy solutions based on their research studies.
U.S. Viral Vector And Plasmid DNA Manufacturing Market By Disease Insights
Based on diseases, the cancer segment dominated the market with the largest revenue share of 38.17% in 2023. An increase in the adoption of vectors for the development of cancer therapies, a large number of research programs, and recent approvals of gene therapy products have led to the growth of the market. Companies have a robust pipeline of cancer gene therapy products, which is expected to boost market growth throughout the forecast period.
The genetic disorders are expected to grow rapidly during the forecast period. Genetic diseases are most commonly congenital; however, some diseases can be acquired by random mutations. The most common genetic diseases include sickle cell anemia and hemophilia, which are characterized by the formation of blood clots and the production of hemoglobin, affecting the oxygen-carrying capacity of the blood.
U.S. Viral Vector And Plasmid DNA Manufacturing Market Recent Developments
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:
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
By Workflow
By Application
By End-use
By Disease
Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Segment Definitions
1.2.1. Vector type
1.2.2. Workflow
1.2.3. Application
1.2.4. End-use
1.2.5. Disease
1.2.6. Estimates and forecasts timeline
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased database
1.4.2. nova one advisor internal database
1.4.3. Secondary sources
1.4.4. Primary research
1.4.5. Details of primary research
1.5. Information or Data Analysis
1.5.1. Data analysis models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity flow analysis (Model 1)
1.7.2. Approach 1: Commodity flow approach
1.7.3. Volume price analysis (Model 2)
1.7.4. Approach 2: Volume price analysis
1.8. List of Secondary Sources
1.9. List of Primary Sources
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights
Chapter 3. Viral Vectors And Plasmid DNA Manufacturing Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent market outlook
3.1.2. Related/ancillary market outlook
3.2. Market Dynamics
3.2.1. Market driver analysis
3.2.1.1. Robust Pipeline for Gene Therapies and Viral Vector Vaccines
3.2.1.2. Technological Advancements in Manufacturing Vectors
3.2.1.3. Highly Competitive Market and Various Strategies Undertaken by Market Entities
3.2.2. Market restraint analysis
3.2.2.1. Regulatory, Scientific, And Ethical Challenges Associated With Gene Therapy And Viral Vectors
3.3. Viral Vectors And Plasmid DNA Manufacturing Market Analysis Tools
3.3.1. Industry Analysis – Porter’s
3.3.2. PESTEL Analysis
3.3.3. COVID-19 Impact Analysis
Chapter 4. Viral Vectors And Plasmid DNA Manufacturing Market: Vector Type Estimates & Trend Analysis
4.1. Global Viral Vectors And Plasmid DNA Manufacturing Market by Vector Type Outlook
4.2. Adeno-associated virus (AAV)
4.2.1. Market estimates and forecasts 2021 to 2033
4.3. Lentivirus
4.3.1. Market estimates and forecasts 2021 to 2033
4.4. Adenovirus
4.4.1. Market estimates and forecasts 2021 to 2033
4.5. Retrovirus
4.5.1. Market estimates and forecasts 2021 to 2033
4.6. Plasmids
4.6.1. Market estimates and forecasts 2021 to 2033
4.7. Others
4.7.1. Market estimates and forecasts 2021 to 2033
Chapter 5. Viral Vectors And Plasmid DNA Manufacturing Market: Workflow Estimates & Trend Analysis
5.1. Global Viral Vectors And Plasmid DNA Manufacturing Market by Workflow Outlook
5.2. Upstream Manufacturing
5.2.1. Market estimates and forecasts 2021 to 2033
5.2.2. Vector Amplification & Expansion
5.2.2.1. Market estimates and forecasts 2021 to 2033
5.2.3. Vector Recovery/Harvesting
5.2.3.1. Market estimates and forecasts 2021 to 2033
5.3. Downstream Manufacturing
5.3.1. Market estimates and forecasts 2021 to 2033
5.3.2. Purification
5.3.2.1. Market estimates and forecasts 2021 to 2033
5.3.3. Fill Finish diagnostic instruments
5.3.3.1. Market estimates and forecasts 2021 to 2033
Chapter 6. Viral Vectors And Plasmid DNA Manufacturing Market: Application Estimates & Trend Analysis
6.1. Global Viral Vectors And Plasmid DNA Manufacturing Market by Application Outlook
6.2. Gene Therapy
6.2.1. Market estimates and forecasts 2021 to 2033
6.3. Cell Therapy
6.3.1. Market estimates and forecasts 2021 to 2033
6.4. Vaccinology
6.4.1. Market estimates and forecasts 2021 to 2033
6.5. Research Applications
6.5.1. Market estimates and forecasts 2021 to 2033
Chapter 7. Viral Vectors And Plasmid DNA Manufacturing Market: End-use Estimates & Trend Analysis
7.1. Global Viral Vectors And Plasmid DNA Manufacturing Market by End-use Outlook
7.2. Pharmaceutical and Biopharmaceutical Companies
7.2.1. Market estimates and forecasts 2021 to 2033
7.3. Research Institutes
7.3.1. Market estimates and forecasts 2021 to 2033
Chapter 8. Viral Vectors And Plasmid DNA Manufacturing Market: Disease Estimates & Trend Analysis
8.1. Global Viral Vectors And Plasmid DNA Manufacturing Market by Disease Outlook
8.2. Cancer
8.2.1. Market estimates and forecasts 2021 to 2033
8.3. Genetic Disorders
8.3.1. Market estimates and forecasts 2021 to 2033
8.4. Infectious Diseases
8.4.1. Market estimates and forecasts 2021 to 2033
8.5. Other
8.5.1. Market estimates and forecasts 2021 to 2033
Chapter 9. Viral Vectors And Plasmid DNA Manufacturing Market: Regional Estimates & Trend Analysis
9.1. Regional Market Share Analysis, 2023 & 2030
9.2. North America
9.2.1. North America market estimates and forecasts 2021 to 2033
9.2.2. U.S.
9.2.2.1. Key country dynamics
9.2.2.2. Regulatory framework
9.2.2.3. Competitive scenario
9.2.2.4. U.S. market estimates and forecasts 2021 to 2033
9.2.2.5. Target disease prevalence
9.2.3. Canada
9.2.3.1. Key country dynamics
9.2.3.2. Regulatory framework
9.2.3.3. Competitive scenario
9.2.3.4. Canada market estimates and forecasts 2021 to 2033
9.2.3.5. Target disease prevalence
9.3. Europe
9.3.1. Europe market estimates and forecasts 2021 to 2033
9.3.2. UK
9.3.2.1. Key country dynamics
9.3.2.2. Regulatory framework
9.3.2.3. Competitive scenario
9.3.2.4. UK market estimates and forecasts 2021 to 2033
9.3.2.5. Target disease prevalence
9.3.3. Germany
9.3.3.1. Key country dynamics
9.3.3.2. Regulatory framework
9.3.3.3. Competitive scenario
9.3.3.4. Germany market estimates and forecasts 2021 to 2033
9.3.3.5. Target disease prevalence
9.3.4. France
9.3.4.1. Key country dynamics
9.3.4.2. Regulatory framework
9.3.4.3. Competitive scenario
9.3.4.4. France market estimates and forecasts 2021 to 2033
9.3.4.5. Target disease prevalence
9.3.5. Italy
9.3.5.1. Key country dynamics
9.3.5.2. Regulatory framework
9.3.5.3. Competitive scenario
9.3.5.4. Italy market estimates and forecasts 2021 to 2033
9.3.5.5. Target disease prevalence
9.3.6. Spain
9.3.6.1. Key country dynamics
9.3.6.2. Regulatory framework
9.3.6.3. Competitive scenario
9.3.6.4. Spain market estimates and forecasts 2021 to 2033
9.3.6.5. Target disease prevalence
9.3.7. Norway
9.3.7.1. Key country dynamics
9.3.7.2. Regulatory framework
9.3.7.3. Competitive scenario
9.3.7.4. Norway market estimates and forecasts 2021 to 2033
9.3.7.5. Target disease prevalence
9.3.8. Sweden
9.3.8.1. Key country dynamics
9.3.8.2. Regulatory framework
9.3.8.3. Competitive scenario
9.3.8.4. Sweden market estimates and forecasts 2021 to 2033
9.3.8.5. Target disease prevalence
9.3.9. Denmark
9.3.9.1. Key country dynamics
9.3.9.2. Regulatory framework
9.3.9.3. Competitive scenario
9.3.9.4. Denmark market estimates and forecasts 2021 to 2033
9.3.9.5. Target disease prevalence
9.4. Asia Pacific
9.4.1. Asia Pacific market estimates and forecasts 2021 to 2033
9.4.2. Japan
9.4.2.1. Key country dynamics
9.4.2.2. Regulatory framework
9.4.2.3. Competitive scenario
9.4.2.4. Japan market estimates and forecasts 2021 to 2033
9.4.2.5. Target disease prevalence
9.4.3. China
9.4.3.1. Key country dynamics
9.4.3.2. Regulatory framework
9.4.3.3. Competitive scenario
9.4.3.4. China market estimates and forecasts 2021 to 2033
9.4.3.5. Target disease prevalence
9.4.4. India
9.4.4.1. Key country dynamics
9.4.4.2. Regulatory framework
9.4.4.3. Competitive scenario
9.4.4.4. India market estimates and forecasts 2021 to 2033
9.4.4.5. Target disease prevalence
9.4.5. Australia
9.4.5.1. Key country dynamics
9.4.5.2. Regulatory framework
9.4.5.3. Competitive scenario
9.4.5.4. Australia market estimates and forecasts 2021 to 2033
9.4.5.5. Target disease prevalence
9.4.6. South Korea
9.4.6.1. Key country dynamics
9.4.6.2. Regulatory framework
9.4.6.3. Competitive scenario
9.4.6.4. South Korea market estimates and forecasts 2021 to 2033
9.4.6.5. Target disease prevalence
9.4.7. Thailand
9.4.7.1. Key country dynamics
9.4.7.2. Regulatory framework
9.4.7.3. Competitive scenario
9.4.7.4. Thailand market estimates and forecasts 2021 to 2033
9.4.7.5. Target disease prevalence
9.5. Latin America
9.5.1. Latin America market estimates and forecasts 2021 to 2033
9.5.2. Brazil
9.5.2.1. Key country dynamics
9.5.2.2. Regulatory framework
9.5.2.3. Competitive scenario
9.5.2.4. Brazil market estimates and forecasts 2021 to 2033
9.5.2.5. Target disease prevalence
9.5.3. Mexico
9.5.3.1. Key country dynamics
9.5.3.2. Regulatory framework
9.5.3.3. Competitive scenario
9.5.3.4. Mexico market estimates and forecasts 2021 to 2033
9.5.3.5. Target disease prevalence
9.5.4. Argentina
9.5.4.1. Key country dynamics
9.5.4.2. Regulatory framework
9.5.4.3. Competitive scenario
9.5.4.4. Argentina market estimates and forecasts 2021 to 2033
9.5.4.5. Target disease prevalence
9.6. MEA
9.6.1. MEA market estimates and forecasts 2021 to 2033
9.6.2. South Africa
9.6.2.1. Key country dynamics
9.6.2.2. Regulatory framework
9.6.2.3. Competitive scenario
9.6.2.4. South Africa market estimates and forecasts 2021 to 2033
9.6.2.5. Target disease prevalence
9.6.3. Saudi Arabia
9.6.3.1. Key country dynamics
9.6.3.2. Regulatory framework
9.6.3.3. Competitive scenario
9.6.3.4. Saudi Arabia market estimates and forecasts 2021 to 2033
9.6.3.5. Target disease prevalence
9.6.4. UAE
9.6.4.1. Key country dynamics
9.6.4.2. Regulatory framework
9.6.4.3. Competitive scenario
9.6.4.4. UAE market estimates and forecasts 2021 to 2033
9.6.4.5. Target disease prevalence
9.6.5. Kuwait
9.6.5.1. Key country dynamics
9.6.5.2. Regulatory framework
9.6.5.3. Competitive scenario
9.6.5.4. Kuwait market estimates and forecasts 2021 to 2033
9.6.5.5. Target disease prevalence
Chapter 10. Competitive Landscape
10.1. Company Categorization
10.2. Strategy Mapping
10.3. Company Market Position Analysis, 2023
10.4. Company Profiles/Listing
10.4.1. Merck KGaA
10.4.1.1. Company overview
10.4.1.2. Financial performance
10.4.1.3. Product benchmarking
10.4.1.4. Strategic initiatives
10.4.2. Lonza
10.4.2.1. Company overview
10.4.2.2. Financial performance
10.4.2.3. Product benchmarking
10.4.2.4. Strategic initiatives
10.4.3. FUJIFILM Diosynth Biotechnologies
10.4.3.1. Company overview
10.4.3.2. Financial performance
10.4.3.3. Product benchmarking
10.4.3.4. Strategic initiatives
10.4.4. Thermo Fisher Scientific
10.4.4.1. Company overview
10.4.4.2. Financial performance
10.4.4.3. Product benchmarking
10.4.4.4. Strategic initiatives
10.4.5. Cobra Biologics
10.4.5.1. Company overview
10.4.5.2. Financial performance
10.4.5.3. Product benchmarking
10.4.5.4. Strategic initiatives
10.4.6. Catalent Inc.
10.4.6.1. Company overview
10.4.6.2. Financial performance
10.4.6.3. Product benchmarking
10.4.6.4. Strategic initiatives
10.4.7. Wuxi Biologics
10.4.7.1. Company overview
10.4.7.2. Financial performance
10.4.7.3. Product benchmarking
10.4.7.4. Strategic initiatives
10.4.8. Takara Bio Inc.
10.4.8.1. Company overview
10.4.8.2. Financial performance
10.4.8.3. Product benchmarking
10.4.8.4. Strategic initiatives
10.4.9. Waisman Biomanufacturing
10.4.9.1. Company overview
10.4.9.2. Financial performance
10.4.9.3. Product benchmarking
10.4.9.4. Strategic initiatives
10.4.10. Genezen laboratories
10.4.10.1. Company overview
10.4.10.2. Financial performance
10.4.10.3. Product benchmarking
10.4.10.4. Strategic initiatives
10.4.11. Batavia Biosciences
10.4.11.1. Company overview
10.4.11.2. Financial performance
10.4.11.3. Product benchmarking
10.4.11.4. Strategic initiatives
10.4.12. Miltenyi Biotec GmbH
10.4.12.1. Company overview
10.4.12.2. Financial performance
10.4.12.3. Product benchmarking
10.4.12.4. Strategic initiatives
10.4.13. SIRION Biotech GmbH
10.4.13.1. Company overview
10.4.13.2. Financial performance
10.4.13.3. Product benchmarking
10.4.13.4. Strategic initiatives
10.4.14. Virovek Incorporation
10.4.14.1. Company overview
10.4.14.2. Financial performance
10.4.14.3. Product benchmarking
10.4.14.4. Strategic initiatives
10.4.15. BioNTech IMFS GmbH
10.4.15.1. Company overview
10.4.15.2. Financial performance
10.4.15.3. Product benchmarking
10.4.15.4. Strategic initiatives
10.4.16. Audentes Therapeutics
10.4.16.1. Company overview
10.4.16.2. Financial performance
10.4.16.3. Product benchmarking
10.4.16.4. Strategic initiatives
10.4.17. BioMarin Pharmaceutical
10.4.17.1. Company overview
10.4.17.2. Financial performance
10.4.17.3. Product benchmarking
10.4.17.4. Strategic initiatives
10.4.18. RegenxBio, Inc.
10.4.18.1. Company overview
10.4.18.2. Financial performance
10.4.18.3. Product benchmarking
10.4.18.4. Strategic initiatives
Cross-segment Market Size and Analysis for Mentioned Segments
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