Summary

U.S. Plasmid DNA Manufacturing Market Summary

The U.S. plasmid DNA manufacturing market size was estimated at USD 803.0 million in 2024 and is projected to reach USD 5,038.0 million by 2033, growing at a CAGR of 23.06% from 2025 to 2033. This expansion is driven by increasing demand for gene therapies, DNA vaccines, and other advanced biologics that rely on high-quality plasmid DNA as a foundational component.

Continued investment in biotechnology research and supportive regulatory frameworks are expected to propel market development further over the forecast period.

Rising Prevalence of Genetic Disorders and Cancer

The rising prevalence of genetic disorders and cancer is a major factor driving growth in the U.S. plasmid DNA manufacturing industry. Advances in genetic research have highlighted the role of gene mutations and abnormalities in various diseases, leading to increased development of gene therapies aimed at treating these conditions at their source. Similarly, cancer treatment is increasingly shifting toward personalized and targeted therapies, many of which depend on plasmid DNA as a vector to deliver therapeutic genes or immune modulators. As diagnostic technologies improve and the population ages, more patients are identified as candidates for these innovative therapies, expanding the demand for plasmid DNA.

Moreover, the complex and individualized nature of genetic and cancer therapies requires highly specialized and scalable plasmid DNA manufacturing processes. Biotech companies and research institutions invest heavily in developing flexible production platforms that meet the' rigorous quality standards and volume demands of clinical and commercial applications. This increased focus on precision medicine and tailored treatments further solidifies plasmid DNA's role as a critical component in the evolving landscape of advanced therapeutics, driving sustained market expansion.

U.S. Plasmid DNA Manufacturing Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this report, Grand View Research has segmented the U.S. plasmid DNA manufacturing market report based on grade, development phase, application, and disease:

• Grade Outlook (Revenue, USD Million, 2021 - 2033)
• R&D Grade
o Viral Vector Development
o AAV
o Lentivirus
o Adenovirus
o Retrovirus
o Others
o mRNA Development
o Antibody Development
o DNA Vaccine Development
o Others
• GMP Grade
• Development Phase Outlook (Revenue, USD Million, 2021 - 2033)
• Pre-Clinical Therapeutics
• Clinical Therapeutics
• Marketed Therapeutics
• Application Outlook (Revenue, USD Million, 2021 - 2033)
• DNA Vaccines
• Cell & Gene Therapy
• Immunotherapy
• Others
• Disease Outlook (Revenue, USD Million, 2021 - 2033)
• Infectious Disease
• Cancer
• Genetic Disorder
• Others

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Table of Contents

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation and Scope
1.2. Segment Definitions
1.2.1. Grade
1.2.2. Development Phase
1.2.3. Application
1.2.4. Disease
1.3. Information analysis
1.4. Market formulation & data visualization
1.5. Data validation & publishing
1.6. Information Procurement
1.6.1. Primary Research
1.7. Information or Data Analysis
1.8. Market Formulation & Validation
1.9. Market Model
1.9.1. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
Chapter 3. 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 Trends and Outlook
3.3. Market Dynamics
3.3.1. Increasing number of patients opting for gene therapy
3.3.2. Robust pipeline for gene therapies
3.3.3. Highly competitive market and various strategies undertaken by market players
3.3.4. Increasing demand for plasmid DNA in various medical therapies
3.4. Market Restraint Analysis
3.4.1. Regulatory, scientific, and ethical challenges associated with gene therapy
3.5. Business Environment Analysis
3.5.1. PESTEL Analysis
3.5.2. Porter’s Five Forces Analysis
Chapter 4. Grade Business Analysis
4.1. Segment Dashboard
4.2. U.S. Plasmid DNA Manufacturing Market Movement Analysis
4.3. U.S. Plasmid DNA Manufacturing Market Size & Trend Analysis, by Grade, 2021 to 2033 (USD Million)
4.4. R&D Grade
4.4.1. R&D Grade Market, 2021 - 2033 (USD Million)
4.4.2. Viral Vector Development
4.4.2.1. Viral Vector Development Market, 2021 - 2033 (USD Million)
4.4.2.2. AAV
4.4.2.2.1. AAV Market, 2021 - 2033 (USD Million)
4.4.2.3. Lentivirus
4.4.2.3.1. Lentivirus Market, 2021 - 2033 (USD Million)
4.4.2.4. Adenovirus
4.4.2.4.1. Adenovirus Market, 2021 - 2033 (USD Million)
4.4.2.5. Retrovirus
4.4.2.5.1. Retrovirus Market, 2021 - 2033 (USD Million)
4.4.2.6. Others
4.4.2.6.1. Others Market, 2021 - 2033 (USD Million)
4.4.3. mRNA Development
4.4.3.1. mRNA Development Market, 2021 - 2033 (USD Million)
4.4.4. Antibody Development
4.4.4.1. Antibody Development Market, 2021 - 2033 (USD Million)
4.4.5. DNA Vaccine Development
4.4.5.1. DNA Vaccine Development Market, 2021 - 2033 (USD Million)
4.4.6. Others
4.4.6.1. Others Market, 2021 - 2033 (USD Million)
4.5. GMP Grade
4.5.1. GMP Grade Market, 2021 - 2033 (USD Million)
Chapter 5. Development Phase Business Analysis
5.1. Segment Dashboard
5.2. U.S. Plasmid DNA Manufacturing Market Movement Analysis
5.3. U.S. Plasmid DNA Manufacturing Market Size & Trend Analysis, by Development Phase, 2021 to 2033 (USD Million)
5.4. Pre-Clinical Therapeutics
5.4.1. Pre-Clinical Therapeutics Market, 2021 - 2033 (USD Million)
5.5. Clinical Therapeutics
5.5.1. Clinical Therapeutics Market, 2021 - 2033 (USD Million)
5.6. Marketed Therapeutics
5.6.1. Marketed Therapeutics Market, 2021 - 2033 (USD Million)
Chapter 6. Application Business Analysis
6.1. Segment Dashboard
6.2. U.S. Plasmid DNA Manufacturing Market Movement Analysis
6.3. U.S. Plasmid DNA Manufacturing Market Size & Trend Analysis, by Application, 2021 to 2033 (USD Million)
6.4. DNA Vaccines
6.4.1. DNA Vaccines Market, 2021 - 2033 (USD Million)
6.5. Cell & Gene Therapy
6.5.1. Cell & Gene Therapy Market, 2021 - 2033 (USD Million)
6.6. Immunotherapy
6.6.1. Immunotherapy Market, 2021 - 2033 (USD Million)
6.7. Others
6.7.1. Others Market, 2021 - 2033 (USD Million)
Chapter 7. Disease Business Analysis
7.1. Segment Dashboard
7.2. U.S. Plasmid DNA Manufacturing Market Movement Analysis
7.3. U.S. Plasmid DNA Manufacturing Market Size & Trend Analysis, by Disease, 2021 to 2033 (USD Million)
7.4. Infectious Disease
7.4.1. Infectious Disease Market, 2021 - 2033 (USD Million)
7.5. Cancer
7.5.1. Cancer Market, 2021 - 2033 (USD Million)
7.6. Genetic Disorder
7.6.1. Genetic Disorder Market, 2021 - 2033 (USD Million)
7.7. Others
7.7.1. Others Market, 2021 - 2033 (USD Million)
Chapter 8. Competitive Landscape
8.1. Participant Categorization
8.2. Company Market Position Analysis, 2024
8.3. Participant’s Overview
8.3.1. Charles River Laboratories
8.3.1.1. Overview
8.3.1.2. Financial Performance
8.3.1.3. Product Benchmarking
8.3.1.4. Strategic Initiatives
8.3.2. Danaher (Aldevron)
8.3.2.1. Overview
8.3.2.2. Financial Performance
8.3.2.3. Product Benchmarking
8.3.2.4. Strategic Initiatives
8.3.3. VGXI, Inc.
8.3.3.1. Overview
8.3.3.2. Financial Performance
8.3.3.3. Product Benchmarking
8.3.3.4. Strategic Initiatives
8.3.4. Kaneka Corp.
8.3.4.1. Overview
8.3.4.2. Financial Performance
8.3.4.3. Product Benchmarking
8.3.4.4. Strategic Initiatives
8.3.5. Lonza
8.3.5.1. Overview
8.3.5.2. Financial Performance
8.3.5.3. Product Benchmarking
8.3.5.4. Strategic Initiatives
8.3.6. Nature Technology
8.3.6.1. Overview
8.3.6.2. Financial Performance
8.3.6.3. Product Benchmarking
8.3.6.4. Strategic Initiatives
8.3.7. Cell and Gene Therapy Catapult
8.3.7.1. Overview
8.3.7.2. Financial Performance
8.3.7.3. Product Benchmarking
8.3.7.4. Strategic Initiatives
8.3.8. Eurofins Genomics
8.3.8.1. Overview
8.3.8.2. Financial Performance
8.3.8.3. Product Benchmarking
8.3.8.4. Strategic Initiatives
8.3.9. Luminous BioSciences, LLC
8.3.9.1. Overview
8.3.9.2. Financial Performance
8.3.9.3. Product Benchmarking
8.3.9.4. Strategic Initiatives
8.3.10. Akron Biotech
8.3.10.1. Overview
8.3.10.2. Financial Performance
8.3.10.3. Product Benchmarking
8.3.10.4. Strategic Initiatives