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U.S. Plasmid DNA Manufacturing Market Size, Share, Trends, Industry Analysis Report By Grade (R&D Grade, GMP Grade), By Development Phase, By Application, By Disease – Market Forecast, 2025–2034

Publisher Polaris Market Research & Consulting LLP
Published Aug 01, 2025
Length 118 Pages
SKU # PLRS20381564

Description

The U.S. plasmid DNA manufacturing market size is expected to reach USD 6,662.09 million by 2034, according to a new study by Polaris Market Research. The report “U.S. Plasmid DNA Manufacturing Market Size, Share, Trends, Industry Analysis Report By Grade (R&D Grade, GMP Grade), By Development Phase, By Application, By Disease – Market Forecast, 2025–2034” gives a detailed insight into current market dynamics and provides analysis on future market growth.

The U.S. plasmid DNA manufacturing market is dedicated to the large-scale production of high-quality plasmid DNA molecules. These small, circular DNA molecules are vital as a starting material in genetic engineering and molecular biology. Plasmid DNA is a critical component for developing advanced therapies, including gene therapies, DNA vaccines, and cell-based treatments. The production process is complex, involving multiple steps such as fermentation, purification, and stringent quality control measures to ensure the final product meets the necessary standards for both research and clinical applications.

The U.S. market is experiencing strong growth, driven by a surge in research and development across the biotechnology and pharmaceutical sectors. There is a high demand for plasmid DNA to support the expanding pipeline of gene and cell therapies in clinical trials. As more companies pursue these innovative treatments for various diseases, they need a reliable and scalable supply of plasmid DNA. The market is also seeing a rise in outsourcing to specialized contract manufacturing organizations, which helps smaller companies and startups access the necessary expertise and infrastructure. This growing trend, along with continuous technological advancements in manufacturing processes, is shaping the competitive landscape and driving the overall market forward.

U.S. Plasmid DNA Manufacturing Market Report Highlights:

By grade, the GMP grade segment held the largest share in 2024. This is because of the strict regulatory needs for advanced therapies in clinical trials and commercial production, which drives demand for high-quality, compliant manufacturing.

Based on development phase, the clinical therapeutics segment accounted for the largest share in 2024. This is a result of the high number of gene and cell therapies currently in human clinical trials, which require a substantial amount of plasmid DNA for large-scale manufacturing.

By application, the cell and gene therapy segment held the largest share in 2024. This is due to plasmid DNA's essential role in producing the viral vectors used to deliver genetic material in these advanced therapies, a field that is witnessing massive growth.

In terms of disease, the cancer segment held the largest share in 2024. This is because of the widespread use of plasmid DNA in developing immunotherapies, gene therapies, and DNA vaccines to treat various forms of cancer, a disease with high global prevalence.

A few key players in the market include Aldevron (a Danaher company), VGXI, Lonza, Charles River Laboratories, Catalent, Thermo Fisher Scientific, and Akron Biotech. Other key players offering services and products in this market are Nature Technology Corporation, Waisman Biomanufacturing, and Kaneka Eurogentec.

Polaris Market Research has segmented the U.S. plasmid DNA manufacturing market report based on grade, development phase, application, and disease:

By Grade Outlook (Revenue – USD Million, 2020–2034)

R&D Grade

GMP Grade

By Development Phase Outlook (Revenue – USD Million, 2020–2034)

Pre-Clinical Therapeutics

Clinical Therapeutics

Marketed Therapeutics

By Application Outlook (Revenue – USD Million, 2020–2034)

DNA Vaccines

Cell & Gene Therapy

Immunotherapy

Others

By Disease Outlook (Revenue – USD Million, 2020–2034)

Infectious Disease

Cancer

Genetic Disorder

Others

Table of Contents

118 Pages
1. Introduction
1.1. Report Description
1.1.1. Objectives of the Study
1.1.2. Market Scope
1.1.3. Assumptions
1.2. Stakeholders
2. Executive Summary
2.1. Market Highlights
3. Research Methodology
3.1. Overview
3.1.1. Data Mining
3.2. Data Sources
3.2.1. Primary Sources
3.2.2. Secondary Sources
4. U.S. Plasmid DNA Manufacturing Market Insights
4.1. U.S. Plasmid DNA Manufacturing Market – Market Snapshot
4.2. U.S. Plasmid DNA Manufacturing Market Dynamics
4.2.1. Drivers and Opportunities
4.2.1.1. Growth in the Gene and Cell Therapy Pipeline
4.2.1.2. Rising Investment in Biotechnology Research
4.2.2. Restraints and Challenges
4.2.2.1. High Cost and Regulatory Complexity
4.3. Porter’s Five Forces Analysis
4.3.1. Bargaining Power of Suppliers (Moderate)
4.3.2. Threats of New Entrants: (Low)
4.3.3. Bargaining Power of Buyers (Moderate)
4.3.4. Threat of Substitute (Moderate)
4.3.5. Rivalry among existing firms (High)
4.4. PESTEL Analysis
4.5. U.S. Plasmid DNA Manufacturing Market Trends
4.6. Value Chain Analysis
4.7. COVID-19 Impact Analysis
5. U.S. Plasmid DNA Manufacturing Market, by Grade
5.1. Key Findings
5.2. Introduction
5.2.1. U.S. Plasmid DNA Manufacturing Market, by Grade, 2020–2034 (USD Million)
5.3. R&D Grade
5.3.1. U.S. Plasmid DNA Manufacturing Market, by R&D Grade, by Region, 2020–2034 (USD Million)
5.4. GMP Grade
5.4.1. U.S. Plasmid DNA Manufacturing Market, by GMP Grade, by Region, 2020–2034 (USD Million)
6. U.S. Plasmid DNA Manufacturing Market, by Development Phase
6.1. Key Findings
6.2. Introduction
6.2.1. U.S. Plasmid DNA Manufacturing Market, by Development Phase, 2020–2034 (USD Million)
6.3. Pre-Clinical Therapeutics
6.3.1. U.S. Plasmid DNA Manufacturing Market, by Pre-Clinical Therapeutics, by Region, 2020–2034 (USD Million)
6.4. Clinical Therapeutics
6.4.1. U.S. Plasmid DNA Manufacturing Market, by Clinical Therapeutics, by Region, 2020–2034 (USD Million)
6.5. Marketed Therapeutics
6.5.1. U.S. Plasmid DNA Manufacturing Market, by Marketed Therapeutics, by Region, 2020–2034 (USD Million)
7. U.S. Plasmid DNA Manufacturing Market, by Application
7.1. Key Findings
7.2. Introduction
7.2.1. U.S. Plasmid DNA Manufacturing Market, by Application, 2020–2034 (USD Million)
7.3. DNA Vaccines
7.3.1. U.S. Plasmid DNA Manufacturing Market, by DNA Vaccines, by Region, 2020–2034 (USD Million)
7.4. Cell & Gene Therapy
7.4.1. U.S. Plasmid DNA Manufacturing Market, by Cell & Gene Therapy, by Region, 2020–2034 (USD Million)
7.5. Immunotherapy
7.5.1. U.S. Plasmid DNA Manufacturing Market, by Immunotherapy, by Region, 2020–2034 (USD Million)
7.6. Others
7.6.1. U.S. Plasmid DNA Manufacturing Market, by Others, by Region, 2020–2034 (USD Million)
8. U.S. Plasmid DNA Manufacturing Market, by Disease
8.1. Key Findings
8.2. Introduction
8.2.1. U.S. Plasmid DNA Manufacturing Market, by Disease, 2020–2034 (USD Million)
8.3. Infectious Disease
8.3.1. U.S. Plasmid DNA Manufacturing Market, by Infectious Disease, by Region, 2020–2034 (USD Million)
8.4. Cancer
8.4.1. U.S. Plasmid DNA Manufacturing Market, by Cancer, by Region, 2020–2034 (USD Million)
8.5. Genetic Disorder
8.5.1. U.S. Plasmid DNA Manufacturing Market, by Genetic Disorder, by Region, 2020–2034 (USD Million)
8.6. Others
8.6.1. U.S. Plasmid DNA Manufacturing Market, by Others, by Region, 2020–2034 (USD Million)
9. Competitive Landscape
9.1. Expansion and Acquisition Analysis
9.1.1. Expansion
9.1.2. Acquisitions
9.2. Partnerships/Collaborations/Agreements/Exhibitions
10. Company Profiles
10.1. Akron Biotech
10.1.1. Company Overview
10.1.2. Financial Performance
10.1.3. Product Benchmarking
10.1.4. Recent Development
10.2. Aldevron (Danaher)
10.2.1. Company Overview
10.2.2. Financial Performance
10.2.3. Product Benchmarking
10.2.4. Recent Development
10.3. Catalent (Novo Holdings A/S)
10.3.1. Company Overview
10.3.2. Financial Performance
10.3.3. Product Benchmarking
10.3.4. Recent Development
10.4. Charles River Laboratories International, Inc.
10.4.1. Company Overview
10.4.2. Financial Performance
10.4.3. Product Benchmarking
10.4.4. Recent Development
10.5. Kaneka Eurogentec (Kaneka Corporation)
10.5.1. Company Overview
10.5.2. Financial Performance
10.5.3. Product Benchmarking
10.5.4. Recent Development
10.6. Lonza Group AG
10.6.1. Company Overview
10.6.2. Financial Performance
10.6.3. Product Benchmarking
10.6.4. Recent Development
10.7. Nature Technology Corporation (Aldevron)
10.7.1. Company Overview
10.7.2. Financial Performance
10.7.3. Product Benchmarking
10.7.4. Recent Development
10.8. Thermo Fisher Scientific
10.8.1. Company Overview
10.8.2. Financial Performance
10.8.3. Product Benchmarking
10.8.4. Recent Development
10.9. VGXI, Inc.
10.9.1. Company Overview
10.9.2. Financial Performance
10.9.3. Product Benchmarking
10.9.4. Recent Development
10.10. Waisman Biomanufacturing
10.10.1. Company Overview
10.10.2. Financial Performance
10.10.3. Product Benchmarking
10.10.4. Recent Development

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