U.S. DNA Manufacturing Market Size, Share & Trends Analysis Report By Type (Plasmid DNA, Synthetic DNA), By Grade (GMP & R&D), By Application (Cell & Gene Therapy, Vaccines, Oligonucleotide-based Drugs), By End-use, And Segment Forecasts, 2025

The U.S. DNA manufacturing market size is projected to reach USD 6.16 billion by 2030, growing at a CAGR of 18.27% during the forecast period, according to a new report by Grand View Research, Inc. The U.S. DNA manufacturing industry is experiencing robust growth, driven by the expanding landscape of personalized medicine, synthetic biology, and the biopharmaceutical sector. As the largest hub for biotechnology innovation, the U.S. leads in adopting advanced technologies for DNA synthesis, gene editing, and therapeutic development.

Technological innovations such as enzymatic DNA synthesis, automated oligonucleotide production, and continuous manufacturing systems are transforming production processes, making them more efficient and scalable. U.S.-based companies also invest heavily in cell-free DNA synthesis platforms, which reduce dependency on traditional microbial systems and shorten development timelines.

Strategic partnerships among biotech firms, academic institutions, and Contract Development and Manufacturing Organizations (CDMOs) accelerate innovation and enable faster market entry in the U.S. DNA manufacturing industry. With critical applications spanning gene and cell therapies, oncology diagnostics, infectious disease research, and vaccine development, the demand for scalable, high-quality DNA solutions continues to grow. Consequently, the U.S. market is positioned to play a foundational role in advancing precision medicine, next-generation biotherapeutics, and cutting-edge diagnostics.

U.S. DNA Manufacturing Market Report Highlights:

By type, synthetic DNA dominated the U.S. DNA manufacturing industry in 2024, accounting for 61.89% of the revenue share. This segment's growth is driven by the rising use of synthetic DNA in modular biologics, customized diagnostics, and next-gen vaccine platforms. Its adaptability for producing complex sequences without relying on live organisms positions it as a preferred choice for rapid prototyping and advanced screening. The increasing role of synthetic DNA in CRISPR workflows, biosensor development, and engineered cell lines further supports its market dominance.
By grade, the GMP grade segment is expanding rapidly with the progression of DNA-based therapies into clinical development and commercial use. The requirement for strict compliance with regulatory standards is pushing manufacturers to invest in quality assurance systems, validated processes, and cleanroom infrastructure. As more therapies approach FDA approval, GMP-grade DNA is becoming essential for clinical trial supply chains, production, and biomanufacturing scale-up.
By application, cell and gene therapy led the market in 2024, capturing a 43.81% revenue share. This leadership stems from the surge in demand for DNA inputs in viral vector production, genetic payload design, and cell reprogramming protocols. As therapies targeting oncology, hematological disorders, and neurological diseases expand, the requirement for precise, high-quality DNA continues to drive segment growth. Investment in clinical-stage programs also contributes to the scaling of DNA production infrastructure.
By end use, pharmaceutical and biotechnology companies represented 49.08% of the market share in 2024. These companies increasingly rely on DNA manufacturing for pipeline development, vaccine innovation, and therapeutic engineering. With a focus on accelerating timelines from discovery to commercialization, the industry is turning to specialized DNA providers for customized, scalable, and regulatory-grade solutions.
In May 2025, VGXI, Inc., a contract development and manufacturing organization (CDMO) specializing in nucleic acid-based therapeutics, announced the successful completion of a U.S. Food and Drug Administration (FDA) inspection at its Conroe, Texas facility. This milestone enables VGXI's client to submit a Biologics License Application (BLA) for clinical trials involving plasmid DNA, a critical component in gene therapies and mRNA vaccines. VGXI's achievement underscores its leadership in plasmid DNA manufacturing, offering scalable and high-purity production capabilities. The company has been a trusted partner in advancing life-changing medical research and innovation worldwide.

Product Code: GVR-4-68040-630-1

Chapter 1. Methodology and Scope

1.1. Market Segmentation and Scope
1.2. Market Definitions
- 1.2.1. Type Segment
- 1.2.2. Grade Segment
- 1.2.3. Application Segment
- 1.2.4. End Use Segment
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
1.10. 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 Dynamics
- 3.2.1. Market driver analysis
- 3.2.2. Market restraint analysis
3.3. 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. U.S. DNA Manufacturing Market: Type Business Analysis

4.1. Type Segment Dashboard
4.2. U.S. DNA Manufacturing Market Type Movement Analysis
4.3. U.S. DNA Manufacturing Market Size & Trend Analysis, by Type, 2018 to 2030 (USD Million)
4.4. Plasmid DNA
- 4.4.1. U.S. Plasmid DNA-based Market, 2018 - 2030 (USD Million)
4.5. Synthetic DNA
- 4.5.1. U.S. Synthetic DNA Market, 2018 - 2030 (USD Million)
  - 4.5.1.1. Gene Synthesis
    - 4.5.1.1.1. U.S. Synthetic DNA Market, 2018 - 2030 (USD Million)
  - 4.5.1.2. Oligonucleotide Synthesis
    - 4.5.1.2.1. U.S. Synthetic DNA Market, 2018 - 2030 (USD Million)

Chapter 5. U.S. DNA Manufacturing Market: Grade Business Analysis

5.1. Grade Segment Dashboard
5.2. U.S. DNA Manufacturing Market Grade Movement Analysis
5.3. U.S. DNA Manufacturing Market Size & Trend Analysis, by Grade, 2018 to 2030 (USD Million)
5.4. GMP Grade
- 5.4.1. U.S. GMP Grade Market, 2018 - 2030 (USD Million)
5.5. R&D Grade
- 5.5.1. U.S. R&D Grade Market, 2018 - 2030 (USD Million)

Chapter 6. U.S. DNA Manufacturing Market: Application Business Analysis

6.1. Application Segment Dashboard
6.2. U.S. DNA Manufacturing Market Application Movement Analysis
6.3. U.S. DNA Manufacturing Market Size & Trend Analysis, by Application, 2018 to 2030 (USD Million)
6.4. Cell & Gene Therapy Market
- 6.4.1. U.S. Cell & Gene Therapy Market, 2018 - 2030 (USD Million)
6.5. Vaccines
- 6.5.1. U.S. Vaccines Market, 2018 - 2030 (USD Million)
6.6. Oligonucleotide-based drugs
- 6.6.1. U.S. Oligonucleotide-based drugs Market, 2018 - 2030 (USD Million)
6.7. Others
- 6.7.1. U.S. Others Market, 2018 - 2030 (USD Million)

Chapter 7. U.S. DNA Manufacturing Market: End Use Business Analysis

7.1. End Use Segment Dashboard
7.2. U.S. DNA Manufacturing Market End Use Movement Analysis
7.3. U.S. DNA Manufacturing Market Size & Trend Analysis, by End Use, 2018 to 2030 (USD Million)
7.4. Pharmaceutical and Biotechnology Companies
- 7.4.1. U.S. Pharmaceutical and Biotechnology Companies Devices Market, 2018 - 2030 (USD Million)
7.5. Academic & Research Institutes
- 7.5.1. U.S. Academic & Research Institutes Market, 2018 - 2030 (USD Million)
7.6. Contract Research Organizations
- 7.6.1. U.S. Contract Research Organizations Market, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

8.1. Company Categorization
8.2. Strategy Mapping
8.3. Company Market Position Analysis, 2024
8.4. Company Profiles/Listing
- 8.4.1. Charles River Laboratories
  - 8.4.1.1. Overview
  - 8.4.1.2. Financial Performance
  - 8.4.1.3. Service Benchmarking
  - 8.4.1.4. Strategic Initiatives
- 8.4.2. VGXI, Inc.
  - 8.4.2.1. Overview
  - 8.4.2.2. Financial Performance
  - 8.4.2.3. Service Benchmarking
  - 8.4.2.4. Strategic Initiatives
- 8.4.3. Danaher (Aldevron)
  - 8.4.3.1. Overview
  - 8.4.3.2. Financial Performance
  - 8.4.3.3. Service Benchmarking
  - 8.4.3.4. Strategic Initiatives
- 8.4.4. . Thermo Fisher Scientific
  - 8.4.4.1. Overview
  - 8.4.4.2. Financial Performance
  - 8.4.4.3. Service Benchmarking
  - 8.4.4.4. Strategic Initiatives
- 8.4.5. Lonza
  - 8.4.5.1. Overview
  - 8.4.5.2. Financial Performance
  - 8.4.5.3. Service Benchmarking
  - 8.4.5.4. Strategic Initiatives
- 8.4.6. GenScript
  - 8.4.6.1. Overview
  - 8.4.6.2. Financial Performance
  - 8.4.6.3. Type Benchmarking
  - 8.4.6.4. Strategic Initiatives
- 8.4.7. Twist Bioscience
  - 8.4.7.1. Overview
  - 8.4.7.2. Financial Performance
  - 8.4.7.3. Service Benchmarking
  - 8.4.7.4. Strategic Initiatives
- 8.4.8. AGC Biologics
  - 8.4.8.1. Overview
  - 8.4.8.2. Financial Performance
  - 8.4.8.3. Service Benchmarking
  - 8.4.8.4. Strategic Initiatives
- 8.4.9. Catalent
  - 8.4.9.1. Overview
  - 8.4.9.2. Financial Performance
  - 8.4.9.3. Service Benchmarking
  - 8.4.9.4. Strategic Initiatives
- 8.4.10. Eurofins Genomics
  - 8.4.10.1. Overview
  - 8.4.10.2. Financial Performance
  - 8.4.10.3. Service Benchmarking
  - 8.4.10.4. Strategic Initiatives

Product Code: GVR-4-68040-630-1

List of Tables

Table 1 List Of Secondary Sources
Table 2 List Of Abbreviations
Table 3 U.S. DNA manufacturing market estimates & forecasts, by type, 2018 - 2030 (USD Million)
Table 4 U.S. DNA manufacturing market estimates & forecasts, by grade, 2018 - 2030 (USD Million)
Table 5 U.S. DNA manufacturing market estimates & forecasts, by application type, 2018 - 2030 (USD Million)
Table 6 U.S. DNA manufacturing market estimates & forecasts, by end use, 2018 - 2030 (USD Million)

List of Figures

Fig. 1 Market snapshot
Fig. 2 Market research process
Fig. 3 Information procurement
Fig. 4 Primary research pattern
Fig. 5 Market research approaches
Fig. 6 Market trends & outlook
Fig. 7 Market segmentation & scope
Fig. 8 Market driver relevance analysis (Current & future impact)
Fig. 9 Market restraint relevance analysis (Current & future impact)
Fig. 10 PESTLE Analysis
Fig. 11 Porter's Five Forces Analysis
Fig. 12 U.S. DNA Manufacturing market: Type outlook key takeaways
Fig. 13 U.S. DNA Manufacturing market: Type movement analysis
Fig. 14 Plasmid DNA market, 2018 - 2030 (USD million)
Fig. 15 Synthetic DNA market, 2018 - 2030 (USD million)
Fig. 16 U.S. DNA Manufacturing market: Grade outlook key takeaways
Fig. 17 U.S. DNA Manufacturing market: Grade movement analysis
Fig. 18 GMP Grade market, 2018 - 2030 (USD million)
Fig. 19 R&D Grade market, 2018 - 2030 (USD million)
Fig. 20 U.S. DNA Manufacturing market: Application outlook key takeaways
Fig. 21 U.S. DNA Manufacturing market: Application movement analysis
Fig. 22 Cell & Gene Therapy market, 2018 - 2030 (USD million)
Fig. 23 Vaccines market, 2018 - 2030 (USD million)
Fig. 24 Oligonucleotide-based drugs market, 2018 - 2030 (USD million)
Fig. 25 Others market, 2018 - 2030 (USD million)
Fig. 26 U.S. DNA Manufacturing market: End Use outlook key takeaways
Fig. 27 U.S. DNA Manufacturing market: End Use movement analysis
Fig. 28 Pharmaceutical and Biotechnology Companies market, 2018 - 2030 (USD Million)
Fig. 29 Contract Research Organizations market, 2018 - 2030 (USD Million)
Fig. 30 Academic & Research Institutes market, 2018 - 2030 (USD Million)
Fig. 31 Key companies profiled

U.S. DNA Manufacturing Market Size, Share & Trends Analysis Report By Type (Plasmid DNA, Synthetic DNA), By Grade (GMP & R&D), By Application (Cell & Gene Therapy, Vaccines, Oligonucleotide-based Drugs), By End-use, And Segment Forecasts, 2025 - 2030

Description

Table of Contents

List of Tables

U.S. DNA Manufacturing Market Growth & Trends:

U.S. DNA Manufacturing Market Report Highlights:

Table of Contents

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

Chapter 3. Market Variables, Trends, & Scope

Chapter 4. U.S. DNA Manufacturing Market: Type Business Analysis

Chapter 5. U.S. DNA Manufacturing Market: Grade Business Analysis

Chapter 6. U.S. DNA Manufacturing Market: Application Business Analysis

Chapter 7. U.S. DNA Manufacturing Market: End Use Business Analysis

Chapter 8. Competitive Landscape

List of Tables

List of Figures