美国DNA 製造市场规模、份额和趋势分析报告：按类型、等级、应用、最终用途和细分市场预测，2025 年至 2030 年

美国DNA 製造市场的成长与趋势：

根据Grand View Research, Inc.的最新报告，预计到2030年，美国DNA製造市场规模将达到61.6亿美元，预测期内的复合年增长率为18.27%。受个人化医疗、合成生物学和生物製药产业扩张的推动，美国DNA製造业正经历强劲成长。作为全球最大的生物技术创新中心，美国在DNA合成、基因编辑和治疗开发等先进技术的采用方面处于领先地位。

酶促DNA合成、自动化寡核苷酸生产和连续製造系统等技术创新正在改变生产流程，使其更有效率、更具可扩展性。美国公司也大力投资无细胞DNA合成平台，以减少对传统微生物系统的依赖，并缩短开发时间。

生物技术公司、学术机构以及受託製造厂商(CDMO) 之间的策略伙伴关係正在加速美国DNA 製造业的创新，并缩短产品上市时间。随着基因和细胞治疗、肿瘤诊断、感染疾病研究和疫苗开发等关键应用的扩展，对可扩展、高品质 DNA 解决方案的需求持续增长。因此，美国市场有望在精准医疗、下一代生物疗法和尖端诊断技术的发展中发挥重要作用。

美国DNA 製造市场报告重点

• 按类型划分，合成DNA在2024年占据了美国DNA製造业的主导地位，占收益占有率的61.89%。此细分市场的成长得益于合成DNA在模组化生技药品、客製化诊断和下一代疫苗平台中日益增长的应用。合成DNA适用于快速原型製作和进阶筛检，因为它可以在不依赖生物体的情况下创建复杂的序列。合成DNA在CRISPR工作流程、生物感测器开发和人工细胞系中日益重要的角色进一步巩固了其在市场上的主导地位。
• 从层级来看，随着DNA治疗方法临床开发和商业应用的推进，GMP级DNA市场正在迅速扩张。严格遵守监管标准正促使製造商投资于品质保证系统、检验的製程和无尘室基础设施。随着越来越多的治疗方法即将获得FDA核准，GMP级DNA对于临床试验供应链、生产和生物製造规模化至关重要。
• 从应用角度来看，细胞和基因治疗在2024年占据市场主导地位，占43.81%的收入份额。这一领先地位归因于病毒载体生产、基因有效载荷设计和细胞重编程通讯协定中对DNA输入需求的激增。随着针对癌症、血液疾病和神经系统疾病的疗法不断扩展，对精准、高品质DNA的需求持续推动该领域的成长。临床阶段计画的投资也促进了DNA生产基础设施的扩张。
• 根据最终用途，製药和生物技术公司将在2024年占据49.08%的市场占有率。这些公司越来越依赖DNA製造来进行产品线开发、疫苗创新和治疗工程。为了缩短从发现到商业化的时间，该行业正在转向专业的DNA供应商，以获得客製化、可扩展且符合监管级别的解决方案。
• 2025年5月，专注于核酸疗法的受託製造厂商(CDMO) VGXI 宣布其位于德克萨斯州康罗的工厂已顺利通过美国食品药物管理局(FDA) 的检查。这一里程碑使 VGXI 的客户能够提交涉及质体DNA（基因疗法和 mRNA 疫苗的关键成分）临床试验的生技药品核准申请 (BLA)。 VGXI 的成就彰显了其在质体DNA 生产领域的领先地位，提供可扩展的高纯度生产能力。 VGXI 是值得信赖的合作伙伴，致力于在全球范围内推动改变生命的医学研究和创新。

目录

第一章调查方法与范围

第二章执行摘要

第三章市场变数、趋势和范围

• 市场展望
  • 母市场展望
  • 相关/附随市场展望
• 市场动态
  • 市场驱动因素分析
  • 市场限制因素分析
• DNA製造市场分析工具
  • 产业分析-波特五力分析
  • PESTEL分析
  • COVID-19影响分析

第四章美国DNA 製造市场：类型业务分析

• 类型细分仪表板
• 美国DNA 製造市场类型趋势分析
• 美国DNA 製造市场规模及趋势分析（按类型）（2018-2030 年）
• 质体DNA
• 合成DNA

第五章美国DNA 製造市场：等级业务分析

• 等级细分仪表板
• 美国DNA製造市场等级波动分析
• 美国DNA 製造市场规模与趋势分析（按等级，2018-2030 年）
• GMP级
• 研发级

第六章美国DNA製造市场：应用业务分析

• 应用程式细分仪表板
• 美国DNA製造市场应用趋势分析
• 美国DNA 製造市场规模和趋势分析（按应用，2018-2030 年）
• 细胞和基因治疗市场
• 疫苗
• 寡核苷酸药物
• 其他的

第七章美国DNA 製造市场：最终用途业务分析

• 最终用途细分仪表板
• 美国DNA製造市场最终用途趋势分析
• 美国DNA 製造市场规模及趋势分析（依最终用途），2018 年至 2030 年
• 製药和生物技术公司
• 学术研究所
• 合约研究组织

第八章 竞争态势

• 公司分类
• 战略地图
• 2024年企业市场分析
• 公司简介/上市公司
  • Charles River Laboratories
  • VGXI, Inc.
  • Danaher（Aldevron）
  • . Thermo Fisher Scientific
  • Lonza
  • GenScript
  • Twist Bioscience
  • AGC Biologics
  • Catalent
  • Eurofins Genomics

U.S. DNA Manufacturing Market Growth & Trends:

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.

Table of Contents

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

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