米国のプラスミドDNA製造市場規模、シェア、動向分析レポート：疾患別、グレード別、用途別、開発段階別、セグメント別予測、2025～2033年

米国のプラスミドDNA製造市場サマリー

米国のプラスミドDNA製造市場規模は、2024年に8億300万米ドルと推計され、2033年には50億3,800万米ドルに達すると予測され、2025年から2033年までのCAGRは23.06%で成長します。この拡大の背景には、遺伝子治療、DNAワクチン、その他高品質プラスミドDNAを基礎成分とする先端生物製剤に対する需要の増加があります。

バイオテクノロジー研究への継続的な投資と支持的な規制の枠組みが、予測期間中に市場開拓をさらに推進すると予想されます。

遺伝子疾患とがんの有病率の上昇

遺伝性疾患とがんの有病率の上昇は、米国のプラスミドDNA製造業界の成長を促進する主な要因です。遺伝子研究の進歩により、様々な疾患における遺伝子変異や異常の役割が浮き彫りになり、これらの疾患を根本から治療することを目的とした遺伝子治療の開発が増加しています。同様に、がん治療も個別化治療や標的治療への移行が進んでおり、その多くは治療遺伝子や免疫調整剤を送達するベクターとしてプラスミドDNAに依存しています。診断技術が向上し、人口が高齢化するにつれて、これらの革新的な治療法の候補として特定される患者が増え、プラスミドDNAの需要が拡大しています。

さらに、遺伝子治療やがん治療の複雑で個別化された性質は、高度に専門化され、拡張可能なプラスミドDNA製造プロセスを必要とします。バイオテクノロジー企業や研究機関は、臨床および商業用途の厳格な品質基準と量的要求を満たす柔軟な生産プラットフォームの開発に多額の投資を行っています。精密医療とオーダーメイド治療への注目の高まりは、プラスミドDNAが進化する先端治療において重要な役割を果たし、市場の持続的な拡大を後押ししています。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 市場の変数、動向、範囲

• 市場系統の見通し
  • 親市場の見通し
  • 関連/補助市場展望
• 市場動向と展望
• 市場力学
  • 遺伝子治療を選択する患者数の増加
  • 遺伝子治療のための強力なパイプライン
  • 競争の激しい市場と市場参入企業による多様な戦略
  • さまざまな医療治療におけるプラスミドDNAの需要増加
• 市場抑制要因分析
  • 遺伝子治療に関連する規制、科学、倫理上の課題
• ビジネス環境分析
  • PESTEL分析
  • ポーターのファイブフォース分析

第4章 グレードのビジネス分析

• セグメントダッシュボード
• 米国のプラスミドDNA製造市場変動分析
• 米国のプラスミドDNA製造市場規模と動向分析（グレード別、2021～2033年）
• R&Dグレード
  • R&Dグレード市場、2021年～2033年
  • ウイルスベクター開発
  • mRNAの開発
  • 抗体開発
  • DNAワクチン開発
  • その他
• GMPグレード
  • GMPグレード市場、2021年～2033年

第5章 開発フェーズのビジネス分析

• セグメントダッシュボード
• 米国のプラスミドDNA製造市場変動分析
• 米国のプラスミドDNA製造市場規模と動向分析（開発フェーズ別、2021～2033年）
• 前臨床治療
• 臨床治療学
• 市販治療薬

第6章 用途ビジネス分析

• セグメントダッシュボード
• 米国のプラスミドDNA製造市場変動分析
• 米国のプラスミドDNA製造市場規模と動向分析（用途別、2021～2033年）
• DNAワクチン
• 細胞・遺伝子治療
• 免疫療法
• その他

第7章 疾患ビジネス分析

• セグメントダッシュボード
• 米国のプラスミドDNA製造市場変動分析
• 米国のプラスミドDNA製造市場規模と動向分析（疾患別、2021～2033年）
• 感染症
• がん
• 遺伝性疾患
• その他

第8章 競合情勢

• 参入企業
• 企業市況分析、2024年
• 参入企業の概要
  • Charles River Laboratories
  • Danaher（Aldevron）
  • VGXI, Inc.
  • Kaneka Corp.
  • Lonza
  • Nature Technology
  • Cell and Gene Therapy Catapult
  • Eurofins Genomics
  • Luminous BioSciences, LLC
  • Akron Biotech

List of Tables

• Table 1 List Of Secondary Sources
• Table 2 List Of Abbreviations
• Table 3 U.S. Plasmid DNA Manufacturing Market by Grade, 2021 - 2033 (USD Million)
• Table 4 U.S. Plasmid DNA Manufacturing Market by Development Phase, 2021 - 2033 (USD Million)
• Table 5 U.S. Plasmid DNA Manufacturing Market by Application, 2021 - 2033 (USD Million)
• Table 6 U.S. Plasmid DNA Manufacturing Market by Disease, 2021 - 2033 (USD Million)
• Table 7 Participant's Overview

List of Figures

• Fig. 1 U.S. plasmid DNA manufacturing market segmentation
• Fig. 2 Market research process
• Fig. 3 Data triangulation techniques
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Market formulation & validation
• Fig. 7 Market outlook
• Fig. 8 Segment snapshot
• Fig. 9 Competitive landscape snapshot
• Fig. 10 Parent market outlook
• Fig. 11 U.S. plasmid DNA manufacturing market driver analysis
• Fig. 12 U.S. plasmid DNA manufacturing market restraint analysis
• Fig. 13 U.S. plasmid DNA manufacturing market: Porter's analysis
• Fig. 14 U.S. plasmid DNA manufacturing market: PESTEL analysis
• Fig. 15 U.S. plasmid DNA manufacturing market: Grade outlook and key takeaways
• Fig. 16 U.S. plasmid DNA manufacturing market: Grade movement analysis
• Fig. 17 U.S. R&D grade market, 2021 - 2033 (USD Million)
• Fig. 18 U.S. viral vector development market, 2021 - 2033 (USD Million)
• Fig. 19 U.S. mRNA development market, 2021 - 2033 (USD Million)
• Fig. 20 U.S. antibody development market, 2021 - 2033 (USD Million)
• Fig. 21 U.S. DNA vaccine development market, 2021 - 2033 (USD Million)
• Fig. 22 U.S. others market, 2021 - 2033 (USD Million)
• Fig. 23 U.S. AAV market, 2021 - 2033 (USD Million)
• Fig. 24 U.S. lentivirus market, 2021 - 2033 (USD Million)
• Fig. 25 U.S. adenovirus market, 2021 - 2033 (USD Million)
• Fig. 26 U.S. retrovirus market, 2021 - 2033 (USD Million)
• Fig. 27 U.S. GMP grade market, 2021 - 2033 (USD Million)
• Fig. 28 U.S. others market, 2021 - 2033 (USD Million)
• Fig. 29 U.S. plasmid DNA manufacturing market: Development phase outlook and key takeaways
• Fig. 30 U.S. plasmid DNA manufacturing market: Development phase movement analysis
• Fig. 31 U.S. pre-clinical therapeutics market, 2021 - 2033 (USD Million)
• Fig. 32 U.S. clinical therapeutics market, 2021 - 2033 (USD Million)
• Fig. 33 U.S. marketed therapeutics market, 2021 - 2033 (USD Million)
• Fig. 34 U.S. plasmid DNA manufacturing market: Application outlook and key takeaways
• Fig. 35 U.S. plasmid DNA manufacturing market: Application movement analysis
• Fig. 36 U.S. DNA vaccines market, 2021 - 2033 (USD Million)
• Fig. 37 U.S. cell & gene therapy market, 2021 - 2033 (USD Million)
• Fig. 38 U.S. immunotherapy market, 2021 - 2033 (USD Million)
• Fig. 39 U.S. others market, 2021 - 2033 (USD Million)
• Fig. 40 U.S. plasmid DNA manufacturing market: Disease outlook and key takeaways
• Fig. 41 U.S. plasmid DNA manufacturing market: Disease movement analysis
• Fig. 42 U.S. infectious disease market, 2021 - 2033 (USD Million)
• Fig. 43 U.S. cancer market, 2021 - 2033 (USD Million)
• Fig. 44 U.S. genetic disorder market, 2021 - 2033 (USD Million)
• Fig. 45 U.S. others market, 2021 - 2033 (USD Million)

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
  • Viral Vector Development
  • AAV
  • Lentivirus
  • Adenovirus
  • Retrovirus
  • Others
  • mRNA Development
  • Antibody Development
  • DNA Vaccine Development
  • 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

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