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2047071

病毒載體和質體DNA生產市場－全球產業規模、佔有率、趨勢、機會和預測：按產品類型、應用、地區和競爭格局分類，2021-2031年

Viral Vector and Plasmid DNA Manufacturing Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Product Type, By Application, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 189 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球病毒載體和質體DNA生產市場預計將從2025年的71.7億美元成長到2031年的134.3億美元，複合年成長率達到11.03%。

該領域專注於生產基因治療和疫苗所需的生物載體和基因模板。其成長主要受慢性病和遺傳疾病日益普遍的推動，這催生了對先進治療方案的需求，以及許多候選療法正處於臨床開發階段。根據美國基因與細胞治療學會 (ASGCT) 預測，到 2025 年，全球將進行超過 3200 項基因治療、細胞治療和 RNA 治療的臨床試驗。然而，市場成長的主要障礙在於將生產規模擴大到商業化程度的技術挑戰。製造商在從實驗室實驗過渡到大規模生產的過程中，難以維持穩定的品質和高產量。這套頸部導致供不應求和成本高昂，阻礙了療法的廣泛應用和整體市場擴張。

市場概覽
預測期 2027-2031
市場規模：2025年 71.7億美元
市場規模：2031年 134.3億美元
複合年成長率：2026-2031年 11.03%
成長最快的細分市場 癌症
最大的市場 北美洲

市場促進因素

全球病毒載體和質體DNA生產市場的主要驅動力是基因和細胞療法臨床研發管線的快速擴張。隨著候選療法從臨床試驗走向商業化，對高品質、符合GMP標準的病毒載體的需求日益成長。大量投資進一步推動了這項需求，再生醫學聯盟預測，到2025年，該領域的投資將達到152億美元，年增30%。資金支持也促進了監管方面的進展，國際細胞和基因治療協會（ISCG）報告稱，上年度美國核准了七種新的細胞和基因治療產品。這立即催生了對可擴展載體生產的即時商業性需求。另一個同樣重要的促進因素是企業對合約研發生產力機構（CDMO）的依賴性日益增強。許多生物製藥公司，尤其是中小企業，由於缺乏專業的基礎設施和技術，選擇將複雜病毒載體的生產外包。這種策略有助於降低技術風險，並加快產品進入市場的速度。牛津生物醫藥公司的銷售額便是這一趨勢的典型例證，其銷售額成長了44%，達到1.288億英鎊，主要得益於市場對慢病毒載體生產服務的強勁需求。這凸顯了合約研發生產機構（CDMO）在臨床創新商業化過程中所扮演的關鍵角色。

市場挑戰

全球病毒載體和質體DNA生產市場面臨的最大障礙是規模化生產至商業化規模所涉及的技術複雜性。與傳統藥物不同，病毒載體和質體DNA的生產依賴複雜的生物過程，這些過程極易受到環境細微變化的影響。因此，製造商在嘗試從實驗室規模化生產過渡到大規模生產時，常常面臨產量和一致性的大幅下降。這項關鍵的生產瓶頸限制了關鍵遺傳物質的供應，並使許多研發者的生產成本居高不下。這種生產限制直接削弱了許多潛在治療方法的商業性可行性，導致市場往往集中在少數幾種成功的治療方法，而非多種可用的藥物。根據再生醫學聯盟（Alliance for Regenerative Medicine）2025年的數據，全球近75%的先進治療方法收入將來自不到10種已商業化的產品。這清楚地表明，規模化障礙如何阻礙了該領域充分利用其豐富的候選療法。

市場趨勢

為了解決持續存在的規模化和品管問題，市場正透過整合自動化和封閉式系統製造技術進行根本性變革。這包括從人工開放式操作轉向全封閉式機器人平台，從而顯著降低污染風險並提高批次間一致性。這項技術進步得到了數位化和機器人設施的大量投資支持，這些設施旨在實現複雜病毒載體製程的工業化。例如，諾華公司在斯洛維尼亞投資 4000 萬歐元建設的全自動生產設施 VIFA One 於 2025 年 2 月投入運作，並在整個生產過程中採用了先進的機器人技術。同時，一個關鍵趨勢是向酵素法和合成 DNA 生產方式的轉變。這意味著從基於細胞的質體發酵轉向更清潔的無細胞合成方法。這種方法可以減少傳統細菌培養中固有的生物變異性和較長的前置作業時間，並為生產高純度遺傳原料提供高效途徑。這些合成模板的日益普及也體現在專業技術供應商的強勁表現上。根據 4basebio 於 2025 年 9 月發布的半年報，該公司 2025 年上半年的合成 DNA 解決方案銷售額達到 120 萬英鎊，比上年度的全年銷售額成長了 25%。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：病毒載體與質體DNA生產的全球市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 依產品類型（質體DNA、病毒載體、非病毒載體）
    • 依應用領域（癌症、遺傳性疾病、感染疾病等）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美病毒載體與質體DNA生產市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲病毒載體與質體DNA生產市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區病毒載體與質體DNA生產市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲病毒載體和質體DNA生產市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美洲病毒載體與質體DNA生產市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章：全球病毒載體與質體DNA生產市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • Oxford Biomedica PLC
  • Cognate BioServices Inc.
  • Cell and Gene Therapy Catapult Ltd.
  • FinVector Vision Therapies
  • Fujifilm Holdings Corporation
  • SIRION Biotech GmbH
  • Merck KGaA
  • Thermo Fisher Scientific Inc.
  • Uniqure NV
  • Catalent Inc.

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 16520

The Global Viral Vector and Plasmid DNA Manufacturing Market is projected to expand from USD 7.17 Billion in 2025 to USD 13.43 Billion by 2031, achieving an 11.03% CAGR. This sector specializes in producing biological vehicles and genetic templates essential for gene therapies and vaccines. Its growth is primarily driven by the rising incidence of chronic and genetic disorders, creating demand for advanced therapeutic solutions, and a significant pipeline of therapeutic candidates in clinical development, with over 3,200 gene, cell, and RNA therapy trials active globally in 2025, as per the American Society of Gene & Cell Therapy. However, a key obstacle to market growth is the technical challenge of scaling production to commercial volumes, where manufacturers face difficulties maintaining consistent quality and high yields when moving from lab to mass production. This bottleneck leads to supply shortages and elevated costs, hindering treatment availability and overall market expansion.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 7.17 Billion
Market Size 2031USD 13.43 Billion
CAGR 2026-203111.03%
Fastest Growing SegmentCancer
Largest MarketNorth America

Market Driver

The Global Viral Vector and Plasmid DNA Manufacturing Market is primarily driven by the rapid expansion of gene and cell therapy clinical pipelines. As therapeutic candidates advance through trials toward commercialization, the need for high-quality, GMP-grade viral vectors escalates. This demand is bolstered by significant capital infusions, with sector investments reaching $15.2 billion in 2025-a 30% year-over-year increase-according to the Alliance for Regenerative Medicine. Such financial support has contributed to regulatory triumphs, including seven new cell and gene therapy product approvals in the U.S. during the preceding year, as reported by the International Society for Cell & Gene Therapy, thereby generating immediate commercial need for scalable vector production. A secondary, yet crucial, driver is the growing dependence on Contract Development and Manufacturing Organizations (CDMOs). Many biopharmaceutical firms, especially smaller and mid-sized ones, outsource complex viral vector production due to a lack of specialized infrastructure and expertise. This strategy helps them mitigate technical risks and accelerate market entry, a trend exemplified by Oxford Biomedica's 44% revenue increase to £128.8 million, largely propelled by strong demand for lentiviral vector manufacturing services, highlighting CDMOs' essential role in commercializing clinical innovations.

Market Challenge

The foremost challenge impeding the Global Viral Vector and Plasmid DNA Manufacturing Market is the technical complexity involved in scaling production to commercial levels. Unlike conventional pharmaceuticals, viral vectors and plasmid DNA production relies on intricate biological processes susceptible to slight environmental changes. Consequently, manufacturers often face substantial reductions in yield and consistency when attempting to transition from laboratory efficacy to mass production. This critical manufacturing bottleneck limits the supply of vital genetic material and keeps production costs excessively high for many developers. Such production constraints directly undermine the commercial viability of numerous potential therapies, leading to a market heavily concentrated on a few successful treatments rather than a wide array of accessible medicines. Data from the Alliance for Regenerative Medicine in 2025 revealed that nearly 75 percent of global advanced therapy revenue came from fewer than ten commercialized products, clearly demonstrating how scalability hurdles prevent the sector from fully leveraging its extensive pipeline of therapeutic candidates.

Market Trends

To address persistent scalability and quality control issues, the market is undergoing fundamental shifts through the integration of automated and closed-system manufacturing. This involves moving from manual, open operations to fully enclosed, robotic platforms, which substantially lowers contamination risks and enhances batch-to-batch consistency. This technological advancement is supported by significant investments in digitized and robotic facilities designed to industrialize complex viral vector processes, such as Novartis's EUR 40 million fully automated VIFA One production facility in Slovenia, launched in February 2025, utilizing advanced robotics across all stages. Concurrently, a crucial trend is the shift toward enzymatic and synthetic DNA production, moving away from cell-based plasmid fermentation to cleaner, cell-free synthesis methods. This approach mitigates biological variability and long lead times inherent in traditional bacterial cultures, providing a streamlined pathway for producing high-purity genetic starting materials. The growing adoption of these synthetic templates is reflected in the strong financial performance of specialized technology providers, with 4basebio reporting £1.2 million in revenue for its synthetic DNA solutions in the first half of 2025, surpassing its previous full year's total by 25%, as per its September 2025 half-year report.

Key Market Players

  • Oxford Biomedica PLC
  • Cognate BioServices Inc.
  • Cell and Gene Therapy Catapult Ltd.
  • FinVector Vision Therapies
  • Fujifilm Holdings Corporation
  • SIRION Biotech GmbH
  • Merck KGaA
  • Thermo Fisher Scientific Inc.
  • Uniqure NV
  • Catalent Inc.

Report Scope

In this report, the Global Viral Vector and Plasmid DNA Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Viral Vector and Plasmid DNA Manufacturing Market, By Product Type

  • Plasmid DNA
  • Viral Vector
  • Non-viral Vector

Viral Vector and Plasmid DNA Manufacturing Market, By Application

  • Cancer
  • Genetic Disorder
  • Infectious Disease
  • Others

Viral Vector and Plasmid DNA Manufacturing Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Viral Vector and Plasmid DNA Manufacturing Market.

Available Customizations:

Global Viral Vector and Plasmid DNA Manufacturing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Viral Vector and Plasmid DNA Manufacturing Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Product Type (Plasmid DNA, Viral Vector, Non-viral Vector)
    • 5.2.2. By Application (Cancer, Genetic Disorder, Infectious Disease, Others)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America Viral Vector and Plasmid DNA Manufacturing Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Product Type
    • 6.2.2. By Application
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Product Type
        • 6.3.1.2.2. By Application
    • 6.3.2. Canada Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Product Type
        • 6.3.2.2.2. By Application
    • 6.3.3. Mexico Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Product Type
        • 6.3.3.2.2. By Application

7. Europe Viral Vector and Plasmid DNA Manufacturing Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Product Type
    • 7.2.2. By Application
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Product Type
        • 7.3.1.2.2. By Application
    • 7.3.2. France Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Product Type
        • 7.3.2.2.2. By Application
    • 7.3.3. United Kingdom Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Product Type
        • 7.3.3.2.2. By Application
    • 7.3.4. Italy Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Product Type
        • 7.3.4.2.2. By Application
    • 7.3.5. Spain Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Product Type
        • 7.3.5.2.2. By Application

8. Asia Pacific Viral Vector and Plasmid DNA Manufacturing Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Product Type
    • 8.2.2. By Application
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Product Type
        • 8.3.1.2.2. By Application
    • 8.3.2. India Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Product Type
        • 8.3.2.2.2. By Application
    • 8.3.3. Japan Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Product Type
        • 8.3.3.2.2. By Application
    • 8.3.4. South Korea Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Product Type
        • 8.3.4.2.2. By Application
    • 8.3.5. Australia Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Product Type
        • 8.3.5.2.2. By Application

9. Middle East & Africa Viral Vector and Plasmid DNA Manufacturing Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Product Type
    • 9.2.2. By Application
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Product Type
        • 9.3.1.2.2. By Application
    • 9.3.2. UAE Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Product Type
        • 9.3.2.2.2. By Application
    • 9.3.3. South Africa Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Product Type
        • 9.3.3.2.2. By Application

10. South America Viral Vector and Plasmid DNA Manufacturing Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Product Type
    • 10.2.2. By Application
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Product Type
        • 10.3.1.2.2. By Application
    • 10.3.2. Colombia Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Product Type
        • 10.3.2.2.2. By Application
    • 10.3.3. Argentina Viral Vector and Plasmid DNA Manufacturing Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Product Type
        • 10.3.3.2.2. By Application

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Viral Vector and Plasmid DNA Manufacturing Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Oxford Biomedica PLC
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Cognate BioServices Inc.
  • 15.3. Cell and Gene Therapy Catapult Ltd.
  • 15.4. FinVector Vision Therapies
  • 15.5. Fujifilm Holdings Corporation
  • 15.6. SIRION Biotech GmbH
  • 15.7. Merck KGaA
  • 15.8. Thermo Fisher Scientific Inc.
  • 15.9. Uniqure NV
  • 15.10. Catalent Inc.

16. Strategic Recommendations

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