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市场调查报告书
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1634636

质粒 DNA 製造市场：现况分析与未来预测（2024-2032）

Plasmid DNA Manufacturing Market: Current Analysis and Forecast (2024-2032)
出版日期: | 出版商: UnivDatos Market Insights Pvt Ltd | 英文 140 Pages | 商品交期: 最快1-2个工作天内

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简介目录

预测期内（2024-2032 年），质粒 DNA 製造市场预计将以 20.11% 的显着复合年增长率成长。这主要是由于製药公司正在进行的研究和开发以及增加的併购活动，以提高其能力并增加对新进展和新技术的瞭解，从而可以加强基于质粒 DNA 的治疗方法的开发，以治疗癌症和爱滋病毒等罕见遗传疾病。此外，监管机构的支持不断增加，进一步推动了质粒 DNA 製造市场的显着成长。

根据质粒等级，全球质粒 DNA 製造市场分为研究级、高品质和良好生产规范 (GMP) 质粒 DNA。其中，GMP 级部分可能是最大的部分，因为它可用于基因治疗和疫苗等临床用途。GMP产品品质要求高，对于满足临床研究和商业分销的监管要求至关重要。此外，由于对高效治疗的需求不断增加，预计未来 GMP 级质粒将显着增长。然而，高品质质粒DNA仍具有强劲的成长潜力，尤其是在I期和II期临床试验以及临床前研究中。此部分最适合于需要比研究级产品纯度高得多但仍不需要完全符合 GMP 的应用。向病毒载体和 mRNA 疗法开发的转变可能会在未来增加对高品质质粒的需求。

根据应用，全球质粒 DNA 製造市场分为基因治疗、DNA 疫苗、免疫疗法等。其中，基因治疗领域将最为突出，因为该技术在治疗遗传疾病和癌症方面具有重要的应用。正在进行的临床试验和基因疗法的批准，特别是基于质粒载体的疗法，凸显了这种技术趋势。另一类疫苗是DNA疫苗，预计该类疫苗将大幅成长，尤其是在COVID-19大流行期间实施基于DNA的技术之后。这项成功激发了人们对开髮用于预防各种传染病和癌症的DNA疫苗的热情。DNA 疫苗的主要优势之一已被证明是其能够激发强大的免疫反应。儘管免疫疗法正在兴起，特别是在癌症领域，但其增长可能比基因疗法和DNA疫苗慢。

从质粒DNA在疾病领域的应用来看，可分为三个部分：癌症、传染病和其他疾病。其中，肿瘤学领域占据市场领先地位，这主要是因为人们对开发治疗各种癌症的新有效疗法的兴趣日益浓厚。个人化医疗，特别是利用质粒DNA增强对肿瘤相关抗原的免疫反应的免疫疗法，是最有前景的创新之一，引起了人们的浓厚兴趣和投资。同时，传染病领域也有望进一步成长，尤其是目前正在研究的DNA疫苗的进展。最近在 COVID-19 大流行期间使用 DNA 疫苗平台重新引起了人们对使用 DNA 疫苗控制和预防新出现的传染病的兴趣，此外，DNA 疫苗还可用于治疗爱滋病毒和肝炎等慢性病毒性疾病。其他应用领域，如遗传疾病和兽医应用，预计也会成长，儘管成长速度低于癌症和传染病。

为了更瞭解质粒 DNA 製造市场的渗透率，我们根据北美（美国、加拿大和北美其他地区）、欧洲（德国、法国、英国、西班牙、义大利和欧洲其他地区）、亚太地区（中国、日本、印度和亚太其他地区）和世界其他地区的全球存在对市场进行了分析。由于癌症和传染病发病率不断上升，预计预测期内（2024-2032 年）亚太地区将以显着的复合年增长率增长。质粒DNA製造市场专注于扩大合作研究活动，以改善产品开发，带来新的治疗药物。

例如，2024年6月，Genexine宣布其子公司VGXI与NASDAQ上市的Sutro Biopharma, Inc.建立战略合作伙伴关係，VGXI是基因治疗、DNA疫苗和RNA药物等核酸生物製药领域领先的合约开发和製造组织（CDMO）。该公司已与 Satro BioPharma 达成战略合作伙伴关係，生产质粒 DNA，用于 Satro BioPharma 正在开发的抗体-药物偶联物 (ADC) 抗癌药物 luvertamab-tazebibulin（缩写为 Luverta）的临床试验。

市场上一些主要的参与者包括 Charles River Laboratories International, Inc.、VGXI, Inc. (GeneOne Life Science)、Catalent Inc. (Novo Holdings)、Akron Biotech.、PlasmidFactory GmbH、DH Life Sciences, LLC、Thermo Fisher Scientific Inc.、Lonza、Merck KGaA 和 GenScript Biotech Corporation。

目录

第1章 市场概况

  • 市场定义
  • 主要用途
  • 利益相关者
  • 限制

第 2 章 分析方法或假设

  • 分析过程
  • 分析方法
  • 受访者简介

第3章 执行摘要

  • 业界总结
  • 各细分领域的展望
    • 市场成长的力量
  • 区域展望

第4章 市场动态

  • 促进因素
  • 机会
  • 阻碍因素
  • 趋势
  • PESTEL 分析
  • 需求面分析
  • 供给侧分析
    • 企业併购（M&A）
    • 投资场景

第5章 全球质粒 DNA 製造市场收入（2022-2032 年）

第6章 质粒等级市场分析

  • 研究级（RG）质粒DNA
  • 高品质（HQ）质粒DNA
  • 良好生产规范 (GMP) 质粒 DNA

第7章 市场分析：依应用分类

  • 基因治疗
  • 脱氧核糖核酸疫苗
  • 免疫疗法
  • 其他

第 8 章 疾病类型市场分析

  • 癌症
  • 感染
  • 其他

第9章 市场分析：按地区

  • 北美
    • 美国
    • 加拿大
    • 其他北美
  • 欧洲
    • 德国
    • 英国
    • 法国
    • 义大利
    • 西班牙
    • 欧洲其他地区
  • 亚太地区
    • 中国
    • 日本
    • 印度
    • 亚太其他地区
  • 世界其他地区

第 10 章 价值链分析

  • 边际分析
  • 进入市场的企业名单

第11章 竞争格局

  • 比赛仪表板
  • 竞争市场定位分析
  • 波特五力分析

第12章 公司简介

  • Charles River Laboratories International, Inc.
    • 公司简介
    • 主要财务指标
    • SWOT分析
    • 产品介绍
    • 近期趋势
  • Catalent Inc. (Novo Holdings)
  • VGXI, Inc (GeneOne Life Science)
  • Thermo Fisher Scientific Inc.
  • Lonza
  • PlasmidFactory GmbH
  • Merck KGaA
  • GenScript Biotech Corporation
  • Akron Biotech.
  • DH Life Sciences, LLC

第13章 缩写与先决条件

第14章附录

简介目录
Product Code: UMHE213133

Plasmid DNA is described as small, circular, and double helix structures compact molecules of DNA present in bacteria and other microorganisms including yeast. In contrast to chromosomal DNA, plasmids are capable of replication within the cell, and they contain genes that may provide the cell with certain advantages, for instance, genes that give resistance to antibiotics. Such plasmids may be as small as a few thousand base pairs or as large as ten thousand base pairs. They are employed mostly in molecular biology and genetic engineering where researchers manipulate certain genes and place them in plasmids to form recombinant DNA for cloning, gene expression, or protein synthesis.

The Plasmid DNA Manufacturing Market is expected to grow with a significant CAGR of 20.11% during the forecast period (2024-2032). This is mainly due to the continuous research and development by pharmaceutical companies, along with increased mergers and acquisitions activities to boost their capacities and to increase their knowledge of new advancements and technologies, which can enhance the development of Plasmid DNA-based therapeutics for cancer, HIV and other rare genetic disorders. Moreover, the growing support from the regulatory bodies is further assisting in the significant growth of the plasmid DNA manufacturing market.

On the basis of plasmid grade, the global plasmid DNA manufacturing market is categorized as research-grade, high-quality, and good manufacturing practice (GMP) plasmid DNA. Of these, the GMP-grade segment is likely to be the largest due to its application in clinical applications such as gene therapy and vaccines. Due to the heightened quality requirements of GMP products, it can make them crucial for meeting regulatory requirements in clinical research and commercial distribution. In addition, owing to the growing need for highly efficient therapies, GMP-grade plasmids can be expected to grow significantly in the future. However, high-quality plasmid DNA is still expected to grow considerably, especially in Phase I and II clinical trials as well as in preclinical studies. This segment is most suitable for applications that demand much higher purity than those offered by research-grade products but that do not yet require full GMP compliance. The shift towards creating viral vectors and mRNA therapies will increase the requirement for premium plasmids in the future.

By the application, the global plasmid DNA manufacturing market is divided into gene therapy, DNA vaccines, immunotherapy, and others. Out of these, the gene therapy segment will be the most prominent one because of the significant application of this technology in dealing with genetic diseases and cancers. The persistence in clinical trials and approval of gene therapy especially plasmid vector-based therapies underlines this trend in this technology. Another type of vaccine is the DNA vaccine, which is expected to grow greatly, especially after the practice of DNA-based techniques during the COVID-19 pandemic. This success has promoted the desire to create DNA vaccines for different infectious illnesses and cancer vaccinations. One of the major advantages of DNA vaccines has been shown to be their capacity to mobilize intense immune responses. Even though immunotherapy is on the rise, especially in the area of cancer, it will have a slower pace of growth than gene therapy and DNA vaccines.

Depending on the application of the plasmid DNA by diseases there are three segments which include cancer, infectious diseases, and others. Among these, the cancer segment is leading the market primarily because of growing concerns regarding the development of new therapies effective in treating different types of cancers. Personalized medicine and specifically immunotherapy, which utilizes plasmid DNA to raise an immune response against tumor-associate antigens are among the most promising innovations generating strong interest and investment. But on the same note, the infectious diseases segment is also expected to move up a notch especially with advancements in DNA vaccines currently being worked upon. The use of DNA vaccine platforms in the recent COVID-19 pandemic has therefore revived the interest in using DNA vaccines and control or prevention of newly emerging epidemic diseases besides application for the management of chronic viral diseases including HIV and hepatitis. The other segment, which has applications in genetic diseases and veterinary use, is forecasted to grow albeit at a slower pace than cancer and infection diseases.

For a better understanding of the market penetration of plasmid DNA manufacturing, the market is analyzed based on its worldwide presence in countries such as North America (U.S., Canada, and the Rest of North America), Europe (Germany, France, U.K., Spain, Italy, Rest of Europe), Asia-Pacific (China, Japan, India, Rest of Asia-Pacific), Rest of World. Asia-Pacific is expected to grow with a significant CAGR in the forecast period (2024-2032) owing to the growing incidence of cancer and infectious diseases. The emphasis is made on the growing collaboration activities to improve product development in the Plasmid DNA Manufacturing market for bringing new therapeutics.

For instance, in June 2024, Genexine announced that its subsidiary VGXI, a leading contract development and manufacturing organization (CDMO) in the field of nucleic acid biopharmaceuticals, including gene therapy, DNA vaccines, and RNA drugs, has formed a strategic partnership with NASDAQ-listed Sutro Biopharma, Inc. to produce plasmid DNA used in the clinical trials of luveltamab tazevibulin (abbreviation: luvelta), an antibody-drug conjugate (ADC) anticancer drug currently under development by Sutro Biopharma.

Some of the major players operating in the market include Charles River Laboratories International, Inc., VGXI, Inc. (GeneOne Life Science), Catalent Inc. (Novo Holdings), Akron Biotech., PlasmidFactory GmbH, DH Life Sciences, LLC, Thermo Fisher Scientific Inc., Lonza, Merck KGaA, GenScript Biotech Corporation.

TABLE OF CONTENTS

1.MARKET INTRODUCTION

  • 1.1. Market Definitions
  • 1.2. Main Objective
  • 1.3. Stakeholders
  • 1.4. Limitation

2.RESEARCH METHODOLOGY OR ASSUMPTION

  • 2.1. Research Process of the Plasmid DNA Manufacturing Market
  • 2.2. Research Methodology of the Plasmid DNA Manufacturing Market
  • 2.3. Respondent Profile

3.EXECUTIVE SUMMARY

  • 3.1. Industry Synopsis
  • 3.2. Segmental Outlook
    • 3.2.1. Market Growth Intensity
  • 3.3. Regional Outlook

4.MARKET DYNAMICS

  • 4.1. Drivers
  • 4.2. Opportunity
  • 4.3. Restraints
  • 4.4. Trends
  • 4.5. PESTEL Analysis
  • 4.6. Demand Side Analysis
  • 4.7. Supply Side Analysis
    • 4.7.1. Merger, Acquisition & Partnerships
    • 4.7.2. Investment Scenario

5.GLOBAL PLASMID DNA MANUFACTURING MARKET REVENUE (USD MN), 2022-2032F

6.MARKET INSIGHTS BY PLASMID GRADE

  • 6.1. Research Grade (RG) Plasmid DNA
  • 6.2. High Quality (HQ) Plasmid DNA
  • 6.3. Good Manufacturing Practice (GMP) Plasmid DNA

7.MARKET INSIGHTS BY APPLICATION

  • 7.1. Gene Therapy
  • 7.2. DNA Vaccines
  • 7.3. Immunotherapy
  • 7.4. Others

8.MARKET INSIGHTS BY DISEASE TYPE

  • 8.1. Cancer
  • 8.2. Infectious Disease
  • 8.3. Others

9.MARKET INSIGHTS BY REGION

  • 9.1. North America
    • 9.1.1. U.S.
    • 9.1.2. Canada
    • 9.1.3. Rest of North America
  • 9.2. Europe
    • 9.2.1. Germany
    • 9.2.2. U.K.
    • 9.2.3. France
    • 9.2.4. Italy
    • 9.2.5. Spain
    • 9.2.6. Rest of Europe
  • 9.3. Asia-Pacific
    • 9.3.1. China
    • 9.3.2. Japan
    • 9.3.3. India
    • 9.3.4. Rest of Asia-Pacific
  • 9.4. Rest of World

10.VALUE CHAIN ANALYSIS

  • 10.1. Marginal Analysis
  • 10.2. List of Market Participants

11.COMPETITIVE LANDSCAPE

  • 11.1. Competition Dashboard
  • 11.2. Competitor Market Positioning Analysis
  • 11.3. Porter Five Forces Analysis

12.COMPANY PROFILES

  • 12.1. Charles River Laboratories International, Inc.
    • 12.1.1. Company Overview
    • 12.1.2. Key Financials
    • 12.1.3. SWOT Analysis
    • 12.1.4. Product Portfolio
    • 12.1.5. Recent Developments
  • 12.2. Catalent Inc. (Novo Holdings)
  • 12.3. VGXI, Inc (GeneOne Life Science)
  • 12.4. Thermo Fisher Scientific Inc.
  • 12.5. Lonza
  • 12.6. PlasmidFactory GmbH
  • 12.7. Merck KGaA
  • 12.8. GenScript Biotech Corporation
  • 12.9. Akron Biotech.
  • 12.10. DH Life Sciences, LLC

13.ACRONYMS & ASSUMPTION

14.ANNEXURE