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市場調查報告書
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1634636

質粒 DNA 製造市場：現況分析與未來預測（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個工作天內

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簡介目錄

預測期內（2024-2032 年），質粒 DNA 製造市場預計將以 20.11% 的顯著複合年增長率成長。這主要是由於製藥公司正在進行的研究和開發以及增加的併購活動，以提高其能力並增加對新進展和新技術的瞭解，從而可以加強基於質粒 DNA 的治療方法的開發，以治療癌症和愛滋病毒等罕見遺傳疾病。此外，監管機構的支持不斷增加，進一步推動了質粒 DNA 製造市場的顯著成長。

根據質粒等級，全球質粒 DNA 製造市場分為研究級、高品質和良好生產規範 (GMP) 質粒 DNA。其中，GMP 級部分可能是最大的部分，因為它可用於基因治療和疫苗等臨床用途。GMP產品品質要求高，對於滿足臨床研究和商業分銷的監管要求至關重要。此外，由於對高效治療的需求不斷增加，預計未來 GMP 級質粒將顯著增長。然而，高品質質粒DNA仍具有強勁的成長潛力，尤其是在I期和II期臨床試驗以及臨床前研究中。此部分最適合於需要比研究級產品純度高得多但仍不需要完全符合 GMP 的應用。向病毒載體和 mRNA 療法開發的轉變可能會在未來增加對高品質質粒的需求。

根據應用，全球質粒 DNA 製造市場分為基因治療、DNA 疫苗、免疫療法等。其中，基因治療領域將最為突出，因為該技術在治療遺傳疾病和癌症方面具有重要的應用。正在進行的臨床試驗和基因療法的批准，特別是基於質粒載體的療法，凸顯了這種技術趨勢。另一類疫苗是DNA疫苗，預計該類疫苗將大幅成長，尤其是在COVID-19大流行期間實施基於DNA的技術之後。這項成功激發了人們對開髮用於預防各種傳染病和癌症的DNA疫苗的熱情。DNA 疫苗的主要優勢之一已被證明是其能夠激發強大的免疫反應。儘管免疫療法正在興起，特別是在癌症領域，但其增長可能比基因療法和DNA疫苗慢。

從質粒DNA在疾病領域的應用來看，可分為三個部分：癌症、傳染病和其他疾病。其中，腫瘤學領域佔據市場領先地位，這主要是因為人們對開發治療各種癌症的新有效療法的興趣日益濃厚。個人化醫療，特別是利用質粒DNA增強對腫瘤相關抗原的免疫反應的免疫療法，是最有前景的創新之一，引起了人們的濃厚興趣和投資。同時，傳染病領域也有望進一步成長，尤其是目前正在研究的DNA疫苗的進展。最近在 COVID-19 大流行期間使用 DNA 疫苗平台重新引起了人們對使用 DNA 疫苗控制和預防新出現的傳染病的興趣，此外，DNA 疫苗還可用於治療愛滋病毒和肝炎等慢性病毒性疾病。其他應用領域，如遺傳疾病和獸醫應用，預計也會成長，儘管成長速度低於癌症和傳染病。

為了更瞭解質粒 DNA 製造市場的滲透率，我們根據北美（美國、加拿大和北美其他地區）、歐洲（德國、法國、英國、西班牙、義大利和歐洲其他地區）、亞太地區（中國、日本、印度和亞太其他地區）和世界其他地區的全球存在對市場進行了分析。由於癌症和傳染病發病率不斷上升，預計預測期內（2024-2032 年）亞太地區將以顯著的複合年增長率增長。質粒DNA製造市場專注於擴大合作研究活動，以改善產品開發，帶來新的治療藥物。

例如，2024年6月，Genexine宣佈其子公司VGXI與NASDAQ上市的Sutro Biopharma, Inc.建立戰略合作夥伴關係，VGXI是基因治療、DNA疫苗和RNA藥物等核酸生物製藥領域領先的合約開發和製造組織（CDMO）。該公司已與 Satro BioPharma 達成戰略合作夥伴關係，生產質粒 DNA，用於 Satro BioPharma 正在開發的抗體-藥物偶聯物 (ADC) 抗癌藥物 luvertamab-tazebibulin（縮寫為 Luverta）的臨床試驗。

市場上一些主要的參與者包括 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。

目錄

第1章 市場概況

  • 市場定義
  • 主要用途
  • 利益相關者
  • 限制

第 2 章 分析方法或假設

  • 分析過程
  • 分析方法
  • 受訪者簡介

第3章 執行摘要

  • 業界總結
  • 各細分領域的展望
    • 市場成長的力量
  • 區域展望

第4章 市場動態

  • 促進因素
  • 機會
  • 阻礙因素
  • 趨勢
  • PESTEL 分析
  • 需求面分析
  • 供給側分析
    • 企業併購（M&A）
    • 投資場景

第5章 全球質粒 DNA 製造市場收入（2022-2032 年）

第6章 質粒等級市場分析

  • 研究級（RG）質粒DNA
  • 高品質（HQ）質粒DNA
  • 良好生產規範 (GMP) 質粒 DNA

第7章 市場分析：依應用分類

  • 基因治療
  • 脫氧核糖核酸疫苗
  • 免疫療法
  • 其他

第 8 章 疾病類型市場分析

  • 癌症
  • 感染
  • 其他

第9章 市場分析：按地區

  • 北美
    • 美國
    • 加拿大
    • 其他北美
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 義大利
    • 西班牙
    • 歐洲其他地區
  • 亞太地區
    • 中國
    • 日本
    • 印度
    • 亞太其他地區
  • 世界其他地區

第 10 章 價值鏈分析

  • 邊際分析
  • 進入市場的企業名單

第11章 競爭格局

  • 比賽儀表板
  • 競爭市場定位分析
  • 波特五力分析

第12章 公司簡介

  • Charles River Laboratories International, Inc.
    • 公司簡介
    • 主要財務指標
    • SWOT分析
    • 產品介紹
    • 近期趨勢
  • 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 縮寫與先決條件

第14章附錄

簡介目錄
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