ウイルスベクターとプラスミドDNA製造の世界市場-2022-2029

市場力学

ウイルスベクターとプラスミドDNA製造の世界市場の成長は、DNAワクチン開発、遺伝子治療、免疫療法などのためのウイルスベクターとプラスミドDNA製造に対する需要の増加などのいくつかの要因によって推進されています。

遺伝子治療や免疫療法に対する需要の増加は、予測期間中に世界のウイルスベクターとプラスミドDNA製造市場を牽引すると見られています。

この市場は、DNAワクチン、遺伝子治療、免疫療法などの開発に向けたウイルスベクターとプラスミドDNA製造の需要増が原動力となっています。高いトランスフェクション効率、効果的な遺伝子導入、安定した遺伝子発現などの利点から、ウイルスベクターおよびプラスミドDNAが成長しています。ウイルスベクターやプラスミドDNAの有効性・安全性を検証する臨床試験が増加しています。

ウイルスベクターやプラスミドDNAの製造受託事業の立ち上げが増加しています。例えば、2019年12月には、株式会社ヘリックスミスとジェノピスが、プラスミドDNA製造の受託製造事業を開始しました。フィージビリティランによる小規模リアクター（60～300L、6～30L）を追加で設置し、少量生産サービスを開始することになります。ジェノピス社は、適切な技術と品質システムを備えています。

ウイルスベクターやプラスミドDNAを製造するために、複数の企業が複数の組織と提携を結んでいます。例えば、2020年6月、オックスフォード・バイオメディカ plcは、英国初の戦略的ワクチン開発および高度製造能力を提供するために設立された非営利団体、ワクチン製造・イノベーションセンター（VMIC）と連携協定を締結しました。この5年間の契約により、両社はウイルスベクターを用いたワクチンの製造を可能にし、この特殊なワクチン製造分野における英国国内の能力を急速に向上させることに貢献することになります。本契約に基づき、VMICはオックスフォード・バイオメディカに製造装置を提供し、オックスフォード・バイオメディカが英国オックスフォードに新設する7,800m2の商業生産施設Oxbox内に、新たに2室のGMP製造室を設置することになります。

ベクターやプラスミドによる治療に伴う変異原性のリスクが市場成長の妨げになる可能性が高い

遺伝子操作されたウイルスベクターやプラスミドDNAは、さまざまな遺伝子治療や免疫療法に利用されているため。これらの遺伝子改変ベクターやプラスミドに関連する挿入変異原性のリスクがあり、市場の成長を抑制する可能性があり、遺伝子治療の高コストも市場の成長を制限する可能性があります。

産業分析

ウイルスベクターとプラスミドDNA製造の世界市場は、ポーターの5力、規制分析、サプライチェーン分析、価格分析など、さまざまな産業要因に基づく市場の詳細な分析を提供します。

世界のウイルスベクターとプラスミドDNA製造市場レポートでは、約45+市場データ表、40+図、180ページの構成で提供しています。

目次

第1章 調査手法と調査範囲

• 調査手法
• 調査目的および調査範囲

第2章 市場の定義と概要

第3章 エグゼクティブサマリー

第4章 市場の力学

• 市場影響要因
  • 促進要因
    • 遺伝子治療および免疫療法の需要拡大
    • 癌や遺伝子疾患などの疾病の発生率の増加
  • 抑制要因
    • 変異原性のリスク
    • 遺伝子治療のコスト高
  • ビジネスチャンス
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• 規制分析
• サプライチェーン分析
• 価格設定分析

第6章 COVID-19の分析

• COVID-19の市場分析
  • COVID-19以前の市場シナリオ
  • COVID-19の現在の市場シナリオ
  • COVID-19の後、または将来のシナリオ
• COVID-19の中での価格ダイナミクス
• 需要-供給スペクトラム
• パンデミック時の市場に関連する政府の取り組み
• メーカーの戦略的な取り組み
• まとめ
• その他

第7章 製品タイプ別

• プラスミドDNA
• ウイルスベクター
  • レトロウイルスベクター
  • アデノウイルスベクター
  • レンチウイルスベクター
  • アデノ随伴ウイルスベクター
  • その他
• 非ウイルス性ベクター

第8章 アプリケーション別

• 癌
• 遺伝性疾患
• 感染症
• その他の疾患

第9章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他の南米地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他アジア太平洋地域
• 中東・アフリカ地域

第10章 競合情勢

• 主な展開と戦略
• 企業シェア分析
• 製品タイプ別ベンチマーク
• 注目の主要企業リスト

第11章 企業プロファイル

• Brammer Bio（Thermo Fisher Scientific Inc.）
  • 企業概要
  • 製品タイプ別ポートフォリオと内容
  • 主なハイライト
  • 財務概要
• Cobra Biologics
• Cell and Gene Therapy Catapult
• FinVector Vision Therapies
• Fujifilm Diosynth Biotechnologies
• MassBiologics
• SIRION Biotech
• Merck KGaA Inc.
• Thermo Fisher Scientific
• Uniqure NV

第12章 ウイルスベクターとプラスミドDNA製造の世界製造市場-DataM

Market Overview

Viral Vector and Plasmid DNA Manufacturing Market size was valued US$ 2.85 billion in 2021 and is estimated to reach US$ XX billion by 2029, growing at a CAGR of 14.2% during the forecast period (2022-2029).

The viral vector is referred to as the tool for delivering genetic material into cells. The modified viral vector is used as a viral vector in gene therapy. Plasmid DNA is a bacterial smaller, circular, and extrachromosomal DNA used in different molecular genetic research such as gene therapy, gene transfer, and recombinant DNA technology due to its self-replication property. A gene of interest is transferred into the target cell for studying the function or expression of a gene.

Market Dynamics

The global viral vector and plasmid DNA manufacturing market growth is driven by several factors such as increasing demand for viral vectors and plasmid DNA manufacturing for developing DNA vaccines, gene therapy, immunotherapy, and others.

Increasing demand for gene therapy and immunotherapy is expected to drive the global viral vector and plasmid DNA manufacturing market during the forecast period.

The market is driven by the increasing demand for viral vectors and plasmid DNA manufacturing for developing DNA vaccines, gene therapy, immunotherapy, and others. There are growing viral vectors & plasmid DNA due to their advantages such as high transfection efficiency, effective gene delivery, and stable gene expression. There is an increase in the number of clinical studies examining the viral vectors' efficacy and safety and plasmid DNA.

There is an increase in the contract manufacturing business launch for viral vectors and plasmid DNA manufacturing. For instance, in December 2019, Helixmith Co., Ltd. and Genopis launched the contract manufacturing business for plasmid DNA production. The company would establish additional smaller-scale reactors (60-300 L, 6-30 L) with feasibility runs and start a small-volume production service. Genopis is equipped with the right technologies and quality systems.

Several companies are entering into a collaboration with several organizations to manufacture viral vectors and plasmid DNA. For instance, in June 2020, Oxford Biomedica plc entered into a collaboration agreement with the Vaccines Manufacturing and Innovation Centre (VMIC), a not-for-profit organization established to provide the UK's first strategic vaccine development and advanced manufacturing capability. This five-year agreement would involve the organizations working collaboratively to enable the manufacture of viral vector-based vaccines, contributing to a rapid increase in the United Kingdom domestic capacity for this specialized vaccine manufacturing field. Under the terms of the agreement, VMIC would provide manufacturing equipment for Oxford Biomedica to equip two new GMP manufacturing suites within Oxford Biomedica's new 7,800 m2 commercial manufacturing center, Oxbox, located in Oxford, United Kingdom.

Risk of mutagenesis associated with vector or plasmid treatments are likely to hinder the market growth

As genetic engineered viral vector and plasmid DNA are being used in various gene therapy and immunotherapy procedures. There is a risk of insertional mutagenesis associated with these genetic modified vectors and plasmids that can restrain the market growth and the high cost of gene treatments can also limit the growth of market.

Industry Analysis

The global viral vector and plasmid DNA manufacturing market provides in-depth analysis of the market based on various industry factors such as porter's five forces, regulatory analysis, supply chain analysis, pricing analysis.

Segment Analysis

The viral vector segment is expected to hold the largest market share in global viral vector and plasmid DNA manufacturing market

The global viral vector and plasmid DNA manufacturing market is segmented on the product type the plasmid DNA, viral vector, and non-viral vector. The viral vector segment accounts for the highest market growth due to the increasing penetration of the viral vectors for targeted delivery, efficient transduction, and controlled gene expression. There is an increase in the viral vectors' usage due to their efficiency in delivering genes into the target cells and protecting the new genes from degradation. Different types of viral vectors such as retrovirus, lentivirus, adenovirus, adeno-associated virus, and herpes simplex virus are used for transferring the nucleic acids into the genetic makeup of cells. Out of these viral vectors, adenovirus and retrovirus are widely used worldwide as these viral vectors have the integration ability with large transgenes and easy production at high titers.

Several companies are focusing on expanding the manufacturing facilities for the viral vectors to meet the increasing demand. For instance, in May 2019, Thermo Fisher Scientific Inc. had opened its new $90 million viral vector contract development and manufacturing organization (CDMO) site in Lexington, MA. The 50,000-square-foot facility would support the development, testing, and manufacture of viral vectors essential for advancing gene and cell therapies globally.

Further, the market is also classified based on cancer, genetic disorder, infectious disease, and other diseases. The cancer segment accounts for the highest market share due to the higher usage of the viral vector and plasmid DNA for delivering the anti-cancer genes. Several biotechnology and pharmaceutical companies are examining the viral vectors or plasmid DNA encoding a therapeutic gene, often an immunomodulatory or suicide gene, in the various cancer gene therapy trials. Clinical studies have demonstrated that the injection of plasmid DNA encoding a cytokine gene has a significant antitumor effect. There are increasing research and development activities for gene therapies and other advanced cell therapies to treat various cancers. The increase in the approval of the viral vector and plasmid DNA-based therapies shall stimulate market growth. For instance, the lentiviral vector-based CAR-T cell therapies are approved for treating Acute Lymphoblastic Leukemia (ALL) and large B cell lymphoma.

Geographical Analysis

North America region holds the largest market share in the global viral vector and plasmid DNA manufacturing market

By region, the global viral vector and plasmid DNA manufacturing market is segmented into North America, South America, Europe, Asia-Pacific, Middle-East, and Africa. Among all of the regions, North America dominated the global viral vector and plasmid DNA manufacturing market and is expected to grow at the highest CAGR during the forecasted period due to the increasing number of clinical studies for evaluating the use of the viral vector and plasmid DNA for the treatment of the genetic disorders, cancer, and infectious diseases. The increase in the approval of advanced cell therapies shall stimulate market growth. There is growing research and development activities of gene therapies. Several companies, institutes, associations, and foundations raise the investment and funding to develop gene therapies. The growing initiatives by the Food and Drug Administration (FDA) for improving the regulatory support for cell and gene therapy shall boost the demand for viral vector and plasmid DNA manufacturing.

The Asia Pacific is expected to witness positive market growth due to the growing clinical transformation and industrialization of advanced therapies medicinal products, including gene therapy manufacturing. There is a presence of several companies manufacturing the viral vector and plasmid DNA. Contract manufacturers are providing several services for viral vector and plasmid DNA manufacturing. There is growing adoption of advanced technologies for manufacturing viral vectors and plasmid DNA.

Competitive Landscape

The global viral vector and plasmid DNA manufacturing market is highly competitive with several international and local markets. Product diversification, revenue generation, and opportunities intensify the market competition. Brammer Bio, Cobra Biologics, Cell and Gene Therapy Catapult, FinVector Vision Therapies, Fujifilm Diosynth Biotechnologies, SIRION Biotech, Merck KGaA Inc., Thermo Fisher Scientific, and Uniqure NV are the leading market players with significant market share.

The major players enter into collaborations, acquisitions, mergers, and licensing activities to increase their market presence. For instance, in Apr 2022, FUJIFILM Diosynth Biotechnology, a Contract Development Manufacturing Organisation that develops recombinant biopharmaceuticals and viral gene therapy announced its manufacturing agreement with Chimeron Bio, RNA company that develops self-amplifying RNA vaccines and therapies that are developed by their own proprietary ChaESAR RNA delivery platform.

In March 2019, Merck entered into the non-binding Memorandum of Understanding with Chinese biotech company GenScript for a strategic alliance focusing on plasmid and viral vector manufacturing. The manufacturing of high-quality plasmids and viral vectors would help in the commercialization of cell and gene therapy. This collaboration would help the company accelerate the industrialization and commercialization of cell and gene therapy in China. Merck would provide GenScript with comprehensive products, training, and consulting services covering process design, facility concept design, and quality management system set-up from lab development to large-scale GMP manufacturing.

Key Companies to Watch

Brammer Bio:

Overview: Brammer Bio is a contract development and manufacturing organization (CDMO) that develops and manufactures viral vector and helps biopharmaceutical companies to deliver breakthrough medicines in form of gene modified cell therapies to patients. Founded in 2013 and headquartered in Florida.

Product Portfolio:

Lipofectamine CRISPRMAX Cas9 Transfection Reagent: It is a 1st lipid nanoparticle optimized reagent for transfection use for CRISPR-Cas9 protein delivery. It is a cost effective, high throughput friendly alternate for electroporation.

Key Developments: In May 2019, Thermo Fisher Scientific Inc., company serving science announced acquisition of Brammer Bio, viral vector manufacturing company for gene therapies for around $1.7 billion.

The global viral vector and plasmid DNA manufacturing market report would provide an access to an approx. 45+market data table, 40+figures and 180pages.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Market Definition and Overview

3. Executive Summary

4. Market Dynamics

• 4.1. Market Impacting Factors
  • 4.1.1. Drivers:
    • 4.1.1.1. The growing demand of gene therapy and immunotherapy
    • 4.1.1.2. Increase in the incidence of diseases such as cancer and genetic disorders.
  • 4.1.2. Restraints:
    • 4.1.2.1. Risk of mutagenesis
    • 4.1.2.2. High cost of gene therapy
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Forces Analysis
• 5.2. Regulatory Analysis
• 5.3. Supply Chain Analysis
• 5.4. Pricing Analysis

6. COVID-19 Analysis

• 6.1. Analysis of Covid-19 on the Market
  • 6.1.1. Before COVID-19 Market Scenario
  • 6.1.2. Present COVID-19 Market Scenario
  • 6.1.3. After COVID-19 or Future Scenario
• 6.2. Pricing Dynamics Amid Covid-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion
• 6.7. Others

7. By Product Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type Segment
  • 7.1.2. Market Attractiveness Index, By Product Type Segment
• 7.2. Plasmid DNA
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
• 7.3. Viral Vector
  • 7.3.1. Retroviral Vectors
  • 7.3.2. Adenoviral Vectors
  • 7.3.3. Lentiviral Vectors
  • 7.3.4. Adeno-Associated Viral Vectors
  • 7.3.5. Others
• 7.4. Non-Viral Vector

8. By Application

• 8.1. Introduction
  • 8.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  • 8.1.2. Market Attractiveness Index, By Application
• 8.2. Cancer
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis, US$ Mn and Y-o-Y Growth Analysis (%), 2021-2029
• 8.3. Genetic Disorder
• 8.4. Infectious Disease
• 8.5. Other Diseases

9. By Region

• 9.1. Introduction
  • 9.1.1. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029, By Region
  • 9.1.2. Market Attractiveness Index, By Region
• 9.2. North America
  • 9.2.1. Introduction
  • 9.2.2. Key Region-Specific Dynamics
  • 9.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
  • 9.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  • 9.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 9.2.5.1. U.S.
    • 9.2.5.2. Canada
    • 9.2.5.3. Mexico
• 9.3. Europe
  • 9.3.1. Introduction
  • 9.3.2. Key Region-Specific Dynamics
  • 9.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
  • 9.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  • 9.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 9.3.5.1. Germany
    • 9.3.5.2. U.K.
    • 9.3.5.3. France
    • 9.3.5.4. Italy
    • 9.3.5.5. Spain
    • 9.3.5.6. Rest of Europe
• 9.4. South America
  • 9.4.1. Introduction
  • 9.4.2. Key Region-Specific Dynamics
  • 9.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
  • 9.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  • 9.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 9.4.5.1. Brazil
    • 9.4.5.2. Argentina
    • 9.4.5.3. Rest of South America
• 9.5. Asia Pacific
  • 9.5.1. Introduction
  • 9.5.2. Key Region-Specific Dynamics
  • 9.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
  • 9.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  • 9.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 9.5.5.1. China
    • 9.5.5.2. India
    • 9.5.5.3. Japan
    • 9.5.5.4. Australia
    • 9.5.5.5. Rest of Asia Pacific
• 9.6. Middle East and Africa
  • 9.6.1. Introduction
  • 9.6.2. Key Region-Specific Dynamics
  • 9.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
  • 9.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application

10. Competitive Landscape

• 10.1. Key Developments and Strategies
• 10.2. Company Share Analysis
• 10.3. Product Type Benchmarking
• 10.4. List of Key Companies to Watch

11. Company Profiles

• 11.1. Brammer Bio (Thermo Fisher Scientific Inc.)
  • 11.1.1. Company Overview
  • 11.1.2. Product Type Portfolio and Description
  • 11.1.3. Key Highlights
  • 11.1.4. Financial Overview
• 11.2. Cobra Biologics
• 11.3. Cell and Gene Therapy Catapult
• 11.4. FinVector Vision Therapies
• 11.5. Fujifilm Diosynth Biotechnologies
• 11.6. MassBiologics
• 11.7. SIRION Biotech
• 11.8. Merck KGaA Inc.
• 11.9. Thermo Fisher Scientific
• 11.10. Uniqure NV

LIST NOT EXHAUSTIVE

12. Global Viral Vector and Plasmid DNA Manufacturing Market - DataM

• 12.1. Appendix
• 12.2. About Us and Usability
• 12.3. Contact Us