Viral Vector & Plasmid DNA Manufacturing Market by Type, Cell Line, Transfection, Indication, Workflow, Application, End User

Description

List of Tables

[193 Pages Report] The Viral Vector & Plasmid DNA Manufacturing Market size was estimated at USD 1.50 billion in 2023 and expected to reach USD 1.88 billion in 2024, at a CAGR 25.34% to reach USD 7.32 billion by 2030.

The market of viral vector and plasmid DNA manufacturing encompasses the production of plasmid DNA and viral vectors used for gene delivery to develop gene therapies and genetically modified organisms. Viral vectors are tools that molecular biologists use to produce genetic material in cells. This procedure can be completed inside a living organism (in vivo) or cell culture (ex vivo). Meanwhile, plasmid DNA is a small circular DNA strand that can be used to transfer genetic material similarly. Applications for these products range significantly and include clinical gene therapy for hereditary diseases, genetic vaccines, and cancer treatment strategies. End-users of viral vector and plasmid DNA products include pharmaceutical and biopharmaceutical companies, academic and research institutions, and clinical research organizations. The evolution of the viral vector and plasmid DNA manufacturing market is influenced by the increasing number of gene therapy candidates entering clinical trials, advancement in molecular biology technologies, rising investment in personalized medicine, and the growing prevalence of targeted diseases. The commitment of regulatory agencies to fast-track approvals for emerging therapies also supports market expansion. However, the market faces certain challenges, such as the high manufacturing cost due to complex production methods, regulatory hurdles, concerns regarding the safety and efficacy of gene therapy products, and the need for highly specialized technical expertise. On the other hand, the latest potential opportunities in the market include developments in vector design to reduce immunogenicity, increases in scale-up production processes to meet market demands, and advancements in gene-editing tools such as CRISPR/Cas9. Emerging economies expanding their biotechnological sectors also present significant opportunities for market players.

KEY MARKET STATISTICS
Base Year [2023]	USD 1.50 billion
Estimated Year [2024]	USD 1.88 billion
Forecast Year [2030]	USD 7.32 billion
CAGR (%)	25.34%

Cell Line: Growing usage of in-vitro cell lines in controlled laboratory environments

In-vitro cell lines are a critical component in the production of viral vectors and plasmid DNA. They are utilized in controlled laboratory environments for the purpose of manufacturing vectors that are used in various research, therapeutic, and vaccine applications. In-vitro systems offer a number of advantages, including higher control over the production process, defined conditions that can lead to high levels of reproducibility and consistency, and the potential for scale-up. Additionally, in-vitro systems can be optimized to improve product yield and quality. In-vivo cell lines involve the production of viral vectors and plasmid DNA within a living organism. This method is employed mostly for certain types of vectors that require post-translational modifications that can only be achieved within the context of a living cell or organism. In-vivo production systems can also harness the natural processes of the organism to potentially improve the quality of the vector or DNA product.

Type: Increasing need for plasmid DNA manufacturing to deliver genetic material into cells

Viral vectors are engineered viruses used as vehicles to deliver genetic material into cells. They have high efficiency for gene delivery and can have either temporary or permanent effects, depending on whether they integrate into the host genome. The high transduction efficiency makes viral vectors particularly useful for gene therapy applications, where persistent expression is required for the therapeutic effect. Adeno-associated viruses (AAV), a type of viral vector are small, non-enveloped viruses that are gaining traction due to their promise in gene therapy applications. Owing to their low pathogenicity and long-term gene expression without integration into the host genome, AAVs are deemed as one of the safest viral vectors. Adenoviruses are medium-sized, non-enveloped viruses that can induce potent immune responses, making them suitable for vaccine delivery and cancer therapy. Their high transduction efficiency and the ability to infect dividing and non-dividing cells underlie their utility in these applications. Lentiviruses, a subclass of retroviruses, facilitate stable gene transfer, which can produce persistent gene expression. They are widely used in in vitro and in vivo biomedical research, particularly for transducing a variety of cell types, including non-dividing cells. Plasmid DNA vectors serve as a key component of many gene therapies and vaccines. As non-viral vectors, they are commonly used for their simplicity, stability, and safety profile compared to viral vectors. They are used in various applications including DNA vaccination, gene therapy, and as tools in cell and molecular biology.

Transfection: Rising popularity of stable transfection for gene therapy and drug development

Stable transfection is a process wherein the transfected DNA integrates into the host genome, resulting in long-lasting and potentially permanent gene expression within the host cell. This technique is essential in gene therapy, drug development, and for producing recombinant proteins. It is ideal for research requiring consistent expression of a gene over extended periods, such as the study of gene function and regulation, or for the production of therapeutic proteins. Because stable transfection involves integration into the cell's genome, it occurs at a much lower frequency than transient transfection and often requires a selection process to isolate cells that have incorporated the foreign DNA. Transient transfection, unlike stable transfection, is a temporary change to host cells, where the transfected DNA does not integrate into the host genome and is diluted out or lost during cell division. This method is favored when quick, short-term gene expression is required, such as in protein production for assay development, vaccine development, or high-throughput screening. Because transient transfection is faster and more straightforward than stable transfection, it is often used during the initial stages of gene expression studies and for generating temporary models of disease.

End User: Expanding the potential of viral vectors & plasmid DNA across pharmaceutical & biopharmaceutical companies for the development and production of next-generation vaccines

Pharmaceutical & biopharmaceutical companies are significant end users of viral vectors and plasmid DNA. Their needs are primarily geared toward the development and production of gene therapies, next-generation vaccines, and personalized medicines. Research Institutes form another critical segment within the viral vector and plasmid DNA market. Their focus is largely on basic biological research and the development of novel therapeutic strategies. These entities typically require smaller batches of viral vectors and plasmid DNA and prioritize flexible manufacturing capabilities to support various research activities and early-stage clinical trials.

Regional Insights

The Americas, particularly the United States, remain at the forefront of biopharmaceutical research, including developing and manufacturing viral vectors and plasmid DNA. Recent investments and initiatives, such as launching advanced therapy production facilities and federal funding for gene therapy manufacturing, underscore the region's capacity in this field. Canada also contributes significantly, with its collaborative approach between academia and industry facilitating advanced research and development in this sector. The EU countries have been proactive in fostering a conducive environment for the growth of advanced therapy medicinal products (ATMPs), which include gene therapies employing viral vectors and plasmid DNA. Customer purchasing behavior in Europe is often influenced by the alignment of product offerings to these regulatory incentives and the established healthcare systems supporting innovative treatments. The Middle East, while still developing in this field, is seeing increased interest and investment in biotechnology, leading to a gradual increase in regional capabilities for manufacturing viral vectors and plasmid DNA. On the other hand, Africa presents a diverse picture, with South Africa heading in research capabilities, albeit on a smaller scale than global leaders. In APAC, China's commitment to biotech innovation is evident in its growing presence in the viral vector and plasmid DNA manufacturing landscape, supported by substantial government investments in research infrastructure and favorable policies for biotech companies. The country's fast-growing biotech sector translates to strong consumer demand and aggressive customer purchasing behavior towards local and international partnerships and technologies. India, while an emerging player in this field, is experiencing burgeoning demand due to its large population and increasing focus on healthcare innovation.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Viral Vector & Plasmid DNA Manufacturing Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Viral Vector & Plasmid DNA Manufacturing Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Viral Vector & Plasmid DNA Manufacturing Market, highlighting leading vendors and their innovative profiles. These include Advanced BioScience Laboratories, Inc., Akron Biotech, Avid Bioservices, Inc., Batavia Biosciences B.V., BioNTech IMFS GmbH, Biovian Oy, c-LEcta GmbH, Charles River Laboratories International, Inc., Creative Biogene, FILTROX AG, Forge Biologics By Ajinomoto Co., Inc., FUJIFILM Diosynth Biotechnologies Inc., GE HealthCare Technologies, Inc., GeneOne Life Science, Inc., Genezen, Genezen Laboratories, Inc., Kaneka Eurogentec S.A., Lonza Group Ltd., Merck KGaA, Miltenyi Biotec B.V. & Co. KG, PerkinElmer Inc., REGENXBIO Inc., Spark Therapeutics, Inc., Takara Bio Inc., Thermo Fisher Scientific Inc., uniQure N.V., and Wuxi AppTec Co., Ltd..

Market Segmentation & Coverage

This research report categorizes the Viral Vector & Plasmid DNA Manufacturing Market to forecast the revenues and analyze trends in each of the following sub-markets:

Type
- Plasmid DNA
- Viral Vector
  - Adeno-Associated Virus
  - Adenovirus
  - Lentivirus
Cell Line
- In-vitro
- In-Vivo

Transfection
- Stable Transfection
- Transient Transfection

Indication
- Cancer
- Genetic Disorder
- Infectious Disease

Workflow
- Downstream Processing
  - Fill-finish
  - Purification

Upstream Processing
- Vector Amplification & Expansion
- Vector Recovery/Harvesting

Application
- Cell Therapy
- Gene Therapy
- Vaccinology

End User
- Pharmaceutical & Biopharmaceutical Companies
- Research Institutes

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Viral Vector & Plasmid DNA Manufacturing Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Viral Vector & Plasmid DNA Manufacturing Market?

3. What are the technology trends and regulatory frameworks in the Viral Vector & Plasmid DNA Manufacturing Market?

4. What is the market share of the leading vendors in the Viral Vector & Plasmid DNA Manufacturing Market?

5. Which modes and strategic moves are suitable for entering the Viral Vector & Plasmid DNA Manufacturing Market?

Product Code: MRR-030298DFFC33

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Increasing number of gene therapy clinical trials worldwide
  - 5.1.1.2. Growing advancement in molecular biology technologies
- 5.1.2. Restraints
  - 5.1.2.1. High cost of manufacturing of viral vector & plasmid DNA solutions
- 5.1.3. Opportunities
  - 5.1.3.1. Growing introduction of novel viral vector & plasmid DNA solutions
  - 5.1.3.2. Rising investment in personalized medicine
- 5.1.4. Challenges
  - 5.1.4.1. Concerns regarding the safety and efficacy of gene therapy products
5.2. Market Segmentation Analysis
- 5.2.1. Cell Line: Growing usage of in-vitro cell lines in controlled laboratory environments
- 5.2.2. Type: Increasing need for plasmid DNA manufacturing to deliver genetic material into cells
- 5.2.3. Transfection: Rising popularity of stable transfection for gene therapy and drug development
- 5.2.4. End User: Expanding the potential of viral vectors & plasmid DNA across pharmaceutical & biopharmaceutical companies for the development and production of next-generation vaccines
5.3. Market Trend Analysis
5.4. Cumulative Impact of Russia-Ukraine Conflict
5.5. Cumulative Impact of High Inflation
5.6. Porter's Five Forces Analysis
- 5.6.1. Threat of New Entrants
- 5.6.2. Threat of Substitutes
- 5.6.3. Bargaining Power of Customers
- 5.6.4. Bargaining Power of Suppliers
- 5.6.5. Industry Rivalry
5.7. Value Chain & Critical Path Analysis
5.8. Regulatory Framework Analysis
5.9. Client Customization

6. Viral Vector & Plasmid DNA Manufacturing Market, by Type

6.1. Introduction
6.2. Plasmid DNA
6.3. Viral Vector

7. Viral Vector & Plasmid DNA Manufacturing Market, by Cell Line

7.1. Introduction
7.2. In-vitro
7.3. In-Vivo

8. Viral Vector & Plasmid DNA Manufacturing Market, by Transfection

8.1. Introduction
8.2. Stable Transfection
8.3. Transient Transfection

9. Viral Vector & Plasmid DNA Manufacturing Market, by Indication

9.1. Introduction
9.2. Cancer
9.3. Genetic Disorder
9.4. Infectious Disease

10. Viral Vector & Plasmid DNA Manufacturing Market, by Workflow

10.1. Introduction
10.2. Downstream Processing
10.3. Upstream Processing

11. Viral Vector & Plasmid DNA Manufacturing Market, by Application

11.1. Introduction
11.2. Cell Therapy
11.3. Gene Therapy
11.4. Vaccinology

12. Viral Vector & Plasmid DNA Manufacturing Market, by End User

12.1. Introduction
12.2. Pharmaceutical & Biopharmaceutical Companies
12.3. Research Institutes

13. Americas Viral Vector & Plasmid DNA Manufacturing Market

13.1. Introduction
13.2. Argentina
13.3. Brazil
13.4. Canada
13.5. Mexico
13.6. United States

14. Asia-Pacific Viral Vector & Plasmid DNA Manufacturing Market

14.1. Introduction
14.2. Australia
14.3. China
14.4. India
14.5. Indonesia
14.6. Japan
14.7. Malaysia
14.8. Philippines
14.9. Singapore
14.10. South Korea
14.11. Taiwan
14.12. Thailand
14.13. Vietnam

15. Europe, Middle East & Africa Viral Vector & Plasmid DNA Manufacturing Market

15.1. Introduction
15.2. Denmark
15.3. Egypt
15.4. Finland
15.5. France
15.6. Germany
15.7. Israel
15.8. Italy
15.9. Netherlands
15.10. Nigeria
15.11. Norway
15.12. Poland
15.13. Qatar
15.14. Russia
15.15. Saudi Arabia
15.16. South Africa
15.17. Spain
15.18. Sweden
15.19. Switzerland
15.20. Turkey
15.21. United Arab Emirates
15.22. United Kingdom

16. Competitive Landscape

16.1. Market Share Analysis, 2023
16.2. FPNV Positioning Matrix, 2023
16.3. Competitive Scenario Analysis
- 16.3.1. Ajinomoto Co., Inc. to Acquire Forge Biologics for USD 620 Million
- 16.3.2. Genezen Secures USD 18.5 Million in Growth Equity to Expand Viral Vector Development and Manufacturing Capabilities
- 16.3.3. CCRM Partners with Membio to Streamline Production of Viral Vectors for Cell and Gene Therapies

17. Competitive Portfolio

17.1. Key Company Profiles
17.2. Key Product Portfolio