Viral Vector and Plasmid DNA Manufacturing Market

Viral Vector and Plasmid DNA Manufacturing Market: Industry Trends and Global Forecasts, Till 2035 - Distribution by Scale of Operation (Preclinical, Clinical and Commercial), Type of Vector (AAV Vectors, Adenoviral Vectors, Lentiviral Vectors, Retroviral Vectors, Plasmid DNA and Other Vectors), Application Area (Gene Therapies, Cell Therapies and Vaccines), Therapeutic Area (Oncological Disorders, Rare Diseases, Neurological Disorders, Sensory Disorders, Metabolic Disorders, Musculoskeletal Disorders, Blood Disorders, Immunological Disorders and Other Disorders), Type of Manufacturer (In-house and Contract Manufacturing Organizations) and Geography (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America and Rest of the World)

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Viral Vector and Plasmid DNA Manufacturing Market Overview

The viral vector and plasmid DNA manufacturing market size is estimated to be worth USD 926.50 million in 2024 to USD 2,950.69 million by 2035 and is expected to grow at compounded annual growth rate (CAGR) of 11.11% during the forecast period 2024 to 2035.

Viral Vector and Plasmid DNA Manufacturing Market, By scale of Operation

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With the increasing number of cell and gene therapies being developed and launched for a wide range of therapeutic areas, these modalities are on their way to become one of the highest valued markets in the biopharmaceutical domain. In fact, in 2021, cell and gene therapy developers raised capital worth more than USD 20 billion, registering an increase of 19% from the amount raised in 2020 (~USD 17 billion). It is worth highlighting that, in February 2024, the USFDA approved Lifileucel, a TIL therapy, for treating patients with advanced melanoma. In March 2024, the USFDA approved CAR-T therapy, lisocabtagene maraleucel (liso-cel), developed by Juno Therapeutics (subsidiary of Bristol-Myers Squib), for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The viral vector and plasmid DNA manufacturing market has also witnessed a significant increase in the partnership and expansion activities over the past few years, with several companies having been acquired by the larger firms. Given the growing demand for interventions that require genetic modification, the viral vector and plasmid DNA manufacturing market is poised to witness substantial growth in the foreseen future.

Viral Vector and Plasmid DNA Manufacturing Market Key Insights

The “Viral Vector and Plasmid DNA Manufacturing Market, Industry Trends and Global Forecasts, Till 2035 Distribution by Scale of Operation (Preclinical, Clinical and Commercial), Type of Vector (AAV Vectors, Adenoviral Vectors, Lentiviral Vectors, Retroviral Vectors, Plasmid DNA and Other Vectors), Application Area (Gene Therapies, Cell Therapies and Vaccines), Therapeutic Area (Oncological Disorders, Rare Diseases, Neurological Disorders, Sensory Disorders, Metabolic Disorders, Musculoskeletal Disorders, Blood Disorders, Immunological Disorders and Other Disorders), Type of Manufacturer (In-house and Contract Manufacturing Organizations) and Geography (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America and Rest of the World)” market report features an extensive study of the current market landscape and opportunities for viral vector and plasmid DNA manufacturing companies during the forecast period. Key takeaways of the viral vector and plasmid DNA manufacturing market report are briefly discussed below.

Market Landscape: Viral Vector and Plasmid DNA Manufacturing Market

The viral vector and plasmid DNA manufacturing landscape features a mix of industry players (well-established companies, mid-sized firms and start-ups / small companies), as well as several academic institutes. It is worth highlighting that several companies that have the required capabilities and facilities to manufacture vectors for both in-house requirements and offer contract services (primarily to ensure the optimum use of their resources and open up additional revenue generation opportunities) have emerged in this domain.

The market has close to 130 companies with capability for viral vector manufacturing and around 95 players that are capable of plasmid DNA manufacturing; of which, majority of the manufacturers are mid-sized companies. Further, it is worth highlighting that close to 65 viral and non viral vector manufacturing companies have developed different platforms that aid in the efficient and large scale production of viral vectors and plasmid DNA.

Viral Vector and Plasmid DNA Manufacturing Market Drivers : Rising Interest in Cell and Gene Therapy Development

Close to 1,500 clinical trials are being conducted, globally, for the evaluation of cell and gene therapies. Over time, it has been observed that the clinical success of these therapies relies on the design and type of gene delivery vector used (in therapy development and / or administration). At present, several innovator companies are actively engaged in the development / production of viral vectors and / or non-viral vectors for cell and gene therapies.

In this context, it is worth mentioning that, over the past few years, multiple viral vector and non-viral vector based vaccine candidates have been developed against COVID-19 (caused by novel coronavirus, SARS-CoV-2) and oncological disorders; this is indicative of lucrative opportunities for companies that have the required capabilities to manufacture vectors and gene therapies.

Market Trends: Facility Expansions to Support the Growing Demand

In May 2023, Touchlight expanded its existing plasmid DNA manufacturing capacity in its UK facility to meet the increasing demand. The expansion has tripled the company’s manufacturing capacity and the company is now capable of manufacturing over 8 kg of plasmid DNA annually. Similarly, in January 2023, Catalent Pharma Solutions, another US-based CDMO, established a new commercial scale plasmid development and manufacturing facility to expand its end-to-end capabilities for the production of GMP grade plasmid DNA in order to fulfill the customer requirements up to 300 L fermentation scale. Such recent developments in this segment indicates that the industry and non-industry players are upgrading their capabilities and infrastructure to accommodate the current and anticipated manufacturing demand.

Market Developments: Manufacturers are Adopting Novel Technologies to Cater to Growing Demand

In order to produce more effective and affordable vectors, several stakeholders are integrating various novel technologies. One such technology is the adoption of single use technologies for vector manufacturing. In January 2023, Canada based CCRM collaborated with Membio to develop single use bioreactor for viral vector production. This trend is also being seen for plasmid DNA manufacturing. In February 2023, Australian CDMO AcuraBio adopted Cytiva’s single use purification technology for plasmid DNA production. These technologies are likely to improve the time to market for vectors and gene therapies.

Recent Developments in Viral Vector and Plasmid DNA Manufacturing Market

Several recent developments have taken place in the field of viral vector and plasmid DNA manufacturing. Some of these recent initiatives have been mentioned below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that we have outlined in our analyses.

  • In March 2024, Charles River Laboratories signed an agreement to manufacture Navega Therapeutics to produce the AAV gene therapy candidate NT-Z001 for phase 1 clinical trials.
  • In February 2024, Bespoke Gene Therapy Consortium (BGTC) selected CDMO Andelyn Biosciences as manufacturing partner for AAV vector based gene therapies for the treatments of CNGB1 Retinitis Pigmentosa 45 and NPHP5 retinal degeneration.
  • In August 2023, AGC Biologics expanded its manufacturing site at Milan for adeno-associated viral vector and lentiviral vector development and manufacturing.
  • In June 2023, INADcure Foundation announced a manufacturing alliance with Charles River Laboratories, under which the latter will be responsible for manufacturing high quality plasmid DNA for phase I/II clinical trials of a gene therapy against Infantile Neuroaxonal Dystrophy.
  • In February 2023, BioNTech announced the completion of its in-house clinical and commercial scale plasmid DNA manufacturing facility at Marburg, Germany.

Scope of Viral Vector and Plasmid DNA Manufacturing Market Report

The viral vector and plasmid DNA manufacturing market report presents an in-depth analysis of the various firms / organizations that are engaged in this market, across different segments, as defined in the below table:

Viral Vector and Plasmid DNA Manufacturing Market: Report Attribute / Market Segmentations

Key Report Attributes

Details

Historical Trend

2018 – 2022

Base Year

2023

Forecast Period

2024-2035

Market Size 2023

$926.5 Million

CAGR

11.11%

Scale of Operaiton

  • Preclinical
  • Clinical
  • Commercial

Type of Vector

  • Adeno Associated Virus Vectors
  • Adenoviral Vectors
  • Lentiviral Vectors
  • Retroviral Vectors
  • Plasmid DNA
  • Other Vectors

Application Area

  • Gene Therapies
  • Cell Therapies
  • Vaccines

Therapeutic Area

  • Oncological Disorders
  • Rare Diseases
  • Neurological Disorders
  • Sensory Disorders
  • Metabolic Disorders
  • Musculoskeletal Disorders
  • Blood Disorders
  • Immunological Disorders
  • Other Disorders

Type of Manufacturer

  • In-house Manufacturers
  • Contract Manufacturing Organizations

Key Geographical Regions

  • North America 
  • Europe
  • Asia-Pacific
  • Middle East and North Africa
  • Latin America and Rest of the World

Key Companies Profiled

  • Advanced BioScience Laboratories
  • AGC Biologics 
  • Aldevron
  • Altruist Biotechnology 
  • BioNTech Innovative Manufacturing Service (a subsidiary of BioNTech)
  • BioReliance (a subsidiary of Merck KGaA)
  • Biovian
  • Celonic
  • Catalent Biologics
  • Cobra Biologics
  • Celonic
  • Centre for Process Innovation
  • CEVEC Pharmaceuticals
  • Charles River Laboratories
  • CoJourney
  • Esco Aster
  • Jiangsu Puxin Biopharmaceutical
  • Lonza
  • Matica Biotechnology
  • Nikon CeLL innovation
  • NorthX Biologics
  • Novartis
  • Oxford BioMedica
  • Resilience
  • Sanofi
  • Thermo Fisher Scientific
  • VectorBuilder
  • Wuxi AppTech

(Full list of 190+ companies captured in the market landscape analysis of the report)

Customization Scope

15% Free Customization Option

PowerPoint Presentation (Complimentary) 

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Exel Data Packs (Complimentary)

  • Market Landscape Analysis
  • Company Competitiveness Analysis
  • Partnerships and Collaborations Analysis
  • Recent Expansions Analysis
  • Strategic Partner Analysis
  • Key Insights
  • Cost Price Analysis
  • Outsourcing: Go / No-Go Framework
  • Capacity Analysis
  • Demand Analysis
  • Survey Analysis
  • Market Sizing and Opportunity Analysis

 

The market report features an extensive study of the rapidly growing market of viral vector and plasmid DNA manufacturing, focusing on contract manufacturers, as well as companies having in-house manufacturing facilities. The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different regions of the globe. Amongst other elements, the report includes:

  • An overview of the current status of the market with respect to the players engaged (both industry and non-industry) in the manufacturing of viral, non-viral and other novel types of vectors and gene therapies. It features information on the year of establishment, company size, location of headquarters, type of product manufactured (vector and gene therapy / cell therapy / vaccine), location of manufacturing facilities, type of manufacturers (in-house and contract services), scale of operation (preclinical, clinical and commercial), type of vector manufactured (AAV, adenoviral, lentiviral, retroviral, plasmid DNA and others) and application area (gene therapy, cell therapy, vaccine and others).

Viral Vector Manufacturing Market Expert Opinion

Viral Vector Manufacturing Market List

Viral Vector Manufacturing Market Landscape

 

  • An analysis of the technologies offered / developed by the companies enagaged in this domain, based on the type of technology (viral vector related platform, non-viral vector related platform and others), type of manufacturer (vector manufacturing, gene delivery, product manufacturing, transduction / transfection, vector packaging and other), scale of operation (preclinical, clinical and commercial), type of vector involved (AAV, adenoviral, lentiviral, retroviral, non-viral and other viral vectors), application area (gene therapy, cell therapy, vaccine and others). It also highlights the most prominent players within this domain, in terms of number of technologies.
  • A region-wise, company competitiveness analysis, highlighting key players engaged in the manufacturing of vectors and gene therapies, across key geographical areas, featuring a four-dimensional bubble representation, taking into consideration supplier strength (based on experience in this field), manufacturing strength (type of product manufactured, number of manufacturing facilites and number of application areas), service strength (scale of operation, number of vectors manufactured and geographical reach) and company size (small, mid-sized and large).
  • Elaborate profiles of key players based in North America, Europe and Asia-Pacific (shortlisted based on proprietary criterion). Each profile features an overview of the company / organization, its financial performance (if available), information related to its manufacturing facilities, vector manufacturing technology and an informed future outlook.
  • Tabulated profiles of the other key players headquartered in different regions across the globe (shortlisted based on proprietary criterion). Each profile features an overview of the company, its financial performance (if available), information related to its manufacturing capabilities, and an informed future outlook.
  • An analysis of partnerships and collaborations established in this domain since 2015; it includes details of deals that were / are focused on the manufacturing of vectors, which were analyzed on the basis of year of partnership, type of partnership (manufacturing agreement, product / technology licensing, product development, merger / acqusition, research and development agreement, process development  / optimization, service alliance, production asset / facility acquisition, supply agreement and others), scale of operation (preclinical, clinical and commercial), type of vector involved (AAV, adenoviral, lentiviral, retroviral, plasmid and others), region and most active players (in terms of number of partnerships). 
  • An analysis of the expansions related to viral vector and non viral vector manufacturing, which have been undertaken since 2015, based on several parameters, such as year of expansion, type of expansion (new facility / plant establishment, facility expansion, technology installation / expansion, capacity expansion, service expansion and others), type of vector (AAV, adenoviral, lentiviral, retroviral, plasmid and others), application area (gene therapy, cell therapy, vaccine and others) and geographical location of the expansion.
  • An analysis evaluating the potential strategic partners (comparing vector based therapy developers and vector purification product developers) for vector and gene therapy product manufacturers, based on several parameters, such as developer strength, product strength, type of vector, therapeutic area, pipeline strength (preclinical and clinical).

 

Viral Vector Manufacturing Market Players

Viral Vector Manufacturing Market Manufacturing Hubs

Viral Vector Manufacturing Market Platforms

 

  • An overview of other viral / non-viral gene delivery approaches that are currently being researched for the development of therapies involving genetic modification.
  • An in-depth analysis of viral vector and plasmid DNA manufacturers, featuring three schematic representations, a three dimensional grid analysis, representing the distribution of vector manufacturers (on the basis of type of vector) across various scales of operation and type of manufacturer (in-house operations and contract manufacturing services), a heat map of viral vector and plasmid DNA manufacturers based on the type of vector (AAV, adenoviral vector, lentiviral vector, retroviral vector and plasmid DNA) and type of organization (industry (small, mid-sized and large) and non-industry), and a schematic world map representation, highlighting the headquarters and geographical location of key vector manufacturing hubs.
  • An analysis of the various factors that are likely to influence the pricing of vectors, featuring different models / approaches that may be adopted by product developers / manufacturers in order to decide the prices of proprietary vectors.
  • An estimate of the overall, installed vector manufacturing capacity of industry players based on the information available in the public domain, and insights generated via both secondary and primary research. The analysis also highlights the distribution of the global capacity by company size (small, mid-sized and large), scale of operation (clinical and commercial), type of vector (viral vector and plasmid DNA) and region (North America, Europe, Asia Pacific and the rest of the world).
  • An informed estimate of the annual demand for viral and non-viral vectors, taking into account the marketed gene-based therapies and clinical studies evaluating vector-based therapies; the analysis also takes into consideration various relevant parameters, such as target patient population, dosing frequency and dose strength.
  • A discussion on the factors driving the market and various challenges associated with the vector production process.
  • A qualitative analysis, highlighting the five competitive forces prevalent in this domain, including threats for new entrants, bargaining power of drug developers, bargaining power of vector and gene therapy manufacturers, threats of substitute technologies and rivalry among existing competitors.

 

Viral Vector Manufacturing Market Competitiveness Analysis

Viral Vector Manufacturing Market Emerging Players

Viral Vector Manufacturing Market Recent Expansions

One of the key objectives of this report was to evaluate the current market size and the future opportunity associated with the viral vector and plasmid DNA manufacturing market, over the coming decade. Based on various parameters, such as the likely increase in number of clinical studies, anticipated growth in target patient population, existing price variations across different types of vectors, and the anticipated success of gene therapy products (considering both approved and late-stage clinical candidates), we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035.

In order to provide a detailed future outlook, our projections have been segmented on the basis of scale of operation (preclinical, clinical and commercial), type of vector (AAV vector, adenoviral vector, lentiviral vector, retroviral vector, plasmid DNA and others), application area (gene therapy, cell therapy and vaccine), therapeutic area (oncological disorders, rare disorders, neurological disorders, sensory disorders, metabolic disorders, musco-skeletal disorders, blood disorders, immunological diseases, and others) and geographical region (North America, Europe, Asia Pacific, MENA, Latin America and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The research, analysis and insights presented in this report are backed by a deep understanding of key insights generated from both secondary and primary research. For the purpose of the study, we invited over 300 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. The opinions and insights presented in this study were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry and non-industry players:

  • Chief Executive Officer, mid-sized company, Netherlands
  • Chief Executive Officer and Chief Scientific Officer, small company, Germany
  • Former Executive and Scientific Director, small company, Belgium
  • Co-Founder and President, mid-sized company, France
  • Former Director, Netherlands-based company
  • Director, Massachusetts-based organization
  • Former Scientific Director, France-based organization
  • Former Managing Director, small company, Japan
  • Scientific Director, small company, US
  • Key Account Management, mid-sized company, Germany
  • Head of Project Management, small company, Germany
  • Director of Business Development, small company, US
  • ATMP Key Account Manager, France-based organization
  • Chief Scientific Officer, small company, France
  • Director of Marketing and Technical Support, mid-sized company, France
  • Head of Communications, mid-sized company, Spain
  • Independent Consultant

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: How big is the viral vector and plasmid DNA manufacturing market?

Answer: The viral vector manufacturing and plasmid DNA manufacturing market is estimated to be worth more than $ 926 million in 2024.

Question 2: Which regions are the current manufacturing hubs for vectors and gene therapies?

Answer: North America emerged as the current manufacturing hub for viral vector manufacturing and gene therapy manufacturing.

Question 3: How is the current and future market opportunity likely to be distributed across key market segments?

Answer: The current and future market opportunity is likely to be distributed across key market segments, including scale of operation, type of vector, application area, therapeutic area, type of manufacturer and geography.

Question 4: Who are the leading players (contract service providers and in-house manufacturers) engaged in the development of vectors (viral and non-viral)?

Answer: The leading players engaged in the development of viral and non viral vector manufacturing include Advanced BioScience Laboratories, AGC Biologics, Aldevron, Altruist Biotechnology, BioNTech Innovative Manufacturing Service, BioReliance, Biovian, Catalent Biologics, Celonic, Centre for Process Innovation, CEVEC Pharmaceuticals, Charles River Laboratories, CoJourney, Esco Aster, Jiangsu Puxin Biopharmaceutical, Lonza, Matica Biotechnology, Nikon CeLL innovation, NorthX Biologics, Novartis, Oxford BioMedica, Resilience, Sanofi, Thermo Fisher Scientific, VectorBuilder and Wuxi AppTec.

Question 5: How to manufacture viral vectors?

Answer: Viral vector manufacturing is a complex process of viral vector production that involves multiple steps to develop cell therapies, gene therapies and viral vector vaccines. The steps involved in viral vector manufacturing include production of the viral vectors using non-pathogenic viruses, purification of these vectors, quality control, followed by the production of final formulation.

Question 6: How is plasmid DNA manufactured?

Answer: The steps involved in manufacturing plasmid DNA include plasmid design, plasmid construction, host cell transformation, culture expansion, plasmid isolation, plasmid purification, and quality control testing.

Question 7: What is the difference between a viral vector and a plasmid vector?

Answer: Viral vectors and plasmid DNA vectors are the biological tools that are used to transport genetic material to the target cell. The key difference between both the vectors lies in their nature and origin. Viral vectors are derived from viruses, whereas plasmid DNA vectors are extrachromosomal DNA elements that carry foreign DNA molecules.

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