Viral Vectors and Plasmid DNA Manufacturing Market Research Report—Global Forecast till 2027

Viral Vectors and Plasmid DNA Manufacturing Market Research Report: Information by Vector Type (Plasmid DNA, Viral Vector, Non-viral Vector), by Disease Type(Cancer, Genetic Disorder, and Infectious Disease), by Applications (Antisense & RNAi Therapy,Gene Therapy,Cell Therapy, Vaccinology, and Research), by Workflow (Upstream Processing and Downstream Processing), by End User (Pharmaceutical and Biopharmaceutical Companies, and Research Institutes) and by Region (North America, Europe, Asia-Pacific, and Rest of the World) - Forecast till 2

ID: MRFR/HC/9195-HCR | December 2022 | Region: Global | 120 Pages         

Viral Vectors and Plasmid DNA Manufacturing Market

Viral Vectors and Plasmid DNA Manufacturing Market is projected to be worth USD 587.5 million at CAGR of 16.92 % during the forecast period.

Segmentation

By Vector Type Plasmid DNA Viral Vector Non-viral Vector
By Disease Type Cancer Genetic Disorder and Infectious Disease
By Applications Antisense & RNAi Therapy Gene Therapy Cell Therapy Vaccinology and Research
By Workflow Upstream Processing and Downstream Processing
By End user Pharmaceutical and Biopharmaceutical Companies and Research Institutes

Key Players

  • Cognate BioServices
  • Inc. (US) Catalent Pharma Solutions (US) Fujifilm Holdings Corporation (Japan) Johnson & Johnson (US) Sanofi Corporation (France) F. Hoffmann-LA Roche Ltd (Switzerland) 4D Molecular Therapeutics (US) Sirion Biotech GmbH (Germany) Voyager Therapeutics (US) Thermo Fisher Scientific
  • Inc. (US) Gene Therapy Catapult (UK) UniQure (Netherlands) MassBiologics (US) Renova Therapeutics (US) Shenzhen SiBionoGeneTech Co.
  • Ltd (China)

Drivers

  • Rising prevalence of genetic disorders and infectious diseases
  • Increasing number of market players involved in new product launch
  • strategic collaborations
  • acquisition
  • and geography expansion
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Viral Vectors and Plasmid DNA Manufacturing Market


As per the research reports by MRFR, the global market for viral vectors and plasmid DNA manufacturing are estimated to attain a valuation of over USD 587.5 million by the end of 2027. The report further predicts that the market will flourish at a robust CAGR of over 16.92% during the assessment era.


Viral vectors refer to intended to transport genetic material into cells and have become a technique for gene transfer owing to stable gene expression, efficient gene delivery, and high transfection efficiency. Plasmid DNA also plays a crucial part in the healthcare industry, as it is used as a therapeutic agent in gene directly therapy or vaccine antigens generation. It is also used as a master-template product to aid the production of the latest and growing biopharmaceutical products and processes, including cell therapies and RNA and in-vitro protein production. The global market for viral vectors and plasmid DNA manufacturing is primarily attributed to the technological advancements in the field. Furthermore, the development of numerous other innovative viral and non-viral gene supply methods being used to develop several therapies is also likely to boost the growth of the market over the forecasted era. Moreover, the increasing demand for DNA therapeutics and R&D on cancer research are anticipated to boost the demand for viral vectors and plasmid DNA manufacturing over the coming years.


COVID-19 Analysis


The rising prevalence of COVID-19 is projected to influence market growth over the forecast period.  As the coronavirus outbreak continues, the majority of the healthcare companies experienced a significant loss, there by hampering the viral vectors and plasmid DNA manufacturing market. The emergence of the COVID-19 pandemic has plummeted the global economy, severely impacting production and demand across numerous verticals and disrupting the supply chain.


The viral vector and plasmid DNA manufacturing market has showcased a positive impact due to the ongoing COVID-19 spread.  The pandemic has created lucrative opportunities for the industry players of viral vectors and plasmid DNA manufacturing market.  For example, in December 2020 and February 2021, AstraZeneca (UK) and Janssen Pharmaceuticals (Belgium) companies developed the COVID-19 viral vector-based vaccine (AZD1222)vaccine.  The innovation of these vaccines by major market players hasacceleratedthe demand for viral vectors, thereby increasing revenue for viral vector manufacturers.


Market Drivers



  • Rising prevalence of genetic disorders and infectious diseases


There has been a surge in the prevalence rate of genetic and infectious diseases inthe past years. According to an article published in the National Institutes of Health (NIH), sickle cell anemia affectedan estimated 100,000 people in the US in 2019. The rising application of gene therapy for the treatment of viral infections such as adeno-associated viruses, poxviruses, herpes simplex viruses, and retroviruses is anticipated to boost the adoption of gene therapies which in turn aids to propel themarket growth of the viral vectors and plasmid DNA manufacturing in the near future.



  • Increasing number of market players involved in new product launch, strategic collaborations, acquisition, and geography expansion


GE Healthcare Life Sciences (US) and Children’s Medical Research Institute (Australia)entered into a collaboration for the development of new affinity ligands for the purification of adeno-associated viral select AAV) vectors used in gene therapies. The collaborationwas focused on multiple AAV types enhancing the chromatographic separation of AAV-based vectors. Thus, such collaborations are anticipated to improve the manufacturing efficiency and scalability of gene the rapies, enabling the availability of viral vectors on a global scale and opening lucrative opportunities in the market.


Furthermore, market players are also engaged in leveraging external capital to advance their business operations.  For instance, in April 2021, Albumedix (UK)collaborated with Cobra Biologics (US) for the upstream and downstream processing of AAV and lentiviral vector. The collaboration is intended for stability enhancement and process optimization.


Market Restraints



  • Challenges in viral vector manufacturing capacities


Manufacturers of viral vector and plasmid DNA whose products are in phase III of clinical trials and commercial production of viral vectors are facing numerous challenges. These challenges includethe unsuitability of many existing vector production technologies with respect to productivity, efficiency, stability, etc. In addition, there is also a necessity for both large and small-volume manufacturing companies in the market to carry out various research activities.


Market Opportunities



  • Increasing employment of viral vectors and plasmid DNA for the R&D of advanced therapies


Viral vectors and plasmid DNA are being used widely for developing gene therapies which is one of the growing areas in advanced therapies. Healthcare companies are involved in innovating  DNA vectors for the production of vaccines.  For instance, in 2021, Touchlight (UK) developed a scalable, rapid, easy-to-transfer, cell-free method to make unique DNA vectors, known as Doggybone DNA (dbDNA). The Touchlight’sdb DNA can be constructed ata multi-gram scale within five days. The company is also investing in growing the number of proof-of-concept studies in animals for DNA-based the rapies, which is also a propelling factor for the market growth.


Technology Analysis


The increase in research activities for the advancement of viral vectors and plasmid DNA and increased use of these vectors in the development of treatments for various diseases such as cancer and sickle cell anemia will significantly contribute to market growth.  For instance, in October 2019, a group of researchers at the National Institutes of Health (NIH) developed a new, improved viral vector for sickle cell anemia treatment. The new viral vector is tentimes efficient than already existing viral vectors based on the hypothesis of researchers. In addition, major market players are also fueling the market growth for viral vector and plasmid DNA manufacturing by new product launches, mergers&acquisitions, and strategic collaborations amongst each other.  For instance, in May 2019, Thermo Fisher Scientific (US) introduced Mag MAX Viral/Pathogen kits and reagents, which use magnetic bead-based technology to purify high-quality nucleic acid from a range of research samples, both manually and through automation. Such innovation by the established companies is anticipated to boost the market growth for viral vectors and plasmid DNA manufacturing.


Segment Overview


Based on the viral vector typeof the global viral vectors and plasmid DNA manufacturing market, the market is segmented into plasmid DNA, viral vectors, and non-viral vectors.


By Type




  • Plasmid DNA




Plasmid DNA is used as a master template to support the production of new and emerging biopharmaceutical products and processes, including RNA &cell therapies and in-vitro protein production. The recent advancements in plasmid DNA have led to the emergence of several other innovative viral and non-viral gene delivery approaches that are used for the development of various the rapies that require gene modification. The major factors helping the market groware the rising preference for plasmid DNA in gene transfer and it susage as a vector in gene therapy and vaccinology. Plasmid DNA is also used as raw material in the production of various viral vectors,further attributing to this segment's market growth.



The viral vectors segment accounted for a major share in 2020. Viral vectors were widely used to develop vaccinesduring the COVID-19 pandemic due to the widespread urgency to contain the spread of this disease globally. High transfection efficiency, effective gene delivery, and stable gene expression have enabledviral vectors a preferred choice for gene transfer which in turn is propelling the market growth.




  • Non-Viral Vector




Non-replicating viral vectors are used in the COVID-19 viral vector vaccines. Increasing adoption of these non-viral vectors for vaccine development in the pandemic further boosts the market growth. According to an article published in PubMed in 2017, the development of non-viral DNA vectors has progressed steadily, especially in plasmid vector length reduction. This factor is also significantly contributing to the market growth of the segment.


By Workflow Type




  • Upstream Processing




Upstream processing includes virus cells, cell culture, and cell recovery. The companies’ shifting focus on offering a broad range of advanced products and services for upstream processingactsas an accelerating factor for the market growth. For instance, Boehringer Ingelheim is involved in offering a high titer plasmid DNA fermentation process that produces high yield plasmid DNA in E. coli biomass. Similarly, GE Healthcare is involved in the development of upstream cell culture processes using modern tools and technologies.



The downstream processing segment dominated the viral vectors andplasmid DNA manufacturing market. Downstream processing is focused on eradicating contaminants originating from host cells or culture media. The process further produces large volumes of concentrated, biologically active viruses that are highly efficient in gene transfer.


By Application




  • Antisense & RNAi Therapy




According to the article published in 2020 in Viruses, RNA interference (RNAi) is being used as an alternative antiviral therapy. RNAi delivery in the form of short interfering RNA (siRNA), short hairpin RNA (shRNA), and micro-RNA (miRNA) have proven efficacy in gene silencing for therapeutic applications against viral diseases. This factor is propelling the market growth of the segment.



Gene therapies in manufacturingviral vectors are widely recommended for various disorders such as sickle cell anemia, cystic fibrosis, hemophilia, Duchenne muscular dystrophy, severe combined immunodeficiency, Parkinson’s diseases, etc.The increasing prevalence of genetic disorders, growing awareness of gene therapy, and infectious diseases globally are likely to upsurge the market growth of gene therapy in the viral vector and plasmid DNA manufacturing market.



The increasing number of companies involved in manufacturing approaches for producing the cell therapies, and to a large degree for viral vector manufacturing processes to meet the clinical requirements for late-phase clinical trials for viral vectors and plasmid DNA is driving the market growth for this segment.




  • Vaccinology




The vaccinology segment dominated the viral vectors and plasmid DNA manufacturing market in 2020. This can be attributed to the rising use of viral vectors in vaccine development owing to their high efficiency-related benefits such as the potential to elicit a wide immune response, easy manufacturing, and safety profiles.




  •  Research




Increasing R&D activities focused on viral vectors and plasmid DNA manufacturing along with rising R&D spending by governments globally are fueling the market growth of this segment.


By Disease Type




  • Cancer




Based on application, cancer dominated the global viral vectors and plasmid DNA manufacturing market in 2020. The growth of this segment can be attributed to viruses that have proven to beefficient as an ideal vector for gene therapy production against severalcancer types. According to the published article in Frontiers in April 2020, the tumor immunotherapy approaches, such as immune checkpoint blockade (ICB) and chimeric antigen receptor T-cell (CAR-T) therapy, have been successful in cancer treatment and has also revolutionized cancer treatment by improving efficacy and extending treatment to a larger proportion of cancer patients.




  • Genetic Disorders




Gene therapies along with viral vectors are widely recommended for a range of genetic disorders, such as severe combined immunodeficiency, sickle cell anemia, cystic fibrosis, Duchenne muscular dystrophy, hemophilia, Parkinson’s disease, and Gaucher disease, among others. Genetic disorders are one of the most focused application segmentsfor gene therapy. The increasing number of genetic disorders and market players involved in the development of viral vectors are acting as a stimulating factor for market growth. For instance, according to the data published in Science Direct in 2020, an incidence of 3.8 per 1,000 chromosomal disorders, 646.4 per 1,000 multifactorial disorders,and 20 per 1,000 single-gene disorders occur every year.



Viral vector-based vaccines are being used widely to fight major diseases, such as HIV-1 and malaria. According to the article published in 2019, HIV/AIDS continues to be a global burden andhas devastating health effects globally, with over 39 million HIV/AIDS-related deaths withmore than 36 million people currently living with HIV. With this rising burden of infectious diseases, there is a need for viral vectors and the manufacturing of plasmid DNA.




  • Others




The other applications of viral vector and plasmid DNA manufacturing include metabolic disorders and heart defects. Increasing adoption of viral vectors for the treatment of metabolic disorders and heart defectsis driving the market growth of this segment. Gene therapy has proved to be an effective treatment for various metabolic disorders caused by genetic defects in both animal models and human clinical trials. These therapies are being used as a viral-mediated gene addition approach which is another key factor boosting the market growth of viral vectors and plasmid DNA manufacturing.


By End user




  • Pharmaceutical and Biopharmaceutical Companies




The increasing number of gene therapy-based R&D programs by many pharmaceuticals and biopharmaceutical companies are triggering the market growth of viral vectors and plasmid DNA manufacturing.




  •  Research Institutes




The research institutes segment dominated the viral vectors and plasmid DNA manufacturing market in 2020. The rising number of research institutes is expected to increase the demand for viral vectors in the global market. National Institute for Physiological Sciences (Japan), Maine Medical Center Research Institute (US), and the Viral Vector Core (VVC) (Belgium)are few research communitiesinvolved in the production of vectors.


By Region




  • North America




North America dominated the market for global viral vectors and plasmid DNA manufacturin gowing to the presence of a large number of research centers involved in the R&D of advanced therapies. In addition, the construction of the manufacturing plants by the players of other regions in North Americais another propelling factor for the market growth of this region. For instance, in February 2021, Vibalogics (Germany)builta virotherapy manufacturing plant in Massachusetts. The company also expanded its manufacturing capabilities with aninvestment of USD 150 million.




  • Asia-Pacific




Asia-Pacific is projected to witness rapid growth in the global viral vectors and plasmid DNA manufacturing market. The market in the Asia-Pacific region has gained momentum in terms of product approvals and pipeline programs pertaining to viral vectors and plasmid DNA manufacturing. This can be attributed to the establishment of accelerated approval pathways, the rising pool of patient population, growing private and government investments, and increasing healthcare needs. Furthermore, the unmet needs in the personalized medicine arena are leading to the increasing demand for viral vector supply.


Competitive Landscape


The viral vectors and plasmid DNA manufacturing market is profitable, both for existing players as well as new entrants. A substantial level ofrivalry is witnessed among the market players in the viral vector and plasmid DNA manufacturing market. Based on MRFR’sanalysis, market players have adopted different strategies, innovative research activities, product approvals, and development techniques to expand their business and secure their position in the global viral vectors and plasmid DNA manufacturing market.

Recent Development



  • May 2021 – Charles River Laboratories International Inc announced the acquisition of US-based Vigene Biosciences, cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) offering viral vector-based delivery solutions for research and clinical applications.

  • February 2022 – a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, Asklepios BioPharmaceutical, Inc., and a biotechnology company pioneering enzymatic DNA production, Touchlight, have disclosed a modified structure to their old joint venture, Touchlight AAV.

  • February 2022 – AGC Biologics, a prominent global Contract Development and Manufacturing Organization, announced the expansion of its collaboration to supply more plasmid DNA starting material for the Pfizer-BioNTech COVID-19 vaccine Comirnaty at the firm’s Heidelberg facility.

  • September 2021- AGC Biologics has announced the expansion of its Heidelberg facility for the production of the latest plant for boosting manufacturing capabilities for its plasmid-DNA (pDNA)messenger and RNA (mRNA) projects.


Key Players



  • Cognate BioServices, Inc. (US)  

  • Catalent Pharma Solutions (US)

  • Fujifilm Holdings Corporation (Japan)

  • Johnson & Johnson (US)

  • Sanofi Corporation (France)

  • Hoffmann-LA Roche Ltd (Switzerland)

  • 4D Molecular Therapeutics (US)

  • Sirion Biotech GmbH (Germany)

  • Voyager Therapeutics (US)

  • Thermo Fisher Scientific, Inc. (US)

  • Gene Therapy Catapult (UK)

  • UniQure(Netherlands)

  • MassBiologics (US)

  • Renova Therapeutics (US)

  • Shenzhen SiBionoGeneTech Co., Ltd (China)


Recent Developments




  • In January 2020, Genopis Inc. (US) announced that it wouldbuild a contract manufacturing business for plasmid DNA production in the United States with its South Korea-based partner Helixmith (South Korea).




  • In April 2018, GE Healthcare (US) created a ‘factory-in-a-box’ facility for the production of viral vector-based drugs, including viral vector vaccines, oncolytic viruses, and gene and cell therapies.




Report Overview:

The study covers the existing short-term and long-term market effects, as well as helping decision-makers to draught short-term and long-term plans for businesses by region. The report covers major regions in North America, Europe, Asia-Pacific, and the Rest of the World. The report analyzes market drivers, restraints, opportunities, challenges, Porter's Five Forces, Value Chain, and impact of COVID-19 on the market. Scope of the Report The scope of the global viral vectors and plasmid DNA manufacturingmarket study includes market size analysis and a detailed analysis of the manufacturer’s products and strategies. The market has been segmented based on product type, application, and region.


Market Segmentation


Global Viral Vectors and Plasmid DNA Manufacturing, by Vector Type




  • Plasmid DNA




  • Viral Vector




  • Non-Viral Vector




Global Viral Vectors and Plasmid DNA Manufacturing, by Workflow Type




  • Upstream Processing




  • Downstream Processing




Global Viral Vectors and Plasmid DNA Manufacturing, by Disease Type




  • Cancer




  • Genetic Disorders




  • Infectious Diseases




  • Others




Global Viral Vectors and Plasmid DNA Manufacturing, by Application




  • Antisense & RNAi Therapy




  •  Gene Therapy




  •  Cell Therapy




  •  Vaccinology




  •  Research




Global Viral Vectors and Plasmid DNA Manufacturing, by End User




  • Pharmaceutical and Biopharmaceutical Companies




  • Research Institutes




Global Viral Vectors and Plasmid DNA Manufacturing, by Region




  • North America




    • US




    • Canada






  • Europe




    • Germany




    • France




    • UK




    • Italy




    • Spain




    • Rest of Europe






  • Asia-Pacific




    • China




    •  Japan




    •  India




    •  Australia




    •  South Korea




    •  Rest of Asia-Pacific






  • Rest of the World




    • Middle East




    • Africa




    • Latin America







Report Scope:

Report Attribute/Metric Details
  Market Size   2027: USD 587.5 million
  CAGR   16.92% : 2027
  Base Year   2019
  Forecast Period   2020-2027
  Historical Data   2018
  Forecast Units   Value (USD Million)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   Vector Type, Workflow, Disease Type,Application and End user
  Geographies Covered   North America, Europe, Asia-Pacific, Rest of the World
  Key Vendors   Cognate BioServices, Inc. (US) Catalent Pharma Solutions (US) Fujifilm Holdings Corporation (Japan) Johnson & Johnson (US) Sanofi Corporation (France) F. Hoffmann-LA Roche Ltd (Switzerland) 4D Molecular Therapeutics (US) Sirion Biotech GmbH (Germany) Voyager Therapeutics (US) Thermo Fisher Scientific, Inc. (US) Gene Therapy Catapult (UK) UniQure (Netherlands) MassBiologics (US) Renova Therapeutics (US) Shenzhen SiBionoGeneTech Co., Ltd (China)
  Key Market Opportunities   Increasing employment of viral vectors and plasmid DNA for the R&D of advanced therapies
  Key Market Drivers   Rising prevalence of genetic disorders and infectious diseases Increasing number of market players involved in new product launch, strategic collaborations, acquisition, and geography expansion


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Frequently Asked Questions (FAQ) :

The Viral Vectors and Plasmid DNA Manufacturing Market can expand at 16.92% CAGR by 2027.

Cognate BioServices, Inc. (US) ,Catalent Pharma Solutions (US),Fujifilm Holdings Corporation (Japan),Johnson & Johnson (US),Sanofi Corporation (France),Hoffmann-LA Roche Ltd (Switzerland),4D Molecular Therapeutics (US),Sirion Biotech GmbH (Germany),Voyager Therapeutics (US),Thermo Fisher Scientific, Inc. (US),Gene Therapy Catapult (UK) are key players of the Viral Vectors and Plasmid DNA Manufacturing Market

By 2027, The Viral Vectors and Plasmid DNA Manufacturing Market value can exceed USD 587.5 million.

North America is the best-performing region of the global Viral Vectors and Plasmid DNA Manufacturing Market

Rising prevalence of genetic disorders and infectious diseases