Report updated on 11th September, 2021: Global Viral Vectors And Plasmid Dna Manufacturing Market By Product Type (Viral Vectors, Plasmid Dna, Non-Viral Vectors), By Disease Indication (Cancer, Inherited Disorders, Viral Infections, Other Applications), By Region And Key Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends And Forecast 2019-2029 (Includes Business Impact of COVID-19)
Trusted Business Insights has published a comprehensive market research report on, Global Viral Vectors and Plasmid DNA Manufacturing Market by Product Type (Viral Vectors, Plasmid DNA, Non-Viral Vectors), By Disease Indication (Cancer, Inherited Disorders, Viral Infections, Other Applications), and by Region -Global Forecast to 2030, which offers a holistic view of the global Viral Vectors and Plasmid DNA Manufacturing market through systematic segmentation that covers every aspect of the target market.
The global Viral Vectors and Plasmid DNA Manufacturing Market is projected to be US$ 556.9 Mn in 2020 to reach US$ 2855.5 Mn by 2030 at a CAGR of 18.3%
Efficacy of gene therapy largely relies on the potential to safely deliver genetic information to target cells, either by the in-vivo or ex-vivo route. Ex-vivo requires the target cells to be extracted from the patient, transfected with the therapeutic gene and returned to the patient once the gene transfer is complete. While, the in-vivo procedure requires the vector to be introduced into the host, where it transduces target cells within the whole organism. Gene transfer has been successfully achieved with the help of viral and non-viral vectors. Currently, both viral and non-viral vectors have registered robust growth in preclinical and clinical settings. In recent years, viral vectors have transformed into the forefront of modern medicine. These have been efficiently employed for treatment of various critical diseases such as infectious diseases, muscular, metabolic, hematologic, ophthalmologic, and cardiovascular diseases and different types of cancer. Moreover, improvements in gene-silencing have been generating reversible effects and become an excellent alternative with the help of viral vectors. Originally developed as an alternative for transfection of naked DNA for molecular genetics experiments, viral vectors are now being aggressively used for gene therapy, as well as for the development of vaccines.
Earlier, rising incidence and prevalence of life-threatening diseases including infectious disease, genetic disorders, cancer, and other indications is expected to be one of the major factors driving the growth of the global viral vector and plasmid DNA manufacturing market. According to the National Cancer Institute: in 2018, around 1.7 Mn new cases of cancer will be diagnosed and about 0.6 Mn people will die from cancer in the US. While in 2012, globally there were 14.1 Mn new cases of cancer and 8.2 Mn cancer-related deaths.
Global Viral Vectors and Plasmid DNA Manufacturing Market Revenue (US$ Mn), 2021 to 2030
However, manufacturing of viral vectors and plasmid DNA is a complex, costly and a time-consuming process. Several products in pre-clinical and clinical stage may not get approved thus leading to an immense loss of investment, efforts and time. This is one of the major factor challenging the growth of the global viral vector and plasmid DNA manufacturing market. Nonetheless, even though certain developing economies are destitute of funding, technological know-how, and infrastructure capabilities they hold immense potential for viral vector and plasmid DNA manufacturing. Countries such as China, India, Brazil, Mexico have a strong manufacturing background in almost every domain. R&D activities, government support, and assistance from major biotechnology companies can help these companies to set-up cost-effective and scalable manufacturing facilities, thus limiting a large financial burden. This is expected to provide lucrative opportunities to the players and further boost the growth of the market.
Global Viral Vectors and Plasmid DNA Manufacturing market is segmented on the basis of product type, disease Indication, and region. On the basis of product type, the market is segmented into viral vectors, plasmid DNA, non-viral vectors. The viral vectors segment accounts for the majority share and is expected to register the highest growth over the forecast period, followed by plasmid DNA segment. On the basis of Disease indication, the market is segmented into Cancers, inherited disorders, viral infections, Other Applications. The Cancers segment accounts for a majority share in the global viral vectors and plasmid DNA manufacturing market.
Global Viral Vectors and Plasmid DNA Manufacturing Market by Product Type, 2018
On the basis of region, the market is segmented into North America, Europe, APAC, South America and Middle East Africa. The APAC accounts for the majority share in the global viral vectors and plasmid DNA manufacturing market, owing rapid increase in population and prevalence of diseases. Europe is expected to register the highest growth rate over the forecast period. Regions such as North America, South America, and MEA are expected to register stable growth over the forecast period.
The research report on the global Viral Vectors and Plasmid DNA Manufacturing market includes profiles of some of major companies such as Merck KGaA (Bioreliance), Gedeon Richter Plc, Lonza Group AG, Thermo Fisher Scientific, Inc, Kaneka Corporation, Mylan NV, Oxford Biomedica PLC, Finvector Oy, Fujifilm Diosynth Biotechnologies U.S.A. Inc., , Aldevron L.L.C, uniQure NV, Molecular Medicine SpA, Biovian Oy, GeneOne Life Science, Inc. (VGXI, INC.), PlasmidFactory GmbH & Co. KG.
Below are the active patents related to Viral Vectors And Plasmid Dna Manufacturing Market.
Patent number: EP1412510A2
Aav vector packaging plasmid for producing wtaav particles or pseudotyped aav particles without helper viruses, by means of a single transfection
The invention relates to AAV vector packaging plasmids for producing (pseudotyped) AAV particles without helper viruses, by means of a single transfection. The AAV vector packaging plasmids for the (pseudotyped) AAV particles contain the following DNA sequences: (a) an AAV rep gene, (b) an AAV cap gene, (c) AAV expression vector DNA sequences and (d) all additional helper virus DNA sequences that are required for the formation of AAV particles. The AAV vector packaging plasmids for producing wtAAV particles are characterised in that they contain (a) the complete AAV genome and (b) all helper virus DNA sequences that are required for the formation of AAV particles. The invention also relates to the use of said AAV packaging plasmids for producing wtAAV particles or pseudotyped AAV particles, in particular for gene therapy or tumour therapy.
Application File Date: 2002-05-08
Application Granted Date: 2014-08-20
Current Assignee: Deutsches Krebsforschungszentrum DKFZ
Patent number: US9045759B2
DNA plasmids with improved copy number
The present invention relates to the production of covalently closed circular (ccc) recombinant DNA molecules such as plasmids, cosmids, bacterial artificial chromosomes (BACs), bacteriophages, viral vectors and hybrids thereof, and more particularly to vector modifications that improve production yield of said DNA molecules in fermentation culture.
Application File Date: 2010-01-19
Application Granted Date: 2015-06-02
Current Assignee: Nature Technology Corp
Patent number: EP1412493B1
Methods and compositions relating to improved lentiviral vector production systems
The present invention provides HIV-derived lentivectors which are multiply modified to create highly safe, efficient, and potent vectors for expressing transgenes for gene therapy. The lentiviral vector comprise various combinations of an inactive central polypurine tract, a stuffer sequence, which may encode drug susceptibility genes, and a mutated hairpin in the 5 leader sequence that substantially abolishes replication. These elements are provided in conjunction with other features of lentiviral vectors, such as a self-inactivating configuration for biosaftey and promoters such as the EF1Alpha promoter as one example. Additional promoters are also described. The vectors can also comprise additional transcription enhancing elements such as the wood chuck hepatitis virus post-transcriptional regulatory element. These vectors therefore provide useful tools for genetic treatments for inherited and acquired disorders, gene-therapies for cancers and other disease, the creation of industrial and experimental production systems utilizing transformed cells, as well as for the study of basic cellular and genetic processes.
Application File Date: 2002-08-01
Application Granted Date: 2011-10-05
Current Assignee: Institut Clayton de la Recherche
Patent number: US20130072548A1
Scalable Manufacturing Platform for Viral Vector Purification and Viral Vectors So Purified for Use in Gene Therapy
Methods for preparing highly purified AAV vector formulations are provided. The highly pure AAV formulations described herein are superior for clinical use.
Application File Date: 2012-07-30
Application Granted Date: 2016-08-09
Current Assignee: Childrens Hospital of Philadelphia CHOP
Key Market Segments:
By Vector Type
- Adeno associated virus (AAV)
- Plasmid DNA
- Upstream Processing
- Vector Amplification & Expansion
- Vector Recovery/Harvesting
- Downstream Processing
- Antisense & RNAi
- Gene Therapy
- Cell Therapy
- Research Applications
- Pharmaceutical and Biopharmaceutical Companies
- Research Institutes
- Genetic Disorders
- Infectious Diseases
Key Market Players included in the report:
- Advanced BioScience
- Aldevron L.L.C
- Audentes Therapeutics
- Batavia Biosciences
- BioMarin Pharmaceutical
- BioNTech IMFS GmbH
- Biovian Oy
- Brammer Bio
- Catalent Inc.
- Cobra Biologics Ltd.
- Finvector Oy
- FUJIFILM Diosynth Biotechnologies U.S.A. Inc.
- Gedeon Richter Plc
- GeneOne Life Science Inc. (VGXI INC.)
- Genezen laboratories
- Kaneka Corporation
- Lonza Group AG
- Merck KGaA (Bioreliance)
- Miltenyi Biotec GmbH
- Molecular Medicine SpA
- Mylan NV
- Oxford Biomedica PLC
- PlasmidFactory GmbH & Co. KG
- RegenxBio, Inc.
- SIRION Biotech GmbH
- Takara Bio Inc.
- Thermo Fisher Scientific Inc
- uniQure NV
- Virovek Incorporation
- Waisman Biomanufacturing
- Wuxi Biologics
Below are the key development related to Viral Vectors And Plasmid Dna Manufacturing Market in 2020 and 2021.
May 2021: INVESTOR RELATIONS. Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. Charles River Laboratories to Acquire Vigene Biosciences to Enhance Gene Therapy Capabilities. Further Expands Charles River’s Scientific Capabilities in the High-Growth Cell and Gene Therapy CDMO Sector. Charles River Laboratories International, Inc. (NYSE: CRL) announced that it has signed a definitive agreement to acquire Vigene Biosciences, Inc., a premier, U.S.-based gene therapy contract development and manufacturing organization (CDMO) providing viral vector-based gene delivery solutions. The purchase price is expected to be $292.5 million in cash, subject to customary closing adjustments. In addition to the initial purchase price, the transaction includes contingent additional payments of up to $57.5 million based on future performance. The transaction is expected to close in the beginning of the third quarter of 2021, subject to regulatory requirements and customary closing conditions. Source
January 2021: Thermo Fisher Buys Novaseps Viral Vector Manufacturing Biz Pays more than $800 million to expand global capacity and address growing demand for cell and gene therapy. Thermo Fisher Scientific has completed the acquisition of Henogen S.A., Novaseps viral vector manufacturing business in Belgium for approximately $879 million. Novasep’s viral vector manufacturing business provides contract manufacturing services for vaccines and therapies to biotechnology companies and large biopharma customers. With two locations in Seneffe and Gosselies, Belgium, Novasep’s viral vector business offers more than 7,000 square meters of clinical and commercial manufacturing capacity. Source
December 2020: Thermo Fisher to open new cGMP plasmid DNA manufacturing facility in US. Thermo Fisher Scientific has announced the construction of a new cGMP plasmid DNA manufacturing facility in Carlsbad, Calif. The site will expand the companys clinical and commercial capabilities for cGMP plasmid DNA used as a critical raw material to develop and manufacture cell and gene-based therapies including life-saving cancer treatments as well as mRNA vaccines. In addition, the site will have the capability to produce large-scale plasmid DNA as a primary drug substance for DNA therapies. As the global plasmid market continues to grow rapidly, the global supply cannot meet the current and projected demand. The 67,000-square-foot facility, expected to be completed in the first half of 2021, will feature advanced technologies, including single use equipment with up to 1,000L scale, digital connectivity and data visibility to enable operational efficiencies and operator training. Source
June 2020: Emergent plots $75M expansion to produce viral vectors for expanding gene therapy business. Maryland-based Emergent BioSolutions has worked its way to the front lines of the COVID-19 vaccine manufacturing field with a suite of deals to produce U.S. supply. But Emergent has more on its mind than a coronavirus shot, and its taking its chances in an increasingly lucrative gene therapy market. Emergent will spend $75 million to add space at its Canton, Massachusetts, live viral vaccine facility to manufacture viral vectors for its growing gene therapy business. Source