Worldwide Markets for Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing, Forecast to 2030 - Robust Pipeline of Therapy Candidates and Technical Advances Projected to Drive the Market

Dublin, Nov. 27, 2019 (GLOBE NEWSWIRE) -- The "Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market (3rd Edition), 2019-2030 (Focus on AAV, Adenoviral, Lentiviral, Retroviral, Plasmid DNA and Other Vectors)" report has been added to ResearchAndMarkets.com's offering.

This report features an extensive study of the rapidly growing market of viral and non-viral vector and gene therapy manufacturing, focusing on contract manufacturers, as well as companies with 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.

At present, 10+ genetically modified therapies have received approval / conditional approval in various regions of the world; these include (in the reverse chronological order of year of approval) Zynteglo (2019), Zolgensma (2019), Collategene (2019), LUXTURNA (2017), YESCARTA (2017), Kymriah (2017), INVOSSA (2017), Zalmoxis (2016), Strimvelis (2016), Imlygic (2015), Neovasculagen (2011), Rexin-G (2007), Oncorine (2005) and Gendicine (2003). In addition, over 500 therapy candidates are being investigated across different stages of development. The growing number of gene-based therapies, coupled to their rapid progression through the drug development process, has created significant opportunities for companies with expertise in vector manufacturing.

Presently, a number of industry (including both well-established companies and smaller R&D-focused initiatives), and non-industry players (academic institutes) claim to be capable of manufacturing different types of viral and non-viral vectors. In addition, there are several players offering novel technology solutions, which are capable of improving existing genetically modified therapy products and upgrading their affiliated manufacturing processes.

Considering prevalent and anticipated future trends, we believe that the vector and gene therapy manufacturing market is poised to grow steadily, driven by a robust pipeline of therapy candidates and technical advances aimed at mitigating existing challenges related to gene delivery vector and advanced therapy medicinal products.

Chapter Outlines

Chapter 2 is an executive summary of the insights captured in our research. The summary offers a high-level view on the likely evolution of the vector and gene therapy manufacturing market in the short to mid-term, and long term.

Chapter 3 is a general introduction to the various types of viral and non-viral vectors. It includes a detailed discussion on the design, manufacturing requirements, advantages, limitations and applications of currently available gene delivery vehicles. The chapter also provides a brief description of the clinical and approved pipeline of genetically modified therapies. Further, it includes a review of the latest trends and innovations in the contemporary vector manufacturing market.

Chapter 4 provides a detailed overview of around 80 companies, featuring both contract service providers and in-house manufacturers that are actively involved in the production of viral vectors and / or gene therapies utilizing viral vectors. The chapter provides details on the year of establishment, scale of production, type of viral vectors manufactured (AAV, adenoviral, lentiviral, retroviral and others), location of manufacturing facilities, applications of vectors (gene therapies, cell therapies, vaccines and others) and purpose of production (fulfilling in-house requirements / for contract services).

Chapter 5 provides an overview of around 30 industry players that are actively involved in the production of plasmid DNA and other non-viral vectors and / or gene therapies utilizing non-viral vectors. The chapter provides details on the year of establishment, scale of production, location of manufacturing facilities, applications of vectors (gene therapies, cell therapies, vaccines and others) and purpose of vector production (fulfilling in-house requirements / for contract services).

Chapter 6 provides an overview of around 80 non-industry players (academia and research institutes) that are actively involved in the production of vectors (both viral and non-viral) and / or gene therapies. The chapter provides details on the year of establishment, scale of production, location of manufacturing facilities, type of vectors manufactured (AAV, adenoviral, lentiviral, retroviral, plasmid DNA and others), applications of vectors (gene therapies, cell therapies, vaccines and others) and purpose of vector production (fulfilling in-house requirements / for contract services).

Chapter 7 features detailed profiles of the US-based contract service providers / in-house manufacturers that possess commercial-scale capacities for the production of viral vectors/plasmid DNA. Each profile presents a brief overview of the company, its financial information (if available), details on vector manufacturing facilities, manufacturing experience and an informed future outlook.

Chapter 8 features detailed profiles of EU based contract service providers / in-house manufacturers that possess commercial-scale capacities for the production of viral vectors/plasmid DNA. Each profile presents a brief overview of the company, its financial information (if available), details on vector manufacturing facilities, manufacturing experience, and an informed future outlook.

Chapter 9 features detailed profiles of Asia-Pacific based contract service provider(s) / in-house manufacturer(s) that possess commercial scale capacities for production of viral vectors/plasmid DNA. Each profile presents a brief overview of the company, its financial information (if available), details on vector manufacturing facilities, manufacturing experience, and an informed future outlook.

Chapter 10 provides detailed information on other viral / non-viral vectors (including alphavirus vectors, Bifidobacterium longum vectors, Listeria monocytogenes vectors, myxoma virus-based vectors, Sendai virus-based vectors, self-complementary vectors (improved versions of AAV), and minicircle DNA and Sleeping Beauty transposon vectors (non-viral gene delivery approach)) that are currently being utilized by pharmaceutical players to develop gene therapies, T-cell therapies and certain vaccines, as well. This chapter presents overview on all the aforementioned types of vectors, along with examples of companies that use them in their proprietary products. It also includes examples of companies that are utilizing specific technology platforms for the development/manufacturing of some of these novel vectors.

Chapter 11 features an elaborate analysis and discussion of the various collaborations and partnerships related to the manufacturing of vectors or gene therapies, which have been inked amongst players. It includes a brief description of the purpose of the partnership models (including licensing agreements, mergers/acquisitions, product development, service alliances, manufacturing, and others) that have been adopted by the stakeholders in this domain, since 2015. It consists of a schematic representation showcasing the players that have forged the maximum number of alliances. Furthermore, we have provided a world map representation of the deals inked in this field, highlighting those that have been established within and across different continents.

Chapter 12 presents a collection of key insights derived from the study. It includes a grid analysis, highlighting the distribution of viral vectors and plasmid DNA manufacturers on the basis of their scale of production and purpose of manufacturing (fulfilling in-house requirement/contract service provider). In addition, it consists of a logo landscape, representing the distribution of viral vector and plasmid DNA manufacturers based on the type of organization (industry / non-industry) and size of employee base. The chapter also consists of six world map representations of manufacturers of viral / non-viral vectors (lentiviral, adenoviral, AAV and retroviral vectors, and plasmid DNA), depicting the most active geographies in terms of the presence of the organizations. Furthermore, we have provided a schematic world map representation to highlight the locations of global vector manufacturing hubs across different continents.

Chapter 13 highlights our views on the various factors that may be taken into consideration while pricing viral vectors/plasmid DNA. It features discussions on different pricing models/approaches that manufacturers may choose to adopt to decide the prices of their proprietary products.

Chapter 14 features 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. This section offers an opinion on the required scale of supply (in terms of vector manufacturing services) in this market. For the purpose of estimating the current clinical demand, we considered the active clinical studies of different types of vector-based therapies that have been registered till date. The data was analysed on the basis of various parameters, such as number of annual clinical doses, trial location, and the enrolled patient population across different geographies. Further, in order to estimate the commercial demand, we considered the marketed vector-based therapies, based on various parameters, such as target patient population, dosing frequency and dose strength.

Chapter 15 features an informed analysis of the overall installed capacity of the vectors and gene therapy manufacturers. The analysis is based on meticulously collected data (via both secondary and primary research) on reported capacities of various small-sized, mid-sized and large companies, distributed across their respective facilities. The results of this analysis were used to establish an informed opinion on the vector production capabilities of the organizations across different types of vectors (viral vectors, plasmid DNA, and both), scale of operation (clinical and commercial) and geographies (North America, EU, Asia-Pacific and the rest of the world).

Chapter 16 presents a comprehensive market forecast analysis, highlighting the likely growth of vector and gene therapy manufacturing market till the year 2030. We have segmented the financial opportunity on the basis of [A] type of vectors (AAV vector, adenoviral vector, lentiviral vector, retroviral vector, plasmid DNA and others), [B] applications (gene therapy, cell therapy and vaccines), [C] therapeutic area (oncological disorders, inflammation & immunological diseases, neurological disorders, ophthalmic disorders, muscle disorders, metabolic disorders, cardiovascular disorders and others), [D] scale of operation (preclinical, clinical and commercial) and [E] geography (North America, Europe, Asia Pacific and rest of the world). Due to the uncertain nature of the market, we have presented three different growth tracks outlined as the conservative, base and optimistic scenarios.

Chapter 17 provides details on the various factors associated with popular viral vectors and plasmid DNA that act as market drivers and the various challenges associated with the production process. This information has been validated by soliciting the opinions of several industry stakeholders active in this domain.

Chapter 18 presents insights from the survey conducted on over 160 stakeholders involved in the development of different types of gene therapy vectors. The participants, who were primarily Director / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.

Chapter 19 summarizes the entire report. The chapter presents a list of key takeaways and offers our independent opinion on the current market scenario and evolutionary trends that are likely to determine the future of this segment of the industry.

Chapter 20 is a collection of transcripts of the interviews conducted with representatives from renowned organizations that are engaged in the vector and gene therapy manufacturing domain. In this study, we spoke to Menzo Havenga (Chief Executive Officer and President, Batavia Biosciences), Nicole Faust (Chief Executive Officer & Chief Scientific Officer, CEVEC Pharmaceuticals), Jeffrey Hung (Chief Commercial Officer, Vigene Biosciences), Olivier Boisteau, (Co-Founder / President, Clean Cells) and Xavier Leclerc (Head of Gene Therapy, Clean Cells), Laurent Ciavatti (Business Development Manager, Clean Cells), Joost van den Berg (Director, Amsterdam BioTherapeutics Unit), Bakhos A Tannous (Director, MGH Viral Vector Development Facility, Massachusetts General Hospital), Colin Lee Novick (Managing Director, CJ Partners), Cedric Szpirer (Executive & Scientific Director, Delphi Genetics), Semyon Rubinchik (Scientific Director, ACGT), Alain Lamproye (President of Biopharma Business Unit, Novasep), Astrid Brammer (Senior Manager Business Development, Richter-Helm), Brain M Dattilo (Business Development Manager, Waisman Biomanufacturing), Marco Schmeer (Project Manager, Plasmid Factory) and Tatjana Buchholz (Marketing Manager, Plasmid Factory), and Nicolas Grandchamp (R&D Leader, GEG Tech).

Chapter 21 is an appendix, which provides tabulated data and numbers for all the figures in the report.

Chapter 22 is an appendix that provides the list of companies and organizations that have been mentioned in the report.

Key Topics Covered

1. Preface
2. Executive Summary
3. Introduction
4. Viral Vector and Gene Therapy Manufacturers (Industry Players): Competitive Landscape
5. Plasmid DNA and Gene Therapy Manufacturers (Industry Players): Competitive Landscape
6. Vector and Gene Therapy Manufacturers (Non-Industry Players): Competitive Landscape
7. Vector and Gene Therapy Manufacturers in North America
8. Vector and Gene Therapy Manufacturers in Europe
9. Vector and Gene Therapy Manufacturers in Asia-Pacific
10. Emerging Vectors
11. Recent Collaborations and Partnerships
12. Key Insights
13. Viral Vector and Plasmid DNA Cost Price Analysis
14. Capacity Analysis
15. Demand Analysis
16. Market Sizing and Opportunity Analysis
17. Key Drivers and Challenges
18. Survey Analysis
19. Concluding Remarks
20. Executive Insights
21. Appendix I: Tabulated Data
22. Appendix II: List of Companies and Organizations

Companies Mentioned

• 4D Molecular Therapeutics
• AbbVie
• Abeona Therapeutics
• Acucela
• Adaptimmune Therapeutics
• Addgene
• Aduro Biotech
• Advanced BioScience Laboratories (ABL)
• Advanced Biotherapeutics Consulting
• Advaxis
• ADVENT
• Adverum Biotechnologies (previously known as Avalanche Biotechnologies)
• Agenzia Italiana del Farmaco
• Agilent Technologies
• Agilis Biotherapeutics
• Aldevron
• Allele Biotechnology
• Alma Bio Therapeutics
• AlphaVax
• Althea Technologies
• American Gene Technologies
• Amgen
• AMSBIO
• Amsterdam BioTherapeutics Unit (AmBTU)
• Anaeropharma Science
• Anemocyte
• apceth Biopharma
• Applied Biological Materials (ABM)
• Applied Genetic Technologies (AGTC)
• Applied Viromics
• ARCO Design/Build
• Areta International
• Asklepios BioPharmaceutical
• Atlantic Bio GMP
• ATVIO Biotech
• Audentes Therapeutics
• Autolus
• AveXis
• Avista Capital Partners
• AVROBIO
• B-MoGen Biotechnologies
• Bamboo Therapeutics
• Batavia Biosciences
• Bavarian Nordic
• Baxter
• Beckman Research Institute
• Belfer Gene Therapy Core Facility, Cornell University
• Benitec Biopharma
• BioCancell
• Biogen
• Biomay
• Biomiga
• BioNTech Innovative Manufacturing Service (previously known as Eufects)
• BioReliance
• Biotec Services International
• Biotechnology Department of San Raffaele
• Biotherapeutics Development Unit, Cancer Research UK
• Biotie Therapies
• Bioverativ
• BioVex
• Biovian
• Blue Sky BioServices
• Bluebird Bio (previously known as Genetix Pharmaceuticals)
• Boehringer Ingelheim BioXcellence
• Brammer Bio (now a part of Thermo Fisher Scientific)
• Brazilian Biosciences National Laboratory (LNBio)
• BRC Clinical Research Facility and Cell Therapy Unit, King's College London
• Brewin Dolphin
• Bristol-Myers Squibb
• Brookside Capital
• California Institute for Regenerative Medicine
• California Institute of Technology
• Calimmune
• Cancer Research UK
• Capsugel
• Carnegie Institution for Science
• Celgene
• Cell and Gene Therapy Catapult
• Cell Therapy and Cell Engineering Facility, Memorial Sloan Kettering Cancer Center
• Celladon
• Cellectis
• Cellular Biomedicine Group
• Celonic
• Center for Biomedicine & Genetics, City of Hope
• Center for Cell & Gene Therapy, Baylor College of Medicine
• Center for Cell and Gene Processing, Takara Bio
• Centre for Cell and Vector Production, Centre for Commercialization of Regenerative Medicine
• CEVEC Pharmaceuticals
• Chiesi Farmaceutici
• Children's GMP, St. Jude Children's Research Hospital
• Children's Hospital of Philadelphia
• CIEMAT
• Cincinnati Children's Hospital Medical Center
• Clean Cells
• Clinical Biotechnology Centre, NHS Blood and Transplant
• Clinical Vector Production Core, University of Pittsburgh
• Cobra Biologics
• CombiGene
• Core Facility for Therapeutic Vectors, Institute of Medical Science Research Hospital
• Cranfield University
• Creative Biogene
• Creative Biolabs
• Creed Commercial Development
• Cytovance Biologics
• Deerfield Management
• Delphi Genetics
• Department of Neuroscience, University of Minnesota
• Desktop Genetics
• Division of Human Gene Therapy, Stanford University
• DNAtrix
• Elixirgen Scientific
• Emergent BioSolutions
• Epeius Biotechnologies
• EUFETS
• Eurofins Genomics
• Eurofins Scientific
• European Society of Gene and Cell Therapy
• ExcellGene
• Finnish Bioindustries
• FinVector (previously known as Ark Therapeutics)
• Fisher BioServices
• Five Prime Therapeutics
• FKD Therapies
• Flash Therapeutics
• Florida Biologix
• Fondazione Telethon
• Foundation Fighting Blindness
• Fraunhofer Institute for Toxicology and Experimental Medicine
• Freeline Therapeutics
• FUJIFILM Diosynth Biotechnologies
• GE Healthcare
• GEG Tech
• Genable Technologies
• Gene and Cell Therapy Lab, Institute of Translational Health Sciences
• Gene Editing and Viral Vector Core, City of Hope
• Gene Medicine Japan
• Gene Silencing and Expression Facility, Robinson Research Institute, University of Adelaide
• Gene Therapy Clinical Vector Production Core, University of Pittsburgh
• Gene Therapy Research Institute
• Gene Transfer Vector Core, Grousbeck Gene Therapy Center
• Gene Transfer Vector Core, Schepens Eye Research Institute
• Gene Transfer, Targeting and Therapeutics Core, Salk Institute for Biological Studies
• GeneCure Biotechnologies
• GeneDetect
• GeneImmune Biotechnology
• Genethon
• GENEWIZ
• GenIbet Biopharmaceuticals
• GenScript
• GenVec
• Genzyme
• GIGA Institute, Liege Universite
• Gilead Sciences
• GlaxoSmithKline
• Green Cross LabCell
• Guy's Hospital, London
• Hercules Capital
• Hong Kong Institute of Biotechnology
• Hookipa Biotech
• Hope Center Viral Vectors Core, Washington University School of Medicine
• Horizon Discovery
• Hospital de Sant Pau
• Human Gene and Cell Therapy Center, Akdeniz University
• Human Stem Cells Institute
• ID Pharma (previously known as DNAVEC)
• Immune Design
• Immune Technology
• ImmunoGenes
• Immunomic Therapeutics
• Inbiomed
• Indiana University Vector Production Facility
• Instituto de Tecnologia Qumica e Biolgica Antnio Xavier
• Intrexon
• InvivoGen
• IPPOX Foundation
• IQVIA Stem Cell Center
• Janelia Research Campus
• Janssen
• Kalon Biotherapeutics
• Kaneka Eurogentec
• Kelley School of Business, Indiana University
• King's College London, Guy's and St Thomas' NHS Foundation Trust
• Kite Pharma
• Kobe Biomedical Innovation Cluster
• Kolon Life Sciences
• Laboratory of Malaria Immunology and Vaccinology
• Lentigen Technology
• Lentiviral Lab, USC School of Pharmacy
• Leuven Viral Vector Core
• Lonza
• Luminous BioSciences
• Lund University
• Lysogene
• Massachusetts Eye and Ear
• Massachusetts Life Science Center
• MassBiologics
• MaxCyte
• Medigene
• MeiraGTx
• Merck
• Merck Serono
• Merial
• Michael J. Fox Foundation for Parkinson Research
• Mila's Miracle Foundation
• MilliporeSigma
• Ministry of Economy and Competitiveness
• Mitsubishi
• Molecular Diagnostic Services
• Molecular Virology Core, Oregon National Primate Research Center, Oregon Health & Science University
• MolMed
• Myeloma Crowd Research Initiative
• NanoCor Therapeutics
• Nantes Gene Therapy Institute
• National Cancer Institute
• National Center for Advancing Translational Sciences
• National Human Genome Research Institute
• National Institute of Neurodegenerative Disorders and Stroke Center Core, University of Minnesota
• National Institutes of Health
• National Virus Vector Laboratory, University of Eastern Finland
• Nature Technology
• Naval Medical Research Center
• Neuroscience CenterVector Core, Massachusetts General Hospital
• Neuroscience Gene Vector and Virus Core, Stanford Medicine
• NewLink Genetics
• Nikon CeLL innovation
• Novartis
• Novasep
• Ocular Gene Therapy Core, National Eye Institute
• Okairos
• Omnia Biologics
• Orchard Therapeutics
• Oxford BioMedica
• Oxford Genetics
• PacificGMP
• Paragon Gene Therapy, Catalent Biologics
• Penn Vector Core, University of Pennsylvania
• Pfizer
• PharmaChem Technologies
• Pinchal & Company
• PlasmidFactory
• Powell Gene Therapy Center, University of Florida
• Precigen
• ProBioGen
• ProMab Biotechnologies
• Protein Sciences
• Provecs Medical
• Puresyn
• Raymond G. Perelman Center for Cellular and Molecular Therapeutics, Children's Hospital of Philadelphia
• Rayne Cell Therapy Suite, King's College London
• REGENXBIO
• Renova Therapeutics
• Richter-Helm BioLogics
• RIKEN BioResource Research Center
• Roche
• Rock Springs Capital
• Rocket Pharmaceuticals
• SAB-Technology
• SAFC
• Sanofi CEPiA
• Sanofi Genzyme
• Sanofi Pasteur
• Sartorius Stedim Biotech
• Scancell
• Selecta Biosciences
• Shanghai Sunway Biotech
• Shenzhen SiBiono GeneTech
• SignaGen Laboratories
• SillaJen
• Sino Biological
• SIRION Biotech
• Sofinnova Ventures
• Spark Therapeutics
• St Thomas' NHS Foundation Trust
• Stevenage Bioscience Catalyst
• Strathmann Biotec
• Stratophase
• Synpromics
• Synthace
• Synthetic Genomics
• System Biosciences
• T. Rowe Price Associates
• Tecrea
• Terry Fox Laboratory
• Texas A&M University
• The Finnish Fair Foundation
• The Goldyne Savad Institute of Gene Therapy, Hadassah Medical Organization
• The Jarvis Lab
• The Wellcome Trust
• The Wellcome Trust / BRC Clinical Research Facility and Cell Therapy Unit (CTU), King's College London
• TheraBiologics
• THERAVECTYS
• Therexsys
• Thermo Fisher Scientific
• TissueGene
• Touchlight Genetics
• Transgene
• Treeway
• Twist Bioscience
• TxCell
• UAB Vector Production Facility
• uniQure
• Unit Biotech & ATMP's, University Medical Center Groningen
• UniTech Pharma
• University of Florida
• University of Iowa Research Foundation
• University of Lige
• University of Massachusetts Medical School System
• University of Oxford Clinical BioManufacturing Facility
• University of Virginia School of Medicine
• Vaccibody
• Vaccine and Gene Therapy Institute
• Valneva
• VBI Vaccine
• Vectalys
• Vector Biolabs
• Vector Core / GMP Facility, UC Davis Health
• Vector Core Laboratory, Powell Gene Therapy Center, University of Florida
• Vector Core of Gene Therapy, Laboratory of Nantes
• Vector Core, Harvard Gene Therapy Initiative
• Vector Core, Telethon Institute of Genetics and Medicine
• Vector Core, University of Michigan Medical School
• Vector Core, University of North Carolina
• Vector Development and Production Facility, Roswell Park Comprehensive Cancer Center
• Vector Development Core Laboratory, UC San Diego School of Medicine
• Vector Production Facility, Indiana University
• Vecura GMP Laboratory, Karolinska Institutet
• VGXI
• Vibalogics
• Vical
• Vigene Biosciences
• Viral Core Facility, NeuroCure
• Viral Core, Seattle Children's Research Institute
• Viral Gene Transfer Core, Massachusetts Institute of Technology
• Viral Vector and Cloning Core, University of Minnesota
• Viral Vector Core / Clinical Manufacturing Facility, Nationwide Children's Hospital
• Viral Vector Core Facility, University of Iowa Carver College of Medicine
• Viral Vector Core Laboratory, National Institute of Environmental Health Sciences
• Viral Vector Core Laboratory, The University of Tennessee Health Science Center
• Viral Vector Core, Duke University
• Viral Vector Core, Emory University School of Medicine
• Viral Vector Core, Maine Medical Research Institute
• Viral Vector Core, Sanford Burnham Prebys Medical Discovery Institute
• Viral Vector Core, The Jackson Laboratory
• Viral Vector Core, The Jenner Institute
• Viral Vector Core, University of Massachusetts Medical School
• Viral Vector Core, University of South Carolina School of Medicine
• Viral Vector Facility, Neuroscience Center Zurich
• Viral Vector Production Laboratory, Mayo Clinic Cancer Center
• Viral Vector Production Unit, Universitat Autnoma de Barcelona-Vall d'Hebrn Institut de Recerca
• Viral Vectors Laboratory, Louisiana State University School of Veterinary Medicine
• ViralGEN
• ViroMed
• Virovek
• VirusTech Core Facility, Karolinska Institutet
• Vivante GMP Solutions
• VIVEbiotech
• Voyager Therapeutics
• Waisman Biomanufacturing
• Weber Laboratory, Icahn School of Medicine at Mount Sinai
• Wellington Management
• West Biotherapy (also known as EFS Atlantic Bio GMP)
• Wolfson Gene Therapy Unit, University College of London
• WuXi AppTec
• Xpress Biologics
• Yposkesi
• Ziopharm Oncology

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