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Outlook for Viral Vector Contract Manufacturing - Gene Therapies, Cell Therapies, and COVID-19 Vaccines

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    Report

  • 62 Pages
  • May 2021
  • Region: Global
  • GlobalData
  • ID: 5328601
Summary

This report is the companion to the publisher’s Gene Therapy Market Opportunity for CMOs - 2019 Edition and Cell Therapy Market Opportunity for CMOs - 2018 Edition reports, which described the demand and supply for contract manufacturing in the gene and cell therapy markets. This latest report examines the approvals and manufacturing outlook for three drug molecule types that all require viral vectors in their production: gene therapies, gene-modified cell therapies, and recombinant vector vaccines. The report is critical for benchmarking the CMO industry's capacity to manufacture these vital vaccines and drugs and forecasting future approvals.

Scope

This 62-page report gives important, expert insight you won’t find in any other source. 22 figures and 15 tables throughout the report illustrate major points and trends. This report is required reading for -
  • CMO executives who must have deep understanding of the vaccine, cell therapy, and gene therapy marketplace to make strategic planning and investment decisions about viral vector manufacturing.
  • Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.
  • Private Equity investors that need a deeper understanding of the market to identify and value potential investment targets.

Reasons to Buy
  • Detailed view of the geographic distribution of viral vector contract manufacturing facilities worldwide and the proportion belonging to dedicated CMOs and excess capacity manufacturers
  • Leader and disruptor companies in the viral vector space
  • Analysis of pipeline and marketed gene therapies, cell therapies, and recombinant vector vaccines, by geography, development stage, and clinical trials
  • A detailed model forecasting future gene therapy, cell therapy, and recombinant vector vaccine approvals, and associated manufacturing volumes
  • Contract manufacturing agreements for the active pharmaceutical ingredient (API) component of these vaccines and therapies

Table of Contents

1 Executive Summary2 Players
3 Technology Briefing
3.1 Gene Therapies
3.2 Gene-Modified Cell Therapies
3.3 Recombinant Vector Vaccines
3.4 What Are Viral Vectors?
4 Trends
5 Industry Analysis
5.1 Pipeline Therapies and Vaccines
5.2 Marketed Therapies and Vaccines
5.3 Clinical Trials
5.3.1 Gene Therapies and Gene-Modified Cell Therapies
5.3.2 Recombinant Vector Vaccines
5.4 Top Therapy Areas and Indications
5.4.1 Gene Therapies and Gene-Modified Cell Therapies
5.4.2 Recombinant Vector Vaccines
6 Approvals and Volume Model
6.1 Projected Sales
6.1.1 Spotlight on Luxturna
6.1.2 Spotlight on Zolgensma
6.1.3 Spotlight on AstraZeneca’s COVID-19 Vaccine
6.1.4 Combined Recombinant Vector Vaccines
6.2 Gene Therapy and Gene-Modified Cell Therapy Volume Model
6.2.1 Product Approval
6.2.2 Benchmark Therapies
6.2.3 Commercial Demand
6.2.4 Clinical Demand
6.3 Recombinant Vector Vaccine Volume Model
6.4 Bioreactor Capacity
7 Value Chain - Contract Manufacturing Capabilities
7.1 Viral Vector Manufacturing Sites
7.2 Company Investments in Viral Vector Manufacturing
7.3 Spotlight on Emergent
7.4 Spotlight on Catalent
7.5 Spotlight on Thermo Fisher Scientific/Patheon
7.6 Other Company Investments
7.7 Contract Manufacturing Agreements
7.8 What It Means
7.8.1 The Future of Manufacturing
7.8.2 Cell Lines and Automation
8 Companies
9 Appendix
9.1 Methodology
9.2 Bibliography
9.3 Primary Research - Key Opinion Leaders
9.4 Further Reading
10 About the Authors
  • Contact Us

List of Tables
Table 1: Trends in Gene Therapy, Gene-Modified Cell Therapy, and Recombinant Vector Vaccines
Table 2: Marketed Gene Therapies, Gene-Modified Cell Therapies, and Recombinant Vector Vaccines
Table 3: Predicted Gene Therapy and Gene-Modified Cell Therapy Approvals
Table 4: Model for Zolgensma and Luxturna Viral Vector Clinical Requirements, 2025
Table 5: Model for Yearly Commercial Gene and Gene-Modified Cell Therapy Viral Vector Requirements
Table 6: Model for Yearly Clinical Gene Therapy and Gene-Modified Cell Therapy Viral Vector Requirements
Table 7: Combined J&J and AstraZeneca COVID-19 Vaccine Dose Demand
Table 8: Model for AAV (HEK293 mammalian cells) Bioreactor Capacity
Table 9: Model for Lentiviral Bioreactor Capacity
Table 10: Model for Adenovirus Bioreactor Capacity
Table 11: Annual Viral Vector Bioreactor Volumes for Gene Therapies and Recombinant Vector Vaccines
Table 12: Bioreactor Needs for Viral Vector Production for Gene Therapies and Recombinant Vector Vaccines
Table 13: Viral Vector Contract Manufacturing Sites and Their Methods of Transfection
Table 14: CMOs with Gene Therapy, Gene-Modified Cell Therapy, or Recombinant Vector Vaccine API Contracts, 2014-2020
Table 15: Further Reading
List of Figures
Figure 1: Leaders and Disruptors: Top Players in Manufacturing
Figure 2: Pipeline Therapies and Vaccines
Figure 3: Transfection Methods Used by Pipeline Gene Therapies and Gene-Modified Cell Therapies
Figure 4: Gene Therapy and Gene-Modified Cell Therapies Trial Starts, 2014-2020
Figure 5: Recombinant Vector Vaccine Trial Starts, 2014-2020
Figure 6: Phase I Trial Starts, 2014-2020
Figure 7: Phase II Trial Starts, 2014-2020
Figure 8: Phase III Trial Starts, 2014-2020
Figure 9: Top Sponsors for Gene Therapy and Gene-Modified Cell Therapy Trials, 2014-2020
Figure 10: Top Sponsors for Recombinant Vector Vaccine Clinical Trials, 2014-2020
Figure 11: Top Therapy Areas for Gene Therapy and Gene-Modified Cell Therapy Clinical Trials, 2014-2020
Figure 12: Top Indications for Gene Therapy and Gene-Modified Cell Therapy Clinical Trials, 2014-2020
Figure 13: Top Indications for Recombinant Vector Vaccine Clinical Trials, 2014-2020
Figure 14: Luxturna Global Sales Forecast ($M)
Figure 15: Zolgensma Global Sales Forecast ($M)
Figure 16: AstraZeneca’s COVID-19 Vaccine Global Sales Forecast ($M)
Figure 17: Combined Recombinant Vector Vaccines Global Sales Forecast
Figure 18: The Contract Manufacturing Value Chain
Figure 19: Viral Vector Dedicated Contract and Excess Capacity Facilities
Figure 20: US Viral Vector Contract Facilities (Dedicated and Excess Capacity)
Figure 21: Top CMOs by Number of Viral Vector Contract Manufacturing Sites
Figure 22: API Contract Manufacturing Agreements

Companies Mentioned

A selection of companies mentioned in this report includes:

  • 4D Molecular Therapeutics Inc
  • Abeona Therapeutics Inc
  • ActogeniX NV
  • Adaptimmune Ltd
  • Adrenas Therapeutics Inc Aspa Therapeutics Inc BridgeBio Pharma Inc
  • Advanced BioScience Laboratories Inc
  • Advantagene Inc
  • Advaxis Inc
  • Advent Srl
  • AGC Biologics SpA
  • Ajinomoto Bio-Pharma Services
  • Albany Molecular Research Inc
  • Albert B. Sabin Vaccine Institute Inc
  • Aldevron LLC
  • Almac Group Ltd
  • Altimmune Inc
  • Amicus Therapeutics Inc
  • Anchiano Therapeutics Ltd
  • Aruvant Sciences Inc
  • ASC Therapeutics Inc
  • Aslan Pharmaceuticals Ltd
  • Aspen Pharmacare Holdings Ltd
  • AstraZeneca KK
  • AstraZeneca Plc
  • AstraZeneca Plc University of Oxford
  • Attwill Medical Solutions
  • Batavia Biosciences BV
  • Baxter Biopharma Solutions
  • Benitec Biopharma Inc
  • BioCell Corp Ltd
  • Biological E Ltd
  • BioReliance Corp
  • bluebird bio Inc
  • Boehringer Ingelheim Biopharmaceuticals GmbH Boehringer Ingelheim RCV GmbH & Co KG
  • BriaCell Therapeutics Corp
  • Caladrius Biosciences Inc
  • Candel Therapeutics
  • Catalent Inc
  • Cell and Gene Therapy Catapult
  • Cell Therapies Pty Ltd
  • Cellectis SA
  • CELLforCURE
  • Celsion Corp
  • Centaur Biopharmaceutical Services Inc
  • Centre C3i
  • Chinook Therapeutics Inc
  • City of Hope
  • Coalition for Epidemic Preparedness Innovations Public Health Vaccines LLC
  • Cobra Biologics Ltd
  • CombiGene AB
  • Corautus Genetics Inc. (Inactive)
  • CRISPR Therapeutics AG
  • Daiichi Sankyo Biotech Co Ltd
  • Decibel Therapeutics Inc
  • DiNAQOR AG
  • Dompe Farmaceutici SpA
  • Editas Medicine Inc
  • Eiger BioPharmaceuticals Inc
  • ElevateBio LLC
  • Emergent BioSolutions Inc
  • enGene Inc
  • Flexion Therapeutics Inc
  • Forte Biosciences Inc
  • Fraunhofer-Gesellschaft zur Forderung der Angewandten Forschung eV
  • Freeline Therapeutics Holdings Plc
  • Fujifilm Diosynth Biotechnologies USA Inc
  • Gamaleya Federal Research Center of Epidemiology and Microbiology
  • Genethon SA Sarepta Therapeutics Inc
  • Genprex Inc
  • Genscript Biotech Corp
  • GenVec LLC
  • GeoVax Labs Inc
  • German Center for Infection Research
  • GlaxoSmithKline Plc
  • Grand River Aseptic Manufacturing Inc
  • Halix BV
  • Handl Therapeutics BV
  • Helocyte Biosciences Inc
  • Helocyte, Inc.
  • Hookipa Pharma Inc
  • IDT Biologika GmbH
  • IN8bio Inc
  • Indapta Therapeutics Inc
  • Innobation Co Ltd
  • Insud Pharma
  • International AIDS Vaccine Initiative
  • Ion Channel Innovations LLC
  • iosBio Pharma Ltd
  • Iovance Biotherapeutics Inc
  • IVERIC bio Inc
  • Janssen Pharmaceutica NV
  • Janssen Pharmaceutica NV Janssen Pharmaceuticals Inc
  • Janssen Pharmaceuticals Inc
  • JCR Pharmaceuticals Co Ltd
  • Jenner Institute
  • Johnson & Johnson
  • Juventas Therapeutics Inc
  • KBI Biopharma Inc
  • Kite Pharma Inc
  • Laboratorio Reig Jofre SA
  • Lentigen Technology Inc
  • Les Laboratoires Servier SAS
  • Lonza Group Ltd
  • Lysogene SAS
  • Massachusetts General Hospital
  • MaSTherCell SA
  • MaxCyte Inc
  • Merck KGaA
  • MilliporeSigma
  • Minaris Regenerative Medicine GmbH
  • Minaris Regenerative Medicine LLC
  • Minaris Regenerative Medicine LLC Showa Denko Materials Co Ltd
  • MTG Biotherapeutics Inc
  • Mustang Bio Inc
  • Noga Therapeutics Ltd
  • Novartis AG
  • Novartis Gene Therapies
  • Novartis International AG
  • Novasep Holding SAS
  • Novavax Inc
  • Ology Bioservices Inc
  • OncoSec Medical Inc
  • Oncternal Therapeutics
  • Orchard Therapeutics Plc
  • Otsuka Holdings Co Ltd
  • Oxford BioMedica Plc
  • Oxford-Emergent Tuberculosis Consortium Limited (Inactive)
  • Passage Bio Inc
  • Patheon NV
  • Patheon NV Patheon Viral Vector Services
  • Pfizer Inc
  • Pharmasyntez
  • Poseida Therapeutics Inc
  • Prevail Therapeutics Inc
  • ProBioGen AG
  • Profectus BioSciences Inc
  • Provecs Medical GmbH
  • PTC Therapeutics Inc
  • Rega Institute for Medical Research
  • RegenxBio Inc
  • ReiThera Srl
  • Renova Therapeutics Inc
  • Richter-Helm BioLogics GmbH & Co KG
  • Rocket Pharmaceuticals Inc
  • SanBio Company Limited
  • Sangamo Therapeutics France SAS
  • Sanofi
  • Sarepta Therapeutics Inc
  • Scenic Biotech BV
  • Selecta Biosciences Inc
  • Selexis SA
  • Sensorion SA
  • SGS Life Science Services
  • Sio Gene Therapies Inc
  • SK Bioscience
  • Spark Therapeutics Inc
  • Symbiosis Pharmaceutical Services Ltd
  • Synlogic Inc
  • Takara Bio Inc
  • Taysha Gene Therapies
  • TCR2 Therapeutics Inc
  • Themis Bioscience GmbH
  • T-Knife GmbH
  • Tonix Pharmaceuticals Holding Corp
  • Triumvira Immunologics Inc
  • TTY Biopharm Co Ltd
  • Ultragenyx Pharmaceutical Inc
  • UniQure NV
  • University of Oxford
  • Valneva SE
  • Vaxart Inc
  • VGXI Inc
  • Vibalogics GmbH
  • Vigene Biosciences Inc
  • ViGeneron GmbH
  • Vir Biotechnology Inc
  • Viralgen
  • Vivebiotech SL
  • Vivet Therapeutics SAS
  • Wacker Chemie AG
  • Waisman Biomanufacturing
  • WuXi AppTec (Shanghai) Co Ltd
  • WuXi AppTec Co Ltd
  • Xyphos Biosciences Inc
  • Yposkesi SAS
  • Zhejiang Hisun Pharmaceutical Co Ltd
  • ZIOPHARM Oncology Inc