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

Pages: 62 Published: May 31, 2021 Report Code: GDPS0036MAR

The bio/pharmaceutical industry is experiencing a shortage of viral vectors, a component needed to produce gene therapies and gene-modified cell therapies, as well as certain COVID-19 vaccines that require a viral vector, notably those from AstraZeneca and Johnson & Johnson (J&J). This report reveals that viral vector production is limited by insufficient manufacturing capacity, an inefficient manufacturing process, and the requirement for complex specialist facilities.

There are 14 therapies/vaccines that use a viral vector (gene therapies, gene-modified cell therapies, and recombinant vector vaccines) marketed in the EU, Japan, US, and/or UK (post-Brexit).

Fiona Barry, Associate Editor of GlobalData PharmSource, comments: “We predict that this number will soar in the near future. We anticipate that over 100 more gene therapies and gene-modified cell therapies will be approved over approximately the next six years. These therapies will all need viral vectors and will exacerbate the manufacturing shortage.

“A second and more immediate stress on the viral vector supply chain is their use in some COVID-19 vaccines, specifically recombinant vector vaccines. AstraZeneca’s and Johnson & Johnson’s vaccines, as well as some COVID-19 vaccines in use in Russia and China, are of this molecule type.”

Barry continues: “The pharmaceutical industry is working to solve this shortage through scaling up facilities and developing more efficient processes. Top contract manufacturing organisations are investing in more sites, and the industry is working on increasing the efficiency of viral vector production by improving upstream and downstream processes.”

Although these were not the first COVID-19 vaccines to reach the public—mRNA vaccines made by Pfizer/BioNTech and Moderna were first to be administered in North America and Europe under Emergency Use Authorizations (EUAs) or equivalent temporary authorizations—there is a significant need for other vaccine types too. Governments have in aggregate placed orders of approximately 900 million doses for AstraZeneca’s and J&J’s COVID-19 vaccines.

On top of the already approved drugs, there are more than 3,000 gene therapies, gene-modified cell therapies, and recombinant vector vaccines in the development pipeline.

Pipeline Gene Therapies, Gene-Modified Cell Therapies, and Recombinant Vector Vaccines

Picture1.jpg

Barry adds: “Regulatory changes would also ease the viral vector bottleneck. If agencies approve standardized viral platforms that could be used interchangeably by therapy developers, this would speed up development, approval, and technology transfer to CMOs.”

Scope

This report is the companion to GlobalData’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.

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

Key Players

  • 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

Table of Contents

1 Executive Summary

2 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

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)

Frequently Asked Questions

$4995

Can be used by individual purchaser only

$14985

Can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company

Get in touch to find out about multi-purchase discounts

reportstore@globaldata.com
Tel +44 (0) 20 7947 2960

GDPR + CCPA Compliant

Personal and transaction information are kept safe from unauthorised use.

Recently Viewed Reports

Looking to stay on top of industry & market trends?

Sign up to receive regular alerts for our latest analysis and reports. No matter your industry focus, you can keep your finger on the pulse with our timely updates.