Gene Therapy Market Opportunity For CMOs – 2019 PharmSource Edition

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All the vital news, analysis, and commentary curated by our industry experts.

This report will explore whether the bio/pharma industry is adequately prepared for future gene therapy developments and whether CDMOs are making appropriate investments in the capacity and technology to support the coming opportunity. This report is a companion to Cell Therapy Market Opportunity for CMOs – 2018 Edition, GlobalData PharmSource, July 2018.

Scope

This 47-page report gives important, expert insight you won’t find in any other source. 28 tables and figures throughout the report illustrate major points and trends. This report is required reading for:

• CMO executives who must have deep understanding of the gene therapy marketplace to make strategic planning and investment decisions.

• Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.

• Pharmaceutical and Biotech companies involved in the development of gene therapies or gene therapy technologies.

• Private equity investors that need a deeper understanding of the market to identify and value potential investment targets.

Reasons to Buy

What are the characteristics of the gene therapy pipeline?

What volumes of viral vector will be required by 2024 for clinical and commercial gene therapy manufacturing, and how many bioreactors will be needed?

How many gene therapies from the current clinical pipeline are predicted to be approved?

What gene therapies have been approved by the FDA and EMA to date?

What is the geographic reach of gene therapy contract manufacturing organizations and what methods of transfection do they use?

What are the steps in the in vivo and ex vivo gene therapy supply chains?

What is the contract manufacturing organization opportunity for gene therapies?

What are the top therapy areas and indications for gene therapy clinical trials, 2013-2019?

How can the gene therapy manufacturing process be made more efficient?

What investments have contract manufacturing organizations and bio/pharmaceutical companies made in gene therapy manufacturing facilities and technologies?

Abeona Therapeutics Inc
Advanced BioScience Laboratories Inc
Adverum Biotechnologies Inc
Alliance for Regenerative Medicine
Amicus Therapeutics Inc
Applied Genetic Technologies Corp
AskBio
Atvio Biotech Ltd
Audentes Therapeutics Inc
AveXis Inc
Axovant Sciences Ltd
Batavia Biosciences BV
Benitec Biopharma Ltd
Biogen Inc
BioNTech SE
BioReliance Corp
Biovian Oy
bluebird bio
Brammer Bio LLC
Candel Therapeutics
Candel Therapeutics
Catalent Inc
Cell & Gene Therapy Catapult
Centre for Commercialization of Regenerative Medicine
Charles River Laboratories International Inc
City of Hope
Clinical BioManufacturing Facility
Cobra Biologics Ltd
Delphi Genetics SA
EMA
Emergent BioSolutions Inc
Evitria SA
Expression Systems LLC
FDA
FinVector Oy
FKD Therapies Oy
Fraunhofer-Gesellschaft zur Forderung der Angewandten Forschung eV
Fujifilm Diosynth Biotechnologies USA Inc
GE Healthcare
GenIbet Biopharmaceuticals SA
Genscript Biotech Corp
Genzyme Corp
GlaxoSmithKline Plc
Helixmith Co Ltd
Hitachi Chemical Co Ltd
Huazhong University of Science & Technology
Human Stem Cells Institute
iCarTAB BioMed Inc
ID Pharma Co Ltd
IDT Biologika GmbH
Instituto de Biologia Experimental e Tecnologica
International Society for Cellular Therapy
Kaneka Eurogentec SA
King's College London
LakePharma Inc
Lonza Group Ltd
MassBiologics
MeiraGTx
Memorial Sloan Kettering Cancer Center
Merck & Co Inc
Merck KGaA
Meridian Life Science Inc
Mitsubishi Tanabe Pharma Corp
MolMed SpA
MTG Biotherapeutics Inc
Nationwide Children's Hospital
NCI Biopharmaceutical Development Program
Neurotech Pharmaceuticals Inc
Nightstar Therapeutics PLC
Novartis
Novasep Holding SAS
OncoSec Medical Inc
Orchard Therapeutics Plc
Orgenesis
Oxford BioMedica Plc
Oxford Genetics Ltd
Paragon Bioservices Inc
Pfizer Inc
Polyplus
RegenxBio Inc
Sangamo Therapeutics Inc
Sanofi
Sarepta Therapeutics Inc
Shenzen SiBiono GeneTech Co Ltd
Sorrento Therapeutics Inc
Spark Therapeutics Inc
Symbiosis Pharmaceutical Services Ltd
Takara Bio Inc
Thermo Fisher Scientific
Tocagen Inc
UNC Vector Core
UniQure NV
Vascular Biogenics Ltd
Vibalogics GmbH
ViGene Biosciences Inc
ViralGen
Virovek InCorp
Voyager Therapeutics
Waisman Biomanufacturing
WuXi AppTec (Shanghai) Co Ltd
WuXi Biologics Co Ltd
Yposkesi SAS
Zelluna Immunotherapy
ZIOPHARM Oncology Inc

Table of Contents

Table of Contents

Executive Summary

Introduction

Commercial Gene Therapy Experience

Gene Therapy Pipeline

The Viral Vector Shortage

Approvals Outlook

Gene Therapy Supply Chain

Demand Models

What It Means

Notes on Methodology

Appendix

Table

Table 1: FDA-Approved, Marketed Gene Therapies

Table 2: EMA-Approved, Marketed Gene Therapies

Table 3: Top 10 Gene Therapy Sponsor Companies, All Development Stages

Table 4: Top 10 Gene Therapy Sponsor Companies, Phases I–III

Table 5: Predicted Gene Therapy Approvals

Table 6: Gene Therapy CMO Sites and their Methods of Transfection

Table 7: Model for Zolgensma and Luxturna Viral Vector Commercial Requirements, 2024

Table 8: Model for Yearly Commercial Gene Therapy Viral Vector Requirements

Table 9: Model for Yearly Clinical Gene Therapy Viral Vector Requirements

Table 10: Model for AAV Bioreactor Capacity

Table 11: Model for Lentiviral Bioreactor Capacity

Table 12: Forecast: Annual Viral Vector Bioreactor Capacity for Clinical and Commercial Gene Therapy

Table 13: Likelihood of Approval “N” values for Gene Therapy

Figures

Figure 1: Zolgensma Global Sales Forecast, 2019–2024 ($M)

Figure 2: Luxturna Global Sales Forecast 2019–2024 ($M)

Figure 3: Pipeline Gene Therapy Drugs by Stage

Figure 4: Phase I–III Gene Therapy Trial Starts by Sponsor Type

Figure 5: Phase I Gene Therapy Trial Starts by Sponsor Type

Figure 6: Phase II Gene Therapy Trial Starts by Sponsor Type

Figure 7: Phase III Gene Therapy Trial Starts by Sponsor Type

Figure 8: Top Ten Sponsors of Phase I–III Gene Therapy Trials, 2013–2019

Figure 9: Top Five Therapy Areas in Gene Therapy Trials, 2013–2019

Figure 10: Top Seven Indications in Gene Therapy Trials, 2013–2019

Figure 11: Reasons for Discontinuations of Gene Therapy Trials, 2013–2019

Figure 12: Top Gene Therapy CMOs by Number of Gene Therapy Facilities

Figure 13: Gene Therapy CDMOs by Number of Gene Therapy Facilities

Figure 14: Geographic Spread of Dedicated Contract Gene Therapy Contract Manufacturing Facilities

Figure 15: Geographic Spread of Excess Capacity Gene Therapy Contract Manufacturing Facilities

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