Product Code: GDPS0028MAR
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.
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 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?
Table of Contents
- Executive Summary
- 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
List of Tables
- 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
List of 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