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Global Cell and Gene Therapy (CGT) Growth Opportunities

  • Report

  • 94 Pages
  • September 2022
  • Region: Global
  • Frost & Sullivan
  • ID: 5654033

The Shift to Prevalent Diseases and Allogeneic Cell Therapies Creates New Growth Opportunities in the CGT Value Chain

This study examines the global cell and gene therapy (CGT) market. It highlights revenue forecasts and key growth opportunities for CGT market participants based on the evolution of their business models and strategic approaches as well as investments and regulations. The study segments the market by product (cell therapy, gene-modified cell therapy, and gene therapy), and it also focuses on subsegments (allogeneic versus autologous; ex vivo versus in vivo). Market forecasts run from 2022 through 2027, and they capture key market developments, such as capacity expansion, mergers and acquisitions, and extension of services offerings set to impact overall CGT market growth.

As CGT moves from ultra-rare indications to more common indications, the rapid expansion of manufacturing capabilities to support the commercial requirements of these diseases will become a necessity. The migration from paper-based data to the digital format will connect individual patient supply chain data with individual patient clinical data and incorporate it into the overall analysis.

Time and speed will become crucial factors to stay ahead of the competition and reap the resulting benefits. The success of CGT in prevalent diseases, such as diabetes and stroke, will be the game changer during the forecast period and lead to new market access models.

The research service also covers the following topics:

  •  Market and Pipeline Snapshot
  •  Key Trends and Value Chain Analysis
  •  CGT Investment and M&A Snapshot
  •  CGT Reimbursement Snapshot
  •  CGT Regulatory Snapshot
  •  Drivers and Restraints
  •  Recent Acquisitions and Capacity Expansion by Major Bio-CDMOs

Table of Contents

1. Strategic Imperatives
  • Why Is It Increasingly Difficult to Grow?
  • The Strategic Imperative 8™
  • The Impact of the Top 3 Strategic Imperatives on the Global CGT Industry
  • Growth Opportunities Fuel the Growth Pipeline Engine™
  • Key Highlights
2. Growth Opportunity Analysis
  • Scope of Analysis
  • Segmentation
  • Definitions
  • Growth Metrics
  • Growth Drivers
  • Growth Restraints
  • Forecast Assumptions
  • Revenue Forecast
  • Revenue Forecast by Product
  • Revenue Forecast Analysis
  • Revenue Forecast by Region
  • Revenue Forecast Analysis by Region
  • Competitive Environment
  • Revenue Share
  • Revenue Share Analysis
3. Growth Environment
  • Key Approved CGTs Until Q1 202 - Upcoming Regulatory Approvals in the US and the EU
  • Pipeline Snapshot
  • Gene Therapy and Genetically Modified Cell Therapies: Pipeline Snapshot
  • Cell Therapies: Pipeline Snapshot
  • CGT for Cancer: A Snapshot
4. Key Trends and Value Chain Analysis
  • CGT Value Chain
  • CGT Stakeholder Ecosystem
  • Traditional Drugs versus CGT Business Models
  • Evolving CGT Business Model: Orchestrated Collaborations between Stakeholders across the Value Chain
  • Key CGT Stakeholders’ Portfolio Strategies
  • CGT Value Chain: Evolving Role of Stakeholders in Digitalization
  • Winning Strategies for CGT Companies
5. CGT Investment and M&A Snapshot
  • Key Trends Driving Investment, Expansion, Partnerships, and M&As
  • Trends in CGT Investment, 2021
  • Notable Start-up Financing, 2021
  • Notable M&As, 2021-Q1 2022
6. CGT Reimbursement Snapshot
  • Current Reimbursement Approach for CGTs: US and EU5
  • Current Reimbursement Approach for CGTs: APAC
  • Examples of Innovative CGT Reimbursement Models
7. CGT Regulatory Snapshot
  • Current Formal Regulatory Meetings with US and EU Regulatory Agencies
  • Approval Exemptions for CGT
  • Early Access Programs for CGT: Facilitated Approval
  • Early Access Programs for CGT: Priority Review
  • Early Access Programs for CGT: Priority Designation
  • Early Access Programs for CGT: Orphan Drug Designation
  • Regulatory Risk Assessment in Early Development
  • China’s Regulatory Environment has Drastically Evolved and Became Supportive for CGT Development, Leading to the Expansion of the Domestic CGT Industry
8. Growth Opportunity Analysis, Cell Therapy
  • Growth Metrics, Cell Therapy
  • Revenue Forecast: Cell Therapy
  • Revenue Forecast by Source
  • Revenue Forecast Analysis
9. Growth Opportunity Analysis, Gene Therapy
  • Growth Metrics, Gene Therapy
  • Revenue Forecast: Gene Therapy
  • Revenue Forecast by Technology
  • Revenue Forecast Analysis
10. Growth Opportunity Analysis, Gene-modified Cell Therapy
  • Growth Metrics, Gene-modified Cell Therapy
  • Revenue Forecast: Gene-modified Cell Therapy
  • Revenue Forecast by Source
  • Revenue Forecast Analysis
11. Growth Opportunity Universe
  • Growth Opportunity 1: Internal Capabilities for GMP-grade Plasmid Manufacturing
  • Growth Opportunity 2: Early Adoption of RWE to Facilitate CGT Approval and Access
  • Growth Opportunity 3: Application of CRISPR/Cas9 to Develop Allogeneic Cell-based Immuno-oncology Therapies
  • Growth Opportunity 4: Scalable Bioreactors and Cryopreservation Solutions
  • Next Steps
  • Your Next Steps
  • List of Exhibits