Table of Content

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

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

Growth Environment
Key Approved CGTs Until Q1 2022
Key Approved CGTs Until Q1 2022 (continued)
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

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

CGT Investment and M&A Snapshot
Key Trends Driving Investment, Expansion, Partnerships, and M&As
Key Trends Driving Investment, Expansion, Partnerships, and M&As (continued)
Trends in CGT Investment, 2021
Notable Start-up Financing, 2021
Notable M&As, 2021–Q1 2022

CGT Reimbursement Snapshot
Current Reimbursement Approach for CGTs: US and EU5
Current Reimbursement Approach for CGTs: APAC
Examples of Innovative CGT Reimbursement Models

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

Growth Opportunity Analysis, Cell Therapy
Growth Metrics, Cell Therapy
Revenue Forecast: Cell Therapy
Revenue Forecast by Source
Revenue Forecast Analysis

Growth Opportunity Analysis, Gene Therapy
Growth Metrics, Gene Therapy
Revenue Forecast: Gene Therapy
Revenue Forecast by Technology
Revenue Forecast Analysis

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

Growth Opportunity Universe
Growth Opportunity 1: Internal Capabilities for GMP-grade Plasmid Manufacturing
Growth Opportunity 1: Internal Capabilities for GMP-grade Plasmid Manufacturing (continued)
Growth Opportunity 2: Early Adoption of RWE to Facilitate CGT Approval and Access
Growth Opportunity 2: Early Adoption of RWE to Facilitate CGT Approval and Access (continued)
Growth Opportunity 3: Application of CRISPR/Cas9 to Develop Allogeneic Cell-based Immuno-oncology Therapies
Growth Opportunity 3: Application of CRISPR/Cas9 to Develop Allogeneic Cell-based Immuno-oncology Therapies (continued)
Growth Opportunity 4: Scalable Bioreactors and Cryopreservation Solutions
Growth Opportunity 4: Scalable Bioreactors and Cryopreservation Solutions (continued)