세포 및 유전자 치료(CGT) 연구의 전망 및 기술의 성장 기회

CGT Landscape Assessment

The CGT landscape has evolved extensively over the past decade. More than 80 CGT products have been commercialized globally, with 34 FDA-approved cell and gene therapies in 2023 alone. The rise in product pipelines and clinical success rates has led to the growing demand for the development of new technology platforms, manufacturing capabilities, and expansion to new disease areas.

Over the past five years, the patent landscape, investment landscape, and clinical trial segment have had consistent growth and activity. All three segments contribute extensively to the growth of CGTs and showcase the promising potential of CGTs for the future. The CGT landscape has three main categories of therapies: cell therapies, gene therapies, and gene-modified cell therapies, with all three progressing well over the past years. Gene-modified cell therapies, such as CAR-T and CAR-NK, have a higher number of clinical programs in the pipeline and are expected to have a high clinical impact in the coming years.

CGT developers are exploring new disease areas, apart from hematological conditions and oncology, to include diabetes, cardiovascular diseases, and neurological conditions, which will boost the demand for CGTs.

The report covers the developments and trends in the CGT landscape. A collaborative environment showing the high adoption of new technologies to improve CGTs will transform the end-to-end capabilities in CGT development and manufacturing.

Patent activity is high because of consistent developments in technology for vector design, cell line manufacturing, digitalization of CGT manufacturing capabilities, and AI integration across the end-to-end CGT development. Venture capital firms see huge potential in the CGT segment in the coming years and have been constant supporters in backing start-ups and mid-sized CGT developers to accelerate their pipelines. In the coming years, the number of CGTs receiving regulatory approvals is predicted to multiply by three fold, and policies will be put in place to increase patient accessibility.

Table of Contents

Strategic Imperatives

• Why Is It Increasingly Difficult to Grow?
• The Strategic Imperative 8™
• The Impact of the Top 3 Strategic Imperatives on the Cell and Gene Therapy Industry
• Growth Opportunities Fuel the Growth Pipeline Engine™
• Research Methodology

Growth Opportunity Analysis

• Scope of Analysis
• Segmentation

Growth Generator

• Growth Drivers
• Growth Restraints
• Macro to Micro Visioning and Implications
• Snapshot of CGT Development
• Global Growth of CGT Approvals
• CGT R&D Outlook
• Manufacturing Expansion: Catalysts for CGT Manufacturing

CGT Patent Analysis

• CGT-Overall Patent Trends
• IP Landscape Gene-modified Cell Therapies
• Top Patent Applicants in Gene-modified Cell Therapies
• IP Landscape-Gene Therapies
• Top Patent Applicants in Gene Therapies
• IP Landscape Stem Cell Therapies
• Top Patent Applicants in Stem Cell Therapies
• An Overview of the Patent Landscape in CGTs

CGT Investment Landscape

• Investment Trends in the CGT Landscape
• Investment Trends in the CGT Expansion of Manufacturing Units
• Investments in CGT Technology Platforms
• Growing Mergers and Acquisitions
• Early-stage CGT Investment Trends by Venture Capitalists
• GV, United States
• SAMSARA BIOCAPITAL, United States
• ARCH VENTURE PARTNERS, United States
• OrbiMed, United States
• ALEXANDRIA, United States
• RA CAPITAL, United States

CGT Publication Trend

• Publication Trends in CGT

R&D Outlook across the Value Chain

• Recent Initiatives and Research Accelerators Driving Innovations
• Global Trends in CGT R&D
• Emerging Technology Areas in CGT Development
• Choice of Vector Depends on Indication and Transgene Expression
• Engineering Viral Vectors to Improve Safety and Functionality
• Innovations in Vector Engineering
• Growing Shift from Autologous to Allogeneic Cell Therapies
• Emerging Technology Trends for CGT Manufacturing
• Shift toward Factory of the Future for CGT Manufacturing
• Notable Recent Collaborations between CGT Platforms and Biopharma Companies to Accelerate CGT Development

CGT Clinical Trial Landscape

• Clinical Pipeline Development of Gene Therapies
• Clinical Development of Gene-modified Cell Therapies
• Clinical Pipeline Development of Stem Cell Therapies

Growth Opportunity Universe in CGT

• Growth Opportunity 1: Capacity and Capability Expansion for CDMOs
• Growth Opportunity 2: Technology Licensing Partnerships
• Growth Opportunity 2: Technology Licensing Partnerships
• Growth Opportunity 3: Shift Towards CGT Development for Chronic Diseases

Appendix

• Technology Readiness Levels (TRL): Explanation

Next Steps

• Benefits and Impacts of Growth Opportunities
• Next Steps
• Take the Next Step
• Legal Disclaimer