The "Cell and Gene Therapy Market Dynamics by Disease Type: Development, Trends, and Forecasts, 4th Edition (2024-2030)" report by Kalorama Information explores the transformative potential of cell and gene therapies in modern medicine. These therapies offer groundbreaking treatments by addressing genetic causes of diseases and modulating the immune system. The report highlights the surge in new therapies and a promising pipeline, with significant clinical trial activity across various therapeutic areas, including oncology and cardiology.
This comprehensive report segments the market by therapeutic areas, providing detailed market estimates, forecasts, and insights into the competitive landscape. It covers global developments in cell, gene, and RNA therapy markets, focusing on key products, research trends, market breakdowns, regional revenues, and competitor analysis.
Key therapeutic areas covered include:
Oncology
Neurology
Musculoskeletal
Dermatology
Cardiology/Non-oncology blood
Other
The report excludes RNA therapies for COVID-19 and mRNA vaccines for infectious diseases, focusing instead on broader gene therapy applications. It also omits cord blood products, considering their classification as transplants.
Methodologically, the report combines primary and secondary research, including interviews with industry participants and comprehensive literature reviews. It provides market highlights, forecasts, and competitive analyses, discussing market indicators, trends, and barriers. Given the nascent stage of gene therapies, forecasts are based on limited precedents, with market size estimates provided for 2024 and projections through 2030.
This report serves as a crucial resource for understanding the evolving landscape of cell and gene therapies, offering valuable insights for stakeholders in the healthcare and biotechnology sectors.
Table of Contents
Chapter 1: Executive Summary
Overview
Scope and Methodology
Market Overview and Potential
Figure 1-1: Global Cell and Gene Therapy Market, by Product Segment, 2024-2030 ($ million) [Cardio/Non-Oncology Blood, Dermatology, Musculoskeletal, Neurology, Oncology, Other]
Table 1-1: Global Cell and Gene Therapy Market, by Product Segment, 2024-2030 ($ million) [Cardio/Non-Oncology Blood, Dermatology, Musculoskeletal, Neurology, Oncology, Other]
Figure 1-2: Global Share of Cell and Gene Therapy Market, by Product Segment, 2024 (%) [Cardio/Non-Oncology Blood, Dermatology, Musculoskeletal, Neurology, Oncology, Other]
Figure 1-3: Global Share of Cell and Gene Therapy Market, by Product Segment, 2029 (%) [Cardio/Non-Oncology Blood, Dermatology, Musculoskeletal, Neurology, Oncology, Other]
Chapter 2: Introduction to Cell and Gene Therapy
Introduction
Table 2-1: Total Numbers of Approved Cell, Gene, & RNA Therapies, by Type, 2022-2024, Global (count, %)
Figure 2-1: Share of Total Global Numbers of Approved Cell, Gene, & RNA Therapies, by Type, January 2025 (%)
Cell Therapy
CAR T
Stem Cells
Adult Stem Cells
Human Embryonic Stem Cells
Table 2-2: Adult vs. Embryonic Stem Cells
Gene Therapy
Table 2-3: Somatic vs. Germ Line Gene Therapy
Viral Vector System and New Developments
Table 2-4: Selected Examples of Viruses in Gene Therapy
Figure 2-2: Estimated Viral Vector Use in Commercialized Cell and Gene Therapies, by Type, 2022 (%)
Non-viral Systems for Transporting Genes
Gene Editing
Cell and Gene Therapy: Characteristics
Table 2-5: Cell Therapy vs Gene Therapy
Staffing
Manufacturing Process for CAR-T
Leukapheresis
Activation
Transduction
Expansion
Cell and Gene Therapy Manufacturing Processes
Table 2-6: Manufacturing Process Time for Select Autologous Cell and Gene Therapies [current and discontinued therapies]
Figure 2-3: Manufacturing Process Time for Select Autologous Cell and Gene Therapies [current and discontinued therapies]
Cost
Reimbursement
Logistics
Mergers and Acquisitions
Table 2-7: Selected Company Mergers and Acquisitions in the Cell and Gene Therapy Market
Deals, Agreements, and Collaborations
Regulatory Developments
Fast Track
Orphan Drug
Breakthrough Therapy
Accelerated Approval
Priority Review
Table 2-8: Regulatory Actions and Guidelines for Cell and Gene Therapy, by Select Country
Gene Therapy Approval Process
Pipeline, Development Overview
Pipeline, Development Progress
Table 2-9: Global Cell, Gene, & RNA Therapy Clinical Trial Growth (pre-clinical I through phase III), 2022-2024 (Count, %)
Figure 2-4: Global Cell, Gene, & RNA Therapy Development Progress (pre-clinical through phase III), as of Q4 2024
Table 2-10: Global Gene Therapy Pipeline, by Phase, 2022-2024 (count, %)
Figure 2-5: Global Gene Therapy Pipeline Shares by Phase, Q4 2024 (%)
Pipeline by Condition and Therapeutic Area
Table 2-11: Global Cell, Gene, & RNA Therapy Pipeline, by Therapeutic Area, 2022-2024 (count, %) [Alimentary/Metabolic, Anticancer, Anti-infective, Blood and Clotting, Cardiovascular, Dermatological, Genitourinary (including sex hormones), Hormonal (excluding sex hormones), Immunological, Musculoskeletal, Neurological, Rare Diseases, Respiratory, Sensory, Miscellaneous, Other]
Figure 2-6: Global Gene Therapy Pipeline Shares, by Therapeutic Area, Q4 2024 (%) [Alimentary/Metabolic, Anticancer, Anti-infective, Blood and Clotting, Cardiovascular, Dermatological, Genitourinary (including sex hormones), Hormonal (excluding sex hormones), Immunological, Musculoskeletal, Neurological, Rare Diseases, Respiratory, Sensory, Miscellaneous, Other]
Table 2-12: Global Cell, Gene, & RNA Therapy Pipeline Excluding Pre-clinical, by Therapeutic Area, 2022-2024 (count, %) [Alimentary/Metabolic, Anticancer, Anti-infective, Blood and Clotting, Cardiovascular, Dermatological, Genitourinary (including sex hormones), Hormonal (excluding sex hormones), Immunological, Musculoskeletal, Neurological, Rare Diseases, Respiratory, Sensory, Miscellaneous, Other]
Table 2-19: Phase III Development - Cell and Gene Therapies, Select Projects
End Users
Hospitals
Research
Wound Care Centers
Cancer Centers
Chapter 3: Cell and Gene Therapy Markets in Oncology
Overview
Biochemistry of Cancer Cells
Causes of Cancer Growth
Environmental Factors, DNA, RNA
Table 3-1: Virus Association with Human Cancer
Cellular Oncogenes
Tumor Suppressor Genes
Global Cancer Burden
Figure 3-1: Estimated Number of New Cancer Cases, Both Sexes, Age 0-85+, All Cancers, 2020 to 2040
Figure 3-2: Incidence of Cancer, by Type, 2020 [Bladder, Breast, Cervix Uteri, Colorectum, Liver, Lung, Oesophagus, Prostate, Stomach, Thyroid]
Figure 3-3: Worldwide Distribution of Cancer Incidence, by Type, 2020 [Breast, Cervix Uteri, Colorectum, Liver, Lung, Prostate, Stomach, Other Cancers]
Figure 5-5: Musculoskeletal Cell, Gene, & RNA Therapy Market Shares, by Company, Estimated 2024 (%) [Sarepta, Vericel, Other Companies]
Chapter 6: Cell and Gene Therapy Markets in Cardiovascular and Blood Disorders
Overview
Cardiovascular Disease
Selected Blood Disorders
Market Outlook
Table 6-1: Cell, Gene, and RNA Therapy Markets in Cardiovascular and Blood Disorders, 2024-2030 ($ million)
Figure 6-1: Cell, Gene, and RNA Therapy Markets in Cardiovascular and Blood Disorders, 2024-2030 ($ million)
Principal Products
Collategene
Hearticellgram
HeartSheet
Leqvio
Neovasculgen
Stempeucel
Zynteglo
Table 6-2: Selected Cell and Gene Therapy in Cardiovascular and Blood Disorders
Phase III Development
Table 6-3: Select Cardiovascular and Blood Disorder in Phase III Cell and Gene Therapy Developments, through January 2025
Market Breakdown of Cell, Gene, and RNA Therapies
Table 6-4: Cardiovascular and Blood Disorders Cell, Gene, & RNA Therapy Markets, by Product Type, Estimated 2024 and Projected 2030 Sales ($ million) [Cell-based Gene Therapy, Non-GM Cell, RNA, Other Gene Therapies]
Figure 6-2: Cardiovascular and Blood Disorders Cell and Gene Therapy Market Distribution, by Product Type, 2024 (%) [Cell-based Gene Therapy, Non-GM Cell, RNA, Other Gene Therapies]
Cardiovascular and Blood Disorders Cell and Gene Therapy Market by Indication
Table 6-5: Cardiovascular and Blood Disorders Cell and Gene Therapy Market, by General Indication, Estimated 2024 and Projected 2030 Sales ($ million) [Blood, Cardiac, Hypercholesterolemia, Vascular]
Regional Market Summary
Table 6-6: Cardiovascular and Blood Disorders Cell and Gene Therapy Market, by Country/Region, Estimated 2024 and Projected 2030 ($ million) [APAC, Europe, North America, ROW]
Figure 6-3: Cardiovascular and Blood Disorders Cell and Gene Therapy Market Summary, by Geographic Region, Estimated 2024 and Projected 2030 Sales ($ million) [APAC, Europe, North America, ROW]
Figure 6-4: Cardiovascular and Blood Disorders Cell and Gene Therapy Market Share, by Geographic Region, Estimated 2024 (%) [APAC, Europe, North America, ROW]
Competitor Summary
Chapter 7: Cell and Gene Therapy Markets in Dermatology
Overview
Table 7-1: Wound Prevalence, by Type [Skin Ulcers: Pressure Injuries, Venous Statis Ulcers, Diabetic Ulcers and Burns: Outpatient Burns, Hospitalized Burns, and Medically Treated Burns]
Market Outlook
Table 7-2: Cell and Gene Therapy Markets in Dermatology, 2024-2030 ($ million)
Figure 7-1: Cell and Gene Therapy Markets in Dermatology, 2024-2030 ($ million)
Principal Products
Adipocel
Apligraf
CureSkin
Dermagraft
Epicel
Grafix
Holoderm
Kaloderm
KeraHeal/KeraHeal-Allo
LaViv
Orcel
Quencell
RECELL
Rosmir
Stempeutics/Cutisera
StrataGraft
Stravix
TransCyte
Vyjuvek
Table 7-3: Cell and Gene Therapy in Dermatological Diseases and Disorders
Trends in Research and Development
Phase III Development
Table 7-4: Select Dermatology Phase III Cell and Gene Therapy Developments, through January 2025
Market Breakdown of Cell and Gene Therapies
Table 7-5: Dermatology Cell and Gene Therapy Markets, by Product Type, Estimated 2024 and Projected 2030 Sales ($ million) [Stem Cells, Skin Cells, Gene/Gene-Modified Cell Therapy]
Dermatology Cell and Gene Therapy Market by Indication
Regional Market Summary
Table 7-6: Dermatology Cell and Gene Therapy Market, by Country/Region, Estimated 2024 & Projected 2030 Sales ($ million) [APAC, Europe, North America, ROW]
Figure 7-3: Dermatology Cell and Gene Therapy Market Summary, by Geographic Region, Estimated 2024 and Projected 2030 ($ million) [APAC, Europe, North America, ROW]
Figure 7-4: Dermatology Cell and Gene Therapy Market Share, by Geographic Region, 2024 (%) [APAC, Europe, North America, ROW]
Competitor Summary
Table 7-7: Dermatology Cell and Gene Therapy Competitor Sales and Market Share, Reported and Estimated 2024 ($ million) [Krystal Biotech, Organogenesis, Smith & Nephew (Osiris), Vericel, Other]
Figure 7-5: Dermatology Cell and Gene Therapy Market Share, by Company, Estimated 2024 (%) [Krystal Biotech, Organogenesis, Smith & Nephew (Osiris), Vericel, Other]
Chapter 8: Cell and Gene Therapy Markets in Other Conditions
Overview
Market Outlook
Figure 8-1: Cell and Gene Therapy Markets in Other Conditions, 2024-2030 ($ million)
Table 8-1: Cell and Gene Therapy Markets in Other Conditions, 2024-2030 ($ million)
Principal Products
Alofisel
Cupistem
Givlaari
Glybera
Holoclar
Luxturna
Oxlumo
Rethymic
Ryoncil/ Prochymal/ Temcell
Tryngolza
Table 8-2: Cell and Gene Therapy in Other Diseases and Disorders
Trends in Research and Development
Market Breakdown of Cell and Gene Therapies
Table 8-3: Other Conditions Cell and Gene Therapy Markets, by Product Type, Estimated 2024 and Projected 2030 Sales ($ million) [Cell-based Gene Therapy; RNA, Antisense Etc.; Stem Cell & Other Cell Therapy; Other Gene Therapy]
Figure 8-2: Other Conditions Cell and Gene Therapy Market Distribution, by Product Type, 2024 (%) [Cell-based Gene Therapy; RNA, Antisense Etc.; Stem Cell & Other Cell Therapy; Other Gene Therapy]
Regional Market Summary
Table 8-4: Other Conditions Cell and Gene Therapy Market, by Country/Region, Estimated 2024 and Projected 2030 ($ million) [Europe, North America, ROW]
Figure 8-3: Other Conditions Cell and Gene Therapy Market Summary, by Geographic Region, Estimated 2024 and Projected 2030 ($ million) [Europe, North America, ROW]
Figure 8-4: Other Conditions Cell and Gene Therapy Market Share, by Geographic Region, Estimated 2024 (%) [Europe, North America, ROW]
Competitor Summary
Chapter 9: Cell and Gene Therapy Market Review
Market Influences
Global Demographics
Table 9-1: Global Population, 1980-2050 (population in millions)
Aging Population
Figure 9-1: Global Population Trends, Total Population vs. Age 65+ Population, 2000-2050
Cost Containment
Table 9-2: Cost Comparisons for Selected Commercialized Cell and Gene Therapies