Global CAR-T Cell Therapy Market – Market Size, Forecasts, Trials & Trends

Global CAR-T Cell Therapy Market – Market Size, Forecasts, Trials & Trends

EXECUTIVE SUMMARY


CAR-T cell therapy is a remarkably promising treatment for cancer patients. This emerging treatment is one of the biggest breakthroughs since the introduction of chemotherapy. CAR-T is a type of immunotherapy where doctors collect immune cells from a patient, modify them in a laboratory, and provide them the power to easily recognize and kill cancer cells and infuse them back into the patient. The infused cells get multiplied and stay in the body as “living drugs.”

In the past, significant successes were made possible by chemotherapy and radiation by killing cancer cells. However, the effects were not permanent. Now, CAR-T cells are providing a compelling alternative.

T-cells form the backbone of CAR-T cell therapy. T-cells are the workhorses of the immune system and they play a key role in directing the immune response and killing cells infected by pathogens.

The purpose of this report is to describe the current status of chimeric antigen receptor T-cells (CAR-T cells), the related patent landscape, funding, deals, research, applications, technologies, the details of the two marketed CAR-T cell products, and the ongoing and late stage clinical trials.

The widespread research activities, worldwide clinical trials and approved treatments (Kymriah and Yescarta) have created a robust CAR-T cell therapy market. This billion dollar market size and its strong growth would not be possible without the remarkable efficacy of Kymriah and Yescarta in treating several types of blood cancers. CAR-T cell therapy has swept the biotech industry by storm, attracting new market participants at a rapid pace.

The main objectives of this report are to provide the reader with the following details:

  • Currently available CAR-T cell therapy products and the treatable indications.
  • The late-stage CAR-T product candidates.
  • Number of clinical trials focusing on CAR-T cells targeting solid tumors.
  • New designs and concepts of CAR-T cells.
  • Funding for CAR-T cell-based research.
  • Key patents filed in recent years.
  • Number of clinical trials involving CAR-T cells.
  • Advantages of CAR-T cell therapy over other immunotherapies and chemotherapies.
  • Number of companies contributing to CAR-T cell therapy market and their product candidates.
Key questions answered in this report are:
  • What are CAR-T cells?
  • What are the various indications for CAR-T cell therapies?
  • Which cancers are treated by the currently available Kymriah and Yescarta?
  • What is the timeline for the development of CAR-T cell therapy?
  • How are autologous and allogeneic CAR-T cells manufactured?
  • What is the structure of a CAR-T cell?
  • What are first generation, second generation, third generation and fourth generation CAR-T cells?
  • What is the mechanism of action of CAR-T cells?
  • What is the future of CAR-T cell therapy with the arrival of new models and concepts?
  • What are the target antigens in CAR-T cell therapy?
  • What are the target antigens in solid tumors?
  • What is the price structure of CAR-T products?
  • How many medical facilities are currently offering CAR-T cell therapy?
  • How many patent applications have been filed?
  • How many deals, partnerships and collaborations have been signed in recent years?
  • What is the funding landscape in the CAR-T space?
  • How many clinical trials are actively conducted in the CAR-T space?
  • Which clinical trials are run by biotech companies?
  • Which clinical trials are conducted by academicia?
  • How do Tisagenlecleucel (Kymriah) and Axicabtagene ciloleucel (Yescarta) bring about the death of cancer cells in hematological malignancies?
  • What is the total cost of treating a patient with CAR-T cell therapy?
  • How much relief is provided by insurance companies to the patients?
  • What are the strengths and weaknesses of the CAR-T cell therapy industry?
  • What is the global market for CAR-T cells?
  • What is the global market for CAR-T cells by geography?
  • What is the market for CAR-T cells by target antigen?
  • How many companies are involved in developing CAR-T cell therapies and what product/technologies are they developing?


  • REPORT OVERVIEW
    • Statement of the Report
    • Executive Summary
    • INTRODUCTION
  • SIXTY YEARS HISTORY OF CAR-T CELL THERAPY
    • Timeline of CAR-T Cell Therapy Development
      • Table Timeline of CAR-T Cell Therapy Development
  • CAR-T MANUFACTURING PROCESSES
    • Manufacturing Autologous CAR-T Cells
    • T-CellSource
    • T-Cell Activation
      • Beads-Based T-Cell Activation
      • Antibody-Coated Magnetic Beads
      • Antibody-Coated Nanobeads
      • Expamer Technology
      • Activation with Anti-CD3 Antibodies
    • Genetic Modification of T-Cells
    • Expansion of CAR-T Cells
      • Expansion of CAR-T Cells using GE Bioreactors
      • Expansion of CAR-T Cells using G-Rex Bioreactors
      • Expansion of CAR-T Cells using Prodigy
      • Expansion of CAR-T Cells through Recursive AAPC Stimulation
    • Clinical CAR-T Cell Manufacturing Quality Checkpoints
      • Qualification of Manufacturing Facilities
      • Qualification of Ancillary Components
        • Table Examples of Ancillary Components for Clinical CAR-T Manufacturing
      • Qualification of Manufacturing Process
    • In-Process Testing and Release Testing of Cellular Products
      • Table Examples of CAR-T Cells Release Tests
    • Allogeneic CAR-T Cells
  • STRUCTURE OF A CAR-T CELL
    • First Generation CAR-T Cells
    • Second Generation CAR-T Cells
    • Third Generation CAR-T Cells
    • Fourth Generation CAR-T Cells
    • Mechanism of Action
    • New CAR Models and Concepts
      • Truck CAR
      • Universal CAR
      • Self-driving CAR
      • Armored CAR
      • Self-destruct CAR
      • Conditional CAR
      • TanCAR
      • Dual CAR
      • Safety CAR )sCAR)
    • Basic Components of CAR
      • Common Deigns of CAR-T Constructs
        • Table Different Types of CAR-T Constructs, Corresponding Antigens and Indications
  • NUMBER OF CAR-T COMPANIES, THEIR RECENT ACTIVITIES
    • Geographical Distribution of CAR-T Cell Therapeutic Companies
      • Table Global Distribution of CAR-T Cell Therapeutic Companies
    • Immunocellular Therapy Companies by Cell Type
      • Table Number of Immunocellular Therapy Companies by Cell Type, Worldwide
    • Market Leaders in CAR-T Cell Therapy and their Recent Activities
      • AbbVie
      • Allogene Therapeutics
      • Amgen
      • Agios Pharmaceutical
      • Atara Biotherapeutics
      • Autolus Limited
      • Bellicum Pharmaceuticals
      • bluebird bio
      • Calibr
      • Carina Biotech
      • CARsgen Therapeutics
      • Celgene Corporation
      • Cellectis
      • Cell Medica
      • Cell Design Labs
      • Celularity
      • Celyad
      • Fate Therapeutics
      • Fortress Bio
      • Gilead Sciences
      • Janssen Biotech
      • Juno Therapeutics
      • JW Therapeutics
      • Kite Pharma
      • Medisix Therapeutics
      • Mustang Bio
      • Nanjing Legend Biotech
      • Novartis
      • Pfizer
      • Precision Biosciences
      • Posedia Therapeutics
      • Shire
      • Sorrento Therapeutics
      • Ziopharm
  • TUMOR-ASSOCIATED TARGET ANTIGENS
    • Antigens on Solid Tumors
      • Table Tumor-Associated Antigens of CAR-T Cell Targets
      • Epidermal Growth Factor Receptor (EGFR)
      • Epidermal Growth Factor Receptor Variant III (EGFRvIII)
      • Human Epidermal Growth Factor Receptor-2 (HER2)
      • Mesothelin (MSLN)
      • Prostate-Specific Membrane Antigen (PSMA)
      • Disialoganglioside 2 (GD2)
      • Interleukin-13Rá2 (IL13Rá2)
      • Glypican-3 (GPC3)
      • Carbonic Anhydrase IX (CAIX)
      • L1 Cell Adhesion Molecule (L1-CAM)
      • Cancer Antigen 125 (CA125) (MUC16)
      • Prominin-1 (CD133)
      • Fibroblast Protein-á (FAP-á)
      • Cancer/Testis Antigen 1B (CTAG1B)
      • Mucin 1 (MUC1)
      • Folate Receptor-á (FR-á)
    • CAR-T Targets in Hematologic Malignancies
      • Table CAR Target Antigens for Hematologic Malignancies and Potential Off-Tumor Targets
      • CD19
      • CD20
      • CD22
      • ROR1
      • CD30
      • CD138
      • CD123
      • NKG2D-L
      • BCMA
      • CD174
    • CAR-T Cell Trials Targeting CD19
      • Table Percent (%) Share of CAR-T Cell Trials Targeting CD19
      • Positive CR Rates in CD19 Targeted Studies in Hematological Malignancies
        • Table Outcome of CAR-T Cell Therapy Trials in Liquid Malignancies, Targeting CD19
      • Outcome of CAR-T Cell Therapy Trials Targeting Antigens other than CD19
        • Table Outcome of CAR-T Cell Therapy Trials in Liquid Malignancies, Except CD19
      • Targets other than CD19 in Hematological Cancers
        • Table Most Frequent CAR-T Cell Targets in Liquid Malignancies (Except CD19)
      • CD30 vs. BCMA Targets for Multiple Myeloma
        • Table Trend in Number of CAR-T Cell Therapy Clinical Trials: CD30 vs. BCMA
    • CAR-T Cell Therapy for Solid Tumors
      • Table Clinical Outcome of CAR-T Cell Therapy Trials in Solid Malignancies
      • CAR-T Cell Targets in Solid Malignancies
        • Table Most Frequent CAR-T Cell Targets in Solid Malignancies
  • TARGET DISEASES FOR CAR-T CELL THERAPY
    • Table Target Diseases and Target Antigens
    • Acute Lymphoblastic Leukemia (ALL)
    • Chronic lymphocytic leukemia (CLL)
    • Non-Hodgkin lymphoma
    • Acute myeloid leukemia (AML)
    • Neuroblastoma
    • Multiple myeloma (MM)
  • PRICING AND PAYMENT MODELS FOR CAR-T THERAPIES
    • Controversies over CAR-T Pricing
    • Hospital Mark-up Costs for Kymriah and Yescarta
      • Table Treatment Acquisition Costs and Mark-Up Costs
    • Cost Effectiveness of Tisagenlecleucel and Axicabtagene
      • Table Long-Term Cost-Effectiveness of Tisagenlecleucel and Axicabtagene
    • Value-Based Price Benchmarks
      • Table Value-Based Price Benchmarks
    • Unit Prices Needed to Reach Cost-Effectiveness Thresholds
      • Table Unit Prices Needed to Reach Cost-Effectiveness Thresholds
    • Alternate Payment Strategies
      • Table Alternate Payment Strategies
  • MEDICAL FACILITIES OFFERING CAR-T THERAPIES
    • Table U.S. Medical Facilities Offering CAR-T Cell Therapies
    • CAR-T Recommended in Europe
    • CAR-T Cell Therapy in Chinese Hospital
    • Canada Joins the CAR-T Club
  • CAR-T THERAPY PATENT LANDSCAPE
    • Number of CAR-T Cell Patents, 2013-2018
    • CAR-T Patent Types
      • Table Major CAR-T Patent Holders
    • A Brief Snapshot of CAR-T Patent Landscape
      • Patents for Anti-CD19 CAR-T
      • Patents for Anti-BCMA CAR-T
      • Patents for Regulatable CAR-T
      • Patents for CAR-T for Solid Tumors
        • Table Select List of CAR-T Patents
    • Major CAR-T Patent Applicants
      • Table Major CAR-T Patent Applicants
  • DEALS, FUNDINGS, PARTNERSHIPS AND COLLABORATIONS
    • Funding for CAR-T
      • Table CAR-T Financing Rounds
    • CAR-T Deals
      • Table CAR-T Deals and Partnerships
    • Initial Public Offering (IPO)
      • Table CAR-T Initial Public Offerings (IPOs)
    • Key CAR-T Technology Deals
      • Table Key CAR-T Technology Deals
      • Deal between Juno Therapeutics and Eureka for a Fully Human ScFv Binding Domain
      • Acquisition of Stage Cell Therapeutics by Juno Therapeutics
      • Collaboration between Juno Therapeutics and Editas Medicine
      • Kite and Alpine in Research and License Agreement
      • Johnson & Johnson Gets PiggyBac Technology from Transposagen
      • Johnson & Johnson and Posedia in a Technology Deal
      • Partnership between Baxalta and Precision Biosciences
      • Novartis, Intellia and Caribou
      • Overall Trends in Oncology Licensing, Joint Venture and Research Deals
        • Table Licensing, Joint Venture and Research Only Oncology Deals from 2013-2017
  • THE LANDSCAPE OF CAR-T CELL THERAPY CLINICAL TRIALS
    • The Surge in Number of CAR-T Clinical Trials
      • Table Number of CAR-T Cell Therapy Clinical Trials, 2007-2018
    • Percentage (%) of Total CAR-T Clinical Trials by Target
      • Table Percentage (%) of Total CAR-T Clinical Trials by Target
    • Research Focus on CAR-T Trials by Indication
      • Table Research Focus of CAR-T Trials by Indication
    • Clinical Trials using CAR-T Cells by Country as of 2018
      • Table Clinical Trials using CAR-T Cells by Country as of 2018
    • CAR-T Clinical Trials to Watch
      • Table Four CAR-T Clinical Trials to Watch
    • CAR-T Projects with Commercial Licensees
      • Table Clinical Stage CAR-T Projects with Commercial Licensees (Excluding China)
    • Clinical CAR-T Constructs with Sole Involvement from Academicia
      • Table Clinical CAR-T Constructs with Sole Involvement from Academia
    • Anti-CD19 CAR-T Studies
      • Table Anti-CD19 CAR-T Studies (Excluding China)
    • CAR-T Studies in Multiple Myeloma and Acute Myeloid Leukemia
      • Table List of CAR-T Studies in Myeloma and Acute Myelogenous Leukemia (AML)
    • CAR-T Cell Therapy for Solid Tumors
      • Table A List of Clinical Studies of CAR-T Therapies in Solid Tumors (Excluding China)
    • Studies of CAR-T Projects Transfected using mRNA Electroporation
      • Table Studies of CAR-T Projects Transfected using mRNA Electroporation
    • CAR-T Projects Incorporating Suicide Genes
      • Table CAR-T Projects Incorporating Suicide Genes
    • Early Stage CAR-T Assets
      • Table A Selection of Preclinical CAR-T Projects
    • Anti-CD22 CAR-T Projects
      • Table Anti-CD22 CAR-T Projects in the Clinic
    • Cytokine Release Syndrome (CRS) with CART19 Therapy
      • Table Cytokine Release Syndrome (CRS) with CART19 Therapy
    • CAR-T Therapy Pipeline Distribution by Indication
      • Table CAR-T Therapy Pipeline Distribution by Indication
    • CAR-T Therapy Pipeline Distribution by Target Antigen
      • Table CAR-T Therapy Pipeline Distribution by Target Antigen
    • Distribution of CAR-T Clinical Trials in China
      • Table Distribution of CAR-T Trials in China
      • CD19-Directed CAR-T Clinical Trials in China
        • Table Clinical Trials of CD19-Directed CAR-T Cells in China
      • Chinese Trials Targeting Non-CD19 Antigens
        • Table Chinese Trials Targeting Non-CD19 Antigens
      • Chinese Trials on Solid Tumors
        • Table A Partial List of Chinese Trials on Solid Tumors
      • Chinese Trials Using Fourth Generation CAR Constructs
        • Table Chinese Trials Using Fourth Generation CAR Constructs
      • Clinical Stage CAR-T Projects in China
        • Table Clinical Stage CAR-T Projects in China
  • CAR-T CELL PRODUCTS IN THE MARKET
    • Tisagenlecleucel (Kymriah)
      • Table Development Timeline for Tisagenlecleucel (Kymriah)
      • Evidences Supporting Effectiveness of Tisagenlecleucel (Kymriah)
      • Medical Necessities for Tisagenlecleucel (Kymriah)
      • Overall Remission Rates in Patients Treated with Kymriah
        • Table Overall Remission Rates in Therapies for r/r Childhood B-ALL
      • Overall Event-Free Survival Rate with Tisagenlecleucel (Kymriah)
        • Table Estimated Event-Free Survival at Six and 12 Months in Therapies for r/r Childhood B-ALL
      • Key Adverse Events in ELIANA Trial
        • Table Key Adverse Events in ELIANA Trial (N=68)
      • Key Adverse Events in JULIET Trial
        • Table Key Adverse Events in the JULIET Trial (N = 99)
      • Budget Impact for Tisagenlecleucel
        • Table Per-Patient Budget Impact Calculations for Tisagenlecleucel Over a Five-Year Time Horizon, Assuming 400 Patients per year over Five Years
      • Overall Adverse Events with Tisagenlecleucel
        • Table Grade 3 or Higher Adverse Events Experienced by Patients in the First Eight Weeks Following Tisagenlecleucel Infusion
      • Per-Patient Potential Budget Impact of Tisagenlecleucel
        • Table Estimated Annualized Total Potential Budget Impact (BI) of Tisagenlecleucel Using Different Prices over a Five-Year Time Horizon, Assuming 617 Eligible Patients per Year
    • Axicabtagene Ciloleucel (Yescarta)
      • Evidences to Support the Effectiveness of Axicabtagene Ciloleucel
        • Table Development Timeline for Axicabtagene Ciloleucel (Yescarta)
      • Medical Necessities for Axicabtagene Ciloleucel (Yescarta)
      • Clinical Benefits of Axicabtagene Ciloleucel (Yescarta)
      • Objective Response Rates (ORR) for Axicabtagene Ciloleucel
        • Table Objective Response Rates (ORR) Reported for Axicabtagene Ciloleucel
      • CRR for Axicabtagene Ciloleucel
        • Table CRR for Axicabtagene Ciloleucel for r/r Adult B-Cell Lymphoma Compared with SCHOLAR-1
      • Adverse Events in ZUMA-Trial
        • Table Key Adverse Events in the ZUMA-1 Trial (N=101)
      • Base-Case Results
        • Table Base-Case Discounted Lifetime Costs and Outcomes
      • Value-Based Benchmark Prices
        • Table Value-Based Price Benchmarks for Tisagenlecleucel and Axicabtagene Ciloleucel
      • Per-Patient Budget Impact of Axicabtagene Ciloleucel
        • Table Per-Patient Budget Impact Calculations for Axicabtagene Ciloleucel over a Five-Year Time Horizon, Assuming 5,902 Patients per Year over Five Years
      • Unit Cost for Healthcare Utilization in CAR-T Therapy
        • Table Unit Cost for Healthcare Utilization in CAR-T Therapy
        • Table Adverse Events Unit Cost
  • INSURANCE COVERAGE FOR CAR-T THERAPY
    • Coverage Policies for Tisagenlecleucel – B-ALL Patients
    • Coverage for Stem Cell Transplantation (SCT) – B-Cell ALL Patients
    • Coverage for Axicabtagene Ciloleucel – B-Cell NHL Patients
    • Coverage for Stem Cell Plantation (SCT) in B-Cell NHL Patients
    • Insurance Coverage by Medicare and Medicaid
  • COMMERCIAL THREATS FOR CAR-T INDUSTRY
    • Competition in a Narrow Field
    • Competition from other Technologies
    • Threat from TCRs
    • Threat of Litigation
  • CHALLENGES TO OVERCOME
    • Lack of Persistence
    • Inadequate Activation
    • Transfection Method
    • Humanized Binding Domains
    • Antigen Escape
    • Lineage Switching
    • Lack of Safety
    • Benefits of CAR-T Cell Therapy
    • CAR-T Cell Therapy: Only the Beginning of the Story
    • A New Standard
  • MARKET ANALYSIS
    • Table Global Market for CAR-T Cell Therapies, 2018-2023
    • Global Market for CAR-T Therapy by Geography
    • Global Market for CAR-T Therapy by Country
    • Global Market for CAR-T Cell Therapy by Targeted Antigens
    • Competitive Landscape
      • Table CAR-T Therapy – Competitive Landscape
  • COMPANY PROFILES
    • AbbVie Inc.
      • Collaboration with Calibr
    • Adaptimmune Therapeutics PLC
      • Pipeline
        • Table Adaptimmune's Product Pipeline
    • Amgen, Inc.
      • Amgen's Collaboration with Kite Pharma
      • Amgen's Collaboration with MD Anderson Cancer Center
    • Atara Biotherapeutics, Inc.
      • Technology
        • Table Atara's Robust T-Cell Immunotherapy Pipeline
      • Atara tab-cel™
      • Atara ATA188
      • Atara ATA230
    • Aurora Biopharma, Inc.
      • CAR-T for Glioblastoma
    • Autolus Therapeutics PLC
      • Technology
    • Bellicum Pharmaceuticals, Inc.
      • GoCAR Technology
        • Table Bellicum's Product Pipeline
      • BPX-501
      • BPX-601
      • BPX-701
    • BioAtla LLC
      • Conditionally Active Biologics (CABs)
      • Agreement with Pfizer
      • Agreement with Sinobioway
    • bluebird bio
      • Technology
        • Table bluebird bio's Cancer Immunotherapy Pipeline
    • Carina Biotech
      • Technology
    • CARsgen Therapeutics, Ltd.
      • Table CARsgen Therapeutics' Pipeline
    • CARTherics
    • Cellectis
      • Products
    • Celularity
      • Table Celularity's Immuno-Oncology Pipeline
    • Celyad SA
      • Table Celyad's Pipeline
    • Creative Biolabs
    • DiaCarta, Inc.
      • Personalized CAR-T Immunotherapy Platform
    • Endocyte, Inc.
      • LU-PSMA-617
      • Adaptor-Controlled CAR-T Therapy
    • F1 Oncology, Inc.
      • Conditionally Active Biologics (CAB) Technology
    • Fate Therapeutics Inc.
      • Table Fate Therapeutics' Immuno-Oncology Product Pipeline
    • Humanigen, Inc.
      • Ifabotuzumab
    • Immune Therapeutics, Inc.
      • CAR-T from Immune Therapeutics
        • Table Intrexon's CAR-T Pipeline
    • Intrexon, Corp.
      • Table Intrexon's CAR-T Pipeline
    • Juno Therapeutics, Inc.
      • Table Juno's CAR-T Programs
    • Kite Pharma, Inc.
      • Product
        • Table Kite Parma's Product Candidates
    • Lion TCR Pte Ltd.
      • Technology
        • Table Lion's Pipeline
    • MaxCyte, Inc.
      • CARMA Platform
    • Mesoblast, Ltd.
      • Partnership with Cartherics
    • Minerva Biotechnologies Corp.
      • Solid Tumor Cancer Portfolio
      • Antibody Therapeutic for MUC1* Positive Cancers
      • Anti-Metastasis Antibody
      • MUC1*
    • Mustang Bio, Inc.
      • Table Mustang Bio's Pipeline of Product Candidates
    • Novartis AG
      • Kymriah (Tisagenlecleucel)
    • Oxford BioMedica PLC.
      • LentiVector Platform
        • Table Oxford BioMedica's Product Pipeline
    • PeproMene Bio Inc.
      • BAFFR R CAR-Cell
        • Table PeproMene's Pipeline
    • Pfizer, Inc.
      • Asset Contribution Agreement with Allogene Therapeutics
    • Posedia Therapeutics Inc.
      • Table Posedia's Pipeline
    • Precision Biosciences, Inc.
      • Precision Biosciences' Cancer Immunotherapy
    • ProMab Biotechnologies Inc.
      • Table CAR-T Products from ProMab
    • Servier Oncology
      • Table Servier's Oncology Pipeline
    • Sorrento Therapeutics, Inc.
      • Table Sorrento's Immuno-Oncology Products
    • TC Biopharm Ltd.
      • ImmuniCAR
      • OmniCAR
      • OmnImmune
    • Tessa Therapeutics Pte Ltd.
      • TT10 EBVSTs
      • TT12 Armored HPVSTs
      • TT14 GPC3-CAR VSTs
      • TT16 HER2-CAR VSTs
    • TILT Biotherapeutics Ltd.
      • Technology
    • Tmunity Therapeutics Inc.
      • Technology
    • TrakCel Ltd.
    • Xyphos
      • ConvertibleCAR Technology
    • ZIOPHARM Oncology, Inc.
      • IL-12 Platform
      • Sleeping Beauty
        • Table Ziopharm's Product Candidates

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