Dublin, Feb. 14, 2019 (GLOBE NEWSWIRE) -- The "Global CAR-T Cell Therapy Market - Market Size, Forecasts, Trials & Trends" report has been added to ResearchAndMarkets.com's offering.

CAR-T cell therapy is a remarkably promising treatment for cancer patients. This emerging treatment represents one of the biggest breakthroughs since the introduction of chemotherapy.

In 2017, the world witnessed a historic CAR-T cell therapy approval when on August 30, 2017, Tisagenlecleucel (Kymriah) was approved by U.S. FDA for the treatment of children and young adults with acute lymphoblastic leukemia (ALL). On May 1, 2018, FDA approved Kymriah for a second indication (diffuse large B-cell lymphoma). By October 18, 2017, the FDA granted approval for Yescarta for treating patients with relapsed/refractory diffuse large B-cell lymphoma (r/rDLBCL) and other rare large B-cell lymphomas. Other notable approvals for CAR-T cell therapy products have also been achieved.

In August 2018, Kymriah and Yescarta secured approval in Europe, indicating the willingness of European regulators to usher in a new age of regenerative medicine. Novartis' Kymriah was given marketing authorization in the EU for the treatment of blood cancers, including B-cell acute lymphoblastic leukemia (ALL) and relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Gilead/Kite Pharma's Yescarta was authorized as a treatment for adult patients with relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma (PMBCL). Health Canada approved Kymriah as the first CAR-T therapy in Canada and the Therapeutic Goods Administration (TGA) approved it as the first CAR-T therapy in Australia.

The market for CAR-T Cell Therapy

CAR-T cell therapy has swept the biotech industry by storm in recent years, creating hope that it could welcome in a new age of cancer treatment. However, the remarkable success stories have come from targeting CD19, which is now considered an antigen that holds the key to a limited range of blood cancers. Presently, this hematological arena is a highly competitive therapy space that is being shared between leading CAR-T companies.

Scientists, investors and developers invariably agree that the key to longer-term success in this space depends on solving two major problems: identifying antigens other than CD19 that can be targeted with CAR-T therapy with strong efficacy and going beyond liquid cancers into solid tumor indications. CAR-T cell products to deal with solid tumors will undoubtedly offer a larger market potential.

However, it is not an easy task to identify the antigens found on the cells of solid tumors. There are reasons why CD19 is the most common target. It is seen solely on B cells, whose destruction via CAR-T therapy offers a straightforward route for treating B-cell leukemias and lymphomas. At the same time, loss of the body's B cells is not particularly problematical, because their antibody-producing function can be reinstated by injecting intravenous immunoglobulin (IVIG) to patients.

Currently, the only two non-CD19-directed CAR-T therapies are those that target CD22 in B-cell malignancies and B-cell maturation antigen (BCMA) in multiple myeloma. CD22 is structurally analogous to CD19, while BCMA is an antigen expressed on plasma cells, whose functional loss can also be replaced with IVIG.

The problem with solid tumors is that there is little evidence of CAR-T being able to overcome the numerous difficulties that exist for these to be targeted efficiently. However, both academic and commercial groups are racing against time to identify the antigens on solid tumor cells and develop suitable CAR-T cells, because it represents large market potential.

There are several reasons which make solid tumors difficult to treat using CAR-T cell therapies. Globally, solid tumors outnumber hematological tumors by 10 to one. In 2015, Novartis and PENN reported that their CART-meso failed to show any effect in patients with mesothelioma, ovarian cancer and pancreatic cancer. Moreover, there was very poor persistence of CAR-T cells in the patients.

The difficulty with solid tumors is that they are usually surrounded by a hostile, immuno-suppressive microenvironment. This environment presents many inhibitory factors that prevent CAR-T cells from reaching them. A typical CAR-T approach will not have success under these conditions. For this reason, Juno and Novartis are engaging in constructing CAR-T cells with novel designs that incorporate additional elements to boost activity within this setting. Currently, these products are in preclinical development.

Key Topics Covered:

1. Report Overview

1.1 Statement of the Report
1.2 Executive Summary
1.3 Introduction

2. History of CAR-T Cell Therapy
2.1 Timeline of CAR-T Cell Therapy Development

3. CAR-T Manufacturing Processes
3.1 Manufacturing Autologous CAR-T Cells
3.2 T-CellSource
3.3 T-Cell Activation
3.4 Genetic Modification of T-Cells
3.6 Clinical CAR-T Cell Manufacturing Quality Checkpoints
3.7 In-Process Testing and Release Testing of Cellular Products
3.8 Allogeneic CAR-T Cells

4. Structure of a CAR-T Cell
4.1 First Generation CAR-T Cells
4.2 Second Generation CAR-T Cells
4.3 Third Generation CAR-T Cells
4.4 Fourth Generation CAR-T Cells
4.5 Mechanism of Action
4.6 New CAR Models and Concepts
4.7 Basic Components of CAR

5. Number of CAR-T Companies, their Recent Activities
5.1 Geographical Distribution of CAR-T Cell Therapeutic Companies
5.2 Immunocellular Therapy Companies by Cell Type
5.3 Market Leaders in CAR-T Cell Therapy and their Recent Activities
5.3.1 AbbVie
5.3.2 Allogene Therapeutics
5.3.3 Amgen
5.3.4 Agios Pharmaceutical
5.3.5 Atara Biotherapeutics
5.3.6 Autolus Limited
5.3.7 Bellicum Pharmaceuticals
5.3.8 bluebird bio
5.3.9 Calibr
5.3.10 Carina Biotech
5.3.11 CARsgen Therapeutics
5.3.12 Celgene Corporation
5.3.13 Cellectis
5.3.14 Cell Medica
5.3.15 Cell Design Labs
5.3.16 Celularity
5.3.17 Celyad
5.3.18 Fate Therapeutics
5.3.19 Fortress Bio
5.3.20 Gilead Sciences
5.3.21 Janssen Biotech
5.3.22 Juno Therapeutics
5.3.23 JW Therapeutics
5.3.24 Kite Pharma
5.3.25 Medisix Therapeutics
5.3.26 Mustang Bio
5.3.27 Nanjing Legend Biotech
5.3.28 Novartis
5.3.29 Pfizer
5.3.30 Precision Biosciences
5.3.31 Posedia Therapeutics
5.3.32 Shire
5.3.33 Sorrento Therapeutics
5.3.34 Ziopharm

6. Tumor-Associated Target Antigens
6.1 Antigens on Solid Tumors
6.2 CAR-T Targets in Hematologic Malignancies
6.3 CAR-T Cell Trials Targeting CD19
6.4 CAR-T Cell Therapy for Solid Tumors

7. Target Diseases for CAR-T Cell Therapy
7.1 Acute Lymphoblastic Leukemia (ALL)
7.2 Chronic lymphocytic leukemia (CLL)
7.3 Non-Hodgkin lymphoma
7.4 Acute myeloid leukemia (AML)
7.5 Neuroblastoma
7.6 Multiple myeloma (MM)

8. Pricing and Payment Models for CAR-T Therapies
8.1 Controversies over CAR-T Pricing
8.2 Hospital Mark-up Costs for Kymriah and Yescarta
8.3 Cost Effectiveness of Tisagenlecleucel and Axicabtagene
8.4 Value-Based Price Benchmarks
8.5 Unit Prices Needed to Reach Cost-Effectiveness Thresholds
8.6 Alternate Payment Strategies

9. Medical Facilities Offering CAR-T Therapies
9.1 CAR-T Recommended in Europe
9.2 CAR-T Cell Therapy in Chinese Hospital
9.3 Canada Joins the CAR-T Club

10. CAR-T Therapy Patent Landscape
10.1 Number of CAR-T Cell Patents, 2013-2018
10.2 CAR-T Patent Types
10.3 A Brief Snapshot of CAR-T Patent Landscape
10.4 Major CAR-T Patent Applicants

11. Deals, Fundings, Partnerships and Collaborations
11.1 Funding for CAR-T
11.2 CAR-T Deals
11.3 Initial Public Offering (IPO)
11.4 Key CAR-T Technology Deals
11.4.1 Deal between Juno Therapeutics and Eureka for a Fully Human ScFv Binding Domain
11.4.2 Acquisition of Stage Cell Therapeutics by Juno Therapeutics
11.4.3 Collaboration between Juno Therapeutics and Editas Medicine
11.4.5 Kite and Alpine in Research and License Agreement
11.4.6 Johnson & Johnson Gets PiggyBac Technology from Transposagen
11.4.7 Johnson & Johnson and Posedia in a Technology Deal
11.4.8 Partnership between Baxalta and Precision Biosciences
11.4.9 Novartis, Intellia and Caribou
11.4.10 Trends in Oncology Licensing, Joint Venture and Research Deals

12. The Landscape of CAR-T Cell Therapy Clinical Trials
12.1 The Surge in Number of CAR-T Clinical Trials
12.2 Percentage (%) of Total CAR-T Clinical Trials by Target
12.3 Research Focus on CAR-T Trials by Indication
12.4 Clinical Trials using CAR-T Cells by Country as of 2018
12.5 CAR-T Clinical Trials to Watch
12.6 CAR-T Projects with Commercial Licensees
12.7 Clinical CAR-T Constructs with Sole Involvement from Academicia
12.8 Anti-CD19 CAR-T Studies
12.9 CAR-T Studies in Multiple Myeloma and Acute Myeloid Leukemia
11.10 CAR-T Cell Therapy for Solid Tumors
12.11 Studies of CAR-T Projects Transfected using mRNA Electroporation
12.12 CAR-T Projects Incorporating Suicide Genes
12.13 Early Stage CAR-T Assets
12.14 Anti-CD22 CAR-T Projects
12.15 Cytokine Release Syndrome (CRS) with CART19 Therapy
12.16 CAR-T Therapy Pipeline Distribution by Indication
12.17 CAR-T Therapy Pipeline Distribution by Target Antigen
12.18 Distribution of CAR-T Clinical Trials in China

13. CAR-T Cell Products in the Market
13.1 Tisagenlecleucel (Kymriah)
13.2 Axicabtagene Ciloleucel (Yescarta)

14. Insurance Coverage for CAR-T Therapy
14.2 Coverage Policies for Tisagenlecleucel - B-ALL Patients
14.2 Coverage for Stem Cell Transplantation (SCT) - B-Cell ALL Patients
14.3 Coverage for Axicabtagene Ciloleucel - B-Cell NHL Patients
14.4 Coverage for Stem Cell Plantation (SCT) in B-Cell NHL Patients
14.5 Insurance Coverage by Medicare and Medicaid

15. Commercial Threats For CAR-T Industry
15.1 Competition in a Narrow Field
15.2 Competition from other Technologies
15.3 Threat from TCRs
15.4 Threat of Litigation

16. Challenges to Overcome
16.1 Lack of Persistence
16.2 Inadequate Activation
16.3 Transfection Method
16.4 Humanized Binding Domains
16.5 Antigen Escape
16.6 Lineage Switching
16.7 Lack of Safety
16.8 Benefits of CAR-T Cell Therapy
16.9 CAR-T Cell Therapy: Only the Beginning of the Story
16.10 A New Standard

17. Market Analysis
17.1 Global Market for CAR-T Therapy by Geography
17.2 Global Market for CAR-T Therapy by Country
17.3 Global Market for CAR-T Cell Therapy by Targeted Antigens
17.4 Competitive Landscape

18. Company Profiles
18.1 AbbVie Inc.
18.2 Adaptimmune Therapeutics PLC
18.3 Amgen, Inc.
18.4 Atara Biotherapeutics, Inc.
18.5 Aurora Biopharma, Inc.
18.6 Autolus Therapeutics PLC
18.7 Bellicum Pharmaceuticals, Inc.
18.8 BioAtla LLC
18.9 bluebird bio
18.10 Carina Biotech
18.11 CARsgen Therapeutics, Ltd.
18.12 CARTherics
18.13 Cellectis
18.14 Celularity
18.15 Celyad SA
18.16 Creative Biolabs
18.17 DiaCarta, Inc.
18.18 Endocyte, Inc.
18.19 F1 Oncology, Inc.
18.20 Fate Therapeutics Inc.
18.21 Humanigen, Inc.
18.22 Immune Therapeutics, Inc.
18.23 Intrexon, Corp.
18.24 Juno Therapeutics, Inc.
18.25 Kite Pharma, Inc.
18.26 Lion TCR Pte Ltd.
18.27 MaxCyte, Inc.
18.28 Mesoblast, Ltd.
18.29 Minerva Biotechnologies Corp.
18.30 Mustang Bio, Inc.
18.31 Novartis AG
18.32 Oxford BioMedica PLC.
18.33 PeproMene Bio Inc.
18.34 Pfizer, Inc.
18.35 Posedia Therapeutics Inc.
18.36 Precision Biosciences, Inc.
18.37 ProMab Biotechnologies Inc.
18.38 Servier Oncology
18.39 Sorrento Therapeutics, Inc.
18.40 TC Biopharm Ltd.
18.41 Tessa Therapeutics Pte Ltd.
18.42 TILT Biotherapeutics Ltd.
18.43 Tmunity Therapeutics Inc.
18.44 TrakCel Ltd.
18.45 Xyphos
18.46 ZIOPHARM Oncology, Inc.

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