Global CAR-T Cell Therapy Market Size, Forecasts, Trials & Trends 2019: Increasing Investments, Major Acquisitions and Large IPOs Driving The Future - ResearchAndMarkets.com

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CAR-T Cell Therapy Market - Market Size, Forecasts, Trials & Trends"
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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.

Driving Forces for the CAR-T Therapy Market

With the growing demand for CAR-T therapies, CAR-T companies are
proliferating. Growing numbers of these companies are supported by:

• Increasing investment flowing into CAR-T cell research
• Landmark approvals of CAR-T cell therapies by the U.S. Food & Drug
  Administration (FDA) and the European Medicines Agency (EMA)
• Major acquisitions within the CAR-T industry
• Large IPOs within the CAR-T industry

As mentioned, 2017 was the first year that the U.S. FDA approved a CAR-T
cell therapy, approving Kymriah in August 2017 and Yescarta in October
2017. Novartis produced Kymriah, a CAR-T therapy used to treat leukemia,
while Gilead/Kite Pharma developed Yescarta, a CAR-T therapy for
patients with lymphomas.

Approvals for these products are now spreading globally, with
authorizations permitted by the EU, Canada, and Australia, among others.
The approval of these early CAR-T cell therapies has opened the gates
for many other types of cell and gene therapies to claim respect, both
from regulators, as well as from the broader scientific and medical
communities.

CAR-T funding is also on the rise. At first, the trend was subtle, but
the tide swelled as CAR-T therapies like Kymriah and Yescarta reached
the marketplace and created a CAR-T funding craze. CAR-T start-ups have
been richly funded by investors eager to get into this trending area of
regenerative medicine.

Following IPOs by CAR-T players Kite Pharma, Bellicum, Juno Therapeutics
and Cellectis totaling over $750 million, CAR-T developer Autolus
announced a $150 million IPO. This has bought the total value of recent
CAR-T initial public offerings (IPO's) to nearly $1 billion.

CAR-T Industry Deal-Making

The CAR-T industry has also witnessed aggressive deal-making in recent
years. Celgene snagged Juno Therapeutics for a shocking $9 billion in
January 2018 and Gilead acquired Kite Pharma for an astounding $11.9
billion in August 2017. After $20 billion of market capitalization from
the CAR-T companies in 2018, the CAR-T market has continued to gain
momentum.

There have also been more than a dozen CAR-T deals between
pharmaceutical companies and academic institutions, with the best known
being the partnership between Novartis and the University of
Pennsylvania (UPenn). When Kymriah became the first CAR-T cell therapy
to be approved in the U.S. in August 2017, it resulted from a 5-year
collaboration between UPenn and Novartis.

CAR-T financing rounds have also proliferated. In one major example,
Cellularity raised $250 million in February 2018 to support the
development of placental-derived products, including T-cells that will
be immune advantaged because of their derivation from the placenta.

Cellularity is looking to burst a major bottleneck in the industry by
deriving T-cells from a single (allogeneic) cell line, potentially
positioning itself to slash the price point for CAR-T treatments. In
another significant example, London-based CAR-T start-up Allogene
Therapeutics entered into an asset contribution deal with Pfizer in
April 2018, as well as announced a $300 million Series A round.

Topics Covered

1. Report Overview

2. History of CAR-T Cell Therapy

3. CAR-T Manufacturing Processes

4. Structure of a CAR-T Cell

5. Number of CAR-T Companies, their Recent Activities

6. Tumor-associated Target Antigens

7. Target Diseases for CAR-T Cell Therapy

8. Pricing and Payment Models for CAR-T Therapies

9. Medical Facilities Offering CAR-T Therapies

10. CAR-T Therapy Patent Landscape

11. Deals, Fundings, Partnerships and Collaborations

12. The Landscape of CAR-T Cell Therapy Clinical Trials

13. CAR-T Cell Products in the Market

14. Insurance Coverage for CAR-T Therapy

15. Commercial Threats For CAR-T Industry

16. Challenges to Overcome

17. Market Analysis

18. Company Profiles

• AbbVie
• Adaptimmune Therapeutics
• Amgen
• Atara Biotherapeutics
• Aurora Biopharma
• Autolus Therapeutics
• Bellicum Pharmaceuticals
• BioAtla
• bluebird bio
• Carina Biotech
• CARsgen Therapeutics
• CARTherics
• Cellectis
• Celularity
• Celyad
• Creative Biolabs
• DiaCarta
• Endocyte
• F1 Oncology
• Fate Therapeutics
• Humanigen
• Immune Therapeutics
• Intrexon Corp.
• Juno Therapeutics
• Kite Pharma
• Lion TCR
• MaxCyte
• Mesoblast
• Minerva Biotechnologies Corp.
• Mustang Bio
• Novartis
• Oxford BioMedica
• PeproMene Bio
• Pfizer
• Posedia Therapeutics
• Precision Biosciences
• ProMab Biotechnologies
• Servier Oncology
• Sorrento Therapeutics
• TC Biopharm
• Tessa Therapeutics
• TILT Biotherapeutics
• Tmunity Therapeutics
• TrakCel
• Xyphos
• ZIOPHARM Oncology

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