|
Forecast
Period
|
2026-2030
|
|
Market
Size (2024)
|
USD
3.25 Billion
|
|
Market
Size (2030)
|
USD
5.72 Billion
|
|
CAGR
(2025-2030)
|
9.85%
|
|
Fastest
Growing Segment
|
Yescarta
|
|
Largest
Market
|
Northeast
Region
|
Market Overview
The
United States CAR-T Cell Therapy market was valued at USD 3.25 Billion in 2024
and is expected to reach USD 5.72 Billion by 2030 with a CAGR of 9.85%. The U.S. CAR-T (Chimeric Antigen
Receptor T-cell) therapy market is rapidly expanding within the broader
immuno-oncology sector, fueled by major advancements in biotechnology and
cellular therapies. CAR-T therapy involves engineering a patient's own T-cells
to target specific cancer cells, thereby enhancing the immune system’s ability
to identify and eliminate malignant cells. This market has gained significant
momentum, driven by the success of CAR-T therapies in treating hematologic
cancers, including large B-cell lymphoma, leukemia, and multiple myeloma.
The
U.S. CAR-T therapy market is poised for continued growth, supported by
advancements in CAR-T technology, broader therapeutic indications, and
increasing treatment accessibility. The potential for CAR-T therapies to be
combined with other cancer treatments and applied to solid tumors presents key
opportunities for market expansion.
With
ongoing regulatory approvals and improvements in manufacturing processes, the
CAR-T cell therapy market is expected to experience robust growth, solidifying
CAR-T therapies as a cornerstone of modern cancer treatment. Despite challenges
related to treatment costs and access, the market’s growth trajectory remains
strong, contributing significantly to the broader oncology landscape in the
years to come.
Key Market Drivers
Increasing Incidence of Cancer
The
increasing incidence of cancer is one of the most prominent factors driving the
growth of the United States CAR-T (Chimeric Antigen Receptor T-cell) therapy
market. In 2025, it is projected that 14,690 children and adolescents aged 0
to 19 will be diagnosed with cancer, with 1,650 expected to succumb to the
disease. This phenomenon directly impacts the demand for innovative cancer
treatments, including CAR-T cell therapies, which have proven to be a
groundbreaking solution, particularly for blood cancers like leukemia and
lymphoma. Cancer remains one of the leading causes of death in the United
States, in 2025, it is estimated that 2,041,910 new cancer cases will be
diagnosed in the United States, with 618,120 projected cancer-related deaths.
The annual cancer incidence rate is expected to be 445.8 per 100,000 men and
women, based on data from 2018–2022. The rise in cancer cases increases the
patient pool that requires novel treatment options. CAR-T therapies, which
offer a unique, personalized approach to treating cancers, are becoming
increasingly relevant as traditional treatments like chemotherapy and radiation
often fail to deliver long-term remissions or carry severe side effects. With a
larger number of cancer patients, there is a heightened need for advanced
therapies like CAR-T, which can target and eradicate cancerous cells with
greater precision and fewer side effects. As the prevalence of cancer rises,
there is a noticeable shift in the oncology treatment landscape toward more
personalized, targeted therapies. CAR-T cell therapy is at the forefront of
this shift. These therapies are tailored to the individual’s immune system,
utilizing modified T-cells to specifically target and kill cancer cells. This
is especially beneficial for patients with cancers that have not responded to
conventional treatments. The growing incidence of cancer, particularly in
cancers with poor prognoses (e.g., certain types of leukemia, lymphoma, and
other hematologic cancers), creates a higher demand for these novel, effective,
and often life-saving therapies.
As
cancer rates rise, there is a corresponding increase in public awareness
regarding treatment options. Patients and healthcare providers are more aware
of emerging therapies such as CAR-T cell treatments due to media coverage,
advocacy groups, and clinical trial results. With the increase in cancer
diagnoses, patients are seeking out more innovative and potentially more
effective treatments, such as CAR-T therapies, to improve their chances of
survival and quality of life. This growing awareness increases the demand for
CAR-T therapies, leading to market growth. Many cancers are diagnosed at later
stages, and some types of cancer become resistant to traditional therapies.
These cancers are often referred to as “refractory,” meaning they do not
respond well to standard treatments. The rising incidence of refractory
cancers, particularly blood cancers, presents a significant challenge to the
medical community. CAR-T therapies are increasingly being used as a solution
for these cases. For patients with relapsed or refractory cancers, CAR-T
therapies offer the possibility of remission when other treatment options have
failed. This unmet medical need is a significant growth driver for the CAR-T
market, as physicians look for more effective treatments to address challenging
cases.
Aging Population
The
aging population in the United States is a significant driver of growth in the
CAR-T (Chimeric Antigen Receptor T-cell) cell therapy market. The population
of Americans aged 65 and older is expected to grow from 58 million in 2022 to
82 million by 2050, representing a 47% increase. The share of this age group
within the total population is projected to rise from 17% to 23%. As the
number of elderly individuals continues to rise, so does the prevalence of
age-related diseases, particularly cancer. CAR-T therapies, known for their
ability to harness the body’s immune system to target and destroy cancer cells,
are increasingly seen as a promising solution for older patients who may not
benefit as effectively from traditional cancer treatments. As people age, the risk of developing various
types of cancer increases. According to the latest data from the National
Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program,
the median age for a cancer diagnosis is 67 years. This indicates that half of
cancer cases are diagnosed with individuals under this age, while the other
half are diagnosed in those above it. A similar trend is observed across
various common cancer types. For instance, the median age at diagnosis is 63
years for breast cancer, 66 years for colorectal cancer, 71 years for lung
cancer, and 68 years for prostate cancer. Given that CAR-T therapies are
particularly effective for treating hematologic (blood) cancers, such as
certain types of leukemia and lymphoma, the rising number of cancer diagnoses
among the aging population directly drives the demand for CAR-T treatments.
Traditional
cancer treatments, such as chemotherapy, radiation, and surgery, may not be as
effective or well-tolerated in elderly patients due to factors like
comorbidities, frailty, and a diminished ability to recover. Older patients
often face higher risks of severe side effects from these treatments. CAR-T
cell therapies offer a more targeted approach, designed to activate the body’s
immune system to attack cancer cells, thus reducing the need for aggressive and
systemic treatments. This makes CAR-T therapy particularly attractive for the
elderly, driving demands such therapies as a safer and more effective
alternative. One of the key advantages of CAR-T therapy is its potential to
offer long-term remission, particularly for patients who have relapsed or are
refractory to other treatments. As cancer remains a leading cause of death in
the elderly, the ability to provide long-term remission or even a potential
cure is especially compelling. The increasing number of elderly cancer
patients, who may not have many treatment options left, contributes to the
growing interest in CAR-T therapies. The ability of CAR-T therapy to deliver
durable responses and high survival rates in certain cancer types aligns with
the needs of an aging population, further driving its adoption. The elderly
population is diverse, with varying medical histories, comorbidities, and
genetic profiles. Personalized medicine, which tailors’ treatment to an
individual’s specific needs, is particularly important for older patients.
CAR-T therapies, being highly personalized and derived from a patient’s own
T-cells, align well with the trend toward individualized treatment plans. As
the demand for precision medicine increases, the elderly population stands to
benefit from CAR-T therapies that offer tailored, effective solutions based on
their unique health conditions.
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Key Market Challenges
High Cost and Accessibility
Issues
One
of the most significant barriers to the growth of the CAR-T therapy market is
its extremely high cost. The cost of a single CAR-T therapy treatment can range
from $373,000 to $500,000, depending on the therapy and the healthcare
provider. This steep price tag primarily arises from the complex and
personalized nature of CAR-T therapy, which involves collecting a patient’s
T-cells, genetically modifying them in a laboratory, and then reinfusing them
into the patient. The high cost of CAR-T therapy is a major concern,
particularly for uninsured patients and those covered by insurance plans that
do not offer comprehensive reimbursement for such cutting-edge treatments.
While insurance companies are increasingly providing coverage for CAR-T
therapies, the high out-of-pocket costs still pose a significant hurdle for a
large portion of the patient population.
The
steep cost of CAR-T therapies places considerable strain on the healthcare
system, particularly with respect to reimbursement and budget allocation for
cancer treatments. Hospitals and treatment centers may face challenges in
absorbing these costs, limiting patient access to CAR-T therapies and reducing
market penetration. Manufacturers also face pressure to balance the high cost of
production with the potential for achieving profitability. While CAR-T
therapies have shown impressive outcomes, the high price point has led to
criticism about the affordability and overall sustainability of the therapy in
the long term.
Manufacturing Complexities and
Scalability Issues
The
process of manufacturing CAR-T cells is highly complex, time-consuming, and
resource-intensive. It involves extracting a patient’s T-cells, modifying them
genetically in a laboratory, expanding the cells, and then reinfusing them back
into the patient. The process requires sophisticated infrastructure and highly
specialized expertise, leading to significant operational challenges.
The
manufacturing of CAR-T cells can take several weeks, during which patients may
experience disease progression. For patients with aggressive cancers, this
delay can potentially reduce the effectiveness of the treatment. The long
turnaround time from cell collection to reinfusion limits the speed at which
patients can receive treatment, making it a less attractive option compared to
conventional therapies, which are typically more immediate. The specialized
nature of CAR-T therapy production means that there are a limited number of
manufacturing facilities capable of producing these treatments. This not only
restricts the availability of CAR-T therapies but also leads to capacity
constraints, as the production process is inherently difficult to scale.
Expanding the number of facilities and enhancing manufacturing efficiencies
remains a challenge for pharmaceutical companies. Maintaining the consistency
and quality of CAR-T cell products across different patients presents
additional challenges. Each CAR-T product is personalized to the individual’s
immune system, making the manufacturing process highly sensitive to variations
in cell quality. Ensuring that the products are of consistently high quality
requires advanced technologies, strict protocols, and significant oversight,
adding to the complexity and cost of production.
Key Market Trends
Expansion of CAR-T
Applications to Solid Tumors
Currently,
CAR-T cell therapies have been most successful in treating hematologic cancers,
such as leukemia, lymphoma, and multiple myeloma. However, a major trend
driving future growth is the expanding application of CAR-T therapies to treat
solid tumors, which represent the bulk of cancer cases in the U.S.
Solid
tumors, which include cancers like breast cancer, lung cancer, and pancreatic
cancer, account for approximately 90% of cancer cases. The potential to apply
CAR-T therapies to these types of cancer dramatically increases the addressable
market for CAR-T treatments, leading to a significant rise in demand for these
therapies. Pharmaceutical companies and research institutions are increasingly
focused on overcoming the challenges associated with targeting solid tumors.
This includes developing CAR-T therapies that can effectively target
tumor-specific antigens present on solid tumor cells, as well as addressing
issues related to tumor microenvironments that hinder CAR-T cell efficacy. Advances
in identifying new and unique antigens on solid tumor cells, as well as
improving the ability of CAR-T cells to penetrate solid tumors, will open up
new therapeutic avenues. If successful, this trend will unlock new revenue
streams and further establish CAR-T therapies as a versatile tool in oncology.
Increased Focus on
Off-the-Shelf CAR-T Therapies
A
growing trend in the CAR-T therapy market is the development of “off-the-shelf”
(or allogeneic) CAR-T products, as opposed to the traditional autologous
(patient-specific) CAR-T therapies. Off-the-shelf CAR-T therapies are derived
from healthy donor cells, rather than the patient's own cells, making them more
readily available and reducing the time and cost associated with individual
cell collection and manufacturing.
One
of the main limitations of current CAR-T therapies is the lengthy manufacturing
process, which can take several weeks to produce personalized T-cells for each
patient. Off-the-shelf CAR-T therapies eliminate the need for this process,
enabling faster administration of the therapy. This is particularly important
for patients with rapidly progressing cancers who require prompt treatment. The
use of donor cells rather than patient-specific cells can lead to significant
cost reductions. The current CAR-T manufacturing process is expensive due to
the need to extract, modify, and expand a patient’s T-cells. Off-the-shelf
CAR-T therapies have the potential to streamline production, reduce costs, and
make CAR-T treatments more accessible to a broader patient population. Off-the-shelf
CAR-T therapies offer the potential for easier scalability. With the ability to
create a universal product that can be stored and distributed in advance,
pharmaceutical companies can better meet demand without facing capacity
constraints associated with personalized therapies. This trend could make CAR-T
treatments more widely available and improve accessibility across a larger
geographic area.
Segmental Insights
Product Insights
Based
on the category of Product, the Yescarta segment emerged as the fastest growing
segment in the United States CAR-T Cell Therapy Market in 2024. Yescarta’s
remarkable success in clinical trials and its subsequent approval by the FDA
has established it as a leader in the CAR-T therapy space. It is particularly
noted for its high response rates and durable remission in patients with
relapsed or refractory large B-cell lymphoma, a type of non-Hodgkin lymphoma.
The therapy’s ability to deliver long-lasting results in patients who have
exhausted other treatment options has been a key driver in its rapid adoption.
Clinical
data has shown that Yescarta can induce complete remission in a significant
proportion of patients with aggressive forms of blood cancer, many of whom have
not responded to other therapies. This high efficacy increases the likelihood
of its adoption by oncologists and healthcare institutions, driving market
demand. Yescarta has demonstrated the ability to provide long-term remission,
which is a critical factor for patients suffering from cancer. The therapy’s
success in providing durable responses has made it a preferred option,
particularly for patients with limited treatment options. As more real-world
evidence continues to support Yescarta’s clinical effectiveness, it further
cements its position as a leading CAR-T therapy, encouraging broader usage
among healthcare providers and fueling growth in the segment.
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Regional Insights
Northeast
Region emerged as the largest market in the United States CAR-T Cell Therapy
Market in 2024, holding the largest market share in terms of value. The
Northeast has a dense concentration of leading academic medical centers, cancer
research institutions, and specialized treatment centers. Prominent
institutions such as Memorial Sloan Kettering Cancer Center in New York and the
Dana-Farber Cancer Institute in Boston are at the forefront of CAR-T therapy
research and clinical trials, which significantly boosts the adoption of these
therapies.
The
region benefits from well-established healthcare systems and greater access to
cutting-edge treatments, including CAR-T cell therapies. These healthcare
centers are equipped with the necessary infrastructure for the manufacturing,
administration, and monitoring of CAR-T treatments, making them early adopters
of such advanced therapies. The Northeast is home to a significant portion of
the U.S. population, with a relatively higher incidence of certain cancers,
particularly hematologic cancers such as leukemia and lymphoma, where CAR-T
therapies have shown considerable success. This contributes to the region’s
higher demand for CAR-T therapies.
Recent Developments
- In
February 2025, CAR-T therapy reached a significant milestone in the treatment
of neuroblastoma. Recent research indicates that GD2 CAR-T cell therapy holds
the potential for curing neuroblastoma, with some patients achieving long-term
remission for over a decade. This breakthrough marks a major advancement in the
treatment of solid tumors.
- In
November 2024- Breakthroughs in CAR-T cell therapy are offering new hope for
the treatment of solid tumors. Scientists are advancing CAR-T technology beyond
its application in blood cancers, working to enhance its delivery, resilience,
and precision to overcome the challenges associated with targeting solid
tumors. These innovations are unlocking significant potential for CAR-T
therapies in treating a broader range of cancers.
- In
November 2024, The U.S. Food and Drug Administration (FDA) has approved
obecabtagene autoleucel (Aucatzyl) for the treatment of adults with relapsed or
refractory B-cell precursor acute lymphoblastic leukemia (ALL). This approval
marks the first indication for obecabtagene autoleucel, also known as obe-cel. The
FDA’s decision was based on the positive results from the open-label,
multicenter, single-group, phase 1/2 FELIX clinical trial.
Key Market Players
- Gilead
Sciences, Inc (US)
- Novartis United States
- AbbVie Inc.
- Myriad Genetics
- NeoGenomics Laboratories
- Intellia Therapeutics (US)
- Agilent Technologies, Inc. (US)
- Abcam plc.
- Bio-Techne. (ExoDx)
- Sangamo Therapeutics, Inc. (US)
|
By
Product
|
By
Disease
|
By
End User
|
By
Region
|
- Abecma (idecabtagene vicleucel)
- Breyanzi (lisocabtagene maraleucel)
- Carvykti
(ciltacabtagene autoleucel)
- Kymriah
(tisagenlecleucel)
- Tecartus
(brexucabtagene autoleucel)
- Yescarta
(axicabtagene ciloleucel)
- Others
|
- Leukemia
- Lymphoma
- Multiple
Myeloma
- Others
|
- Hospitals
- Cancer
Treatment Centers
|
- Northeast
- Midwest
- South
- West
|
Report Scope:
In this report, the United States CAR-T Cell
Therapy Market has been segmented into the following categories, in addition to
the industry trends which have also been detailed below:
- United States CAR-T Cell Therapy Market, By Product:
o Abecma (idecabtagene vicleucel)
o Breyanzi (lisocabtagene maraleucel)
o Carvykti (ciltacabtagene autoleucel)
o Kymriah (tisagenlecleucel)
o Tecartus (brexucabtagene autoleucel)
o Yescarta (axicabtagene ciloleucel)
o Others
- United States CAR-T Cell Therapy Market, By Disease:
o Leukemia
o Lymphoma
o Multiple Myeloma
o Others
- United States CAR-T Cell Therapy Market, By End User:
o Hospitals
o Cancer Treatment Centers
- United States CAR-T Cell Therapy Market, By
Region:
o Northeast
o Midwest
o South
o West
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the United
States CAR-T Cell Therapy Market.
Available Customizations:
United
States CAR-T Cell Therapy market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The
following customization options are available for the report:
Company Information
- Detailed analysis and profiling of additional
market players (up to five).
United States CAR-T Cell Therapy Market is an
upcoming report to be released soon. If you wish an early delivery of this
report or want to confirm the date of release, please contact us at [email protected]