The United States Cell Therapy Manufacturing Market
is expected to grow at an impressive rate during the forecast period,
2024-2028, owing to favorable regulatory policies, increasing investment,
technological advancements, a collaborative ecosystem, and a rising prevalence
of chronic diseases. A pioneering field in medicine, known as cell therapy, has
evolved, promising treatments for diseases that were once considered
inoperable. With tremendous expansion in recent years, the United States has
established itself as a leader in cell therapy manufacturing.
The existence of a favorable regulatory framework
is one of the primary drivers of the cell therapy manufacturing sector in the
United States. Regulatory agencies like the U.S. Food and Drug Administration
(FDA) have implemented procedures to speed up the creation and marketing of
cell therapies. By reducing entrance barriers and encouraging innovation,
programs like the Regenerative Medicine Advanced Therapy (RMAT) designation and
expedited clearance procedures have simplified the manufacturing processes for
cell therapy manufacturers.
The expansion of the cell therapy manufacturing
sector in the United States has been significantly fueled by advancements in
technology and manufacturing infrastructure. Manufacturing procedures for cell
treatment have become more effective, scalable, and reproducible due to
automation and closed-system processing. Cutting-edge technologies including
bioreactors, 3D bioprinting, and gene editing tools have enhanced the
effectiveness and caliber of cell therapies. These innovations have increased
patient access to cell therapies while also improving production capacity and
lowering prices.
Effective cell therapies are in great demand due to
the rising incidence of chronic and degenerative diseases such as cancer,
cardiovascular problems, and neurological issues. With an aging population and
a high disease prevalence, the United States offers an enormous market for the
production of cell therapies. A large-scale manufacturing infrastructure is
required to keep up with the rising demand for cell therapies as clinical
trials for a variety of illnesses have shown encouraging outcomes.
Cell therapies are essential to the paradigm shift
in personalized and precision medicine, which is gaining pace. Cell treatments
can be tailored to each patient, enhancing therapy efficacy and reducing side
effects as the knowledge of molecular biology and genetics advances. The demand
for specialized cell therapy manufacturing techniques that can accommodate
patient-specific therapies, such as autologous therapies that employ a
patient's own cells for treatment, is anticipated to increase as a result of
this trend.
Although autologous cell therapies have
demonstrated encouraging outcomes, scaling and manufacturing complexity remain
challenges. The development of over-the-counter allogeneic treatments is
progressing to overcome these limitations. Allogeneic therapies involve healthy
donor cells that can be amplified and produced in large quantities. The
availability of well-characterized donor cell lines and advancements in gene
editing technologies like CRISPR-Cas9 are expected to drive the increase in
allogeneic cell therapy manufacturing in the United States.
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The landscape of cell therapy manufacturing is
about to undergo a shift due to the integration of advanced production
technology. To improve productivity, reproducibility, and quality control,
manufacturing processes are being automated, robotized, and enhanced with AI.
With the use of these technologies, cell therapy production can be evaluated in
real-time, throughput can be improved, and scaling up can be done quickly.
Closed-system manufacturing platforms are also used, which reduces the chance
of contamination and increase the overall safety level for cell treatments.
An intricate and interrelated supply chain,
including raw materials, reagents, and accessory parts, is used in the manufacturing
of cell therapy products. A significant focus on supply chain optimization is
necessary to guarantee the seamless manufacture and delivery of cell
treatments. To meet the growing demand for cell treatments and ensure their
prompt delivery to patients, it is essential to streamline logistics, secure
the availability of high-quality starting materials, and implement strong
quality management systems.
The United States cell therapy manufacturing market
is a rapidly growing market that provides encouraging treatments for diseases
that were once incurable. Although the sector has a lot of potential to grow,
there are also challenges in its way. The inherent complexity of the
manufacturing process is one of the main challenges associated with cell
therapy. Cell therapies, compared to conventional pharmaceutical production,
involve working with live, sensitive cells that require specific environments
to thrive and expand. Keeping cells healthy, consistent, and viable throughout
the production process is a difficult task. The production process is more
complex as it requires aseptic processing, strict quality control, and
regulatory compliance. To ensure scalable, reproducible, and cost-effective
manufacturing processes, it is necessary to invest in cutting-edge technology,
automation, and process optimization.
The production of cell therapies requires a complex
supply network that includes raw materials, chemicals, growth factors, and
supporting elements. To prevent disruptions and preserve the integrity of the
product, a reliable and robust supply chain is necessary. The manufacturing
process and the outcome of the product can be influenced by the availability,
quality, and consistency of raw materials. To establish standards, improve
logistics, and ensure the availability of high-quality materials for cell
therapy manufacturing, collaboration between manufacturers, suppliers, and
regulatory bodies is crucial.
Growing Prevalence of Chronic Diseases
The growth of the cell therapy manufacturing market
in the United States is expected to be significantly impacted by the rising
prevalence of chronic diseases. Chronic diseases create a significant burden on
individuals, healthcare systems, and the economy. Examples include cancer,
cardiovascular disease, diabetes, and neurodegenerative disorders. There is an
enormous unmet need for novel drugs because conventional therapies for these
disorders frequently have inadequate efficacy or simply address symptoms. Cell
treatment can help in this situation. With the possibility of disease
modification, tissue regeneration, and individualized treatment methods, cell
treatments have demonstrated significant promise in clinical trials for a
variety of chronic diseases. Cell therapy production will be crucial in providing
these needs as they continue to grow, given the demand for efficient and
long-lasting treatments.
Production of cellular products, comprising
genetically modified cells, stem cells, and immune cells that can be used by
patients to treat the underlying causes of chronic diseases, is made possible
by cell therapy manufacturing. To ensure widespread patient access and
commercial sustainability, it is essential that these medicines can be produced
on a large scale and with consistent quality. The rising incidence of chronic
diseases will result in a greater demand for cell therapies, necessitating the
expansion of production capacity.
Technological Advancements
Advances in technology in cell therapy are
anticipated to have a big impact on the expansion of the cell therapy
manufacturing industry in the United States. Cell therapies can now be
developed and produced in novel ways owing to the quick development of
technologies like gene editing, automation, and bioprocessing. These
innovations provide several significant advantages that will fuel the expansion
of the manufacturing market.
Gene editing has been transformed by technologies
like CRISPR-Cas9, which permit precise alterations to cellular DNA and increase
the therapeutic potential of cell treatments. This level of accuracy enables
the creation of highly customized and targeted medicines, improving patient
outcomes. The efficiency, reproducibility, and scalability of manufacturing
processes have all increased because of automation and robotics.
Automation reduces the risk of human error and
improves the entire production workflow by handling complex operations,
including cell culture expansion, media exchange, and quality control.
Additionally, developments in bioprocessing, such as the creation of
bioreactors and 3D bioprinting, have made it easier to produce intricate and
useful cellular structures. These developments increase the therapeutic
potential of cell treatments by enabling the development of tissue-like
structures and the controlled differentiation of stem cells. Additionally,
technological developments have assisted in creating closed-system processing,
which guarantees aseptic conditions and reduces the possibility of
contamination, essential for maintaining the safety and quality of cell
treatments.
By enhancing product quality, boosting production
capacity, and lowering costs, these technologies are expected to accelerate the
development of the cell therapy manufacturing market in the United States as
they continue to advance and become more widely available.
Market
Segmentation
The
United States Cell Therapy Manufacturing Market can be segmented by therapy,
source of cell, scale of operation, source, application, end user, region and
competitive landscape. By therapy, the United States Cell Therapy Manufacturing
Market can be segmented into T-Cell Therapies, Dendritic Cell Therapies, Tumor
Cell Therapies, and Stem Cell Therapies. Based on the source of cell, the market
is divided into Autologous and Allogenic. Based on the scale of operation, the market
is divided into Preclinical, Clinical, and Commercial. Based on the source, the
United States Cell Therapy Manufacturing Market is divided into In-House and
Contract Manufacturing. Based on the application, the Market is divided into
Oncology, Cardiovascular Diseases, Orthopedic Diseases, and Others. Based on
the end user, the market is divided into pharmaceutical & biotechnology
companies, academic & research institutes, and Others.
Market Players
Lonza
Group AG, Thermo Fisher Scientific Inc., GE Healthcare Life Sciences, Merck
KGaA, Fujifilm Holdings Corporation, Novartis International AG, Bristol Myers
Squibb (BMS), Precision Biosciences Inc. are among others some of the leading
companies operating in the market.
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Attribute
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Details
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Base Year
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2022
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Historic
Data
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2018 – 2021
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Estimated Year
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2023
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Forecast
Period
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2024 – 2028
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Quantitative Units
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Revenue in USD Million, and CAGR for 2018-2022
and 2023-2028
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Report
coverage
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Revenue
forecast, company share, competitive landscape, growth factors, and trends
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Segments covered
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By Therapy
By Source of Cell
By Scale of Operation
By Source
By Application
By End User
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Regional
scope
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Northeast
Region; Midwest Region; South Region; West Region
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Key companies profiled
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Lonza Group AG, Thermo Fisher
Scientific Inc., GE Healthcare Life Sciences, Merck KGaA, Fujifilm Holdings
Corporation, Novartis International AG, Bristol Myers Squibb (BMS), Precision
Biosciences Inc.
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|
Customization
scope
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report customization with purchase. Addition or alteration to country,
regional & segment scope.
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|
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Delivery
Format
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PDF and Excel
through Email (We can also provide the editable version of the report in
PPT/Word format on special request)
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Report
Scope:
In
this report, United States Cell Therapy Manufacturing Market has been segmented
into following categories, in addition to the industry trends which have also
been detailed below:
- United States Cell Therapy Manufacturing
Market, By Therapy
- T-Cell
Therapies
- Dendritic
Cell Therapies
- Tumor
Cell Therapies
- Stem
Cell Therapies
- United States Cell Therapy Manufacturing Market, By Source
of Cell
- United States Cell Therapy Manufacturing Market, By Scale of
Operation
- Preclinical
- Clinical
- Commercial
- United States Cell Therapy Manufacturing Market, By Source
- In-House
- Contract
Manufacturing
- United States Cell Therapy Manufacturing Market, By Application
- Oncology
- Cardiovascular
Diseases
- Orthopedic
Diseases
- Others
- United States Cell Therapy Manufacturing Market, By End User
- Pharmaceutical
& Biotechnology Companies
- Academic
& Research Institutes
- Others
Competitive
Landscape
Company
Profiles: Detailed
analysis of the major companies present in the United States Cell Therapy
Manufacturing Market
Available
Customizations:
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).
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