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Forecast Period
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2026-2030
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Market Size (2024)
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USD
1.85 Billion
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CAGR (2025-2030)
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4.74%
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Fastest Growing Segment
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Media
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Largest Market
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Midwest
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Market Size (2030)
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USD 2.41 Billion
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Market Overview
United States Cell Therapy Raw Materials
Market was valued at USD 1.85 Billion in 2024 and is expected to reach USD 2.41
Billion by 2030 with a CAGR of 4.74%. Firms specializing in key inputs such as
culture media, growth supplements, antibodies, sera, and buffers are pivotal in
meeting the demands of cell therapy developers. This market thrives on quality,
reliability, and regulatory compliance, with many suppliers offering GMP‑grade reagents designed to
support advanced cell-based medicinal products.
Regulatory oversight from agencies such
as the FDA reinforces the emphasis on quality, traceability, and safety. Draft
guidance published in recent months sets higher expectations for materials
derived from human or animal origins, further cementing the need for compliant,
transparent supply chains. Nevertheless, the market faces pressures from high
costs associated with raw materials and production. These cost burdens can
impede broader access to cell therapies, particularly as many treatments remain
highly specialized and resource-intensive. Balancing premium quality with
affordability will be key in expanding the market’s reach.
Key Market Drivers
Growth
in Healthcare Industry
In 2022, the United States allocated approximately
17.8% of its Gross Domestic Product (GDP) to healthcare substantially exceeding
the 11.5% average reported by other high-income nations. The expansion of
the healthcare industry in the United States is a key driver propelling the
growth of the cell therapy raw materials market. As demand for advanced
therapeutic solutions continues to rise, particularly in areas such as
oncology, regenerative medicine, and rare diseases, there is increasing
reliance on high-quality raw materials to support the development and
manufacturing of cell-based therapies.
Driven by technological advancements and a growing
focus on personalized medicine, the healthcare sector is witnessing a surge in
clinical trials and commercial approvals of cell therapies. At the IU School
of Medicine, researchers in the field of pharmacogenomics are working to deepen
the understanding of the relationship between genetics and drug response, with
the goal of advancing more personalized and effective medical treatments. In support
of this effort, the Indiana Institute for Personalized Medicine, in partnership
with the IU School of Medicine’s Department of Medical and Molecular Genetics,
has established a CLIA-certified pharmacogenomics laboratory to facilitate
high-quality, clinically applicable research. This trend directly
contributes to higher demand for raw materials such as growth factors,
cytokines, culture media, enzymes, and reagents components that are critical to
the viability, consistency, and scalability of cell therapy products.
Surge
in Technological Advancements
The United States Cell Therapy Raw Materials market is
witnessing robust growth, largely driven by a surge in technological
advancements that are reshaping the cell therapy landscape. Researchers are
exploring the potential of introducing CAR T-cell therapies earlier in the
treatment process, rather than reserving them for cases where multiple prior
therapies have failed. The approved indications for two CAR T-cell therapies
have already been expanded to include use as second-line treatments meaning
they can now be administered after the failure of initial, first-line therapies
for certain adult blood cancers.
As cell-based therapies continue to gain traction in
treating a wide range of diseases including cancer, autoimmune disorders, and
genetic conditions the demand for high-quality, scalable, and compliant raw
materials has increased substantially. One of the most significant factors
fueling this growth is the development of advanced manufacturing technologies.
Innovations in bioprocessing, such as closed-system production, automated cell
expansion platforms, and single-use technologies, have enhanced the efficiency,
safety, and reproducibility of raw material preparation.
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Key Market Challenges
Limited
Supply of Specialized Raw Materials
A critical challenge facing the United
States cell therapy raw materials market is the limited supply of highly
specialized inputs required for the development and manufacturing of advanced
therapies. Cell therapy production depends on a narrow range of raw materials such
as GMP-grade cytokines, growth factors, serum-free media, and other
biologically sourced components that must meet extremely stringent quality,
safety, and regulatory standards. Unlike conventional pharmaceutical
ingredients, many of these materials are complex to produce, highly sensitive
to storage and handling conditions, and often sourced from a small pool of
qualified suppliers.
This constrained supply environment can
create significant bottlenecks, particularly as demand continues to rise from
both clinical research programs and commercial-scale manufacturing efforts. The
issue is further exacerbated by long lead times, batch-to-batch variability,
and the technical difficulty of scaling production without compromising
material integrity. For many manufacturers, the inability to secure a
consistent and timely supply of key raw materials poses a serious risk to
production continuity and regulatory compliance.
Key Market Trends
Surge
in Allogeneic Therapies and Hybrid Formulations
The growing momentum behind allogeneic
therapies and hybrid formulations is emerging as a significant trend shaping
the United States cell therapy raw materials market. Currently,
approximately 195 companies are actively involved in the development of
allogeneic cell therapies across a range of therapeutic areas, with oncology
representing the primary focus. Within this space, stem cell therapies
constitute the largest segment, closely followed by T-cell therapies. North
America holds a leading position in the global market, accounting for more than
60% of total market share.
Unlike autologous therapies, which use a
patient’s own cells, allogeneic cell therapies utilize donor cells, offering
the potential for scalable, off-the-shelf treatment options. This shift is
driving increased demand for standardized, high-quality raw materials that can
support large-scale manufacturing and ensure consistent product quality across
batches. As biopharmaceutical companies increasingly focus on allogeneic
platforms due to their commercial scalability, there is a rising need for raw
materials such as xeno-free culture media, optimized cryopreservation agents,
recombinant proteins, and cell expansion reagents.
Segmental Insights
Product
Insights
Based on Product, Media have emerged as
the fastest growing segment in the United States Cell Therapy Raw Materials
Market in 2024. This is due to their central role in ensuring the viability,
functionality, and reproducibility of cell-based therapies. As cell therapies
move from early-stage research into clinical and commercial production, the
demand for high-performance, GMP-compliant media has increased significantly.
Unlike traditional pharmaceuticals, cell therapies rely on living cells as the
active ingredient, which makes the growth environment specifically the media
used critical to maintaining consistency, safety, and efficacy.
End
Use Insights
Based on End Use, Biopharmaceutical
& Pharmaceutical Companies have emerged as the fastest growing segment in
the United States Cell Therapy Raw Materials Market during the forecast period.
This is due to their central role in driving innovation, commercialization, and
large-scale manufacturing of advanced cell-based therapies. With increasing
investments in regenerative medicine and immunotherapy particularly in areas
such as oncology, autoimmune diseases, and genetic disorders these companies
are rapidly expanding their research pipelines and clinical trial activity.
This surge in development requires a consistent and scalable supply of
high-quality raw materials such as culture media, growth factors, enzymes, and
reagents to support complex and sensitive manufacturing processes.
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Regional Insights
Based on Region, Midwest have emerged as
the dominating region in the United States Cell Therapy Raw Materials Market in
2024. This is due to a combination of strategic infrastructure, robust research
ecosystems, and strong industry presence. This region has become a hub for
biotechnology innovation, particularly in regenerative medicine and cell
therapy manufacturing. One of the primary factors behind the Midwest's
leadership is the concentration of world-renowned research institutions and
academic medical centers. Universities such as the University of Michigan,
Northwestern University, and Mayo Clinic are actively engaged in cutting-edge
cell therapy research and development, fostering continuous innovation and
collaboration with industry stakeholders.
Recent Development
- In May 2024, REPROCELL announced the
launch of its Master Cell Bank (MCB) manufacturing service for the production
of Human Induced Pluripotent Stem Cells (hiPSC) and Human Mesenchymal Stem
Cells (hMSC) intended for therapeutic applications. The process involves
rigorous selection of raw materials and utilizes a proprietary, footprint-free
RNA reprogramming method. To further enhance its capabilities, REPROCELL has
expanded this service by acquiring the Cytocentric Xvivo System Model 2 from
BioSpherix, a closed, GMP-compliant cell culture system enabling the production
of hiPSC and hMSC suitable for clinical and therapeutic use.
- In April 2025, Thermo Fisher Scientific
announced the grand opening of its Advanced Therapies Collaboration Center
(ATxCC) in Carlsbad, California, its first such facility in the United States.
The center is designed to accelerate the development and commercialization of
cell therapies by supporting biotechnology, biopharmaceutical, and
translational customers focused on cell-based immunotherapies. Thermo Fisher
has previously established similar collaboration centers in Singapore and
Korea. This U.S. facility marks the company’s inaugural collaboration center
domestically, with plans to launch an additional center in Philadelphia later
this year. Both centers will provide clinical and commercial cGMP process
development services to Thermo Fisher’s partners.
- In August 2025, ProBio, a leading
contract development and manufacturing organization (CDMO) specializing in gene
and cell therapy, announced the launch of its cGMP-compliant Adeno-Associated
Virus (AAV) manufacturing services at its state-of-the-art 128,000 sq. ft.
facility in Hopewell, New Jersey. This strategic expansion aims to address the
increasing industry demand for high-quality viral vector production and
underscores ProBio’s commitment to advancing transformative gene therapies. The
Hopewell facility is purpose-built to deliver comprehensive, end-to-end AAV
manufacturing solutions that meet global regulatory and quality standards.
- In April 2025, the U.S. Pharmacopeia
(USP) introduced a comprehensive package of reference standards, materials, and
related resources aimed at providing clarity for developers and manufacturers
of AAV-based gene therapies. These resources are designed to assist AAV
manufacturers in standardizing quality assessment and control across the entire
production lifecycle, from raw and starting materials to product release and
stability. The adoption of standardized analytical methods and appropriately
qualified materials is expected to enhance the efficiency of product
development and characterization.
Key Market Players
- Thermo
Fisher Scientific Inc.
- Merck
KGaA
- Actylis.
- ACROBiosystems
- STEMCELL
Technologies
- Grifols,
S.A.
- Charles
River Laboratories
- RoosterBio,
Inc.
- PromoCell
GmbH
- Danaher
Corporation
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By Product
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By End Use
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By Region
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- Media
- Sera
- Cell Culture Supplements
- Antibodies
- Reagents & Buffers
- Others
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- Biopharmaceutical & Pharmaceutical
Companies
- CROs & CMOs
- Others
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- Northeast
- Midwest
- South
- West
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Report Scope
In this report, the United States Cell Therapy Raw
Materials Market has been segmented into the following categories, in addition
to the industry trends which have also been detailed below:
- United States Cell Therapy
Raw Materials Market, By
Product:
o Media
o Sera
o Cell Culture Supplements
o Antibodies
o Reagents & Buffers
o Others
- United States Cell Therapy
Raw Materials Market, By
End Use:
o Biopharmaceutical & Pharmaceutical Companies
o CROs & CMOs
o Others
- United States Cell Therapy
Raw Materials 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 Cell Therapy Raw Materials Market.
Available Customizations:
United States Cell Therapy Raw Materials 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 Cell
Therapy Raw Materials 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]