|
Forecast
Period
|
2026-2030
|
|
Market
Size (2024)
|
USD
931.08 Million
|
|
Market
Size (2030)
|
USD
1597.30 Million
|
|
CAGR
(2025-2030)
|
9.37%
|
|
Fastest
Growing Segment
|
Expansion
|
|
Largest
Market
|
North
America
|
Market Overview
Global Automated And Closed Cell Therapy Processing
Systems Market has valued at USD
931.08 Million in 2024 and is expected to reach USD 1597.30 Million by 2030
with a CAGR of 9.37% during the forecast period. The increasing appeal of regenerative medicine and cell therapies, along
with the numerous advantages associated with automation technologies in their
development, is projected to drive market expansion. Moreover, the increasing
incorporation of software technologies into advanced therapy development
procedures is also expected to stimulate market growth. Additionally, the
rising investments made by biopharmaceutical manufacturers in the development
of cellular therapy products, supported by multiple rounds of funding, are
poised to provide attractive growth prospects for the market.
Key Market Drivers
Growing Popularity of Regenerative Medicine and
Cell Therapies
Regenerative medicine and cell therapies represent
a groundbreaking frontier in modern healthcare, offering new hope for treating
a variety of challenging medical conditions. As these therapies gain momentum
and continue to demonstrate their effectiveness, they are poised to
significantly impact the healthcare industry. One crucial factor enabling the
scalability and efficiency of regenerative medicine and cell therapy production
is the adoption of automated and closed cell therapy processing systems.
The increasing popularity of regenerative medicine
and cell therapies has led to a surge in demand for these groundbreaking
treatments. However, with greater demand comes the need for efficient,
scalable, and consistent manufacturing processes. Automated and closed cell
therapy processing systems offer a solution to this challenge. They can handle
large-scale production while maintaining precise control over cell culture
conditions. This scalability is essential to meet the growing global demand for
these therapies. In
June 2024, Cryoport Systems, LLC joined forces with Minaris Regenerative
Medicine to advance the development of cell and gene therapies. This
partnership is centered on offering integrated solutions for the storage,
transportation, and processing of cell and gene-based products. The
collaboration aims to facilitate the commercialization and clinical trials of
regenerative therapies.
One of the key factors driving the adoption of
automated systems is their ability to enhance quality control and
standardization. Manual cell therapy processing can be prone to human errors
and variability, which can compromise product quality and safety. Automated
systems, on the other hand, provide a controlled and reproducible environment,
ensuring that each batch of cell therapy products meets stringent quality
standards. This level of consistency is crucial for regulatory compliance and
patient safety.
Automation technologies streamline complex cell
therapy manufacturing workflows, significantly reducing production costs. These
systems can perform tasks such as cell culture, harvesting, and processing with
high precision and efficiency. The reduced need for manual labor not only cuts
labor costs but also minimizes the risk of contamination and product loss,
further boosting cost-effectiveness.
The rapid development of regenerative medicine and
cell therapies requires streamlined and efficient manufacturing processes.
Automated systems enable faster production and quicker turnaround times. This
acceleration in development timelines can bring promising therapies to patients
sooner, increasing their accessibility and potentially saving lives.
Regulatory bodies worldwide are recognizing the
potential of regenerative medicine and cell therapies and are establishing
clear guidelines for their development and production. Automated and closed
cell therapy processing systems play a critical role in helping manufacturers
adhere to these regulations. These systems provide the necessary documentation,
traceability, and data integrity required for regulatory approval, ensuring
that therapies can reach the market faster.
As researchers and scientists continue to uncover
the potential of regenerative medicine and cell therapies, new clinical
applications are emerging. These therapies are no longer confined to a niche
market but are being explored for a broader range of medical conditions, from
cancer to degenerative diseases and beyond. The flexibility and adaptability of
automated systems make them ideal for accommodating the diverse needs of this
expanding field.
Benefits of Automation Technologies
In the rapidly evolving field of regenerative
medicine and cell therapies, automation technologies are emerging as a driving
force behind progress and innovation. These cutting-edge technologies offer a
range of benefits that are not only transforming the way cell therapies are
developed and manufactured but are also propelling the growth of the global
automated and closed cell therapy processing systems market. In
May 2024, ADVA Biotechnology and Cellipont Bioservices teamed up to optimize
cell therapy manufacturing through the ADVA-X3 platform. The partnership
focuses on improving the scalability, efficiency, and quality of cell therapy
production processes. This platform is designed to streamline manufacturing,
making it more suitable for large-scale commercial applications.
Automation technologies excel in providing
precision and consistency throughout the cell therapy manufacturing process.
These systems can execute complex tasks with the utmost accuracy, eliminating
human error and variability. By ensuring a controlled and reproducible
environment, they enhance the quality of cell therapy products, making them
more reliable and effective. This precision is essential for both research and
clinical applications, fostering trust among stakeholders and regulatory
bodies.
The scalability and efficiency of automated systems
are paramount in meeting the growing demand for cell therapies. As the
popularity of regenerative medicine and cell therapies continues to rise, the
need for large-scale production becomes apparent. Automation technologies
enable manufacturers to scale up their operations while maintaining consistent
product quality. This not only satisfies the increasing market demand but also
reduces production costs, making therapies more accessible.
Automation technologies streamline and simplify
complex cell therapy manufacturing workflows. These systems can perform a
multitude of tasks, from cell culture and harvesting to processing and quality
control, with minimal human intervention. This streamlining of workflows
reduces the time and resources required for production, ultimately speeding up
the development timeline and bringing therapies to patients sooner.
By automating labor-intensive processes, companies
can significantly reduce labor costs. Automated systems can work around the
clock without the need for rest or breaks, contributing to cost-effectiveness.
The reduction in labor costs translates into more affordable therapies for
patients, widening access and increasing market penetration.
Automation technologies offer robust data
management capabilities, allowing for real-time monitoring, data analysis, and
documentation. This ensures complete traceability of the manufacturing process,
a critical requirement for regulatory compliance. The ability to track and
trace each step of production enhances product safety and quality, making it
easier to obtain regulatory approvals and market access.
Integration of Software Technologies
In the fast-evolving landscape of regenerative
medicine and cell therapies, the integration of advanced software technologies
is emerging as a key driver of innovation and efficiency. These software
solutions are not just streamlining processes; they are also playing a
significant role in boosting the growth of the global automated and closed cell
therapy processing systems market. In February 2021, Cytiva and Brooks Life Sciences entered into an agreement to expand the functionalities of their automated cold chain solutions. Both companies are collaborating to improve the cryogenic cold chain capabilities of Cytiva's automated cold chain system.
One of the most compelling advantages of software
integration in cell therapy processing systems is the ability to provide
real-time monitoring and control. Researchers and manufacturers can track
critical parameters such as temperature, pH levels, and cell viability in
real-time. Any deviations from the desired conditions can be swiftly addressed,
ensuring that the cell therapy production process remains on track. This level
of control enhances the quality and consistency of the final product.
Advanced software technologies enable in-depth data
analysis, allowing researchers and manufacturers to gain valuable insights into
their processes. These insights can be used to optimize production workflows,
identify bottlenecks, and enhance yields. Data-driven decision-making is
becoming increasingly crucial in the competitive cell therapy market, where
efficiency and cost-effectiveness are paramount.
Integration of software technologies enables the
automation of various aspects of cell therapy production, from cell culture to
harvesting and quality control. This automation reduces the need for manual
intervention, minimizing the risk of human errors and increasing overall
efficiency. By streamlining workflows, software integration accelerates
production timelines, allowing therapies to reach patients faster.
The regulatory landscape for cell therapy
manufacturing is becoming more stringent. Software solutions can facilitate
compliance by providing comprehensive documentation and traceability throughout
the production process. This documentation is invaluable when seeking
regulatory approvals, ensuring that therapies meet the required safety and
quality standards.
In an era where remote work and collaboration are
becoming the norm, software integration offers the advantage of remote
monitoring and accessibility. Researchers and manufacturers can monitor and
control cell therapy processes from anywhere in the world, facilitating
collaboration and reducing the need for physical presence in the manufacturing
facility. This flexibility is particularly valuable in global supply chains and
collaborations.
The field of regenerative medicine and cell
therapies is constantly evolving, with new technologies and research findings
emerging regularly. Software-integrated cell therapy processing systems are
designed to be adaptable, allowing them to incorporate and integrate emerging
technologies seamlessly. This adaptability ensures that manufacturers can stay
at the cutting edge of innovation.
Increased Investment by Bio Manufacturers
The field of regenerative medicine and cell
therapies has witnessed a surge in interest and optimism in recent years,
promising groundbreaking treatments for a wide range of medical conditions. A
critical enabler of this progress is the increased investment by bio
manufacturers in the development and commercialization of these therapies. A
noteworthy consequence of this surge in funding is the substantial growth of
the global automated and closed cell therapy processing systems market.
The influx of investments from bio manufacturers
has accelerated research and development efforts in the field of regenerative
medicine and cell therapies. These funds are being used to explore new
therapeutic approaches, conduct pre-clinical and clinical trials, and develop
innovative cell therapy products. This surge in R&D activities has created
a strong demand for automated and closed cell therapy processing systems, as
these technologies are essential for efficiently translating promising therapies
from the laboratory to commercial production.
To meet the growing demand for cell therapies, bio
manufacturers are investing in the construction of state-of-the-art production
facilities. These facilities are designed to handle large-scale manufacturing,
producing cell therapy products at volumes that can cater to the global market.
The adoption of automated cell therapy processing systems is crucial in these
facilities to ensure scalability, consistency, and cost-effectiveness in the
manufacturing process.
The investment surge by bio manufacturers is also
directed towards conducting extensive clinical trials to demonstrate the safety
and efficacy of cell therapies. Successful trial outcomes pave the way for
regulatory approvals and commercialization. Automated and closed cell therapy
processing systems are indispensable in ensuring that therapies produced for
clinical trials are of consistent quality and meet rigorous regulatory
standards. They also enable a smooth transition from clinical trials to commercial-scale
manufacturing.
As bio manufacturers diversify their cell therapy
product portfolios, they require adaptable and versatile processing systems.
Investments allow manufacturers to explore a broader range of cell therapy
applications, from oncology to degenerative diseases and beyond. Automated
systems can be tailored to accommodate various cell types and production
requirements, making them an attractive choice for manufacturers pursuing
diverse therapeutic avenues.
Increased investments by bio manufacturers
contribute to market accessibility and affordability. By funding research,
development, and production capabilities, these investments help bring cell
therapies to a wider range of patients, addressing unmet medical needs.
Automated processing systems play a crucial role in ensuring that cell
therapies are both accessible and affordable, as they optimize production
efficiency and reduce manufacturing costs.
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Key Market Challenges
High Initial Costs
One
of the most significant barriers to the adoption of automated cell therapy
processing systems is the high initial cost associated with acquiring and
implementing these advanced technologies. The investment required to purchase,
install, and configure such systems can be substantial, often running into the
millions of dollars. This poses a particular challenge for smaller biotech
companies and research institutions that may lack the financial resources to
make such large investments. Additionally, the long-term return on investment
(ROI) may not be immediately clear, leading to hesitation among potential
stakeholders. The financial strain associated with these initial costs can
deter many from entering the market or adopting these systems, despite the potential
long-term benefits in terms of efficiency, scalability, and precision.
Technical Expertise
Operating
and maintaining automated cell therapy processing systems demands a high level
of technical expertise that can be difficult to acquire. These systems are
highly sophisticated and require skilled personnel who understand both the
hardware and the software components. The need for specialized knowledge
extends beyond simple operation; staff must also be proficient in
troubleshooting, ensuring system calibration, and addressing any technical
issues that may arise. Training employees to reach this level of competency can
be time-consuming and expensive, as it often requires dedicated training
programs or hiring additional experts. Moreover, the scarcity of qualified
professionals in the field further exacerbates the challenge, creating a talent
gap that can hinder the successful implementation and sustained operation of
automated systems. Without the right technical expertise, companies may
struggle to maximize the potential of these technologies.
Integration with Existing Workflows
Integrating
automated cell therapy processing systems into existing workflows can be a
particularly complex and challenging process. Many organizations have
established, manual processes and infrastructure that may not easily
accommodate new, automated systems. Compatibility issues between the new
automated technologies and legacy equipment or software can create significant
roadblocks. In addition, process modifications may be required to accommodate
the new system, which can lead to operational disruptions or inefficiencies
during the integration period. For example, the automated systems may require
adjustments in how cells are handled, prepared, or cultured, necessitating
retraining of staff or reconfiguration of workspaces. Achieving a seamless
integration is essential for realizing the full benefits of automation, such as
improved efficiency, consistency, and scalability. However, managing the
complexities of integration while maintaining operational continuity is a major
challenge that companies must address to ensure that automation delivers on its
promise.
Key Market Trends
Increasing
Adoption of Automated Systems for Efficiency and Consistency
The demand for automated cell therapy processing
systems is rising globally due to the need for increased efficiency and
consistency in manufacturing processes. Cell therapy, which includes innovative
treatments such as stem cell and gene therapies, has complex production
requirements that necessitate precise control over various parameters,
including temperature, oxygen levels, and pH. Traditionally, manual processing
could result in variability and human error, which compromises product quality
and consistency. Automated systems are designed to standardize processes and
reduce errors, ensuring more reliable outcomes.
Automation improves operational efficiency by
reducing labor costs, minimizing human intervention, and speeding up production
timelines. Furthermore, automation can lead to more reproducible results,
critical in the biopharmaceutical industry where consistency and regulatory
compliance are vital. Automated systems can continuously monitor critical
variables and provide real-time feedback, enabling swift corrective actions
when necessary. As cell therapies continue to grow in prominence, automation
allows manufacturers to scale up production without sacrificing quality, a
crucial factor for meeting the increasing demand for these cutting-edge
therapies.
Moreover, automated systems are increasingly designed
with modularity, enabling them to adapt to different manufacturing needs.
Whether for small-scale, clinical-grade production or large-scale commercial
manufacturing, automated systems offer flexibility and scalability. This
adaptability is particularly valuable in a market that is evolving rapidly, as
manufacturers need to adjust quickly to shifting demand and regulatory
landscapes. Automated solutions can also enhance safety by reducing human
exposure to hazardous biological materials, thereby improving worker safety
while maintaining a sterile environment crucial for cell therapy production. As these systems become more advanced, their
integration with artificial intelligence and machine learning algorithms
further enhances their capabilities. AI and machine learning enable predictive
analytics, optimizing workflows and improving decision-making by analyzing
large datasets to forecast potential problems and suggest preventive actions.
This intelligent processing results in more efficient production cycles and
improves the overall robustness of cell therapy manufacturing processes.
Advancements
in Closed-Loop Systems for Enhanced Product Safety
Closed systems are rapidly becoming the preferred
choice for cell therapy manufacturing due to their ability to reduce
contamination risks and improve product safety. In a closed system, all
processes, from cell collection to processing and final product preparation,
take place within a sealed environment. This configuration prevents external
contaminants, such as bacteria, viruses, or other pathogens, from coming into
contact with the cells, thereby preserving the integrity and purity of the
product. In
October 2022, ScaleReady USA launched the Cue Cell Processing System by
Fresenius Kabi, aimed at automating and simplifying cell therapy manufacturing.
The system improves efficiency by combining cell processing with closed,
automated workflows. This innovation is designed to facilitate the scalable
production of high-quality cell therapies while minimizing manual involvement.
The increasing adoption of closed systems is driven
by the growing need for safety, particularly in clinical settings where
patients’ health is at stake. Cell therapies are designed to be highly
specific, and any contamination during processing can lead to a compromised
therapeutic product, potentially endangering patient safety. As a result,
regulatory agencies worldwide are placing greater emphasis on ensuring that
cell therapy products are free from contaminants. Closed systems play a crucial
role in meeting these stringent regulatory standards and are integral to
maintaining the sterile conditions required for successful cell therapy
treatments.
The closed-loop approach also improves efficiency by
streamlining processes. With a sealed environment, the handling of cells
becomes more controlled, reducing the need for manual interventions that could
introduce variability or errors. This also leads to a reduction in labor costs,
as the reliance on skilled operators is diminished, further boosting
cost-effectiveness. In addition, closed systems often incorporate automated
processes, ensuring that production follows a well-defined, standardized protocol
that reduces the chance of human error. Another advantage of closed systems is their ability
to enhance traceability and documentation. The sealed, integrated nature of
these systems allows for continuous monitoring and real-time data capture,
providing manufacturers with valuable insights into every stage of the
production process. This data can be used for quality control, regulatory
compliance, and continuous improvement of manufacturing practices, ultimately
leading to more robust and reliable cell therapy products.
Segmental Insights.
Type Insights
In 2024, the non-stem cell therapy sector captured
the largest share of revenue and is projected to experience the most rapid CAGR
in the coming forecast period. The expected boost in segment growth is
primarily driven by a rising number of product launches targeting non-stem cell
therapy applications. Additionally, the success of CAR-T therapies has led to
increased investments in the development of non-stem cell therapies, further
contributing to revenue growth.
In February 2023, IASO Biotherapeutics, a clinical-stage
biopharmaceutical company specializing in cutting-edge cell therapies,
announced that the Food and Drug Administration (FDA) had granted Fast Track
(FT) Designation and Regenerative Medicine Advanced Therapy (RMAT) Designation
to its novel BCMA CAR-T CT103A (Equecabtagene Autoleucel) drug. This medication
has the potential to treat Relapsed/Refractory Multiple Myeloma (RRMM), an
aggressive form of blood cancer that no longer responds to conventional cell treatments.
Companies are actively forming partnerships and
collaborations to develop innovative regenerative medicines for the treatment
of chronic conditions. These research endeavors primarily focus on non-stem
cell applications, thereby propelling the growth of the non-stem cell therapy
segment. Furthermore, the increasing emphasis on cell and tissue-based
engineering, driven by its significant clinical potential, is expected to
further accelerate segment growth in the forecast period.
Conversely, the stem cell therapy segment is also
anticipated to experience substantial growth during the forecast period. This
growth is driven by the growing awareness of the therapeutic benefits offered
by stem cell therapies and the increasing research efforts aimed at enhancing
drug effectiveness and understanding disease mechanisms.
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Regional Insights
In 2024, North America asserted its dominance in
the market, capturing the largest share of revenue. This commanding position
was primarily attributed to the increased adoption of advanced technology for
cell therapy processing and a strong focus on achieving high precision and
production throughput. The regional market is poised to continue expanding
steadily.
This growth is driven by the significant demand for regenerative medicines in
the healthcare sector of the region. Furthermore, the substantial investments
made by market players and research institutes are expected to be pivotal in
fostering the region's growth.
In contrast, Europe and Asia Pacific are expected
to witness substantial growth rates during the forecast period. The European
market is anticipated to benefit from a robust facility network and a skilled
workforce in various European countries, which is projected to fuel market
expansion. In recent years, there has been a series of introductions of fully
automated platforms in European countries capable of supporting the entire
bioprocess workflow, from initiation to completion.
On the other hand, the notable growth of the market
in the Asia Pacific region can be attributed to several key factors. These
include increasing government and private investments, rising healthcare needs,
and the establishment of expedited approval pathways for medical products.
Recent Developments
- In September 2024, Vertex Pharmaceuticals
Incorporated entered into a long-term commercial supply agreement with Lonza
for the production of Casgevy, a CRISPR/Cas9 gene-edited cell therapy designed
to treat sickle cell disease and β-thalassemia.
- In December 2023, Miltenyi Biotec and Replay
finalized a licensing and manufacturing agreement to develop GMP-compliant
T-cell receptor (TCR) natural killer (NK) cell therapies targeting PRAME, a
tumor-associated neoantigen.
- In May 2024, YASKAWA ELECTRIC CORPORATION and
Astellas Pharma Inc. formed a partnership to create an advanced cell therapy
platform that combines robotics and pharmaceutical technologies. This
collaboration seeks to simplify the shift from research to large-scale
production, improving both the quality and stability of manufacturing
processes.
- In
September 2024, Multiply Labs revealed a partnership with Legend Biotech to
automate cell therapy manufacturing through the use of advanced robotic
systems. This collaboration is set to assess Multiply Labs' robotic technology,
which is designed to integrate smoothly with current cell therapy processes,
aiming to reduce labor costs and enhance manufacturing throughput.
Key Market Players
- Miltenyi Biotec B.V. & Co. KG
- Lonza Group AG
- Fresenius Kabi AG
- Global Life Sciences Solutions USA LLC
- BioSpherix, LLC
- Terumo Corp
- Sartorius AG
- ThermoGenesis Holdings Inc
- Cellares Corporation
- Thermo Fisher Scientific Inc.
|
By Workflow
|
By Type
|
By Scale
|
By Region
|
- Separation
- Expansion
- Apheresis
- Fill-Finish
- Cryopreservation
- Others
|
- Stem Cell Therapy
- Non-Stem Cell Therapy
|
- Pre-commercial/ R&D Scale
- Commercial Scale
|
- North America
- Europe
- Asia-Pacific
- South America
- Middle East & Africa
|
Report Scope:
In this report, the Global Automated And Closed
Cell Therapy Processing Systems Market has been segmented into the following
categories, in addition to the industry trends which have also been detailed
below:
- Automated And Closed Cell Therapy Processing
Systems Market, By
Workflow:
o Separation
o Expansion
o Apheresis
o Fill-Finish
o Cryopreservation
o Others
- Automated And Closed Cell Therapy Processing
Systems Market, By
Type:
o Stem Cell Therapy
o Non-Stem Cell Therapy
- Automated And Closed Cell Therapy Processing
Systems Market, By
Scale:
o Pre-commercial/ R&D
Scale
o Commercial Scale
- Automated And Closed Cell Therapy Processing
Systems Market, By Region:
o North America
§ United States
§ Canada
§ Mexico
o Europe
§ Germany
§ United Kingdom
§ France
§ Italy
§ Spain
o Asia-Pacific
§ China
§ Japan
§ India
§ Australia
§ South Korea
o South America
§ Brazil
§ Argentina
§ Colombia
o Middle East & Africa
§ South Africa
§ Saudi Arabia
§ UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Automated
And Closed Cell Therapy Processing Systems Market.
Available Customizations:
Global Automated And Closed Cell Therapy Processing
Systems 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).
Global Automated And Closed Cell Therapy Processing
Systems 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
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