|
Forecast
Period
|
2024-2028
|
|
Market
Size (2022)
|
USD
910.65 million
|
|
CAGR
(2023-2028)
|
9.10%
|
|
Fastest
Growing Segment
|
Stem Cell Therapy
|
|
Largest
Market
|
North
America
|
Market Overview
Global Automated And Closed Cell Therapy Processing
Systems Market has valued at USD 910.65 million in 2022 and is anticipated to
project impressive growth in the forecast period with a CAGR of 9.10% through
2028. 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.
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.
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.
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 challenges in the
adoption of automated cell therapy processing systems is the substantial
upfront investment required. The cost of acquiring and implementing these
sophisticated technologies can be prohibitive for smaller biotech companies and
research institutions. The initial financial burden may deter some potential
stakeholders from entering the market.
Technical Expertise
Operating and maintaining automated cell therapy
processing systems requires a high level of technical expertise. Training staff
and ensuring that they have the necessary skills to operate these complex
systems can be a time-consuming and resource-intensive endeavor. A shortage of
skilled personnel in the field can pose a significant challenge for companies
looking to adopt automated technologies.
Integration with Existing Workflows
Integrating automated systems into existing
manufacturing workflows can be a complex process. Compatibility issues, process
modifications, and potential disruptions during integration can be daunting for
companies. Seamless integration is crucial to maximize the efficiency and
benefits of automation, but it can be a major challenge to achieve.
Key Market Trends
Miniaturization and Modularization
Miniaturization of equipment and the development of
modular processing systems are gaining traction. Smaller, more portable systems
allow for greater flexibility in cell therapy manufacturing, making it easier
to set up production facilities and conduct research in various settings. This
trend supports scalability and adaptability in the field.
Advanced Sensor Technologies
The integration of advanced sensor technologies is
becoming increasingly important. These sensors provide real-time monitoring and
feedback on critical parameters such as cell viability, pH levels, and
temperature. Enhanced sensors enable precise control over the manufacturing
environment, ensuring consistent product quality and regulatory compliance.
Closed Systems for Improved Safety
Closed processing systems are becoming the gold
standard for cell therapy manufacturing. These systems reduce the risk of
contamination, ensuring the safety and purity of cell therapy products. As
patient safety is paramount, the adoption of closed systems will continue to
rise, particularly for commercial-scale production.
Segmental Insights
Workflow Insights
Based on the category of Workflow, the most
substantial revenue share in 2022 came from the expansion segment. This growth
can largely be attributed to the extensive range of products available within
this segment. Furthermore, the proliferation of partnerships among market
players, aimed at adopting and applying systems within this segment, has been a
significant driver of its expansion. As an example, Angiocrine Bioscience has
successfully integrated Terumo BCT's quantum cell expansion system to expedite
its cell therapy research efforts.
Moving forward, it is anticipated that the
separation segment will exhibit the highest CAGR during the forecast period.
The cell separation process plays a pivotal role in various cellular
experiments, including molecular analysis, cellular genetic modification,
hybridoma production, and other cell research and analysis-related
applications. The growth in this segment is expected to be bolstered by the
increasing number of research activities in academic universities and other
research settings for these applications.
In addition to expansion and separation, the
workflow segment encompasses apheresis, fill-finish, cryopreservation, and
other components. Cryopreservation and apheresis workflows are also poised for
significant growth, thanks to the rising awareness and acceptance of
regenerative medicines.
In February 2023, Cell and Gene Therapy Catapult, a
UK-based company, made an announcement about its involvement in the development
of an extensive new life science campus in Stevenage, for which the company has
allocated a budget exceeding USD 900 million. This new campus is being
established to meet the surging demand within the life sciences industry.
Type Insights
In 2022, 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, 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 2022, 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, maintaining a Compound Annual Growth Rate (CAGR) from 2023 to 2030.
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 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.
Key Market Players
- Miltenyi Biotec Inc
- Lonza
Group AG
- Fresenius
Kabi AG
- Cytiva
Europe GmbH
- Biospherix
Ltd
- 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
§ Kuwait
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, Tech Sci 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
us at [email protected]