Global Single-use Bioreactors Market on Track to Expand at an Impressive Rate of 20% by 2029.
Technological innovations such
as the launch of large-scale single-use bioreactors, demand from pharmaceutical
companies, CROs & CDMOs, growing biologics market, increasing
biopharmaceutical R&D, and benefits of single-use bioreactors are some of
the key factors driving the market growth.
Single-use
bioreactors use the disposable bag as a substitute for a culture vessel
made of stainless steel or glass. It is widely used by pharmaceutical companies
for cell harvesting, media & buffer preparation, filtration, purification,
and virus inactivation.
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Due to their Ability to Enhance Flexibility, Reduce Investment &
Limit Operational Costs, Single-use Bioreactors Have Become Established in
Modern Biopharmaceutical Processes
Enhanced
flexibility is one of the biggest benefits of single-use bioreactors. There is
a growing trend towards multi-drug facilities, which warrants the production of
different drugs using the same facility with minimum time & cost and
top-notch quality. In such scenarios, one of the key manufacturing challenges
is line clearance and validation of cleaning to ensure there is no carry-over
from earlier batches. Downtime limits the number of batches produced in a given
period.
Single-use
bioreactors significantly reduce the time spent preparing the bioreactor for
the subsequent batch. A line changeover with a stainless-steel bioreactor can
take ~6 to 10 hours and three weeks for a full product changeover while by
using single-use bioreactors it is likely to take 2 hours for line changeover.
If the manufacturing line is composed of all single-use components such as
bags, filters, and connectors, the total time for product changeover can be 48
hours. Single-use bioreactors possess the capability to reduce downtime from
two to three weeks to 48 hours, which in turn can significantly impact a
company's output.
Some
of the other key advantages of using single-use bioreactors are:
·
Elimination of validation issues as no
cleaning process is required
·
Lowers the risk of cross-contamination
·
Reduces operating costs and capital
investments (including space, labour requirements, and utilities)
·
Single-use bags are scalable and can be
adjusted to different volumes
·
Simple installation
Potential
Time Savings for Highly Trained Personnel Another Key Benefit of Single-use
Bioreactors
Generally, drug development research, process development, and scale-up activities are performed by highly qualified and trained personnel. These individuals are involved in every stage of a study from early-stage research through to benchtop manufacturing. With stainless steel or glass benchtop bioreactors, individual components need to be cleaned, assembled, leak-tested, sterilized, and cooled before every trial batch is taken. However, the use of single-use bioreactors almost eliminates these steps, which allows scientists more time to focus on their developmental studies.
Technological
Advancements & Customer-Centric Approach – A Key Factor Bolstering the
Demand of Single-use Bioreactors
Commercially
available single-use bioreactors are robust and provide the high performance
necessary for commercial manufacturing of biopharmaceuticals. Significant
advancements in bioreactor design, film technologies, stirring mechanisms, and
sensor systems have contributed to the increasing adoption of single-use
bioreactors from the lab to the production scale.
To
cater to the changing needs of the customers such as next-generation cell- and
gene-therapies and continuous bioprocessing, suppliers of single-use
bioreactors often work closely with its customers, which in turn is expected to
fuel the demand for single-use bioreactors.
“The uptake of single-use
bioreactors is mainly driven by the activity of the different regions regarding
the development of new disease treatments and biosimilars. In addition,
existing production capacity comes into play and company strategies regarding
the manufacture of clinical material. As the USA is indeed leading in the field
of developing innovative treatments, we see a strong uptake of single-use
bioreactors, but Europe and Asia are not far behind.”
- CEO, Leading Manufacturer of Single-use
Bioreactors, United States
Introduction
of Large-Scale Single-use Bioreactors Set to Drive the Market
Traditionally, single-use
bioreactors were restricted in size due to pressure challenges from the
increased weight of the liquid medium in larger volume bags with 2,000 L being
the upper limit. Therefore, if bio manufacturers required larger volumes, they
had to run several systems in unison or opt for stainless-steel tanks.
However, in the last few years,
considering strong demand from pharmaceutical companies and contract
development and manufacturing organizations (CDMOs), several single-use
bioreactor manufacturers have launched large-scale single-use bioreactors which
are expected to fuel the market growth in the coming years.
Aligned with this trend,
·
In
March 2023, Getinge is expanding its bioreactor line with
the Single-Use Production Reactor (SUPR) system, available initially in 50-litre
and 250-litre sizes, to help expedite the delivery of life-saving medicines and
improve quality of life
·
In
March 2021, Thermo Fisher launched 3,000 L and 5,000 L
HyPerforma DynaDrive single-use bioreactors. It is touted as a next-level
innovation in single-use bioreactors with unmatched design, scalability, and
performance. The system provides improved performance and scalability to larger
volumes and is suitable for fed-batch and perfusion processes
Competitive Landscape Analysis
Some
of the key players operating in the market are Sartorius Stedim Biotech, Thermo
Fisher Scientific, Danaher Corporation, Merck KGaA, Celltainer Biotech BV,
Getinge AB, Eppendorf AG, Cellexus, PBS Biotech Inc., ABEC, Able Corporation
& Biott Corporation, G&G Technologies Inc., Solida Biotech GmbH, and Satake
Chemical Equipment Mfg among others.
Organic and Inorganic Growth Strategies
Adopted by Players to Establish Their Foothold in the Market
Players
operating in this market are adopting both organic and inorganic growth
strategies such as collaborations, acquisitions, and new product launches to
garner market share. For instance,
· In
August 2023, Sartorius and Repligen Corporation
have launched an integrated bioreactor system combining Sartorius’ Biostat STR®
and Repligen’ s XCell® ATF technology, featuring a single direct control
interface to simplify upstream process intensification and optimize facility
equipment and maintenance requirements for biopharmaceutical manufacturers
· In
March 2022, Cellexus has partnered with Verder Liquids to
supply pumps for controlling pH balance in their CellMaker Plus and Low Flow
bioreactor systems, enabling manual or automated injection of acids or alkali
into the bioreactor bag
· In
July 2021, Cytiva and Pall Corporation announced
a $1.5 billion investment over two years to expand manufacturing capacity for
life sciences products at 13 sites, addressing the growing demand for
biotechnology solutions
The market is expected to gain further momentum in the coming years due to technological advancements, rising R&D investments, new product launches, and aggressive organic and inorganic growth strategies followed by the players.
Medi-Tech Insights is a healthcare-focused business research & insights firm. Our clients include Fortune 500 companies, blue-chip investors & hyper-growth start-ups. We have successfully completed 100+ projects in Digital Health, Healthcare IT, Medical Technology, Medical Devices & Pharma Services.
Contact:
Ruta Halde
Associate, Medi-Tech Insights
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