According to Towards Healthcare, insights predict the global single-use assemblies market will increase from USD 13.25 billion in 2024 to USD 58.44 billion by 2034, achieving a CAGR of 16.15%. The market is growing rapidly due to increasing biopharmaceutical production and the need for contamination-free, cost-efficient processing. Technological advancement and regulatory support are further accelerating global adoption.
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Key Takeaways
➤ Single-use assemblies market to cross USD 13.25 billion in 2024.
➤ Market projected at USD 58.44 billion by 2034.
➤ CAGR of 16.15% expected in between 2025 to 2034.
➤ North America dominated the single-use assemblies market revenue shares of approximately 44% in 2024.
➤ Asia Pacific is expected to grow at the fastest CAGR in the market during the forecast period.
➤ By solution type, the standard assemblies segment dominated the market with a revenue share of approximately 57%.
➤ By solution type, the custom assemblies segment is expected to grow at the fastest CAGR in the market during the forecast period.
➤ By product type, the bag assemblies segment led the market with the largest revenue share of approximately 28% in 2024.
➤ By application, the filtration segment held the highest single-use assemblies market share of approximately 32% in 2024.
➤ By application, the fill-finish segment is expected to grow at the fastest CAGR in the market during the forecast period.
➤ By end user, the biopharmaceutical & biotech companies segment held the highest revenue shares of approximately 48% in 2024.
➤ By end user, the contract manufacturing organizations (CMOs) segment is expected to grow at the fastest CAGR in the market during the forecast period.
➤ By processing stage, the upstream processing segment dominated the market with the major revenue share of approximately 52% in 2024.
➤ By processing stage, the fill & finish operations segment is expected to grow at the fastest CAGR in the market during the forecast period.
What are the Single-Use Assemblies?
The single-use assemblies market is driven by growth in demand from the biopharmaceutical sector. The single-use assemblies refer to the pre-assembled, disposable components used to handle fluids, media, and cells without requiring sterilization between batches. They are used for upstream processing, downstream processing, and the fill-finish process.
Key Metrics and Overview
|
Metric |
Details |
|
Market Size in 2025 |
USD 15.39 Billion |
|
Projected Market Size in 2034 |
USD 58.44 Billion |
|
CAGR (2025 - 2034) |
16.15% |
|
Leading Region |
North America share by 44% |
|
Market Segmentation |
By Solution Type, By Product Type, By Application, By End User, By Bioprocessing Stage, By Region |
|
Top Key Players |
Sartorius AG, Thermo Fisher Scientific, Merck KGaA (MilliporeSigma), Danaher Corporation (Cytiva), Saint-Gobain Life Sciences, Avantor, Inc., Pall Corporation, Entegris, Inc., Repligen Corporation, Meissner Filtration Products, Parker Hannifin Corporation, EWPS (formerly Colder Products Company - CPC), KBI Biopharma, Eppendorf AG, ILC Dover LP, FlexBiosys Inc., Gore & Associates, ZETA GmbH, ABEC, Inc., Asahi Kasei Medical Co., Ltd. |
What are the Major Growth Drivers in the
Single-Use Assemblies Market? The growth in the development of biologics
acts as the major driver in the market. Due to increasing demand for vaccines and
antobodies, the use of single-use assemblies is increasing to promote sterile,
scalable, and flexible manufacturing solutions. Additionally, shift towards the
use of single-use technology, contamination control, focus to towards
operational efficiency, and technological advancements are some of the other
market drivers. What are the Key Drifts in the
Single-Use Assemblies Market? The market has been expanding due to the
growing investments to launch and enhance the use of various single-use
assemblies. ➤ In April 2025, a total
of $2 billion will be invested in the U.S. for the next 4 years to support
their innovations, economic competitiveness, and manufacturing across the life
sciences sector by Thermo Fisher Scientific Inc. What is the Significant Challenge in the
Single-Use Assemblies Market? High cost is the major challenge in the
market. Due to their single use, they have to be purchased for every batch,
where the cost of the material and manufacturing also increases their cost,
which makes their repeated use more expensive. Moreover, limited reusability,
material compatibility, validation concerns, and storage challenges are other
market limitations. You can place an order or ask any
questions, please feel free to contact us at sales@towardshealthcare.com Regional Analysis Why did North
America Dominate the Single-Use Assemblies Market in 2024? In 2024, North America captured the biggest
revenue share by 44% in the market, due to the presence of well-developed
industries. At the same time, the growth in R&D and investments also
increased their use. Additionally, the growth in the development of biologics, vaccines, and advanced therapies has also increased their demand.
Furthermore, the increasing technological advancements are also accelerating
their early adoption, which all these factors contribute to the market growth. U.S. biopharmaceutical manufacturers
increasingly adopt single-use assemblies for faster process implementation,
lower contamination risk, and flexible scale-up. Investment in localized supply
chains, facility retrofits, and workforce training supports adoption while
partnerships accelerate integration into commercial biologics and cell therapy production. What Made the
Asia Pacific Grow Notably in the Single-Use
Assemblies Market in 2024? Asia Pacific is expected to host the
fastest-growing cannabidiol market during the forecast period, due to expanding biopharmaceutical manufacturing. This, in turn, is increasing the R&D and clinical trials, which is driving the demand for single-use assemblies, where the
growing CRO are also increasing their use. Moreover, the growing government
support and initiatives are also increasing their use, promoting the market
growth. China's market expands as contract
manufacturers and domestic biotechs increase capacity, driven by biosimilar development,
cost efficiency, and rapid facility buildouts. Local suppliers improve
single-use component quality while regulatory harmonization and technology
transfer accelerate adoption across commercial and clinical manufacturing. Become a valued research partner with us
- https://www.towardshealthcare.com/schedule-meeting Segmental Insights By solution type analysis Why Did the Standard Assemblies Segment Dominate in the Single-Use Assemblies Market in 2024? By solution type, the standard assemblies
segment led the market in 2024, due to their affordability. Moreover, their
pre-validation and documentation also increased their adoption rates, where
their easy integration also increased their demand. Additionally, their
scalability also enhanced their use in R&D activities. By solution type, the custom assemblies
segment is expected to grow at the fastest CAGR in the market during the
forecast period, due to growth in the development of advanced therapies.
Additionally, growing complex bioprocessing is also increasing its demand, as
it offers enhanced efficiency. By product type analysis Which Product Type Segment Held the
Dominating Share of the Single-Use Assemblies Market in 2024? By product type, the bag assemblies segment
held the dominating share of the market in 2024, due to its wide range of
applications. They were also important for bioprocessing. At the same time,
their affordability, scalability, and reduced risk of contamination also
increased their demand. By application analysis What Made Filtration the Dominant Segment in the Single-Use Assemblies Market in
2024? By application, the filtration segment held
the largest share of the market in 2024, as it is essential for upstream,
downstream, and final fill finish stages. They also removed contaminants,
impurities, and microbes, which increased their use for multiple filtration
steps. The growth in the biologics development has also increased their use. By application, the fill-finish segment is
expected to grow at the fastest CAGR in the market during the forecast period,
due to the growing development of advanced therapies. They are being used to
provide sterile production, where the growing startups are also increasing
their use for the development of vaccines and injectables. By end-user analysis How did the Biopharmaceutical &
Biotech Companies Segment dominate the
Single-Use Assemblies Market in 2024? By end user, the contract manufacturing
organizations (CMOs) segment is expected to grow at the fastest CAGR in the
market during the forecast period, driven by increasing outsourcing trends.
Moreover, the growth in innovation has also increased the use. Additionally,
the growing clinical trials is also increasing their demand. By processing stage analysis Why Did the Upstream Processing Segment Dominate in the Single-Use Assemblies Market in 2024? By processing stage, the upstream
processing segment held the largest share of the market in 2024, due to growth
in the demand for bioreactors, filters, and mixers. Moreover, closed single-use
systems were utilized for contamination control. Additionally, growth in cell and gene therapiess
also increased their use. By processing stage, the fill & finish
operations segment is expected to grow at the fastest CAGR in the market during
the forecast period, due to growing demand for injectable biologics and
vaccines. Furthermore, the growth in the demand for personalized medicines is also increasing their use. Get the latest insights on life science
industry segmentation with our Annual Membership: https://www.towardshealthcare.com/get-an-annual-membership Recent Developments in the Single-Use Assemblies Market ➤ In May 2025, in order
to develop and commercialize novel diagnostic tools and tests to provide
support to clinicians to identify better precision medicines for the patient, a
collaboration between Danaher Corporation and AstraZeneca was announced. ➤ In February 2025, a
collaboration between Pall Corporation and MTR Carbon Capture (MTR) was
announced, where they will combine advanced filtration solutions and filter
technologies of Pall Corporation with the Polaris™ membrane system of MTR to
promote the development of a highly modular, scalable, and cost-effective
integrated solution. Single-Use
Assemblies Market Key Players List ◾Merck KGaA (MilliporeSigma) ◾Sartorius AG ◾Danaher Corporation (Cytiva) ◾Thermo Fisher Scientific ◾Pall Corporation ◾Saint-Gobain Life Sciences ◾Entegris, Inc. ◾Avantor, Inc. ◾Parker Hannifin Corporation ◾Repligen Corporation ◾EWPS (formerly Colder Products Company - CPC) ◾Meissner Filtration Products ◾Asahi Kasei Medical Co., Ltd. ◾KBI Biopharma ◾ZETA GmbH ◾Eppendorf AG ◾FlexBiosys Inc. ◾Gore & Associates ◾ILC Dover LP ◾ABEC, Inc. Segments Covered in The Report By Solution Type ● Standard Assemblies ● Custom Assemblies By Product Type ● Bag Assemblies ● Filtration Assemblies ● Bottle Assemblies ● Mixing System Assemblies ● Tubing Assemblies ● Sampling Assemblies ● Others (Manifold assemblies, sensor-integrated
assemblies) By Application ● Filtration ● Cell Culture & Mixing ● Storage ● Sampling ● Fill-Finish ● Fluid Transfer By End User ● Biopharmaceutical & Biotech Companies ● Contract Manufacturing Organizations
(CMOs) Academic & Clinical ● Research Institutes ● Contract Research Organizations (CROs) By Bioprocessing Stage ● Upstream Processing ● Downstream Processing ● Fill & Finish Operations By Region ● South America ● Europe ● Asia Pacific ● MEA Immediate Delivery Available | Buy This
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