Single-Use Bioprocessing Market Projected to Reach US$ 122.92 Billion by 2035, Supported by Expansion of Biomanufacturing Capacity Says Astute Analytica

Single-use bioprocessing offers transformative potential, unlocked by new 6,000 L commercial scalability and 50% CAPEX reductions. With superior sustainability profiles and proven regulatory success, it is now the definitive standard for agile, high-margin commercial manufacturing globally.

Chicago, Jan. 20, 2026 (GLOBE NEWSWIRE) — The global single-use bioprocessing market reached a valuation of USD 30.12 billion in 2025 and is forecasted to expand to USD 122.92 billion by 2035, achieving a robust CAGR of 15.1% from 2026 to 2035.

Today, the Single-Use Bioprocessing (SUB) market has definitively transcended clinical boundaries to become the operational backbone of commercial biomanufacturing. Fueled by an urgent industry mandate for flexible capacity, the sector is witnessing a technological breakthrough, exemplified by Thermo Fisher’s 5,000 L DynaDrive and ABEC’s 6,000 L systems, which now rival stainless-steel throughput. This structural shift is validated by massive capital projects, including Samsung Biologics’ 180,000 L capacity expansion, confirming SUB’s viability for high-volume production.

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Financially, the value proposition is compelling. As per Astute Analytica’s finding, Stakeholders leveraging single-use platforms realize a 40% to 50% reduction in CAPEX and accelerate facility commissioning by nearly 18 months. Operational efficiency is equally transformative in the single-use bioprocessing market, with CDMOs like WuXi Biologics utilizing agile, disposable workflows to manage a USD 20.1 billion backlog while cutting water and energy consumption by 46%. As sustainability becomes a regulatory priority and downstream innovations achieve 17x higher yields, SUB is no longer an alternative but the competitive standard. With the FDA approving 16 single-use-manufactured biologics in 2024 alone, the market is poised for sustained, high-velocity growth, fundamentally redefining the cost structure of global drug delivery.

Key Findings in Single-Use Bioprocessing Market

• Asia Pacific is poised to surge at the fastest CAGR throughout the forecast period from 2026 to 2035.
• North America commanded a dominant revenue share of 34.75%.
• By Workflow, the upstream bioprocessing segment claimed a substantial revenue share.
• By Product, the simple & peripheral elements segment seized the largest revenue share.
• By End-use, the biopharmaceutical manufacturers segment dominated with the biggest revenue share.

By Workflow, Upstream Bioprocessing Dominates By Enabling High Density Perfusion Architectures

Upstream bioprocessing commands the lion’s share of revenue in single-use bioprocessing market propelled by its pivotal role in enabling high-density perfusion architectures that redefine productivity benchmarks. Traditional fed-batch processes cap cell densities at 20-30 million cells/mL, but perfusion modes—powered by single-use ATF filtration integrated into bioreactor bags—sustain 100+ million cells/mL over 30-60 day campaigns. This eliminates stainless steel’s sterilization nightmares: complex piping loops prone to biofilm buildup and validation delays. Disposable assemblies turn the bioreactor into a plug-and-play engine, slashing changeover times from weeks to hours and boosting titers 5-10x.

The value proposition skyrockets “value per batch.” Reinforced films withstand shear forces and extended runs, justifying premiums of 20-30% over basic bags. With downstream lagging in continuous purification—still bottlenecked by Protein A costs at $14,000/L—upstream captures 55% market share. Investments flood in: Cytiva’s XDR platforms and ABEC’s ATB™ exemplify scalability to 6,000L, fueling perfusion for bispecifics and cell therapies. North American retrofits amplify this, with Amgen-like hybrids yielding 40% OPEX cuts. Asia Pacific’s scale-out farms parallelize perfusion lines, hitting commercial volumes in 12 months. Upstream isn’t just dominant; it’s the intensification vanguard, locking revenue as biopharma chases yield revolutions amid biosimilar wars.

By Product, Simple and Peripheral Elements Capture Value Through The Integration of Sensor Intelligence

Dismissed as commoditized, simple and peripheral elements—tubing, connectors, filters—seize 40% revenue of the single-use bioprocessing market via smart integration of PAT sensors, morphing passive plastics into data powerhouses. Pre-welded pH, DO, and biomass probes enable real-time CPP monitoring, sidestepping reusable sensor risks in sterile bags. A basic manifold jumps from $500 to $5,000 with embedded intelligence, compliant with FDA’s stringent PAT mandates. Automation surges demand: single-use pinch valves and flow sensors sync with DCS in “ballroom” facilities, digitizing fluid paths for Industry 4.0 precision.

This razor-blade evolution absorbs fixed instrumentation budgets, with high-margin kits bundling RFID-tracked assemblies. Failure rates—1-5% from pinholes—drop 60% via overwraps and laser welds, per USP <665>. Sartorius and Millipore lead, offering 20% discounts on sensorized manifolds for ADCs and vectors. Post-pandemic normalization cuts lead times to 8 weeks, but 12.8% CAGR persists, driven by closed GMP imperatives. Vulnerabilities linger—resin shortages inflate filter costs 15%—yet volume reigns: a 2,000L run devours 500+ units. Peripherals transcend simplicity; they’re the neural network of bioprocessing, embedding compliance and analytics into disposables for agile, high-velocity operations.

By End Use, Biopharmaceutical Manufacturers Lead By Optimizing Asset Utilization Ratios

Biopharmaceutical manufacturers dominate the single-use bioprocessing market with 60% share, weaponizing single-use to skyrocket asset utilization from 60% to 95%+. Steel-era downtime—30-40% on CIP/SIP—vanishes as suites become generic shells, with assemblies handling Week 1 vaccines and Week 2 mAbs. This consumes vast consumables: monthly blockbuster sites outpace yearly pilots, fueling baseload demand amid 14% underlying growth post-stockpile burn-off.

“Clinical-to-commercial” standardization seals the deal—uniform films/connectors across scales nix tech transfer headaches, locking multi-year contracts. Pfizer and GSK exemplify evolutive facilities: 2-4 day modality switches versus steel’s weeks, yielding 30% OPEX savings. CDMOs nibble niches but lack volume heft. Inventory recalibration stabilizes leads at 6 months, unleashing capacity for 300+ mAb pipelines. Risks like $500M writedowns fade as AI optimizes assemblies. Biopharma’s scale—24/7 campaigns—ensures leadership, blending flexibility with reliability to command the market’s economic core in a multipolar biologics arena.

Accelerating Innovation in the Single-Use Bioprocessing Market Through Advanced Reactor Technologies

The single-use bioprocessing market is witnessing a technological surge defined by unprecedented bioreactor scales and efficiency. Thermo Fisher Scientific recently launched the 5,000 L HyPerforma DynaDrive, the largest commercial system of its class, offering a robust 20:1 turndown ratio. Such innovations drive demand as they deliver a 190% increase in oxygen mass transfer compared to legacy designs. Competitors match these strides, with ABEC achieving blend times of under 60 seconds in their Custom Single Run systems, which now reach maximum working volumes of 6,000 L. These advancements allow manufacturers to achieve a 41% lower cost per gram using high-volume DynaDrive systems.

Furthermore, the sector sees expanded capabilities in mixing and automation. Cytiva introduced the Xcellerex magnetic mixer in 2,000 L and 3,000 L capacities to solve large-scale buffer preparation challenges. Sartorius also strengthened the single-use bioprocessing market by releasing the Biostat STR Generation 3, which supports scalable volumes from 50 L to 2,000 L with native DeltaV automation. High-volume efficiency is crucial, as Thermo Fisher’s 5,000 L workflow demonstrates a 27% reduction in product and packaging waste versus 2,000 L legacy systems. These engineering breakthroughs confirm that single-use technologies can now rival stainless steel in performance.

Massive Facility Expansions Highlight the Demand for Single-Use Bioprocessing Capacity

Global leaders are aggressively expanding manufacturing footprints to accommodate soaring demand in the single-use bioprocessing market. Samsung Biologics will operationalize Plant 5 by April 2025, adding 180,000 L of capacity to its network. Upon the completion of Bio Campus II, the company’s total capacity will reach a staggering 784,000 L, covering an area of 96,000 m2. Fujifilm Diosynth Biotechnologies is similarly investing USD 1.2 billion in its Holly Springs expansion. The site will house 8 new large-scale bioreactors, each boasting a capacity of 20,000 L, solidifying the shift toward flexible manufacturing.

Smaller players and diverse regions are also contributing to this capacity boom. Syngene International operationalized its Unit 3 facility in late 2024, bringing 20 KL of total capacity online through 10 distinct single-use bioreactors. In Europe, CPi Biotech invested USD 11 million (EUR 10 million) to establish a new facility spanning 36,000 sq ft. Such investments underscore the industry’s reliance on the single-use bioprocessing market to scale operations rapidly. Operational readiness is faster, with single-use technology capable of reducing facility construction timelines by 18 months compared to traditional builds.

CDMOs Drive Market Growth Managing Hundreds of Complex Biological Projects

Contract Development and Manufacturing Organizations are the primary engines propelling the single-use bioprocessing market. WuXi Biologics reported managing a massive portfolio of 742 integrated projects as of mid-2024. The firm added 61 new projects in just the first half of the year, highlighting the sector’s velocity. Their pipeline is diverse, containing 123 bispecific antibody projects and 167 Antibody-Drug Conjugate programs. Additionally, 23 vaccine projects are currently under development. To support this volume, WuXi employs 4,200 scientists dedicated to these complex modalities.

Commercial readiness within the CDMO sector is equally impressive. WuXi Biologics completed 16 Process Performance Qualifications in 2024 and has scheduled another 24 for 2025. The company currently holds a service backlog valued at USD 20.1 billion, reflecting sustained long-term demand. Lonza is also expanding its capabilities by adding 2 new bioconjugation suites to its Ibex Dedicate facility. These figures illustrate how CDMOs rely on the flexibility of the single-use bioprocessing market to manage high-mix portfolios. WuXi supports these efforts with a workforce of 12,435 staff globally and maintains a high talent retention rate of 94%.

Operational Economics and Efficiency Gains Are Reshaping Manufacturing Cost Structures

Financial incentives are accelerating the adoption of the single-use bioprocessing market. Capital expenditure for single-use facilities is typically reduced by 40% to 50% compared to traditional stainless-steel plants. Operational speed is another benefit, as Thermo Fisher’s 5L DynaDrive system increases productivity by 27% compared to glass reactors. Researchers can run 141 experiments annually with these systems versus only 111 with glass, effectively reducing the workflow cycle time to 31 days from 39 days. These efficiency gains translate directly to the bottom line.

Technical performance metrics further justify the investment. ABEC’s large-scale bioreactors now support oxygen transfer rates exceeding 45 1/hr, ensuring high cell density growth. Thermo Fisher’s 3,000 L systems offer 12:1 turndown ratios, enhancing economic flexibility for varied batch sizes. Risk mitigation is also monetizable; Cytiva estimates that a single minor leak in a large mixer can cost a manufacturer USD 60,000 to USD 100,000 in lost material. Avoiding such losses through reliable single-use technologies is a key economic proposition for stakeholders in the single-use bioprocessing market.

Downstream Market Evolution and Increasing Commercial Scale Adoption Rates

The downstream segment of the single-use bioprocessing market is expanding rapidly to match upstream productivity. This sub-sector was valued at USD 1.57 billion in 2024 and is projected to rise to USD 1.79 billion in 2025. Single-use chromatography systems commanded a 35.6% market share in 2024, driven by innovations like Sartorius’s “Sartobind Rapid A Lab.” These membrane units offer 17 times higher antibody yields than resin columns and are rated for 100 purification cycles. Repligen further supports this growth by offering lead times of just 8 weeks for its large-scale OPUS pre-packed columns.

Broader adoption statistics reveal the dominance of disposable systems. Single-use bioreactor systems held an 81.19% market share within the reactor segment in 2024. Commercial-scale systems ranging from 500 L to 2,000 L accounted for 52.44% of revenue, while the pilot-scale segment is growing at a CAGR of 17.11%. Mammalian cell culture applications dominate with 62.34% of the share, and monoclonal antibody production accounts for 45.21% of usage. Bags and connectors see usage rates exceeding 85% across facilities, confirming the ubiquity of the single-use bioprocessing market.

Regulatory Approvals and Commercial Successes Validate Disposable Manufacturing Platforms

Regulatory bodies are increasingly endorsing products manufactured via the single-use bioprocessing market. The FDA approved 50 new drugs in 2024, 16 of which were biologics that heavily rely on single-use components. Among these, 13 monoclonal antibodies were approved, serving as a key driver for disposable reactor demand. WuXi Biologics supported 16 commercial manufacturing projects in the first half of 2024 alone. The firm also has 56 late-phase projects preparing for commercialization, indicating a robust pipeline of future approvals.

Commercial validation is evident in the operational success of these platforms. WuXi’s ability to manage dozens of late-stage projects proves that single-use technologies meet stringent GMP requirements. The seamless transition from clinical to commercial scale is a hallmark of the modern single-use bioprocessing market. Regulatory agencies now view these flexible facilities as standard, facilitating faster approvals for complex biologics. As more products reach the market, the reliance on disposable flow paths continues to solidify as the industry standard.

Supply Chain Localization and Strong Financials Signal Long Term Market Stability

Localization strategies are enhancing the resilience of the single-use bioprocessing market. Sartorius India delivered 50 pallet tanks for single-use mixing in 2024 and has committed to an investment plan running through 2027. The Indian arm currently employs 670 people to support local supply needs, reducing lead times for regional manufacturers. Such moves mitigate global supply chain risks. Financially, Sartorius generated sales revenue of EUR 3.4 billion in 2024, maintaining a healthy underlying EBITDA margin of 28.0%.

These financial metrics indicate sustained corporate health and the capacity for continued R&D investment. Strong margins allow companies to innovate further, ensuring the single-use bioprocessing market remains dynamic. Localization efforts by major suppliers ensure that critical consumables are available where needed, supporting the uninterrupted operation of global biomanufacturing sites. The convergence of solid financial performance and strategic supply chain expansion positions the industry for prolonged growth through 2025 and beyond.

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Single-use Bioprocessing Market Key Players:

• ABEC Inc.
• Avantor Inc.
• Cellexus
• Celltainer Biotech BV
• CESCO Bioengineering Co.
• Danaher Corp
• Distek Inc.
• Entegris Inc.
• Eppendorf AG
• GEA Group
• Meissner Filtration Products
• Merck
• OmniBRx Biotechnologies
• Parker Hannifin (Domnick Hunter)
• PBS Biotech Inc.
• Repligen Corporation
• Saint-Gobain Life Sciences
• Sartorius AG
• Solventum
• Thermo Fisher Scientific Inc.
• Other Prominent Players

Key Market Segmentation:

By Product

• Simple & Peripheral Elements
  • Tubing, Filters, Connectors, & Transfer Systems
  • Bags
  • Sampling Systems
  • Probes & Sensors
    • pH Sensor
    • Oxygen Sensor
    • Pressure Sensors
    • Temperature Sensors
    • Conductivity Sensors
    • Flow Sensors
    • Others
  • Others
• Apparatus & Plants
  • Bioreactors
    • Upto 1000 L
    • Above 1000 L to 2000 L
    • Above 2000 L
  • Mixing, Storage, & Filling Systems
  • Filtration System
  • Chromatography Systems
  • Pumps
  • Others
• Work Equipment
  • Cell Culture System
  • Syringes
  • Others

By Workflow

• Upstream Bioprocessing
• Fermentation
• Downstream Bioprocessing

By End-Use

• Biopharmaceutical Manufacturers
• CMOs & CROs
• In-house Manufacturers
• Academic & Clinical Research Institutes

By Region

• North America
• Europe
• Asia Pacific
• Middle East and Africa
• South America

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About Astute Analytica

Astute Analytica is a global market research and advisory firm providing data-driven insights across industries such as technology, healthcare, chemicals, semiconductors, FMCG, and more. We publish multiple reports daily, equipping businesses with the intelligence they need to navigate market trends, emerging opportunities, competitive landscapes, and technological advancements.

With a team of experienced business analysts, economists, and industry experts, we deliver accurate, in-depth, and actionable research tailored to meet the strategic needs of our clients. At Astute Analytica, our clients come first, and we are committed to delivering cost-effective, high-value research solutions that drive success in an evolving marketplace.

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Astute Analytica
Phone: +1-888 429 6757 (US Toll Free); +91-0120- 4483891 (Rest of the World)
For Sales Enquiries: [email protected]
Website: https://www.astuteanalytica.com/ 

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