# Single Use Pump Market

> Single Use Pump Market Research Report By Product (Equipment, Accessories), By Flow Rate (High Flow, Low Flow), By Application (Upstream Bioprocessing, Downstream Bioprocessing, Fill-Finish Operations), By End-Use (Biopharmaceutical & Pharmaceutical Companies, CROs & CMOs, Academic & Research Institutes), By Material of Construction (Medical-Grade Polyethylene, Fluoropolymers, Silicone & Thermoplastic Elastomers, Others) - Forecast to 2035

- **Forecast Period:** 2026-2035
- **CAGR:** 13.4%
- **2025:** USD 0.68 Billion
- **2035:** USD 2.39 Billion
- **Key Players:** Watson-Marlow Fluid Technology Solutions (Spirax Group), PSG (Dover) – Quattroflow, Levitronix, Repligen Corporation, Xylem, Thermo Fisher Scientific, Sartorius AG, Cytiva (Danaher)

**Report ID:** MRFR/EnP/24648-HCR · **Pages:** 100 · **Author:** Chitranshi Jaiswal · **Last Updated:** October 21, 2026

**URL:** https://www.marketresearchfuture.com/reports/single-use-pump-market-26299

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## Market Summary

## Single Use Pump Market Summary

The Single Use Pump Market was valued at USD 0.68 Billion in 2025 and is projected to reach USD 0.77 Billion in 2026, climbing to USD 2.39 Billion by 2035 at a CAGR of 13.4% over 2026–2035. Two catalysts anchor this outlook. The revised EU GMP Annex 1, in force since August 2023, pushes manufacturers toward closed, pre-sterilized fluid paths [2]. At the same time, [biologics](https://www.marketresearchfuture.com/reports/biologics-market-1339) capacity commitments, including Eli Lilly's USD 27 billion plan for four new US plants announced in February 2025, are adding thousands of litres of single-use bioreactor volume that every pump must serve [21].

Stainless-steel transfer lines, with their clean-in-place and steam-in-place cycles, are steadily giving way to disposable pump technology built on gamma- or X-ray-irradiated fluid paths. Peristaltic heads, quaternary diaphragm units, and magnetically levitated centrifugal [pumps](https://www.marketresearchfuture.com/reports/pumps-market-7423) now handle media transfer, chromatography feeds, and filtration loops without cleaning validation. The scale of investment is visible in [Thermo Fisher Scientific](https://www.thermofisher.com/us/en/home/life-science/lab-equipment/speedvac-vacuum-concentrators/lab-vacuum-pumps/customized-pump-fluid-handling-solutions.html)'s USD 4.1 billion agreement to acquire Solventum's purification and filtration business, a bet on integrated single-use downstream suites [11].

North America leads the Single Use Pump Market with a 34.6% revenue share, supported by the world's densest cluster of biologics innovators and CDMOs. Asia-Pacific is the fastest-growing region at a 14.0% CAGR, driven by South Korean, Chinese, and Indian capacity additions. Europe ranks second with a 30.2% share, lifted by Annex 1 compliance spending. Over the next decade, procurement will shift from one-off skid purchases toward recurring consumable programs.

## Key Report Takeaways

### • By Product

- Equipment held 70.4% of the Single Use Pump Market in 2025, reflecting the pump's presence at every bioprocess stage.
- Accessories, including tubing sets, connectors, and pump cartridges, are forecast to grow at a 16.9% CAGR through 2035.

### • By Flow Rate

- Low Flow pumps captured a 50.2% share in 2025, anchored by cell and gene therapy protocols that demand tight volumetric accuracy.
- High Flow systems are expanding at a 14.3% CAGR as commercial monoclonal antibody plants scale to 5,000–20,000 L [bioreactors](https://www.marketresearchfuture.com/reports/bioreactor-market-43158).

### • By Application

- Upstream Bioprocessing accounted for 41.9% of 2025 revenue on the strength of entrenched disposable bioreactor use.
- Downstream Bioprocessing is projected to post a 14.8% CAGR as producers attack purification bottlenecks.

### • By End-Use

- Biopharmaceutical & Pharmaceutical Companies generated 57.2% of 2025 demand in the Single Use Pump Market
- CROs & CMOs record the fastest 15.0% CAGR, fueled by CDMO facility build-outs.

### • By Material of Construction

- Medical-Grade Polyethylene retained a 43.5% share in 2025 due to its cost and irradiation stability.
- Fluoropolymers are on track for a 16.5% CAGR as low-extractable liners gain favor.

### • By Region

- North America generated 34.6% of global revenue in 2025.
- Asia-Pacific is forecast to advance at a 14.0% CAGR through 2035.
- South America contributed USD 0.03 Billion in 2025, concentrated in Brazil.

## Market Size and Forecast (2021–2035)

Estimates for the Single Use Pump Market combine supplier revenue mapping for pump drives, heads, and consumables with a bottom-up count of installed single-use bioreactor capacity and downstream skids, then validate the result against primary interviews with process engineers, procurement heads, and CDMO operations leaders. Historical values reflect shipments net of destocking effects, and forecasts follow capacity pipelines published by biologics manufacturers and industry surveys.

## Market Drivers

## Driver Impact Analysis

| Driver | ~% Impact on CAGR | Geographic Relevance | Impact Timeline | Ref |
| --- | --- | --- | --- | --- |
| Biologics capacity expansion on single-use platforms | +3.2% | Global, led by North America and Asia-Pacific | Medium-term (2–4 yr) | , [21] |
| CDMO and CMO facility build-out | +2.6% | North America, South Korea, Europe | Short-term (≤2 yr) | [13], [15] |
| Cell and gene therapy commercialization | +2.1% | North America, Europe | Long-term (≥4 yr) | [5] |
| EU GMP Annex 1 closed-processing requirements | +1.8% | Europe, with global spillover | Short-term (≤2 yr) | [2] |
| Continuous bioprocessing adoption under ICH Q13 | +1.5% | North America, Europe, Japan | Long-term (≥4 yr) | [4] |
| Biosimilar production growth in emerging markets | +1.4% | Asia-Pacific, South America | Medium-term (2–4 yr) |  |

### Biologics Capacity Expansion on Single-Use Platforms

Biologics makers are adding capacity at a pace not seen since the early monoclonal antibody era, and new suites default to disposable bioreactors. Eli Lilly's USD 27 billion US manufacturing program and FUJIFILM Diosynth's USD 3.2 billion Holly Springs campus both rely heavily on single-use trains [20], [21]. Each 2,000 L bioreactor typically pairs with several pumps for media feed, harvest, and buffer transfer, so pump demand scales almost linearly with installed volume.

### CDMO and CMO Facility Build-Out

Outsourcing is reshaping procurement. Samsung Biologics completed its 180,000 L Plant 5 in April 2025, and Novo Holdings closed its USD 16.5 billion acquisition of Catalent in December 2024, signalling long-horizon commitment to contract capacity [13], [15]. CDMOs favor single-use pumps because rapid product changeover is their core economic lever. A multi-client facility cannot absorb days of cleaning validation between campaigns without losing billable capacity.

### Cell and Gene Therapy Commercialization

Autologous and allogeneic therapies run in small batches where shear damage or cross-contamination can destroy an entire patient dose. The Alliance for Regenerative Medicine tracks more than 1,900 active developers worldwide, with a growing roster of approved products moving into commercial supply [5]. These processes rely almost exclusively on low-shear peristaltic and [centrifugal pumps](https://www.marketresearchfuture.com/reports/centrifugal-pump-market-7351) operating below 2 bar, making the segment structurally dependent on disposable fluid paths.

### EU GMP Annex 1 Closed-Processing Requirements

The revised Annex 1, effective 25 August 2023, requires every sterile manufacturer to document a contamination control strategy and favors closed systems wherever feasible [2]. Pre-assembled, pre-sterilized pump assemblies simplify that documentation because sterility assurance shifts to the supplier's validated irradiation process. European fill-finish and drug-substance sites are replacing open transfers with welded tubing sets and sealed pump heads to close audit gaps.

### Continuous Bioprocessing Adoption Under ICH Q13

ICH Q13, adopted in November 2022, gave regulators and manufacturers a shared framework for continuous production [4]. Perfusion upstream and multi-column capture downstream require pumps that run reliably for 30 days or longer with variable-speed control. That shifts specifications toward durable tubing, in-line pressure sensing, and automation-ready drives, raising both unit value and accessory replacement frequency across extended campaigns.

### Biosimilar Production Growth in Emerging Markets

India's Production Linked Incentive scheme for [pharmaceuticals](https://www.marketresearchfuture.com/reports/pharmaceutical-market-67551), carrying an outlay of INR 15,000 crore, explicitly targets complex generics and biologics . Chinese and South Korean biosimilar makers are pursuing similar export-led strategies. New plants in these markets are designed single-use from day one because capital budgets are tighter and stainless infrastructure plus water-for-injection systems would delay start-up by 12–18 months.

## Restraints

## Restraints Impact Analysis

| Restraint | ~% Impact on CAGR | Geographic Relevance | Impact Timeline | Ref |
| --- | --- | --- | --- | --- |
| Plastic waste and sustainability scrutiny | −1.4% | Europe, North America | Long-term (≥4 yr) |   |
| Extractables and leachables validation burden | −1.1% | Global | Medium-term (2–4 yr) | [9] |
| Supply chain constraints for resins, films, and sterilization capacity | −0.9% | Global | Short-term (≤2 yr) | [10] |
| Flow and pressure limits at very large scale | −0.7% | North America, Europe | Medium-term (2–4 yr) |   |
| Higher per-batch costs for dedicated high-volume products | −0.6% | Global | Long-term (≥4 yr) | [19] |

### Plastic Waste and Sustainability Scrutiny

Single-use assemblies generate large amounts of plastic garbage that are either burned or sent to the landfill after only one batch. Disposal and environmental impact are becoming the most cited single-use issues by survey respondents from BioPlan Associates. As corporate net-zero targets loom, several manufacturers are now running life-cycle comparisons before authorizing disposable lines, stalling decisions on high-volume operations.

### Extractables and Leachables Validation Burden

USP <665> has defined expectations for the characterization of plastic components in contact with medicinal products [9]. Every new pump liner or tubing formulation might lead to new extractables investigations, risk evaluations and regulatory filings. Many smaller biotechs don’t have the analytical staff to do this job, which lengthens qualification timelines and makes it less attractive to transfer from current suppliers.

### Supply Chain Constraints for Resins, Films, and Sterilization Capacity

The 2021-2022 single-use component scarcity saw certain lead times expand beyond 12 months. Gamma irradiation is further hampered by a limited cobalt-60 supply, with industry associations flagging capacity tightness [10]. Manufacturers who encountered these delays now have greater safety stocks or dual-source assemblies, adding expense and sometimes delaying new single-use adoption.

### Flow and Pressure Limits at Very Large Scale

Pressure and throughput are mechanically limited by the disposable tubing and pump heads. For lengthy runs, there is a risk of tube fatigue and spallation at harvest and buffer volumes for 15,000–20,000 L bioreactors. This means some stainless or hybrid transfer lines are still used in large commercial plants, preventing single-use penetration in the highest-volume operations.

### Higher Per-Batch Costs for Dedicated High-Volume Products

For a blockbuster antibody manufactured continuously in a dedicated facility, cleaning savings may not offset recurring consumable spend. IQVIA projects mounting price pressure on biologics as biosimilars expand [19], which pushes cost-sensitive producers to scrutinize every consumable line item and occasionally retain reusable equipment.

## Opportunities

## Single Use Pump Market Opportunities

### Greenfield Biologics Plants in India and Southeast Asia

Emerging markets are the cleanest way to grow, because new factories have no stainless legacy. India’s PLI incentives and Singapore’s biomanufacturing cluster concept are luring biosimilar and vaccine capacity to be built around single-use trains . Suppliers that develop local assembly, irradiation partnerships, and application engineering teams can secure multi-year consumable contracts early.

### Pump-as-a-Service and Connected Consumable Models

Connected pumps that log flow, pressure, and tubing run-hours create a data stream suppliers can monetize. Vendors can bundle drives at low upfront cost and earn recurring revenue from tubing sets, predictive replacement alerts, and batch-record analytics. This model suits CDMOs that prefer operating expenditure over capital outlays and supports the Single Use Pump Market's shift toward accessory-led revenue.

### Integrated Continuous Downstream Suites

Purification can account for over half of manufacturing cost for some recombinant proteins, making it the prime target for efficiency gains. Pump suppliers that pre-integrate low-hold-up manifolds, pressure sensors, and control software into continuous chromatography and filtration skids can capture higher value per installation.

### Recyclable and Low-Carbon Fluid-Path Materials

Sustainability pressure creates room for differentiated materials. [Polyethylene](https://www.marketresearchfuture.com/reports/polyethylene-market-1056)-based assemblies designed for mechanical recycling, along with take-back programs for used tubing, can turn a restraint into a selling point for European buyers facing scope 3 reporting. Early movers can win preferred-supplier status in tenders that score environmental performance.

### Pandemic Preparedness and mRNA Platforms

CEPI's 100 Days Mission calls for vaccine availability within 100 days of a pathogen threat [16]. Warm-base mRNA facilities need precise low-pulsation pumps for lipid nanoparticle mixing and must be ready to scale rapidly. Government-funded preparedness contracts provide a stable, non-cyclical demand layer for suppliers.

## Future Outlook

## Single Use Pump Market Future Outlook

### Automation and Digital Process Control

Pumps are becoming nodes in automated, data-rich bioprocess networks. Drives with embedded sensors, OPC-UA connectivity, and feedback loops tied to online biomass or pressure readings will become standard by the early 2030s. This evolution favors suppliers with software capabilities and raises switching costs once a pump platform is embedded in a validated control architecture.

### Platform Economics and Consumable Lock-In

Revenue in the Single Use Pump Market will increasingly come from proprietary tubing, cartridges, and manifolds rather than drives. Once a fluid path is written into a regulatory filing, changing suppliers requires revalidation, which entrenches incumbents for the life of a product. Vendors will compete on breadth of validated kits and on contamination-free processing assurance backed by documented sterility data.

### Advanced Therapies and Distributed Manufacturing

Cell and gene therapies, mRNA platforms, and personalized medicines favor smaller, distributed facilities over centralized plants. CEPI's preparedness goals and growing advanced therapy approvals point toward networks of modular, single-use sites [5], [16]. Low-flow pumps with high precision and fast changeover will benefit most from this structural shift.

### Sustainability and ESG Reporting

Pharmaceutical companies face growing scope 3 disclosure requirements, and plastic waste is a visible line item. IQVIA projects global medicine spending to exceed USD 2 trillion by 2028, implying rising production volumes and waste [19]. Suppliers offering recyclable materials, take-back schemes, and life-cycle data will gain an edge as ESG scoring enters procurement criteria for the Single Use Pump Market.

## Segment Insights

## Single Use Pump Market Segmentation

### By Product

| Segment | Key Metric (2025) | Primary Demand Driver |
| --- | --- | --- |
| Equipment | 70.4% share | Pump drives and heads at every bioprocess stage |
| Accessories | 16.9% CAGR (2026–2035) | Batch-to-batch replacement of tubing, connectors, and cartridges |

Within the Single Use Pump Market, Equipment covers peristaltic pumps, quaternary diaphragm pumps, and magnetically levitated centrifugal pumps. Peristaltic units dominate aseptic transfers, while quaternary diaphragm systems gain ground in precision chromatography dosing. Accessories grow faster because every batch consumes tubing sets, connectors, and pump cartridges, and continuous campaigns require periodic switch-out of wetted parts. Suppliers increasingly bundle drives with validated fluid-path kits to capture lifecycle value.

### By Flow Rate

| Segment | Key Metric (2025) | Primary Demand Driver |
| --- | --- | --- |
| High Flow | 14.3% CAGR (2026–2035) | Large single-use bioreactors and perfusion media circulation |
| Low Flow | 50.2% share | Cell and gene therapy and small-batch precision dosing |

Low Flow pumps lead the Single Use Pump Market because cell and gene therapy protocols require tight volumetric accuracy below 100 L/min and gentle handling of fragile cells. High Flow models grow faster as commercial antibody plants scale single-use bioreactors to 5,000–20,000 L. Modular drive designs now let one motor platform cover both flow envelopes, and variable-speed control is blurring traditional cut-offs.

### By Application

| Segment | Key Metric (2025) | Primary Demand Driver |
| --- | --- | --- |
| Upstream Bioprocessing | 41.9% share | Disposable bioreactor feeds and media transfer |
| Downstream Bioprocessing | 14.8% CAGR (2026–2035) | Single-use chromatography and filtration skids |
| Fill-Finish Operations | USD 0.11 Billion | Closed filling under Annex 1 |

Upstream Bioprocessing holds the largest share of the Single Use Pump Market thanks to entrenched disposable bioreactor use for media and feed transfer. Downstream Bioprocessing grows fastest as manufacturers deploy single-use chromatography, virus filtration, and tangential flow filtration to clear purification bottlenecks for high-titre processes. Fill-Finish Operations benefit from Annex 1's push for closed transfers into filling lines.

### By End-Use

| Segment | Key Metric (2025) | Primary Demand Driver |
| --- | --- | --- |
| Biopharmaceutical & Pharmaceutical Companies | 57.2% share | Validated, audit-ready commercial production |
| CROs & CMOs | 15.0% CAGR (2026–2035) | Multi-client facilities requiring fast changeover |
| Academic & Research Institutes | USD 0.06 Billion | Process development and translational research |

Biopharmaceutical & Pharmaceutical Companies remain the largest buyers in the Single Use Pump Market, prioritizing validated hardware and long-term supply agreements. CROs & CMOs grow fastest because rapid product changeover drives their utilization economics, and new CDMO mega-plants in South Korea and the US are designed single-use throughout. Academic & Research Institutes buy smaller benchtop systems for process development.

### By Material of Construction

| Segment | Key Metric (2025) | Primary Demand Driver |
| --- | --- | --- |
| Medical-Grade Polyethylene | 43.5% share | Cost efficiency and irradiation stability |
| Fluoropolymers | 16.5% CAGR (2026–2035) | Low extractables and chemical resistance |
| Silicone & Thermoplastic Elastomers | USD 0.17 Billion | Flexible peristaltic tubing |
| Others | 7.5% share | Specialty polymers for niche applications |

Medical-Grade Polyethylene leads the Single Use Pump Market on cost and compatibility with gamma irradiation, making it the default for bags, liners, and manifolds. Fluoropolymers grow fastest because their low extractables profile simplifies USP <665> assessments for sensitive biologics [9]. Silicone & Thermoplastic Elastomers remain essential for peristaltic tubing, where flexibility and fatigue life determine run duration.

## Regional Market Share Analysis

## Regional Market Share Analysis

| Region | Key Metric (2025) | Primary Investment Themes |
| --- | --- | --- |
| North America | 34.6% share | Biologics reshoring, CDMO expansion, cell and gene therapy |
| Europe | 30.2% share | Annex 1 compliance, continuous processing, sustainability |
| Asia-Pacific | 14.0% CAGR (2026–2035) | Biosimilars, CDMO mega-plants, government incentives |
| South America | USD 0.03 Billion | Vaccine self-sufficiency, public-sector biologics |
| Middle East & Africa | USD 0.02 Billion | Localization mandates, vaccine fill-finish |
| Total | USD 0.68 Billion | — |

Regional performance in the Single Use Pump Market tracks where biologics capacity is being built. North America and Europe hold the installed base, while Asia-Pacific captures a growing share of new plants.

### North America

| Country | Key Metric (2025) | Key Driver |
| --- | --- | --- |
| US | 86.0% of regional share | Large-scale biologics reshoring and CDMO investment |
| Canada | CAGR 13.9% | Federal biomanufacturing and vaccine capacity strategy |
| Mexico | USD 0.011 Billion | Nearshoring of pharmaceutical production |

The US anchors regional demand through a combination of innovator R&D, commercial biologics output, and the world's largest cell and gene therapy pipeline. Multi-billion-dollar programs from Eli Lilly, FUJIFILM Diosynth, and others are adding single-use suites across North Carolina, Indiana, and Texas [20], [21]. The BIOSECURE Act, passed by the House in September 2024, encourages sponsors to shift contract work toward domestic and allied CDMOs [17]. Canada's investments in domestic vaccine capacity add steady demand.

### Europe

| Country | Key Metric (2025) | Key Driver |
| --- | --- | --- |
| Germany | 24.8% of regional share | Biologics hubs and supplier headquarters |
| UK | CAGR 13.1% | Cell and gene therapy manufacturing clusters |
| France | USD 0.030 Billion | Vaccine and biologics reindustrialization plans |
| Italy | 9.6% of regional share | Contract fill-finish capacity |
| Spain | CAGR 12.7% | Biosimilar and plasma-derived production |
| Nordic Countries | USD 0.022 Billion | Insulin and GLP-1 capacity expansion |
| Russia | 3.1% of regional share | Import substitution programs |
| Rest of Europe | CAGR 11.8% | Swiss, Irish, and Belgian biologics investment |

Annex 1 is the defining regional catalyst, prompting sterile manufacturers to close open transfers and document contamination control strategies [2]. Germany hosts major single-use suppliers and large biologics sites, while Denmark's GLP-1 and insulin expansions lift Nordic volumes. Sustainability expectations are also strongest in Europe, pushing buyers to evaluate recyclable assemblies alongside price and performance.

### Asia-Pacific

| Country | Key Metric (2025) | Key Driver |
| --- | --- | --- |
| China | 35.5% of regional share | Domestic biologics and biosimilar capacity |
| India | CAGR 17.2% | PLI scheme and biosimilar exports |
| Japan | USD 0.032 Billion | Regenerative medicine regulatory pathway |
| South Korea | 12.8% of regional share | CDMO mega-plants |
| ASEAN | CAGR 15.6% | Singapore biomanufacturing hub |
| Rest of Asia-Pacific | USD 0.013 Billion | Australian mRNA and cell therapy capacity |

South Korea's Samsung Biologics and Celltrion operate some of the largest biologics campuses globally, and Plant 5's 180,000 L addition illustrates the scale of regional investment [13]. China continues to build domestic biologics capacity while local pump and tubing suppliers emerge. India's growth stems from biosimilar exporters using PLI incentives to build single-use plants . Japan's conditional approval pathway for regenerative products sustains low-flow demand.

### South America

| Country | Key Metric (2025) | Key Driver |
| --- | --- | --- |
| Brazil | 58.0% of regional share | Public-sector vaccine and biologics technology transfer |
| Argentina | CAGR 11.9% | Biosimilar manufacturing base |
| Rest of South America | USD 0.006 Billion | Regional vaccine fill-finish projects |

Brazil leads through public institutes such as Fiocruz and Butantan, whose technology transfer agreements bring single-use processes into domestic vaccine and biologics production. Argentina hosts established biosimilar makers serving South American markets. Currency volatility and import duties raise consumable costs, so buyers often prioritize suppliers with regional distribution and stock.

### Middle East & Africa

| Country | Key Metric (2025) | Key Driver |
| --- | --- | --- |
| Saudi Arabia | CAGR 14.6% | Vision 2030 pharmaceutical localization |
| UAE | 22.0% of regional share | Biotech free zones and vaccine fill-finish |
| South Africa | USD 0.004 Billion | African vaccine manufacturing initiatives |
| Egypt | CAGR 12.3% | Regional generics and biologics hub ambitions |
| Rest of MEA | 15.5% of regional share | Donor-funded vaccine projects |

Localization policy drives this region. Saudi Arabia's Vision 2030 targets domestic production of strategic medicines, and the UAE has attracted vaccine fill-finish partnerships. South Africa's mRNA technology transfer hub supports continental manufacturing goals. Projects are small but tend to adopt single-use designs fully, since they lack legacy stainless infrastructure.

## Competitive Benchmarking

## Competitive Benchmarking

The Single Use Pump Market shows medium concentration, with an estimated HHI of roughly 800–950 and the top five suppliers holding an estimated 45–55% of revenue. Diversified flow-technology groups compete with specialist pump makers and integrated bioprocess suppliers. Acquisitions and joint development agreements are the primary tools for widening portfolios, while proprietary fluid-path consumables create durable customer lock-in.

| Company | Est. Revenue Share Range | Key Offerings for Single Use Pump Market | Strategic Positioning |
| --- | --- | --- | --- |
| Watson-Marlow Fluid Technology Solutions (Spirax Group) | ~14–18% | Peristaltic pumps, single-use tubing and fluid-path assemblies | Broadest peristaltic portfolio with integrated consumables |
| PSG (Dover) – Quattroflow | ~10–13% | Quaternary diaphragm pumps and single-use pump chambers | Leader in low-shear, high-pressure downstream applications |
| Levitronix | ~7–10% | Magnetically levitated single-use centrifugal pumps | Ultra-low-shear technology for cell therapy and perfusion |
| Repligen Corporation | ~6–9% | Flow path assemblies, filtration systems, fluid management | Downstream integration through acquisitions |
| Xylem | ~5–8% | Sanitary and single-use pump solutions | Diversified water and fluid technology group |
| Thermo Fisher Scientific | ~5–7% | Single-use bioprocess systems and fluid transfer components | Integrated upstream-downstream single-use suite |
| Sartorius AG | ~4–6% | Single-use bioprocess platforms with integrated pumping | End-to-end bioprocess workflow supplier |
| Cytiva (Danaher) | ~4–6% | Single-use chromatography and filtration systems | Downstream systems leader with installed base |
| Avantor (Masterflex) | ~3–5% | Peristaltic pumps and tubing | Strong laboratory and pilot-scale channel |
| Verder Group (Verderflex) | ~2–4% | Peristaltic and hose pumps | Cost-competitive industrial-to-pharma bridge |
| Saint-Gobain Life Sciences | ~2–4% | Pharmaceutical-grade tubing and assemblies | Materials specialist for fluid paths |

## Recent News & Developments

## Recent News & Developments

- European Commission (August 2023): The revised EU GMP Annex 1 took effect, requiring contamination control strategies and favoring closed systems, a direct catalyst for pre-sterilized pump assemblies [2].

- FUJIFILM Diosynth Biotechnologies (April 2024): Announced additional investment bringing its Holly Springs, North Carolina campus to about USD 3.2 billion, expanding large-scale single-use demand [20].
- US House of Representatives (September 2024): Passed the BIOSECURE Act, encouraging sponsors to shift contract manufacturing toward domestic and allied CDMOs [17].
- Novo Holdings (December 2024): Completed its USD 16.5 billion acquisition of Catalent, consolidating global fill-finish and biologics contract capacity [15].
- Thermo Fisher Scientific (February 2025): Agreed to acquire Solventum's purification and filtration business for USD 4.1 billion, strengthening integrated downstream single-use offerings [11].
- Eli Lilly (February 2025): Announced USD 27 billion for four new US manufacturing sites, signalling sustained biologics capacity growth [21].
- Samsung Biologics (April 2025): Completed Plant 5 with 180,000 L capacity, raising regional demand for high-flow single-use systems [13].

## Report Scope

| Parameter | Details |
| --- | --- |
| Market Scope | Single-use pump equipment and accessories used across upstream, downstream, and fill-finish bioprocessing for biopharmaceutical companies, CROs and CMOs, and research institutes in the Single Use Pump Market |
| Study Period | 2021–2035 |
| Base Year | 2025 |
| Historical Data | 2021–2024 |
| Forecast Period | 2026–2035 |
| Market Size in 2025 | USD 0.68 Billion |
| Market Size in 2035 | USD 2.39 Billion |
| CAGR (2026–2035) | 13.4% |
| Fastest Growing Segments | Accessories (16.9% CAGR); Fluoropolymers (16.5% CAGR); CROs & CMOs (15.0% CAGR); Downstream Bioprocessing (14.8% CAGR) |
| Regions Covered | North America, Europe, South America, Asia Pacific, Middle East and Africa and ROW |
| Companies Profiled | Watson-Marlow Fluid Technology Solutions, PSG (Dover), Levitronix, Repligen Corporation, Xylem, Thermo Fisher Scientific, Sartorius AG, Cytiva, Avantor, Verder Group, Saint-Gobain Life Sciences |
| Valuation Currency | USD Billion |
| Methodology | 350+ primary expert interviews; bottom-up market sizing; top-down validation; data triangulation; scenario-based forecasting; real-time project tracking |

## Frequently Asked Questions

**Q: How should buyers choose between peristaltic and quaternary diaphragm designs in the Single Use Pump Market?**
A: Peristaltic heads suit low-shear transfers and fast tubing swaps. Quaternary diaphragm pumps deliver near-pulseless flow at higher pressures for chromatography and filtration, so process pressure and hold-up volume should decide [6].

**Q: What documentation should procurement teams request from suppliers?**
A: Request USP &lt;665&gt;-aligned extractables data, irradiation validation, and lot-level change notification commitments. Suppliers unable to guarantee advance change notice expose users to costly regulatory resubmissions [9].

**Q: Why is X-ray sterilization gaining attention for pump assemblies?**
A: Cobalt-60 constraints have lengthened gamma irradiation queues, so assembly makers are qualifying X-ray as an alternative. Material compatibility must be re-verified because polymers respond differently to each modality [10].

**Q: When does stainless steel stay more economical than options in the Single Use Pump Market?**
A: Dedicated plants running one high-volume product almost continuously can still favor stainless systems. The crossover typically appears at very large batch scales with campaigns lasting several months [3].

**Q: How do connector standards affect integration of pump skids?**
A: Mixing proprietary aseptic connectors across vendors complicates closed-system assembly and spare-parts inventories. Buyers increasingly specify industry-common connectors in tenders to preserve supplier flexibility [7].

**Q: What investment risks matter most in the Single Use Pump Market?**
A: Destocking cycles, like the one seen in 2023, can depress consumable orders for several quarters. Investors should track CDMO utilization and biologics approvals as leading indicators of reorders [14].

**Q: Can single-use pumps support mRNA and lipid nanoparticle production?**
A: Yes, low-pulsation pumps feed the mixers that form lipid nanoparticles, where flow-ratio precision controls particle size. Pandemic preparedness programs keep this use case active beyond COVID-19 vaccines [16].


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*This Markdown endpoint is provided for AI systems and LLM crawlers. For the full interactive report visit https://www.marketresearchfuture.com/reports/single-use-pump-market-26299*