Single-Use Bioprocessing Products Market to Reach USD 36000 million by 2031 | CAGR 18.6% | North America Leads with 32% Share | Key Players: Thermo Fisher Scientific, Sartorius, Danaher

Market Overview

The global Single-Use Bioprocessing Products Market was valued at USD 9,200 million in 2022 and is projected to reach USD 36,000 million by 2031, growing at a CAGR of 18.6% during the forecast period 2024-2031. Single-use bioprocessing involves the use of containers, conduits, and active consumables that come into contact with process fluids only once before being discarded, replacing traditional glass or stainless-steel systems with disposable plastics. This technology is widely applied across various biopharmaceutical processes, including filtration, mixing, purification, upstream expression, storage, and separation, enabling flexible, scalable, and contamination-free production. The rapid adoption of single-use bioprocessing products is being driven by the growing demand for biologics, vaccines, and advanced cell and gene therapies, along with the increasing number of contract manufacturing organizations (CDMOs) and biopharma R&D facilities globally.

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Recent Developments:

✅ January 2026: In the United States, biopharmaceutical companies expanded the adoption of single-use mixing and filtration systems to increase process efficiency and reduce contamination risk in biologics manufacturing.

✅ January 2026: In Europe, CDMOs and biopharma manufacturers implemented large-scale single-use upstream expression and purification systems to support vaccine and monoclonal antibody production.

✅ January 2026: In Japan, pharmaceutical firms integrated advanced single-use storage and separation technologies into modular bioprocessing facilities to enhance flexibility and scalability.

✅ December 2025: In the United States, manufacturers invested in single-use consumables such as media bags, tubing sets, and connectors to accelerate development timelines and reduce cleaning validation requirements.

✅ December 2025: In Asia-Pacific, increasing biologics production capacity and government support for vaccine manufacturing drove the adoption of disposable bioprocessing platforms across upstream and downstream operations.

✅ November 2025: In Europe, research institutions and contract manufacturing facilities deployed automated single-use bioprocessing solutions for high-throughput protein production and purification workflows.

Mergers & Acquisitions:

✅ January 2026: A U.S.-based bioprocessing solutions provider acquired a single-use consumables manufacturer to strengthen its portfolio of upstream and downstream disposable products.

✅ December 2025: A European CDMO completed the acquisition of a single-use filtration and mixing technology firm to expand its scalable biologics production capabilities.

✅ December 2025: In Japan, a pharmaceutical equipment company acquired a regional single-use components supplier to enhance end-to-end bioprocessing offerings.

✅ October 2025: An Asia-Pacific CDMO acquired a single-use bioprocessing technology startup to integrate modular disposable platforms into its biologics manufacturing services.

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Key Players:
Thermo Fisher Scientific Inc. | Sartorius AG | Danaher Corp. | Merck KGaA | Avantor, Inc. | 3M | Eppendorf AG | Saint-Gobain Biopharm | Progenics Pharmaceuticals | Gore | Others

Key Highlights with Market Share:

• Thermo Fisher Scientific Inc. - Holds 15% share, offering a comprehensive portfolio of single-use bioprocessing products, including media bags, tubing, and integrated bioreactor systems.

• Sartorius AG - Holds 13% share, providing single-use filtration assemblies, bioreactor systems, and modular upstream/downstream processing solutions.

• Danaher Corp. - Holds 12% share, delivering single-use consumables and integrated bioprocessing platforms for biologics and vaccine production.

• Merck KGaA - Holds 10% share, focusing on single-use filtration, mixing, and downstream processing solutions for scalable biomanufacturing.

• Avantor, Inc. - Holds 8% share, supplying single-use media bags, connectors, and bioprocess consumables for upstream and downstream operations.

• 3M - Holds 7% share, providing filtration membranes and single-use assemblies for high-purity biologics production.

• Eppendorf AG - Holds 6% share, offering single-use bioreactors, mixers, and automation solutions for lab and pilot-scale applications.

• Saint-Gobain Biopharm - Holds 5% share, specializing in tubing, connectors, and single-use fluid handling systems for bioprocessing.

• Progenics Pharmaceuticals - Holds 4% share, supplying niche single-use components for upstream and downstream biologics production.

• Gore - Holds 3% share, focusing on high-performance single-use filtration and fluid transfer technologies.

Market Segmentation:

By product, single-use bioreactors (SUBs) lead the market with approximately 30% share due to their critical role in upstream biologics production. Tubing, connectors, and clamps collectively account for around 20%, providing essential fluid handling and assembly components. Disposable mixers, bags, and containers represent about 15%, supporting flexible and contamination-free mixing and storage processes. Disposable filter cartridges, sampling systems, tangential flow filtration (TFF), membrane adsorbers, and purification devices together hold roughly 20%, enabling downstream processing and purification efficiency. Preassembled tubing and rigging, along with other components, make up the remaining 15% of the market.

By application, filtration dominates with 25%, driven by the need for high-purity biologics and regulatory compliance. Cell culture and upstream production account for 30%, reflecting the growing biologics and vaccine pipelines. Mixing and purification applications hold about 20%, supporting efficient and scalable downstream workflows. Storage systems contribute roughly 15%, while other applications make up the remaining 10%, including sample collection, reagent preparation, and analytical workflows.

By end-user, biopharmaceutical manufacturers hold the largest share at 50%, leveraging single-use bioprocessing products for large-scale biologics, vaccines, and cell/gene therapy production. Life science R&D companies and academic research institutes account for around 30%, using these systems for lab-scale process development, pilot studies, and early-stage research. Other end-users, including contract research organizations (CROs) and specialty biotech firms, make up 20% of the market.

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Regional Insights:

North America leads the single-use bioprocessing products market with approximately 32% share, driven by the presence of major biopharmaceutical companies, advanced R&D infrastructure, and early adoption of disposable bioprocessing technologies.

Europe holds around 25%, supported by stringent regulatory standards, growing contract development and manufacturing organization (CDMO) activity, and high biologics production.

Asia-Pacific contributes roughly 28%, fueled by expanding biologics manufacturing capacity, government initiatives supporting vaccine and therapeutic production, and increasing adoption of single-use systems in countries such as China, Japan, and India.

Latin America accounts for about 10%, driven by emerging biopharma infrastructure and increasing vaccine manufacturing efforts.

Market Dynamics:

Drivers:
The global single-use bioprocessing products market is primarily driven by the rising demand from biopharmaceutical companies and the growing adoption of single-use technologies. The market benefits from faster implementation, reduced risk of product cross-contamination, lower capital costs, and environmentally friendly operations. The increasing prevalence of chronic diseases has spurred the need for biologics, vaccines, and advanced therapies, fueling the adoption of single-use systems across both upstream and downstream processes. For example, in 2021, the FDA approved 14 biologics for the treatment of various chronic conditions, highlighting the ongoing expansion of biologics manufacturing and the corresponding demand for flexible single-use bioprocessing solutions. Single-use technologies also enhance operational efficiency by reducing sterilization requirements between batches, lowering water and energy consumption, and minimizing contamination risks, making them increasingly attractive for CDMOs, biotech firms, and large pharmaceutical companies.

On the other hand, the market faces restraints related to extractables and leachables. Materials used in single-use systems, such as plastics, tubing, and connectors, can release chemical compounds under certain conditions. Extractables are compounds that can be released from the materials under laboratory conditions, while leachables are a subset of these chemicals that actually migrate into the product during production. Although there are no strict regulations explicitly governing extractables and leachables, organizations like the Single-Use Bio-Process Systems Alliance (BPSA) have provided guidelines for testing and validation. Manufacturers must rigorously evaluate and control for these compounds to ensure product safety and regulatory compliance, which can increase development costs and slow adoption, particularly at commercial scale.

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