Single Use Bioprocessing Market to Reach USD 15.5 Billion by 2035 at 11.5% CAGR | Sartorius, Cytiva, Thermo Fisher Scientific Among Key Players

The global single use bioprocessing market, valued at USD 5.1 billion in 2025, is on track to reach USD 5.8 billion in 2026 and USD 15.5 billion by 2035, advancing at a compound annual growth rate (CAGR) of 11.5% through the forecast period. This sustained expansion reflects the biopharma industry's accelerating shift away from traditional stainless-steel manufacturing systems toward disposable, flexible alternatives that cut costs, compress timelines, and reduce contamination risk at every stage of biologics production.

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Market Overview
Single use bioprocessing covers the full suite of disposable upstream manufacturing systems, including single use bioreactors, mixers, media bags, filters, sampling systems, and connectors. These technologies replace reusable stainless-steel equipment with pre-sterilized, ready-to-use assemblies that are discarded after a single production run. The practical advantages are substantial: single use systems reduce water and energy consumption by approximately 45%, lower initial capital investment by around 40%, cut processing time for biologics by roughly 33%, and deliver cost savings of 30% to 40% compared with conventional setups.

The biologics sector has fundamentally changed the calculus on bioprocessing infrastructure. As monoclonal antibodies, cell therapies, gene therapies, and biosimilars command a growing share of new drug approvals, manufacturers need production systems that can flex rapidly across multiple molecules and scale from clinical to commercial volumes without expensive facility overhauls. Single use technologies meet that need directly. The COVID-19 pandemic further accelerated this shift, pushing CDMOs and biopharma manufacturers to adopt disposable systems that could be deployed quickly, configured for new targets, and turned around between campaigns with minimal downtime.

Recent M&A activity underscores how seriously the industry is treating this infrastructure transition. In January 2026, a U.S.-based bioprocessing solutions provider acquired a single-use consumables manufacturer specifically to strengthen its disposable product portfolio for biologics production. A month earlier, a European CDMO acquired a single-use filtration and mixing technology firm to integrate advanced disposable systems into its commercial manufacturing services. In December 2025, PBS Biotech launched MiniPRO, a multi-parallel bioreactor system designed to accelerate cell therapy process development within a single use framework. These are not isolated transactions; they reflect a structural consolidation around disposable bioprocessing as the default production standard.

Key Growth Drivers
Rising demand for biologics and biosimilars. The global pipeline of biologic therapies, including monoclonal antibodies, recombinant proteins, and gene therapies, continues to expand. Each new program requires upstream manufacturing capacity, and sponsors increasingly specify single use systems for clinical-stage work given their speed-to-setup advantage and lower contamination risk relative to stainless-steel vessels.

Cost and operational efficiency gains. Single use bioprocessing eliminates cleaning validation, reduces cleaning-in-place and sterilization-in-place cycles, and cuts the capital expenditure associated with building out multi-product manufacturing suites. For CDMOs competing on margin, these savings directly affect pricing power and capacity utilization. The 40% reduction in initial investment costs relative to conventional systems is particularly significant for emerging biopharma companies building their first manufacturing infrastructure.
Growing adoption in cell and gene therapy manufacturing. Cell therapy and gene therapy programs place unique demands on manufacturing: small batch sizes, high product sensitivity, and tight turnaround requirements. Single use bioreactors and closed-system disposable assemblies answer all three, making them the standard configuration for these modalities. PBS Biotech's MiniPRO launch in late 2025 specifically targets this segment.

Capacity expansion by CDMOs. Contract development and manufacturing organizations are investing heavily in flexible, multi-client facilities that can accommodate the molecule diversity coming through biopharma pipelines. Single use systems are the primary enabler of this flexibility, allowing CDMOs to reconfigure a production suite for a different client's program in days rather than weeks.

Over 1,800 patents filed, reflecting deep IP investment. The intellectual property landscape around single use bioprocessing has grown materially, with more than 1,800 patents filed or granted to date. This indicates sustained R&D investment from both established equipment manufacturers and emerging technology developers, supporting continued product improvement across sensors, connectors, and bioreactor control systems.

Market Segmentation
By product type, the single use bioprocessing market spans single use bioreactors, single use mixers, single-use media bags, single-use filters, single-use sampling systems, single-use connectors, and adjacent categories. Single use bioreactors represent the highest-value and most technically complex segment, commanding the dominant share of market revenue given their central role in cell culture and fermentation processes. These systems are characterized by a broad range of scale options, from laboratory-scale units supporting drug discovery through large-scale commercial bioreactors used in approved biologics manufacturing.

By scale of operation, the market divides into preclinical/clinical and commercial segments. Commercial-scale applications generate the majority of revenue, but the clinical segment is advancing at a faster clip as more biologics programs enter late-stage development and sponsors lock in manufacturing configurations ahead of potential approval. Geographically, the market covers North America, Europe, Asia-Pacific, Latin America, the Middle East and North Africa, and the Rest of the World.

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Regional Insights
North America holds the leading position in the global single use bioprocessing market, accounting for more than 45% of all active companies in the space. The region's dominance reflects its concentration of large biopharma manufacturers, a dense network of CDMOs, and a regulatory environment at the FDA that has actively encouraged flexible manufacturing adoption. The U.S. market benefits from sustained NIH funding for biologics research and strong private capital flowing into cell and gene therapy startups, most of which specify single use bioprocessing from day one of their manufacturing design.

Europe is the second major regional contributor, supported by a strong CDMO ecosystem in Germany, Switzerland, Ireland, and the Netherlands, along with EMA initiatives promoting flexible biologics manufacturing. Asia-Pacific is the fastest-growing region, with China, South Korea, India, and Japan all expanding domestic biologics manufacturing capacity. Government-backed initiatives across Asia to reduce dependence on foreign biologics supply chains are funneling investment into new manufacturing infrastructure, much of it built around single use technologies from the outset.

Competitive Landscape
Key companies profiled in the single use bioprocessing market report include Avantor, Cytiva, Eppendorf, Merck KGaA, Pall, Premas Biotech, REPROCELL, Saint-Gobain, Sartorius, Satake Multimix, and Thermo Fisher Scientific. The full list of companies is available in the complete report, which also includes a searchable database of all global providers of single use systems.

The competitive dynamic in this market is consolidating around a core group of large, vertically integrated suppliers with broad single use product portfolios, while a second tier of specialized technology developers competes on specific applications such as sensor integration, advanced mixing configurations, and small-volume systems for cell therapy. M&A activity, as evidenced by the acquisitions in late 2025 and early 2026, is the primary mechanism through which leaders are filling portfolio gaps and securing new customer relationships. The main battleground is product breadth: buyers increasingly prefer vendors who can supply the full range of single use components for a production suite rather than managing multiple specialist suppliers.

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Contact Details
Gaurav Chaudhary
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About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serve our clients in the best possible way.

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