Single Use Downstream Bioprocessing Market Reach US$ 4.71 Bn by 2032

The single use downstream bioprocessing market, projected to be valued at USD 1.74 billion in 2025, is set for rapid expansion, with expectations to reach USD 4.71 billion by 2032, registering a strong CAGR of 15.3% over the forecast period. This growth is primarily fueled by the increasing adoption of single-use technologies in biopharmaceutical manufacturing due to their cost-effectiveness, reduced risk of cross-contamination, and operational flexibility. As the demand for biologics, including monoclonal antibodies, vaccines, and cell and gene therapies, rises, manufacturers are increasingly shifting toward disposable downstream systems to streamline workflows and accelerate production timelines.

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The single-use downstream bioprocessing market is witnessing accelerated growth, fueled by the biopharmaceutical industry’s increasing shift toward flexible, scalable, and contamination-free manufacturing solutions. The growing adoption of biologics—including monoclonal antibodies, vaccines, and cell and gene therapies—is driving demand for disposable technologies that streamline purification and separation processes. Single-use chromatography systems, filtration units, and sampling tools are increasingly favored over traditional stainless-steel setups due to their lower capital investment, faster changeovers, and reduced risk of cross-contamination.

In April 2022, Thermo Fisher Scientific inaugurated a new single-use technology manufacturing facility in Ogden, Utah. The $44 million, state-of-the-art site expands production capacity for high-quality materials used in developing next-generation biologics and vaccines. This facility forms part of Thermo Fisher’s broader $650 million multi-year investment aimed at enhancing global bioprocessing infrastructure. By bolstering the supply of flexible and reliable single-use systems, this strategic move directly supports growing industry demand for scalable and contamination-free downstream biomanufacturing solutions.

Moreover, regulatory agencies such as the U.S. FDA and European Medicines Agency (EMA) are increasingly emphasizing process validation and data integrity in bioprocessing, prompting companies to invest in single-use technologies that integrate advanced sensors and automation for real-time monitoring. These developments are transforming the downstream landscape, enabling faster product turnaround and compliance with current Good Manufacturing Practices (cGMP).

With ongoing R&D in polymer durability, sensor integration, and scalable design, the single-use downstream bioprocessing market is set to remain a cornerstone of next-generation biomanufacturing strategies, particularly as companies prioritize speed, flexibility, and cost-efficiency in post-pandemic biologics production.

The market is witnessing a surge in the adoption of single-use systems embedded with advanced sensors and automation tools. These “smart” systems enable real-time monitoring of critical downstream parameters such as pressure, flow rate, conductivity, and pH, improving process control and batch consistency. Vendors like Sartorius and Cytiva are increasingly offering integrated solutions that comply with data integrity and regulatory expectations (e.g., 21 CFR Part 11). This trend supports Quality by Design (QbD) approaches and enhances compliance in GMP manufacturing.

In June 2023, Waters Corporation and Sartorius expanded their collaboration to incorporate the PATROL UPLC Process Analysis System with Sartorius’ Resolute BioSMB multi-column chromatography platform. This provides real-time analytical data during downstream operations, such as protein A capture and viral vector purification, empowering point-of-decision analytics and faster, data-driven control.

The rapid growth of mRNA-based therapeutics and cell and gene therapies is significantly influencing downstream process design. These therapies require flexible and closed-system purification solutions, prompting strong demand for scalable single-use filtration, chromatography, and sterile sampling technologies. Manufacturers like Thermo Fisher and Getinge are launching single-use platforms tailored for viral vectors, lipid nanoparticles, and autologous cell therapy workflows, reinforcing this shift in market dynamics.

In September 2023, Getinge introduced the AppliFlex ST GMP, a turnkey single-use bioreactor platform designed for clinical-scale mRNA, viral vector, and cell/gene therapy production. The system enables seamless scale-up from lab to clinical use with closed-system consumables and full cGMP compliance, directly supporting downstream purification and sterile workflows.

As environmental concerns intensify—especially around plastic waste—biopharma purchasers are seeking biodegradable or recyclable single-use components. Though SUB has clear sustainability advantages in energy and water savings, reliance on disposable plastics raises scrutiny. The industry is moving toward sustainable disposables, and innovators can capture share by developing greener materials, recyclable systems, and closed-loop waste solutions.

In January 2024, Green Elephant Biotech launched plant-based PLA labware, such as 96‑well plates under the CellScrew system, made entirely from polylactic acid. These supplies meet biocompatibility standards and significantly reduce carbon emissions and dependency on petroleum-based plastics.

As digital transformation advances in biopharma, there's a growing opportunity to integrate digital twin technology into single-use downstream systems. Digital twins—virtual replicas of bioprocesses—can simulate, monitor, and optimize unit operations like filtration and chromatography in real time. This enables predictive control of critical parameters, minimizes product loss, and enhances scale-up efficiency. Vendors that embed digital modeling tools into single-use skids or systems can gain a competitive advantage, especially among CMOs and CDMOs focused on data-driven manufacturing.

In May 2025, Samsung Biologics announced the deployment of hybrid digital twins that combine computational fluid dynamics (CFD), mechanistic modeling, and machine learning to monitor and optimize downstream parameters such as mixing, mass balances, and product quality. These digital “shadow” models integrate inline sensors—including Raman spectroscopy—to enable automated, real-time control of purification workflows in GMP environments.