December 9, 2023

Single-Use Bioprocessing Market: Industry Trends and Future Forecast

In a groundbreaking shift within the biopharmaceutical industry, single-use technology is emerging as the preferred choice over traditional stainless steel systems. These disposable systems have rapidly gained traction, offering unmatched advantages for biotechnology and pharmaceutical markets.

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Biopharma Facilities Embrace Single-Use Technology

Vaccine manufacturers were among the early adopters of single-use technology due to its inherent advantages, including eliminating the need for cleaning and minimizing cross-contamination risks. Today, more than 90% of biopharma facilities incorporate single-use components, with the single-use bioprocessing market projected to reach approximately US$6 billion by 2026. Key components of single-use systems include pre-sterilized disposable bags, tubing, fittings, connectors, and bioreactors with capacities up to 2,000 liters for cell culture processes.

Flexibility and Cost Efficiency Drive Adoption

One of the standout features of single-use systems is their adaptability. Changing bag sizes is a straightforward process compared to the complexities of acquiring and installing new stainless steel vessels. The arduous task of cleaning traditional stainless steel vessels, coupled with the associated challenges of process development, validation, and utility consumption, makes single-use technology a more practical and cost-effective choice.

Matching Batch Sizes with Precision

With the evolution of personalized medicines, batch sizes for many products have significantly decreased, often reaching 2,000 liters or less. This shift aligns perfectly with the capabilities of single-use technology, making it an ideal choice for emerging fields like cell and gene therapies, where it is deployed from the outset, spanning clinical, process development, and commercial manufacturing suites.

Environmental Sustainability and Safety

The sustainability advantages of single-use systems are unmistakable. Traditional stainless steel bioreactors demand substantial amounts of water, energy, and cleaning products, contributing to a higher carbon footprint. Case studies have revealed that adopting single-use systems can result in substantial annual savings in water, electricity, and carbon emissions.

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Overcoming Challenges

Despite its many benefits, some industry players remain cautious about fully embracing single-use technology. Concerns related to chemical release from polymers in single-use products contaminating drugs have raised questions about validation and supply chain security. However, the adoption of single-use technology is gaining ground globally, including in less developed markets in South America, the Middle East, Asia, and Africa.

Upstream Workflow Takes the Lead

In 2020, the upstream workflow segment accounted for over half of the global single-use bioprocessing market revenue. While single-use systems have been traditionally associated with upstream processes such as cell-culture seeding and media preparation, advancements in downstream processing are fueling further growth in this segment.

North America Leads, Asia Pacific Surges

North America dominated the single-use bioprocessing market in 2020, capturing approximately one-third of global market revenue. This stronghold is attributed to a high number of contract manufacturers adopting disposables, substantial R&D investments by large-scale biopharmaceutical companies, and patent expirations of biologics. Meanwhile, Asia Pacific is experiencing rapid growth, driven by government initiatives, improved R&D infrastructure, and investments. China and India, as pharmaceutical manufacturing hubs, are expected to register the fastest compound annual growth rate (CAGR) in the coming years.

Key Players Prepare for Post-COVID-19 Surge

The heightened demand for bioprocessing equipment, driven by the need to vaccinate billions against COVID-19, has spurred investments and expansions. Avantor is ramping up single-use bioprocessing equipment production capacity, while Wuxi Biologics and Chine CDMO have initiated facilities equipped with cutting-edge single-use bioreactors. In 2020, Danaher acquired GE Healthcare’s biopharma business for US$20 billion, solidifying its position in the industry. Other prominent players actively shaping the global single-use bioprocessing market include Thermo Fisher Scientific, Inc., Merck KGaA, Sartorius AG, Pall Corporation, Eppendorf AG, Rentschler Biopharma SE, Lonza, Meissner Filtration Products, Inc., JM BioConnect, Boehringer Ingelheim GmbH, Danaher Corporation, Avantor Inc., and Kuhner AG.

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This press release first seen on Brilad