U.S. Single-use Bioprocessing Market Size, Share & Trends Analysis Report, By Product (Simple & Peripheral Elements, Apparatus & Plants, Work Equipment), By Workflow (Upstream, Fermentation, Downstream), By End-use, And Segment Forecasts, 2024 - 2030

U.S. Single-use Bioprocessing Market Trends

The U.S. single-use bioprocessing market size was estimated at USD 8.02 billion in 2023 and is expected to register a CAGR of 15.72% from 2024 to 2030. The surge in demand for biopharmaceuticals in the country has led suppliers to enhance their offerings of disposable systems, catering to the evolving needs of end-users. Notably, significant technological advancements in bioreactor designs, mixing systems, and fluid assemblies are driving the adoption of single-use technology in biopharmaceutical developments.

The U.S. single-use bioprocessing market accounted for nearly 29% of the global single-use bioprocessing market, dominating the industry by a landslide. This trend aligns with the country’s focus on capacity expansion for biopharmaceutical manufacturing and the commercial advantages offered by single-use equipment, such as cost-effectiveness and reduced contamination risk.

The biopharmaceutical sector in the U.S. is known for its high research and development intensity, driving the adoption of single-use technologies for a more flexible and efficient approach, leading to substantial revenue growth. Moreover, the U.S. FDA foresees approving 10 to 20 cell & gene therapy products annually by 2025, based on current clinical success rates and a promising product pipeline. This is expected to accelerate the adoption of disposable containers and equipment in bioprocessing, addressing the demand-supply gap. Many companies are enhancing their manufacturing capabilities to meet the rising demand.

Efforts are underway in the country to standardize the use of single-use technology and address challenges related to extractables and leachables. Suppliers are actively working on enhancing single-use bioreactor working volumes to meet the increasing market demand. These initiatives are expected to drive further adoption of disposable systems in biopharmaceutical development.

A June 2021 White House report suggested boosting funding for advanced manufacturing technologies by the Department of Health and Human Services, the Department of Defense, and other agencies to enhance continuous manufacturing and biomanufacturing of APIs, signaling a rising trend towards disposable biomanufacturing technologies. Moreover, the market is benefitting from a diverse range of disposable systems tailored to meet specific customer requirements. This diversity in product offerings, including media optimization, cell culturing, filtration, and fill/finish stages, is projected to boost the adoption of single-use technology in the country’s biopharmaceutical sector.

Market Concentration & Characteristics

The industry is characterized by a high degree of innovation, owing to the continuous advancements and high product development. Companies are constantly introducing new and technologically advanced products to meet the evolving needs of biopharmaceutical manufacturers. Introduction of the BioPharmaPro family of advanced products and services by Trelleborg Healthcare and Medicall in August 2023 exemplifies the market’s product expansion.

The industry experiences a significant amount of mergers and acquisitions among leading players. Recent examples include Thermo Fisher Scientific‘s strategic collaboration with Arsenal Biosciences for efficient manufacturing processes of programmable T cells for cancer treatment.

Stringent guidelines for biosafety, quality control, and other factors set by regulatory authorities pose significant challenges for industry growth. Compliance with these regulations is crucial for manufacturers to ensure product quality, safety, and adherence to industry standards, making regulatory compliance a key consideration for industry players.

Companies are focusing on developing and introducing new and innovative products and increasing production for existing products to cater to the diverse needs of biopharmaceutical manufacturers and meet the rising demand. For example, in May 2021, Lonza announced USD 884 million investment for building two new mammalian facilities in Visp, Switzerland, and Portsmouth, U.S. The Portsmouth facility houses up to eight 2000 L single-use bioreactors along with reusable bioreactors at Visp facility to meet the growing demand of biologics.

The industry is experiencing regional expansion and companies are expanding in various states due to several factors. In North America, robust investments in biopharmaceutical research and development, coupled with a supportive regulatory framework favoring the adoption of single-use bioprocessing technologies, are driving industry growth. For example, in June 2022, Merck announced the expansion of its existing CDMO facility in Wisconsin, U.S. to increase the production of HPAPIs (highly potent active pharmaceutical ingredients) and meet the growing demand of therapies for critical cancer.

Product Insights

Simple & peripheral elements led the market in 2023 and accounted for over 45% of the revenue share generated. Moreover, the segment is also expected to register the fastest CAGR over the forecast period. This is attributable to the increasing importance of bioprocessing in manufacturing. Besides the production reactor, other accessories necessary for biopharma manufacturing also fall under this category.

Tubing, filters, connectors, and transfer systems were the most consumed products within the segment in 2023. In addition to these products’ implementation by biomanufacturers, they are also applied in lab scale settings and academic institutes due to availability and adoption of various scaled down single-use solutions. Thus, the larger customer base and enhanced sterility impacts segment growth positively.

The apparatus & plants segment is expected to witness lucrative growth from 2024 to 2030, largely due to the diverse range of single-use bioreactors on offer. In line with the trend towards single-use solutions, a significant number of such bioprocessing products have been launched over time. Besides bioreactors, other systems like filtration, mixing, and chromatography have also been made commercially available for biopharmaceutical processing.

Workflow Insights

Upstream bioprocessing dominated the market in 2023, generating nearly 58% of the total revenue share generated owing to the wide implementation of single-use bioreactors in bioprocessing. It is also anticipated to have the fastest CAGR over the forecast period, which is attributable to the wide usage of other disposables systems in the segment, such as single-use bags, mixing systems, and sensors. Continuous developments and betterment in technologies have also been driving the expected growth. For instance, in May 2023, Danaher Corporation merged Cytiva and Pall under the Cytiva brand. This merger simplified customer access to bioprocess technologies and services. The combined entity offered a broad product portfolio across the bioprocess spectrum, thereby facilitating the development of novel therapeutics.

The fermentation sector is expected to experience rapid expansion during the forecast period, driven by substantial advancements that boost revenue. The fundamental requirement for any fermentation bioprocess production is to uphold ideal manufacturing conditions like oxygen, temperature, pH, and other factors in the fermenter. Technological improvements have led to the development of optimized and engineered single-use fermenters (SUFs), contributing to this segment’s growth.

End-use Insights

Biopharmaceutical manufacturing occupied the largest market revenue share in 2023 at approximately 57.6%. The rise in biopharmaceutical manufacturing is attributed to the substantial commercial success of biologics. Bio manufacturers, the primary users of single-use technologies, can be divided into in-house manufacturers and contract organizations. Contract manufacturing/research services provide numerous advantages that are increasing their adoption in the bioprocessing market. Conversely, in-house manufacturing is an appropriate choice for companies with substantial capital, offering benefits like internal process troubleshooting and quick supply due to flexible batch planning.

Key U.S. Single-use Bioprocessing Company Insights

The market is characterized by a significant degree of consolidation. The competitive landscape is intense, attributed to the considerable presence of numerous entities, including well-established corporations, small to medium-sized enterprises, and CROs. Some important companies in the U.S. single-use bioprocessing market include Sartorius AG; Danaher; Thermo Fisher Scientific, Inc.; Merck KGaA; Avantor, Inc.; and Eppendorf SE.

Key players are adopting business strategies like diversifying their product range, strengthening distribution networks, and expanding global manufacturing capabilities through partnerships, collaborations, and acquisitions to retain a substantial market share. For instance, in March 2022, Kuhner AG and Entegris, Inc. collaborated to develop a 2500 L single-use bioreactor. This partnership aimed to utilize Kuhner’s large scale ideal approach and Entegris’ innovation and supply chain.

Recent Developments

• In March 2024, Lonza acquired Roche’s Genentech facility in Vacaville for USD 1.2 billion. This strategic move significantly expanded its large-scale biologics manufacturing capacity, catering to the growing demand for mammalian therapies.

• In May 2023, Eppendorf launched the Bioprocess Autosampler, an innovative device enabled continuous and precise sampling from multiple bioreactors, enhancing data acquisition for optimizing yield and product quality. 

• In April 2023, Merck introduced Ultimus Film with a woven nylon structure, offered superior strength and leak resistance in bioprocessing liquid applications. Addressing manufacturers’ concerns about bag leaks, the Ultimus Film’s durability and resilience minimized risks and improved operational efficiency.

• In August 2022, Thermo Fisher Scientific inaugurated a significant single-use technology production facility in Greater Nashville to meet the increasing demand for bioprocessing materials essential for manufacturing vaccines and advanced treatments like cancer therapies.

• In May 2022, Entegris, Inc. announced the operational launch of a new Life Sciences Technology Center in Massachusetts to empower the company's life science clientele by leveraging Entegris' proficiency in addressing cold supply chain complexities.

• In February 2022, Sartorius completed the acquisition of Novsep’s chromatography division, enhancing its continuous biomanufacturing portfolio with innovative additions. This acquisition complemented the company's previous advancements in optimized systems for membrane-based chromatography.

U.S. Single-use Bioprocessing Market Report Scope

U.S. Single-use Bioprocessing Market Report Segmentation

This report forecasts revenue growth at the country level and analyzes the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. single-use bioprocessing market report based on product, workflow, and end-use.

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Simple & Peripheral Elements

    • Tubing, Filters, Connectors, & Transfer Systems

    • Bags

    • Sampling Systems

    • Probes, Sensors, & Flow Meters

      • pH Sensor

      • Oxygen Sensor

      • Pressure Sensors

      • Temperature Sensors

      • Conductivity Sensors

      • Flow Meters & Sensors

    • Others

  • Apparatus & Plants

    • Bioreactors

      • Upto 1000L

      • Above 1000L to 2000L

      • Above 2000L

    • Mixing, Storage, & Filling Systems 

    • Filtration System

    • Chromatography Systems

    • Pumps

    • Others

  • Work Equipment

    • Cell Culture System

    • Syringes

    • Others

• Workflow Outlook (Revenue, USD Million, 2018 - 2030)

  • Upstream

  • Fermentation

  • Downstream

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Biopharmaceutical Manufacturer

    • CMOs & CROs

    • In-house Manufacturer

  • Academic & Clinical Research Institutes