According to latest report, the U.S. Single-use Bioprocessing market size was USD 8.15 billion in 2023, calculated at USD 9.43 billion in 2024, and is expected to reach around USD 35.13 billion by 2033, expanding at a CAGR of 15.73% from 2024 to 2033.
According to latest report, the U.S. Single-use Bioprocessing market size was USD 8.15 billion in 2023, calculated at USD 9.43 billion in 2024, and is expected to reach around USD 35.13 billion by 2033, expanding at a CAGR of 15.73% from 2024 to 2033.
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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.
Key Takeaways:
- Simple & peripheral elements led the market in 2023 and accounted for over 45% of the revenue share generated.
- The apparatus & plants segment is expected to witness lucrative growth from 2024 to 2033.
- Upstream bioprocessing dominated the market in 2023, generating nearly 58.15% of the total revenue share generated owing to the wide implementation of single-use bioreactors in bioprocessing.
- The fermentation sector is expected to experience rapid expansion during the forecast period, driven by substantial advancements that boost revenue.
- Biopharmaceutical manufacturing occupied the largest market revenue share in 2023 at approximately 57.6%.
Global Single-use Bioprocessing Market Size, share and Growth
The global U.S. single-use bioprocessing market size was worth around USD 33.07 billion in 2024 and is predicted to grow around USD 128.24 billion by 2033 with a compound annual growth rate (CAGR) of roughly 16.25% between 2024 and 2033. North America dominated the market with the largest revenue share of 34.45% in 2023.
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The Advantages of Single-Use Systems in Biopharmaceutical Manufacturing
Single-use systems have revolutionized biopharmaceutical manufacturing, offering numerous advantages over traditional stainless steel systems. This article explores the benefits of single-use systems in biopharmaceutical manufacturing, highlighting their impact on efficiency, cost-effectiveness, flexibility and contamination control. Single-use technologies significantly streamline manufacturing operations and reduce turnaround times by replacing the need for extensive cleaning, validation and sterilization processes associated with reusable systems. Furthermore, they minimize the risk of cross-contamination, enable more flexible manufacturing processes and provide a scalable and cost-effective solution for both small-scale and large-scale production.
Single-use systems (SUS) in biopharmaceutical manufacturing
Single-use systems (SUS) have gained significant traction in biopharmaceutical manufacturing as an alternative to traditional stainless steel systems. Unlike traditional systems, which involve reusable equipment such as tanks, filters and tubing, single-use systems comprise disposable components that are used once and then discarded. This shift toward single-use technology stems from the need for greater operational efficiency, flexibility and cost-effectiveness in the biopharmaceutical industry.
Traditional systems often require time-consuming and resource-intensive processes such as cleaning, validation and sterilization after each use. These processes can result in extended downtime between manufacturing runs, hampering productivity and delaying time-sensitive production schedules. In contrast, single-use systems eliminate the need for these extensive cleaning and sterilization procedures. After use, the entire single-use assembly is disposed of, allowing for faster turnaround times and increased manufacturing capacity.
Another crucial aspect to consider is contamination control. Traditional systems pose a risk of cross-contamination between batches, even with meticulous cleaning procedures. Single-use systems mitigate this risk by using disposable components that are sterile and pre-validated. This minimizes the chances of contamination and ensures product integrity.
Furthermore, single-use systems offer unparalleled flexibility in manufacturing processes. With traditional systems, changing product lines or adapting to different production scales often requires significant equipment reconfiguration or even complete system replacement. Single-use systems, on the other hand, can be customizable and allow for easy and quick modifications, enabling manufacturers to respond swiftly to market demands and optimize production efficiency.
Lastly, the cost-effectiveness of single-use systems is a notable advantage. Although the initial investment in single-use components may be higher, the overall costs of cleaning, maintenance and validation for reusable systems can be significant. These systems eliminate these recurring expenses, making them a more financially viable option, particularly for small-scale or contract manufacturing organizations.
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By 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 2033, 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.
By Workflow Insights
Upstream bioprocessing dominated the market in 2023, generating nearly 58.15% 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.
By 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.
U.S. Single-use Bioprocessing 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.
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.
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Clinical Trials Market : The global clinical trials market size was estimated at USD 81.90 billion in 2023 and is projected to hit around USD 153.59 billion by 2033, growing at a CAGR of 6.49% during the forecast period from 2024 to 2033.
Biomarkers Market: The global Biomarkers market size was estimated at USD 81.19 billion in 2023 and is projected to hit around USD 284.76 billion by 2033, growing at a CAGR of 13.37% during the forecast period from 2024 to 2033.
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Genomics Market: The global genomics market size was estimated at USD 33.90 billion in 2023 and is projected to hit around USD 157.47 billion by 2033, growing at a CAGR of 16.6% during the forecast period from 2024 to 2033.
Next Generation Sequencing Market : The global next generation sequencing market size was estimated at USD 9.19 billion in 2023 and is projected to hit around USD 66.04 billion by 2033, growing at a CAGR of 21.8% during the forecast period from 2024 to 2033.
Oncology Market : The global oncology market size was estimated at USD 222.36 billion in 2023 and is projected to hit around USD 521.60 billion by 2033, growing at a CAGR of 8.9% during the forecast period from 2024 to 2033.
Cancer Gene Therapy Market : The global cancer gene therapy market size was exhibited at USD 2.95 billion in 2023 and is projected to hit around USD 18.11 billion by 2033, growing at a CAGR of 19.9% during the forecast period 2024 to 2033.
Cell Therapy Market: The global cell therapy market size was exhibited at USD 4.85 billion in 2023 and is projected to hit around USD 37.42 billion by 2033, growing at a CAGR of 22.67% during the forecast period 2024 to 2033.
mRNA Therapeutics Market : The global mRNA therapeutics market size was valued at USD 12.19 billion in 2023 and is projected to surpass around USD 58.90 billion by 2033, registering a CAGR of 17.06% over the forecast period of 2024 to 2033.
Cell and Gene Therapy Market : The global cell and gene therapy market size was estimated at USD 18.13 billion in 2023 and is projected to hit around USD 97.33 billion by 2033, growing at a CAGR of 18.3% during the forecast period from 2024 to 2033.
U.S. Clinical Trials Market : The U.S. clinical trials market size was valued at USD 25.81 billion in 2023 and is projected to surpass around USD 41.57 billion by 2033, registering a CAGR of 4.88% over the forecast period of 2024 to 2033.
Some of the prominent players in the U.S. single-use bioprocessing market include:
- Sartorius AG
- Danaher
- Thermo Fisher Scientific, Inc.
- Merck KGaA
- Avantor, Inc.
- Eppendorf SE
- Corning Incorporated
- Lonza
- PBS Biotech, Inc.
- Meissner Filtration Products, Inc.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. single-use bioprocessing market
Product
- 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
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- Cell Culture System
- Syringes
- Others
Workflow
- Upstream
- Fermentation
- Downstream
End-use
- Biopharmaceutical Manufacturer
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- CMOs & CROs
- In-house Manufacturer
- Academic & Clinical Research Institutes
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