Single-use Bioprocessing Market (By Product: Simple & Peripheral Elements, Apparatus & Plants, Work Equipment; By Workflow: Upstream, Downstream; By End-use) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The global single-use bioprocessing market size was estimated at around USD 27.96 billion in 2023 and it is projected to hit around USD 126.24 billion by 2033, growing at a CAGR of 16.27% from 2024 to 2033.

Key Pointers

• North America led the market with the largest market share of 35% in 2023.
• Asia Pacific region is projected to witness the fastest growth rate during the forecast period.
• By Product, the segment of simple and peripheral elements held the largest revenue share of 50% in 2023.
• By Workflow, the upstream bioprocessing segment emerged as the market leader in 2023.
• By Workflow, the fermentation segment is anticipated to grow at the noteworthy CAGR over the forecast period.
• By End-use, the biopharmaceutical manufacturers captured the maximum market share in 2023.

Single-use Bioprocessing Market Overview

In recent years, the biopharmaceutical industry has witnessed a significant paradigm shift towards single-use bioprocessing solutions. This transformative trend has revolutionized the way biopharmaceuticals are manufactured, offering unparalleled flexibility, cost-effectiveness, and efficiency. In this overview, we delve into the dynamics driving the single-use bioprocessing market and its implications for the biopharmaceutical sector.

Single-use Bioprocessing Market Growth Factors

The growth of the single-use bioprocessing market is propelled by an increasing demand for biologics and biosimilars fuels the adoption of single-use systems due to their ability to streamline production processes and reduce costs. Additionally, the inherent flexibility and scalability of single-use bioprocessing solutions enable manufacturers to quickly adapt to changing market dynamics and scale production as needed, driving market expansion. Moreover, the stringent regulatory requirements in the biopharmaceutical industry necessitate the adoption of technologies that minimize the risk of contamination and ensure product quality and safety, further driving the demand for single-use systems.

Single-use Bioprocessing Market Trends:

• Rapid Adoption of Single-Use Technologies: Biopharmaceutical manufacturers are increasingly embracing single-use bioprocessing solutions due to their inherent flexibility, scalability, and cost-effectiveness.
• Expansion of Biologics Pipeline: The growing pipeline of biologics, including monoclonal antibodies, vaccines, and cell therapies, is driving the demand for single-use bioprocessing technologies to meet the production requirements of these complex therapeutics.
• Integration of Automation and Data Analytics: Automation and data analytics technologies are increasingly being integrated into single-use bioprocessing workflows to enhance process control, efficiency, and product quality, thereby driving productivity and regulatory compliance.
• Advancements in Material Science: Ongoing advancements in material science are improving the performance and robustness of single-use components, addressing concerns related to extractables, leachables, and compatibility with biopharmaceutical processes.
• Emergence of Next-Generation Single-Use Bioreactors: Next-generation single-use bioreactors featuring advanced monitoring and control capabilities, as well as increased process intensification, are facilitating the transition from stainless-steel to single-use systems for upstream bioprocessing operations.

Single-use Bioprocessing Market Challenges:

• Extractables and Leachables: Concerns regarding the release of extractable and leachable compounds from single-use materials into biopharmaceutical products pose a significant challenge. Ensuring the safety and compatibility of single-use components with biopharmaceutical processes requires comprehensive characterization and risk assessment.
• Scalability for Large-Scale Manufacturing: While single-use systems offer scalability for small to mid-scale bioproduction, challenges remain in scaling up to large-scale manufacturing. Ensuring consistent performance, robustness, and cost-effectiveness at larger scales requires innovative engineering solutions and process optimization.
• Variability in Product Quality: Variability in single-use components, such as film thickness, surface properties, and welding techniques, can impact product quality and process performance. Addressing variability through stringent quality control measures and standardized testing protocols is essential to ensure product consistency and regulatory compliance.
• Regulatory Compliance: Meeting regulatory requirements for single-use systems, particularly regarding validation, documentation, and change management, presents challenges for manufacturers. Ensuring traceability, reliability, and data integrity throughout the product lifecycle is crucial to demonstrate compliance with regulatory standards.
• Cost Considerations: While single-use bioprocessing offers advantages in terms of reduced capital investment and operational costs, the overall cost-effectiveness of single-use systems compared to traditional stainless-steel equipment remains a subject of debate. Balancing cost considerations with performance, scalability, and product quality is essential for decision-making in bioprocess development and manufacturing.

Product Insights

The segment of simple and peripheral elements dominated the market in 2023, holding a significant market share of 50%. This was primarily attributed to continuous innovations in these products and the increasing importance of bioprocessing operations within the overall manufacturing process. Tubing, filters, connectors, and transfer systems were the key contributors to this segment's dominance, with tubing and connectors being commonly provided by most single-use suppliers in a format compatible with single-use bags, bioreactors, and other bioprocessing equipment. For example, Thermo Fisher Scientific, Inc. offers customization options to integrate tubing and connectors into its bioprocessing container bags and other equipment, further bolstering this segment's growth.

On the other hand, the segment of apparatus and plants is projected to exhibit rapid growth throughout the forecast period, driven primarily by its extensive penetration in the bioprocessing domain, largely fueled by the availability of a diverse range of single-use bioreactors. These bioreactors come in various working volume ranges, starting from as low as 15 mL and extending up to 6000 L. For instance, products like the Ambr 15 and 250 from Sartorius AG cater to smaller volumes, while larger volumes are served by offerings such as the CSR 7500 SUB from ABEC. This diverse range of options empowers end-users to seamlessly scale their production processes from clone selection and benchtop production to the harvesting of high-volume yields of biologics. Consequently, the availability of such a broad spectrum of apparatus and plants for bioprocessing is expected to be a major driver for this segment's growth.

Workflow Insights

The upstream bioprocessing segment emerged as the market leader in 2023, holding the largest share. This dominance can be attributed to ongoing developments and advancements in technologies specifically tailored for upstream bioprocessing. Notably, products like the Ambr 15 micro-bioreactor system from Sartorius AG exemplify this trend, offering high-throughput upstream process development alongside efficient cell culture processing and media and feed optimization. With automated experimental setup and sampling capabilities, these advanced solutions have the potential to significantly reduce the time required for upstream bioprocessing operations, thus fueling growth within this segment.

Conversely, the fermentation segment is poised to experience a notable compound annual growth rate (CAGR) over the forecast period. This anticipated growth is largely driven by the introduction of several innovative fermentation offerings designed to optimize conditions for bioprocessing reactions. For instance, Thermo Fisher Scientific, Inc.'s HyPerforma Enhanced S.U.F enhances oxygen mass transfer and temperature control within the culture by increasing the surface areas of turbine impellers and cooling jackets, respectively. Additionally, companies like Cytiva are actively introducing single-use fermentation solutions such as the Xcellerex XDR MO, a stirred tank system boasting powerful mixing capabilities, efficient temperature control, and high oxygen transfer capacities tailored for microbial cell culture. These significant innovations are expected to contribute substantially to revenue generation within the fermentation segment.

End-use Insights

Biopharmaceutical manufacturers emerged as the dominant players in the market, capturing the highest share in 2023. This dominance is attributed to the increasing commercial success of biologics in recent years and the growing reliance on contract manufacturing and research services. Contract research organizations (CROs) and contract manufacturing organizations (CMOs) offer numerous advantages in bioprocessing operations, including scalability, flexibility, reduced internal infrastructure requirements, and dedicated supply channels. These benefits are driving the widespread adoption of contract services and are expected to contribute positively to industry growth in the foreseeable future.

Meanwhile, academic and clinical research institutes are projected to exhibit the fastest compound annual growth rate (CAGR) during the period 2024-2033. The availability of benchtop-scale bioprocessing equipment and advancements in single-use systems have accelerated their adoption in academic and research settings. For instance, institutes like the National Institute for Bioprocessing Research and Training (NIBRT) in Ireland provide contract research services for biologics while also offering workshops and training programs focused on single-use technologies. Furthermore, the involvement of academic institutes and scientific communities in the development of novel biologics such as cell and gene therapies and vector production is expected to drive increased adoption of single-use systems, thanks to their cost reduction and flexibility benefits.

Regional Insights

In 2023, North America commanded the largest revenue share, accounting for over 35% of the market. This can be attributed to the region's well-established pharmaceutical and biomanufacturing industry, along with a high level of research and development (R&D) activities. Additionally, the increasing emphasis on vaccine production to combat diseases has propelled the demand for single-use bioprocessing equipment in the region. Moreover, the presence of the Bio-process System Alliance (BPSA) in North America, dedicated to advancing the adoption of single-use technologies, is expected to further boost sales of disposable systems.

Conversely, the Asia Pacific region is projected to witness the fastest growth rate during the forecast period. The region's expanding bioprocessing market has attracted multiple investments from global companies, facilitating the establishment of regional presence and tapping into untapped opportunities. Furthermore, the growing interest of contract service providers in expanding their operations in the Asia Pacific region, coupled with the trend of adopting disposable systems in contract manufacturing organizations (CMOs), is driving continued investments by both local and global companies. For example, in September 2021, Lonza expanded its drug development facility in Singapore, enhancing its capacity to meet the increasing manufacturing demands in the region.

Single-use Bioprocessing Market Key Companies

• Sartorius AG
• Danaher
• Thermo Fisher Scientific, Inc.
• Merck KGaA
• Avantor, Inc.
• Eppendorf SE
• Corning Incorporated
• Lonza
• PBS Biotech, Inc.
• Meissner Filtration Products, Inc.

Single-use Bioprocessing Market Segmentations:

By Product

• Simple & Peripheral Elements
  • Tubing, Filters, Connectors, & Transfer Systems
  • Bags
  • Sampling Systems
  • Probes & Sensors
    • pH Sensor
    • Oxygen Sensor
    • Pressure Sensors
    • Temperature Sensors
    • Conductivity Sensors
    • Flow Sensors
    • Others
  • 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

By Workflow

• Upstream Bioprocessing
• Fermentation
• Downstream Bioprocessing

By End-use

• Biopharmaceutical Manufacturers
  • CMOs & CROs
  • In-house Manufacturers
• Academic & Clinical Research Institutes

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)