The Single-use Bioprocessing Market size was estimated at USD 15.56 billion in 2023 and expected to reach USD 17.96 billion in 2024, at a CAGR 15.79% to reach USD 43.43 billion by 2030.

Single-use bioprocessing refers to biopharmaceutical production methods that use disposable, single-use containers and assemblies instead of traditional stainless-steel systems. This technology is crucial for reducing costs, increasing efficiency, and enhancing flexibility in the production of biologics, vaccines, and other biopharmaceutical products. Its necessity stems from the rapid demand for scalable and cost-efficient bioprocessing solutions that can easily adapt to varying production scales and meet stringent regulatory standards. The primary applications lie in upstream and downstream bioprocessing tasks, including cell culture, fermentation, purification, and fluid handling. End-use scope primarily encompasses pharmaceutical and biotechnology companies, contract research organizations, and academic research institutions.
Key growth factors include increased biologics demand, improved process efficiency, less cross-contamination risk, and reduced time required for cleaning and validation procedures. The ongoing COVID-19 pandemic has further accelerated demand for quick vaccine production, presenting a potential opportunity for manufacturers to expand their portfolios with single-use systems. Market players can capitalize on this by investing in innovation and producing diverse, scalable, and modular single-use systems. However, challenges persist, including high initial investment costs, concerns over plastic waste, and dependency on supplier quality assurance for single-use components. Innovations focusing on sustainable materials, advanced automation, and integrated bioprocessing systems can mitigate these barriers.
The industry presents abundant opportunities in the realm of hybrid systems combining single-use and stainless-steel technologies to offer flexibility while managing large-scale operations. Collaborating with academic and research institutions can spur innovation and enhance product offerings to meet emerging bioprocessing needs. Moreover, expanding geographic presence in emerging markets with rising biopharmaceutical activities can be instrumental for growth. While the market is dynamic and fast-evolving, success lies in addressing environmental concerns, enhancing system interoperability, and ensuring regulatory compliance. Continued research and development focused on integrating artificial intelligence and machine learning can further revolutionize single-use bioprocessing, making it a cornerstone of modern biomanufacturing strategies.
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Market Dynamics
The market dynamics represent an ever-changing landscape of the Single-use Bioprocessing Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.
- Market Drivers
- Global emphasis on pandemic preparedness and outbreak response
- Growing need for biologics and biosimilars increasing the use of flexible manufacturing systems
- Market Restraints
- Issues regarding standardization and complexities in integrating the single-use bioprocessing systems
- Market Opportunities
- Growing pipeline of personalized medicines and cell therapies
- Advancements in materials and the integration of automation and robotics with single-use systems
- Integration of advanced spectroscopy probes into single-use bioprocessing solutions
- Market Challenges
- Regulatory and compliance challenges, along with environmental and sustainability concerns associated with single-use bioprocessing adoption
Market Segmentation Analysis
Product Type: Importance of chromatography and filtration systems in the purification process by enabling efficient separation and ensuring the sterility of the final product
Apparatus & plants within the single-use bioprocessing market stands as a crucial segment, supporting the seamless execution of various bioprocesses through its comprehensive product offerings, including bioreactors, chromatography systems, filtration systems, mixing, storage, & filling systems, and pumps. Bioreactors are central to this category, with their sub-segmentation into 1001L to 2000L, above 2000L, and up to 1000L capacities, offering tailored solutions to meet diverse production scales and process requirements. The 1001L to 2000L range is ideal for mid-scale production, balancing capacity and operational efficiency, making it attractive for firms looking to expand without a massive footprint. Bioreactors above 2000L cater to large-scale biomanufacturing, enabling high-volume production with stringent quality control, which is crucial for large biopharma companies. The up to 1000L bioreactors serve small-scale and pilot projects, offering agility and cost-effectiveness, particularly beneficial for startups and research labs. Collectively, these bioreactor options underscore the industry's move toward flexible and rapid-response manufacturing strategies, ensuring adaptability to evolving market needs. Chromatography systems within this segment illustrate their indispensability in the purification and separation processes, driven by advancements in chromatography media and the need for high-purity outputs. These systems support intricate separation tasks and are pivotal in downstream processing. Filtration systems complement these operations, ensuring sterility and removing particulates, thereby maintaining the integrity of the bioprocessing environment. Their versatility in handling different filtration needs, from micro to ultra-filtration, renders them a staple in upstream and downstream phases. Mixing, storage, and filling systems emphasize operational efficiency, allowing seamless transitions from one production phase to another. These systems ensure optimal mixing, preserve product quality during storage, and facilitate efficient filling operations, which is vital for maintaining the efficacy and quality of bioproducts. Pumps are integrated across various stages of the process, providing precision, hygiene, and reliability in fluid transfer operations, which are essential for maintaining the efficiency and consistency of bioprocesses. They are distinguished by their ability to handle liquid substance transfers with precision, minimizing contamination risk.
Simple & peripheral elements are essential for ensuring efficient and contaminant-free operations. This category includes critical components such as bags, Probes and sensors, and sampling systems. Bags are fundamental in the simple and peripheral elements category, offering versatile solutions for fluid handling, storage, and transportation. These bags are designed to ensure sterility and minimize contamination risks, making them ideal for the biopharmaceutical industry, where maintaining product integrity is critical. Available in various sizes and configurations, single-use bags cater to a wide range of applications, to the final fill of biopharmaceutical products. Probes and sensors are indispensable for ensuring precise and reliable monitoring of various process parameters. These sensors contribute significantly to the efficiency and quality of biomanufacturing. Conductivity sensors are crucial for monitoring ionic concentrations, which is vital in processes such as chromatography and fermentation. Flow sensors provide accurate readings that help maintain the right fluid dynamics, which is essential for upstream and downstream processes. Oxygen sensors are integral for regulating and optimizing aerobic fermentation, directly impacting product yield and quality. pH sensors are used extensively to maintain optimal acidity levels, which are critical for enzyme activity and product stability. Pressure sensors ensure safe operation by monitoring system pressure, preventing leaks, and ensuring structural integrity. Temperature sensors play a key role in maintaining optimal thermal conditions, which is critical for the efficacy of biological reactions. Together, these sensors enable real-time data collection and process control, enhancing the bioprocessing operations' overall reliability, efficiency, and output quality. Sampling systems are essential for the periodic collection of bioprocess samples, enabling quality control and process optimization. Tubing, filters, connectors, and transfer systems are indispensable for the safe and efficient movement and filtration of liquids within the bioprocessing setup, ensuring that the materials are transferred in a sterile and uncontaminated manner. Filters are critical for ensuring sterility by removing contaminants and particulates and safeguarding product quality and integrity. Connectors facilitate secure and leak-proof connections, preventing cross-contamination and ensuring consistent operational performance. Together, these components enhance the modularity and flexibility of bioprocessing setups, allowing manufacturers to adapt more readily to changing production needs and regulatory standards.
Work equipment enhances operational efficiency and ensures sterility throughout the manufacturing cycle. This category includes critical components such as cell culture systems and syringes. Cell culture systems are designed to provide optimal environments for the growth and proliferation of cells, which is essential for the production of biologics, vaccines, and cell therapies. These systems typically use single-use technologies to reduce the risk of contamination and cross-contact, ensuring high yield and consistent quality. On the other hand, syringes play a critical role in the precise dosing and transfer of liquids, from small-volume sampling to large-scale material filling. In single-use setups, syringes are instrumental in reducing contamination risk while transferring sensitive biological materials. Together, they contribute to streamlined, flexible, and scalable bioprocessing operations, meeting the industry's demand for agile and cost-effective manufacturing solutions while adhering to stringent quality standards.
Workflow Stage: Integration of advanced technologies to achieve more data-driven quality assurance methodologies
The upstream processing stage of single-use bioprocessing is the initial stage, focusing on the cultivation of living cells that produce the desired bioproducts. It includes activities such as cell culture, fermentation, and media preparation. Single-use technologies in this phase, including disposable bioreactors, offer flexibility, reduced contamination risks, and lower capital costs compared to traditional stainless-steel systems. Downstream processing follows, involving the recovery and purification of the bioproduct from the culture. This stage includes centrifugation, filtration, and chromatography. Single-use systems, such as disposable centrifuge bags and filters, provide a significant advantage in reducing changeover time between batches and improving sterility. Fill-finish operations are the final steps before product packaging, where the purified bioproduct is filled into vials or syringes and finished with appropriate labeling and packaging. In single-use systems, these activities benefit from reduced cleaning requirements and enhanced sterility. Quality control and analytics ensure the product meets regulatory standards, encompassing various tests, including potency, purity, and safety assessments. This segment is witnessing an integration of advanced technologies such as real-time data analytics and biosensors to oversee product consistency and safety, indicating a shift toward more data-driven quality assurance methodologies. Single-use platforms can facilitate rapid testing and offer ease of use through disposable sampling devices. Together, these workflow segments highlight a holistic approach to single-use bioprocessing, with innovations converging around enhancing system integration and operational efficiency.
Porter’s Five Forces Analysis
The porter's five forces analysis offers a simple and powerful tool for understanding, identifying, and analyzing the position, situation, and power of the businesses in the Single-use Bioprocessing Market. This model is helpful for companies to understand the strength of their current competitive position and the position they are considering repositioning into. With a clear understanding of where power lies, businesses can take advantage of a situation of strength, improve weaknesses, and avoid taking wrong steps. The tool identifies whether new products, services, or companies have the potential to be profitable. In addition, it can be very informative when used to understand the balance of power in exceptional use cases.
PESTLE Analysis
The PESTLE analysis offers a comprehensive tool for understanding and analyzing the external macro-environmental factors that impact businesses within the Single-use Bioprocessing Market. This framework examines Political, Economic, Social, Technological, Legal, and Environmental factors, providing companies with insights into how these elements influence their operations and strategic decisions. By using PESTLE analysis, businesses can identify potential opportunities and threats in the market, adapt to changes in the external environment, and make informed decisions that align with current and future conditions. This analysis helps companies anticipate shifts in regulation, consumer behavior, technology, and economic conditions, allowing them to better navigate risks and capitalize on emerging trends.
Market Share Analysis
The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Single-use Bioprocessing Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
FPNV Positioning Matrix
The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Single-use Bioprocessing Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Recent Developments
New Fill4Sure Assembly by SaniSure aims to streamline drug manufacturing, cut costs, and enhance production efficiency
Snishure launched a custom Fill4Sure single-use filling assembly designed to address critical challenges in the drug manufacturing process, such as high operational costs and limited production speeds. This product aimed to offer cost-efficient and customizable assembly solutions. Its key features included extremely clean, low particulate 2D surge bags, silicone over-molding high-performance tubing, and oil and adhesive-free needles. These features aim to streamline biomanufacturing processes, reduce costs, increase efficiency, and maintain product purity in the long term. [Published On: November 04, 2024]
Avantor's strategic alliance with NIBRT streamlines mAbs manufacturing through advanced equipment and training
Avantor expanded its partnership with the National Institute for Bioprocessing Research and Training (NIBRT) to address biopharma industry bottlenecks by providing advanced aseptic fluid handling equipment and specialized training focused on monoclonal antibody (mAbs) manufacturing. This collaboration supplies NIBRT with Masterflex pump systems to mimic real-world workflows, enhancing trainee hands-on experience. Avantor seeks to optimize downstream processes, reducing delays and improving productivity By improving large-scale fluid handling in closed systems. [Published On: October 23, 2024]
TekniPlex Healthcare to showcase single-use bioprocessing solutions and sustainable packaging innovations at CPHI Milan 2024
TekniPlex Healthcare is poised to spotlight innovative single-use bioprocessing solutions, focusing on customizable barrier films and advanced tubing systems, at CPHI Milan. The company aims to strengthen its market position within the expanding biologics sector by showcasing its manufacturing capabilities and sustainable blister packaging solutions incorporating recycled content, The introduction of the upgraded Pentafill A25 Filling & Sealing Machine promises improved sterility and versatility, enhancing production efficiency. [Published On: September 19, 2024]
Strategy Analysis & Recommendation
The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Single-use Bioprocessing Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.
Key Company Profiles
The report delves into recent significant developments in the Single-use Bioprocessing Market, highlighting leading vendors and their innovative profiles. These include Agilitech, Aseptic Group, Avantor, Inc., Bionet Servicios Técnicos SL, BioPharma Dynamics Ltd., CellBios Healthcare & Lifesciences Pvt. Ltd., Compagnie de Saint-Gobain, Corning Incorporated, Cytiva by Danaher Corporation, Entegris, Inc., Eppendorf SE, Foxx Life Sciences, Freudenberg Group, Getinge AB, Kuehne + Nagel International AG, Lonza Group AG Ltd., Meissner Corporation, Merck KGaA, Mettler-Toledo International Inc., Parker-Hannifin Corporation, PBS Biotech, Inc., PharmNXT Biotech, PSG Dover by Dover Corporation, Repligen Corporation, SaniSure, Sartorius AG, Satake Multimix Corporation, Single Use Support GmbH, Tekni-Plex, Inc., Thermo Fisher Scientific Inc., and Watson-Marlow Fluid Technology Solutions by Spirax Group PLC.
Market Segmentation & Coverage
This research report categorizes the Single-use Bioprocessing Market to forecast the revenues and analyze trends in each of the following sub-markets:
- Product Type
- Apparatus & Plants
- Bioreactors
- 1001L to 2000L
- Above 2000L
- Upto 1000L
- Chromatography Systems
- Filtration System
- Mixing, Storage, & Filling Systems
- Pumps
- Bioreactors
- Simple & Peripheral Elements
- Bags
- Probes & Sensors
- Conductivity Sensors
- Flow Sensors
- Oxygen Sensor
- pH Sensor
- Pressure Sensors
- Temperature Sensors
- Sampling Systems
- Tubing, Filters, Connectors, & Transfer Systems
- Work Equipment
- Cell Culture System
- Syringes
- Apparatus & Plants
- Workflow Stage
- Downstream Processing
- Fill-Finish Operations
- Quality Control & Analytics
- Upstream Processing
- Application
- Aseptic Filling
- Cell Culture
- Filtration
- Mixing
- Purification
- Sampling
- Storage
- End User
- Academic & Research Institutes
- Contract Manufacturing Organizations & Contract Research Organizations
- Pharmaceutical & Biotechnology Companies
- Region
- Americas
- Argentina
- Brazil
- Canada
- Mexico
- United States
- California
- Florida
- Illinois
- New York
- Ohio
- Pennsylvania
- Texas
- Asia-Pacific
- Australia
- China
- India
- Indonesia
- Japan
- Malaysia
- Philippines
- Singapore
- South Korea
- Taiwan
- Thailand
- Vietnam
- Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom
- Americas
This research report offers invaluable insights into various crucial aspects of the Single-use Bioprocessing Market:
- Market Penetration: This section thoroughly overviews the current market landscape, incorporating detailed data from key industry players.
- Market Development: The report examines potential growth prospects in emerging markets and assesses expansion opportunities in mature segments.
- Market Diversification: This includes detailed information on recent product launches, untapped geographic regions, recent industry developments, and strategic investments.
- Competitive Assessment & Intelligence: An in-depth analysis of the competitive landscape is conducted, covering market share, strategic approaches, product range, certifications, regulatory approvals, patent analysis, technology developments, and advancements in the manufacturing capabilities of leading market players.
- Product Development & Innovation: This section offers insights into upcoming technologies, research and development efforts, and notable advancements in product innovation.
Additionally, the report addresses key questions to assist stakeholders in making informed decisions:
- What is the current market size and projected growth?
- Which products, segments, applications, and regions offer promising investment opportunities?
- What are the prevailing technology trends and regulatory frameworks?
- What is the market share and positioning of the leading vendors?
- What revenue sources and strategic opportunities do vendors in the market consider when deciding to enter or exit?
- Preface
- Research Methodology
- Executive Summary
- Market Overview
- Market Insights
- Single-use Bioprocessing Market, by Product Type
- Single-use Bioprocessing Market, by Workflow Stage
- Single-use Bioprocessing Market, by Application
- Single-use Bioprocessing Market, by End User
- Americas Single-use Bioprocessing Market
- Asia-Pacific Single-use Bioprocessing Market
- Europe, Middle East & Africa Single-use Bioprocessing Market
- Competitive Landscape
- List of Figures [Total: 25]
- List of Tables [Total: 427 ]
- List of Companies Mentioned [Total: 31]

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