Single Use Bioprocessing Market

The global single-use bioprocessing market, valued at $17.7 billion in 2024, is projected to reach $34.9 billion by 2029, with a CAGR of 14.5%. This market is driven by increased adoption by CDMOs and CMOs, enhanced productivity, reduced cross-contamination risks, and lower capital investment. However, challenges like leachables, extractables, and regulatory hurdles may hinder growth. Key opportunities lie in emerging markets, while North America currently dominates the industry. Major players include Sartorius AG, Danaher Corporation, Merck KGaA, and Thermo Fisher Scientific. The market's growth is primarily attributed to the expanding biologics sector, with key applications in upstream and downstream bioprocessing.

Single Use Bioprocessing Market Trends

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Attractive Opportunities in the Single-Use Bioprocessing Market

Global Single-Use Bioprocessing Market Dynamics

DRIVER: Increased productivity & reduced risk of cross contamination

Single-use systems offer a streamlined approach, eliminating the need for extensive cleaning procedures by employing disposable components. This feature enables manufacturers to accelerate product substitutions and process transitions, thereby maximizing equipment utilization and overall production throughput. By minimizing downtime and enhancing operational efficiency, single-use bioprocessing technologies allow manufacturers to meet increasing demand for biologics and accelerate time-to-market for new therapies, ultimately driving revenue growth and market expansion. Moreover, single-use systems offer a closed and disposable design, minimizing the risk of microbial contamination and cross-contamination between batches. This inherent sterility significantly enhances product purity and consistency, meeting stringent regulatory requirements and supporting consumer confidence in the safety and efficacy of biologic drugs.

RESTRAINT: Issues related to leachable & extractives

Leachables are chemical compounds that migrate from the single-use materials (such as plastic bags, tubing, and filters) into the biopharmaceutical product, while extractable are substances that can be extracted from the single-use materials under extreme conditions, such as high temperatures or different solvents. The presence of leachables and extractables in biopharmaceutical products can pose risks to product quality, safety, and regulatory compliance, thereby presenting a significant obstacle to the widespread adoption of single-use bioprocessing technologies.

Leachables and extractables have the potential to interact with the biologic drug substance or product formulation, leading to undesirable effects such as product degradation, alteration of therapeutic efficacy, or even toxicity to patients. The identification, characterization, and mitigation of leachables and extractables require comprehensive analytical testing and risk assessment strategies, adding complexity and cost to the development and manufacturing process.

OPPORTUNITY: Untapped market potential in emerging economies

The global bioprocessing market has witnessed substantial growth, driven largely by the adoption of single-use technologies (SUTs). These technologies offer significant advantages over traditional stainless-steel systems, including reduced risk of contamination, lower capital costs, and increased operational flexibility. While developed markets in North America and Europe have seen widespread adoption of SUTs, there remains considerable untapped market potential in emerging economies. These regions present a unique opportunity for expansion due to several factors, including growing healthcare needs, increasing investments in biopharmaceutical infrastructure, and favorable government policies. Emerging countries such as China, India, Brazil, and Mexico are expected to offer significant growth opportunities for players operating in the single use bioprocessing market.

CHALLENGE: Lack of standardization of single use designs

The lack of standardization affects various aspects of bioprocessing, from manufacturing and integration to regulatory compliance and supply chain management, posing substantial hurdles for widespread adoption and efficient implementation. There is variability in design and components across different manufacturers. Unlike traditional stainless-steel systems, which have well-established industry standards, single-use systems are often custom-designed, leading to inconsistencies. The absence of standardized connectors, tubing, and other components means that systems from different suppliers are often not compatible with one another. This lack of interchangeability complicates system integration and increases the risk of operational inefficiencies. Additionally, different manufacturers may use varying materials and production methods, leading to differences in the quality and performance of single-use components. This variability can affect the reproducibility of bioprocesses and the consistency of product quality, such as variations in the material composition of single-use bags or filters, which can lead to differing rates of leachable, impacting the final product's safety and efficacy.

Global Single-Use Bioprocessing Industry Ecosystem Analysis

The single-use bioprocessing market ecosystem comprises raw material suppliers, single-use bioprocessing product manufacturers, and end users such as pharmaceutical and biotechnology manufacturers, CMOs & CROs, and academic & research institutes. Single-use bioprocessing products manufacturers provide single use bioreactor, filtration system & filters, chromatography system & consumables, assemblies, among other consumables & equipment.

The single-use bags & containers segment dominated single-use bioprocessing industry in 2023.

Based on consumables, the single-use bioprocessing market is segmented into single-use bags and containers, filters, chromatography columns, assemblies, sensors, and other consumables. In 2023, single-use bags and containers segment dominated the market. Bags provide a single-use disposable alternative to traditional glass and rigid plastic carboys in many bioprocess applications. They enhance process reliability by reducing the risk of cross-contamination from batch to batch and from product to product. They also eliminate the time and expense of clean-in-place (CIP) & sterilization-in-place (SIP) operations, thus optimizing capacity utilization. The expanded application of single-use bags across biomanufacturing processes drives the market for single-use media bags & containers.

The upstream segment dominated the single-use bioprocessing industry in 2023.

Based on workflow, the single-use bioprocessing market is segmented into upstream and downstream bioprocessing. In 2023, the upstream bioprocess segment accounted for the largest share of the single-use bioprocessing market. The large share of this segment can be attributed to the wide use of single-use bioprocessing in biopharmaceutical formulation, which supports the growth of upstream bioprocessing. Further, the increasing demand for biologics like cell & gene therapy and mAbs support the market’s growth.

North America was the largest regional market for the single-use bioprocessing industry in 2023.

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The global single-use bioprocessing market is segmented into six major regions—North America, Europe, the Asia Pacific, Latin America, Middle East and Africa. North America was the largest segment in 2023 in the single-use bioprocessing market, followed by Europe and the Asia Pacific. Factors such as the presence of key biopharmaceutical research and development facilities in the region, rising demand for key biopharmaceutical products including monoclonal antibodies, vaccines, gene therapies, and cell therapies, among others are responsible for the largest share of this segment.

Key players in the single-use bioprocessing market include Sartorius AG (Germany), Danaher Corporation (US), Thermo Fisher Scientific, Inc. (US), Merck KGaA (Germany), Avantor, Inc. (US), 3M Company (US), Repligen Corporation (US), Entegris (US), Getinge AB (Sweden), Parker Hannifin Corporation (US), Alfa Laval Corporate AB (Sweden), Saint-Gobain (France), Eppendorf SE (Germany), Corning Incorporated (US), Eaton Corporation plc (Ireland), METTLER TOLEDO (US), Porvair PLC (UK), Lonza (Switzerland), ABEC, INC. (US), NewAge Industries (US), PBS Biotech, Inc. (US), Sentinel Process Systems, Inc. (US), Meissner Filtration Products, Inc. (US), SATAKE MultiMix Corporation (Japan), Hamilton Company (US), Membrane Solutions (US), Cole-Parmer Instrument Company, LLC (US), Distek, Inc. (US), Esco Lifesciences Group Ltd. (US), and TECNIC Bioprocess solutions (Spain).

Scope of the Single Use Bioprocessing Industry:

This report categorizes the single use bioprocessing market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Equipment
  • Single-Use Bioreactor, By Scale Range
    • ≤10 L
    • 11–100 L
    • 101–500 L
    • 501–1,500 L
    • >1,500 L
  • Single-Use Mixing Systems, By Scale
    • Manufacturing Scale
    • Pilot Scale
    • R&D Scale
  • Single-Use Filtration Systems, BY SCALE
    • Manufacturing Scale
    • Pilot Scale
    • R&D Scale
  • Single-Use Chromatography Systems
  • Other Single-Use Systems
• Consumables
  • Single-Use Bags And Containers
    • 2D Single-Use Bags And Containers
    • 3D Single-Use Bags And Containers
  • Single-Use Filters
  • Single-Use Chromatography Columns
  • Single-Use Assemblies
    • Bags Assemblies
    • Bottle Assemblies
    • Filtration Assemblies
    • Mixing System Assemblies
    • Other Single-Use Assemblies
  • Single-Use Sensors
    • Ph Sensors
    • Oxygen Sensors
    • Pressure Sensors
    • Temperature Sensors
    • Conductivity Sensors
    • Flow Sensors
    • Other Single-Use Sensors
  • Other Single-Use Consumables
    • Tubing
    • Connectors
    • Disconnectors
    • Adaptors
    • Valves
• Other Consumables

By Application

• Filtration
• Cell Culture
• Mixing
• Purification
• Storage & Transfer
• Other Applications

By Workflow

• Upstream Bioprocessing
• Downstream Bioprocessing

By Molecule Type

• Monoclonal Antibodies
  • Single-Use Bioreactors
  • Single-Use Filtration Systems
  • Single-Use Chromatography Systems
  • Single-Use Mixing Systems
  • Other Single-Use Systems
  • Single-Use Consumables
• Vaccines
  • Single-Use Bioreactors
  • Single-Use Filtration Systems
  • Single-Use Chromatography Systems
  • Single-Use Mixing Systems
  • Other Single-Use Systems
  • Single-Use Consumables
• Therapeutic Proteins & Peptides
  • Single-Use Bioreactors
  • Single-Use Filtration Systems
  • Single-Use Chromatography Systems
  • Single-Use Mixing Systems
  • Other Single-Use Systems
  • Single-Use Consumables
• Cell & Gene Therapies
  • Single-Use Bioreactors
  • Single-Use Filtration Systems
  • Single-Use Chromatography Systems
  • Single-Use Mixing Systems
  • Other Single-Use Systems
  • Single-Use Consumables

By End User

• Pharmaceutical & Biotechnology Companies
• CMOs & CROs
• Academic & Research Institutes

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific (RoAPAC)
• Latin America
  • Brazil
  • Mexico
  • RoLATAM
• Middle East
  • GCC
    • Saudi Arabia
    • UAE
    • Rest of GCC
  • Rest of Middle East
• Africa

Recent Developments of the Single Use Bioprocessing Industry:

• In April 2024, Cytiva introduced the Xcellerex magnetic mixer, a single-use mixing system in 2,000 and 3,000 L capacities for large-scale mAb, vaccine, and genomic medicine manufacturing processes.
• In April 2023, Merck KGaA launched the Ultimus single-use process container film designed to provide extreme durability and leak resistance for single-use assemblies used for bioprocessing liquid applications.

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