Overview


According to FutureWise analysis, the Single Use Bioprocess Systems market is estimated to be US$ 29.59 billion in 2023 and is expected to reach US$ 99.18 billion in 2031 at a CAGR of 16.30%.

A single-use bioprocess system represents a paradigm shift in biopharmaceutical manufacturing, introducing a dynamic and efficient approach to producing complex therapeutic molecules. Unlike conventional stainless-steel systems that require extensive cleaning, sterilization, and validation between batches, single-use systems offer a comprehensive solution that embraces disposable, pre-sterilized components for each production cycle. These components include bioreactor bags, tubing sets, connectors, filters, sensors, and disposable chromatography columns. Crafted to cater to specific bioprocessing needs, these components are engineered from materials that ensure the integrity and safety of the final biopharmaceutical product. The advantages of single-use bioprocess systems are multifaceted and impactful. Firstly, their inherent flexibility and rapid deployment empower biopharmaceutical manufacturers to swiftly establish and transition between different production setups, facilitating an agile response to changing market demands. Moreover, eliminating rigorous cleaning and sterilization processes significantly reduces the risk of cross-contamination, assuring the highest product quality and patient safety.

FutureWise Market Research has published a report that provides an insightful analysis of Single Use Bioprocess System Market trends affecting overall market growth. This report will provide a detailed analysis of market share, regional insights, and competitor analysis that includes the stature of key manufacturers operational in this industry.

By the end of the forecast period, FutureWise research analysts project that the Single Use Bioprocess System Market will experience significant growth. According to the analysis, this report will help understand the information referring to the total valuation held by this industry. Additionally, this report will help understand the growth opportunities held by various segments of this market and further assist in making better strategic and expansion decisions by key stakeholders of an organization.

  • Thermo Fisher Scientific Inc.
  • Sartorius Stedim Biotech
  • Danaher Corporation
  • Merck Millipore
  • Parker Hannifin Corp
  • Mettler-Toledo International, Inc.
  • Eppendorf AG
  • Celltainer Biotech B.V.
  • Applikon Biotechnology
  • Cellexus Ltd.

(Note: The list of the major players will be updated with the latest market scenario and trends)

Recent Development in Single Use Bioprocess System Market

  • In April 2023, Boehringer Ingelheim unveiled its state-of-the-art Biologics Development Center in Germany, valued at $386 million. This advanced facility is strategically designed for the production of therapeutic proteins and antibodies and the development of substances intended for clinical trials. Remarkably, the center constitutes more than 50% of the company's extensive research pipeline.
  • Continuing the momentum, Sartorius Stedim Biotech, a prominent global biopharmaceutical company, inked a significant deal in March 2023. The acquisition of Polyplus, amounting to over 2.4 billion euros, marks a pivotal move. Polyplus specializes in developing and manufacturing high-quality transfection and other DNA/RNA delivery reagents, along with plasmid DNA in GMP grade. These components play a crucial role in producing viral vectors indispensable for cutting-edge gene and cell therapies and other innovative therapeutic solutions.

Another noteworthy development in March 2023 comes from Thermo Fisher Scientific, which announced a strategic collaboration enhancement with Arsenal Biosciences. This collaboration has facilitated the creation of efficient manufacturing processes for advanced cancer treatments, mainly focusing on next-generation autologous programmable T cells for combating cancer. This research-driven partnership holds great promise for advancing the landscape of cancer therapy.

By Component

  • Bioreactors
    • Cell Culture Bioreactors
    • Fermentation Bioreactors
  • Mixers
  • Bioprocess Containers
  • Transfer and Storage Bags
  • Sampling Systems
  • Filtration Systems
  • Chromatography Columns
  • Probes and Sensors
  • Tubing Assemblies
  • Connectors and Clamps
  • Filling Systems

By Application

  • Research Development (RD)
  • GMP and Commercial Production

By End User

  • Biopharmaceutical Companies
  • Contract Research Organizations
  • Contract Manufacturing Organizations
  • Research Institutes

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

The market is segmented by region into North America, Latin America, Europe, Asia-Pacific, and Middle East & Africa. North America registered the highest share in the market in 2022. The primary reason for North America's dominant revenue share is its well-developed pharmaceutical and biomanufacturing sector, along with extensive research and development endeavors. Additionally, the surge in demand for single-use bioprocessing equipment is propelled by a growing emphasis on manufacturing vaccines to bolster disease prevention measures in the region. Furthermore, the Bio-process System Alliance (BPSA) presence in North America, with its goal of promoting the use of single-use technologies, is anticipated to provide an extra boost to the sales of disposable systems in the area.

Moreover, by application, GMP and Commercial production accounted for more than 70% share, and by component, bioreactors held more than 43% share globally in 2022. Additionally, by end-user, biopharmaceutical companies accounted for more than 52% share. Amongst the end-user segment, the biopharmaceutical company is poised for substantial growth over the forecast period, which is attributed to various factors, including the rigorous adoption of single-use technologies and systems due to their associated advantages. These advantages encompass reduced initial investment and research and development costs, economical labor and material expenses, and convenient disposability, outperforming conventional bioprocessing methods. Moreover, this positive trajectory drives the growing demand for biologics and heightened company activities.

Drivers for Single Use Bioprocess System Market

The adoption and growth of single-use bioprocess systems are propelled by various pivotal drivers that have reshaped the biopharmaceutical manufacturing landscape. These drivers underscore the advantages, progressions, and evolving demands within the industry, collectively contributing to the escalating prominence of single-use technologies. Notably, the unparalleled flexibility of single-use systems empowers biopharmaceutical manufacturers to establish swiftly and transition between diverse production setups. This dynamic agility proves indispensable for promptly responding to shifting market demands, expediting process development, and ensuring the timely creation of innovative therapies. The inherent disposability of single-use components significantly mitigates the risk of cross-contamination between batches, reinforcing the preservation of product integrity and patient safety, which are paramount in biopharmaceutical manufacturing. Moreover, the streamlined setup, assembly, and disassembly of single-use components yield notable time savings, reducing downtime, heightened production efficiency, and accelerated time-to-market for novel treatments.

Restraints for Single Use Bioprocess System Market

The adoption and growth of single-use bioprocess systems come with various constraints and challenges that necessitate thoughtful consideration within biopharmaceutical manufacturing. These limitations emphasize the importance of meticulous planning, inventive solutions, and strategic oversight. Among the foremost restraints encountered in embracing single-use systems is cost. While these systems offer cost efficiencies in specific dimensions, particularly in resource-intensive cleaning and sterilization, the cumulative expenses associated with disposable components can become substantial, especially in large-scale manufacturing. This financial dynamic can pose a significant hurdle, particularly for entities engaged in high-volume production. Furthermore, the environmental implications warrant prudent examination. Although single-use systems hold promise in curbing water and energy consumption, the disposability of components contributes to heightened waste generation. The intricate considerations surrounding disposable plastics and the intricacies of waste management underscore the need for a comprehensive approach to minimizing environmental impact.

Opportunities for Single Use Bioprocess System Market

Within biopharmaceutical manufacturing, many opportunities beckon for the ongoing expansion and advancement of single-use bioprocess systems. These prospects are rooted in the industry's evolving demands, the continuous march of technological innovations, and the broader context of healthcare. By embracing these opportunities, the potential exists to reshape the production paradigms and elevate the efficacy of therapeutic development. Among the key avenues to explore is the acceleration of research and development endeavors facilitated by single-use systems' cost-effective and agile testing and optimization capabilities. Moreover, in regions where healthcare infrastructure is burgeoning, these systems present a pragmatic solution, bypassing the need for extensive facility investments and expediting the establishment of biomanufacturing capabilities, thus enhancing access to critical therapies. The horizon also encompasses continuous manufacturing and intensified processes, where single-use systems simplify the complexities inherent in constant processing, ultimately improving overall efficiency. Not to be overlooked is the seamless integration of cutting-edge sensor technology, automation, and data analytics into single-use systems, a fusion that promises real-time monitoring, stringent quality control, and meticulous process optimization, culminating in heightened efficiency and the assurance of exceptional product quality.

Trends for Single Use Bioprocess System Market

The landscape of single-use bioprocess systems is in a constant state of evolution, propelled by significant trends that are shaping the future of biopharmaceutical manufacturing. These trends, driven by technological advancements, shifting industry dynamics, and evolving healthcare needs, are driving the transformation of single-use systems. Key among these trends is the integration of cutting-edge technologies like advanced sensors, automation, and real-time monitoring, which augment the capabilities of single-use systems by enabling precise control, improved process monitoring, and data-driven decision-making. Another pivotal trend is the growing emphasis on customization and modularity, allowing biopharmaceutical manufacturers to tailor single-use systems to specific process requirements, enhancing flexibility and adaptability. Moreover, the industry's focus on process standardization and digitalization, exemplified by initiatives such as Process Analytical Technology (PAT) and data exchange standards like the Bioprocessing Equipment (BPE) standard, is playing a pivotal role in influencing the development of single-use systems, aimed at fostering greater interoperability, data sharing, and overall process efficiency.

  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants

  • FutureWise research report will help you understand the growth prospects, key trends, and data points affecting the market's growth.
  • A detailed review of strategies being opted by the players in this market, and a thorough market share registered by the key companies globally as well as on a regional basis.

  • To provide with an exhaustive analysis on the of Single Use Bioprocess System Market By Component, By Application, By End User and By Region.
  • To cater comprehensive insights on factors such as drivers, restraints, trends, opportunity, and additionally segmental and regional factors impacting market growth.
  • To evaluate current market trends and forecast micro-markets and the overall market projections which are represented in the format of data-sets and ppt.
  • To predict the market size, in key regions— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  • To provide information on competitors which includes landscape mapping, technological advancements, R&D spending, news concerning strategic alliances, and new product launches.

  • We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
  • The customization Mobility Care offered are free of charge with purchase of any license of the report
  • You can directly share your requirements/changes to the current table of content to: sales@futurewiseresearch.com

Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1. Years Considered for the Study
         3.2. Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders
  • 2.   Research Methodology
    •   1. Research Data
         1.1. Secondary Data
          1.1.1. Key Data from Secondary Sources
         1.2. Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study
  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Global Single Use Bioprocess System Market Variables, Trends and Scope
    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Single Use Bioprocess System Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Single Use Bioprocess System Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Single Use Bioprocess System Market, By Component Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Bioreactors
         1.1. Cell Culture Bioreactors
         1.2. Fermentation Bioreactors
        2. Mixers
        3. Bioprocess Containers
        4. Transfer and Storage Bags
        5. Sampling Systems
        6. Filtration Systems
        7. Chromatography Columns
        8. Probes & Sensors
        9. Tubing Assemblies
          10. Connectors & Clamps
          11. Filling Systems

  • 8.   Global Single Use Bioprocess System Market, By Application Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Research Development (RD)
        2. GMP and Commercial Production

  • 9.   Global Single Use Bioprocess System Market, By End User Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Biopharmaceutical Companies
        2. Contract Research Organizations
        3. Contract Manufacturing Organizations
        4. Research Institutes

  • 10.   North America Single Use Bioprocess System Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2023-2031

  • 11.   Latin America Single Use Bioprocess System Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2023-2031

  • 12.   Europe Single Use Bioprocess System Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2023-2031

  • 13.   Asia Pacific Single Use Bioprocess System Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2023-2031

  • 14.   Middle East and Africa Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2023-2031

  • 15.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 16.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)
    •   1. Thermo Fisher Scientific Inc.
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. Sartorius Stedim Biotech
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Danaher Corporation
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. Merck Millipore
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. Parker Hannifin Corp
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. Mettler-Toledo International, Inc.
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. Eppendorf AG
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. Celltainer Biotech B.V.
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9. Applikon Biotechnology
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview
        10. Cellexus Ltd.
         10.1. Company Overview
         10.2. Product Portfolio
         10.3. SWOT Analysis
         10.4. Financial Overview
         10.5. Strategic Overview

  • 17.   Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the healthcare regulations initiated by Danaher Corporationinistrations
        5. The overall economic slowdown of the developing and developed nations
  • 18.   FutureWise SME Key Takeaway Points for Client

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