Global Single-Use Bioprocessing Market was Valued at USD 9.88 Bn in 2022, with an Estimated CAGR of 20.5% (2023- 2031)

Single-use bioprocessing has recently experienced a significant increase in biopharmaceutical manufacturing market share, as well as technical advancements ranging from material properties to Industry 4.0 application. Single-use bioprocessing is a new concept in biopharmaceutical production. A significant number of biomanufacturing process steps in biopharmaceutical companies’ facilities are expected to be transformed by single-use bioprocessing. There is a huge potential for making processes more cost-effective due to the simplicity and customization of several components of bioprocessing technology, as well as the decrease of cost-of-goods.

Global Single-Use Bioprocessing Market Revenue & Forecast, (US$ Million), 2015 – 2031

Due to the speed, flexibility, and cheaper capital investment that single-use process solutions and facilities enable, demand for them surged dramatically during the Covid-19 pandemic. End users and suppliers were concerned about continuing and potential shortages due to a rise in single-use product demand; also, there is a worldwide shortage of several important high-purity polymers, creating increasing delays in production. In a recent poll, 75% of biopharma respondents and 70% of supplier respondents cited a lack of single-use systems and other supply concerns as a significant worry in bioprocessing following Covid-19. Thus to overcome this the market participants are highly looking forward to expand their presence in the various regions.

Global Single-Use Bioprocessing Market Challenges

Uncertainties about regulatory acceptability and regards about plastics safety are prominent hurdles for the single-use bioprocessing market. These obstacles must be solved in order for such technology to be extensively used in commercial GMP production. Many of the plastics now utilised in the manufacture of single-use equipment are decades-old legacy polymers that have long been employed in the manufacture of medical devices (including implants) and pharmaceutical packaging. Current SUT plastics are not hazardous. However, they frequently lack recent research and assessments that are appropriate and relevant for biopharmaceutical manufacturing applications, testing that regulators may need. Thus to overcome these challenges requires collaboration among industry stakeholders, continuous technological advancements, regulatory alignment for the further growth of the global single-use bioprocessing market.

Report Coverage and Deliverables

Global Single-Use Bioprocessing Market Growth Factors

A move towards single-use bioprocessing has increased production agility and flexibility. The development of single-use systems has also provided a solid platform for improving the manufacture of a variety of biopharmaceuticals, including mRNA, allogeneic cell treatments, and viral-vectored gene therapies. Single-use bioprocessing systems enable quick and flexible scale-up of production, allowing biopharmaceutical companies to respond to market demands and changing production needs efficiently. Furthermore as global outsourcing and contract manufacturing increase, single-use bioprocessing systems provide an adaptable and cost-effective solution for manufacturing various biopharmaceutical products. Thus these factors will all contribute to the overall growth of the global single-use bioprocessing market.

Single-use or disposable bioprocessing equipment is now used for 85% of pre-commercial scale, i.e., preclinical and clinical, biopharmaceutical production, and is growing in popularity for commercial products manufacturing. With single-use (disposable) bioprocessing systems currently dominating the pre-commercial market and a trend towards greater adoption for commercial scale manufacturing, single-use will soon dominate much of biopharmaceutical manufacturing. Most commercial biopharmaceutical manufacturing, especially of high-volume products, will continue to employ fixed stainless steel systems since they are frequently more cost-effective at large volumes. However, single-use facility will come to dominate bioprocessing in terms of the number of facilities, process lines, the work of bioprocessing specialists, and the amount of products made, particularly at clinical sizes.

In recent years, the biopharmaceutical business has seen substantial expansion, diversity, and advancements, particularly in the field of cell and gene therapies (CGT). Cell and gene therapies (CGTs) hold enormous potential in the battle against previously incurable illnesses. Scaling up cell and gene therapies from development and research to commercialization has presented manufacturers with a new set of challenges in recent years. With the pressing need to accelerate the market reach of these life-changing new medications, there is a substantial danger of implementing wasteful workflow methods. Single-use solutions continue to be successful ways for effectively scaling up these processes while lowering risks and costs.

The dynamic nature of the biopharmaceutical industry requires continuous process innovation. North America is a major hub for the biopharmaceutical industry, with a significant number of biotech companies, pharmaceutical giants, and research institutions. As the market for biopharmaceuticals continues to grow, the demand for efficient and flexible manufacturing processes like single-use bioprocessing has increased. As the industry evolves and technology continues to improve, it’s likely that single-use bioprocessing will continue to play a pivotal role in shaping the future of single-use bioprocessing market in the region.

Competitive Landscape

The report also offers extensive research on the key players in the global single-use bioprocessing market and details on the competitiveness of these players. The competitive landscape is characterized by partnerships, joint ventures, mergers and acquisitions, and collaborations aimed at accelerating the development and deployment of single-use bioprocessing. The competitive landscape for single-use bioprocessing technologies is likely to evolve with new entrants, technological advancements, and increasing market demand.

Key players operating in the global single-use bioprocessing market are

• AGILITECH
• Avantor, Inc.
• COLDER PRODUCTS COMPANY
• Corning Incorporated
• Cytiva
• Entegris
• Eppendorf SE
• GE Healthcare
• Kuhner AG
• Lonza
• Meissner Filtration Products, Inc.
• Merck KGaA
• PBS Biotech, Inc.
• Sanisure
• Sartorius AG
• Thermo Fisher Scientific, Inc.
• Other Industry Participants

Global Single-Use Bioprocessing Market Report Coverage

Global Single-Use Bioprocessing Market

By Products

• Disposable bioreactors
• Mixers
• Containers
• Tubing
• Connectors
• Sampling systems
• Purification devices and columns
• Probes/sensors
• Others

By Workflow

• Upstream Bioprocessing
• Downstream Bioprocessing

By Application

• Monoclonal Antibody Production
• Vaccine Production
• Cell Therapy Manufacturing
• Gene Therapy Manufacturing
• Microbial Fermentation
• Viral Vector Production
• Others

By End Users

• Biopharmaceutical Companies
• Contract Manufacturing Organizations (CMOs)
• Research and Academic Institutes
• Others

By Region

• North America (U.S., Canada, Mexico, Rest of North America)
• Europe (France, The UK, Spain, Germany, Italy, Nordic Countries (Denmark, Finland, Iceland, Sweden, Norway), Benelux Union (Belgium, The Netherlands, Luxembourg), Rest of Europe)
• Asia Pacific (China, Japan, India, New Zealand, Australia, South Korea, Southeast Asia (Indonesia, Thailand, Malaysia, Singapore, Rest of Southeast Asia), Rest of Asia Pacific)
• Middle East & Africa (Saudi Arabia, UAE, Egypt, Kuwait, South Africa, Rest of Middle East & Africa)
• Latin America (Brazil, Argentina, Rest of Latin America)

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Table of Contents

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Note: This ToC is tentative and can be changed according to the research study conducted during the course of report completion.

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**Exclusive for Multi-User and Enterprise User.

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Global Single-Use Bioprocessing Market Segmentation

By Products

By Workflow

By Application

By End Users

By Region

**Note: The report covers cross-segmentation analysis by region further into countries

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The Niche Research approach encompasses both primary and secondary research methods to provide comprehensive insights. While primary research is the cornerstone of our studies, we also incorporate secondary research sources such as company annual reports, premium industry databases, press releases, industry journals, and white papers.

Within our primary research, we actively engage with various industry stakeholders, conducting paid interviews and surveys. Our meticulous analysis extends to every market participant in major countries, allowing us to thoroughly examine their portfolios, calculate market shares, and segment revenues.

Our data collection primarily focuses on individual countries within our research scope, enabling us to estimate regional market sizes. Typically, we employ a bottom-up approach, meticulously tracking trends in different countries. We analyze growth drivers, constraints, technological innovations, and opportunities for each country, ultimately arriving at regional figures.Our process begins by examining the growth prospects of each country. Building upon these insights, we project growth and trends for the entire region. Finally, we utilize our proprietary model to refine estimations and forecasts.

Our data validation standards are integral to ensuring the reliability and accuracy of our research findings. Here’s a breakdown of our data validation processes and the stakeholders we engage with during our primary research:

• Supply Side Analysis: We initiate a supply side analysis by directly contacting market participants, through telephonic interviews and questionnaires containing both open-ended and close-ended questions. We gather information on their portfolios, segment revenues, developments, and growth strategies.
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The forecasts we provide are based on a comprehensive assessment of various factors, including:

• Market Trends and Past Performance (Last Five Years): We accurately analyze market trends and performance data from preceding five years to identify historical patterns and understand the market’s evolution.
• Historical Performance and Growth of Market Participants: We assess the historical performance and growth trajectories of key market participants. This analysis provides insights into the competitive landscape and individual company strategies.
• Market Determinants Impact Analysis (Next Eight Years): We conduct a rigorous analysis of the factors that are projected to influence the market over the next eight years. This includes assessing both internal and external determinants that can shape market dynamics.
• Drivers and Challenges for the Forecast Period:Identify the factors expected to drive market growth during the forecast period, as well as the challenges that the industry may face. This analysis aids in deriving an accurate growth rate projection.
• New Acquisitions, Collaborations, or Partnerships: We keep a close watch on any new acquisitions, collaborations, or partnerships within the industry. These developments can have a significant impact on market dynamics and competitiveness.
• Macro and Micro Factors Analysis:A thorough examination of both macro-level factors (e.g., economic trends, regulatory changes) and micro-level factors (e.g., technological advancements, consumer preferences) that may influence the market during the forecast period.
• End-User Sentiment Analysis: To understand the market from the end-user perspective, we conduct sentiment analysis. This involves assessing the sentiment, preferences, and feedback of the end-users, which can provide valuable insights into market trends.
• Perspective of Primary Participants: Insights gathered directly from primary research participants play a crucial role in shaping our forecasts. Their perspectives and experiences provide valuable qualitative data.
• Year-on-Year Growth Trend: We utilize a year-on-year growth trend based on historical market growth and expected future trends. This helps in formulating our growth projections, aligning them with the market’s historical performance.

Research process adopted by TNR involves multiple stages, including data collection, validation, quality checks, and presentation. It’s crucial that the data and information we provide add value to your existing market understanding and expertise. We have also established partnerships with business consulting, research, and survey organizations across regions and globally to collaborate on regional analysis and data validation, ensuring the highest level of accuracy and reliability in our reports.