Single-Use Assemblies Market Projected to Reach USD 58.83 Billion by 2034, Expanding at a CAGR of 16.5%

The global single-use assemblies market is expected to gain market growth during the forecast period of 2025-2034. Polaris Market Research analyses the market to account for USD 58.83 billion by 2034 and is expected to register a CAGR of 16.5% in the above-mentioned forecast period. The market was valued at USD 12.80 billion in 2024.

Market Overview:
A single-use assembly is a solution designed for bioprocessing that can either be custom designed or pre-made as a single-use flow path for particular procedures or unit functions for biotech and biopharmaceutical firms. Whether it is inceptive drug detection or extensive drug production, a unique assembly can be created for that particular application and in the required quantity. With countless component variations, applications can span from tangential flow filtration (TFF) to chromatography.

There are several procedures and applications of biopharmaceutical manufacturing that may involve single-use assemblies, including lab and drug detection, cell cultivation, upstream processing and downstream bioprocessing, vaccine production, patient conveyance system, fill and finish, and more. Cell and gene therapy, an increasingly fast-growing area of biotechnology, also requires single-use assemblies.

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Market Drivers:
Growing Usage in Biopharmaceuticals: Biopharmaceuticals that include vaccines, monoclonal antibodies, and recombinant proteins, need excessively regulated and sterile production environments. Single-use assemblies offer an efficient solution to meet these strict needs by reducing the risk of contamination and ensuring product integritys. As per the Biotechnology Innovation Organization, the biopharmaceutical sector has developed speedily, with biologics displaying 46% of the aggregate US prescription drug market by sales in 2021, driving up the single-use assemblies market demand.

Cost Effectiveness: Conventional stainless steel systems need thorough cleaning, sterilization, and verification, causing excessive functional prices and downtime. Single-use systems discard these needs, notably decreasing cleaning and sustenance costs.

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Key Contenders:
Tactical alliances and partnerships in biopharmaceutical firms and contract manufacturing organizations are driving market reach. Key companies are mentioned below:
• 3M Company
• Becton, Dickinson and Company
• Bio-Rad Laboratories, Inc.
• Danaher Corporation
• Eppendorf AG
• GE Healthcare Life Sciences
• Koch Membrane Systems, Inc.
• Lonza Group
• Merck KGaA, Darmstadt, Germany
• Pall Corporation
• Repligen Corporation
• Saint-Gobain Performance Plastics
• Sartorius Stedim Biotech S.A.
• Thermo Fisher Scientific Inc.
• Waters Corporation

Single-Use Assemblies Industry Developments:
• September 2024: MilliporeSigma introduced a new single-use reactor designed to accelerate the manufacturing process of antibody-drug conjugates, enhancing production efficiency in the biopharmaceutical industry.

• July 2023: Sartorius Stedim Biotech completed its acquisition of Polyplus, a company specializing in technologies for cell and gene therapies. This strategic acquisition aims to expand Sartorius Stedim Biotech's portfolio, particularly in the field of gene therapies and gene-modified cell therapies.

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Segment Categorization:
The report includes segmentation of the single-use assemblies market based on product, application, end users, and region. Based on product, the bag assemblies segment holds the largest market share due to extensive application in biopharmaceutical manufacturing for the repository, mixing, and conveyance of crucial fluids.

Based on application, the filtration segment holds the largest market share due to its important part in ensuring the sterility and integrity of biopharmaceutical products.

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By Product Outlook
• Bag Assemblies
• Filtration Assemblies
• Bottle Assemblies
• Tubing Assemblies
• Others

By Application Outlook
• Filtration
• Cell Culture & Mixing
• Storage
• Sampling
• Fill-finish Applications
• Others

By End Users Outlook
• Biopharmaceutical & Pharmaceutical Companies
• CROs & CMOs
• Academic & Research Institutes

Regional Perspective:
• North America
o US
o Canada

• Europe
o Germany
o France
o UK
o Italy
o Spain
o Netherlands
o Russia
o Rest of Europe

• Asia Pacific
o China
o Japan
o India
o Malaysia
o South Korea
o Indonesia
o Australia
o Vietnam
o Rest of Asia Pacific

• Middle East & Africa
o Saudi Arabia
o UAE
o Israel
o South Africa
o Rest of Middle East & Africa

• Latin America
o Mexico
o Brazil
o Argentina
o Rest of Latin America

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