Global Single Use Assemblies Market - 2024-2031

Overview

Global Single Use Assemblies Market reached US$ 4.2 billion in 2023 and is expected to reach US$ 9.8 billion by 2031, growing at a CAGR of 11.2% during the forecast period 2024-2031.

Single Use Assemblies are pre-assembled fluid management solutions used in biopharmaceutical and biotechnology industries. They consist of components like tubing, connectors, filters, and storage bags, designed for single use to minimize contamination risks, reduce cleaning and validation requirements, and enhance process flexibility. They offer cost savings, reduced downtime, and increased operational efficiency, especially in biologics production, cell and gene therapy, and vaccine manufacturing, where sterility is crucial.

Market Dynamics: Drivers & Restraints

Rise of advancements in single use assemblies

The global single-use assemblies market is witnessing a surge in the development of technologically advanced products, offering streamlined workflows, portability, and rapid implementation. This trend has led to the creation of affordable, innovative, integrated, and ready-to-implement single-use assemblies, which are expected to experience significant demand growth, particularly in mature markets with high adoption rates.

For instance, in April 2023, Merck has announced the launch of its Ultimus Single-Use Process Container Film, designed to provide extreme durability and leak resistance for single use assemblies used for bioprocessing liquid applications.

Bag leaks have long been a top pain point for biomanufacturers, with the cost of a single leak ranging from € 45,000 to € 511,000. To protect against such leaks, abrasions, tears, and material fatigue, Ultimus film is designed with a proprietary woven nylon structure and provides enhanced bag strength, improved durability, and resilience.

Regulatory hurdles

The global single use assemblies market faces several challenges, including high costs, disposal concerns, environmental impact, regulatory hurdles, and potential limitations in large-scale operations or viscous fluid processes. The initial investment in single-use technologies is substantial, especially for smaller biopharmaceutical companies and startups. Additionally, concerns about disposal and environmental impact of single-use plastics, as well as regulatory hurdles related to material validation, extractables, and leachables testing, further limit widespread adoption.

Segment Analysis

The global single use assemblies market is segmented based on product type, solution, application, end user and region.

The bag assemblies from the product type segment accounted for approximately 41.3% of the single use assemblies market share

The bag assemblies from the product type segment accounted for approximately 41.3%. Bag assemblies are crucial components in the global Single Use Assemblies Market, used for fluid storage, mixing, and transfer in bioprocessing applications. These pre-sterilized, disposable bags are available in various sizes and configurations to meet specific needs. They reduce cross-contamination risk and cleaning and validation efforts, making them essential in regulated industries like biopharmaceuticals. Their flexibility, ease of integration, and ability to scale from research to full production make them integral to single-use technologies, particularly in biologics and vaccine manufacturing.

Geographical Analysis

North America is estimated to hold about 38.4% of the total market share throughout the forecast period

North America is estimated to hold about 38.4% of the total market share throughout the forecast period due to growth in the biotechnology and pharmaceutical industries, advancement in products, and increasing incidence of diseases such as cancer coupled with investments and funding in drug discovery research.

For instance, in April 2024, Watson-Marlow Fluid Technology Solutions (WMFTS), a manufacturer of peristaltic pumps and associated fluid path technologies, announced the launch of WMArchitect, a range of flexible, single-use solutions for biopharmaceutical fluid management. The platform builds on predecessors such as puresu and asepticsu and is designed to streamline a biopharma company's process, safeguard product, and reduce regulatory burden.

Market Segmentation

By Product Type

• Bag Assemblies
• Filtration assemblies
• Bottle Assemblies
• Mixing systems
• Others

By Solution

• Standard Solution
• Customized solution
• Others

By Application

• Purification and filtration
• Aseptic transfer
• Cell culture and mixing
• Storage
• Sampling
• Formulation and fill finish

By End User

• Pharmaceutical and Biopharmaceutical companies
• Academic and research institutes
• CROs and CMOs
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

The major global players in the market include Therma Fisher Scientific, Inc, Merck KgaA, Sartorius AG, Danahar Corporation, Avantor, Saint Gobain, Entegris, Parker Haniffn Corp, Intellitech, Inc, Antylia Scientific among others.

Key Developments

• In August 2023, Trelleborg Healthcare and Medical launched the BioPharmaPro family of advanced products and services for fluid path single-use equipment to boost the development of advanced therapies.
• In April 2023, Merck KGaA launched Ultimus, a SU process container film, to provide superior strength & leak resistance in single-use assemblies. In April 2022, Thermo Fisher Scientific developed a new SU manufacturing site in Utah, U.S. With this Utah facility, (part of the USD 650 Billion multi-year expansion plan), the company envisions providing bioprocessing solutions at even inland locations.

Why Purchase the Report?

• To visualize the global single-use assemblies market segmentation based on product type, solution, application, end user, and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of the single-use assemblies market level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global single use assemblies market report would provide approximately 64 tables, 61 figures and 186 pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies