Single Use Assemblies Market by Product, Solution, Application, End User

List of Tables

[189 Pages Report] The Single Use Assemblies Market size was estimated at USD 6.70 billion in 2023 and expected to reach USD 7.51 billion in 2024, at a CAGR 11.48% to reach USD 14.35 billion by 2030.

Single use assemblies (SUA) are pre-assembled, sterilized, and disposable components utilized in the biopharmaceutical industry to streamline manufacturing processes, reduce cross-contamination risks, and improve operational efficiency. The market comprises various products such as bags, tubing sets, filters, connectors, and aseptic transfer systems. The market is driven by several factors, such as increased adoption of single-use technology in pharmaceutical manufacturing due to its economic benefits, such as reduced capital investment and lower cleaning costs. Additionally, increasing demand for biopharmaceuticals has led manufacturers to focus on improving production efficiency by adopting single-use assembly solutions. However, regulatory concerns due to waste disposal, leachable and extractable, and the vast availability of the multi-use system are lowering the penetration of the single use assemblies market. However, increasing focus on sustainable solutions, including the development of eco-friendly materials and recycling programs, address environmental concerns associated with single use assemblies. Furthermore, developing advanced materials with better mechanical properties, durability, and performance under varying temperatures or pressures has enhanced the efficiency and reliability of single use assemblies.

KEY MARKET STATISTICS
Base Year [2023]	USD 6.70 billion
Estimated Year [2024]	USD 7.51 billion
Forecast Year [2030]	USD 14.35 billion
CAGR (%)	11.48%

Product: Development of single use filtration assemblies in reducing cross-contamination risks and faster turnaround times

Bag assemblies consist of various single-use bags designed for fluid management, storage, and transportation in bioprocessing applications. These bags are made from multiple layers of films and materials, such as ethylene-vinyl acetate (EVA) or polyethylene-based film structures. The selection of bag material often depends on factors such as biocompatibility requirements, gas barrier properties, chemical compatibility, and mechanical strength. Bottle assemblies, similar to bag assemblies but with rigid structures, are used for storing and handling various liquid components involved in the manufacturing process. They are made from plastic materials such as polyethylene terephthalate (PET), polypropylene (PP), and polycarbonate (PC). Bottle assemblies offer advantages such as ease of handling and customization to accommodate specific application requirements, including liquid dispensing systems and sterile vent filters. Filtration assemblies play a crucial role in the purification process by separating contaminants from desired molecules using membrane filters with defined pore sizes. These single-use filtration devices have gained significant popularity due to their reduced risk of cross-contamination compared to traditional stainless-steel systems. Mixing system assemblies are designed to meet various mixing requirements within the bioprocess industry. These systems are vital for media preparation, buffer exchange, and drug product formulation.

Solution: Standard solutions offering accessible and cost-effective alternative for mainstream production processes

Customized solutions are tailored to meet the precise requirements of individual clients or applications. These bespoke products are designed with specific configurations, materials, and components that optimize performance in unique process environments. In many cases, customization is essential for achieving product compatibility with existing equipment or addressing distinctive challenges associated with specialized manufacturing processes. Customized solutions include various options, including custom-manufactured components, bespoke connectors, and application-specific tubing materials. Some key benefits of customized single use assemblies include optimized performance, reduced risk, and streamlining regulatory compliance by aligning more closely with application-specific quality standards and requirements. Standard single use assemblies offer a range of core features suitable for various biopharmaceutical production environments. These off-the-shelf options are designed with general industry requirements, incorporating materials and components that comply with common regulatory standards. Standard solutions typically cater to a broader market segment, offering cost-effective and readily available alternatives to more specialized assemblies. Subcategories within standard solutions encompass ready-to-use filtration assemblies, pre-sterilized disposable bags, and standardized tubing sets.

Application: Increasing demand for single use assemblies in cell culture & mixing to boost vaccine development

Cell culture & mixing primarily focuses on cultivating cells under controlled conditions. Single use assemblies play a key role by simplifying mixing procedures through disposable mixing bags or bioreactors that can be easily replaced without extensive cleaning procedures. Single assemblies are increasingly being used in this field due to their advantages, such as reduced risk of cross-contamination and increased flexibility in scaling up production. The mixing aspect involves combining different components during the manufacturing process. Fill-finish applications involve the aseptic filling of sterile drug products into their final containers, such as vials or syringes. Adopting SUA, such as disposable filling needles and tubing, significantly reduces the risk of product contamination from traditional reusable equipment while improving operational efficiency. Single-use systems minimize downtime between production runs since cleaning and sterilization procedures are eliminated.

Filtration is a critical step within various stages of biopharmaceutical manufacturing, including clarification of cell culture harvests, virus removal, and sterile filtration for purified drug products. Using SUA, such as single-use filter capsules and pre-sterilized disposable filter modules, ensures consistent product quality with reduced risk of cross-contamination and minimized downtime for cleaning and sanitization. The flexibility offered by SUA allows manufacturers to easily scale their filtration processes, catering to the changing market dynamics and production demands. Furthermore, SUA is gaining traction in the sampling domain due to benefits such as the prevention of cross-contamination between samples, reduced labor costs, and simplified workflows. Single-use sampling systems such as pre-sterilized sample bags eliminate the need for cleaning and autoclaving, ensuring rapid turnaround time during processing. In storage applications, SUA provides several advantages where disposable storage bags offer greater flexibility in terms of capacity variations and can be expanded or collapsed according to the volume requirements. They also reduce contamination risks by eliminating the need for cleaning between uses.

End User: Integrating single use assemblies across contract research organizations for quicker processing and process changeover time

In academic and research institutes, single use assemblies are primarily used for sterile fluid transfer, sample preparation, and cell culture applications. These organizations prefer disposable systems due to their lower risk of cross-contamination, reduced cleaning requirements, and shorter turnaround times between experiments. Biopharmaceutical and pharmaceutical companies utilize single use assemblies in various drug development and production processes, such as upstream cell culture, downstream purification, formulation, filling, and storage. The preference for disposable systems stems from their ability to minimize risks associated with product contamination while streamlining operational efficiency through reduced plant downtime and labor costs. CROs and CMOs involved in outsourced drug discovery services employ single use assemblies for drug screening assays or compound library testing as well as clinical trial material production under cGMP conditions. Single use technologies offer these organizations flexibility in accommodating different client requirements and rapid changeovers between projects, mitigating cross-contamination risks, and ensuring regulatory compliance.

Regional Insights

In the Americas region, especially North America, the expansion of the biotechnology and pharmaceutical industries is playing a major role in driving demand for single use assemblies. This expansion is attributed to rising investments in research & development activities, increasing prevalence of chronic diseases, and growing awareness about the benefits of biopharmaceuticals. Additionally, stringent regulatory guidelines promoting safety and environmental sustainability encourage manufacturers to switch from traditional stainless-steel systems to disposable alternatives. Furthermore, across Europe, the market potential is largely driven by rapid advancements in the European biopharmaceutical industry, such as developing new sensors and analytics tools enabling better process monitoring and control in single-use systems. The presence of several leading players, coupled with strong government support for research initiatives, has led to increased adoption of single-use technologies in this region. Moreover, emerging markets such as India and China offer immense growth opportunities due to their expanding bio-manufacturing capabilities. Manufacturers are also focusing on reducing their carbon footprint by adopting greener production methods, which include implementing single use assemblies.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Single Use Assemblies Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Single Use Assemblies Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Single Use Assemblies Market, highlighting leading vendors and their innovative profiles. These include 3M Company, Accuflow Systems, Inc., AdvantaPure by NewAge Industries, Inc., Ami Polymer Pvt. Ltd., Antylia Scientific, Avantor, Inc., avintos AG, BioProcess Engineering Services Limited, BioPulse Solutions Pvt. Ltd., Cellexus Limited, Cobetter Filtration Group, Colly Flowtech AB, Compagnie de Saint-Gobain S.A., Corning Incorporated, Danaher Corporation, Distek, Inc., Dover Corporation, DrM, Dr. Mueller AG, DuPont de Nemours, Inc., DWK Life Sciences GmbH, Entegris, Inc., Foxx Life Sciences, GE HealthCare Technologies Inc., Getinge AB, ILC Dover LP, Intellitech, Inc., Keofitt A/S, Liquidyne Process Technologies, Inc, Lonza Group Ltd., Meissner Corporation, Merck KGaA, Owen Mumford Limited, Parker-Hannifin Corporation, Pharsol Ltd., Purity One, Repligen Corporation, Romynox B.V., SaniSure Inc., Sartorius AG, Satake Multimix Corporation, Single Use Support GmbH, Thermo Fisher Scientific Inc., Trelleborg AB, and WHK BioSystems, LLC.

Market Segmentation & Coverage

This research report categorizes the Single Use Assemblies Market to forecast the revenues and analyze trends in each of the following sub-markets:

Product
- Bag Assemblies
- Bottle Assemblies
- Filtration Assemblies
- Mixing System Assemblies

Solution
- Customized Solutions
- Standard Solutions

Application
- Cell Culture & Mixing
- Fill-finish Applications
- Filtration
- Sampling
- Storage

End User
- Academic & Research Institutes
- Biopharmaceutical & Pharmaceutical Companies
- Contract Research Organizations & Contract Manufacturing Organizations

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Single Use Assemblies Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Single Use Assemblies Market?

3. What are the technology trends and regulatory frameworks in the Single Use Assemblies Market?

4. What is the market share of the leading vendors in the Single Use Assemblies Market?

5. Which modes and strategic moves are suitable for entering the Single Use Assemblies Market?

Product Code: MRR-221461476903

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Rising focus of economies in biosimilar development
  - 5.1.1.2. Rising expansion of the pharmaceutical sector with private and public investments
- 5.1.2. Restraints
  - 5.1.2.1. Issues related to the disposal of waste upon filtering and production scalability
- 5.1.3. Opportunities
  - 5.1.3.1. Continuous advancements and improvements in single-use assemblies
  - 5.1.3.2. Increasing development and usage of customized single use assemblies
- 5.1.4. Challenges
  - 5.1.4.1. Concerns pertinent to leachables and extractables
5.2. Market Segmentation Analysis
- 5.2.1. Product: Development of single use filtration assemblies in reducing cross-contamination risks and faster turnaround times
- 5.2.2. Solution: Standard solutions offering accessible and cost-effective alternative for mainstream production processes
- 5.2.3. Application: Increasing demand for single use assemblies in cell culture & mixing to boost vaccine development
- 5.2.4. End User: Integrating single use assemblies across contract research organizations for quicker processing and process changeover time
5.3. Market Trend Analysis
- 5.3.1. Availability of patents and expansion of single-use assemblies product portfolios in the Americas
- 5.3.2. Expansion of the pharmaceutical industry with increasing single-use assemblies' production facilities in the Asia-Pacific region
- 5.3.3. Presence of significant native market vendors with increasing research & development activities to introduce novel single use assemblies in the EMEA region
5.4. Cumulative Impact of High Inflation
5.5. Porter's Five Forces Analysis
- 5.5.1. Threat of New Entrants
- 5.5.2. Threat of Substitutes
- 5.5.3. Bargaining Power of Customers
- 5.5.4. Bargaining Power of Suppliers
- 5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis

6. Single Use Assemblies Market, by Product

6.1. Introduction
6.2. Bag Assemblies
6.3. Bottle Assemblies
6.4. Filtration Assemblies
6.5. Mixing System Assemblies

7. Single Use Assemblies Market, by Solution

7.1. Introduction
7.2. Customized Solutions
7.3. Standard Solutions

8. Single Use Assemblies Market, by Application

8.1. Introduction
8.2. Cell Culture & Mixing
8.3. Fill-finish Applications
8.4. Filtration
8.5. Sampling
8.6. Storage

9. Single Use Assemblies Market, by End User

9.1. Introduction
9.2. Academic & Research Institutes
9.3. Biopharmaceutical & Pharmaceutical Companies
9.4. Contract Research Organizations & Contract Manufacturing Organizations

10. Americas Single Use Assemblies Market

10.1. Introduction
10.2. Argentina
10.3. Brazil
10.4. Canada
10.5. Mexico
10.6. United States

11. Asia-Pacific Single Use Assemblies Market

11.1. Introduction
11.2. Australia
11.3. China
11.4. India
11.5. Indonesia
11.6. Japan
11.7. Malaysia
11.8. Philippines
11.9. Singapore
11.10. South Korea
11.11. Taiwan
11.12. Thailand
11.13. Vietnam

12. Europe, Middle East & Africa Single Use Assemblies Market

12.1. Introduction
12.2. Denmark
12.3. Egypt
12.4. Finland
12.5. France
12.6. Germany
12.7. Israel
12.8. Italy
12.9. Netherlands
12.10. Nigeria
12.11. Norway
12.12. Poland
12.13. Qatar
12.14. Russia
12.15. Saudi Arabia
12.16. South Africa
12.17. Spain
12.18. Sweden
12.19. Switzerland
12.20. Turkey
12.21. United Arab Emirates
12.22. United Kingdom

13. Competitive Landscape

13.1. Market Share Analysis, 2023
13.2. FPNV Positioning Matrix, 2023
13.3. Competitive Scenario Analysis
- 13.3.1. Repligen Announces Agreement to Acquire Fluid Management Innovator Metenova
- 13.3.2. Qosina Adds OneShot Single-Use Filling Needles from Overlook Industries to Its Bioprocess Components Portfolio
- 13.3.3. Sartorius and Repligen Launch Upstream Processing Intensification System
- 13.3.4. Trelleborg Launches BioPharmaPro Product Line
- 13.3.5. AdvantaPure Launches Single Use Solution for Tubing Management
- 13.3.6. Getinge AB to Acquire High Purity New England, Inc., a Provider of Single-use Solutions for Bioprocessing Applications
- 13.3.7. Merck KGaA Launches Ultimus Film to Offer Superior Strength and Leak Resistance in Single-use Assemblies
- 13.3.8. U.S.-based Foxx Life Sciences to Invest INR 200 Crore in Telangana
- 13.3.9. Thermo Fisher Scientific, Inc. Expands Single-Use Technology in China
- 13.3.10. Merck Invests More than Euro 130 Million to Strengthen Manufacturing Capabilities in Molsheim, France
- 13.3.11. Stevanato Group and Owen Mumford Sign Exclusive Collaboration Agreement for the Innovative Aidaptus Auto-Injector

14. Competitive Portfolio

14.1. Key Company Profiles
14.2. Key Product Portfolio