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

List of Tables

The Single Use Assemblies Market was valued at USD 6.70 billion in 2023, expected to reach USD 7.51 billion in 2024, and is projected to grow at a CAGR of 11.48%, to USD 14.35 billion by 2030.

Single Use Assemblies (SUAs) are essential components in bioprocessing, designed for single-use purposes to minimize contamination risks, streamline operations, and enhance flexibility. These assemblies, comprising bag assemblies, filtration assemblies, tubing, and connectors, are crucial for efficient drug and vaccine production, especially in biopharmaceuticals. Their applications range from upstream and downstream processes to storage and transport, driven by the biopharma industry's need to expedite development timelines and achieve regulatory compliance while maintaining sterility and product integrity. The SUA market is expanding due to increasing bioprocessing demands, a rising focus on sustainability, and smaller batch production trends. Growth is further propelled by technological advancements aiding cost-effective, scalable solutions. Additionally, the COVID-19 pandemic underscored the need for flexible manufacturing systems, fostering SUA adoption. Emerging markets and personalized medicine represent significant opportunities as organizations seek to cater to varied demand profiles. Companies can capitalize on these opportunities by investing in innovations such as hybrid systems and improving material recyclability to address environmental concerns. However, the market faces challenges such as cost barriers for small to mid-scale manufacturers, concerns regarding extractables and leachables, and the need for standardization across components. Regulatory hurdles can impede swift implementation, necessitating comprehensive guidelines and validation processes. To navigate these challenges, fostering partnerships with regulatory bodies for developing standardized protocols is recommended, as well as investing in robust testing methodologies that guarantee safety and compliance. Innovations may focus on enhancing the mechanical reliability of SUAs and developing advanced monitoring systems for real-time process control. As the market is characterized by rapid technological evolution, agility is paramount, with R&D geared towards developing customizable assemblies tailored to specific processes. A strategic focus on these areas can help businesses sustain competitive advantage and drive the market forward.

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%

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Single Use Assemblies Market

The Single Use Assemblies Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

Market Drivers
- Rising focus of economies in biosimilar development
- Rising expansion of the pharmaceutical sector with private and public investments
Market Restraints
- Issues related to the disposal of waste upon filtering and production scalability
Market Opportunities
- Continuous advancements and improvements in single-use assemblies
- Increasing development and usage of customized single use assemblies
Market Challenges
- Concerns pertinent to leachables and extractables

Porter's Five Forces: A Strategic Tool for Navigating the Single Use Assemblies Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Single Use Assemblies Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Single Use Assemblies Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Single Use Assemblies Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Single Use Assemblies Market

A detailed market share analysis in the Single Use Assemblies Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Single Use Assemblies Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Single Use Assemblies Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

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

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:

Based on Product, market is studied across Bag Assemblies, Bottle Assemblies, Filtration Assemblies, and Mixing System Assemblies.
Based on Solution, market is studied across Customized Solutions and Standard Solutions.
Based on Application, market is studied across Cell Culture & Mixing, Fill-finish Applications, Filtration, Sampling, and Storage.
Based on End User, market is studied across Academic & Research Institutes, Biopharmaceutical & Pharmaceutical Companies, and Contract Research Organizations & Contract Manufacturing Organizations.
Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

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. Porter's Five Forces Analysis
- 5.3.1. Threat of New Entrants
- 5.3.2. Threat of Substitutes
- 5.3.3. Bargaining Power of Customers
- 5.3.4. Bargaining Power of Suppliers
- 5.3.5. Industry Rivalry
5.4. PESTLE Analysis
- 5.4.1. Political
- 5.4.2. Economic
- 5.4.3. Social
- 5.4.4. Technological
- 5.4.5. Legal
- 5.4.6. Environmental

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

Companies Mentioned

1. DrM, Dr. Mueller AG
2. Compagnie de Saint-Gobain S.A.
3. Repligen Corporation
4. Danaher Corporation
5. Foxx Life Sciences
6. 3M Company
7. Keofitt A/S
8. SaniSure Inc.
9. Dover Corporation
10. GE HealthCare Technologies Inc.
11. Accuflow Systems, Inc.
12. avintos AG
13. Merck KGaA
14. Getinge AB
15. DWK Life Sciences GmbH
16. Entegris, Inc.
17. Ami Polymer Pvt. Ltd.
18. BioPulse Solutions Pvt. Ltd.
19. Trelleborg AB
20. Antylia Scientific
21. Pharsol Ltd.
22. Sartorius AG
23. Romynox B.V.
24. AdvantaPure by NewAge Industries, Inc.
25. Avantor, Inc.
26. Satake Multimix Corporation
27. Cobetter Filtration Group
28. Purity One
29. Colly Flowtech AB
30. Parker-Hannifin Corporation
31. Cellexus Limited
32. Owen Mumford Limited
33. ILC Dover LP
34. Meissner Corporation
35. WHK BioSystems, LLC
36. Single Use Support GmbH
37. BioProcess Engineering Services Limited
38. Distek, Inc.
39. Liquidyne Process Technologies, Inc
40. Thermo Fisher Scientific Inc.
41. DuPont de Nemours, Inc.
42. Corning Incorporated
43. Intellitech, Inc.
44. Lonza Group Ltd.