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North America Single-Use Bio-Processing Systems Market

North America Single-Use Bio-Processing Systems Market By Type (Single-Use Bioreactors, Single-Use Mixers, Single-Use Bags, Single-Use Connectors, Others); By Application (Research & Development, Manufacturing, Process Development, Commercial Production, Others); By End-User (Pharmaceutical & Biotechnology Companies, Contract Research Organizations (CROs), Academic & Research Institutes, Contract Manufacturing Organizations (CMOs), Others) – Growth, Share, Opportunities & Competitive Analysis, 2024 – 2032

Summary
Table Of Content

REPORT ATTRIBUTE	DETAILS
Historical Period	2020-2023
Base Year	2024
Forecast Period	2025-2032
North America Single-Use Bio-Processing Systems Market Size 2023	USD 6,077.11 million
North America Single-Use Bio-Processing Systems Market, CGR	16.14%
North America Single-Use Bio-Processing Systems Market Size 2032	USD 20,110.11 million

Market Overview

North America Single-Use Bio-Processing Systems market size was valued at USD 6,077.11 million in 2024 and is anticipated to reach USD 20,110.11 million by 2032, at a CAGR of 16.14% during the forecast period (2024-2032).

The North America Single-Use Bio-Processing Systems market is driven by the growing demand for biopharmaceuticals and the need for cost-effective, flexible manufacturing solutions. These systems offer significant advantages, including reduced risk of cross-contamination, lower capital investment, and faster production times, making them highly attractive to biopharma companies. The shift toward personalized medicine and biologics production further boosts market growth, as single-use systems enable more scalable and adaptable operations. Technological advancements, such as improvements in sensor integration and automation, are enhancing system performance and efficiency. Additionally, the trend toward sustainability in manufacturing, driven by environmental concerns and regulatory pressures, is pushing the adoption of these systems due to their reduced environmental footprint. These factors, coupled with the ongoing development of new therapeutic modalities, are fueling the continued expansion of the single-use bio-processing systems market in North America.

The North America Single-Use Bio-Processing Systems market demonstrates strong geographical presence across the United States, Canada, and Mexico, driven by advancements in biopharmaceutical manufacturing and supportive regulatory environments. The U.S. leads in terms of technological adoption, research capabilities, and the presence of major biopharma hubs, while Canada and Mexico are emerging markets with growing investments in biotechnology infrastructure and production capacity. Key players shaping the competitive landscape include Thermo Fisher Scientific Inc., Danaher Corporation, Pall Corporation, Corning Incorporated, and Repligen Corporation, among others. These companies are actively involved in product innovation, strategic partnerships, and expansion efforts to meet rising demand for flexible and efficient bioprocessing solutions. Their continuous focus on R&D, sustainability, and automation further drives market evolution. With growing emphasis on personalized medicine and biologics, the regional market is well-positioned for sustained growth and technological advancement in the years ahead.

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Market Insights

The North America Single-Use Bio-Processing Systems market was valued at USD 6,077.11 million in 2024 and is projected to reach USD 20,110.11 million by 2032, growing at a CAGR of 16.14%.

The global single-use bio-processing systems market was valued at USD 17,326.05 million in 2024 and is projected to reach USD 57,663.39 million by 2032, growing at a CAGR of 16.22% from 2024 to 2032.

Growing demand for biologics and personalized therapies is driving rapid adoption of single-use technologies in biopharmaceutical manufacturing.
Increasing preference for flexible, cost-effective, and contamination-free solutions supports the shift from traditional stainless-steel systems to disposable systems.
Integration of automation, AI, and sensor technologies is improving process efficiency and boosting adoption across various stages of bioproduction.
Leading companies such as Thermo Fisher Scientific, Danaher Corporation, and Pall Corporation are competing through innovation and strategic partnerships.
Material durability issues and concerns over extractables and leachables present ongoing challenges in widespread system adoption.
The U.S. dominates the regional market, while Canada and Mexico are emerging as key growth areas with expanding biopharma capabilities.

Report Scope

This report segments the North America Single-Use Bio-Processing Systems Market as follows:

Market Drivers

Increasing Demand for Biopharmaceuticals

The rising demand for biopharmaceuticals, driven by the growing prevalence of chronic diseases and the expanding biologics market, is one of the primary drivers of the North American single-use bio-processing systems market. As biopharma companies continue to develop new therapies, particularly biologics and biosimilars, they require more efficient and flexible manufacturing solutions. For instance, the U.S. Food and Drug Administration (FDA) has reported a significant increase in biologics approvals, reflecting the growing demand for advanced therapies in the region. Single-use bio-processing systems offer a high degree of scalability, enabling manufacturers to meet the increasing demand for these complex drugs. The ability to rapidly scale production without the need for significant capital investment or infrastructure changes makes single-use systems an attractive option, accelerating their adoption in biopharma manufacturing.

Technological Advancements and Automation

Advancements in sensor technology, process monitoring, and automation are significantly improving the performance and efficiency of single-use bio-processing systems. With the integration of sophisticated sensors and real-time data collection, manufacturers can monitor various parameters, such as temperature, pressure, and pH, throughout the bio-processing cycle. For instance, American Pharmaceutical Review reports that automation and AI-driven digitalization are improving efficiency and regulatory compliance in North American biomanufacturing. This enhanced level of control improves the consistency and quality of the final product, which is crucial in biologics production. Moreover, automation of various bio-processing stages, from media preparation to cell culture and filtration, has further streamlined operations. These technological advancements are helping to reduce human error, increase process repeatability, and drive overall efficiency, contributing to the growing popularity and adoption of single-use systems in the North American market.

Cost-Effectiveness and Flexibility

Single-use bio-processing systems provide biopharma manufacturers with substantial cost savings and greater operational flexibility. Traditional stainless steel systems require significant upfront capital investment, complex cleaning and sterilization procedures, and more extended downtime between production runs. In contrast, single-use systems are pre-sterilized and disposable, reducing the need for cleaning, validation, and maintenance. This leads to lower operational costs, faster turnaround times, and increased throughput. Furthermore, single-use systems are ideal for smaller batch production, allowing manufacturers to adapt to fluctuating market demands and optimize production processes without large-scale investments in fixed infrastructure. The cost-effectiveness and operational flexibility of single-use systems have made them a preferred choice, driving growth in the market.

Sustainability and Environmental Considerations

Sustainability has become a critical factor in the adoption of single-use bio-processing systems in North America. Traditional bioprocessing systems, particularly those that require the use of stainless steel tanks and complex cleaning procedures, have a larger environmental footprint due to energy consumption and water usage for cleaning. In contrast, single-use systems reduce waste and environmental impact, as they do not require cleaning or sterilization between production runs. The shift toward more sustainable manufacturing practices in the biopharma industry is being driven by growing environmental concerns, regulatory pressures, and the increasing demand for greener, more efficient processes. As a result, single-use bio-processing systems are gaining traction as an eco-friendly alternative, further propelling their adoption in the North American market.

Market Trends

Growth of Personalized Medicine

A prominent trend in the North American single-use bio-processing systems market is the rise of personalized medicine. As personalized therapies, including gene therapies and cell-based treatments, become more prevalent, the need for flexible and scalable manufacturing solutions grows. For instance, the U.S. Food and Drug Administration (FDA) has reported a significant increase in approvals for gene and cell therapies, reflecting the growing demand for personalized medicine. Single-use bio-processing systems offer the required agility for smaller batch production and the ability to quickly adjust to specific patient needs. These systems allow for efficient and cost-effective production of personalized drugs, enabling biopharma companies to meet the increasing demand for tailored treatments. This trend towards precision medicine is expected to continue driving the adoption of single-use systems, particularly in clinical trial and small-scale production environments.

Regulatory Advancements and Industry Standardization

Regulatory advancements and increased standardization in the biopharma industry are shaping the adoption of single-use bio-processing systems. In North America, regulatory agencies such as the FDA and EMA are increasingly providing clear guidelines and frameworks for the use of single-use technologies in biopharmaceutical manufacturing. For instance, the FDA has issued updated guidance on single-use bioprocessing systems, emphasizing safety, quality, and contamination control. These regulations are helping to address safety, quality, and performance concerns while encouraging the adoption of single-use systems. Furthermore, the industry is moving toward greater standardization in system components and workflows, making it easier for manufacturers to integrate single-use technologies across different stages of the production process. As regulatory clarity and standardization continue to improve, biopharma companies will be more confident in adopting single-use bio-processing systems, further driving market growth.

Integration of Artificial Intelligence and Data Analytics

The integration of artificial intelligence (AI) and advanced data analytics into bio-processing systems is revolutionizing the industry. AI and machine learning algorithms are being used to optimize manufacturing processes by analyzing large datasets from sensors and process control systems. These technologies enhance process monitoring, predictive maintenance, and quality control, enabling more precise and efficient bio-manufacturing. The combination of real-time data monitoring and advanced analytics helps biopharma companies detect potential issues early, reduce downtime, and improve overall product consistency. As these technologies continue to advance, their integration into single-use bio-processing systems will further drive the market’s growth by enhancing productivity and product quality.

Increasing Focus on Modular and Scalable Solutions

Another key trend is the increasing demand for modular and scalable bio-processing solutions. As biopharma companies shift toward more flexible and adaptable production systems, modular single-use bio-processing platforms are gaining popularity. These systems can be easily customized to suit different production requirements, whether for large-scale manufacturing or small clinical batches. Modular solutions also allow for quick reconfiguration of the production line to accommodate varying process needs, improving overall operational efficiency. This trend toward modularity enables biopharma manufacturers to respond rapidly to market changes, product launches, and fluctuations in demand, all while maintaining optimal production performance. The move towards scalable, modular systems is expected to continue driving the adoption of single-use bio-processing technologies in the North American market.

Market Challenges Analysis

Limited Durability and Compatibility Concerns

One of the key challenges facing the North American single-use bio-processing systems market is the limited durability of certain materials used in these systems. While single-use technologies provide numerous advantages, such as reduced risk of contamination and cost savings, the lifespan of disposable components can be a concern. Some materials may degrade over time or become incompatible with specific bioprocessing applications, leading to potential issues in long-term use. For instance, the Bio-Process Systems Alliance (BPSA) has developed industry-wide standards for integrity testing to address concerns related to durability and compatibility in single-use systems. Additionally, manufacturers must ensure that disposable components are compatible with the varied needs of different biopharmaceutical processes, such as cell culture, filtration, and fermentation. As a result, ensuring that single-use systems can meet the demands of complex and diverse production environments, while maintaining performance over time, remains a significant challenge.

Regulatory and Safety Concerns

Another challenge in the adoption of single-use bio-processing systems is navigating the complex regulatory landscape and addressing safety concerns. While regulatory agencies like the FDA have provided clearer guidelines for the use of single-use technologies, compliance with these regulations can still be a cumbersome and costly process for manufacturers. The industry also faces ongoing scrutiny regarding the safety and integrity of single-use components, especially in critical biopharmaceutical applications. Concerns about the potential for leachables or extractables from disposable components contaminating the final product may hinder some companies from fully embracing these systems. Ensuring the safety, quality, and regulatory compliance of single-use technologies is vital for industry growth, but it requires ongoing investment in research, development, and regulatory alignment.

Market Opportunities

The North American single-use bio-processing systems market presents several growth opportunities driven by the increasing demand for biologics and personalized medicine. As the biopharmaceutical industry shifts towards more individualized treatment options, including gene therapies and cell-based therapies, there is a growing need for flexible, scalable production systems. Single-use systems are well-suited to accommodate these needs, offering the agility required for small batch and personalized drug production. The ability to quickly scale up or down without significant capital investment allows biopharma companies to respond rapidly to market demands, providing a clear opportunity for the continued adoption of single-use systems. Additionally, advancements in cell culture technologies and biologics manufacturing are further driving this demand, positioning single-use bio-processing solutions as a key enabler in the production of cutting-edge therapies.

Furthermore, increasing regulatory clarity and standardization within the industry is opening up new avenues for the market’s expansion. As regulatory agencies such as the FDA continue to provide guidelines for the use of single-use technologies, biopharma companies gain confidence in adopting these systems for large-scale production. This, coupled with the growing focus on sustainability and cost-efficiency in manufacturing, presents significant opportunities for suppliers of single-use bio-processing systems. The continued development of modular, customizable solutions also enables manufacturers to address a broader range of production needs, from early-phase development to commercial-scale manufacturing. As a result, the North American market is poised for continued growth, driven by technological innovations, regulatory support, and an expanding pipeline of biopharmaceutical products.

Market Segmentation Analysis:

By Type:

The North American single-use bio-processing systems market is segmented into various product types, each catering to distinct biopharmaceutical manufacturing needs. Among these, single-use bioreactors are the most prominent, as they play a critical role in cultivating cells for the production of biologics, including monoclonal antibodies, vaccines, and gene therapies. These bioreactors provide flexibility, scalability, and a reduced risk of contamination, making them a preferred choice for many manufacturers. Single-use mixers are also gaining traction due to their ability to efficiently blend solutions and maintain homogeneity in production processes, particularly in cell culture and media preparation. Single-use bags, which are commonly used for storage, transport, and mixing of biological materials, represent another significant segment. These bags are cost-effective and eliminate the need for cleaning and sterilization. Single-use connectors and other related components also contribute to the market, offering critical functionality for seamless integration of processes in modular systems. Overall, each product type enhances operational efficiency and meets the growing demand for flexible, scalable, and contamination-free bioprocessing.

By Application:

The North American market for single-use bio-processing systems is also segmented by application, including research & development (R&D), manufacturing, process development, commercial production, and others. The R&D segment is crucial, as these systems enable biopharmaceutical companies to rapidly test and develop new therapies without the need for extensive infrastructure investments. As many companies continue to shift towards personalized medicine, single-use systems support the flexible production methods required for smaller batches. In manufacturing, single-use systems provide scalability for larger production volumes, while also offering cost savings and reduced risk of cross-contamination. The process development segment focuses on optimizing manufacturing processes for new therapeutics, often requiring flexible solutions that single-use systems can provide. For commercial production, single-use bio-processing technologies enable more efficient and sustainable manufacturing of high-demand biologics. As biopharma companies increase production to meet global demand, these systems allow for rapid scaling without significant capital expenditure. Each application segment reflects the diverse uses of single-use systems, which support the evolving needs of the biopharmaceutical industry.

Segments:

Based on Type:

Single-Use Bioreactors
Single-Use Mixers
Single-Use Bags
Single-Use Connectors
Others

Based on Application:

Research & Development
Manufacturing
Process Development
Commercial Production
Others

Based on End- User:

Pharmaceutical & Biotechnology Companies
Contract Research Organizations (CROs)
Academic & Research Institutes
Contract Manufacturing Organizations (CMOs)
Others

Based on the Geography:

S.
Canada
Mexico

Regional Analysis

United States

The United States holds the dominant share of the North America single-use bio-processing systems market, accounting for approximately 78% of the total regional revenue in 2024. This leadership position is driven by the presence of a well-established biopharmaceutical industry, strong R&D infrastructure, and a high rate of adoption of advanced manufacturing technologies. Major pharmaceutical companies and contract manufacturing organizations (CMOs) in the U.S. are heavily investing in flexible and scalable production systems, which includes single-use technologies. Regulatory support from agencies such as the FDA, combined with a focus on biologics and personalized therapies, continues to reinforce market growth. Additionally, the presence of top biotechnology hubs like Boston, San Diego, and the San Francisco Bay Area further accelerates innovation and demand for single-use systems, especially in research, process development, and clinical-scale production.

Canada

Canada represents a growing market within North America, contributing around 12% of the regional market share. The country is witnessing increased investment in biotechnology and life sciences, supported by government funding and collaborative initiatives between academia and industry. Canadian biopharma companies are increasingly adopting single-use bio-processing technologies to enhance production efficiency, reduce capital expenditure, and ensure compliance with evolving regulatory standards. Additionally, the emergence of small and mid-sized biotech firms is fueling demand for flexible, modular systems that support small-scale and pilot production. The growing emphasis on sustainable and efficient manufacturing practices is also encouraging the adoption of single-use solutions across both research and commercial manufacturing applications in the Canadian life sciences sector.

Mexico

Mexico accounts for approximately 7% of the North American single-use bio-processing systems market. While the market is still developing compared to the U.S. and Canada, it shows strong potential due to rising investments in pharmaceutical manufacturing and increasing collaborations with global biopharma firms. The country’s strategic location, cost-effective labor, and expanding healthcare infrastructure make it an attractive destination for outsourced bioprocessing activities. As multinational companies establish or expand their production facilities in Mexico, the adoption of single-use systems is expected to grow steadily, especially for applications such as clinical trial manufacturing and small-batch production. The government’s support for innovation and pharmaceutical exports also plays a role in shaping market expansion.

Key Player Analysis

Thermo Fisher Scientific Inc.
Danaher Corporation
Corning Incorporated
Entegris, Inc.
Meissner Filtration Products, Inc.
Repligen Corporation
PBS Biotech, Inc.
Avantor, Inc.
Saint-Gobain Performance Plastics
Pall Corporation

Competitive Analysis

The North America Single-Use Bio-Processing Systems market is highly competitive, driven by innovation, strategic partnerships, and product development among leading players. Key market participants include Thermo Fisher Scientific Inc., Danaher Corporation, Pall Corporation, Corning Incorporated, Entegris Inc., Meissner Filtration Products Inc., Repligen Corporation, PBS Biotech Inc., Avantor Inc., and Saint-Gobain Performance Plastics. These companies compete by offering comprehensive single-use product portfolios such as bioreactors, bags, connectors, and mixers that cater to various stages of biopharmaceutical manufacturing. Market participants are heavily investing in research and development to enhance product performance, improve material compatibility, and integrate automation into single-use solutions. The focus remains on offering complete systems that cover upstream and downstream processes, including bioreactors, filtration units, mixing systems, and fluid management solutions. Companies are increasingly forming strategic partnerships with biopharmaceutical manufacturers and research organizations to co-develop customized systems and address evolving industry demands. Mergers and acquisitions are also a common strategy to expand product portfolios and geographic presence. In addition, many players are focusing on improving the sustainability of their products by exploring recyclable materials and reducing waste. The competitive landscape continues to evolve as technological advancements, regulatory support, and the growing demand for personalized therapies shape the future of single-use bio-processing in North America.

Recent Developments

In April 2025, Thermo Fisher Scientific launched the 5L DynaDrive Single-Use Bioreactor, a bench-scale system designed for seamless scalability from 1 to 5,000 liters. This new bioreactor offers a 27% productivity increase over glass bioreactors, enhanced sustainability with biobased films, and consistent performance across different scales, supporting both large and small biopharma manufacturers. The DynaDrive S.U.B. supports robust production across scales and has the flexibility to accommodate a variety of cell lines and processing modalities.
In April 2025, Sartorius Stedim Biotech entered a strategic partnership with Tulip Interfaces to drive digital transformation in single-use bioprocessing. The collaboration introduced Biobrain® Operate powered by Tulip, a suite of digital manufacturing applications that integrate with Sartorius equipment to reduce process variability, digitize operations, and ensure regulatory compliance. This partnership aims to advance paperless manufacturing and optimize resource efficiency in bioprocessing.
In March 2025, Corning introduced new technologies to support advanced therapy applications, including the Ascent™ Fixed Bed Reactor (FBR) and expanded cell expansion platforms like HYPERStack®, HYPERFlask®, and CellSTACK®. These platforms feature closed systems and automation to reduce contamination risk and enhance scalability for bioprocess applications.
In April 2023, Merck KGaA launched the Ultimus® Single-Use Process Container Film, featuring ten times greater abrasion resistance than other films, improved durability, and leak resistance for single-use assemblies. The technology is now available in Mobius® 3D process containers, enhancing operational efficiency and cell growth performance.

Market Concentration & Characteristics

The North America Single-Use Bio-Processing Systems market exhibits a moderately high level of market concentration, with a few dominant players accounting for a significant share of total revenue. These companies possess strong R&D capabilities, extensive product portfolios, and established relationships with major biopharmaceutical manufacturers. The market is characterized by rapid innovation, with a focus on developing customizable, modular systems that address the evolving needs of small-scale and large-scale biologics production. Additionally, the industry emphasizes stringent quality standards and regulatory compliance, which reinforces the presence of established players with proven track records. Despite this concentration, opportunities remain for smaller firms and new entrants to carve niches through specialized solutions, particularly in areas like advanced sensors, automation, and sustainability. The market also demonstrates a strong orientation toward partnerships and collaborations, reflecting the need for integrated solutions and faster time-to-market. Overall, the market is dynamic, quality-driven, and responsive to the fast-changing landscape of biopharmaceutical manufacturing.

Report Coverage

The research report offers an in-depth analysis based on Type, Application, End-User and Geography. It details leading market players, providing an overview of their business, product offerings, investments, revenue streams, and key applications. Additionally, the report includes insights into the competitive environment, SWOT analysis, current market trends, as well as the primary drivers and constraints. Furthermore, it discusses various factors that have driven market expansion in recent years. The report also explores market dynamics, regulatory scenarios, and technological advancements that are shaping the industry. It assesses the impact of external factors and global economic changes on market growth. Lastly, it provides strategic recommendations for new entrants and established companies to navigate the complexities of the market.

Future Outlook

The market will continue to grow due to increasing demand for biologics and personalized medicine.
Adoption of automation and smart technologies will enhance efficiency and reduce human error.
Manufacturers will focus on developing more sustainable and recyclable single-use components.
Regulatory clarity and support will encourage broader implementation of single-use systems.
Small and mid-sized biotech firms will drive demand for flexible, modular processing solutions.
Partnerships between technology providers and biopharma companies will strengthen innovation.
Continuous improvements in material science will reduce concerns about extractables and leachables.
Integration of real-time data analytics will improve process monitoring and control.
Expansion of manufacturing facilities in Canada and Mexico will support regional growth.
The market will see increased use of single-use systems in commercial-scale production settings.

CHAPTER NO. 1 : INTRODUCTION 19

1.1.1. Report Description 19

Purpose of the Report 19

USP & Key Offerings 19

1.1.2. Key Benefits for Stakeholders 19

1.1.3. Target Audience 20

1.1.4. Report Scope 20

CHAPTER NO. 2 : EXECUTIVE SUMMARY 21

2.1. Single-Use Bio-Processing Systems Market Snapshot 21

2.1.1. North America Single-Use Bio-Processing Systems Market, 2018 – 2032 (USD Million) 22

CHAPTER NO. 3 : GEOPOLITICAL CRISIS IMPACT ANALYSIS 23

3.1. Russia-Ukraine and Israel-Palestine War Impacts 23

CHAPTER NO. 4 : SINGLE-USE BIO-PROCESSING SYSTEMS MARKET – INDUSTRY ANALYSIS 24

4.1. Introduction 24

4.2. Market Drivers 25

4.2.1. Growing Adoption of Disposable Technologies in Biopharmaceutical Manufacturing 25

4.2.2. Increasing Demand for Cost-Effective and Scalable Bioprocessing Solutions 26

4.3. Market Restraints 27

4.3.1. Concerns Related to Leachables and Extractables in Single-Use Systems 27

4.4. Market Opportunities 28

4.4.1. Advancements in Bioprocessing Technology Driving Innovation in Single-Use Systems 28

4.5. Porter’s Five Forces Analysis 29

4.6. Buying Criteria 30

CHAPTER NO. 5 : IMPORT EXPORT ANALYSIS 31

5.1. Import Analysis by North America 31

5.1.1. North America Single-Use Bio-Processing Systems Market Import Volume/Revenue, By North America, 2018 – 2023 31

5.2. Export Analysis by North America 32

5.2.1. North America Single-Use Bio-Processing Systems Market Export Volume/Revenue, By North America, 2018 – 2023 32

CHAPTER NO. 6 : DEMAND SUPPLY ANALYSIS 33

6.1. Demand Analysis by North America 33

6.1.1. North America Single-Use Bio-Processing Systems Market Demand Volume/Revenue, By North America, 2018 – 2023 33

6.2. Supply Analysis by North America 34

6.2.1. North America Single-Use Bio-Processing Systems Market Supply Volume/Revenue, By North America, 2018 – 2023 34

CHAPTER NO. 7 : PRODUCTION ANALYSIS 35

7.1. Production Analysis by North America 35

7.1.1. North America Single-Use Bio-Processing Systems Market Production Volume/Revenue, By North America, 2018 – 2023 35

CHAPTER NO. 8 : PRICE ANALYSIS 36

8.1. Price Analysis by Type 36

8.1.1. North America Single-Use Bio-Processing Systems Market Price, By Type, 2018 – 2023 36

8.1.2. North America Type Market Price, By Type, 2018 – 2023 36

CHAPTER NO. 9 : RAW MATERIALS ANALYSIS 37

9.1. Key Raw Materials and Suppliers 37

9.2. Key Raw Materials Price Trend 37

CHAPTER NO. 10 : MANUFACTURING COST ANALYSIS 38

10.1. Manufacturing Cost Analysis 38

10.2. Manufacturing Process 38

CHAPTER NO. 11 : ANALYSIS COMPETITIVE LANDSCAPE 39

11.1. Company Market Share Analysis – 2023 39

11.2. Value Chain Analysis 39

11.2.1. North America Single-Use Bio-Processing Systems Market: Company Market Share, by Volume, 2023 40

11.2.2. North America Single-Use Bio-Processing Systems Market: Company Market Share, by Revenue, 2023 41

11.2.3. North America Single-Use Bio-Processing Systems Market: Top 6 Company Market Share, by Revenue, 2023 41

11.2.4. North America Single-Use Bio-Processing Systems Market: Top 3 Company Market Share, by Revenue, 2023 42

11.3. North America Single-Use Bio-Processing Systems Market Company Volume Market Share, 2023 43

11.4. North America Single-Use Bio-Processing Systems Market Company Revenue Market Share, 2023 44

11.5. Company Assessment Metrics, 2023 44

11.5.1. Stars 44

11.5.2. Emerging Leaders 44

11.5.3. Pervasive Players 44

11.5.4. Participants 44

11.6. Start-ups /SMEs Assessment Metrics, 2023 44

11.6.1. Progressive Companies 44

11.6.2. Responsive Companies 45

11.6.3. Dynamic Companies 45

11.6.4. Starting Blocks 45

11.7. Strategic Developments 46

11.7.1. Acquisitions & Mergers 46

New Product Launch 46

North America Expansion 46

11.8. Key Players Product Matrix 47

CHAPTER NO. 12 : PESTEL & ADJACENT MARKET ANALYSIS 48

12.1. PESTEL 48

12.1.1. Political Factors 48

12.1.2. Economic Factors 48

12.1.3. Social Factors 48

12.1.4. Technological Factors 48

12.1.5. Environmental Factors 48

12.1.6. Legal Factors 48

12.2. Adjacent Market Analysis 48

CHAPTER NO. 13 : SINGLE-USE BIO-PROCESSING SYSTEMS MARKET – BY TYPE SEGMENT ANALYSIS 49

13.1. Single-Use Bio-Processing Systems Market Overview, by Type Segment 49

13.1.1. Single-Use Bio-Processing Systems Market Revenue Share, By Type, 2023 & 2032 50

13.1.2. Single-Use Bio-Processing Systems Market Attractiveness Analysis, By Type 51

13.1.3. Incremental Revenue Growth Opportunity, by Type, 2024 – 2032 51

13.1.4. Single-Use Bio-Processing Systems Market Revenue, By Type, 2018, 2023, 2027 & 2032 52

13.2. Single-Use Bioreactors 53

13.3. Single-Use Mixers 54

13.4. Single-Use Bags 55

13.5. Single-Use Connectors 56

13.6. Others 57

CHAPTER NO. 14 : SINGLE-USE BIO-PROCESSING SYSTEMS MARKET – BY APPLICATION SEGMENT ANALYSIS 58

14.1. Single-Use Bio-Processing Systems Market Overview, by Application Segment 58

14.1.1. Single-Use Bio-Processing Systems Market Revenue Share, By Application, 2023 & 2032 59

14.1.2. Single-Use Bio-Processing Systems Market Attractiveness Analysis, By Application 60

14.1.3. Incremental Revenue Growth Opportunity, by Application, 2024 – 2032 60

14.1.4. Single-Use Bio-Processing Systems Market Revenue, By Application, 2018, 2023, 2027 & 2032 61

14.2. Research & Development 62

14.3. Manufacturing 63

14.4. Process Development 64

14.5. Commercial Production 65

14.6. Others 66

CHAPTER NO. 15 : SINGLE-USE BIO-PROCESSING SYSTEMS MARKET – BY END-USER SEGMENT ANALYSIS 67

15.1. Single-Use Bio-Processing Systems Market Overview, by End-user Segment 67

15.1.1. Single-Use Bio-Processing Systems Market Revenue Share, By End-user, 2023 & 2032 68

15.1.2. Single-Use Bio-Processing Systems Market Attractiveness Analysis, By End-user 69

15.1.3. Incremental Revenue Growth Opportunity, by End-user, 2024 – 2032 69

15.1.4. Single-Use Bio-Processing Systems Market Revenue, By End-user, 2018, 2023, 2027 & 2032 70

15.2. Pharmaceutical & Biotechnology Companies 71

15.3. Contract Research Organizations (CROs) 72

15.4. Academic & Research Institutes 73

15.5. Contract Manufacturing Organizations (CMOs) 74

15.6. Others 75

CHAPTER NO. 16 : SINGLE-USE BIO-PROCESSING SYSTEMS MARKET – NORTH AMERICA ANALYSIS 76

16.1. Type 76

16.1.1. North America Single-Use Bio-Processing Systems Market Revenue, By Type, 2018 – 2023 (USD Million) 76

16.2. North America Single-Use Bio-Processing Systems Market Revenue, By Type, 2024 – 2032 (USD Million) 76

16.3. Application 77

16.3.1. North America Single-Use Bio-Processing Systems Market Revenue, By Application, 2018 – 2023 (USD Million) 77

16.3.2. North America Single-Use Bio-Processing Systems Market Revenue, By Application, 2024 – 2032 (USD Million) 77

16.4. End-user 78

16.4.1. North America Single-Use Bio-Processing Systems Market Revenue, By End-user, 2018 – 2023 (USD Million) 78

16.4.2. North America Single-Use Bio-Processing Systems Market Revenue, By End-user, 2024 – 2032 (USD Million) 78

16.5. U.S. 79

16.6. Canada 79

16.7. Mexico 79

CHAPTER NO. 17 : COMPANY PROFILES 80

17.1. Thermo Fisher Scientific Inc. 80

17.1.1. Company Overview 80

17.1.2. Product Portfolio 80

17.1.3. Swot Analysis 80

17.1.4. Business Strategy 81

17.1.5. Financial Overview 81

17.2. Danaher Corporation 82

17.3. Corning Incorporated 82

17.4. Entegris, Inc. 82

17.5. Meissner Filtration Products, Inc. 82

17.6. Repligen Corporation 82

17.7. PBS Biotech, Inc. 82

17.8. Avantor, Inc. 82

17.9. Saint-Gobain Performance Plastics 82

17.10. Pall Corporation 82

List of Figures

FIG NO. 1. North America Single-Use Bio-Processing Systems Market Revenue, 2018 – 2032 (USD Million) 22

FIG NO. 2. Porter’s Five Forces Analysis for North America Single-Use Bio-Processing Systems Market 29

FIG NO. 3. North America Single-Use Bio-Processing Systems Market Import Volume/Revenue, By North America, 2018 – 2023 31

FIG NO. 4. North America Single-Use Bio-Processing Systems Market Export Volume/Revenue, By North America, 2018 – 2023 32

FIG NO. 5. North America Single-Use Bio-Processing Systems Market Demand Volume/Revenue, By North America, 2018 – 2023 33

FIG NO. 6. North America Single-Use Bio-Processing Systems Market Supply Volume/Revenue, By North America, 2018 – 2023 34

FIG NO. 7. North America Single-Use Bio-Processing Systems Market Production Volume/Revenue, By North America, 2018 – 2023 35

FIG NO. 8. North America Single-Use Bio-Processing Systems Market Price, By Type, 2018 – 2023 36

FIG NO. 9. Raw Materials Price Trend Analysis, 2018 – 2023 37

FIG NO. 10. Manufacturing Cost Analysis 38

FIG NO. 11. Manufacturing Process 38

FIG NO. 12. Value Chain Analysis for North America Single-Use Bio-Processing Systems Market 39

FIG NO. 13. Company Share Analysis, 2023 40

FIG NO. 14. Company Share Analysis, 2023 41

FIG NO. 15. Company Share Analysis, 2023 41

FIG NO. 16. Company Share Analysis, 2023 42

FIG NO. 17. Single-Use Bio-Processing Systems Market – Company Volume Market Share, 2023 43

FIG NO. 18. Single-Use Bio-Processing Systems Market – Company Revenue Market Share, 2023 44

FIG NO. 19. Single-Use Bio-Processing Systems Market Revenue Share, By Type, 2023 & 2032 50

FIG NO. 20. Market Attractiveness Analysis, By Type 51

FIG NO. 21. Incremental Revenue Growth Opportunity by Type, 2024 – 2032 51

FIG NO. 22. Single-Use Bio-Processing Systems Market Revenue, By Type, 2018, 2023, 2027 & 2032 52

FIG NO. 23. North America Single-Use Bio-Processing Systems Market for Single-Use Bioreactors, Revenue (USD Million) 2018 – 2032 53

FIG NO. 24. North America Single-Use Bio-Processing Systems Market for Single-Use Mixers, Revenue (USD Million) 2018 – 2032 54

FIG NO. 25. North America Single-Use Bio-Processing Systems Market for Single-Use Bags, Revenue (USD Million) 2018 – 2032 55

FIG NO. 26. North America Single-Use Bio-Processing Systems Market for Single-Use Connectors, Revenue (USD Million) 2018 – 2032 56

FIG NO. 27. North America Single-Use Bio-Processing Systems Market for Others, Revenue (USD Million) 2018 – 2032 57

FIG NO. 28. Single-Use Bio-Processing Systems Market Revenue Share, By Application, 2023 & 2032 59

FIG NO. 29. Market Attractiveness Analysis, By Application 60

FIG NO. 30. Incremental Revenue Growth Opportunity by Application, 2024 – 2032 60

FIG NO. 31. Single-Use Bio-Processing Systems Market Revenue, By Application, 2018, 2023, 2027 & 2032 61

FIG NO. 32. North America Single-Use Bio-Processing Systems Market for Research & Development, Revenue (USD Million) 2018 – 2032 62

FIG NO. 33. North America Single-Use Bio-Processing Systems Market for Manufacturing, Revenue (USD Million) 2018 – 2032 63

FIG NO. 34. North America Single-Use Bio-Processing Systems Market for Process Development, Revenue (USD Million) 2018 – 2032 64

FIG NO. 35. North America Single-Use Bio-Processing Systems Market for Commercial Production, Revenue (USD Million) 2018 – 2032 65

FIG NO. 36. North America Single-Use Bio-Processing Systems Market for Others, Revenue (USD Million) 2018 – 2032 66

FIG NO. 37. Single-Use Bio-Processing Systems Market Revenue Share, By End-user, 2023 & 2032 68

FIG NO. 38. Market Attractiveness Analysis, By End-user 69

FIG NO. 39. Incremental Revenue Growth Opportunity by End-user, 2024 – 2032 69

FIG NO. 40. Single-Use Bio-Processing Systems Market Revenue, By End-user, 2018, 2023, 2027 & 2032 70

FIG NO. 41. North America Single-Use Bio-Processing Systems Market for Pharmaceutical & Biotechnology Companies, Revenue (USD Million) 2018 – 2032 71

FIG NO. 42. North America Single-Use Bio-Processing Systems Market for Contract Research Organizations (CROs), Revenue (USD Million) 2018 – 2032 72

FIG NO. 43. North America Single-Use Bio-Processing Systems Market for Academic & Research Institutes, Revenue (USD Million) 2018 – 2032 73

FIG NO. 44. North America Single-Use Bio-Processing Systems Market for Contract Manufacturing Organizations (CMOs), Revenue (USD Million) 2018 – 2032 74

FIG NO. 45. North America Single-Use Bio-Processing Systems Market for Others, Revenue (USD Million) 2018 – 2032 75

List of Tables

TABLE NO. 1. : North America Single-Use Bio-Processing Systems Market: Snapshot 21

TABLE NO. 2. : Drivers for the Single-Use Bio-Processing Systems Market: Impact Analysis 25

TABLE NO. 3. : Restraints for the Single-Use Bio-Processing Systems Market: Impact Analysis 27

TABLE NO. 4. : North America Single-Use Bio-Processing Systems Market Revenue, By Type, 2018 – 2023 36

TABLE NO. 5. : Key Raw Materials & Suppliers 37

TABLE NO. 6. : North America Single-Use Bio-Processing Systems Market Revenue, By Type, 2018 – 2023 (USD Million) 76

TABLE NO. 7. : North America Single-Use Bio-Processing Systems Market Revenue, By Type, 2024 – 2032 (USD Million) 76

TABLE NO. 8. : North America Single-Use Bio-Processing Systems Market Revenue, By Application, 2018 – 2023 (USD Million) 77

TABLE NO. 9. : North America Single-Use Bio-Processing Systems Market Revenue, By Application, 2024 – 2032 (USD Million) 77

TABLE NO. 10. : North America Single-Use Bio-Processing Systems Market Revenue, By End-user, 2018 – 2023 (USD Million) 78

TABLE NO. 11. : North America Single-Use Bio-Processing Systems Market Revenue, By End-user, 2024 – 2032 (USD Million) 78

Frequently Asked Questions

What is the current size of the North America Single-Use Bio-Processing Systems market?

The market was valued at USD 6,077.11 million in 2024 and is projected to reach USD 20,110.11 million by 2032, growing at a CAGR of 16.14%.

What factors are driving the growth of the North America Single-Use Bio-Processing Systems market?

Key drivers include rising demand for biologics, personalized medicine, automation, cost efficiency, and sustainability in biopharma manufacturing.

What are the key segments within the North America Single-Use Bio-Processing Systems market?

Segments include Single-Use Bioreactors, Mixers, Bags, Connectors, and applications like Manufacturing, R&D, and Commercial Production.

Who are the major players in the North America Single-Use Bio-Processing Systems market?

Key players include Thermo Fisher Scientific, Danaher Corporation, Pall Corporation, Corning, and Repligen Corporation.

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