USD 2.7 billion
Single-Use Assemblies Market Size, Share, Growth Analysis, By Product(Bag Assemblies, 2D bag assemblies, 3D bags assemblies, Filtration Assemblies), By Application(Filtration, Cell Culture & Mixing, Storage, Sampling), By Solution(Customized Solutions, and Standard Solutions), By Region - Industry Forecast 2024-2031
Report ID:
SQMIG35H2153 |
Region:
Global |
Published Date: March, 2024
Pages:
219
|Tables:
94
|Figures:
66
Single-Use Assemblies Market Insights
Global Single-Use Assemblies Market size was valued at USD 2.7 billion in 2022 and is poised to grow from USD 3.21 billion in 2023 to USD 12.73 billion by 2031, growing at a CAGR of 18.80% during the forecast period (2024-2031).
Single-use assemblies encompass pre-assembled plastic fluid pathways and self-contained products, constructed by combining various standard components, often ready for immediate use and gamma irradiated to ensure sterility. Commonly employed components encompass sampling bottles, filters, tubing, check valves, clamps, sterile connectors, fittings, and seals. The burgeoning biologics market, coupled with continuous technological strides in bioprocessing, amplified biopharmaceutical Research and Development (R&D), and the extensive adoption of single-use assemblies by diverse Contract Manufacturing Organizations (CMOs), are poised to propel industry expansion during the projected period.
Nonetheless, regulatory considerations linked to leachable, extractables, waste management, and the availability of multi-use systems might temper the penetration of single-use assemblies. The advent of COVID-19 has further accelerated the escalating demand for such assemblies, as disposable technology facilitates swift production and development of therapies and vaccines, enhancing precision and efficiency. A pertinent example is Entegris, Inc.'s Aramus single-use bag assembly, utilized to store COVID-19 vaccines requiring ultra-low temperatures for preservation.
The upsurge in cancer prevalence and infectious diseases is fueling the production of novel biologics for diagnosis and treatment. A rise in cancer cases and infectious diseases like lower respiratory infections and HIV, attributed to factors such as climate shifts and urbanization, augments the industry's prospects. Innovative vaccine developments, exemplified by Moderna's mRNA-based HIV vaccine clinical trial, spotlight cutting-edge technologies' role in the biologics arena. Collaborative endeavors to combat emerging infectious diseases with pandemic potential further underscore the drive towards novel vaccine alternatives.
US Single-Use Assemblies Market is poised to grow at a sustainable CAGR for the next forecast year.
Market Snapshot - 2024-2031
Global Market Size
Largest Segment
Customized Solutions
Fastest Growth
Customized Solutions
Growth Rate
18.80% CAGR
Global Single-Use Assemblies Market ($ Bn)
Country Share for North America Region (%)
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Single-Use Assemblies Market Segmental Analysis
The Global Single-Use Assemblies Market is segmented on the basis of Product, Application, Solution, End – Use, Region. By Product, the market is segmented into Bag Assemblies, 2D bag assemblies, 3D bags assemblies, Filtration Assemblies, Others. By Application, the market is segmented into Filtration, Cell Culture & Mixing, Storage, Sampling, Fill-finish Applications, Others. By End – User, the market is segmented into Biopharmaceutical & Pharmaceutical Companies, CROs & CMOs. By Solution, the market is segmented into Customized Solutions, and Standard Solutions. By Region, the market is segmented into North America, Europe, Latin America, Asia- Pacific, Middle East and Africa.
Single-Use Assemblies Market Analysis By Application
The filtration sector established its dominance within the industry in 2022, commanding a substantial revenue share of 28.70% across the overall landscape. The adoption of single-use assemblies for filtration processes is witnessing rapid expansion due to the inherent benefits they offer in filtration procedures. Single-Use Technologies (SUTs) not only yield cost and time savings but also exhibit remarkable efficiencies, such as reducing integrity testing by 90%, sterile connections by 90%, and tubing time by up to 90%. The utilization of single-use filtration systems also results in time savings since they are pre-assembled and ready for immediate use, unlike conventional filtration setups.
The commercial triumph of biopharmaceuticals necessitates the establishment of multiple manufacturing facilities to cater to the escalating market demand. Biopharmaceutical manufacturers are increasingly adopting single-use facilities to expedite product turnaround and accommodate multiple manufacturing processes within the same area. This growing demand for single-use applications within the biopharmaceutical sector has prompted major industry players to expand their global single-use production facilities.
Concurrently, the cell culture & mixing segment is poised to achieve a remarkable Compound Annual Growth Rate (CAGR) of 20.33% from 2023 to 2030. This growth trajectory is primarily propelled by heightened demand for biopharmaceuticals, favorable government policies, and augmented investment in Research and Development (R&D) initiatives. The escalated need for mammalian cell lines in upstream bioprocessing further fuels industry expansion. Notably, the adoption of cell culture techniques is on the rise as biopharmaceutical entities and researchers increasingly focus on developing vaccines for a wide spectrum of diseases, including rubella, polio, smallpox, chickenpox, and hepatitis. Moreover, the global prevalence of infectious and chronic diseases, including the ongoing impact of conditions like COVID-19, is expected to act as a robust catalyst for market growth throughout the study period.
Single-Use Assemblies Market Analysis By End-Use
In 2022, the biopharmaceutical & pharmaceutical companies segment asserted its dominance on a global scale, commanding the highest share, exceeding 45.61% of the total revenue. The surge in existing biopharmaceutical manufacturing infrastructures is a primary driver behind the escalating demand for single-use assemblies. A case in point is the notable investment made by Alexion in June 2022, funneling USD 70 million into novel drug production warehousing and equipment to bolster manufacturing operations in Ireland. This expansion initiative is geared towards augmenting the biologics drug substance portfolio. Similarly, Upperton Pharma Solutions embarked on a USD 16 million investment in May 2022, facilitating facility expansion to significantly enhance R&D space and introduce a tenfold increase in GMP manufacturing capacity.
Anticipated to exhibit the swiftest Compound Annual Growth Rate (CAGR) during the forecast period, the CROs & CMOs segment is undergoing substantial growth at 19.57%. In recent times, Contract Manufacturing Organizations (CMOs) have widely embraced the integration of single-use assemblies across most, if not all, of their bioprocessing operations. The widespread adoption of single-use assemblies by CMOs expedites processing and process changeover, resulting in reduced turnaround times and heightened flexibility across various client projects. This swift adaptability facilitated by single-use equipment enhances CMO efficiency, thereby contributing to overall cost reduction. Furthermore, an increasing number of CMO facilities are transitioning towards near-complete reliance on single-use technology. This strategic shift not only leads to savings in campaign and facility costs but also aids in curbing operational expenditures and capital investments.
Global Single-Use Assemblies Market By Solution
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Single-Use Assemblies Market Regional Insights
In 2022, North America established its dominance in the regional market, securing a commanding 36.45% share. This substantial foothold can be attributed to robust growth within the biotechnology and pharmaceutical sectors, product advancements, and the escalating prevalence of diseases like cancer. Concurrently, investments and funding channeled into drug discovery research have fueled this surge. For instance, a notable development unfolded in August 2022 when Thermo Fisher Scientific Inc. unveiled a cutting-edge single-use technology manufacturing facility in Greater Nashville, spanning 400,000 square feet with an investment of USD 105 million. This strategic move aimed to satisfy the escalating demand for bioprocessing materials crucial in crafting revolutionary therapies and vaccines, particularly for cancer and other ailments. The Nashville site constitutes a vital component of the company's ambitious USD 650 million multi-year initiative, focused on elevating its bioprocessing production capabilities.
Meanwhile, the Asia Pacific region is projected to exhibit the swiftest Compound Annual Growth Rate (CAGR) of 21.64% from 2023 to 2030, propelled by strategic maneuvers by key industry players. In 2021, Sartorius directed substantial investments towards China, enhancing its production capacity with additional cleanroom space dedicated to the manufacturing of single-use filters and bags. Concurrently, Cytiva, in September 2021, announced a substantial USD 52.5 million investment to establish a disposable manufacturing facility in South Korea. This expansion aligns with the aim of providing the bioprocessing sector with essential single-use bags integral to COVID-19 vaccine production.
Global Single-Use Assemblies Market By Geography
- Largest
- Fastest
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Single-Use Assemblies Market Dynamics
Single-Use Assemblies Market Drivers
Reduced Cross-Contamination Risk
- The disposable nature of single-use assemblies minimizes the risk of cross-contamination, enhancing product safety and quality.
Quick Scale-Up
- The ability to rapidly scale up production, especially evident during the COVID-19 pandemic for vaccine manufacturing, is a major driver for the adoption of single-use assemblies.
Single-Use Assemblies Market Restraints
Limited Reusability
- Single-use assemblies, by nature, lack reusability, which might increase operational costs in the long run and generate waste.
Regulatory Compliance
- Stringent regulatory requirements for single-use systems, especially in pharmaceutical and biotech sectors, can pose challenges and delays in product approvals.
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Single-Use Assemblies Market Competitive Landscape
The competitive landscape of the Global Single-Use Assemblies Market is dynamic and driven by a mix of established players and emerging entrants. Industry leaders such as Thermo Fisher Scientific, Sartorius AG, Danaher Corporation, and Merck KGaA dominate the market with their extensive product portfolios, robust R&D capabilities, and global distribution networks. These companies offer a wide range of single-use assembly solutions catering to various industries, fostering innovation and technological advancement.
Additionally, specialized players like Entegris, Saint-Gobain Performance Plastics, and Parker Hannifin Corporation excel in providing high-quality components and materials essential for single-use systems, contributing to the market's growth and diversification. Meissner Filtration Products, Repligen Corporation, and GE Healthcare are noteworthy contenders that have carved a niche with their expertise in filtration technologies, downstream processing, and bioprocessing solutions.
The market's competitive landscape is characterized by collaborations, partnerships, and acquisitions, as companies strive to expand their product offerings and global presence. The evolving regulatory landscape, increasing demand for sustainable solutions, and advancements in bioprocessing techniques are likely to further intensify competition. As new players continue to innovate and established giants adapt to changing market dynamics, the Global Single-Use Assemblies Market is poised for both fierce competition and collaborative growth.
Single-Use Assemblies Market Top Player’s Company Profile
- Thermo Fisher Scientific Inc. (USA)
- Sartorius AG (Germany)
- Danaher Corporation (USA)
- Merck KGaA (Germany)
- Entegris, Inc. (USA)
- Saint-Gobain Performance Plastics (France)
- Parker Hannifin Corporation (USA)
- Meissner Filtration Products, Inc. (USA)
- Repligen Corporation (USA)
- GE Healthcare (USA)
Single-Use Assemblies Market Recent Developments
- In October 2022, Single Use Support, an Austrian provider of solutions, added new single-use bioprocess containers under the IRIS brand. Utilizing its expertise, the company continued to pursue its vendor-agnostic strategy while offering dependable process solutions for biopharmaceutical fluid management.
- The Thermo Scientific DynaSpin Single-Use Centrifuge system was introduced in September 2022 at the Bioprocess International conference in Boston, Massachusetts by Thermo Fisher Scientific Inc. For large-scale cell culture harvesting, the technology is intended to offer the best single-use option.
Single-Use Assemblies Key Market Trends
- Rapid Adoption Across Industries: Single-Use Assemblies are witnessing widespread adoption across pharmaceuticals, biotechnology, and food processing industries due to their flexibility, reduced contamination risk, and operational efficiency.
- Personalized Medicine and Bioprocessing: The growing emphasis on personalized medicine and the rise of bioprocessing applications have driven the demand for single-use assemblies, enabling efficient and adaptable production processes.
Single-Use Assemblies Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Product types team that Collects, Collates, Correlates, and Analyzes the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to our Global Single-Use Assemblies Market Analysis, conclusions drawn from market trends highlight its escalating adoption across diverse industries, including pharmaceuticals, biotechnology, and food processing. The convenience, reduced cross-contamination risk, and streamlined operational efficiency offered by single-use assemblies have driven their widespread acceptance.
Notably, the market's expansion has been propelled by the increasing emphasis on cost-effectiveness, flexibility, and sustainable practices. The shift towards personalized medicine and bioprocessing further underlines the market's growth potential. However, challenges related to regulatory compliance and limited reusability have been observed as potential hindrances.
The COVID-19 pandemic has also underscored the importance of single-use solutions in enabling rapid scale-up of production for vaccines and therapeutics. Looking ahead, advancements in materials, technology, and manufacturing processes are anticipated to address existing limitations, fostering continued growth in the Global Single-Use Assemblies Market. Stakeholders must stay vigilant to evolving industry dynamics and regulatory landscapes to harness the sector's full potential.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 2.7 billion |
| Market size value in 2031 | USD 12.73 billion |
| Growth Rate | 18.80% |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
|
| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Single-Use Assemblies Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Single-Use Assemblies Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Single-Use Assemblies Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Single-Use Assemblies Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Single-Use Assemblies Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Single-Use Assemblies Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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