Global Single-use Assemblies Market Size, Share & Industry Trends Analysis Report By Solution, By Product, By End User, By Application (Filtration, Cell Culture & Mixing, Storage, Sampling, Fill-finish), By Regional Outlook and Forecast, 2022 – 2028

Global Single-use Assemblies Market Size, Share & Industry Trends Analysis Report By Solution, By Product, By End User, By Application (Filtration, Cell Culture & Mixing, Storage, Sampling, Fill-finish), By Regional Outlook and Forecast, 2022 – 2028

The Global Single-use Assemblies Market size is expected to reach $8.6 billion by 2028, rising at a market growth of 23.4% CAGR during the forecast period.

A single-use assembly is a ready-to-use, customer-specific all-in-one solution comprised of multiple plastic components that are combined into a single whole. Single-use assemblies consist of prefabricated plastic fluid pathways and self-contained goods. Typically ready-to-use and gamma-irradiated to maintain sterility, they are constructed from a variety of standard components and are gamma-irradiated to ensure sterility.

Sample bottles, filters, check valves, tubing, clamps, fittings, sterile connectors, and seals are among the most often used industrial goods. The expanding biologics market, continuing technological advancements in bioprocessing, rising biopharmaceutical R&D, and widespread acceptance of single-use assemblies by several CMOs are estimated to drive industry expansion throughout the coming years.

Sometimes, (bio)pharmaceutical and life science companies assemble their proprietary single-use process systems. Certainly, it needs to be executed securely. If the connection between components is not properly made, cross-contamination or leakage may occur. This might put the safety and quality of the final product in jeopardy and prolong the production process. Standardization of single-use models and assemblies would provide the biopharmaceutical industry with rapid, simple, and cost-effective solutions, as is commonly acknowledged.

As the biopharmaceutical business extends its use of single-use technologies, suppliers struggle to keep up with demand. A widely recognized standardization method for single-use items could help relieve these supply concerns. This would not only aid the industry by helping to ensure timely manufacturing, but it would also increase patients' access to necessary therapies.

COVID-19 Impact Analysis

The majority of businesses have ceased manufacturing or reduced it to an absolute minimum level. During the initial phase of the pandemic, governments' COVID-19-responsive measures, including lockdown and social isolation, led to the shutdown of production plants. With very few industrial operations permitted, the industrial sector's demand for numerous raw items has decreased dramatically. During the economic crisis, very few new Single-Use Assemblies were deployed by these industries, implying that these variables had a significant impact on the market for Single-Use Assemblies.

Market Growth Factors

Higher Deployment Along With The Reduced Risk Of Cross-Contamination

Due to the significant advantages of single-use solutions over conventional bioprocessing technologies, the popularity of single-use assembly is steadily increasing. These include quicker incorporation of single-use assembly components into the bioprocess cycle and a reduced likelihood of cross-contamination. Single-use assemblies are ergonomically intended to hold integrated single-use flow channels, allowing for a faster setup and a smaller footprint.

Rapid Development In Emerging Nations All Over The World

In the modern era, urbanization along with various other technological advancements within several sectors throughout economies all over the world is one of the major factors that is boosting the development of these countries. Various under-developed countries are emerging at a very fast pace in recent years. Moreover, emerging markets are anticipated to provide major development prospects for single-use assembly market participants. This is due to the presence of less severe regulatory policies as well as a low-cost and trained workforce in their respective pharmaceutical and biopharmaceutical industries.

Market Restraining Factors

An Increasing Number Of Concerns Regarding Leachable And Extractable

Leachable are substances found in drug products due to leaching from containers, seals, and processing components, whereas extractables are molecules that may be extracted from source materials using proper solvents under rigorous laboratory conditions. Leachable can therefore be considered as a subset of extractable. Due to the usage of additives to promote stability and aid in the creation of material components, extractable and leachable are typically connected with elastomeric and polymeric materials.

Product Outlook

Based on Product, the Single-use Assemblies Market is segmented into Bag Assemblies, Filtration Assemblies, Bottle Assemblies, Mixing System Assemblies, and Other Products. In 2021, the filtering assemblies segment garnered a significant revenue share of the single-use assemblies market. Increased regulatory standards and the need to reduce the risk of contamination have prompted mass and final fill processes to employ filtration assemblies.

Solution Outlook

On the basis of Solution, the Single-use Assemblies Market is bifurcated into Standard Solutions and Customized Solutions. In 2021, the standard solutions segment witnessed the highest revenue share in the single-use assembly market. The rise in the growth of the segment is attributed to the fact that standard solutions are widely adopted in the pharmaceutical and biopharmaceutical industries due to the benefits they provide, including manufacturing process efficiency with reduced capital and operational expenditure, improved flexibility through the use of pre-qualified components to build assemblies, decreased implementation time, and increased production planning flexibility.

Application Outlook

By Application, the Single-use Assemblies Market is segregated into Filtration, Cell Culture & Mixing, Storage, Sampling, Fill-finish Applications, and Other Applications. In 2021, the cell culture & mixing segment garnered a substantial revenue share of the single-use assemblies market. The growth of the segment is primarily driven by the increasing demand for biopharmaceuticals, supportive government regulations, and increased R&D expenditures. In addition, the increased demand for mammalian cell lines for upstream bioprocessing is moving the industry forward.
 
End-User Outlook

Based on End-User, the Single-use Assemblies Market is categorized into Biopharmaceutical & Pharmaceutical Companies, CROs & CMOs, and Academic & Research Institutes. In 2021, the biopharmaceutical & pharmaceutical companies segment procured the largest revenue share of the single-use assemblies market. The geriatric population's demand for biopharmaceuticals is rising since the aged are more susceptible to diseases/disorders that are treated using biologics. This has caused biopharmaceutical companies to place a greater emphasis on generating inexpensive, low-cost biologics.

Regional Outlook

By Region, the Single-use Assemblies Market is analyzed across North America, Europe, Asia-Pacific, and LAMEA. In 2021, North America accounted for the largest revenue share of the single-use assemblies market. The substantial proportion of the North American market can be due to the region's well-established biopharmaceutical industry, the extensive availability of single-use assemblies provided by regional market players, and the growing manufacturing of biologics and biosimilars.

The major strategies followed by the market participants are Acquisitions. Based on the Analysis presented in the Cardinal matrix; Thermo Fisher Scientific, Inc. and Saint-Gobain Group are the forerunners in the Single-use Assemblies Market. Companies such as Sartorius Stedim Biotech S.A., Parker-Hannifin Corporation and Entegris, Inc. are some of the key innovators in Single-use Assemblies Market.

The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Thermo Fisher Scientific, Inc., Sartorius Stedim Biotech S.A. (Sartorius AG), Danaher Corporation, Merck Group, Avantor, Inc., Parker-Hannifin Corporation, Saint-Gobain Group (CertainTeed), Corning Incorporated, Repligen Corporation, and Entegris, Inc.

Recent Strategies deployed in Single-use Assemblies Market

Partnerships, Collaborations and Agreements:

Dec-2021: Sartorius entered into a partnership with HOF Sonderanlagenbau, a fully integrated total design and build environment. Under this partnership, the companies would integrate the horizontal plate freeze-thaw units of HOF into Sartorius’ portfolio in order to offer a full suite of compatible freeze-thaw consumables and equipment.

Product Launches and Product Expansions:

Oct-2021: Thermo Fisher released the Thermo Scientific HyPeak chromatography system, a single-use chromatography system for bioprocessing applications. The new solution aimed to buffer consumption amid downstream operations in order to enhance product yield and operate under the Emerson DeltaV automation infrastructure to facilitate integration and tech transfer.

Acquisitions and Mergers:

Sep-2022: Parker Hannifin took over Meggitt, a British international company. This acquisition aimed to strengthen the company's ability to expand its capabilities in order to create a more-electric portfolio and offer more innovative ideas to clean technologies as well as advanced air mobility.

Aug-2022: Sartorius completed its acquisition of Albumedix, a science-driven company. With this acquisition, the company aimed to expand and strengthen its position as a vendor of innovative chemically defined media and critical ancillary materials.

Mar-2022: Thermo Fisher acquired Max Analytical Technologies, a manufacturer of FTIR-based gas analysis solutions. Following this acquisition, the company aimed to expand as well as complement the FTIR instrument, service, and software portfolio of Thermo Fisher. Furthermore, this acquisition would also increase the width of vibrational spectroscopy services and solutions throughout a range of market segments.

Sep-2021: Saint-Gobain acquired Equflow, a leading provider of Flowmeters. Following this acquisition, the company would leverage the fluid measurement technologies of Equflow throughout all of its businesses to expand its capabilities in the single-use space.

Jun-2021: Avantor took over RIM Bio, a leader in manufacturing single-use bioprocess bags and assemblies. This acquisition aimed to enable the company to more effectively serve its customers through the expansion of its single-use manufacturing, distribution, as well as cleanroom capabilities throughout the AMEA region.

Nov-2020: Sartorius acquired BIA Separations, a Slovenian purification specialist. Through this acquisition, the company aimed to integrate BIA Separations into its subgroup.

Oct-2020: Repligen took over ARTeSYN Biosolutions, a privately-held company. This acquisition aimed to strengthen its hollow fiber systems portfolio while also complementing its chromatography and TFF filtration product ranges.

Apr-2020: Sartorius took over selected life science businesses of Danaher, an American globally diversified conglomerate. Following this acquisition, the company aimed to expand its Bioprocess Solutions Division's downstream processing portfolio.

Geographical Expansions:

Aug-2022: Thermo Fisher expanded its geographical footprint with the launch of the largest single-use technology manufacturing facility in Greater Nashville. Through this geographical expansion, the company aimed to accelerate the manufacturing of its single-use technologies product manufacturing. Furthermore, the new manufacturing facilities would also allow pharmaceutical businesses to offer medicines to patients faster.

Dec-2021: Avantor expanded its geographical footprint in Massachusetts with the launch of a new single-use logistics hub in Westminster. Following this geographical expansion, the company aimed to strengthen its global biopharma supply chain. In addition, the new facility would also offer logistics and distribution management while enabling the company to leverage its existing facilities throughout North America.

Scope of the Study

Market Segments covered in the Report:

By Solution

• Standard Solutions
• Customized Solutions

By Product

• Bag Assemblies
• Filtration Assemblies
• Bottle Assemblies
• Mixing System Assemblies
• Others

By End User

• Biopharmaceutical & Pharmaceutical Companies
• CROs & CMOs
• Academic & Research Institutes

By Application

• Filtration
• Cell Culture & Mixing
• Storage
• Sampling
• Fill-finish
• Others

By Geography

• North America
• US
• Canada
• Mexico
• Rest of North America
• Europe
• Germany
• UK
• France
• Russia
• Spain
• Italy
• Rest of Europe
• Asia Pacific
• China
• Japan
• India
• South Korea
• Singapore
• Malaysia
• Rest of Asia Pacific
• LAMEA
• Brazil
• Argentina
• UAE
• Saudi Arabia
• South Africa
• Nigeria
• Rest of LAMEA

Companies Profiled

• Thermo Fisher Scientific, Inc.
• Sartorius Stedim Biotech S.A. (Sartorius AG)
• Danaher Corporation
• Merck Group
• Avantor, Inc.
• Parker-Hannifin Corporation
• Saint-Gobain Group (CertainTeed)
• Corning Incorporated
• Repligen Corporation
• Entegris, Inc.

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