Home Biotechnology Single-Use Assemblies Market Size, Share & Trends Report, 2031

Single-Use Assemblies Market

Single-Use Assemblies Market Size, Share & Trends Analysis Report By Product (Bag Assemblies, Filtration Assemblies, Bottle Assemblies, Tubing Assemblies, Other Products), By Application (Filtration, Cell Culture and Mixing, Storage, Sampling, Fill-finish Applications, Other Applications), By Solution (Customized Solutions, Standard Solutions), By End-user (Biopharmaceutical and Pharmaceutical Companies, CROs and CMOs, Academic and Research Institutes) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Report Code: SRBI55629DR
Study Period 2019-2031 CAGR 19.4%
Historical Period 2019-2021 Forecast Period 2023-2031
Base Year 2022 Base Year Market Size USD 11,132.5 Million
Forecast Year 2031 Forecast Year Market Size USD 54907.5 Million
Largest Market North America Fastest Growing Market Europe

Market Overview

The global single-use assemblies market size was valued at USD 11,132.5 million in 2022 and is projected to reach a value of USD 54,907.5 million by 2031, registering a CAGR of 19.4% during the forecast period (2023-2031). The growing necessity in the pharmaceutical industry is a major factor in the single-use assembly market growth.

Single-use assemblies, single-use systems (SUS), or disposable systems are commonly employed in the biopharmaceutical and biotechnology industries. They are intended to make the production and processing of biopharmaceutical products such as vaccines, monoclonal antibodies, and other biologics easier. These assemblies often comprise single-use bags, tubing, connectors, filters, and other components that allow for hygienic and efficient fluid handling without cleaning and sterilizing between batches.

Rapid and simple deployment, a reduced danger of cross-contamination, increased R&D expenditure by biopharmaceutical companies, and a burgeoning biologics industry are factors driving market expansion. The use of single-use assemblies in the global biopharmaceutical industry has grown over time due to their benefits, such as reduced cross-contamination risks, easier cleaning procedures, and tailored solutions. This helps to speed drug research and manufacture. Biopharmaceutical businesses' increased R&D spending contributes considerably to the single-use assemblies market share.

Market Dynamics

Global Single-Use Assemblies Market Drivers

Biopharmaceutical Industry Growth

The biopharmaceutical business is quickly increasing, fueled by the development of new biologics, vaccines, and cell treatments. Single-use assemblies are ideal for the flexible and efficient manufacture of these items, making them indispensable in this market. The global biopharmaceutical market has been expanding rapidly. According to EvaluatePharma data, global biopharmaceutical sales are expected to reach around USD 320 billion in 2021. This expansion results from developing and commercializing new biologics, such as monoclonal antibodies.

Biopharmaceuticals account for approximately 20% of the global medicines sector. The extensive use of pharmaceuticals as chemotherapeutic medications, including but not limited to vaccines, allergic agents, and cell therapies. People living with Cancer can also benefit from it. As a result of the rapid growth of biopharmaceuticals, the need for single-use bioprocessing equipment is increasing significantly.

Furthermore, many biopharmaceutical products, including mAbs, require regulatory approval from the US FDA and the European Medicines Agency. Single-use technologies are generally recognized and have acquired regulatory approval, making them essential to these items' manufacturing processes. As a result, the biopharmaceutical industry's growth and the utilization of single-use assemblies market trend may have continued to evolve since then.

Global Single-Use Assemblies Market Restraints

Limited Reusability

The limited reusability of single-use assemblies is a significant barrier to their acceptance, particularly in industries where equipment and components are frequently reused. Single-use systems are intended for one-time usage, which might result in increased waste output and potentially higher long-term expenditures.

Bioreactors are critical in biopharmaceutical manufacturing for cell culture operations. Traditional stainless-steel bioreactors can be reused after careful cleaning and sterilization between batches. On the other hand, single-use bioreactors are intended for one-time usage and disposal. As a result, single-use methods may not be as cost-effective for large-scale biomanufacturing, as the accumulation of disposal costs might become significant over time. In such circumstances, classic stainless-steel systems, with their reusability, may be more financially appealing.

Global Single-Use Assemblies Market Opportunities

Regulatory Support and Compliance

The regulatory support and guidance provided by agencies such as the US FDA and the European Medicines Agency (EMA) for single-use technologies provide opportunities for companies to improve regulatory compliance and streamline the clearance process for biopharmaceutical products.

The FDA has issued guidance documents such as "Quality Considerations for Single-Use Systems in Premarket Submissions" and "Chemistry, Manufacturing, and Controls (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)" addressing the use of single-use systems in the biopharmaceutical industry. These standards give a road map for manufacturers to follow to ensure the safety, quality, and performance of single-use components.

Furthermore, the BLA process entails rigorous monitoring of production procedures, including single-use technology, for biopharmaceutical enterprises seeking FDA approval. Companies that follow FDA criteria have a competitive advantage when obtaining approval. As a result, this has aided in the widespread adoption of single-use technologies in the biopharmaceutical and biotechnology industries.

Regional Analysis

The global single-use assemblies market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global Single Use Assemblies market shareholder and is estimated to grow at a CAGR of 19.1% over the forecast period. This significant stake can be attributed to the rise of the biotechnology and pharmaceutical sectors, product advancement, and the rising incidence of diseases such as Cancer, as well as investments and funding in drug discovery research. For example, Thermo Fisher Scientific Inc. inaugurated its single-use technology production site in Greater Nashville in August 2022. The 400,000-square-foot USD 105 million facilities enable the company to fulfill the growing demand for bioprocessing materials needed to develop breakthrough cancer treatments and vaccines.

Additionally, according to the International Trade Administration (ITA), which the United States Department of Commerce runs to encourage and support foreign investment in the country, the United States has the world's largest biopharmaceutical market, accounting for nearly one-third of global sales, and it leads the world in biopharmaceutical research and development. The United States has one of the best domestic conditions in the world for pharmaceutical research and commercialization, with low market barriers. The advanced pharmaceutical and biopharmaceutical sectors encourage sales of single-use assemblies and a favorable domestic climate.

Europe is anticipated to exhibit a CAGR of 19.5% over the forecast period. Germany is expected to lead the European single-use assembly market during the projection period. Biological therapeutic choices have a greater influence on the single-use assemblies market in this country than pharmacological therapeutic options. As a result, the German biopharmaceutical contract manufacturing sector is experiencing increased demand, improving single-use assembly sales. More biopharmaceutical research and clinical trials are being undertaken to save costs and focus on outsourcing most research tasks.

Furthermore, European nations have demonstrated a significant commitment to sustainability. The potential for single-use assemblies to lessen the environmental impact of bioprocessing has been identified. European biopharmaceutical businesses are investing in these technologies to meet sustainability objectives.

Asia-Pacific is expected to have the quickest CAGR due to strategic advances by key companies. Sartorius, for example, made significant investments in China and Beijing in 2021, where additional cleanroom space was developed to make bags and single-use filters. Furthermore, Cytiva stated in September 2021 that it will invest USD 52.5 million in the construction of a disposable manufacturing facility in South Korea. This expansion aims to provide single-use bags to the bioprocessing industry, which are utilized to manufacture COVID-19 vaccines.

In addition, several pharmaceutical and biopharmaceutical companies plan to develop their single-use production facilities in rising markets such as China, India, and South Korea to make these countries a hub for outsourcing bioprocesses.

Report Scope

Report Metric Details
Segmentations
By Product
  1. Bag Assemblies
    1. 2D bag assemblies
    2. 3D bag assemblies
  2. Filtration Assemblies
  3. Bottle Assemblies
  4. Tubing Assemblies
  5. Other Products
By Application
  1. Filtration
  2. Cell Culture and Mixing
  3. Storage
  4. Sampling
  5. Fill-finish Applications
  6. Other Applications
By Solution
  1. Customized Solutions
  2. Standard Solutions
By End-user
  1. Biopharmaceutical and Pharmaceutical Companies
  2. CROs and CMOs
  3. Academic and Research Institutes
Company Profiles Thermo Fisher Scientific Sartorius AG Danaher Corp. Merck KGaA Avantor Lonza Saint-Gobain Corning Inc. Entegris KUHNER AG
Geographies Covered
North America U.S. Canada
Europe U.K. Germany France Spain Italy Russia Nordic Benelux Rest of Europe
APAC China Korea Japan India Australia Singapore Taiwan South East Asia Rest of Asia-Pacific
Middle East and Africa UAE Turkey Saudi Arabia South Africa Egypt Nigeria Rest of MEA
LATAM Brazil Mexico Argentina Chile Colombia Rest of LATAM
Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends
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Segmental Analysis

The global single-use assembly market is segmented based on product, applications, solutions, end-users, and region.

The market is further segmented by product into Bag Assemblies, Filtration Assemblies, Bottle Assemblies, and tubing Assemblies.

Filtration Assemblies account for the largest share of the market. Filtration assemblies are single-use filters and associated components used in the pharmaceutical and biotechnology industries to purify and sterilize bioprocess fluids. In 2022, the filtering assemblies segment accounted for 30% of total revenue. Increased regulatory opportunities and the desire to reduce contamination risk have pushed the usage of filtration assemblies in bulk and final fill operations. Because they eliminate sterilizing processes and the associated validation protocols, single-use filtration assemblies provide a versatile and efficient alternative to stainless-steel systems. 

Bag assemblies comprise single-use bags of biocompatible materials for storing, transporting, and handling liquids and powders in various bioprocessing applications.

The segment can be bifurcated by application into Filtration, Cell Culture and mixing, Storage, Sampling, and Fill-finish Applications.

Filtration is the most common application in the market. Single-use assemblies filter bioprocess fluids to eliminate contaminants, particles, and microbes in filtration applications. This procedure is critical for ensuring the final biopharmaceutical product's purity and sterility. In 2022, the filtration segment dominated the industry with a revenue share of 29% of total revenue. Because of their advantages infiltration, the use of single-use filtration assemblies is fast expanding. SUTs save not just money and time but also 90 percent integrity testing, 90 percent sterile connections, and up to 90 percent tubing time. Unlike traditional filtering systems, single-use flirtation systems save process time because they are ready to use. Several manufacturing facilities will be required to address the growing market demand for biopharmaceuticals. 

Cell culture and mixing applications include cultivating and propagating cells in bioreactors using single-use assemblies. Mixing is necessary for uniform growth and the distribution of nutrients and gasses. Single-use cell culture and mixing assemblies enable versatile and scalable procedures, allowing for efficient cell growth and bioprocess optimization.

Based on solutions, the market is divided into Customized, Standard.

Customized solutions are a significant contributor to the market. Customized single-use solutions are assemblies manufactured to satisfy a specific customer's needs, application, or process. These solutions are frequently developed with the end user or manufacturer to address unique issues or optimize a specific bioprocessing operation. In 2022, the customized solutions segment dominated the global industry, accounting for 75% of overall sales. Pharmaceutical businesses, labs, and other end-users can easily integrate the devices into their processes, speeding production and minimizing the trouble of sterilizing and cleaning with a single order. 

Standard single-use solutions are pre-designed and off-the-shelf assemblies for various common bioprocessing applications. These solutions are intended to fulfill the needs of a wide range of customers and are often easy to get and deploy without requiring substantial modification.

Based on end-users, the market is sub-segmented into Biopharmaceutical and Pharmaceutical Companies, CROs and CMOs, and Academic and Research Institutes.

Biopharmaceutical and pharmaceutical Companies are the primary end-users of the market. Established biopharmaceutical and pharmaceutical firms involved in the research, development, production, and commercialization of pharmaceutical goods such as biologics, vaccines, and traditional pharmaceuticals are included in this section. Single-use assemblies are used by biopharmaceutical and pharmaceutical businesses at many stages of product research and manufacture, including cell culture, fermentation, purification, and fill-finish procedures.

CROs and CMOs provide biopharmaceutical and pharmaceutical companies with outsourced services such as research, development, clinical trials, and contract manufacturing of biopharmaceutical products.

Market Size By Product

Recent Developments

  • October 2023- Thermo Fisher Scientific and Boehringer Ingelheim signed a companion diagnostic agreement to select patients with NSCLC for targeted therapy treatment.
  • September 2023- Sartorius Life Science Group offered the Picus® 2 Electronic Pipette, the latest addition to their electronic pipette range.

Top Key Players

Single-Use Assemblies Market Share of Key Players

Thermo Fisher Scientific Sartorius AG Danaher Corp. Merck KGaA Avantor Lonza Saint-Gobain Corning Inc. Entegris KUHNER AG

Frequently Asked Questions (FAQs)

What is the estimated size of the Single-Use Assemblies Market?
The global single-use assemblies market size was valued at USD 11,132.5 million in 2022 and is projected to reach a value of USD 54,907.5 million by 2031, registering a CAGR of 19.4% during the forecast period (2023-2031).  
North America region has the highest growth rate in the Single-Use Assemblies Market.
The key players in the global Single-Use Assemblies Market include Thermo Fisher Scientific, Sartorius AG, Danaher Corp., Merck KGaA, Avantor, Lonza, Saint-Gobain, Corning Inc., Entegris, and KUHNER AG.
Biopharmaceutical Industry Growth are some key drivers supporting the growth of the Single-Use Assemblies Market.
The global single-use assembly market is segmented based on product, applications, solutions, end-users, and region.


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