Single-use Assemblies Market (By Product: Bag Assemblies, Filtration Assemblies; By Application: Filtration, Storage; By Solution: Customized Solution, Standard Solution; By End-use) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The global single-use assemblies market size was estimated at USD 12.14 billion in 2023 and it is expected to surpass around USD 67.18 billion by 2033, poised to grow at a CAGR of 18.66% from 2024 to 2033. The single-use assemblies market is driven by the increasing demand for flexible and cost-effective solutions in biopharmaceutical manufacturing.

Key Pointers

• North America led the market with the largest market share of 37% in 2023.
• Asia Pacific is expected to expand at the highest CAGR from 2024 to 2033.
• By Product, the filtration assemblies held the largest revenue share of 30% in 2023.
• By Application, the filtration segment registered the maximum market share of 29% in 2023.
• By Application, the cell culture & mixing segment is anticipated to grow at the noteworthy CAGR of 20.56% from 2024 to 2033.
• By Solution, the customized solutions contributed the largest market share of 72% in 2023.
• By End-use, the biopharmaceutical and pharmaceutical contributed the largest market share of 46% in 2023.

Single-use Assemblies Market Growth

The growth of the single-use assemblies market can be attributed to several key factors driving its expansion. Firstly, the surging demand for biopharmaceuticals has propelled the adoption of single-use assemblies as they provide a flexible and cost-effective solution, allowing manufacturers to meet varying production scales efficiently. Additionally, the inherent advantages of these assemblies, such as minimizing cross-contamination risks and enhancing operational flexibility, contribute significantly to their increased utilization. The support from regulatory bodies, which recognize the compliance benefits and expedited validation processes associated with single-use technologies, further fuels market growth. As the biopharmaceutical industry continues to evolve, the market for single-use assemblies is expected to witness sustained expansion, with ongoing advancements addressing environmental concerns and fostering standardization within the industry.

Single-use Assemblies Market Trends:

• Increasing Adoption in Bioprocessing: Single-use assemblies are witnessing a rising trend in adoption within the bioprocessing sector, driven by their ability to offer flexible and scalable solutions for biopharmaceutical manufacturing.
• Technological Advancements and Innovation: Ongoing technological advancements, including improvements in material science and manufacturing processes, are contributing to the development of more advanced and efficient single-use assembly technologies.
• Rapid Growth of Biopharmaceutical Industry: The exponential growth of the biopharmaceutical industry is a significant trend propelling the demand for single-use assemblies, as they cater to the industry's need for streamlined and cost-effective manufacturing processes.
• Expansion of Applications: Single-use assemblies are finding expanded applications beyond traditional uses, such as in fill-finish operations, cell culture, and purification processes, showcasing their versatility and adaptability across various stages of biopharmaceutical production.
• Rise in Outsourcing to CDMOs: Contract Development and Manufacturing Organizations (CDMOs) are increasingly incorporating single-use assemblies due to their advantages in cost-efficiency, reduced cleaning validation requirements, and quicker turnaround times, reflecting a growing trend in outsourcing biopharmaceutical production.
• Emphasis on Quality and Compliance: Quality and compliance remain at the forefront of industry priorities. Single-use assemblies, with their potential to facilitate adherence to stringent regulatory standards, are becoming integral to maintaining high-quality biopharmaceutical production processes.
• Continuous Improvement in Validation Processes: The industry is witnessing continuous efforts to improve and standardize validation processes associated with single-use technologies, making them more efficient and ensuring their seamless integration into existing biopharmaceutical manufacturing workflows.

Product Insights

Filtration assemblies dominated the market with the highest share, accounting for approximately 30% in 2023. The increased focus on regulatory compliance and the imperative to reduce contamination risks have driven the widespread adoption of filtration assemblies in both bulk and final fill operations. Single-use filtration assemblies, serving as a flexible and efficient alternative to stainless-steel systems, eliminate sterilization steps and associated validation protocols. Notably, the segment of bag assemblies is anticipated to exhibit the fastest Compound Annual Growth Rate (CAGR) of 20.03% from 2024 to 2033. Within the biopharmaceutical sector, various sizes and shapes of single-use bag assemblies find versatile applications, including cell cultivation, formulation, sampling bags, buffer mediums, and feed processes.

The extensive integration of single-use bags across bio-manufacturing processes has expanded their utility to drug substance transportation. Single-use bag assemblies enable the rapid assembly and configuration of diverse sterile fluid-processing circuits. Additionally, these bags present an appealing solution for shipping and bulk freezing, offering advantages such as reduced maintenance costs, lower capital investments, decreased shipping expenses due to lighter weight, and the elimination of validation or cleaning requirements. The bag assemblies segment is further categorized into 2D and 3D, with 2D bag assemblies holding the largest share, driven by technological advancements.

Application Insights

In 2023, the filtration segment took the lead in the industry, capturing a substantial revenue share of 29%. Single-Use Technologies (SUTs) not only offer cost and time savings but also present efficiencies in integrity testing, sterile connections, and tubing, reducing these processes by 90%. The immediate usability of SUTs contrasts with conventional filtration systems, saving valuable process time. To keep pace with the escalating market demand for biopharmaceuticals, manufacturers are increasingly adopting single-use facilities. This strategic shift facilitates faster product turnaround times and accommodates multiple product manufacturing processes within the same facility, supporting the commercial success of biopharmaceuticals.

Anticipated to exhibit the highest Compound Annual Growth Rate (CAGR) of 20.56% from 2024 to 2033, the cell culture & mixing segment is poised for significant growth. This surge is attributed to the growing demand for biopharmaceuticals, supportive governmental policies, and increased research and development investments. Additionally, the rising demand for mammalian cell lines in upstream bioprocessing is a key driver of this growth. Notably, biopharmaceutical companies and researchers are increasingly utilizing cell culture techniques to develop vaccines for various diseases, including rubella, polio, smallpox, chickenpox, and hepatitis. The prevalence of infectious diseases such as COVID-19 and chronic conditions globally further contributes to the optimistic market outlook during the study period.

Solution Insights

The industry is classified into customized solutions and standard solutions based on offerings, with customized solutions dominating the market in 2023, accounting for a substantial share of 72%. This prevalence can be attributed to the seamless integration capabilities these solutions provide to pharmaceutical companies, laboratories, and other end-users. By facilitating streamlined production and eliminating the need for sterilization and cleaning, these customized solutions offer efficiency with a single order. Many key players in the market prioritize offering tailored solutions to meet the specific needs of users.

Manufacturers offering bespoke solutions play a crucial role in addressing supply chain constraints, component incompatibility, and meeting specific requirements, ensuring that the systems evolve to meet future needs. Major industry players like Sartorius AG, Thermo Fisher Scientific, Inc., Merck, and Danaher have consistently advanced technologies for Single-Use (SU) systems. Their diverse range of custom products caters to the growing demands of the biopharmaceutical industry. Continuous developments and portfolio expansions in these customized products further propel their integration into various bio manufacturing processes, driving the overall progress of the bioprocessing industry.

End-use Insights

In 2023, the biopharmaceutical and pharmaceutical companies took the lead in the industry, holding the highest market share at 46%. The expansion of current manufacturing facilities for biopharmaceuticals has been a significant driver for the increased demand for single-use assemblies. A notable example is Alexion's investment of USD 70 million in June 2022, directed towards novel drug production warehousing facilities and equipment in Ireland, aimed at enhancing manufacturing capabilities and expanding the biologics drug substance portfolio. Similarly, Upperton Pharma Solutions invested USD 16 million in May 2022 for facility expansion, contributing to increased R&D space and a substantial 10-fold expansion in GMP manufacturing space.

Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) are poised to exhibit the fastest Compound Annual Growth Rate (CAGR) of 19.745% during the forecast period. In recent years, CMOs have extensively integrated Single-Use Technologies (SUT) into their bioprocesses. Single-use assemblies play a crucial role in expediting processing and process changeover times for CMOs. The inherent short turnaround time and flexibility provided by single-use equipment enhance CMO efficiency, leading to overall cost reduction. Additionally, the growing number of CMO facilities fully adopting single-use technology proves instrumental in saving on campaign and facility costs, contributing to reduced operating costs and capital investments.

Regional Insights

In 2023, North America asserted dominance in the market, securing a significant share of 37%. This prominence is credited to the burgeoning biotechnology and pharmaceutical sectors, advancements in product development, and the escalating incidence of diseases like cancer. The region also benefits from substantial investments and funding in drug discovery research. A notable example is Thermo Fisher Scientific Inc.'s move in August 2022, where it inaugurated a USD 105 million, 400,000-square-foot single-use technology manufacturing site in Greater Nashville.

Asia Pacific is anticipated to register the swiftest Compound Annual Growth Rate (CAGR) from 2024 to 2033, driven by strategic initiatives from key industry players. In 2021, Sartorius made substantial investments in China, creating additional cleanroom space in Beijing for the production of bags and single-use filters. Another significant development was announced in September 2021 by Cytiva, planning to construct a disposable manufacturing facility in South Korea with a substantial investment of USD 52.5 million. This expansion aims to cater to the bioprocessing industry's demand for single-use bags, particularly in the production of COVID-19 vaccines.

Single-use Assemblies Market Key Companies

• Thermo Fisher Scientific, Inc.
• Merck KGaA
• Sartorius AG
• Danaher Corporation
• Avantor
• Lonza
• Saint-Gobain
• Corning Incorporated
• Entegris
• KUHNER AG

Single-use Assemblies Market Segmentations:

By Product

• Bag Assemblies
  • 2D bag assemblies
  • 3D bag assemblies
• Filtration Assemblies
• Bottle Assemblies
• Tubing Assemblies
• Other Products

By Application

• Filtration
• Cell Culture & Mixing
• Storage
• Sampling
• Fill-finish Applications
• Other Applications

By Solution

• Customized Solutions
• Standard Solutions

By End-use

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

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa