Single-Use Assemblies Market Revenue, Top Companies, Report 2033


16 Jul 2024

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The global single-use assemblies market revenue was valued at USD 11.34 billion in 2023 and is poised to grow from USD 13.21 billion in 2024 to USD 52.20 billion by 2033, at a CAGR of 16.5% during the forecast period 2024 – 2033. The increasing prevalence of cancer and infectious diseases is expected to enhance the growth of the single-use assemblies market.

Single-Use Assemblies Market Statistics

Market Overview

The single-use assemblies market deals with the solution developed for a bioprocedure that is custom-designed or provided off-the-shelf as a single-use stream path for specific biopharmaceutical applications. The growing biologics market, increasing research and development activities by biopharmaceutical companies, increasing demand for low-risk contamination systems, and growing adoption of single-use assemblies in biopharmaceutical manufacturing are expected to enhance the growth of the market.

In addition, increasing new product introductions by major market players, the increasing demand for established roles and novel therapeutics of single-use assemblies in production lines, increasing demand for monoclonal antibodies, cell therapies, and vaccines, and various strategic initiatives undertaken by industry participants to expand their business avenues are further anticipated to enhance the growth of the single-use assemblies market during the forecast period.

  • The increasing deployment and lower risk of cross-contamination fuel the growth of single-use assemblies.
  • The growing standardization and industrialization coupled with various other technical breakthroughs in various countries are expected to drive the growth of the market.
  • The rising commercialization and development of technologically cutting-edge single-use assembly products with quick deployment, simple operation, and simplified workflows are further anticipated to accelerate the growth of the market.

Cost savings and flexibility of single-use assemblies to fuel market growth.

Single-use assemblies provide remarkable time flexibility and efficiency as compared to traditional assemblies in biopharmaceutical manufacturing. Singl-use assemblies require time-consuming and labor-intensive steps. All single-use assemblies can be discarded after use, which enables increased manufacturing capacity and faster turnaround times. This leads to optimized time efficiency in the production procedure.

In addition, in biopharmaceutical manufacturing, single-use assemblies provide significant cost savings. Single-use assemblies need less facility space and infrastructure. Reusable assemblies often necessitate dedicated sterilization and cleaning areas, along with capital expenses and increasing facility and equipment storage. It also helps to reduce the need for such infrastructure and enables more efficient utilization of resources and space. These factors are expected to enhance the growth of the single-use assemblies market.

However, challenges related to extractives and leachables may restrain the market growth. Suppliers offer data related to extractable from their products relying on analysis under several likely procedure conditions, but leachables can only be fixed by testing the drug goods. Single-use assemblies are produced from plastic films made of various polymer layers. Each layer adds to the chemical or physical properties needed for the single-use assemblies to function properly in bioprocessing. Still, these layers may have their own set of additives, such as stabilizers, plasticizers, fillers, and antioxidants, to obtain the essential characteristics.

In addition, due to extractables and leachables not being developed yet, regulations related to the contamination of single-use assemblies. These factors may restrain the growth of the single-use assemblies market.

Single-Use Assemblies Market Highlights

Report Attribute Key Statistics
Market Revenue in 2024 USD 13.21 Billion
Market Revenue by 2033 USD 52.20 Billion
Market CAGR 16.5% from 2024 to 2033
Quantitative Units Revenue in USD million/billion, Volume in units
Largest Market North America
Base Year 2023
Forecast Period 2024 to 2033
Regions Covered North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa

Single-Use Assemblies Market Top Companies

  • Antylia Scientific
  • Avantor, Inc.
  • Corning Incorporated
  • Danaher Corporation
  • Entegris
  • SaniSure
  • Flexbiosys
  • Kuhner AG
  • Lonza
  • Meissner Filtration Products
  • Merck KGaA
  • Newage Industries
  • Pall Corporation
  • Parker-Hannifin Corporation
  • Repligen Corporation
  • Romynox
  • Watson-Marlow Fluid Technology Solutions
  • Saint-Gobain Performance Plastics
  • Sartorius Stedim Biotech
  • Thermo Fisher Scientific, Inc.

Recent Innovation in the Single-Use Assemblies Market by SaniSure

  • In April 2024, a global player in the field of single-use bioprocessing products, SaniSure, launched Fill4Sure, a custom single-use filling assembly designed to expedite drugs to market and build security, efficiency, and repeatability into drug product filling. Fill4Sure provided a solution to the critical challenges drug manufacturers experience throughout the fill-finish process, such as limited speed and high costs.

Recent Innovation in the Single-Use Assemblies Market by Watson-Marlow Fluid Technology Solutions

  • In April 2024, a manufacturer of peristaltic pumps and associated fluid path technologies, Watson-Marlow Fluid Technology Solutions (WMFTS), announced the launch of WMArchitect, a range of flexible, single-use solutions for biopharmaceutical fluid management. The platform builds on predecessors such as Purest and Asepticsu and is designed to streamline a biopharma company’s process, safeguard products, and reduce regulatory burden.

Regional Insights

Asia Pacific is expected to grow fastest during the forecast period. The increasing expansion of the single-use assemblies in the region can be attributed to elements such as life sciences research, higher capital spending in pharmaceutical research and development activities, and the existence of a favorable corporate environment.

In addition, increasing strategic activities of major key players and growing incomes are further expected to drive the growth of the single-use assemblies market in the region. The governments in the Asia Pacific are providing incentives to establish world-class biomanufacturing hubs and promote healthcare innovations, which will expand the regional supply chain network. China, India, Japan, and South Korea are the major countries in the region.

  • For instance, the U.S. and Canada life science business of Merck KGaA, Merck and Darmstadt, Germany, technology and a leading science company, launched the Life Science business sectors signed an agreement with the Wuxi National High-Tech Industrial Development Zone’s Administrative Management Committee to expand the company’s first Asia Pacific Mobius® Single-Use manufacturing center in China.

North America dominated the single-use assemblies market in 2023. The region dominated the market for single-use assemblies due to the strong presence of biotechnology and pharmaceutical industries. The U.S. and Canada are the major countries in the region. These countries have the largest pharmaceutical companies with robust research and development infrastructure. In addition, a favorable regulatory environment improves the use of technologies that enhance the flexibility and efficiency of bio-manufacturing operations.

  • For instance, in June 2023, freeze-thaw logistic solutions and leading provider of fluid management, Single Use Support, for the biopharmaceutical industry, was excited to announce its further expansion into the United States market.

KUFSTEIN - The company has experienced significant growth in recent years with a local sales team in the United States and distribution partners in South America and Asia. The increased expansion into the US market is a natural step for Single-Use Support as it looks to better serve and global footprint its consumers in the whole of North America.

Market Potential and Growth Opportunity

Emerging knowledge of sustainability

Single-use assemblies are more environmentally friendly than traditional assemblies. Less than 0.01% of global plastic waste generated yearly stems from single-use assemblies utilized in biopharma. Moving stainless steel to single-use assemblies can potentially reduce the carbon emissions and water and energy consumption of the pharma and biopharma industries. Single-use assembly manufacturers are aware of the increasing deployment of the industry and need strategies to adopt long-term sustainability. In addition, manufacturers of single-use assemblies are required to improve the separation of the product into the base materials after use. Therefore, most single-use products are very simple to recycle and disassemble. These are some major opportunities that are expected to boost the growth of the single-use assembly market in the coming years.

Single-Use Assemblies Market News

  • In August 2023, Trelleborg Healthcare and Medical launched the BioPharmaPro family of innovative products, materials, and services for fluid path single-use equipment to accelerate the advancement of life-changing therapies.
  • In August 2023, in Bengaluru, at the HAL market, a single-use plastic-free campaign was launched by the Circular Waste Solutions project. The aim behind this launch was to eliminate the use of single-use plastic in the markets and encourage the use of alternatives.

Market Segmentation

By Product 

  • Bag Assemblies
  • Filtration Assemblies
  • Tubing Assemblies
  • Bottle Assemblies
  • Others

By Application

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

By Solution

  • Customized
  • Standard

By End-User

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

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