일회용 어셈블리 시장 규모, 점유율, 동향 분석 보고서 : 제품별, 용도별, 솔루션별, 최종 용도별, 지역별, 부문별 예측(2025-2030년)

Single-use Assemblies Market Growth & Trends:

The global single-use assemblies market size is expected to reach USD 31.87 billion by 2030, registering a CAGR of 16.24% from 2025 to 2030, according to a new report by Grand View Research, Inc. Life science companies are eager to avoid the cost and time of cleaning needed with stainless steel. The augmented expansion of the international biotech industries has offered a growth environment, in which novel, disposable technologies are becoming more significant. As pharmaceutical companies, distributors, CDMOs, and manufacturers converge around the benefits of single-use assemblies, the industry will grow at a faster pace during the forecast period. From therapies for rare diseases to cancer research, the impact of single-use technology in accelerating cutting-edge research into these conditions is set to grow, thereby propelling industry growth.

In addition, the growing biologics market will further offer lucrative opportunities during the study period. Eradicating the risk of contamination is the major challenge faced by biopharmaceutical manufacturers, which currently involves high-level monitoring of critical manufacturing solutions. Single-use assemblies support manufacturers in overcoming this difficulty by eliminating or reducing the necessity for sterilization between the batches, thereby filtering the operational capability. SUTs are considered one of the important areas of growth among biomanufacturing companies, as several biopharmaceutical companies are venturing into disposable assembly offerings for the production of all sorts of biopharmaceuticals.

Moreover, SUTs are now being heavily adopted for the clinical manufacturing of biopharmaceuticals and have become more conventional within commercial manufacturing facilities. SUTs permit biologics manufacturers to reduce the facilities' footprint by almost 20% due to the need for utilities, which generate steam, water, and clean-in-place solutions. Furthermore, as per the research by BioProcess International, the engineers estimated that the capital expenditure for the single-use facility is 25-45% less than for a facility established on stainless-steel equipment. Similarly, they also estimated that single-use facilities need half the energy and water during operations and can be built in 18 months. Whereas the stainless-steel facility takes three years. Owing to such advantages, the adoption of single-use assemblies is increasing, thereby driving industry growth.

In recent years, CMOs have been integrating single-use assemblies into most or all their bioprocess. CMOs broadly use single-use assemblies for quicker processing and process changeover time. The quick turnaround time and flexibility between process runs and various client projects allowed by single-use assemblies can enhance the CMO efficiency, which, in turn, aids in the reduction of the overall costs. In addition, the growing number of CMO facilities are essentially fully single-use. CMOs adoption of single-use technology can save on campaign and facility costs, which helps reduce the operating costs and capital investments. Furthermore, single-use assemblies in CMOs decrease the complexity and reduces lead times in upstream processes.

They also enhance the quality of products by preventing cross-contamination in downstream processes, especially for processes handling potent or toxic materials, such as antibody-drug conjugates and viral vectors. Moreover, stringent regulatory requirements in the manufacturing systems also endorse the adoption of single-use assemblies in CMOs.COVID-19 has augmented an already rapidly rising demand for single-use assemblies as the SUTs allow for the speedy production and development of therapies and vaccines and improve accuracy and time. For instance, Aramus single-use bag assembly developed by Entegris, Inc. was used for the storage of COVID-19 vaccines as the vaccines need extremely low temperatures to preserve. With low leachable and extractable and an extensive operating-temperature variety, the patented single-use bags were ideal for cold chain storage and collection.

In addition, key manufacturers are also accelerating investment projects or increasing their capital expenditures. For instance, Pall Corp., invested USD 114 million to upsurge its single-use output. These investments comprise additional manufacturing capacity at 6 current manufacturing facilities in the United States and Europe. Moreover, MilliporeSigma, Thermo Fisher, and Cytiva have also augmented growth plans to support the industry's backlog. For instance, in March 2021 Merck announced the addition of a single-use assembly production unit at its Life Science Center in Molsheim, France. The investment of USD 26.25 million will accelerate the European expansion plans of the company for single-use products critical to manufacturing vaccines and lifesaving therapies. On the other hand, regulatory concerns due to leachable and extractable might hamper the growth of disposable assemblies in the forecast period.

Leachable and extractable are set of undesired impurities in the product stream, these are compounds that can move into the product from manufacturing systems, packaging containers, or other product-contact systems. Extractable is extracted from the contact materials under extreme conditions, such as treatment with a harsh solvent or elevated temperature conditions. Leachable compounds, on the other hand, are those that are leached into the final product from contact materials during normal or real-time storage conditions. North America dominated the global industry in 2023 due to the growth in the biotechnology and pharmaceutical industries, advancement in SUT products, and increasing incidence of diseases, such as cancer coupled with increasing investments and funding in drug discovery research. Asia Pacific is expected to grow at a considerable CAGR over the forecast years owing to the strategic activities by key players coupled with funding by the government for biopharmaceutical R&D.

Single-use Assemblies Market Report Highlights:

• The filtration assemblies segment led the industry in 2024. Increased regulatory prospects and the need to diminish the risk of contamination have promoted the use of filtration assemblies for bulk and final fill operations
• The bag assemblies segment is expected to grow at a lucrative CAGR over the forecast period. Advantages, such as no need for validation or cleaning, lower shipping cost due to less weight, and low maintenance cost & capital investment drive the segment growth
• The customized solutions segment captured the highest revenue share in 2024. Several companies offer customized solutions to fast-track pharmaceutical manufacturing and drug development
• The pharmaceutical & biotechnological companies end-user segment led the global industry in 2024. The growth of the current manufacturing facilities for biopharmaceuticals drives the demand for single-use assemblies
• The CROs & CMOs segment is expected to grow at the fastest CAGR over the forecast period. In recent years, CMOs have been integrating single-use technology into most or all their bioprocess
• The quick turnaround time and flexibility between process runs and various client projects allowed by single-use equipment can enhance the CMO efficiency, which aids in the reduction of the overall costs

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Product
  • 1.2.2. Application
  • 1.2.3. Solution
  • 1.2.4. End use
• 1.3. Research Methodology
• 1.4. Information Procurement
• 1.5. Information or Data Analysis
  • 1.5.1. Data analysis models
• 1.6. Market Formulation & Validation
• 1.7. List of Secondary Sources
• 1.8. List of Primary Sources
• 1.9. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. Single-use Assemblies Market Variables and Trends

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent market outlook
  • 3.1.2. Related/ancillary market outlook
• 3.2. Market Dynamics
  • 3.2.1. Market driver analysis
    • 3.2.1.1. Advantages of Single-use Assemblies In Bio manufacturing
    • 3.2.1.2. Growing Biologics Market
    • 3.2.1.3. Increasing Biopharmaceutical R&D
  • 3.2.2. Market restraint analysis
    • 3.2.2.1. Regulatory Concerns Over Leachable & Extractable
• 3.3. Single-use Assemblies Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
  • 3.3.2. PESTEL Analysis
  • 3.3.3. COVID-19 Impact Analysis

Chapter 4. Single-use Assemblies Market: Product Estimates & Trend Analysis

• 4.1. Product Segment Dashboard
• 4.2. Global Single-use Assemblies Market Product Movement Analysis
• 4.3. Global Single-use Assemblies Market Size & Trend Analysis, by Product, 2018 to 2030 (USD Million)
• 4.4. Bag Assemblies
  • 4.4.1. Bag Assemblies Market Size & Forecasts and Trend Analyses, 2018 to 2030 (USD Million)
  • 4.4.2. 2D Bag Assemblies
    • 4.4.2.1. 2D Bag Assemblies Market Size & Forecasts and Trend Analyses, 2018 to 2030 (USD Million)
  • 4.4.3. 3D Bag Assemblies
    • 4.4.3.1. 3D Bag Assemblies Market Size & Forecasts and Trend Analyses, 2018 to 2030 (USD Million)
• 4.5. Filtration Assemblies
  • 4.5.1. Filtration Assemblies Market Size & Forecasts and Trend Analyses, 2018 to 2030 (USD Million)
• 4.6. Bottle Assemblies
  • 4.6.1. Bottle Assemblies Market Size & Forecasts and Trend Analyses, 2018 to 2030 (USD Million)
• 4.7. Tubing Assemblies
  • 4.7.1. Tubing Assemblies Market Size & Forecasts and Trend Analyses, 2018 to 2030 (USD Million)
• 4.8. Others
  • 4.8.1. Others Market Size & Forecasts and Trend Analyses, 2018 to 2030 (USD Million)

Chapter 5. Single-use Assemblies Market: Solution Estimates & Trend Analysis

• 5.1. Solution Segment Dashboard
• 5.2. Global Single-use Assemblies Market Solution Movement Analysis
• 5.3. Global Single-use Assemblies Market Size & Trend Analysis, by Solution, 2018 to 2030 (USD Million)
• 5.4. Customized Solutions
  • 5.4.1. Customized Solutions Market Size & Forecasts and Trend Analyses, 2018 to 2030 (USD Million)
• 5.5. Standard Solutions
  • 5.5.1. Standard Solutions Market Size & Forecasts and Trend Analyses, 2018 to 2030 (USD Million)

Chapter 6. Single-use Assemblies Market: Application Estimates & Trend Analysis

• 6.1. Application Segment Dashboard
• 6.2. Global Single-use Assemblies Market Application Movement Analysis
• 6.3. Global Single-use Assemblies Market Size & Trend Analysis, by Application, 2018 to 2030 (USD Million)
• 6.4. Filtration
  • 6.4.1. Filtration Market Size & Forecasts and Trend Analyses, 2018 to 2030, (USD Million)
• 6.5. Cell Culture & Mixing
  • 6.5.1. Cell Culture & Mixing Market Size & Forecasts and Trend Analyses, 2018 to 2030, (USD Million)
• 6.6. Storage
  • 6.6.1. Storage Market Size & Forecasts and Trend Analyses, 2018 to 2030, (USD Million)
• 6.7. Sampling
  • 6.7.1. Sampling Market Size & Forecasts and Trend Analyses, 2018 to 2030, (USD Million)
• 6.8. Fill-finish Applications
  • 6.8.1. Fill-finish Applications Market Size & Forecasts and Trend Analyses, 2018 to 2030, (USD Million)
• 6.9. Others
  • 6.9.1. Others Market Size & Forecasts and Trend Analyses, 2018 to 2030, (USD Million)

Chapter 7. Single-use Assemblies Market: End Use Estimates & Trend Analysis

• 7.1. End Use Segment Dashboard
• 7.2. Global Single-use Assemblies Market End Use Movement Analysis
• 7.3. Global Single-use Assemblies Market Size & Trend Analysis, by End Use, 2018 to 2030 (USD Million)
• 7.4. Biopharmaceutical & Pharmaceutical Companies
  • 7.4.1. Biopharmaceutical & Pharmaceutical Companies Market Size & Forecasts and Trend Analyses, 2018 to 2030 (USD million)
• 7.5. CROs & CMOs
  • 7.5.1. CROs & CMOs Market Size & Forecasts and Trend Analyses, 2018 to 2030 (USD million)
• 7.6. Academic & Research Institutes
  • 7.6.1. Academic & Research Institutes Market Size & Forecasts and Trend Analyses, 2018 to 2030 (USD million)

Chapter 8. Single-use Assemblies Market: Regional Estimates & Trend Analysis

• 8.1. Regional Market Share Analysis, 2024 & 2030
• 8.2. Regional Market Dashboard
• 8.3. North America
  • 8.3.1. U.S.
    • 8.3.1.1. Key country dynamics
    • 8.3.1.2. Regulatory framework
    • 8.3.1.3. Competitive scenario
    • 8.3.1.4. U.S. market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.3.2. Canada
    • 8.3.2.1. Key country dynamics
    • 8.3.2.2. Regulatory framework
    • 8.3.2.3. Competitive scenario
    • 8.3.2.4. Canada market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.3.3. Mexico
    • 8.3.3.1. Key country dynamics
    • 8.3.3.2. Regulatory framework
    • 8.3.3.3. Competitive scenario
    • 8.3.3.4. Mexico market estimates and forecasts 2018 to 2030, (USD Million)
• 8.4. Europe
  • 8.4.1. UK
    • 8.4.1.1. Key country dynamics
    • 8.4.1.2. Regulatory framework
    • 8.4.1.3. Competitive scenario
    • 8.4.1.4. UK market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.4.2. Germany
    • 8.4.2.1. Key country dynamics
    • 8.4.2.2. Regulatory framework
    • 8.4.2.3. Competitive scenario
    • 8.4.2.4. Germany market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.4.3. France
    • 8.4.3.1. Key country dynamics
    • 8.4.3.2. Regulatory framework
    • 8.4.3.3. Competitive scenario
    • 8.4.3.4. France market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.4.4. Italy
    • 8.4.4.1. Key country dynamics
    • 8.4.4.2. Regulatory framework
    • 8.4.4.3. Competitive scenario
    • 8.4.4.4. Italy market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.4.5. Spain
    • 8.4.5.1. Key country dynamics
    • 8.4.5.2. Regulatory framework
    • 8.4.5.3. Competitive scenario
    • 8.4.5.4. Spain market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.4.6. Norway
    • 8.4.6.1. Key country dynamics
    • 8.4.6.2. Regulatory framework
    • 8.4.6.3. Competitive scenario
    • 8.4.6.4. Norway market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.4.7. Sweden
    • 8.4.7.1. Key country dynamics
    • 8.4.7.2. Regulatory framework
    • 8.4.7.3. Competitive scenario
    • 8.4.7.4. Sweden market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.4.8. Denmark
    • 8.4.8.1. Key country dynamics
    • 8.4.8.2. Regulatory framework
    • 8.4.8.3. Competitive scenario
    • 8.4.8.4. Denmark market estimates and forecasts 2018 to 2030, (USD Million)
• 8.5. Asia Pacific
  • 8.5.1. Japan
    • 8.5.1.1. Key country dynamics
    • 8.5.1.2. Regulatory framework
    • 8.5.1.3. Competitive scenario
    • 8.5.1.4. Japan market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.5.2. China
    • 8.5.2.1. Key country dynamics
    • 8.5.2.2. Regulatory framework
    • 8.5.2.3. Competitive scenario
    • 8.5.2.4. China market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.5.3. India
    • 8.5.3.1. Key country dynamics
    • 8.5.3.2. Regulatory framework
    • 8.5.3.3. Competitive scenario
    • 8.5.3.4. India market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.5.4. Australia
    • 8.5.4.1. Key country dynamics
    • 8.5.4.2. Regulatory framework
    • 8.5.4.3. Competitive scenario
    • 8.5.4.4. Australia market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.5.5. South Korea
    • 8.5.5.1. Key country dynamics
    • 8.5.5.2. Regulatory framework
    • 8.5.5.3. Competitive scenario
    • 8.5.5.4. South Korea market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.5.6. Thailand
    • 8.5.6.1. Key country dynamics
    • 8.5.6.2. Regulatory framework
    • 8.5.6.3. Competitive scenario
    • 8.5.6.4. Thailand market estimates and forecasts 2018 to 2030, (USD Million)
• 8.6. Latin America
  • 8.6.1. Brazil
    • 8.6.1.1. Key country dynamics
    • 8.6.1.2. Regulatory framework
    • 8.6.1.3. Competitive scenario
    • 8.6.1.4. Brazil market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.6.2. Argentina
    • 8.6.2.1. Key country dynamics
    • 8.6.2.2. Regulatory framework
    • 8.6.2.3. Competitive scenario
    • 8.6.2.4. Argentina market estimates and forecasts 2018 to 2030, (USD Million)
• 8.7. MEA
  • 8.7.1. South Africa
    • 8.7.1.1. Key country dynamics
    • 8.7.1.2. Regulatory framework
    • 8.7.1.3. Competitive scenario
    • 8.7.1.4. South Africa market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.7.2. Saudi Arabia
    • 8.7.2.1. Key country dynamics
    • 8.7.2.2. Regulatory framework
    • 8.7.2.3. Competitive scenario
    • 8.7.2.4. Saudi Arabia market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.7.3. UAE
    • 8.7.3.1. Key country dynamics
    • 8.7.3.2. Regulatory framework
    • 8.7.3.3. Competitive scenario
    • 8.7.3.4. UAE market estimates and forecasts 2018 to 2030, (USD Million)
  • 8.7.4. Kuwait
    • 8.7.4.1. Key country dynamics
    • 8.7.4.2. Regulatory framework
    • 8.7.4.3. Competitive scenario
    • 8.7.4.4. Kuwait market estimates and forecasts 2018 to 2030, (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Company/Competition Categorization
• 9.2. Strategy Mapping
• 9.3. Company Position Analysis, 2024
• 9.4. Company Profiles/Listing
  • 9.4.1. Thermo Fisher Scientific, Inc.
    • 9.4.1.1. Company overview
    • 9.4.1.2. Financial performance
    • 9.4.1.3. Product benchmarking
    • 9.4.1.4. Strategic initiatives
  • 9.4.2. Merck KGaA
    • 9.4.2.1. Company overview
    • 9.4.2.2. Financial performance
    • 9.4.2.3. Product benchmarking
    • 9.4.2.4. Strategic initiatives
  • 9.4.3. Sartorius AG
    • 9.4.3.1. Company overview
    • 9.4.3.2. Financial performance
    • 9.4.3.3. Product benchmarking
    • 9.4.3.4. Strategic initiatives
  • 9.4.4. Danaher Corporation
    • 9.4.4.1. Company overview
    • 9.4.4.2. Financial performance
    • 9.4.4.3. Product benchmarking
    • 9.4.4.4. Strategic initiatives
  • 9.4.5. Avantor
    • 9.4.5.1. Company overview
    • 9.4.5.2. Financial performance
    • 9.4.5.3. Product benchmarking
    • 9.4.5.4. Strategic initiatives
  • 9.4.6. Lonza
    • 9.4.6.1. Company overview
    • 9.4.6.2. Financial performance
    • 9.4.6.3. Product benchmarking
    • 9.4.6.4. Strategic initiatives
  • 9.4.7. Saint-Gobain
    • 9.4.7.1. Company overview
    • 9.4.7.2. Financial performance
    • 9.4.7.3. Product benchmarking
    • 9.4.7.4. Strategic initiatives
  • 9.4.8. Corning Incorporated
    • 9.4.8.1. Company overview
    • 9.4.8.2. Financial performance
    • 9.4.8.3. Product benchmarking
    • 9.4.8.4. Strategic initiatives
  • 9.4.9. Entegris
    • 9.4.9.1. Company overview
    • 9.4.9.2. Financial performance
    • 9.4.9.3. Product benchmarking
    • 9.4.9.4. Strategic initiatives
  • 9.4.10. KUHNER AG
    • 9.4.10.1. Company overview
    • 9.4.10.2. Product benchmarking
    • 9.4.10.3. Strategic initiatives