SUS (Single Use System) for Biopharma Process Market, Global Outlook and Forecast 2025-2032

MARKET INSIGHTS

Global SUS (Single Use System) for Biopharma Process market size was valued at USD 6040 million in 2024 and is projected to reach USD 22220 million by 2032, exhibiting a CAGR of 21.0% during the forecast period.

SUS (Single Use Systems) for Biopharma Process refers to disposable bioprocessing equipment used in pharmaceutical manufacturing, designed for single-use applications before disposal. These systems primarily include single-use bioreactors, disposable sterile bags, and filtration systems, offering significant advantages in contamination control and operational flexibility compared to traditional stainless steel systems.

The market growth is driven by increasing biopharmaceutical production, demand for cost-effective manufacturing solutions, and regulatory emphasis on contamination prevention. While North America and Europe currently dominate with 32% market share each, Asia-Pacific is emerging as a strong contender with 31% share, fueled by expanding biomanufacturing capabilities in China and India. Major players like Danaher, Thermo Fisher, and Sartorius collectively control approximately 73% of the market, leveraging their extensive product portfolios and technological expertise.

MARKET DYNAMICS

MARKET DRIVERS

Accelerated Adoption of Biopharmaceuticals to Propel Market Expansion

The global biopharmaceutical industry is undergoing a transformative shift toward single-use systems (SUS) due to their operational efficiency and cost-effectiveness. With biopharmaceuticals accounting for over 30% of the total pharmaceutical pipeline, the demand for flexible manufacturing solutions has never been higher. Single-use technologies eliminate cross-contamination risks while reducing cleaning validation requirements, making them particularly valuable for complex biologics production. The market is further stimulated by the growing preference for modular facilities, where SUS implementations can reduce capital expenditures by 30-40% compared to traditional stainless-steel systems.

Pandemic Preparedness Driving Strategic Stockpiling Initiatives

The COVID-19 pandemic served as a catalyst for biopharma companies to reassess their supply chain resilience, leading to increased investments in SUS technologies. Vaccine manufacturers particularly benefited from the rapid deployment capabilities of single-use systems, with some COVID-19 vaccine production facilities being commissioned in under 12 months using SUS platforms. This demonstrated responsiveness has prompted governments worldwide to include single-use components in their national stockpiling strategies for pandemic preparedness. The ability to quickly scale production while maintaining sterility assurance continues to position SUS as a critical component in global health security frameworks.

➤ For instance, multiple mRNA vaccine producers reported 50-60% faster facility commissioning times when implementing single-use systems compared to traditional alternatives during the pandemic response.

Technological Advancements in Bioprocessing Equipment

Continuous innovations in single-use bioreactor designs and sensor technologies are expanding the application scope of SUS in biopharma processes. Recent developments include the introduction of single-use systems capable of supporting 2000L+ bioreactor volumes with improved mixing efficiency and mass transfer characteristics. These advancements address historical limitations of scale, enabling SUS adoption for commercial-scale manufacturing. Furthermore, the integration of advanced process analytical technologies (PAT) with single-use components provides real-time monitoring capabilities, enhancing process control and product quality assurance in bioprocessing operations.

MARKET RESTRAINTS

Supply Chain Vulnerabilities in Polymer Materials

The SUS market faces significant challenges stemming from its reliance on specialized polymer materials. Over 80% of single-use systems incorporate multilayer films that require pharmaceutical-grade certifications, creating dependencies on limited supplier networks. Recent geopolitical tensions and trade restrictions have exposed vulnerabilities in the availability of critical components, with lead times for certain SUS components extending beyond 12 months during peak demand periods. This material scarcity not only impacts production schedules but also contributes to price volatility, with some SUS components experiencing cost increases of 25-35% in recent years.

Regulatory Uncertainty in Extractables and Leachables

While regulatory agencies generally recognize the benefits of single-use technologies, concerns persist regarding extractables and leachables (E&L) characterization. The absence of universally standardized testing protocols creates ambiguity in qualification requirements, potentially adding 6-9 months to product development timelines. Companies must navigate varying regional expectations, with some health authorities requesting extensive E&L data packages that can comprise hundreds of compounds. This regulatory complexity increases validation costs and may delay market entry for biopharmaceutical products manufactured using SUS technologies.

Other Restraints

Limited Recycling Infrastructure
The environmental impact of single-use systems has emerged as a growing concern, with current recycling rates for SUS components estimated below 15%. The complex composition of multilayer films and specialized plastics presents technical challenges for conventional recycling processes. While some manufacturers have initiated take-back programs, the lack of standardized disposal protocols creates additional compliance burdens for end-users, particularly in regions with stringent waste management regulations.

MARKET OPPORTUNITIES

Emerging Biologics Pipeline Creating New Application Areas

The rapid expansion of novel biologic modalities presents significant growth opportunities for SUS providers. Cell and gene therapies in particular demonstrate 40% higher adoption rates of single-use technologies compared to traditional biologics production. This preference stems from the need for closed-system processing and reduced changeover times between different product campaigns. With over 2,000 cell and gene therapy candidates in clinical development globally, SUS manufacturers have a substantial addressable market. Emerging applications in viral vector production, allogeneic cell therapies, and personalized medicines are expected to drive innovation in specialized single-use configurations.

Asian Market Expansion Through Localization Strategies

Asia-Pacific represents the fastest-growing region for SUS adoption, with projected CAGR exceeding 25% through 2030. This growth stems from increasing biologics manufacturing capacity in countries like China, South Korea, and Singapore. Localization of SUS production is becoming a strategic priority, with several global players establishing regional manufacturing hubs to reduce lead times and logistics costs. Domestic manufacturers are also gaining traction by offering cost-competitive alternatives that meet regional quality standards. Partnerships between international technology providers and local contract manufacturers are creating hybrid solutions optimized for Asia-Pacific market requirements.

➤ Recent market analysis indicates that localized SUS production in Asia can reduce total cost of ownership by 18-22% through reduced tariffs and transportation expenses.

Integration of Industry 4.0 Technologies

The convergence of single-use technologies with digital transformation initiatives presents compelling opportunities for market expansion. Smart SUS components featuring embedded sensors and RFID tracking enable complete digital twins of bioprocesses, enhancing data integrity and operational visibility. These connected solutions allow for predictive maintenance of disposable equipment and automated inventory management of consumables. Early adopters report 30% reductions in downtime through implementation of such intelligent single-use systems. As biopharmaceutical manufacturers increasingly digitize their operations, the demand for advanced SUS with integrated Industry 4.0 capabilities is expected to grow substantially.

Segment Analysis:

By Type

Single-use Bioreactors Lead Market Growth Due to Increasing Adoption in Biopharmaceutical Production

The market is segmented based on type into:

• Single-use Bioreactor

  • Subtypes: Stirred-tank, wave-induced, and others

• Disposable Sterile Bags

  • Subtypes: 2D bags, 3D bags, and others

• Disposable Filtration System

• Other

By Application

Bio-pharmacy Segment Dominates Due to Growing Demand for Monoclonal Antibodies and Vaccines

The market is segmented based on application into:

• Bio-pharmacy

• CDMO (Contract Development and Manufacturing Organization)

• Other

By Material

Plastic Polymers Remain Preferred Choice for Single Use Systems in Biopharma

The market is segmented based on material into:

• Plastic Polymers

• Stainless Steel Components

• Other Materials

By Scale

Large-scale Manufacturing Accounts for Significant Adoption of SUS in Commercial Production

The market is segmented based on scale into:

• Small-scale (R&D and clinical production)

• Large-scale (Commercial production)

COMPETITIVE LANDSCAPE

Key Industry Players

Market Leaders Focus on Innovation and Expansion to Maintain Dominance

The global SUS (Single Use System) for Biopharma Process market features a semi-consolidated competitive landscape dominated by major multinational corporations and emerging regional players. Danaher Corporation and Thermo Fisher Scientific collectively hold approximately 45% market share as of 2024, leveraging their extensive product portfolios and established distribution networks across key biopharma hubs.

Sartorius AG and Merck KGaA have significantly strengthened their positions through strategic acquisitions and technology partnerships. In 2023 alone, these companies invested over $500 million combined in R&D for advanced single-use technologies, focusing on improving scalability and leachables management - critical pain points in bioprocessing.

While Western companies dominate in technological sophistication, Asian manufacturers like Lepure China and Tofflon are gaining traction by offering cost-effective alternatives, particularly in the growing Asia-Pacific market which represents 31% of global demand. Their ability to provide competitively priced disposable bioreactors has enabled penetration into price-sensitive CDMO segments.

Market differentiation increasingly revolves around system integration capabilities. Leading players now offer comprehensive single-use platforms combining bioreactors, mixers, and filtration systems with advanced monitoring technologies. This transition from component suppliers to integrated solution providers creates higher barriers to entry for smaller competitors.

List of Key SUS (Single Use System) for Biopharma Process Companies

• Danaher Corporation (U.S.)

• Thermo Fisher Scientific Inc. (U.S.)

• Sartorius AG (Germany)

• Merck KGaA (Germany)

• Lepure China (China)

• JYSS Bio-Engineering (China)

• Tofflon (China)

• Duoning Biotechnology (China)

• ABEC (U.S.)

• AUSTAR (China)

SUS (SINGLE USE SYSTEM) FOR BIOPHARMA PROCESS MARKET TRENDS

Accelerated Adoption of Single-Use Bioreactors Driving Market Expansion

The biopharmaceutical industry is witnessing rapid adoption of single-use bioreactors (SUBs), which now account for over 35% of global bioprocessing capacity. This surge is primarily attributed to their significant advantages over traditional stainless-steel systems, including reduced contamination risks, lower capital expenditure (up to 40% savings), and faster turnaround times between batches. The SUB segment alone is projected to grow at a CAGR of 23.5% through 2032, with capacities now reaching 5,000 liters for commercial-scale production. Furthermore, recent advancements in sensor integration allow real-time monitoring of critical process parameters, enhancing both yield consistency and regulatory compliance.

Other Trends

Sustainability-Driven Product Innovation

Environmental concerns are pushing manufacturers to develop eco-friendly single-use solutions, with bio-based plastics now comprising 15-20% of new product launches. While traditional plastics remain dominant, the industry is seeing increased investment in recyclable multilayer films and plant-derived polymers that maintain sterility while reducing environmental impact. Regulatory pressures in Europe and North America are accelerating this shift, with 60% of surveyed manufacturers prioritizing sustainable materials in their 2025 roadmaps.

Asia-Pacific Emerges as High-Growth Manufacturing Hub

The APAC region's SUS market is expanding at 24.8% CAGR, nearly 20% faster than the global average, driven by biopharma outsourcing growth and government initiatives like China's "Made in China 2025" biomanufacturing plan. Local players now supply 45% of regional demand, with Chinese firms like Lepure Bio and Tofflon gaining market share through competitively priced modular systems. Meanwhile, multinationals are establishing regional production facilities - Sartorius opened Asia's largest single-use assembly plant in Singapore in 2023 with 50,000m² capacity to serve both local CDMOs and multinational clients.

Regional Analysis: SUS (Single Use System) for Biopharma Process Market

North America
North America holds a dominant position in the SUS market, accounting for approximately 32% of global revenue, driven by robust biopharmaceutical R&D investments and stringent regulatory frameworks like FDA mandates. The U.S. leads innovation, with companies such as Thermo Fisher and Danaher accelerating the adoption of single-use bioreactors and filtration systems due to their cost efficiency and reduced contamination risks. While regulatory compliance remains a key driver, challenges include raw material supply chain disruptions and sustainability concerns. The region’s focus on personalized medicine and cell-and-gene therapies further propels demand, with CDMOs (Contract Development and Manufacturing Organizations) increasingly adopting SUS solutions for flexible production.

Europe
Europe matches North America’s market share (32%) owing to advanced biomanufacturing ecosystems and strict EU GMP guidelines promoting single-use technologies. Countries like Germany and France are hubs for biopharmaceutical production, with Sartorius and Merck spearheading innovations in disposable bag systems and modular bioreactors. The region emphasizes environmental sustainability, pushing vendors to develop recyclable SUS components. However, high costs and material dependency on non-European suppliers pose challenges. The EMA’s evolving regulations on leachables/extractables testing could reshape market dynamics, incentivizing local R&D investments.

Asia-Pacific
As the fastest-growing region (31% market share), Asia-Pacific leverages low-cost manufacturing and expanding biopharma sectors in China, India, and South Korea. Local players like Lepure China and Tofflon compete with global giants by offering cost-effective disposable systems, particularly for biosimilars and vaccines. While traditional stainless-steel equipment still dominates in cost-sensitive markets, rising biologics demand and government initiatives (e.g., China’s "Pharma 4.0" plan) are accelerating SUS adoption. Challenges include uneven regulatory harmonization and skepticism about long-term reliability of single-use systems in large-scale production.

South America
South America represents a nascent but promising market, with Brazil and Argentina focusing on local biopharma production to reduce import reliance. Limited regulatory oversight and budgetary constraints slow SUS adoption, though CDMOs and small-scale vaccine manufacturers increasingly opt for disposable systems. Economic volatility impacts capital expenditure, but partnerships with global SUS providers (e.g., ABEC’s collaborations in Argentina) signal incremental growth. The region’s biosimilar development programs could unlock opportunities if infrastructure investments align with SUS scalability needs.

Middle East & Africa
The MEA market remains underserved but exhibits potential with biotech hubs in Israel and Saudi Arabia investing in localized vaccine production. Limited in-house expertise and high import costs hinder SUS deployment, though multinationals are exploring joint ventures to tap into unmet demand. The UAE’s focus on biopharma free zones and South Africa’s vaccine initiatives may drive gradual adoption, contingent on stable funding and technology transfers. While growth is slower compared to other regions, long-term prospects hinge on healthcare modernization and regional supply chain diversification.

Report Scope

This market research report offers a holistic overview of global and regional markets for the forecast period 2025–2032. It presents accurate and actionable insights based on a blend of primary and secondary research.

Key Coverage Areas:

• ✅ Market Overview

  • Global and regional market size (historical & forecast)

  • Growth trends and value/volume projections

• ✅ Segmentation Analysis

  • By product type or category

  • By application or usage area

  • By end-user industry

  • By distribution channel (if applicable)

• ✅ Regional Insights

  • North America, Europe, Asia-Pacific, Latin America, Middle East & Africa

  • Country-level data for key markets

• ✅ Competitive Landscape

  • Company profiles and market share analysis

  • Key strategies: M&A, partnerships, expansions

  • Product portfolio and pricing strategies

• ✅ Technology & Innovation

  • Emerging technologies and R&D trends

  • Automation, digitalization, sustainability initiatives

  • Impact of AI, IoT, or other disruptors (where applicable)

• ✅ Market Dynamics

  • Key drivers supporting market growth

  • Restraints and potential risk factors

  • Supply chain trends and challenges

• ✅ Opportunities & Recommendations

  • High-growth segments

  • Investment hotspots

  • Strategic suggestions for stakeholders

• ✅ Stakeholder Insights

  • Target audience includes manufacturers, suppliers, distributors, investors, regulators, and policymakers

FREQUENTLY ASKED QUESTIONS:

What is the current market size of Global SUS (Single Use System) for Biopharma Process Market?

-> Global SUS (Single Use System) for Biopharma Process market was valued at USD 6,040 million in 2024 and is projected to reach USD 22,220 million by 2032 at a CAGR of 21.0%.

Which key companies operate in Global SUS (Single Use System) for Biopharma Process Market?

-> Key players include Danaher, Thermo Fisher, Sartorius, Merck, Lepure China, SATAKE MultiMix, JYSS Bio-Engineering, Tofflon, Duoning Biotechnology, ABEC, and AUSTAR. The top five players hold about 73% market share.

What are the key growth drivers?

-> Key growth drivers include rising demand for biopharmaceuticals, cost-effectiveness of single-use systems, reduced contamination risks, and increasing adoption in contract manufacturing organizations (CDMOs).

Which region dominates the market?

-> North America and Europe are the largest markets, each holding 32% share, followed by Asia-Pacific with 31% market share.

What are the emerging trends?

-> Emerging trends include development of hybrid systems, smart single-use technologies with IoT integration, sustainability-focused innovations, and increasing adoption in biosimilars production.