Single-use Assemblies Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Single-use Assemblies Market is projected to expand from USD 3.57 Billion in 2025 to USD 5.02 Billion by 2031, registering a CAGR of 5.85%. These assemblies comprise integrated, pre-sterilized plastic components - such as connectors, tubing, and manifolds - that form a cohesive system for managing biopharmaceutical fluids. The primary catalysts for market growth are the urgent need to negate cross-contamination risks between production batches and the demand for flexible manufacturing setups that lower capital costs and minimize changeover times. Reflecting improved logistics, the Bio-Process Systems Alliance noted in 2024 that apprehension regarding supply chain security for these products declined by 14%, signaling increased industry confidence.

Despite this growth trajectory, the sector confronts substantial hurdles related to the environmental footprint of rising plastic waste from these disposable items. The disposal of such non-biodegradable materials requires sophisticated waste management protocols to comply with international sustainability targets. Consequently, in regions with rigorous environmental regulations, the complexity of aligning waste practices with ecological goals could potentially decelerate the rate of market adoption.

Market Drivers

The escalating global demand for biopharmaceuticals and biologics serves as the central force driving the uptake of single-use assemblies. As the industry hastens the output of vaccines, monoclonal antibodies, and cell therapies, producers are increasingly depending on disposable technologies to maintain supply chain consistency and manage large-scale processing needs.

Moving from clinical trials to commercial production requires durable fluid management systems that allow for rapid deployment, avoiding the delays common with permanent infrastructure. This momentum is highlighted by financial results; Sartorius reported in its '9M 2025 Earnings Release' in October 2025 that its Bioprocess Solutions Division achieved a 9.9 percent revenue increase in constant currencies, growth specifically attributed to the robust sales of biomanufacturing consumables. To meet this rising need, Sartorius invested 305 million euros in 2025 toward global production and research facilities, underscoring the industry's dedication to future capacity.

Additionally, the reduction of energy and water consumption in bioprocessing has become a critical influence on market adoption as firms align their operations with rigorous environmental targets. By substituting traditional stainless steel apparatus with single-use assemblies, manufacturing sites can remove energy-heavy steam-in-place (SIP) and clean-in-place (CIP) processes, thereby drastically reducing their water usage and utility footprint. This transition represents a strategic core rather than simple regulatory adherence. As noted in a September 2024 Cytiva article titled 'Single-use and sustainability', 62% of biopharma companies have identified sustainability as their top priority for the coming five years. This focus is catalyzing a broad shift away from reusable vessels and permanent piping toward disposable options, ensuring operational efficiency remains compatible with environmental stewardship.

Market Challenges

A significant obstacle restricting the wider growth of the Global Single-use Assemblies Market is the considerable environmental impact caused by the disposal of plastic waste. In contrast to conventional stainless-steel systems that are sanitized and reused, single-use assemblies are intended for a single application, resulting in a steady stream of solid bio-hazardous refuse. This dependence on disposable multi-layer polymers stands in direct opposition to the strict net-zero objectives and sustainability mandates increasingly embraced by regulatory bodies and biopharmaceutical manufacturers. Therefore, in areas with stringent environmental laws, the high expense and operational difficulty involved in incinerating or handling this non-recyclable waste deter the complete substitution of traditional equipment.

The scale of this challenge is highlighted by recent industry forecasts concerning waste buildup. In 2024, the Bio-Process Systems Alliance estimated that plastic waste linked to biopharmaceutical manufacturing is set to rise sharply, reaching 11,700 metric tons annually by 2028. This anticipated growth underscores the heavy burden of waste management, effectively compelling companies to balance the operational agility of single-use technologies against their mounting ecological consequences. Consequently, the struggle to reconcile these disposable products with circular economy standards persists as a major factor slowing market penetration.

Market Trends

The landscape of single-use technologies is being transformed by the rise of regionalized manufacturing and supply chain hubs, as biopharmaceutical firms decentralize production to guarantee local supply and reduce geopolitical vulnerabilities. This strategic evolution involves building standardized "cookie-cutter" facilities in crucial regional markets, employing single-use assemblies to duplicate processes without the extensive infrastructure demanded by conventional stainless-steel plants. Financial data supports this trend; in its '2024 Annual Results' released in March 2025, WuXi Biologics announced a 13.1% year-over-year rise in non-COVID revenue, a growth directly credited to the successful expansion of its manufacturing operations in Europe and other areas.

Simultaneously, the creation of specialized assemblies tailored for cell and gene therapies is accelerating, spurred by the rigorous standards required for these advanced treatments. Unlike standard biologics, cell and gene therapies often demand assemblies capable of enduring cryopreservation temperatures and strictly limiting particulate contamination to safeguard small-volume patient batches. Nevertheless, the industry confronts a significant gap in capabilities; according to Cytiva's 'Global Biopharma Index 2025' published in October 2025, over 25% of biopharma executives indicated that their existing supply chains are ill-equipped to handle advanced modalities like cell and gene therapies, underscoring a critical market demand for purpose-built disposable components.

Key Players Profiled in the Single-use Assemblies Market

• Thermo Fisher Scientific Inc.
• Sartorius AG
• Danaher Corporation
• Merck KGaA
• Avantor, Inc.
• Parker Hannifin Corp.
• Repligen Corporation
• Corning Incorporated
• Meissner Filtration Products, Inc.
• Dover Corporation
• TSE Industries, Inc.
• Fujimori Kogyo Co., Ltd.

Report Scope

In this report, the Global Single-use Assemblies Market has been segmented into the following categories:

Single-use Assemblies Market, by Product:

• Bag Assemblies (2D bag assemblies
• 3D bag assemblies)
• Filtration Assemblies
• Bottle Assemblies
• Tubing Assemblies
• Others

Single-use Assemblies Market, by Application:

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

Single-use Assemblies Market, by End user:

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

Single-use Assemblies Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Single-use Assemblies Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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