Single-Use Assemblies Market Report 2025

This Single-Use Assemblies report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.

The single-use assemblies market size has grown exponentially in recent years. It will grow from $6.12 billion in 2024 to $7.48 billion in 2025 at a compound annual growth rate (CAGR) of 22.1%. The growth in the historic period can be attributed to biopharmaceutical manufacturing, flexibility and cost efficiency, reduction of cross-contamination risks, regulatory compliance in biomanufacturing, demand for modular and plug-and-play systems.

The single-use assemblies market size is expected to see exponential growth in the next few years. It will grow to $17.3 billion in 2029 at a compound annual growth rate (CAGR) of 23.3%. The growth in the forecast period can be attributed to expansion of personalized medicine, gene and cellTherapy production, continuous biomanufacturing adoption, modular and flexible biomanufacturing facilities, emerging markets and global biomanufacturing hubs, single-use manufacturing for vaccine production. Major trends in the forecast period include advanced sensor integration in single-use assemblies, iot and data analytics for bioprocess monitoring, automated and robotic single-use systems, disposable chromatography columns and membranes, single-use tangential flow filtration (tff) systems, scalable and standardized single-use processes.

The growing demand for biopharmaceuticals and an increase in life science R&D are anticipated to drive the growth of single-use assemblies. Biopharmaceuticals are advanced medicines derived from living cells or organisms, often produced through innovative biotechnological methods. Single-use systems play a crucial role in biopharmaceutical manufacturing, while rising investments in life science R&D contribute to the development of new drugs. For example, in June 2023, the European Federation of Pharmaceutical Industries and Associations (EFPIA), a Belgium-based organization representing the pharmaceutical sector, reported significant growth in the European pharmaceutical industry, with production increasing from $352.48 billion in 2021 to $369.95 billion in 2022. Therefore, the demand for biopharmaceuticals and the expansion of life science R&D are key factors propelling the growth of single-use assemblies.

The increasing number of clinical trials is anticipated to drive the growth of the single-use assemblies market. Clinical trials, essential for assessing the safety and efficacy of new medical treatments, interventions, or drugs, rely on flexible and cost-effective solutions for bioprocessing, sample handling, sterile filtration, and fluid transfer - areas where single-use assemblies play a pivotal role. In August 2023, ClinicalTrials.gov reported a significant increase in registered studies, reaching 464,218 compared to 399,496 in 2021 across all 50 U.S. states and 221 countries globally. This rise in clinical trial participation, with 31% in the U.S. and 53% in non-U.S. locations, is poised to contribute significantly to the growth of the single-use assemblies market.

Major companies in the single-use assemblies market are adopting advanced technologies, such as filling assemblies, to maintain their competitive edge. A filling assembly is a system designed for the accurate and efficient dispensing and packaging of liquid or semi-liquid products into containers, ensuring precise measurements and minimizing contamination. For instance, in April 2024, SaniSure, a US-based manufacturer of single-use systems and components, introduced Fill4Sure, a custom single-use filling assembly aimed at expediting drug market entry while enhancing security, efficiency, and repeatability in drug product filling. Fill4Sure addresses critical challenges in the fill-finish process, such as high costs and slow speeds, providing cost-effective, tailor-made assemblies that can easily scale to meet industry demands. Key features include low-particulate 2D surge bags, durable silicone overmolding, high-performance tubing for accuracy, and contamination-free needles, all designed to streamline biomanufacturing processes and enhance supply chain reliability.

Major companies operating in the single-use assembly market are strategically focusing on innovative services to gain a competitive advantage. The introduction of services such as FlexConnexx, a novel single-use assembly production service by High Purity New England Inc., exemplifies this approach. FlexConnexx aims to reduce lead times and enhance reliability within the single-use supply chain by providing dedicated cleanroom facilities, exclusive teams, expedited deliveries, and managed inventory. This service empowers customers to independently oversee single-use assembly production, resembling the operations of contract development and manufacturing organizations (CDMOs).

For example, in May 2024, Novo Holdings A/S, a Denmark-based investment company, acquired a 60% majority stake in Single Use Support GmbH for an undisclosed sum. This acquisition enables Novo Holdings to enhance its manufacturing capabilities and supply chain, particularly in support of its pharmaceutical subsidiary. Single Use Support GmbH is an Austria-based company that specializes in providing single-use assemblies for the life sciences sector.

Major companies operating in the single-use assemblies market include Avantor Inc., Corning Incorporated, Danaher Corporation, Thermo Fisher Scientific Inc., Sartorius AG, Merck KGaA, Entegris Inc., KUHNER AG, Lonza Group Ltd., Saint-Gobain India Pvt. Ltd., Parker Hannifin Corporation, Repligen Corporation, Meissner Filtration Products, NewAge Industries Inc., Antylia Scientific, Romynox B.V, Global Life Sciences Solutions USA, Wego Pharmaceutical, Eppendorf AG, Finesse Solutions, GE Healthcare Life Sciences, GEA Group AG, Infors AG, MilliporeSigma, Pall Corporation, PendoTECH, SaniSure Inc., Keofitt A/S, Intellitech Inc., Dover Corporation, Foxx Life Sciences, TSE Industries Inc., Fujimori Kogyo Co. Ltd., Compagnie Générale des Établissements Michelin, Cellexus Ltd., Fluid Flow Products Inc.

North America was the largest region in the single-use assemblies market in 2024. The regions covered in single-use assemblies market analysis report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the single-use assemblies market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.

Single-use assemblies are comprehensive, ready-to-use systems comprised of various plastic components integrated into a single unit, ensuring the sterilized flow of pharmaceutical products. These assemblies offer advantages such as reduced cross-contamination and leakage concerns, minimized production interruptions, and lower costs. They find application in connecting medical and laboratory instruments and equipment.

The primary types of products in the single-use assemblies market include filtration assemblies, bag assemblies, bottle assemblies, and mixing system assemblies. Filtration assemblies are employed for vacuum filtering tissue culture media, biological fluids, High-Performance Liquid Chromatography (HPLC) samples, and other aqueous solutions. These assemblies are designed to remove particulate matter from water through the passage of fluid through porous media. Solutions in the single-use assemblies market can be either standard or customized, catering to diverse needs. Various applications of single-use assemblies include cell culture and mixing, filtration, storage, sampling, and fill-finish applications. End users of these assemblies span biopharmaceutical and pharmaceutical companies, contract research organizations (CROs), contract manufacturing organizations (CMOs), and academic and research institutes.

The single-use assemblies market research report is one of a series of new reports that provides single-use assemblies market statistics, including single-use assemblies industry global market size, regional shares, competitors with an single-use assemblies market share, detailed single-use assemblies market segments, market trends and opportunities, and any further data you may need to thrive in the single-use assemblies industry. This single-use assemblies market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The single-use assemblies market consists of sales of 2D and 3D single-use assemblies. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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