Single-Use Assemblies Global Market Report 2024

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 size has grown exponentially in recent years. It will grow from $5.1 billion in 2023 to $6.27 billion in 2024 at a compound annual growth rate (CAGR) of 22.9%. The growth observed in the historical period can be attributed to several factors, including increased adoption in biopharmaceutical manufacturing, the flexibility and cost efficiency offered by single-use assemblies, the reduction of cross-contamination risks associated with their use, adherence to regulatory compliance in biomanufacturing, and the demand for modular and plug-and-play systems in the pharmaceutical and biotechnology industries.

The single-use assemblies market size is expected to see exponential growth in the next few years. It will grow to $14.16 billion in 2028 at a compound annual growth rate (CAGR) of 22.6%. The anticipated growth in the forecast period can be attributed to various factors, including the expansion of personalized medicine, increased production of gene and cell therapies, the adoption of continuous biomanufacturing, the development of modular and flexible biomanufacturing facilities, the emergence of markets and global biomanufacturing hubs, and the use of single-use manufacturing for vaccine production. Key trends expected in the forecast period include advanced sensor integration in single-use assemblies, the implementation of IoT (Internet of Things) and data analytics for bioprocess monitoring, the use of automated and robotic single-use systems, the application of disposable chromatography columns and membranes, the utilization of single-use tangential flow filtration (TFF) systems, and the development of scalable and standardized single-use processes in the biomanufacturing industry.

The growth of single-use assemblies is expected to be propelled by an increased demand for biopharmaceuticals and a rise in life science research and development (R&D). Biopharmaceuticals, advanced medicines derived from living cells or organisms, are often produced using cutting-edge biotechnological techniques, and single-use systems play a crucial role in their manufacturing. The surge in R&D spending in the life sciences sector, such as pharmaceutical production in Europe reaching $351 billion (€300,000 million) in 2021, showcases a 5% increase from 2020. Notably, R&D investment in the Spanish pharmaceutical industry witnessed a 9.2% rise in 2021, reaching 1,267 million euros. Consequently, the combined factors of heightened demand for biopharmaceuticals and increased life science R&D expenditures are key drivers of the growth in 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.

Technological advancements are emerging as a prominent trend in the single-use assembly market. Leading companies are incorporating innovative technologies, such as the Thermo Scientific HyPeak chromatography system - a single-use chromatography system capable of handling flows from one liter per hour to 80 liters per hour. This system features unique attributes like zero dead-leg and a ring flush valve manifold, enhancing product yield and operational efficiency. Technological innovation is a key strategy for companies to maintain their market positions and offer advanced solutions.

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).

In June 2021, Avantor Inc., a U.S.-based science, chemical, and materials company, acquired RIM Bio for an undisclosed amount. This strategic acquisition positions Avantor to better serve its customers and capitalize on opportunities in the growing global bioproduction market by expanding its single-use production, distribution, and cleanroom capabilities in the AMEA region. RIM Bio, based in China, is a manufacturer of single-use bioprocess bags and assemblies used in the production of biopharmaceutical products.

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 2023. 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.

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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