USD 2.27 billion
Report ID: SQMIG35H2153 | Region: Global | Published Date: August, 2023 | Pages: 157 | Tables: 94 | Figures: 66
Single-Use Assemblies Market size was valued at USD 2.27 billion in 2021 and is poised to grow from USD 2.7 billion in 2022 to USD 10.71 billion by 2030, growing at a CAGR of 18.8% in the forecast period (2023-2030).
Single-use assemblies encompass pre-assembled plastic fluid pathways and self-contained products, constructed by combining various standard components, often ready for immediate use and gamma irradiated to ensure sterility. Commonly employed components encompass sampling bottles, filters, tubing, check valves, clamps, sterile connectors, fittings, and seals. The burgeoning biologics market, coupled with continuous technological strides in bioprocessing, amplified biopharmaceutical Research and Development (R&D), and the extensive adoption of single-use assemblies by diverse Contract Manufacturing Organizations (CMOs), are poised to propel industry expansion during the projected period.
Nonetheless, regulatory considerations linked to leachable, extractables, waste management, and the availability of multi-use systems might temper the penetration of single-use assemblies. The advent of COVID-19 has further accelerated the escalating demand for such assemblies, as disposable technology facilitates swift production and development of therapies and vaccines, enhancing precision and efficiency. A pertinent example is Entegris, Inc.'s Aramus single-use bag assembly, utilized to store COVID-19 vaccines requiring ultra-low temperatures for preservation.
The upsurge in cancer prevalence and infectious diseases is fueling the production of novel biologics for diagnosis and treatment. A rise in cancer cases and infectious diseases like lower respiratory infections and HIV, attributed to factors such as climate shifts and urbanization, augments the industry's prospects. Innovative vaccine developments, exemplified by Moderna's mRNA-based HIV vaccine clinical trial, spotlight cutting-edge technologies' role in the biologics arena. Collaborative endeavors to combat emerging infectious diseases with pandemic potential further underscore the drive towards novel vaccine alternatives.
US Single-Use Assemblies Market is poised to grow at a sustainable CAGR for the next forecast year.
Global Market Size
USD 2.27 billion
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The Global Single-Use Assemblies Market is segmented on the basis of Product, Application, Solution, End – Use, Region. By Product, the market is segmented into Bag Assemblies, 2D bag assemblies, 3D bags assemblies, Filtration Assemblies, Others. By Application, the market is segmented into Filtration, Cell Culture & Mixing, Storage, Sampling, Fill-finish Applications, Others. By End – User, the market is segmented into Biopharmaceutical & Pharmaceutical Companies, CROs & CMOs. By Solution, the market is segmented into Customized Solutions, and Standard Solutions. By Region, the market is segmented into North America, Europe, Latin America, Asia- Pacific, Middle East and Africa.
Single-Use Assemblies Market Analysis By Application
The filtration sector established its dominance within the industry in 2022, commanding a substantial revenue share of 28.70% across the overall landscape. The adoption of single-use assemblies for filtration processes is witnessing rapid expansion due to the inherent benefits they offer in filtration procedures. Single-Use Technologies (SUTs) not only yield cost and time savings but also exhibit remarkable efficiencies, such as reducing integrity testing by 90%, sterile connections by 90%, and tubing time by up to 90%. The utilization of single-use filtration systems also results in time savings since they are pre-assembled and ready for immediate use, unlike conventional filtration setups.
The commercial triumph of biopharmaceuticals necessitates the establishment of multiple manufacturing facilities to cater to the escalating market demand. Biopharmaceutical manufacturers are increasingly adopting single-use facilities to expedite product turnaround and accommodate multiple manufacturing processes within the same area. This growing demand for single-use applications within the biopharmaceutical sector has prompted major industry players to expand their global single-use production facilities.
Concurrently, the cell culture & mixing segment is poised to achieve a remarkable Compound Annual Growth Rate (CAGR) of 20.33% from 2023 to 2030. This growth trajectory is primarily propelled by heightened demand for biopharmaceuticals, favorable government policies, and augmented investment in Research and Development (R&D) initiatives. The escalated need for mammalian cell lines in upstream bioprocessing further fuels industry expansion. Notably, the adoption of cell culture techniques is on the rise as biopharmaceutical entities and researchers increasingly focus on developing vaccines for a wide spectrum of diseases, including rubella, polio, smallpox, chickenpox, and hepatitis. Moreover, the global prevalence of infectious and chronic diseases, including the ongoing impact of conditions like COVID-19, is expected to act as a robust catalyst for market growth throughout the study period.
Single-Use Assemblies Market Analysis By End-Use
In 2022, the biopharmaceutical & pharmaceutical companies segment asserted its dominance on a global scale, commanding the highest share, exceeding 45.61% of the total revenue. The surge in existing biopharmaceutical manufacturing infrastructures is a primary driver behind the escalating demand for single-use assemblies. A case in point is the notable investment made by Alexion in June 2022, funneling USD 70 million into novel drug production warehousing and equipment to bolster manufacturing operations in Ireland. This expansion initiative is geared towards augmenting the biologics drug substance portfolio. Similarly, Upperton Pharma Solutions embarked on a USD 16 million investment in May 2022, facilitating facility expansion to significantly enhance R&D space and introduce a tenfold increase in GMP manufacturing capacity.
Anticipated to exhibit the swiftest Compound Annual Growth Rate (CAGR) during the forecast period, the CROs & CMOs segment is undergoing substantial growth at 19.57%. In recent times, Contract Manufacturing Organizations (CMOs) have widely embraced the integration of single-use assemblies across most, if not all, of their bioprocessing operations. The widespread adoption of single-use assemblies by CMOs expedites processing and process changeover, resulting in reduced turnaround times and heightened flexibility across various client projects. This swift adaptability facilitated by single-use equipment enhances CMO efficiency, thereby contributing to overall cost reduction. Furthermore, an increasing number of CMO facilities are transitioning towards near-complete reliance on single-use technology. This strategic shift not only leads to savings in campaign and facility costs but also aids in curbing operational expenditures and capital investments.
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In 2022, North America established its dominance in the regional market, securing a commanding 36.45% share. This substantial foothold can be attributed to robust growth within the biotechnology and pharmaceutical sectors, product advancements, and the escalating prevalence of diseases like cancer. Concurrently, investments and funding channeled into drug discovery research have fueled this surge. For instance, a notable development unfolded in August 2022 when Thermo Fisher Scientific Inc. unveiled a cutting-edge single-use technology manufacturing facility in Greater Nashville, spanning 400,000 square feet with an investment of USD 105 million. This strategic move aimed to satisfy the escalating demand for bioprocessing materials crucial in crafting revolutionary therapies and vaccines, particularly for cancer and other ailments. The Nashville site constitutes a vital component of the company's ambitious USD 650 million multi-year initiative, focused on elevating its bioprocessing production capabilities.
Meanwhile, the Asia Pacific region is projected to exhibit the swiftest Compound Annual Growth Rate (CAGR) of 21.64% from 2023 to 2030, propelled by strategic maneuvers by key industry players. In 2021, Sartorius directed substantial investments towards China, enhancing its production capacity with additional cleanroom space dedicated to the manufacturing of single-use filters and bags. Concurrently, Cytiva, in September 2021, announced a substantial USD 52.5 million investment to establish a disposable manufacturing facility in South Korea. This expansion aligns with the aim of providing the bioprocessing sector with essential single-use bags integral to COVID-19 vaccine production.
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Single-Use Assemblies Market Drivers
Reduced Cross-Contamination Risk
Single-Use Assemblies Market Restraints
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The competitive landscape of the Global Single-Use Assemblies Market is dynamic and driven by a mix of established players and emerging entrants. Industry leaders such as Thermo Fisher Scientific, Sartorius AG, Danaher Corporation, and Merck KGaA dominate the market with their extensive product portfolios, robust R&D capabilities, and global distribution networks. These companies offer a wide range of single-use assembly solutions catering to various industries, fostering innovation and technological advancement.
Additionally, specialized players like Entegris, Saint-Gobain Performance Plastics, and Parker Hannifin Corporation excel in providing high-quality components and materials essential for single-use systems, contributing to the market's growth and diversification. Meissner Filtration Products, Repligen Corporation, and GE Healthcare are noteworthy contenders that have carved a niche with their expertise in filtration technologies, downstream processing, and bioprocessing solutions.
The market's competitive landscape is characterized by collaborations, partnerships, and acquisitions, as companies strive to expand their product offerings and global presence. The evolving regulatory landscape, increasing demand for sustainable solutions, and advancements in bioprocessing techniques are likely to further intensify competition. As new players continue to innovate and established giants adapt to changing market dynamics, the Global Single-Use Assemblies Market is poised for both fierce competition and collaborative growth.
Single-Use Assemblies Market Top Player’s Company Profile
Single-Use Assemblies Market Recent Developments
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Product types team that Collects, Collates, Correlates, and Analyzes the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to our Global Single-Use Assemblies Market Analysis, conclusions drawn from market trends highlight its escalating adoption across diverse industries, including pharmaceuticals, biotechnology, and food processing. The convenience, reduced cross-contamination risk, and streamlined operational efficiency offered by single-use assemblies have driven their widespread acceptance.
Notably, the market's expansion has been propelled by the increasing emphasis on cost-effectiveness, flexibility, and sustainable practices. The shift towards personalized medicine and bioprocessing further underlines the market's growth potential. However, challenges related to regulatory compliance and limited reusability have been observed as potential hindrances.
The COVID-19 pandemic has also underscored the importance of single-use solutions in enabling rapid scale-up of production for vaccines and therapeutics. Looking ahead, advancements in materials, technology, and manufacturing processes are anticipated to address existing limitations, fostering continued growth in the Global Single-Use Assemblies Market. Stakeholders must stay vigilant to evolving industry dynamics and regulatory landscapes to harness the sector's full potential.
|Market size value in 2021||USD 2.27 billion|
|Market size value in 2030||USD 10.71 billion|
|Forecast Unit (Value)||USD Billion|
|Regions covered||North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA)|
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For the Global Single-Use Assemblies Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Global Single-Use Assemblies Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
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