Single-use Filtration Assemblies Market Size, Share & Trends Analysis Report By Type, By Product (Filters, Membranes, Cassettes, Cartridges), By Application (Biopharmaceuticals, Laboratory Use), And Segment Forecasts, 2019 - 2026

Report Overview

The global single-use filtration assemblies market size was estimated at USD 3.0 billion in 2018 and is projected to exhibit a CAGR of 11.2% during the forecast period. The transformative impact of single-use technology in the development and production of biopharmaceuticals has led to its extensive implementation in cGMP manufacturing suites. The technology also allows in-house production to smaller biotech firms, thus providing control over clinical production.

Suppliers are also focused on ensuring complete transparency over the supply chain of raw materials used while manufacturing single-use components. On the other hand, the presence of a cross-industry collaboration group, such as the BioPhorum Operations Group, safeguards the implementation of disposables by virtue of best practice guides.

The inception of new bioprocessing tools, novel therapeutics, and the gradual shift from small molecule to large molecule drug products has led to an increase in pressure on biomanufacturers. As a result, contract manufacturers are employing this technology as a viable business solution to address client and stakeholder needs.

Moreover, the expansion of the biopharmaceutical industry and constantly growing CMOs-dependent small and emerging players have posed a threat to well-established in-house manufacturers. As a result, in-house manufacturers such as Amgen have begun considering single-use filtration products to maintain their share in the pharmaceutical manufacturing market.

Furthermore, the incorporation of single-use filtration units in manufacturing facilities enables end-users in expanding their economic capabilities. This is because single-use components offer fast turnaround and eliminate ancillary activities such as cleaning and changeover validation.

Despite the significant adoption, the market still lags in replacing multi-use stainless steel products in the large-scale manufacturing process. This, in turn, has created substantial opportunities for new market entrants to mark their presence by the launch of single-use filtration units for large-scale operations.

Single-Use Filtration Assemblies Market Trends

The growing utilization of reusable filtering devices among biopharmaceutical companies is propelling the market forward. This is because single-use filtration assemblies are normally sterile and are used to replace traditional pharmaceutical processing items for recycling, in-house sterilization, and cleaning. These factors are expected to drive the market over the forecast period.

The shifting of manufacturers’ focus from small molecule medicines to large molecule therapeutic products is propelling the market growth. One of the primary factors driving the growth of the single-use filtration assembly market is the abundance of bioscience investment funds. Other indirect market growth variables include rising R&D expenditure for product innovations and the strength of venture capital investments.

Single-use assembly items are formed from processed plastics, they frequently suffer from container contamination produced by chemicals found in drug products induced by leaching from closures, containers, and processing components. Furthermore, the majority of pharmaceutical procedures need high temperatures during operation, resulting in the creation of unwanted and unknown compounds that may pollute the finished product. This is expected to hinder their acceptance in the market, leading to limiting the market growth.

The increasing presence of global and local pharmaceutical and biopharmaceutical enterprises is a primary driver of demand for single-use assembly. As pharmaceutical and biopharmaceutical manufacturing expands, government officials in these nations are prioritizing excellent manufacturing practices and certified laboratory processes. The adoption of regulatory measures limiting the import and delivery of pharmaceuticals that are polluted or impure after bioprocessing is predicted to raise opportunities for cost-effective single-use assemblies.

Single-use assemblies are positively impacted by the pandemic as they are used in research for COVID-19 vaccine development. Many companies are creating vaccines through different R&D operations. These have been popular during the pandemic as the demands were met by the suppliers. Many commonly used drugs such as hydroxychloroquine saw a surge in demand. As a result, the pharmaceutical and biotechnology sectors are expected to grow due to the demand for COVID-19 treatment drugs and vaccines. Therefore the pandemic has led the market to grow positively.

Type Insights

Use of conventional Tangential Flow Filtration (TFF) has been known to damage sensitive biotherapeutics by recirculating the product solution. A substantial number of companies have actively invested in advancing the use of TFF systems to enhance downstream bioprocessing.

For instance, Pall Corporation offers in line single-pass TFF (SPTFF) disposable technology, which is designed to address the abovementioned limitation and can be employed for pilot-scale manufacturing, R&D, process development, and large-scale GMP manufacturing. Such advancements have led to the high usage rate of TFF, thereby contributing to the large revenue share of this segment.

On the other hand, single-use centrifugation method lacks capacity, which fuels costs and increases waste generation. As a result, a number of companies are investing in the development of solutions that can replace the need for centrifuge in single-use bioprocessing operations. This has led to the lowest penetration of centrifugation in the current market.

Application Insights

Currently, the major application of single-use filtration assemblies is in biomanufacturing. Perpetual expansion of contract biomanufacturing arena is one of the key drivers, as contract manufacturers are considered as early adopters of single-use technology.

Biopharma manufacturers are engaged in boosting their organic revenue growth through new facilities or new capacity expansion projects on the virtue of single-use technology. This has led to the dominance of the bioprocessing segment in the market.

Being one of the primary end-users of single-use technology, laboratories have contributed significantly to revenue generation. Bioprocessing and laboratory-use collectively accounted for nearly 79.0% of the revenue in 2018.

Product Insights

Filters, cartridges, membranes, and cassettes are estimated to account for substantial revenue share in the overall market. These fall under the class of disposable bioprocess filtration systems that incorporate high-efficiency membranes and also facilitate high-temperature metabolic operations.

Furthermore, single-use cassettes deliver notable improvements in process economics as compared to conventional TFF cassettes. Use of disposable cassettes eliminates several non-value-added steps of pre-use and post-use Clean-in-Place (CIP), resulting in reduction of the overall time for membrane filtration process and increased productivity.

Disposable syringes reported the least penetration owing to the fact that syringes can be used multiple times. Furthermore, chances of cross contamination while using the same syringe is comparatively less than other products. This leads to a reduction in the purchase rate of the product.

Regional Insights

There is a strong presence of a substantial number of small and mid-size biopharmaceutical entities (SMEs) in the U.S. that lack resources. They are adopting single-use filters as a cost-saving strategy to address the challenge of cost constraints and budget and this is one of the key contributors resulting in North America’s dominant position in the market.

Asia Pacific is estimated to grow at the fastest pace throughout the forecast period. Lower labor and operating cost across the region is one of the primary factors driving the expansion of the biopharmaceutical sector in Asian countries, thereby spurring the use of disposable filters in the region. China is anticipated to exhibit the fastest CAGR owing to exponential growth in the number of contract deals in the pharmaceutical arena. Furthermore, the growing usage of biotherapeutics over chemical entities is anticipated to influence the adoption of disposable filters within the China bioprocessing sector.

Key Companies & Market Share Insights

Some of the key companies that offer a wide range of disposable filters are 3M; MEISSNER FILTRATION PRODUCTS, INC.; Sartorius AG; Repligen Corporation; Danaher; Cellab; Merck Millipore; Thermo Fisher Scientific, Inc.; Medela; and DrM, Dr. Mueller AG. These entities are engaged in the development of advanced and custom solutions in line with changing needs of end-users. Mergers and acquisitions are one of the key strategies adopted by vendors to expand their product portfolio. Acquisition of Sigma Aldrich by Merck KGaA, Pall Corporation by Danahar, and Membrane GmbH by 3M are few examples of mergers and acquisitions in the market that have positively influenced growth. Companies are leveraging acquisitions in order to accelerate innovations in the market.

Recent Developments

• In April 2022, Thermo Fisher Scientific announced the development of its new R&D and engineering facility, India Engineering Center (IES) in Hyderabad, India. It is expected to result in more jobs in the region

• In March 2021, Pall Corporation, a life science firm, acquired Pall-Austar Lifesciences Limited, a JV of Austar and Pall. The acquisition aims to enhance production capacity to meet China's requirement for single-use technology supply chains which is being driven by COVID-19

Single-Use Filtration Assemblies Market Report Scope

Global Single-Use Filtration Assemblies Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis on latest industry trends in each of the sub-segments from 2015 to 2026. For the purpose of this study, Grand View Research has segmented the global single-use filtration assemblies market report on the basis of type, application, product, and region:

• Type Outlook (Revenue, USD Million, 2015 - 2026)

  • Membrane Filtration

    • Tangential Flow Filtration (TFF)

      • Ultra/Diafiltration

      • Micro-Filtration

    • Direct Flow Filtration (DFF) /Dead-end Filtration /Normal Flow Filtration

  • Depth Filtration

  • Centrifugation

  • Others

• Application Type Outlook (Revenue, USD Million, 2015 - 2026)

  • Pharmaceuticals Manufacturing Market

  • Bioprocessing/Biopharmaceuticals Market

  • Laboratory Use

• Product Outlook (Revenue, USD Million, 2015 - 2026)

  • Filters

  • Cartridges

  • Membranes

  • Manifold

  • Cassettes

  • Syringes

  • Others

• Regional Outlook (Revenue, USD Million, 2015 - 2026)

  • North America

    • The U.S.

    • Canada

  • Europe

    • The U.K.

    • France

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

  • Latin America

    • Brazil

  • Middle East & Africa

    • South Africa