Tangential Flow Filtration Market

The global tangential flow filtration market in terms of revenue was estimated to be worth $1.9 billion in 2023 and is poised to reach $3.6 billion by 2028, growing at a CAGR of 13.5% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. The growth of this market can be attributed to factors such as the rising R&D spending in pharma-biotech companies, and continuous technological advancements in filtration technologies.

Attractive Opportunities in the Tangential Flow Filtration Market

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Tangential Flow filtration Market Dynamics

DRIVER: Technological advancements in TFF systems

TFF technology has advanced significantly, leading to more efficient, reliable, and cost-effective processes. Some of the advancements in TFF technology include:

• Single-pass TFF: SPTFF reduces process volumes through inline concentration in one single pass through a series of membranes without retentate recirculation. This technology links upstream and downstream operations and can ensure continuous production. SPTFF is also a continuous process and can be run with another step. This is convenient for reducing volumes to eliminate tank bottlenecks and reduce column sizes, especially in existing facilities where space may be limited. For instance, using Pellicon cassettes (Merck KGaA) in SPTFF mode effectively concentrates biomolecules.
• Single-use TFF systems: Single-use TFF systems have become increasingly popular in recent years due to their convenience and cost-effectiveness. These systems eliminate the need for cleaning and validation, reducing the risk of contamination and downtime. Single-use TFF systems also provide flexibility in scale-up and scale-down operations, making them ideal for small and mid-sized companies. For instance, Cytiva has offered their ÄKTATM readyfluxTM, an automated, single-use TFF system for pilots and small-scale manufacturing.
• Automated TFF systems: Automation has made TFF processes more reliable and reproducible. Automated TFF systems allow for real-time monitoring and control of key process parameters such as pressure, flow rate, and transmembrane pressure. These systems also minimize operator intervention, reducing the risk of errors and variability. KRONOS by Solaris is a benchtop TFF system in the market.
• Enhanced fouling control: Fouling is a common issue in TFF processes that can reduce efficiency and increase downtime. Advances in fouling control technologies, such as backflushing and pulsing, have improved the fouling resistance of TFF systems. These technologies help to remove fouling layers from the membrane surface, allowing for continuous and efficient filtration. For example, Hydrosart Ultrafilter (Sartorius AG) is extremely hydrophilic, making it non-protein binding and virtually non-fouling.
• Integration with other downstream processes: TFF technology is being integrated with other downstream processes, such as chromatography and virus removal. This integration has led to more efficient and streamlined processes, reducing processing time and cost.

RESTRAINT: Competition from alternative technologies

TFF faces competition from alternative filtration technologies such as centrifugation. Centrifugation is often used in the early stages of bioprocessing, where large volumes of liquid must be processed quickly. For example, in biopharmaceutical production, the biotech company Novartis uses centrifugation to separate and concentrate cells for its CAR-T cell therapy drug, Kymriah. Another alternative technology is microfiltration, which uses a membrane with pores that allow small particles and molecules to pass through while retaining larger ones. Microfiltration is often used to remove bacteria and other microorganisms from bioprocess streams. Ultrafiltration is another alternative technology using a membrane to separate and concentrate molecules based on size and charge. Ultrafiltration is often used in the final stages of bioprocessing to concentrate and purify proteins and other biomolecules.

OPPORTUNITY: Increasing demand for biologics

The demand for biologics has been increasing steadily over the years, driven by several factors, such as the growing prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders, an aging population, and advancements in biotechnology. The increasing demand for biologics is also reflected in the number of new biologic drugs approved by regulatory agencies. For instance, in 2022, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved more than 30 new oncology agents and new indications for previously approved agents during Q4 2022. Most of these approvals were for new biologics or new indications, with more than 11 different biologics and biosimilars receiving at least one approval.

TFF is an essential step in the upstream and downstream processing of biologics. It separates and purifies the target biologic from other components in the cell culture, such as cell debris, DNA, and proteins. As the demand for biologics continues to grow, the need for TFF in the manufacturing process of these biologics is expected to increase, creating opportunities for market growth in the TFF market.

CHALLENGE: Increased complexities introduced by the interaction of charged excipients and proteins to restrict the market growth

Charged excipients are commonly used in the biopharmaceutical industry as stabilizers, protectants, and enhancers of solubility and bioavailability. However, these excipients can also introduce increased complexities when interacting with proteins during the purification process, which can restrict the growth of the market. High-concentration protein formulations have been targeted by biopharmaceutical manufacturers to enable subcutaneous administrations. The subcutaneous administration of biopharmaceutical products can provide better patient convenience than intravenous administration. Overall, the interaction of charged excipients and proteins can introduce increased complexities that can impact the efficiency and effectiveness of the TFF process. While charged excipients offer many benefits in terms of stabilizing and enhancing the solubility and bioavailability of biopharmaceuticals, it is important for biopharmaceutical companies to carefully consider these factors when selecting purification technologies.

The systems segment dominated Tangential Flow filtration Market in 2022

On the basis of products, the market is segmented into systems, membrane filters, and other tff products. The systems segment accounted for the largest share of the market in 2022, due to various advantages of this segment for instance, single-use automated TFF solutions are fully scalable from lab to GMP manufacturing and increase flexibility during process development. The use of single-use TFF systems reduces the assembly and set-up time and capital cost as well as enhances manufacturing productivity.

North America was the largest regional market for Tangential Flow filtration Market.

The market is segmented into five major regions—North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. In 2022, North America accounted for the largest share of the market, followed by Europe. The presence of key players in the region are the main factors driving the growth of the market in North America. Asia Pacific is expected to have the highest growth during the forecast period.

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Key players in the tangrential flow filtration market are Danaher Corporation (US), Merck KGaA (Germany), Sartorius AG (Germany).

Tangential Flow Filtration Market Report Scope

This report categorizes the tangential flow filtration market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Systems
  • TFF Reusable Systems
  • TFF Single-Use Systems
• Membrane Filters
  • Cassettes
  • Cartridges and Capsules
• Other TFF Products

By Membrane Material

• Polyethersulfone (PES)
• Polyvinylidene Difluoride (PVDF)
• Nylon
• Polyetrafluoroethylene (PTFE)
• Mixed Cellulose Ester & Cellulose Acetate (MCE & CA)
• Polycarbonate Tracked Etched (PCTE)
• Regenerated Cellulose
• Other Materials ( Polypropylene (PP), Ceramic, Polyacrylonitrile, and Polyolefin)

By Technique

• Microfiltration
• Ultrafiltration
• Nanofiltration
• Other Techniques (Reverse osmosis and Ion exchange)

By Application

• Global Market, by Final Product Processing
  • Active Pharmaceutical Ingredient (API) Filtration
  • Protein Purification
  • Vaccine and Antibody Processing
  • Formulation and Filling Solutions
  • Viral Clearance
• Global Market, by Raw Material Filtration
  • Media Buffer Filtration
  • Prefiltration
  • Bioburden Testing
  • Cell Separation
  • Water Purification

By End User

• Pharmaceutical & Biotechnology Companies
• CMOs & CROs
• Academic Institutes & Research Laboratories

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • China
  • Japan
  • India
  • Rest of Asia Pacific (RoAPAC)
• Latin America (LATAM)
  • Brazil
  • RoLATAM
• Middle East and Africa (MEA)

Recent Developments

• In May 2022, Merck KGaA invested over USD 476.7 million to expand its membrane and filtration manufacturing in Ireland.
• In December 2021, Repligen Corporation acquired Bioflex Solutions, which offers single-use fluid management products.
• In June 2021, Repligen Corporation signed an agreement to acquire Polymem, which offers hollow-fiber membranes and modules.
• In March 2021, Pall Corporation acquired Austar Lifesciences Limited. The acquisition aimed to expand the company’s capacity to support single-use technology.

Frequently Asked Questions (FAQ):

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