The global tangential flow filtration market is expected to grow at a CAGR of 7.4% between 2018–2030.
Tangential flow filtration (TFF) is a quick and effective purification procedure used in various branches of biology, including biochemistry, protein chemistry, immunology, and microbiology. The tangential flow filtration market incorporates a broad scope of TFF systems, including reusable and single-use systems, membranes, and accessories used in tangential flow filtration processes in the biopharmaceutical industry.
The pollution of bio-therapeutics, water, and other laboratory constituents is discovered in laboratories, biopharmaceuticals, and biotechnology research centers. Subsequently, there is a steadily expanding interest in novel lab filtration methods broadly utilized by different research businesses. The biopharmaceutical and biotech ventures have grown significantly because of expanded production and R&D activities. This element gives the global tangential flow filtration market good chances to develop.
Tremendous progress has been made in recent years, including advances in continuous manufacturing and the versatility of single-use technologies. In any case, there has been a new shift towards continuous processing, which can increase the importance of in-line monitoring and the complexity of bacteria and other unnecessary particles for clearance and inactivation.
Besides, there is an essential requirement for improving new technologies that enable real-time confirmation of bacteria or virus inactivation, freedom to help process improvement, and assessing the impact of process deviations during manufacturing. As a result, filtration clearance studies are being carried out to confirm if the elimination steps are feasible. This is critical for the successful approval of biopharmaceutical research processes.
The increasing number of new biologics, combined with biosimilar competition, is fueling global biologics demand. It necessitates the expansion of existing manufacturing capacities and the adoption of advanced technologies. However, high initial setup costs and biologics manufacturing are the primary factors impeding market growth, particularly in developing and underdeveloped countries.
As biologics are more sensitive than chemical drugs, they require more planning, investment, and experienced personnel to manufacture. To produce high-quality products, manufacturing must be carefully constructed and closely monitored. A large-scale facility, for example, will cost USD 200–500 million and take four to five years to build, whereas a small-scale facility will cost USD 30–100 million and take four to five years.
Furthermore, biologics are temperature sensitive, prone to shearing and degradation, and are not as long-lasting as small molecules. Thus, companies in the biologics industry are outsourcing manufacturing to gain access to external expertise, technology, and capacity that would otherwise be unavailable in-house. This will ultimately raise the cost of finished goods and may stifle market growth.
Biosimilars cost between USD 100 million and USD 200 million to develop and manufacture, while generics cost about USD 1 million to USD 5 million to produce. Well-established companies with manufacturing and commercialization experience have significant advantages over new and emerging companies. The high cost of process technologies and significant initial investment costs make it difficult for new biologic manufacturers to enter the market, further impeding the market growth.
The global tangential flow filtration market is growing due to the expansion of the biopharmaceutical sector, rising pharmaceutical company funding, the increasing adoption of single-use technologies, and the benefits of tangential flow filtration. Tangential filtration techniques are used for various purposes, including downstream processing in bio-manufacturing, separation and purification of biomolecules, and upstream harvesting.
Companies have introduced advanced and novel filtration techniques, such as tangential flow filtration, that the industry requires due to the allocation of resources for R&D activities. According to studies, ultrafiltration applications have increased in the last decade, which has increased demand for the same. Ultrafiltration membranes are currently in high demand in the industry, closely followed by microfiltration membranes.
The interest in tangential flow filtration expanded fundamentally during the COVID-19 pandemic. The COVID-19 pandemic has impacted all the areas and nations worldwide. Starting around 2020, the worldwide extraneous stream filtration market is seeing an abrupt fall sought after for the item. A few end-user applications saw a total or halfway end underway. With the quickly spreading infection, over 100 nations all over the planet were constrained to settle on difficult choices like an entire or partial lockdown.
Also, the nations that had not forced lockdown restricted the development of individuals and merchandise to control the spread of the infection. This has additionally affected the activities of the business. Strict unofficial laws and lockdown in North American, European, and Asian nations, including India, have decreased the generally modern result. This is noteworthy because of the reduced creation limit and the closure of the plants.
The COVID-19 represented a social and financial crisis. Production, store network, and R&D activities were seriously impacted territories of the biotechnology, pharmaceuticals, and quality treatment market because of the COVID-19.
Based on application, the global market is divided into single-use tangential flow filtration systems, reusable tangential flow filtration systems, filtration accessories, and membrane filters. Filter membranes' growth can be attributed to their widespread use in biologics manufacturing and laboratory settings. Furthermore, the use of filter membranes in other industry verticals has led to advancements in membrane technology, increased operational efficiencies, and decreased membrane production costs, resulting in their increased adoption even in small operations.
Filter membranes are microporous plastic films with specific pore sizes that, primarily through surface capture, retain particles or microorganisms larger than their pore sizes. Membrane filtration technology is widely used in a variety of industries. Membrane filtration is commonly used in laboratories to remove particulates and contamination. Tangential flow filtration filter membranes can be used in microfiltration applications such as clarifying cells and cell lysates. They are used in ultrafiltration applications to concentrate diafiltration or recombinant proteins such as monoclonal antibodies.
Based on technology, the global market is divided into ultrafiltration, microfiltration, reverse osmosis, and nanofiltration. Ultrafiltration (UF) is a type of membrane filtration in which pressure or concentration gradients cause separation through a semipermeable membrane. Suspended solids and high molecular weight solutes are retained, while water and low molecular weight solutes pass through the membrane. Ultrafiltration membrane pores can remove particles as small as 0.001–0.1 m from fluids.
This technology is preferred over other filtrations because of the consistent product quality, cost-efficiency, ease of operation, and lack of involvement of other chemicals. Ultrafiltration membranes are used to concentrate and fractionate protein streams and concentrate viruses, desalt, and exchange buffers.
North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa are the market segments. As a technologically advanced country, the United States and US-based firms have implemented tangential flow filtration technology in various procedures and the drug manufacturing process.
The United States leads the world in pharmaceutical R&D spending and is also the largest market for bulk drugs and finished dosage formulations. The US market is a free market economy. According to the Pharmaceutical Research and Manufacturers Association (PhRMA), US companies conduct more than half of the world's pharmaceutical R&D (USD 75 billion) and own the intellectual property rights to the majority of new medicines. Several high-performing and internationally renowned research facilities can be found in Canada. Further, the Canadian government recently invested in top research labs.
The bioprocessing industry in China is maintaining its momentum through ongoing investments in the life sciences and biopharmaceuticals sectors and the expansion of manufacturing capacity. Further, global biologics manufacturers keep a close eye on China because of the market opportunities for establishing manufacturing plants and expanding their businesses. This fuels the country's adoption of various types of filtration systems, such as tangential flow filtration.
With the country's increasing pharmaceutical and biopharmaceutical manufacturing capacities, the Indian market for tangential flow filtration is being driven by a growing number of biologics manufacturers. India is expected to become one of the world's fastest-growing bioregions. Furthermore, a more significant number of regional and global bioprocessing equipment manufacturers are expected.
In recent years, the life sciences industry has been one of the South Korean government's top priorities. The South Korean Ministry of Trade, Industry, and Energy expects this industry, including pharma and biotech, to grow at a rate of 4% by 2022, up from 1.8% in 2021. Long-term development in this sector will be the primary growth strategy over the forecast period.